|Gail Adinamis||GlobalCare Clinical Trials|
Gail Adinamis has 40 years of comprehensive global clinical trials experience is founder and CEO of GlobalCare Clinical Trials, a global patient-centric service organization that conducts study visits at patients’ homes or alternate settings via a global network of mobile healthcare providers to support traditional, virtual or hybrid studies
|Bardia Akbari, PharmD||Science37|
Senior Vice President, Clinical Operations
As SVP of Clinical Operations at Science37, Dr. Akbari oversees Metasite Clinical Operations which includes all functions from pre-contract study planning to complete study execution. He has over 15 years of global pharmaceutical and biotech industry expertise from clinical operations to business development. Most recently, Dr. Akbari served as the Vice President and Global Head of Oncology Clinical Operations at Genentech, overseeing operational planning of over 140 clinical studies across 20 compounds annually. During his tenure, his passion for innovation and focus on data-driven decision making led to successful execution of clinical development programs that launched eight important products in several indications. Dr. Akbari is credited with institution of predictive modeling and data visualization as core clinical operation disciplines. During his career Dr. Akbari has held a variety of positions in Medical Affairs, Clinical Science, Clinical Operations, Alliance Management, and Business Development. He earned his BS in Pharmacy from University of Colorado and a Doctorate of Pharmacy (PharmD) from State University of New York in Buffalo.
|Demissie Alemayehu, PhD||Pfizer|
Vice President, Biostatistics, and Head of Statistical Research and Data Science
Demissie Alemayehu, PhD, is currently Vice President and Head of Statistical Research and Data Science Center (SRDC) in the Global Biometrics and Data Management organization at Pfizer Inc. He has over 25 years of leadership experience in the pharmaceutical industry and has held positions of increasing responsibility within Pfizer since 1995. Over the years, he has been involved in extensive regulatory submissions and life-cycle management in major therapeutic areas. Demissie has been influential externally, with decades of research and teaching experience at major institutions, including Western Michigan and Columbia universities. He has held important offices at key professional societies and has served on editorial boards of major journals. He is an elected Fellow of the American Statistical Association and holds a PhD degree in Statistics from the University of California at Berkeley. He has published extensively on pertinent statistical topics in refereed journals, and his current areas of focus include precision medicine, Big Data analytics, and health technology assessment.
|Srinivasan Anandakumar||Saama Technologies|
Senior Director, Clinical Analytics
Srini Anandakumar leads clinical analytics innovation at Saama and is responsible for leading the solution development for next-generation clinical repositories based on Big Data and AI. He has more than a decade of experience of building clinical analytics solution for enabling both analytics and submission pathways. His experience includes product management and consulting in the clinical R&D space. His current passion is exploring the possibility of AI applications to bring in efficiencies in clinical development.
|Julia Andrews, MPH||UBC|
Strategic Feasibility Manager, Program Delivery
Julia Andrews has worked in the pharmaceutical industry for over five years gaining diverse experience in biomedical research at an academic medical center, a CRO and a pharmaceutical company. She is currently a strategic feasibility manager at UCB, a global biopharmaceutical company where she leads feasibility activities for clinical trials, planning enrollment scenarios and selection of countries and sites. As part of study startup, Julia has worked hard to support CRO partnerships for successful program delivery. She is from Raleigh/Durham and enjoys being a new mom.
|Jonathan Andrus||Clinical Ink|
Chief Buisiness Officer
As Chief Business Officer, Jonathan leads Clinical Ink’s solution management and compliance teams to help organizations better leverage eSource, eCOA and ePRO data. With more than twenty years of experience, Mr. Andrus brings expertise developing eClinical services that integrate data and technology to help companies optimize study execution. At Clinical Ink, Mr. Andrus focuses on P&L across Clinical Ink’s products and services, and he is also focused on building relationships and forging strategic partnerships.
Head, Quality and Operations for Process and Procedures, Quality and Operations
Odette Anyangwe is the Head of Quality and Operations for Process and Procedures at Roche. senior Leader, within the Pharma industry, with extensive experience in shaping strong business performance and strategies, defining and delivering Quality, Compliance and Training objectives with particular focus on a performance driven culture. I have over 15 years of experience in Phase I - III trials in the Pharmaceutical and Public Health sectors, with broad international experience in Medical, Scientific Research and Operations. She works with multidisciplinary teams on major projects across the public and private sectors involving quality practices and an all-encompassing approach to quality risk management. She also has experience in performing audits and supporting regulatory inspections. She is a member of TransCelerate's Quality Management System workstream.
Founder & CEO
Débora S. Araujo has over a decade of experience in the pharmaceutical industry working and consulting for Fortune 500 companies. During her time in this industry her special focus has been on the business aspects of clinical trials including: clinical contracting and financial management, clinical outsourcing and CRO/vendor management, global clinical trial budgeting and forecasting, clinical financial analytics and metrics/KPIs, site budget development and negotiations, Fair Market Value (FMV) and global investigator site payments. She has also utilized her expertise and knowledge to drive practical change in this industry via thought leadership material, conference presentations and consulting engagements. Débora’s passion for driving practical change in the industry led her to launch ClinBiz (www.clinbiz.com), an online platform with a dedicated YouTube channel, podcast, blog and much more where clinical research professionals can stay connected and updated on the latest topics, trends and technologies related to the business aspects of clinical trials. Débora has also recently published a book on clinical trial agreement negotiations named ‘The Four Villains of Clinical Trial Agreement Delays and How To Defeat Them’ which quickly became an Amazon’s #1 New Release in the pharmaceutical and biotechnology category.
Founder & CEO
Drawing on his engineering background, and inspired by his work in clinical research, Rick Arlow built the first version of the Complion software platform. In close collaboration with leading medical centers, Complion’s industry-leading workflow and document management software was born. Since then, he has built a world-class team experienced in clinical research. He is a frequent lecturer for several professional research organizations including ACRP, MAGI and SCRS. Previously, Rick was involved with a biotech business resulting in several patents and was recognized in Business Week’s “Top 25 Under 25 Entrepreneurs”.
Central Monitoring Manager, Risk Management - Central Monitoring
Ritsuko Ashby is a Central Monitoring Manager in Janssen R&D’s Risk Management – Central Monitoring Group. She has implemented ARBM for Pharma and Medical Device trials. Prior to joining Janssen R&D, Ritsuko had over 10 years of experience in Data Management in Johnson & Johnson Medical Device sector and several years at a local government office in Japan.
Associate Director, Vendor Management
I have almost 20 years of experience in the Biopharmaceutical and Medical Device industries in various disciplines such as project management, software development and validation and auditing with the most recent and current experience in global strategic vendor management to drive sustainable value of outsourcing relationships. I hold an MBA and BA from the Lake Forest Graduate School of Management and The University of Texas at Austin, respectively.
|Justin Bandura, JD||Boehringer Ingelheim|
Contract Manager, Clinical Operations
Justin Bandura is a Clinical Trial Contract Manager at Boehringer Ingelheim and an attorney admitted in Connecticut. Prior to his career in pharma, he was in sales for over a decade in the areas of medical device and industrial outsourcing. Heavily influenced by his time in medical device sales, Justin brings a collaborative approach to clinical contract negotiations focused on long term sponsor-site relationships.
Global Head, BioAsset Management
Dr. Mohan Bangalore has about 20 years of industry experience in both drug discovery and clinical development. He started his career as a bench scientist in Biomarker group at GlaxoSmithKline (GSK) and then moved on to various roles of increasing responsibilities including Clinical Pharmacology, Outsourcing & Vendor Management, Clinical Operations, Alliances & Program Management, and Continuous Improvement in both Pharmaceutical (GSK, Wyeth/Pfizer, BMS) and CRO (PAREXEL) industries. Currently, Dr. Bangalore is the Global Head of Biological Asset Management group in Discovery Supply department at GSK. Prior to this, Mohan led country (India) level clinical R&D operations for PAREXEL. Mohan holds a PhD in Molecular Biology and an MBA degree.
|Charissa Barger, MS||University of Southern California|
Recruitment Specialist, Alzheimer's Therapeutic Research Institute
Charissa Barger is a Recruitment Specialist for the University of Southern California’s Alzheimer’s Therapeutic Research Institute (USC ATRI). She leads patient recruitment and retention activities for the Alzheimer’s Disease Neuroimaging Initiative 3 (ADNI3) and Memory Improvement through Nicotine Dosing (MIND) studies. Charissa is a member of the Alzheimer’s Clinical Trial Consortium (ACTC) Recruitment Unit and serves as the Communications Liaison for the Diversity and Inclusion Committee. She is an alumnus of USC (MA ‘13), the Colburn Conservatory of Music (AD ‘11) and the University of Michigan (BM ‘08).
|Dorothee Bartels||Boehringer Ingelheim|
Professor, Chief Digital Science Officer, BI X GmbH
Dorothee B. Bartels used to be Corporate Head of Global Epidemiology at Boehringer Ingelheim (BI) for 10 years and for nearly two years Chief Digital Science Officer in the digital incubator of BI. In 2019 she worked with Google on different healthcare projects. She holds a Professorship of Epidemiology and Public Health at Hannover Medical School and is Adjunct Professor at McGill University, where she lectures in the course of Advanced Pharmacoepidemiology. Her research is focused on secondary data use and data linkages, on innovative real-world data analysis approaches, new strategies for faster drug developments and approvals, and digital epidemiology, in particular combining AI/ML and traditional epidemiological methods.
Distinguished Scientist & Scientific Associate Vice President
Dr. Bateman is currently Scientific Associate Vice President and the Scientific Lead for Bioanalysis in the Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism at Merck & Co. where he has worked for over 20 years. He is the co-founder of the Merck Smart Trials initiative aimed at enabling a more patient-centric clinical trial approach. A major focus of his research is on developing and implementing patient-centric sample collection technologies to enable remote studies.
|Elodie Baumfeld Andre, PhD||Pfizer|
Senior Director, Epidemiology Strategy & Policy Lead, Worldwide Safety and Regulatory
Elodie Baumfeld Andre is the Epidemiology Strategy Lead within the Worldwide Medical & Safety group at Pfizer. In this role, Elodie’s focus is on generating Real World Evidence to support regulatory decision-making and driving continued innovation by implementing novel clinical designs and developing operating models. She is also responsible for helping to set the strategic vision for the role of epidemiology within Pfizer and serves as an ambassador to the broader scientific and regulatory community to showcase the group’s research and innovation. Prior to this role, Elodie was the Chief of Staff to the Worldwide Research & Development (WRD) President. As Chief of Staff, Elodie was responsible for managing C-Suite level operations, closely supporting the WRD Leadership Team, handling specific cross-WRD compliance requirements, and ensuring WRD activities were aligned with the overall WRD Strategy and Portfolio. She was also responsible for forming and leading the Executive & Compliance Operations team that provides operational support to the President’s Office and ensures compliance and execution of key corporate and division-specific SOPs and policies. Previously, she was Director of Business Operations for Global Health & Value (GH&V) directing all operational aspects of the team’s initiatives and priorities, including the operating plan process, budget accountability, compliance, governance and reporting. In this capacity, she worked closely with the GH&V leadership team on strategic planning, colleague engagement and communication, and measurement/assessment of critical initiatives. In 2011, she served as an Associate Medical Director responsible for several established products in the cardiovascular, neuroscience & pain and inflammation portfolios. Her early career experience in Health Economics & Outcomes Research enabled her to help strategically support and position various medicines in the U.S. and Canadian markets. Elodie has a bachelor’s degree in physics from Université Toulon-Var in France, a Master’s in Pharmacology and PhD in PharmacoEpidemiology and Biostatistics from Université de Montréal in Canada.
|Michael Benecky, PhD||GlaxoSmithKline|
Senior Director, Global Regulatory Affairs, Precision and Digital Medicine, R&D Chief Regulatory Office
Mike received his BA in Biochemistry from the University of Wisconsin-Milwaukee and PhD in Biophysical Chemistry from Princeton University. Mike continued his academic research career as a Post-Doctoral Fellow at Northwestern University and as an Assistant Professor at the University of Wisconsin Medical School-Milwaukee Clinical Campus. Mike gained expertise in the preparation of FDA IDE and PMA medical device submissions for lasers used for vision correction surgery at Bio-Reg Associates. At QIAGEN (formerly Digene), Mike led the Regulatory /Clinical Affairs Group that prepared numerous FDA PMA submissions for the first FDA approved HPV DNA test for cervical cancer screening. Mike Benecky joined GSK in October 2011 as Senior Director, Global Regulatory Affairs in Precision and Digital Medicine located in Research Triangle Park, North Carolina. Mike currently assists GSK Teams in regulatory strategy during use of digital health technology in both clinical trial and commercial settings. Recent projects include the commercial launch of the MyAsthma mobile medical app in the EU and inclusion of digital sensors and mobile apps within GSK clinical development programs.
|Jasmine Benger||Center for Information and Study on Clinical Research Participation (CISRP)|
Senior Project Manager, Research Services
Jasmine Benger is the Research Services Senior Project Manager at CISCRP. She is responsible for supporting the design, implementation, analysis and reporting of a variety of CISCRP research studies including the Perceptions & Insights studies and numerous Patient Advisory Boards and workshops. Prior to CISCRP, she has over 5 years of experience working in the public health field specifically with maternal and child populations in a variety of different capacities. She holds a Bachelor of Science in Nutrition from Framingham State University.
Senior GCP Strategy Lead, Site Innovation Group Lead
Ruma Bhagat MPH, MBBS is a Senior GCP Strategy Lead, Site Innovation Group Lead at Genentech. She has over 15 years of experience in clinical research, specializing in GCP, project management and design thinking. She is also a subteam lead on TransCelerate BioPharma's Interpretation of Guidances and Regulations workstream.
|Karina Bienfait, PhD||Merck|
Principal Scientist & Head, Global Genomics Policy, Process & Compliance
Karina Bienfait, PhD is a Principal Scientist in Translational Medicine at Merck Research Laboratories, and the head of Global Genomics Policy, Process and Compliance (GPPC). As head of GPPC, Dr. Bienfait works closely with Merck’s global subsidiaries to evaluate global laws and regulations pertaining to genomics and biobanking; and to develop strategies to address countries recalcitrant to genomic research. In this capacity, she works closely with global health authorities and ethical boards to negotiate approvals for genomic research in the context of Merck’s clinical trials. Dr. Bienfait also oversees the development of Merck policies, processes, and consent related to genomic research, and is responsible for ensuring compliant use of biospecimens. Dr. Bienfait completed an internship in Clinical Psychology at Nassau University Medical Center and a postdoctoral fellowship in Clinical Psychopharmacology in the Department of Psychiatry at Rutgers’ Robert Wood Johnson Medical School. She holds a PhD in Clinical Psychology from St. John's University and a BA in Psychology and French from New York University.
|Jennifer Bolton||Boston Scientific Corporation|
Senior Fellow, Regulatory Affairs
Jennifer Bolton is a Senior Fellow, Regulatory Affairs, at Boston Scientific Corporation. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world, specifically with less-invasive technologies engineered to diagnose and treat a wide range of medical conditions. Jennifer has 24 years of Regulatory experience. She’s led key market and clinical approvals for many cardiovascular and peripheral products including the ACURATE neo2 Aortic Valve System and the WATCHMAN Left Atrial Appendage Closure Device. She’s currently working with transcatheter aortic and mitral repair/replacement technologies, facilitates a Regulatory Strategy Board, and volunteers with a local Medtech Accelerator for early-stage startups. Jennifer previously supported global strategies for some of Boston Scientific’s left atrial appendage closure devices, drug-eluting stents, abdominal and thoracic aortic stent grafts, peripheral balloons and guidewires, and vascular surgery grafts/fabrics. Prior to Boston Scientific, Jennifer worked with orthopedic implants at US Medical Products (now Consensus Orthopedics).
|Wes Bonner||Meridien Research|
Vice President, Strategic Development
I am the VP, Strategic Development for Meridian Clinical Research. My role is a combination of Business Development, PI liaison, and new PI/site expansion. I am responsible for cultivating relationships with all (48) physicians across North America to enhance Meridian's site network and operations. Before joining MCR, I accrued 17 years of experience working with 4 major pharmaceutical companies including BMS, Pfizer (Pharmacy & Upjohn), Sanofi (11 years) and Otsuka.
|Jeffrey Botkin, MD||University of Utah|
Professor, Pediatrics and Medical Ethics
Jeffrey Botkin is a Professor of Pediatrics and an Adjunct Professor of Human Genetics and Internal Medicine at the University of Utah. He is the past Chief of the Division of Medical Ethics and Humanities and served as the Associate Vice President for Research Integrity from 2002 to 2019. Dr. Botkin is the Principal Investigator for the NIH funded University of Utah Center of Excellence for Ethical, Legal and Social implications of human genetics. He is a member of the National Advisory Council for the National Human Genome Research Institute and a member of the NIH Council of Councils. He is the recent Chair of the DHHS Secretary’s Advisory Committee on Human Research Protections and a former member of the Secretary’s Advisory Committee on Heritable Diseases in Newborns. Dr. Botkin chaired the consensus committee for the National Academies of Science, Engineering and Medicine’s for its 2018 report on the Return of Individual Research Results.
|Chuck Bradley||FibroGen, Inc.|
Vice President, Clinical Development
Charles Bradley is VP Clinical Development and Head of Clinical Operations at FibroGen Inc. located in San Francisco, CA. Dr. Bradley is an experienced clinical research professional with an in-depth background in all phases of drug development. He is a seasoned senior manager with knowledge of resource allocation, portfolio management, budgetary processes, outsourcing strategies, and regulatory requirements associated with drug development. He has expertise in driving clinical programs forward in entrepreneurial environments, smaller biotech companies, and large traditional pharmaceutical companies. Chuck received his Ph.D. in bioanalytical chemistry from the University of Delaware, received post-doctoral training in Clinical Pharmacology at Uniformed Services University, and is Board Certified in Applied Pharmacology.
|David Burrow, PharmD, JD||FDA|
Director, Office of Scientific Investigations, Office of Compliance, CDER, FDA
David Burrow currently serves as the acting Director of the Office of Scientific Investigations (OSI), within the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC). In this role, he is responsible for the strategic administration of CDER’s pre-, and post-market Bioresearch Monitoring (BIMO) programs – including all administrative, advisory, and enforcement actions taken by the office.
|Bill Byrom||Signant Health|
Vice President, Strategy and Innovation
Bill Byrom has worked in the Pharmaceutical Industry for 28 years. Combining practical experience of roles within clinical development with a keen interest in leveraging technology, Bill is a key strategic thinker helping to shape the direction and application of eClinical solutions. Bill is a thought leader in patient-facing technologies including electronic patient-reported outcome solutions, the use of wearables and connected devices, and new novel technology-derived endpoints.<
|Walt Cao, PhD||Zeta Therapeutics, Inc.|
Dr. Walt Cao has 17+ years combined experience in academia, pharmaceutical industry (Boehringer-Ingelheim and Abbvie), and U.S. Food and Drug Administration (FDA) for Hematology/Oncology products clinical translation and clinical development and marketing application. Dr. Cao was the Primary Clinical Pharmacology Reviewer for OPDIVO ((nivolumab) 2014) approval in the first indication of melanoma in FDA and had been the primary or secondary reviewer for other over 10 NME NDA/BLA applications, and other over 500 IND phase 1-phase 3 clinical trial protocols and meeting packages. Dr. Cao has extensive experiences for both new chemical entities (NCE) and new biological entities (NBE) drug development and marketing application.
Associate Director, Clinical Budget Management
No bio available
|Cindy Casaceli||University of Rochester Medical Center|
Director, Clinical Trials Coordination Center
Ms. Casaceli has over 20 years of experience in the conduct of multi-center clinical trials and has overseen the operation of the Clinical Trials Coordination Center (CTCC), which is an academic based research organization (ARO). Her background is in Biochemistry and Computer Science. She has an MBA in Computer and Information systems and training in team leadership. Over the last 10 years in her position as the Director of the Clinical Trials Coordination Center she provides oversight and guidance on multiple studies incorporating digital tools.
Section Manager, Clinical Planning & Resource Management
Jamie earned her Bachelors of Science in Allied Medical Professions degree (Health Information Management and Systems) from The Ohio State University. She has been working for Abbott Nutrition for over 16 years where she has held positions of increasing clinical, operational, budgetary, and leadership responsibilities. In her current role, Jamie manages the Clinical Planning and Resource Management department. This group is mainly responsible for project management activities, ranging from creating project plans (cost, timing, resources) for potential clinical studies to negotiating study budgets and contracts for approved clinical studies. The group acts as a clinical research liaison for many departments, including Project Management, Clinical Operations, Legal, Procurement, Nutrition Science, and Finance.
|Emily Castellanos, MD||Flatiron Health|
Associate Medical Director
Emily Castellanos is a board-certified medical oncologist and hematologist who serves as associate medical director at Flatiron Health, where she performs outcomes research focusing on the generation of real-world evidence. She has published in thoracic oncology as well as health services on topics including patient treatment preferences, financial hardship and changes in insurance coverage for cancer patients following the Affordable Care Act. Emily earned her BS with distinction in biological sciences from Stanford University. She then received her medical degree from Vanderbilt University Medical Center, where she remained for her clinical training. She completed her residency in internal medicine, and after serving as chief resident she remained at Vanderbilt for her hematology/oncology fellowship. Prior to coming to Flatiron, she served on the faculty in the division of hematology/oncology at Vanderbilt University Medical Center and earned her MPH with a focus on health policy.
Risk Based Monitoring Program Lead, Clinical Sciences and Operations, Global Product Development
No bio available
Executive Director, R&D Finance
Chris Chan is Senior Director of R&D Finance at FibroGen, Inc, and has over 25 years industry experience, including 20 managing clinical trial & R&D finances for biopharmaceutical companies of various sizes. He holds an MBA from UC Berkeley’s Haas School of Business and is a Certified Management Accountant (CMA) & Certified Financial Manager (CFM). Chris is participating in his 6th SCOPE conference as a speaker.
Senior Director, DevOps
No bio available
|Stephanie Clark||Janssen R&D (J&J)|
Director, Risk Management-Central Monitoring
Stephanie Clark is a Director in Janssen R&D’s Risk Management-Central Monitoring Group, which is dedicated to the implementation of Analytical Risk-Based Monitoring on clinical trials. In this role, Stephanie has contributed to the creation and management of processes, technology, and resources to support an analytical and risk-based model of clinical trial management and monitoring that has now supported more than 170 clinical studies across multiple sectors at Johnson & Johnson (including Pharma, Medical Devices, and Consumer products). She has also participated as a member of the TransCelerate BioPharma Risk-Based Monitoring Initiative. Stephanie has over 15 years of experience in clinical research and drug development. Prior to her ARBM-focused work, she worked in clinical trial and site management at Janssen R&D and Centocor R&D, at RPS, Inc and at ICON in a variety of therapeutic areas and also in basic immunological research at Children’s Hospital of Philadelphia.
President & CEO
Ivor Clarke, CEO of SubjectWell, has 15+ years of C-suite experience in online marketing and SaaS solutions. SubjectWell, the first risk-free clinical trial marketplace for patient recruitment, raises awareness to engage patients who have not participated in clinical trials. Previously, Clarke co-founded Brightfire and Hoot Call. He has degrees in human computer interaction and information and decision systems from Carnegie Mellon University.
Product Lead, Shared Investigator Platform Life Sciences Products & Platforms
Larissa drives adoption of the Shared Investigator Platform across the clinical ecosystem. With extensive experience in clinical trial informatics and technology, especially in oncology, Larissa led strategy and products for Medidata, Thompson Reuters, and Eviti (now NantHealth). She helped transform the Coalition of Cancer Cooperative Groups into a national leader in cancer-trial matching services and patient advocacy during her nine-year tenure. Larissa earned her Masters in Journalism from Temple University.
|Anca Copaescu||Clinical Maestro by Strategikon Pharma|
CEO and Founder
Anca has over 15 years of experience in the industry, working both on the CRO and the Sponsor side. She is currently the Founder and CEO of Strategikon Pharma, developer of Clinical MaestroTM, the industry’s only end-to-end cloud-based platform for clinical trial budgeting, sourcing and budget management including strategic alliance/partnership management. Prior roles included Head of Clinical Outsourcing and Analytics at BioMarin, Strategy/M&A at both PharmaNet (Syneos) and ICON.
|Erin Creedon||Ethicon (J&J)|
Associate Director, Clinical Operations
Erin Creedon is an RN with over 20 years of experience in clinical research, both in the pharmaceutical and medical device sectors. Prior to her career in research, Erin worked as a medical-surgical RN before transitioning to her role as a research nurse. She then worked with a mid-sized CRO as a lead site manager and training and development associate for over 8 years. She has been with Ethicon’s clinical operations group for over 11 years where she currently is Ethicon’s global clinical operations leader. In this role, Erin and her team are responsible for the oversight and management of all Ethicon’s sponsored clinical trials. Erin led the pilot initiatives to introduce targeted source data verification and adaptive onsite/offsite monitoring into clinical trials at Ethicon. Over the last few years she has partnered with colleagues in the J&J pharmaceutical sector to leverage their ARBM efforts for the harmonization of tools and processes so that ARBM could formally be utilized in the medical device space.
|Cathy Critchlow, PhD||Amgen|
Vice President, Center for Observational Research
As Head of the Center for Observational Research (CfOR), Dr. Critchlow provides operational and strategic leadership for the design and conduct of observational research within Amgen. The CfOR Real World Data (RWD) Platform provides widespread access to patient health data and visualization and analytic tools based on innovative technologies to aid teams in the generation of real-world evidence in support of drug development and commercialization of Amgen products. Dr. Critchlow joined Amgen in 2004 where she led a number of Therapeutic Areas within Global Epidemiology prior to being named Head of CfOR in 2012. Prior to joining Amgen, Dr. Critchlow was a faculty member in Epidemiology at the University of Washington. Dr. Critchlow was a member of the Endocrinologic and Metabolic Advisory Committee of the Food and Drug Administration and has served on a number of research review committees for the National Institutes of Health. Dr. Critchlow earned her Bachelor’s Degree from Stanford University, and both her Master’s Degree in biomathematics and her doctorate degree in epidemiology from the University of Washington. Dr. Critchlow is an Affiliate Professor of Epidemiology at the University of Washington and a Fellow of the American College of Epidemiology.
Digital Platform Leader
Michelle Crouthamel is the digital platform leader of the Clinical Innovation Unit at GlaxoSmithKline (GSK). Michelle’s passion for driving patient-centricity in the pharmaceutical industry led her to become an ‘Intrapreneur’ at GSK, and the founding member of the Clinical Innovation Unit, which focuses on harnessing digital technologies and platforms to improve patient engagement and clinical trials. Michelle is currently leading the strategy and pilot programs of e-Recruitment and m-Health platforms, and is involved in the industry-wide consortium, TransCelerate, eSource work stream. Over past 15 years, Michelle led many successful programs in discovery and development at both Merck and GSK, is an inventor who holds multiple patents, and has published extensively in the areas of Neuroscience, Oncology, and Digital Health. Michelle has a Master’s Degree from the Institute of Neuroscience, and a Bachelor’s degree in Nursing from the National Yang-Ming University, Taiwan. She is currently pursuing a doctoral degree at Fox Business School, Temple University with a research focus on the Patient-Centricity in the pharmaceutical industry.
|Chris Crucitti||Signant Health|
Chief Commercial Officer
Christopher L. Crucitti, MS, leads the commercial functions of Signant Health, as well as the go-to-market strategy, to drive the continued growth of our already market-leading clinical technology solutions. Chris brings significant experience and expertise in the clinical and R&D domains. He has led organizations to significant revenue and profitability growth, while maintaining a high level of customer service and quality delivery. Chris holds an MS from American University and a BS from Ithaca College.
|Laura Davis||Janssen Pharmaceuticals, Inc.|
Business Technology Leader, Biotherapeutic Development, Information Technology
As the Business Technology Leader for Biotherapeutic Development at Janssen, Laura is responsible for the technology strategy that supports the development of safe, quality, biotherapeutic products that comply with Good Manufacturing Practices and International Regulatory Guidelines. In her 12 years of service at J&J, she has spanned roles in R&D, Quality, and IT across the Pharmaceutical and Medical Device industries with major focuses on laboratory integration, Chain of Custody, and Product Complaint/Regulatory Reporting. She is married with a 3-year-old son and lives in the Philadelphia suburb of Pennsylvania. She graduated from University of Pittsburgh with a BA in chemistry.
Director, Development Design Center
No bio available
|Eric Delente||IQVIA Technologies|
Head, Patient Consent
Eric Delente, known as a pioneer of eConsent, heads the patient consent group for DrugDev, An IQVIA Company. An entrepreneur at heart, Eric has over 20-years experience leading technical and creative teams in the design and development and of numerous award-winning applications for the medical, academic and research communities. Co-founder of SecureConsent (acquired by DrugDev), he designed and developed pharma’s definitive eConsent solution, used on over 100 trials worldwide.
|Robert DiCicco, PharmD||IBM Watson Health|
Deputy Chief Health Officer
Rob DiCicco is currently the Deputy Chief Health Officer at IBM Watson Health. Rob previously served as Vice President of the Clinical Innovation and Digital Platforms Group at GlaxoSmithKline. He was also the Work Stream Leader for the Common Protocol Template Project sponsored by TransCelerate BioPharma and one of the Team Leaders for CTTI's Novel Endpoints Work Stream as part of the mHealth in Clinical Trials Initiative. Rob has more than 25 years of experience in clinical development in a variety of leadership positions in CRO, mid-sized and large pharmaceutical companies. He received his Doctorate of Pharmacy degree at the University of the Sciences of Philadelphia. Over the course of his career he has had a key role in the development of a number of successful new medicines. Rob’s area of expertise includes clinical pharmacology and experimental medicine, innovative clinical trial design, project management and ethics in human research.
|Sina Djali||Johnson & Johnson|
Head, Clinical and Operations Analytics
Sina Djali has over 25 years of experience in drug and clinical development in various companies and academia. Currently he is the Senior Director Head of Integrated Clinical and Operations Analytics in Global Clinical and Development Organization in Jansen Pharmaceuticals. In this role Sina is responsible for incorporating Risk Management Principals in the day to day R&D clinical operations and coordinating data warehousing and analytics solutions in support of clinical trial conduct. Prior to this role, Sina has served in several functions in Analytical Risk Based Monitoring, Quality, Regulatory Affairs and Neuroscience Research at Janssen R&D, Wyeth Pharmaceuticals and Sanofi Aventis Pharmaceuticals.
No bio available
|Keith Dorricottwzbczfcwvarxvs||metrics champion consortium|
Keith Dorricott is an Ambassador for the Metrics Champion Consortium and the Director of Dorricott Metrics & Process Improvement Ltd. He worked in R&D, process development, packaging technology and manufacturing whilst at Kodak Ltd. In 2005 he moved industry into the area of clinical trials and worked for two major CROs leading corporate process improvement. He qualified as a Black Belt in Six Sigma in 2002 and a Master Black Belt in Lean Sigma in 2007. He assists the Metrics Champion Consortium (MCC) by facilitating work groups on centralized monitoring, central lab metrics, vendor oversight, Imaging, and by developing tools to assist with risk assessment and control. He received the MCC Champion Award in 2016 for making significant contributions to advancing the MCC mission to improve the efficiency, quality and effectiveness of clinical trials. Keith regularly presents at conferences on the definition and use of metrics as well as the practicalities of quality risk management and risk-based monitoring.
|Eleanore Doyle||Syneos Health|
Executive Vice President, FSP Strategic Solutions
Eleanore Doyle, Executive Vice President, FSP Strategic Solutions Syneos Health, has a keen appreciation for identifying and optimizing customer objectives. She is responsible for building and maintaining long-term relationships with sponsors, ensuring exceptional customer service, and increasing market reputation for Syneos Health FSP solutions.
|Steven Draikiwicz, MD||Sanofi|
Global Medical Bioinformatics Lead
Steven Draikiwicz is the Global Medical Bioinformatics Lead at Sanofi. He is responsible for the global deployment of real-world data, artificial intelligence and digitalization in Clinical Sciences Operations. His background includes a Medical Degree from Drexel College of Medicine, with board certification in Internal Medicine and sub-specialization in Allergy and Immunology. Prior to his current role at Sanofi, he has been a key contributor to the Dupixent and anti-IL-33 programs including the Dupixent submissions for asthma and nasal polyposis.
Global Operations, R&D, Lead, Managing Director, Global Operations
Jennifer Duff is a Managing Director in the Accenture Life Sciences North America Operations practice. She has over 20 years of experience in the life sciences industry and over 15 years of experience in business process outsourcing. Jennifer leads Accenture’s Life Sciences Operations business, is responsible for shaping the innovation agenda at our most strategic clients and works extensively in the delivery of Clinical Data Management Services.
IT Lead, Core Clinical Solutions & Services
Pam Duffy, BS, MS, is the IT lead for Clinical Development Operations and Clinical Pharmacology at Pfizer. She has worked in Clinical IT for the last decade with previous experience in IT supporting both molecular and animal models. Pam holds a BS from the University of Connecticut in Marketing and Business Management and an MS from Columbia University NYC in Technology Leadership
Principal Scientist, Advanced Analytics Center
Dr. Bhaskar Dutta is an analytics expert with specific interest in digital health. He completed his undergraduate education at the Indian Institute of Technology (IIT) and perused graduate studies at the University of Maryland. Throughout his career, he has led projects on analysis, interpretation, and visualization of multi-dimensional data from genomics, proteomics, metabolomics, clinical trials, and streaming data from wearable sensor. Currently, he is actively involved in end-to-end design, development, and deployment of a digital health study at AstraZeneca.
Feasibility and Recruitment Partner, Director
Marie Eckerd has held leadership positions in clinical data management, project management and global project management throughout a 30- year career in the pharmaceutical industry. Her work today focuses on feasibility and recruitment data analyses for lung cancer studies, serving as chair for the AstraZeneca sponsored oncology clinical study platform, and serves as a member of the EHR strategy workstream, among other special projects. Marie recently completed certification in data analytics to improve drive data-driven decisions in a rapidly evolving clinical development environment.
Associate Director, Portfolio Relationship Management, R&D Procurement
Krista Emmons is an Associate Director of Portfolio Relationship Management in the R&D Procurement function at Astellas Pharma Global Development in Northbrook, IL where she is responsible for strategic business relationships for a portfolio of service providers. She has more than 15 years of experience supporting clinical research activities with key areas of focus in governance implementation, strategic sourcing initiatives, and clinical technology solutions such as IRT and eCOA. Prior to joining Astellas in 2017, she was a Director of Portfolio Leadership at Parexel Informatics.
|Mike Eveland||PRA Health Sciences|
Executive Director, Business Development
No bio available
|Todd Everhart||Signant Health|
Clinical Vice President, Internal Medicine
An Innovator, educator, and leader in the pharmaceutical and biotechnology industries with over 23 years of experience in the practice of medicine and over 12 years of experience in clinical research. Board-certified in Internal Medicine and a Fellow of the American College of Physicians, he has worked in all phases of clinical development in numerous therapeutic areas and is an expert in medical monitoring, medical data review, data visualization, data analytics, and technology adoption.
Senior Director, Head of Global Feasibility
Michelle Everill, Global Head of Feasibility at Janssen, is developing a global feasibility center of excellence with a significant focus on data analytics and strategic application. She has been working to improve feasibility and site selection in both pharma and CROs since 2010. Before then, her career started working as a study coordinator and patient recruitment specialist at a site and then in Clinical Operations at CROs. Michelle’s passion is developing people and teams to discover new ways of brining more impactful products to market more efficiently, increasing quality of life and finding cures for patients across the world.
|Jane Fang, MD, MS||AstraZeneca|
Director, Leader of Digital Clinical Innovations, RWD/RWE for Clinical Trials
Jane started career as physician scientist with training in healthcare management and informatics. She has 25 years of broad experiences across from medical practice, clinical, immunology research to clinical innovation strategy and advanced analytics in healthcare and biopharmaceutical industries. Jane has provided various leadership roles in building clinical innovations, RWE/RWD practice for clinical trials and digital capabilities to enable better clinical research and trial delivery.
|Jeremy Faulks, PharmD||Thrifty White Pharmacy|
Director, Specialty Pharmacy and Pharmacy Procurement, Pharmacy Operations
Jeremy leads the specialty pharmacy division for Thrifty White Pharmacy. In his current role, he is focused on building and enhancing Thrifty White’s specialty pharmacy offerings. Thrifty White’s pharmacy model is built around driving quality and patient outcomes through the patient-pharmacist relationship, and by creating strong local partnerships across the communities they serve. Prior to joining Thrifty White, Jeremy was senior manager of specialty pharmacy at Target, where he managed all aspects of Target’s specialty pharmacy program, including operations, strategic planning, and team development. Over the past 8 years he has championed specialty at retail programs and the power of the in-person, patient-pharmacist relationship. Jeremy obtained his Doctor of Pharmacy from the University of Wisconsin, where he graduated with a focus on business management.
|Christina Fawcett||PRA Health Sciences|
Senior Director, Operations
Christina is responsible for providing oversight and support for post-marketing and real-world evidence studies. Her role includes developing and overseeing operational strategy and risk mitigation/management, as well as financial and quality oversight. She has experience with a wide variety of study designs, including interventional studies and long-term disease monitoring studies, disease and product registries, and retrospective data collection.
Practice Leader, Applied Analytics & Artificial Intelligence
Gabriela has spent 20 years in various roles across both pharma and CROs with much of her recent focus spent on building and leading highly effective global feasibility, site selection and patient engagement organizations. Gabriela’s current role as Practice Leader within the Data Science and Artificial Intelligence organization has continued to refine this mission with an additional emphasis on extracting maximum value for our patients by leveraging data science to provide valuable insights to better select investigators for clinical studies. Previously she has led global Feasibility, Site Selection and Patient Engagement groups at Covance and UCB. Prior to UCB, Gabi spent over ten years at Quintiles where she held positions of increasing responsibility. Gabi also held positions at Kimberly-Clark and Cordis earlier in her career. Gabi received her B.S. Degree in Chemistry from the University of Florida.
|Rosalie Filling||Endo Pharmaceuticals|
Vice President, Clinical Operations, Research and Development
Rosie earned her B.S. in Biology, Minor in Chemistry from the University of Pittsburgh. She has 19 years of clinical trial experience. Rosie began her career at PPD as a Research Assistant and moved into her first management position at PPD. She was responsible for the rapid site start-up and ongoing management of enrollment and site regulatory requirements across all therapeutic areas. After 5 years, she left PPD and began her pharmaceutical Sponsor career at Guilford Pharmaceuticals in Baltimore, MD. At Guilford, Rosie was responsible for the overall strategy for execution of clinical trials including the outsourcing needs and overall budget management for all of Research & Development. Guilford was acquired by MGI Pharma. Post the acquisition, Rosie was chosen to lead the new Clinical Operations team to establish a new set of processes and strategy for the new organization. MGI’s focus was on acute care and oncology. The new organization was very successful and was later acquired by Eisai. During Rosie’s tenure at Eisai, she moved into post-marketing and was responsible for executing Oncology and CNS post-marketing trials. Rosie then joined Teva in 2009, where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Rosie joined Lupin in August 2014 to stand up the Clinical Operations Division. She recently joined Endo Pharmaceuticals in February 2018 as Vice President, Clinical Operations accountable for Clinical Operations, Biometrics, and Medical Writing. She has surrounded herself with highly skilled and energized colleagues and has laid the foundation for a successful clinical operations department. Rosie has been an active contributor to 6 NDAs, 8 SNDAs, and 6 ANDAs. Rosie resides with her husband of 18.5 years, Josh. They have 2 daughters Marlee (17) and Chloe (13) and two adorable boxer puppies, Brutus and Bodi. In her spare time you can find her at the gym, hiking or on the sidelines watching her daughters play soccer!
|Gerald Finken||Center Point Clinical Services, LLC|
Gerald Finken, RPh, MS, is a licensed pharmacist and has over 37 years of experience in the biotechnology and pharmaceutical industries focusing entirely on pharmacist related activities. He has worked as a community pharmacist, an independent clinical supplies consultant and has held management positions with Bristol-Myers Squibb Company and PRACS Institute, Ltd. In 1997, he founded CSM, where he invented On-Demand packaging and labeling, Clinical Trial Research Pharmacist (CTRP®) services and pioneered Direct-to-Patient services. In 2013, he founded Center Point Clinical Services and subsequently created the innovative Siteless CRO model. He currently serves as CEO for Center Point. Mr. Finken focuses on innovation, disruptive business strategies, and growth opportunities—including the further development of the role of the pharmacist in clinical research. Mr. Finken received his Bachelor of Science degree from Rutgers College of Pharmacy, in New Brunswick, NJ; and his Master of Science degree from Kean College, in Union, NJ.
|Aaron Fleishman||BBK Worldwide|
Director, Market Development
As Director of Market Development for BBK Worldwide, Aaron helps pharmaceutical sponsors, advocacy organizations, and patient thought leaders to create and deploy award-winning, innovative strategies that generate awareness and engagement surrounding clinical research. Aaron’s efforts have resulted in the development of new educational and interactive resources to help improve the overall study participation experience while ensuring that patients and caregivers remain at the center of every campaign.
|Balazs Flink, MD||Bristol-Myers Squibb|
Head, Clinical Trial Analytics
Graduated as a physician, explored medicine from the academic perspective before joining BMS in 2005. Held roles with increasing responsibilities in R&D most recently have led the full integration of the Clinical Trial Analytics group in the newly formed Business Insights and Analytics organization. My main goal in this new corporate wide analytics group is to challenge the status quo, establish common consciousness in R&D and to drive strategy and execution through data and insights.
|Emmanuel Fombu, MD, MBA||Johnson & Johnson|
Global Commercial Strategy and Digital Innovation
Dr. Fombu is a recognized authority on the convergence of digital technologies and healthcare. He is an author, physician and medical futurist with over 10 years combined experience in clinical medicine, drug development, medical affairs, research, pragmatic trials and product lifecycle management strategy in biopharmaceutical industry and private equity. His current focus for Novartis is how digital technologies can be leveraged to better measure Novartis product’s real-world effectiveness and value, and also to design more comprehensive disease management systems in partnership with digital health startups, payers and providers. In addition to his book, The Future of Healthcare: Human and Machine Partnering for Better Outcomes, Dr. Fombu has authored multiple research papers and abstracts in renowned peer reviewed journals. As a medical futurist and 2017 winner of the prestigious New York City Health Business Leaders Boldest Digital Health Influencer Award, Dr. Fombu is a champion and advocate for value-based healthcare, personalized medicine, mhealth, nanotechnology, big data, artificial intelligence, machine learning and digital medicine. He serves as an external advisory board member at the Massachusetts Institute of Technology’s MIT.nano project. Dr. Fombu did his clinical training at Emory-Crawford Long Hospital and holds an MBA from Cornell University’s Johnson School of Business and a certification in Artificial Intelligence: Implications for business strategy from MIT’s Sloan school of management and Computer Science Artificial Intelligence Lab. He lives in New York City.
|Diana Foster, PhD||Total Clinical Trial Management|
Dr. Diana L. Foster currently serves as the CEO of Total Clinical Trial Management (TCTM). Dr. Foster is a recognized expert in the intricacies of site management and an innovator in the use of strategic marketing and positioning tactics. Her early tenure as head of an SMO gave her a unique understanding of how sites operate and what they need to reach enrollment goals within targeted timelines, thus leading to a proven model with results.
Senior Director and Global Head, Data Science
Brooks Fowler is the Senior Director, Data Science, at AbbVie. The AbbVie DS organization covers conventional data management accountabilities, including clinical trials systems development, data capture, data cleaning and data warehousing. In addition, DS provides clinical analytics to key stakeholders across the clinical development functions. Analytics use cases are changing rapidly with the advent of device-driven data, access to eMR data, and real-world data in many forms and from many sources. The required skills to be successful in this environment have prompted a fundamental transformation of the DS organization toward a focus on advanced analytical capabilities and the recruitment of individuals with skill sets to support new use cases. While conventional data management remains a core accountability, the DS organization is quickly preparing for the future. Brooks holds a BS in Information and Decision Sciences from the University of Illinois at Chicago, and an MBA from the Kellogg School of Management at Northwestern University. He worked to start two healthcare companies prior to joining the industry in 2000.
Lead Analyst, Operations Excellence
No bio available
Head, Global Trial Optimization
Over 19 years industry experience in the management and operation of global clinical trials across a wide range of therapeutic areas and phases. Extensive experience in the design and implementation of cross functional process and directing change initiatives in global organisations. Head of The Global Trial Optimization Group at Regeneron, partnering with teams to optimize operational trial design and placement through the utilization of innovation and data and analytics. A key focus of this group is to centralise efforts to obtain and leverage external expertise from trial participants, disease experts and trial sites in to align the scientific design of a study with the perspectives of patients and study site staff.
|Amanda Fu, MD, MBA||RedBud Pharma|
Founder and CEO
Dr. Amanda Fu has 15 years extensive global clinical trial development and operational experience and an outstanding proven track record in Asia, Europe and North America. She has diverse knowledge, skill sets and training in medical practice, clinical science, public health, and global regulatory affairs. Broad combinations of clinical practice and clinical science, medicine and business management, individual medicine and public health. She has developed and managed global clinical trials across multiple therapeutic areas and at different development phases.
|Lauren Gadsby, MBA||Janssen|
Program Manager, Investigator & Patient Engagement
Lauren Gadsby is a Program Manager, Investigator & Patient Engagement for Janssen R&D. Lauren provides strategic leadership for engagement programs. She translates insights into strategies that deliver a differentiated clinical trial experience for patients and investigators and ensure trials meet recruitment and retention objectives. Lauren works cross-functionally to shape compliant processes for new initiatives and ensure seamless delivery and execution of strategy. She has experience developing and implementing programs to improve diversity in clinical trials and recently won an enterprise award for work to improve diversity in lupus research as one of the leaders on a clinical operations study team.
|Luis Garcia-Gancedo, PhD||GlaxoSmithKline|
Fellow & Director, Digital Biomarkers
Dr. Luis Garcia-Gancedo is the Director of Digital Biomarkers at GlaxoSmithKline (GSK). With a background in Physics and Electronic Engineering, Luis spent a number of years as a Research Associate in the Engineering Department at the University of Cambridge and as a College Lecturer at Newnham College (University of Cambridge) before joining GSK. Currently he leads the development of a strategic portfolio of novel digital measures of disease progression (digital biomarkers) to support GSK’s pipeline of innovative medicines. This includes pioneering new digital tools and data science approaches to investigate these measurements in our therapeutic clinical studies with the aim to collect ‘real-world’ data that reflects a reasonable approximation of how study participants usually live their lives, ultimately enabling a better understanding of disease manifestation and a better assessment of drug efficacy. Luis’ long-term mission is to use digital technologies to improve the lives of patients, helping them do more, feel better and live longer.
|Jennifer Goldsack||Digital Medicine Society (DiMe)|
Jen Goldsack leads Strategy, Portfolio and Operations at HealthMode and serves as the Interim Executive Director of the Digital Medicine Society (DiMe). Previously, Jen spent several years at the Clinical Trials Transformation Initiative (CTTI) where she led development and implementation several projects within CTTI’s Mobile Program and was the operational co-lead on the first randomized clinical trial using FDA’s Sentinel System.
|Melanie Goodwin, MSc||Pfizer|
Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development
Melanie Goodwin is the Director of Patient Recruitment Programs at Pfizer and has been focused on clinical trial enrollment and retention in the pharmaceutical industry for 20 years. Her recruitment and retention experience spans across sponsor, CRO, Patient Recruitment agency, and research site, providing a unique and rounded view of the challenges and solutions. She has developed enrollment and retention strategies for over 200 clinical trials across all study Phases and therapeutic areas. Melanie holds a B.Sc. and M.Sc from Saint Joseph’s University in Philadelphia, Pennsylvania.
Pablo Graiver is Co-Founder of Antidote Technologies Ltd. (a/k/a TrialReach Ltd.) and serves as its Chief Executive Officer and Executive Director. Pablo Graiver served as Vice President of Business Development, Europe of Kayak Software Corporation. He has over 12 years of entrepreneurial and management experience in the online industry. He was an early member of NetJuice, one of the largest Internet incubators in Europe; MD at Donde Comprar.com, the first e-commerce directory in Spanish; and later co-founder and Vice President of Strategy at Kelkoo, acquired by Yahoo! in 2004. Pablo Graiver set up and launched Kayak.com in Europe, and served as European Sales Director at ValueClick (NASDAQ: VCLK). He studied Biology and Business Administration at UAM in Madrid.
|Christina Greene, Esq||Merck Sharp & Dohme Corp.|
Associate Director, Global Site Agreements
Christina Greene (Christy) left her career as a family and estate planning, private practice attorney in 2015 and joined Merck as a site agreements specialist supporting Merck’s clinical trials in North America and Europe, Middle East and Africa (EMEA). In September 2017, she focused her attention on the EMEA region in a new role as the Global Site Agreements Lead supporting EMEA, and additionally assumed the role of acting lead with respect to CRO site agreements process management. In her time with Merck, Christy has driven process and quality improvements with respect to site contracting, including active involvement in updating Merck’s CTRA Negotiation Guidelines, developing global and country templates for all aspects of clinical trials, and delivering clinical trials negotiation and contracting trainings to EMEA Clinical Operation Managers (COMs) and CRO partners. Christy earned her law degree from Widener University School of Law and her B.S. degree from Penn State University (We Are!), and is currently pursuing a masters degree in Business Intelligence and Analytics from St. Joseph’s University.
|Alyson Gregg, MBA||Janssen R&D|
Director, Patient Insights
Alyson Gregg is the Director of patient insights for Janssen. In this role, Alyson is focused on leading Janssen to incorporate direct patient insights on clinical trial protocol. To involve patients more throughout the clinical trial process, Alyson works with compound development teams to modify trials as appropriate, and to improve the patient experience and clinical trial success. Alyson has 20 years of experience at Johnson & Johnson in roles of increasing responsibility, most recently as U.S. Commercial Insights and Strategy Director for the Neuroscience business.
|Glenda Guest||President, Assured of Quality Consulting & Training|
Glenda Guest BS, CCRA, RQAP-GCP, TIACR,FACRP, has an extensive background in the clinical research industry having worked as a monitor, project manager, data manager, database programmer, quality assurance auditor and senior trainer since joining the clinical research profession with Norwich Clinical Research Associates (NCRA) in 1997. Now an independent consultant for her own company, Assured of Quality Consulting & Training, she specializes in clinical quality assurance auditing, development of clinical quality management systems and advanced GCP and FDA Regulations training. With 20+ years of regulated research experience and her extensive background in a clinical CRO she has developed a unique perspective, not only of the regulatory requirements for pharmaceutical and device development and market approval, and insights from collaboration with multiple sponsor companies’ varying approaches in meeting those requirements.
|Tammy Guld||Janssen Clinical Innovation|
Tammy Guld is the Senior Director, Team Leader of Janssen Clinical Innovation (JCI). Janssen Clinical Innovation is dedicated to making clinical trials faster, less costly, and a better experience for all stakeholders, especially our patients. Through the design and conduct of novel trials and demonstration projects, JCI generates data and knowledge about feasibility, impact, and value. Tammy provides strategic and operational leadership to this team and is accountable for the overall performance & portfolio optimization. Tammy joined Janssen R&D after spending 20 years at Bristol-Myers Squibb where she most recently served as the Executive Director and Head of Central Clinical Planning & Solutions. In this role, she was responsible for centralized operational solutions that ensured the best trial experiences possible for patients, caregivers, and investigational sites; capabilities included Clinical Trial Engagement, Alliance Management, Contracting & Payments, Trial Disclosure, and Digital Health. Tammy holds a Master of Science degree in Clinical Pharmacology from Thomas Jefferson University and a Bachelor of Science in Biochemistry from Bucknell University.
|Laurie Halloran||Halloran Consulting Group|
Laurie founded Halloran Consulting Group in 1998 after working for 10+ years in varied positions in Clinical Development in both CROs and biopharma companies. She has built a successful $25MM US consultancy and is recognized as an industry expert in life sciences. Halloran’s focus in clinical research includes integrated development planning and advising and directing FDA regulatory strategy as well as representing our clients to FDA through filings, protocol development and implementation and directing trials and CROs on behalf of small and mid-size clients. She is currently focused on growing and leading a management consulting practice within the company dedicated to using the insights, efficiencies and expertise gained through Halloran’s work with biopharma start-ups to build fit-for-purpose organizations that can become the model for the future of drug development.
|Sarah Halmrast||Clinical Supplies Management, Inc.|
Vice President, Global Project Management
I have worked in the Clinical Supplies industry since 2000 wearing various hats over time, but specifically more tied to Project Management of Clinical Supplies and working with various clients to meet the unique differences of their clinical trials. Directly and indirectly implemented various processes, such as label printing capabilities and On-Demand packaging operations. Developed initial process of Direct to Patient activities at CSM and continue to be involved in process improvement of DtP. Currently, my main focus is on harmonizing Project Management teams between various locations in the US and EU. My husband and I have been blessed with three beautiful, strong-willed children that keep our schedule busy.
Associate Director, Risk Based Monitoring, Project Operations and Business Performance
Gayle is a Lead Risk Based Monitoring Project Advisor at IQVIA with over 20 years of experience in clinical research and over 15 years at IQVIA. In her role, she is responsible for creating and enhancing RBM business processes as well as identifying and prioritizing technology investments to transform the way Clinical Development delivers. Gayle and her team are responsible for integrating and streamlining processes associated with clinical delivery to drive higher quality and productivity-based project outcomes, enabling employees to perform their work more effectively cross-functionally, focusing on the implementation of Risk Based Monitoring processes and methodologies.
|Matthew Harlin||Otsuka Pharmaceutical Companies|
Associate Director, Clinical Pharmacology
Matt Harlin is Associate Director, Clinical Pharmacology at Otsuka Pharmaceutical Development & Commercialization, where he has worked for over 10 years. During that time, he has held several roles within Clinical Pharmacology, including leading an initiative to implement collection of biospecimens for future use during all interventional clinical trials. He obtained a Master’s in Biotechnology from John’s Hopkins University, and is currently a Clinical Pharmacology lead on several early and late-phase compounds.
Clinical Program Benchmark Manager, Patient Engagement & Recruitment
With operational expertise and extensive industry relationships, Lani has worked across all therapeutic categories in Phases I-IV including rare diseases, medical devices, and incorporating innovative technologies. Ms. Hashimoto’s perspective is patient-empathetic while encompassing the whole study context from investigator site needs to patient recruitment’s impact on downstream resources and processes. Lani’s expertise also includes feasibility, patient privacy and advocacy initiatives. Joining Novartis in October 2014, Lani is focused on connecting patients to clinical research. In her current role, Lani supports new indications and programs with early evidence to support decisions, patient engagement facilitation, and patient recruitment strategic planning.
|Greg Hersch, PhD||Novartis|
Head, Innovation, Global Development Operations
No bio available
|Heather Hirsch||CRISPR Therapeutics|
Senior Director, Translational Pharmacology, Head of Clinical Biomarkers and Exploratory Research
Dr. Heather Hirsch is currently a Senior Director in Translational Pharmacology and the Head of Clinical Biomarkers and Experimental Research at CRISPR Therapeutics. Prior to CRISPR, Heather was the Director of Translational Genomics at Jounce Therapeutics Inc where she focused on immuno-oncology therapies. Her group, which encompassed both informatics as well as wet bench genomics capabilities, contributed to target identification, pipeline support of specific therapies, indication selection and biomarker support in clinical trials. Prior to Jounce Therapeutics, Heather was an associate principal scientist in Genetics and Discovery Pharmacogenomics at Merck Research Laboratories focusing on Oncology and Immunomodulatory Regulators. She worked on many preclinical and clinical stage small molecule and biologics-based programs including Keytruda. Much of the work in this setting was using genomics technologies to understand mechanism of action for drug therapies as well as understanding how genomics can help identify potential responders. Heather received her PhD from Michigan State University in Cell and Molecular Biology and did a postdoctoral fellowship at Harvard Medical School.
|Kyle Holen, MD||AbbVie|
Head, Development Design Center, Research and Development
Kyle Holen was trained as a medical oncologist and practiced in an academic setting prior to joining AbbVie in 2009. Since then, he has worked as a medical director, project lead, and executive medical director in oncology. His most recent role, as head of the development design center, is focused on shaping the future of clinical research at AbbVie.
|Angelique Hopkins||Bristol-Myers Squibb Company|
Director, Clinical Trial Analytics, Business Insights and Analytics
No bio available
Associate Director, Business Strategy & Operations, Analytics and Data Sciences
Amanda Hovda has more than 16 years of experience in the pharmaceutical industry in various sponsor and CRO roles at companies including PAREXEL, UCB Biosciences, and Biogen. She possesses a varied skillset in full service CRO, FSP, and all types of vendor contracts. Amanda has an MBA with a focus in Organizational Leadership and has a passion for striking the right balance between savings/vendor bottom line to fuel a successful and collaborative relationship structure. In Amanda’s current role, she is the Head of Business Strategy and Operations in Analytics and Data Sciences for Biogen. As the first Vendor Management team within an R&D Business function at Biogen, Amanda and her team are regularly consulted by R&D External Operations to provide feedback on best practices and contribute to process development to achieve alignment within the R&D Organization.
Clinical Data Scientist
Ashley has over 10 years’ experience in Clinical Data Management both within the CRO and Pharmaceutical industries. Ashley started his career in the late phase Data Management department at PAREXEL working on numerous trials, across multiple therapeutic areas and in a variety of EDC systems. He progressed into a Data Management operational leadership position where he had overall accountability, as an account lead, for the execution of the Data Management strategy on numerous complex Oncology studies. Ashley joined the Oncology team within the Data Monitoring and Management department at Pfizer in 2018 and is currently assigned to a number of key pivotal trials. He is an Oracle InForm EDC SME and is putting his knowledge and experience to good use working on a number of internal AI process development initiatives.
Associate Director, Risk Management & Central Monitoring
Lewis Hower is a Director in Janssen R&D’s Risk Management-Central Monitoring Group, which is dedicated to the implementation of Analytical Risk-Based Monitoring on clinical trials. In this role, Lewis has contributed to the creation and management of processes, resources, and technology to support the analytical and risk-based model of clinical trial management and monitoring that has now supported more than 170 clinical studies at Johnson & Johnson. Lewis is the TA Lead in Infectious Disease and Vaccines and has been with Janssen/Johnson & Johnson for approximately 17 years with prior experience in quality organizations and preclinical research/drug development.
Associate Director, Global Clinical Operations
An innovation award winning operational strategy expert, blockchain advocate and patient engagement thought leader with over 17 years in the NHS on commission by the DOH and in Industry (Hoffman La-Roche, Amgen, ALMAC, ICON and Biogen). An R&D transformation change champion. Currently part of the DIA Patient Engagement Voluntary Community Leadership team. Experience across various therapeutic areas and phases of trials in drug development include creation and execution of successful strategies for research protocols and CRO oversight, patient and site feasibility, expertise in technologies such as eCOA and IVRS, creation of optimal drug packaging and administration concepts, mapping the patient journey, planning and executing effective global site and patient engagement campaigns using direct to patient methods, leading and coaching remote and complex global teams.
|Jane Jacob, PhD, CCRP||Orthofix|
Vice President, Research and Clinical Affairs
With over 15 years’ experience in clinical research, following 15 years in academia, Dr. Jacob ‘s experience working within the corporate infrastructure as well as establishing successful sponsor/site relationships, has allowed her to successfully develop and launch both large and small clinical trials across the research spectrum – retrospective, post market and IDE studies. She has been a study coordinator, then a CRA, a manager, director and is now Vice President of Research and Clinical Affairs at several medical device companies.
Central Monitoring Manager, Integrated Data Analytics and Reporting, Global Clinical Development Operations
Joi Jenkins is a Central Monitoring Manager in Janssen R&D’s Risk Management-Central Monitoring Group, which is dedicated to the implementation of Analytical Risk-Based Monitoring in clinical trials. In this role, Joi leads the preparation, conduct and follow-up of the cross-functional Central Monitoring Working Group for ARBM studies. She has also participated as a member of the TransCelerate BioPharma Shared Investigator Platform team, recently helped lead Janssen’s Site Staff Training Process Improvement and is an Investigator Engagement Ambassador, within Janssen R&D. Joi has over 26 years of experience in clinical research and drug development. Prior to her ARBM-focus, she worked in a variety of therapeutic areas of clinical trial and site management at Janssen R&D, Cephalon, Inc. and Drug Research and Analysis.
|Mark Joing, MBA||Menlo Therapeutics Inc.|
Vice President, Clinical Operations
Mark Joing is Vice President, Clinical Operations at Menlo Therapeutics. He joined Menlo in 2016 and is responsible for clinical trial execution and project management. Mr. Joing brings 20+ years of drug development experience at large and small pharmaceutical companies to Menlo. For five years prior to joining Menlo, Mr. Joing was VP of Clinical Operations and Project Management at Nora Therapeutics, a biotechnology company focused on developing therapeutics to address significant unmet needs in reproductive medicine. As part of the senior management team at Nora, he led multiple Phase 1 and 2 clinical studies in the US and Europe. Prior to Nora, Mr. Joing headed Clinical Operations and Project Management at Nuvelo, a late-stage drug development company. He was the recipient of Nuvelo’s inaugural George Rathmann Award to recognize his significant contribution to Nuvelo’s mission of improving the lives of patients through the discovery, development and commercialization of novel acute cardiovascular and cancer therapies. Earlier in his career, Mr Joing held roles in Supply Chain and Production Management at 3M Pharmaceuticals and Abbott Laboratories. Mr. Joing holds a B.S. in chemical engineering from Northwestern University and M.B.A. from Stanford University.
|Charlotte Jones-Burton, MD, MS||Otsuka Pharmaceutical Development & Commercialization, Inc.|
Vice President, Global Clinical Development
Dr. Jones-Burton is dedicated to creating healthier communities globally through drug development, patient advocacy and people engagement/empowerment. Her three-pronged approach reflect her personal values of community, service and health and wellness. Charlotte combines her leadership in research/drug and people development with her clinical acumen in order to positively impact the lives of patients and communities who suffer with chronic diseases. Charlotte is a pharmaceutical executive who has spent over a decade in the pharmaceutical industry leading clinical trial development for multiple medicines across various disease areas including cardiovascular and renal diseases. She is currently VP, Global Clinical Development, Nephrology at Otsuka Pharmaceutical Development & Commercialization, Inc. She earned a medical degree and Master of Science degree in Epidemiology and Preventive Medicine, with a concentration in Clinical Research, from the University of Maryland School of Medicine. Charlotte’s postgraduate training included an internal medicine residency and a nephrology fellowship at the University of Maryland Medical Systems. Charlotte is active in numerous professional associations and organizations and co-founded Women of Color in Pharma, a non-profit professional society focused on transforming the pharmaceutical landscape with women of color. As its president, Charlotte is leading the growth of the organization in the US and EU.
|Hassan Kadhim||Bristol-Myers Squibb|
Director, Clinical Trial Business Capabilities, GCO
No bio available
|Sujay Kakarmath, MD||Partners Healthcare Pivot Labs|
Lead Scientist, Data Science and Artificial Intelligence
Dr. Kakarmath is a digital health scientist at Partners Healthcare Pivot Labs and an Instructor at Harvard Medical School. His research is focused on the evaluation of the clinical utility of digital health solutions, including machine learning and artificial intelligence-based products. Dr. Kakarmath's team works closely with technology innovators from academia, startups and industry giants to guide the ideation, design, prototyping, validation, and deployment of digital health solutions. His work has been published in prestigious journals and showcased at major academic conferences such as those of the American Academy of Neurology, the American Medical Informatics Association, the International Society for Pharmacoeconomics and Outcomes Research, the Connected Health Conference, Precision Medicine Summit and HIMSS.
|Aaron Kamauu, MD||PAREXEL|
MS, MPH, Vice President, Scientific Data Assets
Dr. Kamauu (MD, MS Biomedical Informatics, MPH, University of Utah School of Medicine) leads innovation in leveraging healthcare data supporting a variety of clinical research, informatics, clinical trials, and drug development activities, including pharmacoepidemiology, outcomes research, protocol design, site identification, and data-driven patient recruitment. He has a unique combination of clinical, biomedical informatics, drug development, and public health experience in the application of innovative biomedical informatics methodologies that supports individual patient care and population-based observations.
Associate Director, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development
Nechama Katan, Associate Director at Pfizer, is a “Data Wizard with Personality.” She helps organizations access and use their data to drive business decisions. Nechama blends an ability to write code and provide prototypes with an interest in driving the “business conversation." In addition to working with various organizations, she is an experienced instructor in Statistics, Operations, Data presentation and Metrics development. Her education includes an MSc from NYU in Mathematics and an MA from Columbia University in Statistics.
Head, Clinical Analytics
Nareen Katta works as a Senior Director and Head of Clinical Analytics at AbbVie. Nareen has over 15 years of experience in the pharmaceutical industry. In his current role, Nareen is responsible for building and executing the clinical analytics strategy for AbbVie’s clinical development organization. In addition, Nareen engages in active dialogue and collaboration with cross-functional leaders and industry peers, on topics like big data, robotic process automation, artificial intelligence, machine learning, digital health, interoperability etc. Nareen has a Masters in Electrical Engineering from The University of Texas at Arlington, and MBA from University of Chicago Booth School of Business.
Senior Director, Head, Outsourcing and Procurement
Ly is a well-known expert and leader in the operations, outsourcing, and vendor management with more than 25 years of experience in the biotech/pharmaceutical industry in large and small companies across all phases of research. Ly has extensive background in both clinical and R&D in clinical operations and outsourcing and contracts management. Ly expertise includes business and operations strategies, strategic sourcing, governance management, and quality/compliance. Ly has built and lead multiple groups at Genentech, Allergan, Ultragenxy, and currently at MyoKardia. In her current role, she heads the clinical outsourcing, site budget/CTAs, and business analytics functions.
|Mike Keens||Firma Clinical Research|
Mr. Keens serves as Chief Operating Officer for Firma Clinical Research. He leverages his knowledge and landscape experience to help Biotech and Pharmaceutical Sponsors identify project/program needs and examine how Firma may deploy expertise and resources to support these needs to achieve their drug development goals. Mr. Keens earned his undergraduate degree in Biology/Psychology from James Madison University, and his Master’s degree in Public Health from The University of Virginia.
|Michael Kelsh, PhD||Amgen|
Director, Center for Observational Research
No bio available
Senior Director, Biostatistics & Programming
Francis has been working in the Life Sciences industry for over 30 years working in and leading Biometrics functions for larger companies like Pfizer, Novartis and Roche. He has always been interested in how new technology and access to data can improve Health care and how Life Sciences will have to adjust to the new paradigms that are created by these factors. Francis has a keen focus on Innovation and how Data can help improve the Healthcare ecosystem.
|Patrick Kenney||UCB Biosciences, Inc.|
Director, Strategic Partnering Lead, Global Clinical Sciences & Operations
Patrick Kenney is a Director in the Strategic Clinical Partnering department at UCB Biosciences. He has served in a variety of roles over his 25 years in the industry starting out as a clinical microbiologist in a research and development setting. This lead to work in various project and people management roles at both CRO and Pharma organizations providing a strong background for his current role which includes the operational oversight of key strategic partners.
Global Head, Data Operations
No bio available
|Faisal Khan, PhD||AstraZeneca|
Executive Director, Advanced Analytics and Artificial Intelligence
No bio available
|David Kiger||Datacubed Health|
Chief Commercial Officer
David has spent his career at the intersection of the technology and life science world, executing and managing business development, client management, innovation, go-to-market offering strategies, as well as product and services marketing. Before coming to Datacubed Health, David was Chief Commercial Officer of Bioclinica, accountable for global business development, corporate marketing, sales operations, and technical solutions. Prior to that, David ran the services innovation strategy and marketing for PAREXEL Informatics. David also led the PAREXEL North American eClinical and Medical Imaging business development. David has also worked at Commerce One, Siebel Systems, and Accenture where he led management consulting client services and delivery. David is a graduate of The University of Wisconsin, Whitewater where he graduated summa cum laude.
|Jessica Kim||BBK Worldwide|
Director, Research, Digital Strategy
As the Director of Research and Digital Strategy for BBK Worldwide, Jessica has her pulse on the latest in healthcare consumer trends. She leverages her insight to ensure BBK's patient recruitment and engagement efforts align with the needs of today's patient, while ensuring they contribute a positive study experience.
|Joseph Kim, MBA||Eli Lilly|
Senior Advisor, Patient Experience and Design Innovation
Joseph Kim serves as a Senior Advisor in Patient Experience and Design Innovation at Lilly, focusing on developing and implementing innovative patient engagement solutions. He has spent nearly 20 years in the Pharma industry utilizing a unique approach that integrates his experiences working for Sponsors such as Shire and Merck, CROs, and technology vendors. He has a robust combination of experience that includes early and late phase clinical research, and a well-known history of innovation in the clinical research industry, recognized as one of “Top 100 individuals on the 2015 MedicineMakers Power List, and “20 Innovators Changing the Face of the Clinical Trials Industry” by CenterWatch in 2013. He holds a BS in Molecular Biology from Lehigh University and an MBA from Villanova. He can be reached at email@example.com and on Twitter: @JoPeKim
|Jeff Kingsley, DO, MBA, CPI, FACRP||IACT Health|
Dr. Kingsley is founder and CEO of IACT Health, a research management organization, and 15 wholly owned and integrated clinical research offices in multiple cities in two states. The family of companies conduct phase Ib through IV research in nearly every medical specialty; inpatient and outpatient; pharmaceutical, biotechnology, and medical device. He has dedicated his career to clinical research since 2006. Dr. Kingsley is the current COO and Chair for hyperCORE International, LLC Centers of Research Excellence. He is also the past Chair of the Board of Trustees for the Association for Clinical Research Professionals which represents more than 13,000 clinical research professionals internationally. He is the former Treasurer for ACRP and APCR, Past President of ABSAME, sits on three additional Boards, and participates on numerous other local, national, and international committees. Dr. Kingsley obtained his CPI in 2009 and his FACRP in 2017.
Director, Life Sciences & Health IT
Serving as Exostar’s Director of Health IT & Life Sciences, Kenny has consulted and advised some of the world’s largest Healthcare and Biopharmaceutical companies in enabling on-demand access to eClinical technology using digital identities that securely extend trust across traditional enterprise boundaries. In his tenure, his thought-leadership supported the development of Federal Health IT Standards during the advent of Electronic Health Records (EHR’s).
|Andrew Kornberg||The Royal Children's Hospital Melbourne|
Associate Professor & Senior Neurologist
A/Prof Andrew Kornberg is a paediatric neurologist with considerable neuromuscular experience. He completed Paediatric Neurology and Neuromuscular Fellowships in the United States working in St Louis, USA. He has had extensive laboratory and clinical experience in immune-mediated neurologic syndromes, including Guillain-Barré syndrome, Miller Fisher syndrome, multifocal motor neuropathy, chronic inflammatory demyelinating polyneuropathy (CIDP), childhood multiple sclerosis and acute disseminated encephalomyelitis.
|Jim Kremidas||Association of Clinical Research Professionals (ACRP)|
Jim Kremidas is currently the Executive Director for ACRP, a nonprofit association the represents the clinical research enterprise. Prior to that he conducted consulting services for a variety of clients, including support for investigator sites, academic institutions, sponsors and suppliers. He was the SVP of Patient Recruitment at two large CROs for more than six years, where he and his team were responsible for developing and implementing patient enrollment strategies for global clinical trials. Prior to that, he spent 24 years with Eli Lilly and Company. From 1999 to 2008 he led their clinical trial patient recruitment and retention efforts. In this role, he focused on predicting and accelerating the enrollment rates for all corporate studies. While in Strategic Sourcing he was responsible for the outsourcing of clinical development projects to strategic suppliers, including CROs, scientific staffing firms and patient recruitment suppliers. Before his assignment in clinical development strategic sourcing, Mr. Kremidas led Lilly’s efforts to select and establish relationships with direct to consumer and professional advertising agencies, as well as to implement standardized processes for the development and implementation of marketing materials. He is on the advisory board of CISCRP (a nonprofit organization focused on enhancing patient participation in clinical trials) and is also a volunteer for the Clinical Trial Transformation Initiative (CTTI) with Duke and the FDA. He is a frequent presenter at industry conferences and his articles/papers have been published in a wide variety of trade journals.
|Harlan Krumholz, MD||Yale-New Haven Hospital Center for Outcomes Research and Evaluation|
Harlan Krumholz, the Harold H. Hines, Jr. Professor of Medicine at Yale School of Medicine, is a cardiologist and the Director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation. He leads initiatives to improve the quality and outcomes of clinical decisions and healthcare delivery, reduce disparities, enable transparency in practice and research, and avoid wasteful practices. His team has led national improvement initiatives, architected national measurement strategies, developed a platform for research and clinical care improvement in China, promoted patient-centric approaches to research and care, and created strategies and tools to enable open science and advance scientific integrity. He led the Robert Wood Johnson Foundation Clinical Scholars Program at Yale for more than two decades. He founded the American Heart Association Quality of Care and Outcomes Research Council Annual Conference and was the founding editor of Circulation: Cardiovascular Quality and Outcomes. He founded HugoHealth, a patient-centric platform to engage people as partners in research and facilitate the secure movement of digital health data. He is a member of the National Academy of Medicine and was a founding Governor of the Patient-Centered Outcomes Research Institute. He has published more than 1000 articles and has an h-index of 192. Dr. Krumholz received a BS from Yale, an MD from Harvard Medical School, and a Masters in Health Policy and Management from the Harvard University School of Public Health.
|Delphine Lagarde, PhD||F. Hoffmann-La Roche AG|
Ethics Lead in Biosample & Repository Management
Molecular Biologist by training, obtained her PhD in Plant Sciences at the University of Montpellier, France in 1996. Worked for a couple of Biotech companies before joining Roche in summer 2002 to lead a team working on SNP discovery in Type 2 Diabetes. With her team, implemented and supported the automated RNA profiling and protein biomarker analysis in Roche clinical trials until 2007 when decided to focus on Ethics and Compliance in Sample Management. Was Head of the Roche Biosample Repository between 2008 and 2014, and is since 2014 fully dedicated to Ethics related questions and Consent management in her role as Ethics Lead in Biosample & Repository Management.
|Jim Lane||Longboat Clinical|
Chief Buisiness Officer
Jim has worked at the forefront of online investigator site support since 2006, having been a key member of the management team behind the success of the first-to-market investigator portal. Following the acquisition of that product by ICON plc, Jim enjoyed a highly successful 3 years with ICON's Business Development team before joining Longboat. Previously, Jim has held senior positions at various industry-leading IT companies including Symantec, Microsoft, NETg (Skillsoft), and AST Computers (Samsung).
|Jacob LaPorte, PhD||Novartis|
Vice President, Global Head, Digital Development
Jake LaPorte, PhD, is Global Head of Digital Development at Novartis and responsible for leading the company’s digital efforts within their Global Drug Development organization. Jake began his career at McKinsey & Company, where he was a leader in their Pharmaceutical R&D practice, during his six-year tenure, developing an expertise in large, complex transformations and innovation. It was on a fateful, extended journey in Asia-Pacific, however, where Jake read Ray Kurzweil’s The Singulatiry is Near and became captivated by the possibility of digitalizing the Pharmaceutical R&D engine – he has focused his career to the realization of this concept ever since. He co-founded Snapdragon Chemistry, with the Head of the Chemistry Department at MIT, which seeks to enable companies to implement continuous flow chemistry in discovery, development and manufacturing, with the ultimate goal of fully digitalizing chemical synthesis. Most recently, Jake has held various leadership positions at PPD, Inc., where he collaborated with executives to develop and implement C-level, strategic initiatives, including a long-term transformation to create industry-leading approaches to clinical development in key therapeutic areas. Jake completed his Ph.D. in Organic Chemistry from Harvard University, where he was an HHMI doctoral fellow, and received his B.Sc. in Biochemistry and Mathematics, summa cum laude, from the University of Delaware.
|Andy Lawton||Risk Based Approach Ltd.|
Director & Consultant
Andy Lawton has extensive experience in computing, statistics, data management, system design, Quality Management and Risk Based Approach in both Computer System Validation and clinical trials. He is currently consultant and director of Risk Based Approach Ltd. Previously, Andy held a variety of position at Boehringer Ingelheim. Andy was a Founding Committee Member of ACDM, Member of TransCelerate RBM work stream and a Member of EFPIA WG on Data Transparency. His publications include the TransCelerate papers on SDV and Central Monitoring in the TIRS Journal, for which he won “best author of the year 2015 and 2016” from the DIA.
|Trong Kim Le||Bristol-Myers Squibb|
Group Director, Center for Observational Research & Data Sciences (CORDS), Business Insights & Analytics
Kim Le has over 19 years of experience in real-world research using large observational databases. She is currently a Group Director in the Center for Observational Research & Data Sciences at Bristol-Myers Squibb, where she leads a team of 11 professionals to conducts real-world research across the oncology portfolio. She received holds a Masters of Public Health and is a PhD candidate in Epidemiology.
|Nirosha Lederer, PhD||Duke-Robert J. Margolis, MD, Center for Health Policy|
Managing Associate, Real World Evidence
Nirosha Mahendraratnam Lederer, PhD MSPH is a Managing Associate at the Duke-Margolis Center for Health Policy, where she helps lead the Center’s real-world evidence (RWE) portfolio. Immediately prior, she was a Subject Matter Expert in the Oncology Center of Excellence at FDA. While there, she helped implement patient-focused drug development in cancer products including clinical trial study design and product review, as well as foster consensus across US and ex-US healthcare stakeholders on best practices for patient-reported outcome capture, analysis, and communication. Dr. Lederer has over a decade of pharmaceutical policy and health economics and outcomes research experiences including providing evidence-generation advisory services at Avalere Health, working in commercial and medical roles at Genentech and Bristol-Myers Squibb, respectively, and serving on Capitol Hill during the passage of the Affordable Care Act. She received her PhD in Health Outcomes and Policy from the UNC Chapel Hill with a focus on large database analyses and decision-sciences. She received her MSPH in Health Policy & Management from the Johns Hopkins Bloomberg School of Public Health and BA in Public Health from the Johns Hopkins University.
|Disa Lee Choun, EMBA||UCB|
Head, Innovation, Global Clinical Sciences and Operations
Disa has years of experience working in technology and innovation especially in the pharmaceutical industry. In her current role as Director Head of Innovation, GCSO at UCB, she is responsible for evaluating and piloting innovative solutions in clinical trials. Prior to joining the pharma, she was a co-founder of an IT company. She has an EMBA and BS in Pharmaceutical Chemistry. In 2017, Disa started a cross-industry collaboration on blockchain via PhUSE. Recently, she was awarded Top 100 Women in Technology and featured on the cover of CIO Look celebrating Women in Tech 2019. Her passion is on closing the gap for patients with unmet needs and exploring the right technologies (Blockchain, Internet of Things, Artificial Intelligence/machine learning, robotics, data discovery tools, and others) to accelerate the implementation of end-to-end patient solution.
|Hugh Levaux, PhD||Protocol First|
Founder & CEO
Dr. Hugh Levaux is Founder CEO of Protocol First. The company offers innovative software solutions for clinical research. Leading products are P1 EDC, a full eClinical research platform and Clinical Pipe, the industry’s first system-agnostic EHR-to-EDC connector application. Dr. Levaux has over 2 decades of clinical research experience.
Senior Director, Clinical Innovation, Global Product Development
No bio available
|Henry Levy||Veeva Systems|
General Manager, Veeva Vault CDMS
As general manager of Veeva Vault CDMS, Henry is responsible for the Veeva Vault CDMS product and sales. Henry has spent 25 years in the life sciences industry. Prior to Veeva, Henry was chief commercial officer for PPD, as well as the global head of Accenture's life sciences R&D practice.
Sr. Director, R&D Technology
April currently leads clinical technologies for site and patient engagement at GSK. Previously April spent several years at IQVIA where she served as the Head of IQVIA’s Clinical Design and Planning suite of technology solutions. There she led the strategic development and delivery of a portfolio of SaaS technology products that address critical business needs for Sponsors and CROs worldwide with a focus on protocol design, trial optimization and cost optimization. Prior roles included data management, clinical operations, consulting and site selection with various Sponsors (GSK was one!) and CROs.
Director, Project Management, Project Management Office, Global Clinical Trial Operations
Rachel Lewis works in the Project Management Office of Global Clinical Trial Operations at Merck & Co, where she leads global cross-functional teams in designing and deploying RBM processes and advanced analytical systems. She is also a member of TransCelerate's RBM workstream. Rachel started her biopharmacuetical career in Sydney, Australia, as a Medical Information Associate and has since held various roles within Clinical Operations including Clinical Research Associate (CRA), Clinical Project Manager, and Clinical Research Manager. In recent years, Rachel led the melanoma and merkel cell carcinoma clinical research program at Merck & Co, USA, overseeing clinical scientist activities and contributing to numerous successful filings. Rachel received her Bachelor of Pharmacy from the University of Sydney, Australia with honors in Pharmacology.
Senior Director, Regulatory Policy
Gracie Lieberman is a Biostatistician with 30+ years of experience in oncology clinical trials. Gracie is a Senior Director of Regulatory Policy at Genentech, and one of her focus areas is utilization of Real-World Evidence in regulatory decision-making. For the past 26 years at Genentech, Gracie has gained experience in all phases of drug development, from pre-IND to post-marketing, drug/diagnostic co-development, and collection/evaluation of Patient Reported Outcomes (PROs). Gracie served on review and oversight committees, advising and guiding molecule development teams. She participated in select internal strategic initiatives and external cross-industry workshops. During the first 8 years of her professional career, Gracie worked at the Institute of Tuberculosis and Pulmonary Diseases in Warsaw, Poland, where she assisted surgeons and oncologists collect, analyze and interpret data from lung cancer trials. Gracie has a Master’s Degree in Biostatistics from the University of North Carolina at Chapel Hill.
Senior Director, Strategic Partnerships
Holger Liebig is a Senior Director Strategic Partnerships at Parexel International. He supports and consults some of Parexel’s Strategic Partnerships on internal and external governance, KPI definition, change management and process alignment. Holger is a certified Lean Six Sigma Black Belt with over 29 years of industry experience.
|John Linnell||Patient Advocate|
Clinical Trial Participant and Member of AZ’s Patient Partnership Program
John was diagnosed with COPD in 2005. His career was as a retail District Manager then as a Marketing Director. He left the workforce in 2011. After engaging in an educational internet video on COPD and sharing his story at conferences, John realized his efforts would be best spent doing advocacy work for the COPD community. John is a member of the Board of Directors for the US COPD Coalition, the Executive Board of Directors for EFFORTS, and on the Governing Board for the COPD Foundation PPRN (Patient Powered Research Network). John also sat as a Patient Reviewer for Peer Review Medical Research Programs for the Department of Defense for several years. John is also currently a Co-investigator for a 3-year PCORI funded study at Johns Hopkins University School of Medicine: “Impact of a Peer Support Program Amongst COPD Patients and Their Caregivers”.
Independent Advisor, Former Head of Clinical Innovation
No bio available
Vice President, Global R&D Quality
Janis Little is Vice President, Global R&D Quality at Allergan. In this role she is responsible for oversight of the R&D quality function, setting strategic direction for the organization and ensuring development and implementation of a risk-based audit program, inspection management, product development quality assurance, and medical device quality oversight. Janis currently leads TransCelerate’s Clinical QMS Workstream and was a co-author of the Clinical QMS conceptual framework.
Associate Director, Clinical Metrics & Analytics, Global Development Operations
Ankit Lodha has high-end expertise in big data analytics and interpretation of clinical operations data in the pharmaceutical/ biotechnology industry. In his current position, Ankit is responsible for building the Takeds's (L-Shire) organization capability as a world-class leader in measuring CROs clinical analytics performance dashboard and functional health metrics. He is also responsible for designing meaningful metrics, setting the data strategy supporting the measurement of CRO performance, generating real-time dashboard for patient enrollment, site quality and forecasting study start-ups and cycle times. Before this position he has worked at Amgen, AstraZeneca and Pfizer within their respective Analytics and Innovation groups providing strategic services, supporting metrics and data management needs of senior leadership teams. He holds a Bachelors in Biotechnology Engineering from Dr. D.Y. Patil University, Masters in Business of Bioscience from Keck Graduate Institute and MBA from University of Redlands - School of Business.
|Kelly Loughner||Boehringer Ingelheim|
Senior Associate Director, Site Enablement
Kelly Loughner is an experienced Senior Associate Director Of Clinical Contracting with a demonstrated history of working in the pharmaceuticals industry. Skilled in Negotiation, Medical Devices, Biotechnology, Management, and Healthcare.
|Andy MacKelfresh||Duke Clinical Research Institute|
Project Leader, Clinical Research Informatics
Andy MacKelfresh is a Project Leader who partners with faculty and clients to advance clinical care by accomplishing research studies that require advanced harmonization of data from networks of clinical and real-world sources. Andy has 17 years’ experience in the clinical trials industry, focusing on innovation and research informatics. Andy holds an MBA, BS in Mathematics, and a Certificate in Clinical Research Conduct and Management.
Global Head, Real World Evidence Strategy
Charles Makin leads Biogen’s Real World Evidence Strategy team, overseeing RWE projects across all therapeutic areas for marketed and pipeline products. Before joining Biogen, Mr. Makin served as the General manager/VP for ICON’s RWE-Late Phase Research unit, the world’s second-largest research group dedicated to prospective data collection; and led the team – comprised of several hundred biostatisticians, medical affairs personnel, project/program managers and data management professionals based in >40 countries – to the 2018 Late-Phase CRO Leadership Award. Prior to that, he held leadership positions in major drug commercialization research companies such as IMS, Mapi and Optum, including the roles of VP/Americas Head, Real-World Strategy and Analytics, Head of Observational Outcomes Research (Americas) and Global Head of Research Design and Proposal Development. He has also worked on the payer side (Anthem and Humana), where he led RWE initiatives, economic evaluations and health outcomes research studies. In nearly two decades in RWE, HEOR and drug commercialization, Mr. Makin has developed and implemented drug value, safety and effectiveness roadmaps for most of the top 20 pharmaceutical companies to influence payers, clinicians and HTA bodies and positively impact market access. He has served as Principal Investigator on over a 100 retrospective database analyses (EMR, linked, claims), global registries, medical chart reviews, economic models, PRO studies, physician surveys, ITC/NMAs, SLRs and GVDs across every major therapeutic area. He has also developed >25 value development plans and product market profiles and published on health policy. He has authored over 70 peer-reviewed manuscripts and scientific presentations, serves on the editorial board for multiple journals, and is an invited speaker at several conferences in the US and EU. Mr. Makin holds a BS in Pharmacy from the University of Pune, an MS in Pharmacy Administration (major in outcomes research) from Purdue University, as well as an MBA (Marketing), summa cum laude, and a Master of Management, summa cum laude, both from Goldey-Beacom College. He has also completed a Pharmacoeconomics and Outcomes research Fellowship from Humana.
|Marina Malikova, PhD||Boston University School of Medicine|
Executive Director, Surgical Translational Research: Operations and Compliance
Marina Malikova, PhD, MSci, MA, CCRA, RAC Executive Director, Surgical Translational Research: Operations and Compliance. Dr. Malikova has over 14 years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology. Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She has a strong background in biomedical sciences and has completed her postdoctoral fellowship in the field of cell signaling and cell migration. She also holds a Master’s Degree in Clinical Investigation, Certification in Project Management from Boston University and board certified in Regulatory Affairs (RAC). In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, strategic planning, and macro-management of research programs. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance. Dr. Malikova has 12 years of teaching experience as an Instructor for Clinical and Biomedical Sciences Program, Metropolitan College. She has developed and taught several courses such as: Design and Conduct of Clinical Trials, Drug Development, Introductory Pharmacology, Clinical Trials Management at Boston University, School of Medicine. She also serves as an Instructor of the Good Clinical Practices (GCPs) course for the Master of Science Program in Clinical Investigation, Division of Graduate Medical Sciences, Boston University, School of Medicine. Dr. Malikova is a member of Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Affairs Professionals Society (RAPS) and European Society of Radiology (ESR).
Chief Product Officer
Fred Martin has built a career in healthcare over the course of nearly two decades, and has developed healthcare systems, BI/Analytics solutions, workflow tools for hospitals, and more. As Chief Product Officer at Medrio, he has overseen the development and release of Medrio eConsent, major upgrades to Medrio eSource, and numerous feature releases in Medrio EDC. Martin holds an MBA from the University of Michigan, Ann Arbor; an MILR from Cornell University; and a BA from the University of Colorado, Boulder.
Senior Resource Manager, Clinical Operations
I started my career in Finance at AT&T back in 1987. I spent 11 years in the Telecommunications business during which time I earned my BA and MBA degrees. In 1998, I moved into the Pharmaceutical business, joining J&J in Raritan, NJ, providing financial support to the clinical teams in preclinical, development and medical affairs. In 2008, I started my career at Bayer Healthcare as the US R&D Controller. Since then, I have moved into the role of Sr. Resource Manager, supporting the Oncology study teams with clinical trial budgeting, forecasting and resource planning. As an integrated member of the study teams, my role often leads to special initiative support such as implementing an automatic site payment solution in the US.
Executive Director, Head of Advanced Science and Collaboration Group
Robert “Joe” Mather is the head of Pfizer’s Advanced Science and Collaboration Group. Joe has over twenty years of pharmaceutical research and development experience. Joe joined the Digital Medicine & Translational Medicine Team after tenures with Pfizer’s and Astra Zeneca’s Neuroscience organizations. Joe is currently leading a group of translational scientists, engineers and project managers engaged in the development of novel digital biomarkers for Pfizer’s Early Clinical Development Organization.
Global Trial Manager
Christine is currently working as a Central Statistical Surveillance Specialist at Janssen Pharmaceuticals, a J&J company. Christine has over 13 years of global clinical trial operational leadership experience between both early and late phase clinical development trials in various therapeutic areas, with a focus in Neuroscience. Christine was an instructor for Clinical Project Management for 3 years as a part of a post-graduate Clinical Research program at Humber College in Toronto. Christine has a MS in Neuroscience from the University of British Columbia and a BS in Physiology with a minor in Chemistry from the University of Toronto.
|Megan McBride, MPH||Janssen, The Pharmaceutical Companies of Johnson & Johnson|
Associate Director, Janssen Clinical Innovation, GCDO, R&D
Megan McBride is an Associate Director with Janssen Clinical Innovation. As part of this core clinical innovation function within Janssen R&D, she leads patient engagement initiatives to drive innovation into the clinical operating model to improve clinical trials for all stakeholders. She currently leads projects focused on data transparency, access and a global trial community for trial participants for Janssen’s R&D programs. With 20+ years’ experience leading global clinical programs in the US, EU, Africa and Asia, Megan has worked across diverse teams and communities, NGOs, global foundations, government organizations and pharma. Building on this diverse background she is dedicated to bringing new perspectives and approaches to the trial process. Megan holds an MPH from the Johns Hopkins University Bloomberg School of Public Health.
|Ann McCabe||Daiichi Sankyo|
Director, Process Excellence & Risk Management
Ann McCabe is currently the Director, Process Excellence & Risk Management at Daiichi Sankyo. She has worked in clinical research for over 20 years at various global pharma, biotech, medical device and consulting companies. She has worked in the areas of Clinical Operations, Quality, Process Improvement and Training and is PROSCI certified. She is currently leading implementation efforts for Risk Based Quality Management (ICH E6 R2), study/partner metrics and CRO Oversight for Daiichi Sankyo. She has Bachelor’s degrees in Biology and Medical Technology from the University of Delaware.
No bio available
|Mary McGowan||The Myositis Association|
With over 35 years of non-profit management experience, Mary McGowan currently serves as Executive Director of The Myositis Association. As the primary representative and spokesperson for this international rare disease advocacy organization serving patients, care partners, families and clinicians, McGowan ensures successful implementation of the strategic direction and increases TMA’s visibility and brand recognition among key audiences nationally. Prior to joining TMA, McGowan served as CEO of WomenHeart the National Coalition for Women with Heart Disease. During her 8 years with WomenHeart, McGowan ensured the organization’s long-term growth and sustainability as the leading voice for the 48 million American women living with or at risk of heart disease. McGowan also served as Executive Director of the Allergy & Asthma Network, the leading nonprofit organization dedicated to eliminating suffering and death due to asthma, allergies and related conditions. She held various positions with the American Academy of Pediatrics during her service of 18 years. McGowan earned a Masters Degree in Human Resources Development from the George Washington University and a B.A. from Trinity University.
|Kelly McKee||Vertex Pharmaceuticals|
Head, Patient Recruitment
Kelly Johnston McKee is a clinical trial innovator and problem solver with a focus on improving the patient experience through patient recruitment, retention, and engagement and currently serves as the Head of Patient Recruitment for Vertex Pharmaceuticals. Kelly has been in the industry for over 20 years with previous positions at Lilly, Merck, and Sanofi-Aventis. She has an in-depth understanding of novel tactics and technology in protocol feasibility, site selection, and patient recruitment as was named Clinical Researcher of the Year by Pharma Times in 2012 and one of Centerwatch’s Top Innovators in 2018.
Associate Director, Clinical Operations
Mike McLaughlin, MS, MSEd, RAC, has over 20 years of clinical research experience working in various roles at both small and large pharmaceutical companies and in a variety of CRO environments. Since 2017, he has served as Associate Director, Clinical Operations at Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in medical dermatology.
|Jyotsna Mehta||Karyopharm Therapeutics|
Senior Director & Head, HEOR
Jyotsna Mehta works at Karyopharm as Senior Director, Head of HEOR. Jyotsna has over 20 years of combined experience in academia, regulatory affairs and pharmaceutical industry working in both global and US roles spanning multiple therapeutic areas with a strong foundation in pharmaceutical sciences, real world evidence, epidemiology, health outcomes, pharmacoeconomics and more recently in digital health and data science. Prior to Karyopharm, Jyotsna launched her own startup that has designed a digital platform to help patients in between their visits to the doctor. She launched the Keva Advisor app for asthma patients on google and android phones in Dec 2018. Prior to that, she worked in various positions in HEOR function at AstraZeneca, Sanofi, EMD Serono and Alkermes contributing to product strategy, evidence generation and market access. She is an Adjunct Associate Professor at the University of Rhode Island and serves on the advisory board of Evidence based toxicology collaboration at John Hopkins University. She was listed by NASDAQ among the top 20 influential entrepreneurs in 2019. She received her MS in Pharmacoeconomics and Pharmacopepidemiology from the University of Rhode Island and a Bachelor’s in Pharmaceutical sciences from University of Mumbai.
Vice President, Global Clinical Sciences and Delivery TA Head of Oncology
As of July 1, 2019, Carrie is the Vice President, Global Clinical & Sciences Delivery TA Head for Oncology reporting at GSK. Carrie has over 20 years of global drug development experience spanning all stages of pharmaceutical research from phase 1 first-in-human trials through phase III global registration and phase IV post-commitment approvals. Her pharmaceutical career began in early development at Pfizer, Inc. where she helped design, run and analyze clinical trials across multiple therapeutic areas before landing in oncology, where she has remained for more than 17 years. She has experience in both small biotech and large pharma, in solid tumor and hematologic malignancies. In her most recent previous role, Carrie was responsible for leading Data Management, Programming, Site Management & Monitoring, Trial Management, eTMF, Sample Management, Clinical Business Operations/Vendor Management and Contracting at TESARO. Prior to TESARO, Carrie was the VP, Head of Clinical Development Operations at Kura Oncology. She has also held positions of increased responsibility at Millennium: The Takeda Oncology Company and EMD Serono. Prior to joining the pharmaceutical industry, she was a neuro-surgical nurse in Connecticut. She holds a BS in Nursing from the University of Rhode Island as well as an MBA from Boston University.
|Carol Millerwzbczfcwvarxvs||spaulding clinical research|
Senior Director, Business Development
No bio available
Matt Miller is President at StudyKIK and has been a leader in the use of digital and social media campaigns for patient recruitment on a single site and multi-site level with experience at a major CRO. Matt has developed cutting edge techniques to patient recruitment using social media for various therapeutic areas and disease states.
|Xiaoyao Conny Mo, MD||Beijing Renheguangtong (RHGT) Co., Ltd.|
Partner, Lead of Medical Safety Consulting
Xiaoyao Conny MO is partner, lead of medical safety consulting in Beijing Renheguangtong (RHGT) Co., Ltd. She provides medical safety consulting and pharmacovigilance (PV) services to industry, regulators and HCPs. She has approximately 18 years international leading biopharmaceutical companies working experience ranging from clinical research, medical information to Pharmacovigilance in J&J/Pfizer/Merck/AZ China medical and Global R&D. Xiaoyao is PV executives with expertise in medical safety, risk management, operational excellence and compliance. She plays a leadership role for internal and external partnerships, brings global and international perspective to medical safety sciences and practices through her insights and intimate understanding of medical product safety laws, regulations and standards. Xiaoyao lead China Industry PV working stream in RDPAC (R&D based Pharmaceutical Association Committee) from 2004 to 2014. She was invited by CFDA as ICH expertise, Multidisciplinary group, China CFDA ICH Study Group from 2009-2012. She reviewed the translations of ICH clinical safety sections from English to Chinese in 2006-2007. She was core teaching faculty and key PV program trainer for NMPA Executive Development Center. Prior to industry, she was a respiratory physician practiced in Beijing Xuanwu Hospital, China.
|David Morin, MD FACP CPI FACRP||Holston Medical Group|
Director, Research, Clinical Research
Dr. David Morin has participated as a Principal Investigator in hundreds of studies (Phase I-IV) since 1989. A Certified Principal Investigator (CPI) since 2007 and an ACRP Credentialed Clinical Research Trainer (CCRT) in 2010. He received the “Outstanding Physician Leadership in the Profession” award by ACRP 2012. He currently serves on the ACRP Board of Trustees and the Academy Board. He is a member of the ACRP Governance and Awards &Recognition Committee. He also served on the CPI committee. He is a chief instructor for ACRP and also assists with the development of educational programs. He achieved his pharmacy and medicine degree with honors, and completed residency training at the University of Virginia in Charlottesville. More recently, he studied computer science at Northwestern University. He is Board Certified in Internal Medicine and is a Fellow of the American College of Physicians. He continues to practice medicine and is the Director of Research for Holston Medical Group, a large physician owned multispecialty practice headquartered in Kingsport, TN. He co-founded several companies including Trike, LLC which developed SiteOptex™ software, a proprietary methodology aimed at improving the efficiency of clinical research.Past activities included serving as a teaching attending for the ETSU College of Medicine, employee health director for a large hospital system, medical director of a CRO and an Accountable Care Organization. Also as a pharmaceutical consultant, speaker, author, and protocol writer.
Senior Manager, Systems, Analytics & Reporting, Business Operations
Laila Mork has been working in the pharmaceutical industry for over 15 years spanning clinical data management, clinical trial operations, and drug development operations. She has a masters in public health in biostatistics and epidemiology from Loma Linda University and is passionate about data analytics and process improvement.
|Matthew Moyer, MS, MBA||Merck & Co., Inc.|
PMP, Director, Clinical Supply Technology, Global Clinical Supply
Matthew Moyer has 16 years of pharmaceutical development experience and is Director of Clinical Supply Technology for Merck. Matt is the central point of contact for all of Merck’s clinical supply innovation efforts, leading the incorporation of new packaging, labeling, distribution, and other enabling technologies to drive more informed and timely decisions related to the conduct of clinical trials. Matt also leads the TransCelerate Patient Technology initiative, aimed at enabling and accelerating the use of patient-facing technology to improve the science and convenience of clinical trials. Matt earned a BS in Chemistry from Albright College, an MS in Pharmaceutical Sciences from Temple University, an MBA from Lehigh University, and is certified in Project Management (PMP).
Senior Vice President, Head, Clinical Business Development
John Musante is currently SVP of QPS a global leader in Pre-Clinical and Clinical Services and heads up Global Business Development. John is a career operations executive with deep experience in all aspects of the pharmaceutical P&L and commercial operations with more than thirty years, in both public and privately owned companies in Pharmaceutical, Healthcare IT and Clinical Research . His experiences have afforded him the opportunity to participate in leadership roles through challenging business growth cycles building for the future. He has have provided strategic leadership support in operational re-structuring, business development, clinical operations, supply chain, and commercial operations. Specific activities included company and product licensing and acquisitions, commercial operations, marketing, and early & late stage pharmaceutical clinical business development. He has joined companies tasked with the responsibility to integrate functions, build strong teams and develop new strategies for growth.
|Laurie Myers, MBA||Merck & Co., Inc.|
Global Health Literacy Director, Global Population Health
Since 2010, Laurie has led Merck’s global health literacy efforts in support of improved patient communications, including medication labeling, packaging, clinical trial materials, lay summaries, and patient education. Laurie has worked to include respondents with low health literacy into patient labeling research, earning a national health literacy award. She works and speaks internationally. She has co-chaired two US working groups on lay summaries and health literacy in clinical trials, at the MRCT (Multi-Regional Clinical Trials Center of Brigham and Women’s and Harvard). She served as an invited member of the EMA lay summaries working group, where she helped to influence guidance to reflect principles of health literacy, numeracy, and readability. She did a plenary session at the 2017 Asia Health Literacy Conference and recently at an EU labeling conference, highlighting global best practices in patient labeling. She was an invited speaker by the FDA at a 2017 labeling conference, with an international audience of over 2000 people in 42 countries. She has co-authored multiple publications, and serves on the US National Academies Health Literacy Roundtable. She won an MM&M Top 40 Healthcare Transformers Award in 2018. She has a Bachelor’s degree from Yale and an MBA from Wharton.
Head, Operational Intelligence and Innovation
Jane is the Head, Operational Intelligence and Innovation for Roche, working at Genentech. Her passion is driving innovation into the way we design and execute trials to get medicines to patients faster. She's worked at Genentech for 17 years in many roles, including line manager and a operational program manager. In prior lives she held various roles in global trial management at QLT, Sanofi and Lilly. She's a Canuck who loves San Francisco and the ocean.
Manager, Clinical Biospecimen Operations
Matthew Nguyen has been at BioMarin Pharmaceutical Inc. for 3 years and manages the operations section of the Clinical Biospecimen Management Group. He started his career as a Clinical Research Coordinator and uses his coordinator experience to provide a site-level perspective in order to enhance the biospecimen management process.
|Graham Nicholls||Almac Group|
Graham Nicholls, as Director of Biostatistics at Almac Clinical Technologies, leads the Biostatistics Group responsible for providing consultancy advice on randomization methodology and IXRS® (IRT) implementation. He has over 18 years of experience working within IRT companies (>10 years at Almac). Graham holds a Bachelor of Science in statistics from the University of Newcastle-upon-Tyne, UK, and a Master’s of Science in Biometry from the University of Reading, UK.
Global Director, Patient Services, Patient Services
Prior to working in the pharmaceutical industry, Valeria has developed an international legal background, completing a law degree with a focus on the European and International legislation. She is now responsible for complete set-up and leadership of the patient retention division “patient primary” providing global solutions to reduce the burden of patient participation and maximize clinical trial success. Patient primary identifies pharma and patient needs and provides a variety of innovative solutions to match them.
|Mike Nolte||Signant Health|
Mike Nolte is a seasoned operational leader whose career spans the healthcare, technology and financial services industries. Previously, Mike has served in executive leadership roles at Influence Health, MedAssets, GE Healthcare IT, and McKinsey & Company. He started his career as a U.S. Army Officer for an airborne, rapid deployment, medical supply chain and maintenance organization. Mike holds an MBA from The University of Chicago Booth School of Business and a Bachelors from Notre Dame.
|Tamara O'Black, JD||Minneapolis Heart Institute Foundation (MHIF)|
Sr. Director, Compliance, Quality & Regulatory
Tam O’Black is the Senior Director of Compliance, Quality & Regulatory at the Minneapolis Heart Institute Foundation®. With more than 25 years of experience working and consulting for and with IRBs, sites and sponsors in the areas of research operations, compliance, program development and strategic planning, monitoring and auditing, and contract review and negotiation, she provides insight on the tools, resources, infrastructure and culture necessary to support quality research.
Senior Director, Clinical Operations
I have been working in the pharmaceutical industry for nearly 20 years. My main area of focus has primarily been in clinical operations where I have managed various phases of development from an IND filing up through a successful NDA approval. I have covered several therapeutic areas, including oncology, anemia, idiopathic pulmonary fibrosis and rare disease indications in pediatric populations. In addition to clinical operations, I have extensive experience in clinical budgeting, vendor selection and governance activities supporting programs that ranged from large Phase 3 global studies to small rare orphan pediatric studies. I believe that clear and consistent communication across all active contributors sets the foundation for any clinical study. Without it, studies likely fail, get delayed and in the end cost more with regards to time, resources and money for everyone involved in the study.
Director, Metrics and Performance, GMD
No bio available
|Richard O'Hara||Endo Pharmaceuticals, Inc|
Director, Clinical Business Operations, Clinical Operations
Rick O’Hara has been an Associate Director of Project Management and Business Operations at Endo Pharmaceuticals since February of 2012. Prior to this role, Rick spent about 13 years at Johnson & Johnson in various clinical outsourcing roles. His experience at J&J spanned across many therapeutic areas and all phases of clinical research. He also worked on J&J’s FSP models. Before J&J, Rick spent 2 years at Covance as a Business Manager and 4 years at the University of Pennsylvania as a Business Administrator. The early part of Rick’s career was spent performing various financial management roles within the banking industry. Rick holds both a BS and an MBA from St. Joseph’s University in Philadelphia and he lives in Rydal PA.
Associate Director, Site Partnerships
Chrystal is the US Development Operations Site Development Lead working within the AstraZeneca team responsible for Phase I through Phase III programs. Recognizing that success of the 2017 AZ US insourced management strategy hinged on building partnerships with key clinical research sites, she has capitalized on the talent within the US Team by developing and deploying site liaisons at over 50 community healthcare systems and academic institutions. The liaison role is designed to build sustainable partnerships based on mutual accountability, transparency and solution focused action. She diligently pursues opportunities to exemplify AstraZeneca’s commitment to be the industries Sponsor of Choice by leading staff attendance at professional meetings, serving on cross industry work groups and championing internal programs to industrialize site and trial management. Chrystal joined MedImmune in 2016 prior to transitioning to US team in 2017. Previously she worked in the transplant community for 20 years as a UNOS reginal director championing transplant hospital and organ procurement agency collaboration and as a transplant administrator with two academic institutions. Locally, she chairs several committees and leads fundraising activities for a children’s cancer organization whose mission is to improve the lives of the children and families undergoing treatment through support, assistance and kindness. Day to day she serves as the personal chauffeur to three children, a patient husband and incorrigible French bulldog.
|Ken Olovich||Eli Lilly and Company|
Director, Sourcing and Finance, Chorus Division
Mr. Ken Olovich is the Chief Financial and Procurement Officer for Chorus. Ken has over 23 years of pharmaceutical research experience. As one of the original founding members of The Chorus Group in 2002, Ken can be credited with designing and implementing much of the Chorus approach to clinical vendor relations, contracting, finance and budgeting, quality, and general operations.Prior to Chorus, Mr. Olovich served as Team Leader for Clinical Trial Operations in the Neuroscience Therapeutic Area where he supervised clinical associates and support staff in the planning and implementation of phase I/II neurology and psychiatry clinical trials. Prior to that role, Mr. Olovich was the Clinical Sourcing Team Leader within the Lilly Procurement division. Ken earned his Masters of Business Administration from Indiana Wesleyan University and his Bachelor of Pharmacy from Purdue University.
Senior Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development
Brendan is the Sr. Director of Pfizer’s Patient Recruitment Team. Brendan has 15 years of patient recruitment experience from the CRO and Sponsor sides. He has his BS in Pharmaceutical Marketing and Masters in Clinical Trials Sciences.
|Carlos Orantes||Meridien Research|
Mr. Orantes joined the Meridien site network as their CEO on April of 2019 to lead their expanding business across North America. He brings over 25 years of experience in the drug development industry including CROs, Clinical Site and other development services including executive and operational management, process re-engineering, compliance and business development. Prior to joining Meridien he was the CEO of Accel Research, where he led the expansion of their North American site network business. Prior to that, his roles included COO of Frontage Laboratories, CEO of AVANZA Laboratories, GM/VP for Bridge Laboratories, and various roles at Covance covering operations, quality assurance, process improvement and management roles of increasing responsibility. Mr. Orantes earned an MBA from Old Dominion University, and a BS in biology from George Washington University. He is Six Sigma Black Belt certified from the Six Sigma Academy.
|Julian Ortiz||Janssen Research and Development|
Associate Director, Risk Management and Central Monitoring, Infectious Diseases and Vaccines, Integrated Data Analytics and Reporting
Julian Ortiz is an Associate Director in Risk Management and Central Monitoring team in the Janssen pharmaceutical companies. He has worked for Janssen since 2007 as CRA, senior CRA, LTM, Specialist Central Monitor, senior specialist CM and Manager CM. He has extensive experience in clinical trials field work and in central monitoring activities. He is actively working with data for new technologies and machine learning to improve the efficiency and quality of clinical trials monitoring activities.
Associate Director, Vendor Management
No bio available
|Ozgur Ozkan, PhD||Janssen|
IT Director, Clinical Decision Support
Ozgur Ozkan, PhD is a Decision Science Director with Biometrics and Information Sciences group at AstraZeneca Pharmaceuticals. His work is focused on modeling of clinical development processes and implementation of decision analysis methods and tools. He helped drug development teams in a various therapy areas including cardiovascular and metabolic disease, respiratory, oncology and neuroscience. Prior to AZ, Ozgur spent five years at Health Market Science developing data and analytics solutions to help with commercial strategy. Earlier in his career, he led the development of simulation-based training and decision-support solutions at a consulting firm.
|John Page, MD, ScD||Amgen|
Medical Director and Lead of Predictive Analytics, Center for Observational Research
John leads the Predictive Analytics Group within the Center for Observational Research at Amgen and was previously on faculty at Harvard University and University of Newcastle, Australia. Has completed ScD in Epidemiologic Methods and Biostatistics (Harvard), MSc in Medical Statistics (London School of Hygiene and Tropical Medicine), medical degree (University of West Indies), and Internal Medicine residency (Albert Einstein College of Medicine)
Senior Manager, Business Analytics and Resource Management
No bio available
|Ramya Palacholla, MD||Partners HealthCare Pivot Labs|
Ramya Palacholla is a Physician and one of the Lead Scientists at Partners Healthcare Pivot Labs. She is also a faculty member of the Harvard Medical School. Currently, Dr. Palacholla works with a multidisciplinary team that develops and executes digital health strategy and research projects in collaboration with top pharmaceutical, research and medical technology companies. She is passionate about her research focused on validation of innovative health technology solutions for improving patient lives. Dr. Palacholla has published her work in several health care journals and presented her research on innovative technologies on international platforms such as the World Economic Forum (also presented at the G8 Summit), served as a reviewer for health technology journals, and spoken at national conferences as a thought leader in the field of health care research and innovation.
|Raj Pallapothu||Bayer Pharmaceuticals|
mHealth Global Business Lead, mHealth Global Advocate
Raj Pallapothu is Global Business Lead for mHealth Connected Platform at Bayer Pharma USA. He has responsibility in designing, developing and commercialize world’s first data source agnostic mHealth ecosystem in supporting next generation Clinical trials whilst setting up transformative business processes, compliance framework – by leveraging advanced Platform technologies, Data Science & Analytic tools. Raj is a trained Medical Doctor from Australia & Health Care Entrepreneur with close to 2 decades of experience in Strategies & Partnerships, Technologies and Product Management. Prior joining Bayer, he had the pleasure of working with tens of Global Enterprises in the space of Consumer Health Care, Device manufacturing, Precision Health, Tele-Medicine, Wireless technology firms along with Startup’s and Venture Capitalist firms. Raj visited 5000+ Hospitals & Specialty Clinics in various countries like USA, Canada, Brazil, Kenya, South Africa, India, China, Taiwan, South Korea, Singapore, UK, France, Germany, Switzerland, Australia etc, and participated in multiple international Government’s led missions.
Senior Director, MC2 Global Monitoring & Clinical Operations (Japan & China)
Vinod has a 19-year career as a business leader, lean-six sigma coach and process innovation expert in the biotechnology, automotive and aerospace industries. Vinod had worked for 10 years in the automotive industry becoming an expert in the Toyota Production system. Vinod than transitioned his expertise to the Healthcare industry starting with Covidien and now with Medtronic in deploying innovative thinking and process management across the clinical research operations organization. Vinod has been the leader of the global Monitoring organization within Medtronic’s operations group for the past 4 years where Risk Based Monitoring has become widely adopted in clinical trial execution. Vinod is a mechanical engineer and speaks 5 languages.
Director, Clinical Data Management, Data Operations
With over 18 years of Data Management experience in Healthcare & Clinical Research, Arun has a passion for transforming the healthcare data acquisition, analysis & reporting processes with a purpose to expedite the drug development process enabling access to life changing medicines sooner to our society. He has been associated with Novartis since last 13 years & currently leading the Data Management innovation workstream. He has been instrumental in pioneering modern automation techniques like RPA, NLP, ML & AI in Data Operations and is seen as one of the thought leaders in embracing digital transformation.
Contract Coordinator, Clinical Planning & Resource Management
Gisele is a Contract Coordinator who works with Abbott Nutrition’s R&D Scientific & Medical Affairs department managing resources and projects. Gisele believes mastering resource management is the key to happiness. Gisele has worked at Abbott Nutrition for over 10 years. Gisele holds a Masters of Business Administration from the Ohio University.
Senior Director, Precision Medicine, Experimental Medicine Unit
Dr. Piccoli is a recognized international expert in clinical biomarkers with extensive contributions to in vitro diagnostics (IVD) and clinical chemistry. He joined GSK in 2018 as Head, Clinical Biomarkers, Oncology, and is currently Senior Director in Precision Medicine and Companion Diagnostics. Prior, he has successfully led clinical and analytical teams in the pharmaceutical, biotechnology, and medical/companion diagnostics industries at Novartis, J&J, and BMS, and founded three biotechnology companies including a CLIA regulated CRO to conduct medical device trials and accelerate IVD submissions to the FDA. In addition, he has served on the Medical Devices Panel in Immunology of the FDA (CDRH) and is engaged in public/private partnerships (Critical Path Institute, Predictive Safety Testing Consortium, FNIH, Biomarkers Consortium, Alzheimer's Drug Discovery Foundation, and Bill Gates Catalyst 3), and is senior author of the C-Path white paper to advance and harmonize scientific and regulatory aspects of biomarker qualification for regulatory submissions.
Matt steers physIQ's product roadmap, focusing on the future of medicine at the intersection of machine learning and clinical applications. In addition to his role as CTO at physIQ, Matt has run the company’s clinical trials and was the regulatory lead for the company’s foundational FDA clearance.
Global Director, Contract Management and Monitoring Operations
A strategic, results driven finance and operations executive leader with significant diversified global experience with increasing levels of managerial responsibility in the pharmaceutical, life sciences and biotech industries. Experience in financial management, controlling, R&D, financial planning & analysis, budgeting & forecasting, accounting, clinical development, process improvement, project management, contract management and change management. Customer focused, innovative, strategic, hands-on manager with strong communication and leadership skills and a record of success in directing, motivating teams to achieve results in a multi-national matrix corporate environment.
|Angela Radcliffe||Capgemini Invent|
R&D Practice Lead, Life Science
Angela Radcliffe is a brand transformer who has been innovating in healthcare for over two decades. She is committed to the pursuit of more authentic patient engagement, giving data ownership back to consumers, the promotion of health literacy for all, and normalizing clinical research a care option.
Director, Regulatory Affairs - Devices and Digital Health
Suraj Ramachandran, MS, RAC, is a Director, Regulatory Affairs in the Device and Digital Health Center of Excellence at Merck based in Rahway, NJ. With over 10 years of experience, Suraj is currently responsible for supporting various medical devices and combination products, such as auto injectors, prefilled syringes, inhalers and contraceptives. In addition, he is heavily involved in providing guidance for digital solutions and has led many development efforts regarding medical device software, intended for both domestic and international markets. In previous industry roles, he was responsible for an infusion pump platform as well as supporting all new product development and lifecycle maintenance activities including regulatory submissions, design control, audits, and CAPAs. Suraj is also an active participant on the TransCelerate Patient Technology Workstream and leads the Regulatory sub team within this initiative. Suraj holds both a Bachelor’s and Master’s Degree in Biomedical Engineering from the University of Michigan. In addition, he has earned the RAPS RAC certification.
Head, AI & Data Science, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development
Prasanna Rao is an AI practitioner and Industry Thought Leader whose current role is the Head of Artificial Intelligence and Data Science for Data Management and Monitoring at Pfizer. He has over 25 years of experience in Information technology and Analytics, with 10 years in Healthcare and Life Sciences. In his previous role as a Watson Architect at IBM Watson Health, he was instrumental in implementing Watson Clinical Trial Matching, an Artificial Intelligence solution used by several Provider institutions to match patients to trials. He has also participated in a Transcelerate POC initiative for downstream automation of Common Protocol Template. He has researched several use cases in Clinical Development and evaluated various AI/ML techniques to solve these challenging use cases.
Director, Head, Clinical Outsourcing
Ratan Ratnesh is a director and head of clinical outsourcing at Otsuka. Prior to joining Otsuka, Ratan worked at Wyeth and Novartis where he managed different categories related to clinical outsourcing. Ratan has broad experience in strategic sourcing, clinical outsourcing, operations and supply chain improvements in Fortune 500 and growth companies. He started his career in management consulting specializing in supply chain across different industries and moved to clinical outsourcing in early 2000. He received his Bachelors in Mechanical Engineering from National Institute of Technology, India and an MBA from University of Louisiana.
|Jim Reilly||Veeva Systems|
Vice President, Vault Clinica
As Vice President of Clinical Market Strategy at Veeva, Jim is responsible for customer engagement, market adoption, and strategic alliances. For the last 15 years, Jim has held a variety of senior positions in life sciences technology, where he has led software delivery and sales efforts in clinical operations, regulatory, clinical data standards, and content management.
|Debra Reinhard||Bristol-Myers Squibb|
Head, TM Enabling Solutions, Translational Medicine
A sought-after speaker and subject matter expert with over 29 years’ experience in the Pharmaceutical industry, Deb’s career has spanned Corporate and R&D Finance and strategy, as well as broad Informatics roles in support of Research and Development. Leveraging her training as a Six Sigma Black Belt and a Lean Sigma Kaizen Leader, she brings to her current role as Head of Translational Medicine Enabling Solutions a strong process and program management background. Her organization drives the development and execution of translational and clinical sampling strategies from Discovery through Life Cycle management trial execution as well as Translational Research and Integrated Sciences. She is responsible for evolving the capability of the BMS biorepository, redesigning informed consent processes and tools, and ensuring robust operational interfaces with specialty labs, academic labs and key opinion leaders for Clinical Biomarkers and Imaging modalities. Her experience led to Deb’s appointment as a core member of TransCelerate’s eConsent initiative to create an industry aligned position on consent processes and technologies.
|Karen Renzi||Praxis Communications, LLC|
Director of Strategy
Karen Renzi has led all patient recruitment and retention strategy development since joining Praxis in 2016. Along with a dedicated strategy team, Renzi coordinates tactical efforts across other key in-house agency departments (analytics, media, PR, digital, operations) as well as leveraging strategic partners to craft customized recommendations for each study we support. Renzi has 20 years of multi-channel marketing experience, with a strong emphasis on digital channels.
Associate Director, Global Strategic Sourcing
Todd has over twenty five years of experience in the pharmaceutical/biotech industry, mostly within clinical development and outsourcing. He has successfully held positions which focus on scientific research, clinical operations, supplier governance and team management resulting in a well-rounded perspective and understanding of drug development and how best to leverage the power of outsourcing. On the personal side, Todd grew up in upstate New York and earned a BS in Chemistry from the University of New Hampshire. After a few years working on the East Coast, he moved out west and has been living/working in the San Francisco Bay Area ever since. Currently, Todd lives in beautiful Sonoma County with his wife and dogs.
Manager, Clinical Analytics, Data and Statistical Science, Research & Development
Erin Reynolds is passionate about discovering the underlying story in data, while motivating others to get excited about the power in telling that story. She earned her MS in Applied Probability and Statistics from Northern Illinois University, and has five years of experience in the biopharmaceutical industry. Erin is a manager on the Clinical Analytics team at AbbVie and is a lead on the cross-functional team that implemented Risk Based Monitoring.
|Jennifer Ribeiro||Bristol-Myers Squibb|
Informed Consent Process Lead, Global Clinical Documentation & Submissions, Global Clinical Operations
Jennifer has been with Bristol-Myers Squibb for 15 years and has held various roles across the organization. The majority of her experience is in sample management and her passion is informed consent. Currently she is the global process lead for informed consent managing the framework across BMS. She has an undergraduate degree in Biology & her MBA.
|Meg Richards, PhD||PRA Health Sciences|
Executive Director, Real World Solutions
Margaret (Meg) Richards, PhD, MPH, Executive Director, Real World Solutions, joined PRA with over 30 years' experience as an epidemiologist and health services researcher in both the public and private sectors.
|Lindsey Riley||The Michael J. Fox Foundation for Parkinson's Research|
Senior Associate Director, Research Partnerships
Lindsey has a multi-disciplinary public health background and 10+ years of experience managing clinical and translational research in both academic and non-profit research settings. Since joining the Michael J. Fox Foundation in 2016, she has managed several MJFF-sponsored cohort studies, and focuses primarily on study operations & strategic planning. Lindsey graduated from Washington College with a BA in Psychology and holds a Masters in Public Health from New York University.
Senior Manager, Clinical Pricing & Payments
Joe Robbins has over 12 years experience working in clinical trial budgeting and site payments working on multiple cross functional projects to optimise clinical trial delivery.
Associate Director, Clinical Outsourcing
No bio available
|Krupa Rocks||Abbott Medical Devices Division|
Associate Director, Clinical Data Systems
Krupa Rocks is Associate Director, Clinical Data Systems at Abbott Medical Devices division, located in Sylmar, California, where she is responsible for leading the development of custom integrated solutions to assist both sponsor as well as site personnel in managing clinical trials. These solutions include web-based platforms, mobile platforms, and backend integrations to solve a wide spectrum of business needs ranging from data visualizations and clinical trial maintenance to physician and site facing applications. Krupa has been with Abbott (formerly, St. Jude Medical) for 16 years where she started her career as a Clinical Data Analyst. She worked her way up into Software Engineering which is her biggest passion. Krupa has a Bachelor’s degree in Computer Science and a Master’s in Biomedical Engineering, specializing in Medical Informatics.
Patient Recruitment & Retention Lead
Samantha Rogers is a Patient Recruitment & Retention Lead at Takeda, where she develops and executes recruitment and retention campaigns for clinical studies, and is a member of Takeda’s cross-functional Patient Centricity team. Prior to joining Shire in 2016, Sam worked at a patient recruitment agency and has a background in health promotions and public health. Outside of work, Sam enjoys spending time with family and friends, playing tennis, traveling, and reading.
|Christina Román, MPH||Cystic Fibrosis Foundation|
Senior Community Engagement Manager, Community Partnerships
As Senior Community Engagement Manager for the Cystic Fibrosis Foundation, Christina Román works to help embed the voice of the patient community into the work of the Foundation. Before joining the Community Partnerships team Christina worked on the Clinical Trials team for 3 years and at Colorado Children’s Hospital for 2 years supporting the cystic fibrosis team. She holds a master's degree in public health from the University of Colorado. Originally from Estes Park, Colo., Christina now lives in Washington, D.C. with her husband and daughter.
|Len Rosenberg, PhD, RPh||The Leukemia & Lymphoma Society/Beat AML LLC|
Head, Clinical Operations
Dr. Rosenberg is Head, Clinical Operations at Beat AML, of The Leukemia & Lymphoma Society and also Managing Partner of eP2Consulting. He brings 30+ years of BioPharma and CRO experience. With his diverse background, he brings tremendous insights to optimizing the drug development cycle and leveraging innovative technologies and solutions.
|Bennett Rosenthal||SOPHiA GENETICS|
Product Manager, Biopharma
Bennett Rosenthal is a Product Manager for the BioPharma business unit at SOPHiA GENETICS. Bennett has spent his career in roles centered around partnership and business development, most recently with an emphasis on digital strategy, patient recruitment, and site selection. Bennett studied at the University of North Carolina at Wilmington, earning a bachelor’s degree in business administration. Bennett is passionate about improving the lives and health of patients around the world by providing access to treatment.
|Jennifer Ross||Almac Group|
Jennifer Ross is a Lead Biostatistician at Almac Clinical Technologies, where she provides statistical consultancy on randomization methodology and IXRS® implementation. Jennifer has over 11 years of IXRS. Biostatistics experience. Jennifer holds a Bachelor of Arts in Psychology from LaSalle University, a Master of Science in Statistics and a Master of Philosophy in Education in Psychometrics from the University of Pennsylvania.
|Audrey Rossow||ARossow Consulting|
Audrey Rossow is the owner of A Rossow Consulting, LLC located in central Massachusetts. She has 25+ years’ experience in pharmaceutical and biotech clinical development, Phases 1 through 3b. Her core work is in project management and clinical operations. She is passionate about site engagement and support, patient recruitment and retention, and sponsor oversight of their CROs. She can be reached at firstname.lastname@example.org and her website is http://www.arossowconsulting.com.
|Sharin Roth||Otsuka Pharmaceutical Companies|
Director, Clinical Pharmacology, Bioanalysis
Sharin Roth is Director of Clinical Pharmacology, Bioanalysis and Biomarkers at Otsuka Pharmaceutical Development & Commercialization. She has worked in the pharmaceutical industry for 14 years on development of both small chemical entities and biologics. She received a Master’s in Analytical Chemistry at University of California, Riverside where she studied separation sciences. She currently manages a biorespository at Otsuka, which includes specimens collected in clinical trials.
|Jonathan Rowe, PhD, MS, MA||Pfizer|
Executive Director & Head, Quality Performance and Risk Management
Jonathan Rowe has 20 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Head of Clinical Development Quality Performance and Risk Management at Pfizer, where his responsibilities include monitoring, modeling and predicting the Pfizer GCP Quality Management System, leading the analysis of Pfizer’s Clinical Trial Quality Performance and ensuring clinical trial quality risk management is built into all trials. At Pfizer he has held a number of roles including Clinical Director, with responsibility for the Phase IIIb and IV Lipitor program; Director, Intellectual Property Strategy Management; and Senior Director of Process and Performance. Jonathan spent a number of years in “small pharma” as the Head of Intellectual Property and Portfolio Strategy for Amarin and Dignity Sciences. Jonathan earned his PhD and MS at the Albert Einstein College of Medicine and his M.A. from Binghamton University.
|Thorsten Ruppert||Association of Research-Based Pharmaceutical Companies (vfa)|
Senior Manager, Research, Development and Innovation
Dr. Thorsten Ruppert is senior manager for research, development and innovation in the Association of Research-Based Pharmaceutical Companies - vfa. In 1999 he received a doctorate in biochemistry at the Free University in Berlin. Also in 1999 he joined NOXXON Pharma AG as a scientist in the Department of Research & Development. From there he moved internally in the clinical research department and in 2002 he became Director of Scientific Marketing, Division of Business Development. In 2004 he joined the vfa, where as Senior Manager Research, Development & Innovation he is responsible for a clinical trials, personalized medicine and biobanking.
|Claire Russell||PRA Health Sciences|
Executive Director, Patient Experience
Claire is a strategic digital, traditional and social media marketing communications executive with over 20 years of experience working within both global agency and in-house corporate environments. Her transition from consumer-driven digital and social media marketing campaign design to patient-centered digital-engagement strategies, began 8 years ago as one of the founding members of a Digital Patient unit for a global CRO.
|Leily Saadat-Lajevardi||Janssen R&D|
Team Leader, Clinical Insights & Experience Group
Leily Saadat-Lajevardi is a Program Team Leader within the Clinical Insights & Experience Group in Janssen R&D. In this role, Leily oversees the patient and site engagement efforts across the Oncology, Cardiovascular & Metabolics and Neuroscience therapeutic areas. Her team serves as the patient recruitment/retention and site engagement SMEs supporting the clinical operations and clinical teams at the study and program levels. Prior to this role, Leily worked in Marketing within the Self-Care division of the Consumer Sector within Johnson & Johnson.
|David Sall||Patient Enrollment Advisors|
President & CEO; Co-Creator of the SCOPE Participant Engagement Award
No bio available
Director, Portfolio Relationship Management, R&D Procurement
As Director, John is responsible for leading the R&D Procurement Department’s Supplier Relationship Management team at Astellas Pharma US, Inc. in the management of Phases II - IV clinical supplier enterprise level relationships in support of the Medical & Development pipeline. At the enterprise level, John's team partners with Vendor Managers, business stakeholders/executives and clinical suppliers to maximize value creation and capture through the management of supplier risk, performance, relationships and capabilities. John graduated magna cum laude from Fairleigh Dickinson University, College at Florham earning a B.Sc. in Chemistry and was awarded the American Institute of Chemists Student Award by the Maxwell Becton College of Arts and Sciences. He holds a Juris Doctorate from Rutgers Law School-Newark and is a graduate of the law school's Minority Student Program. John is a trained Lean Six Sigma Black Belt and is pursuing his certification. John gives credit to the Rahway, NJ school system's Minorities in Engineering Program for motivating him, as a young student, to pursue a career in the pharmaceutical industry. John's work philosophy is to be a humble leader, own your strategy and be willing to take risks to challenge conventional thinking.
|Maryanne Santilli||Novo Nordisk|
Senior Director, Scientific Alliance Management
No bio available
|Miranu Sasu, PhD||Janssen|
Clinical Operations and Data Science
No bio available
|Richard Scaife||Pharmaceutical Contract Management Group (PCMG)|
Richard worked as an Intensive Care Unit Nurse in the UK and Saudi Arabia, managed a British Aerospace Medical Centre in Saudi, returning to the UK in 1990 to join Ciba-Geigy in Pharma sales roles, Sales Management and ultimately CNS portfolio Brand Management. He moved to the CRO sector in 1997 with Covance, then Fisher Clinical Services in Health Economics/Reimbursement and Marketing roles, then leading a BD and Proposals unit at Quintiles before joining Daiichi-Sankyo in 2005. The following thirteen years in clinical development outsourcing (moving to Mitsubishi Tanabe Pharma in 2009 to become Global Outsourcing Lead) have included EU and global level achievements ranging from creating a new outsourcing and contracts function, negotiating global CRO agreements whilst building long-term, effective, CRO working relationships. Since January 2017 Richard has been working on a freelance basis with financial, pharma and biotech companies on a broad range of clinical outsourcing projects whilst continuing his role as Committee Chair for the PCMG since 2013, having joined this Pharma outsourcing association in 2006.
Executive Director, Clinical Operations
Doug is an Executive Director in Development Operations at AstraZeneca. Heading up US Site Management and Monitoring for Phase I through III programs, he oversees a group of 280 people who are both regionally and headquarters-based and responsible for site selection, contracting, start-up, eTMF and CTMS maintenance, monitoring and project leadership. Doug led the transformation to an in-house monitoring group in 2017 and was the proud recipient of the Society for Clinical Research Sites Eagle Award for best sponsor in 2018. Additional contributions and roles have included leading late-phase, full-service outsourcing (SCOUT), development and implementation of the late-phase sourcing strategy and implementation of risk-based quality management for the AstraZeneca enterprise. Joining AstraZeneca in 2015, Doug previously worked at Pfizer for 17 years and Eli Lilly and Company for 8 years, having held a wide variety of positions in clinical research, including clinical development, project management, portfolio management and data management.
Associate Director, Program Lead for Phase I Studies
Mark has over 20 years of experience in clinical research. After spending several years conducting benchtop research across multiple solid organ transplantation programs, he became a study coordinator for ICU trials. For the past 14 years, Mark has worked in the pharmaceutical industry as a monitor and has held various lead positions. As a Program Lead for Phase I studies, Mark leads the internal and outsourced site management and monitoring personnel across all activities from site qualification and start-up through database lock. Mark was integral with developing the Risk Based Monitoring model implemented at Allergan for Phase I studies.
DVM, MBA, CEO
Dr. Laurent Schockmel is a 30-year veteran of the life sciences, technology, data, and services industries. Laurent has deep experience in clinical, commercial, data, and technology and has held executive management positions at organizations such as Truveris, IMS Health, Cegedim, and Gemini Consulting. Laurent is currently the CEO of Antidote.
|Jessica Scott, MD, JD||Takeda|
Head, R&D, Patient Engagement
Jessica oversees Patient Engagement (PE) across Takeda R&D. Jessica’s team partners closely with researchers and study teams in Neuroscience, Gastroenterology, Oncology and Rare Disease on a global level to bring the perspective of those living with conditions in these disease areas to partner with Takeda in the development of new medicines. In addition to embedding patient engagement in R&D, Jessica and her team also partner closely with Patient Advocacy and the Patient Recruitment and Retention Team to support delivery of medicines of value to patients. Jessica brings to Takeda a unique combination of medicine and law, together with innovative thinking in rapidly changing environments with the goal of improving the lives of patients. She joins us from GSK where she was Director, Medical Policy and Advocacy, where she led numerous efforts related to patient-centricity, including the development of a novel approach to sharing individual results with study participants, optimizing the clinical trial experience and developing the science of patient input. In 2011, before joining GSK, Jessica pioneered the development and implementation of an innovative program for improving patient outcomes through early dispute resolution in her role as Director, Healthcare ADR Innovation at Carolina Dispute Settlement Services. Jessica received her MD from Tufts University School of Medicine and completed her residency in Family Medicine at the University of Virginia. She practiced Family Medicine in North Carolina for more than a decade. Jessica also attended Campbell University School of Law, graduating with honors where she is currently licensed to practice law. She is also a certified mediator and is trained as a collaborative law attorney. Jessica has served on the NC Bar Association Health Law Section Council and the Ethics Committee.
Senior Director, Global Feasibility
Earl Seltzer, Senior Director of Global Feasibility at Covance, has over 14.5 years of industry experience with expertise in investigator site operations management, global feasibility assessment and implementation, and therapeutic strategy development. Earl is an industry speaker in feasibility best practices, site-CRO-sponsor relations, and pediatric/rare disease trial feasibility, and is an SME of internal LabCorp and Covance proprietary assets. He is based in Raleigh, North Carolina.
|Oriol Serra, MBA||Pfizer|
Head of Site Intelligence & Site Selection, Study Optimization, Global Product Development
As functional Head for Site Intelligence & Site Selection based in La Jolla, CA. Oriol provides leadership, strategic direction and oversight to effectively deliver country & site feasibility globally. Oriol´s main interest is shifting the paradigm in the Feasibility & Design Optimization of clinical programs to accelerate the development of innovative drugs for patients in need. Oriol holds a Bachelor in Biological Sciences from the Fairleigh Dickinson University, MS Clinical Trials Management from the International University Barcelona and an Executive MBA from University of California San Diego-Rady School of Management.
|Jatin Shah, MD||Karyopharm Therapeutics|
As Karyopharm’s Executive Vice President, Chief Medical Officer, Dr. Jatin Shah is responsible for overseeing the company’s ongoing clinical programs. Dr. Shah brings significant medical oncology experience to Karyopharm from his prior work at The University of Texas MD Anderson Cancer Center (MD Anderson), including work as a treating physician for patients with multiple myeloma and clinical research. For nearly ten years at MD Anderson, Dr. Shah served as an Associate Professor and Associate Program Director of the Malignant Hematology Fellowship, as well as Director of Myeloma Clinical and Translational Research in the Department of Lymphoma/Myeloma, Division of Cancer Medicine. Dr. Shah received his medical degree from Ohio State University College of Medicine, Columbus, Ohio, and his undergraduate degree, also from Ohio State University, in Mechanical Engineering. He completed an internship and residency in internal medicine at the Cleveland Clinic Foundation, Cleveland, Ohio, and a fellowship in hematology/oncology at the University of Alabama at Birmingham. Dr. Shah holds board certification in hematology and oncology from the American Board of Internal Medicine. He has served as principal investigator/co-investigator for numerous relapsed/refractory multiple myeloma studies and has published articles and abstracts in many peer-reviewed journals.
Senior Director, Clinical Development Execution
No bio available
|Jack Sheehan, PhD||Janssen|
Director, Real-World Value and Evidence, Neuroscience
Jack Sheehan, RPh, MBA, PhD, is a Director, Real-World Value and Evidence, Neuroscience, Janssen Scientific Affairs (JSA). Jack has more than 10 years of industry experience in psychiatry, metabolics, neurology, and anti-infectives therapeutic areas. He holds a PhD in Molecular Pharmacology from SUNY Stony Brook and a BS in Pharmacy from Rutgers. He also completed post-doctoral training in Pathophysiology at the University of Pennsylvania and an MBA specialized in economics at New York University.
|Deborah Shepard, PhD||Pfizer|
Senior Manager, Biomarker Assay Specialist, Global Product Development, Oncology
Deborah Shepard, PhD, is a Senior Manager, Biomarker Assay Specialist in the Oncology Clinical Assay Group in Global Product Development at Pfizer. She is responsible for scientific technical oversight and operational management of external and internal partners performing clinical trial biomarker sample analyses aligned with translational oncology strategies. Prior to joining Pfizer in 2015, she held positions of increasing responsibility in project management, lab management, and data management at Quintiles. Deborah holds a PhD in biochemistry from the University of Wisconsin at Madison.
|Daniela Shikova||FindMeCure Foundation|
Daniela Shikova has been working in the healthcare area for almost 10 years previously coordinating health awareness and policy projects as a Programme and Projects Manager in disease-specific and umbrella patient organisations. She has always been a medical affairs enthusiast and a firm believer in health innovations and technologies that can disrupt the way patients' needs are met. In 2017 she joins FindMeCure team with her biggest dream to help at least one person or save at least one life while working on her desk each day. Daniela is currently a Managing Director of FindMeCure Foundation working towards creating a global network of clinical trial navigators within patient advocacy groups to better serve their members in terms of clinical trials education and support. Daniela has been leading the strategic partnership programmes of the foundation aiming to foster clinical trials awareness and patient engagement in research.
Director of Innovation, Pharma R&D Clinical Operations
Michelle Shogren has over 20 years of experience in Clinical Research across many different roles. She began her journey as a research nurse and site director. From there she became a Clinical Research Associate at a CRO, and finally joined Bayer in 2008 where she has held multiple roles in Clinical Operations, Business Excellence and Innovation. Her greatest passion is customer focused innovation and responding to the voice of the patients and sites.
|Kristen Signs||Boehringer Ingelheim|
Senior Associate Director, Clinical Operations
No bio available
|Christina Silcox, PhD||Duke University|
Managing Associate, Duke-Margolis Center for Health Policy
Christina Silcox is a Managing Associate at the Duke-Margolis Center for Health Policy, working on policy solutions to advance innovation in health and health care and improve regulation, reimbursement, and long-term evaluation of medical products. Dr. Silcox’s portfolio includes multiple areas in digital health policy and real-world evidence, with a focus on medical devices. Currently, she is concentrating on challenges to regulating and adopting of artificial intelligence-enabled software as a medical device, using mHealth to collect real-world data, and characterizing real-world data quality and relevancy. Her projects have included the use of patient-generated health data in medical device evaluations, the exploration of value-based payments for medical devices, and the convening the National Evaluation System for health Technology (NEST) Planning Board. Before she joined Duke-Margolis, Dr. Silcox was a senior fellow at the National Center for Health Research, focused on federal regulation of and policies for medical products. She earned a MS from the Massachusetts Institute of Technology (MIT) in Electrical Engineering and a PhD in Medical Engineering and Medical Physics from the Harvard-MIT Division of Health Sciences and Technology (HST).
|Alex Simmonds||Noona Healthcare|
Head, Clinical Trial Solutions
Alex Simmonds is a proven life sciences and tech startup leader with strengths in innovation and intra/entrepreneurship, strategy setting, disruptive & emergent capabilities, project/program/portfolio management, process improvement, talent development. Seeking to exude centered calm and clear thinking and the quickest path to results despite back to back meetings and seemingly endless conference calls.
|Cassandra Smith, MBA||Janssen R&D|
Associate Director, Diversity and Inclusion in Clinical Trials Lead
No bio available
|Alan Smith, PhD||Bellicum Pharmaceuticals, Inc.|
Executive Vice President, Technical Operations
Alan Smith, PhD is a Biotechnology Executive and has over 30 years of experience in Executive Management roles for areas that include: Research & Development, Operations, Manufacturing and Quality. He is currently the Executive Vice President of Technical Operations at Bellicum Pharmaceuticals. Prior to Bellicum, he served as the Vice President of Research & Development and Cellular Therapeutics for LifeNet Health and its subsidiary, The Institute of Regenerative Medicine. He was responsible for research, product development, cell production, research tissue, and cardiovascular research for the company, including program management and general operations of the institute. Before this season of his career, Dr. Smith owned a consulting business in the cell therapy industry and fulfilled other Senior Executive Management roles for companies like: Cognate BioServices, Osiris Therapeutics, Aastrom Biosciences, Geneic Sciences, and Baxter Healthcare Corporation. He is a published co-author on numerous journal articles and has been an Adjunct Professor for Eastern Virginia Medical School, California State University-Long Beach and Utah State University. Dr. Smith earned his BS degree in Chemistry in 1976, and a PhD degree in Biochemistry in 1982.
Manager, Biospecimen Operations, Clinical Biomarker
No bio available
Global Feasibility & Site Intelligence Director
Sandra has over 20 years Clinical Operations experience at AstraZeneca. During this time, she has held various roles of increasing leadership from Data Management, Monitoring Management, Study Leadership and Management, Regional Business Strategy & Planning, and more recently has been leading Patient Centricity and Sponsor of Choice strategy, driving adoption of patient and site centric practices across AZ global Clinical Operations business. Today, Sandra is Head of Global Feasibility & Site Intelligence driving optimization in feasibility and date driven site selection strategy at AZ. Sandra completed her Hon BSc Degree in Biology/Pharmacology from McMaster University, Hamilton ON.
Senior Manager, Device Functionality Safety and Digital Connectivity
Michael Song is the head of Biologic Device Functionality, Safety and Digital Connectivity within AstraZeneca Biopharmaceutical Development. In his current role, he oversees device functionality and safety; primary container science and technology; biocompatibility; container closure integrity; and digital connectivity development. Prior to his current role, Michael was head of Device and Package Engineering department at Adello Biologics. He also has held key engineering and toxicology SME positions at Stryker and Kavlico, a member of Schneider Electric. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.
|Antonieta Sosa||Janssen Clinical Innovation|
Antonieta Sosa has over 20 years of experience in the pharmaceutical and biotech industry holding positions in Safety, Regulatory Compliance and Clinical Operations in both small biotech and large pharma. In her current role as Director in the Clinical Innovation group, she is responsible for leading the strategy and hands-on execution of a portfolio of transformational projects dedicated to driving innovation into the clinical operating model. She holds degrees in Biology and Health Sciences from the University of Southern California.
|Ginger Spitzer||Foundation for Sarcoidosis Research|
As Executive Director of Foundation for Sarcoidosis Research since 2012, Ginger Spitzer leads the implementation of a new strategic plan to support the Foundation’s mission and to raise vital funds in a cost-effective and time-efficient manner. Building on the Foundation’s previous successes, Ginger leads a comprehensive plan that both highlights and unifies the FSR’s multiple research and education initiatives with the goal of bringing accelerated changes for sarcoidosis patients. With nearly 25 years of experience in managing non-profit organizational operations, Ginger provides expertise in organizational growth, best practices operations, and funder relations. Her professional endeavors encompass executive management positions for nonprofits with both a service and advocacy mission throughout nationally and globally. She also has held numerous adjunct university teaching positions. She currently is a member of the American Thoracic Society PAR committee, as well as the PAR Awards Committee and the PAR Health Disparities Committee. In addition, she is a member of DIA, a 2015 Fellow of DIA-PEC, and associate editor of the DIA-PEC Newsletter, as well as a member of the Global Genes Foundation Alliance, Pfizer Rare Disease Advocacy Board, and numerous other industry boards and professional organizations.
Co-Founder and President
Michael is a Co-founder of CLARINESS and provides executive leadership and strategic direction to the company and its subsidiaries. He brings more than 20 years of experience in launching and strategic management of organizations across consumer and business-to-business industries. Michael earned a degree in finance & accounting from the University of St. Gallen in Switzerland. He sits on the Advisory Board of CISCRP (The Center for Information and Study on Clinical Research Participation) and is a regular speaker on several patient recruitment conferences.
|Lilly Stairs||Savvy Cooperative|
Patient Advocate; Board Member, AARDA; Head of Client Relations
Lilly is recognized as a leading voice in the rapidly growing patient engagement field having built award winning patient ambassador programs and powerful awareness campaigns that united patients and industry. She has served as an advocate for over a decade, transitioning into patient advocacy after she was diagnosed with multiple autoimmune diseases. Lilly currently serves as the Head of Client Relations at Savvy Cooperative, a patient-owned co-op dedicated to giving patients direct ways to share their experiences with health innovators, and advocating that they be fairly compensated for their contributions. She also serves as a Board Member for the American Autoimmune Related Diseases Association (AARDA) and is a Lead Patient Advisor for Clara Health, ZappRx, and Janssen.
|Alicia Staley, MBA||Medidata; & Trial Volunteer|
Senior Director, Patient Engagement
Alicia Staley is the Sr. Director Patient Engagement for mHealth at Medidata. She has over 20 years of experience in software design and information systems management and works to infuse the patient perspective throughout the product development lifecycle and help engage patients in novel ways. Alicia is also a three-time cancer survivor, first diagnosed with Hodgkin’s disease as a sophomore during college. Over the past 10 years, she's applied her engineering background to improve the patient experience for those dealing with cancer. With an extensive network of patient advocates and non-profit organizations, she collaborates with a wide range of stakeholders to help improve processes and policies that impacts patient care and clinical trials. She’s co-led numerous research studies on how patients share information in online forums and seek out clinical trial opportunities.
|Linda Sullivan||Metrics Champion Consortium|
Co-Founder & President
Linda B. Sullivan is Co-Founder & President of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has been a featured speaker at Performance Metrics, Risk-Based Monitoring, Quality Management & Clinical Trial Oversight industry meetings. Ms. Sullivan received a BS in Biology from Trinity College and a MBA from Dartmouth College where she was named a Tuck Scholar.
|David Swank||Bristol-Myers Squibb|
Technical Director, Strategic Options and Assessments, R&D
Dave Swank is a Technical Director at Bristol-Myers Squibb, where he has worked for the past 14 years in the Strategic Options & Assessment department. Prior to joining BMS, Dave spent three years at GlaxoSmithKline as a Decision Scientist. In his current role, he helps project teams address difficult pharmaceutical development decisions by framing issues, facilitating the creation of development options, simulations, and financial analysis. Decision Analysis is Dave’s second career. Prior to joining GSK, he spent 17 years at Rohm and Haas Company as a research process engineer and manager. He has a MS in Chemical Engineering from Clemson University and a BS in Chemical Engineering from Michigan Technological University.
|David Tabano, PhD, MA||Bristol-Myers Squibb|
Associate Director, Center for Observational Research & Data Sciences (CORDS), Business Insights & Analytics
David brings over ten years of experience in healthcare analytics and research. His background is in advanced statistical analysis and econometric modeling, as well as database management and healthcare informatics. David leads several real-world data research studies for Bristol-Myers Squibb across multiple indications and therapeutic areas. He has led multisite projects within several national real-world data networks, including the Cancer Research Network (CRN), the Health Care Systems Research Network (HCSRN) and National Patient-Centered Clinical Research Network (PCORnet). He served as the lead analyst for Data Science in the PCORnet Cancer Collaborative Research Group. David holds a masters degree in Economics and a PhD in Pharmaceutical Outcomes Research from the University of Colorado.
Director, Clinical Biomarker Specimen Management
No bio available
Director, Safety Management, Global Regulatory Affairs and Clinical Safety
Rob Taylor, Director, Global Regulatory Affairs and Clinical Safety, Safety Management, Merck Rob Taylor has led Global Regulatory Affairs and Clinical Safety teams and programs at Merck for over 22 years. He is the key business stakeholder and owner for applications used to support Global Clinical Safety and Pharmacovigilance. He is a leader in innovation and strategy within R&D and is involved in the future direction of exploratory initiatives, focused on patient safety. Rob recently directed a first in industry implementation of a complete end-to-end signaling, analytics, reporting and case processing platform. Combined with his experience in drug safety and business and technical leadership, Rob is leading exploratory disruptive initiatives to streamline and potentially change the way we use and manage patient safety information.
|Rehbar Tayyabkhan||Regeneron Pharmaceuticals|
Head, Research & Global Development Sourcing, Strategic Sourcing & Procurement
No bio available
Patient and Site Engagement Lead, Development Operations
I have spent the last 19 years working within Clinical Operations. During this time, I have held various roles where I have successfully planned and led the delivery of multiple clinical studies across various therapeutic areas. In these roles I was responsible to ensure project standards and scientific requirements from study design concept through study closeout. Currently, I am leading Patient and Site Engagement across Clinical Operations within AstraZeneca. In this role I work with clinical development teams to gather patient and site input to our protocols prior to finalization. Once we have gathered this input, I work with the clinical teams to implement adjustments or modifications based on the patient and site input. In addition, we review what operational adjustments should be made to ensure the study runs as efficiently as possible.
|Piet Theisohn||Bayer AG Pharma Division|
Director, Head, Resource Management in Clinical Operations, R&D-ClinOps - Business Excellence & Innovation
I have almost 20 years experience in the Pharma industry. Since more than 10 years I'm heading Resource Management in Bayer's clinical development.
|David Thompson, PhD||Syneos Health|
Senior Vice President, Real World and Late Phase
David Thompson, PhD is Senior Vice President, Real World Research for Syneos Health. Dave is a health economist by training with 25+ years of experience conducting real-world research and consulting for clients in the biopharmaceutical sector. Dave is Editor-in-Chief of ISPOR’s publication, Value & Outcomes Spotlight, a position he has held since 2008, and serves on the advisory board of the Duke-Margolis Real-World Evidence Collaborative as well as the steering committee for the Clinical Trials Transformation Initiative (CTTI), a group co-founded by Duke and the FDA.
Associate Director, DSS
Aman Thukral is the head of Digital Operations and eCOA at AbbVie. He has over twelve years of experience in clinical development, technology planning & business-technology alignment. In his current role, he is responsible for eCOA operations, wearables and sensors, piloting new technology initiatives & digital partner for patient engagement group. Before this position, he had worked in Deloitte, Cognizant & GlaxoSmithKline at various levels
|George Tiger||Almac Group|
Vice President, Global - Business Development
Since 2015, George has served as Vice President Global Business Development where he is responsible for all global commercial activities within the Almac Clinical Technologies business unit. In addition to direct sales strategy and execution, George collaborates with other members of the Almac leadership team to strengthen sales channels, advance coordination between Almac business units, including Almac ONE, and expand strategic client relationships.
|Lisa Tindell, RN||Minneapolis Heart Institute Foundation (MHIF)|
Sr. Director, Clinical Research Operations
Lisa Tindell is the Senior Director of Research Operations at the Minneapolis Heart Institute Foundation® and a key member of the Executive Leadership team that drives the organizational strategy. With 28 years of professional nursing experience, Lisa leads a large team of clinical research staff who, together, drive toward operational effectiveness while delivering on strategic goals in support of the organizational mission.
Director, Site Intelligence & Selection, Study Optimization, Global Product Development
Currently working at Pfizer as a Director in Site Intelligence and Selection, Mary-Anne has acquired a vast amount of clinical trial experience having been in the industry for almost 20 years. In her current position at Pfizer Mary-Anne strives to improve the experience of working with Pfizer by building knowledge of sites and capabilities, thus ensuring that patients have access to clinical trials, through an improved site selection process.
|Jennifer Tontini||Educational Measures|
Vice President, Global Business Development
Jennifer Tontini is Vice President, Global Business Development with Educational Measures. She is recognized as a thought leader in adult education, instructional design and technology, strategic engagement, and is a certified Change Management Professional (CMP). Jenn has spent nearly 20 years developing and executing interactive education, marketing, and training strategies for clients in many verticals, with a primary focus on biopharmaceutical companies, their MedComm companies and agencies, and their CROs.
Manager, Central Statistical Surveillance
Dorothea (Dolly) is currently working as a Central Statistical Surveillance Manager at Janssen Pharmaceuticals, a J&J company. She has over 25 years of experience in all aspects of Clinical Biostatistics and Data Management (BSDM) from protocol and CRF development through PMA/FDA Panel presentation, post-approval requirements and development of SOPs. She worked over 7 years in 2 CRO companies and joined J&J in 2001 in the medical device sector. Dolly has a MS in Statistics from University of Massachusetts – Lowell, and a BS in Mathematics, with a minor in Computer Science from University of Massachusetts – Dartmouth.
|Caro Unger||Clovis Oncology|
Senior Clinical Operations Standards and Innovation Manager
Caro Unger is a Senior Manager in Clinical Operations Standards and Innovation at Clovis Oncology. She has 15 years of industry experience in clinical operations, inspection readiness, and process standardization. Starting as a CRA in immunoncology, she has primarily worked for small and midsize oncology sponsor companies in various roles throughout her career, often more than one at once: monitoring, translational medicine operations, project management, and process improvement. At Clovis for the past 6 years, she has transitioned from managing clinical studies to focusing on operational innovation and excellence across the company.
|David Van Brunt, PhD||AbbVie|
Senior Research Fellow and Head, HEOR Division of Evidence and Analytics
Dr. Van Brunt leads the Division of Evidence and Analytics, a team within AbbVie’s department of Health Economics and Outcomes Research (HEOR) that focuses on the expansion of Real-World Evidence and Patient-Centered Outcomes. Dr. Van Brunt’s PhD is in Psychology, with concentrations in in Behavioral Medicine and research methodology. His clinical residency with the US Air Force culminated in his role as Chief of Psychology Services at US Strategic Command Headquarters, where he first shifted his attention from individual to population health. He joined industry from the faculty of the College of Medicine at the University of TN Health Sciences Center. Having published in top-tier medical journals and authored book chapters and treatment manuals, he has recently focused on leading teams to success in finding new applications for real-world evidence and assessing value in healthcare.
|Corinne Vasquez||Abbott Medical Devices Division|
Staff Clinical Systems Analyst
Corinne Vasquez is a Staff Clinical Data Systems Analyst at Abbott Medical Devices division, located in Sylmar, California, where she is managing Clinical Data Systems Analysts as well as serving as a Project Lead/Manager for numerous Clinical Data Systems related efforts. She has been with Abbott (formerly St. Jude Medical) within the Clinical Data Systems department for 12 years and has lead several successful system implementations such as the EDC Study Portal. Corinne is also responsible for providing training and customer support on the use of Clinical Data Systems. She has presented at numerous conferences including SCDM and is very excited to share her experience with one of Abbott’s Best In Class tools, the EDC Study Portal.
|Philippe Verplancke, PhD||XClinical GmbH|
Global Head, Business Development
Dr. Philippe Verplancke earned a Ph.D. in the field of nuclear fusion research at the Max Planck Institute for Plasma Physics. After working at McKinsey & Company, in 1999, when he started developing electronic patient diaries at Nets Technologies GmbH. In 2002, he founded XClinical with the vision of creating a user-friendly EDC system based on CDISC standards. As Global Head of Business Development, he manages the active relationship with our partners and customers and accelerates the growth of our business.
Statistician, Clinical Statistics
Vanja Vlajnic is a Clinical Statistician, supporting the late-stage cardiovascular franchise at Bayer. He is the co-lead of the Biostatistics Innovation Center Data Mining group and is highly involved in developing strategies for the analysis of high-dimensional data in the clinical space. Vanja has a Master’s of Applied Statistics from Penn State University, a Master’s of Experimental Psychology with a focus in Behavioral Neuroscience from Seton Hall University, and is a PhD candidate in Systems Engineering with a focus on Biomedical Engineering from Colorado State University. He has published and given talks in the areas of machine learning applications to clinical data, the analysis of high-dimensional data from digital biomarkers, causal learning and causal inference, clinical assessment tools in schizophrenia, and visual perception. He is a member of Phi Beta Kappa, the American Statistical Association, and the Vision Sciences Society.
Associate Director, R&D External Operations, R&D Quality, Operations & Performance
Gretchen Voolich helped to establish the R&D External Operations (Strategic Vendor Management) group at Biogen where she continues to lead best vendor practice for the R&D Business. As the parent operational vendor management group that is part of the greater Quality, Operations and Performance division at Biogen, R&D External Operations sets the direction and guidance for the R&D Business on how best to maximize value received from our external relationships with suppliers, vendors and academic collaborations. As an Industry professional with over 17 years of experience, Gretchen has primarily held various positions in Clinical Operations having worked for a variety of sponsor companies including Boston Scientific, Stryker Biotech and Wyeth Pharmaceuticals in both the biologic and device settings. She is passionate about people and relationships and where our scientific discipline meets the human condition. She holds degrees from Rutgers University and Harvard University and as a native New Englander, lives in Boston MA.
|Michael Walega||Bristol-Myers Squibb|
Head, Global Data Management & Centralized Monitoring
Since the summer of 2018, Mike Walega has held the position of Head of Centralized Monitoring at BMS. In this capacity, he is responsible for directing the team’s activities, as well as driving improvements in the BMS RBM methodology. He has an MS in Biostatistics and a BS in Biology and is a Six Sigma Master Black Belt.
|Shirley Wang, PhD||Harvard Medical School|
Assistant Professor, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital
Shirley is an Assistant Professor at the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, Harvard Medical School. She is focused on developing innovative, non-traditional analytic methods to understand the safety and effectiveness of medication use in clinical care as well as facilitating appropriate use of complex methods for analyzing large observational healthcare data. To that end, she has developed enhancements to epidemiologic study designs and analytic methods as well as led efforts to guide appropriate use of complex methods for analyzing large observational healthcare data. Her methods work has been recognized with awards from two international research societies. Shirley recently co-led a joint task force for the International Society for Pharmacoepidemiology (ISPE) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) focused on increasing decision-maker confidence in use of ‘real world’ evidence. She is currently co-Director of the REPEAT Initiative, a non-profit program focused on improving the transparency and reproducibility of database studies.
|Xia Wang, PhD||AstraZeneca|
Director, Health Informatics & Global Medicines Development
Xia holds a Director position at Health Informatics group within the AstraZeneca clinical development unit. Xia has records of accomplishment in applying novel informatics solutions and real-world data analytics to all phases of medicines development life cycles, spanning diabetes, respiratory and autoimmune therapeutic areas. Currently Xia is leading informatics efforts in AstraZeneca Real World Evidence (RWE) studies to support clinical studies design, patient safety, epidemiology, comparative effectiveness, payer & pricing strategy and marketing research. Prior to stepping into the clinical domain, Xia was with the AstraZeneca drug discovery unit in the areas of informatics and computational modeling to support candidate drug identification and optimization. Xia holds a Ph.D. in computational chemistry and has extensive training in broad areas of Informatics.
Director, Advanced Therapy Services
Stephanie joined LabConnect in 2009 bringing more than 10 years of combined central and specialty laboratory project management experience across domestic and global clinical trials. At LabConnect, Stephanie combines her experience working with biomarkers and complex sample collection and logistical requirements to help develop LabConnect’s comprehensive sample tracking platform. She has a degree in chemistry from The College of Staten Island as well as a law degree from John Jay College of Criminal Justice.
|Neil Weisman||Continuum Clinical|
Neil Weisman, President of Continuum Clinical, helps pharmaceutical and biotech companies bring new therapies to market faster and more efficiently by solving critical communication challenges that impact the clinical development process. With nearly 20 years of experience, Neil leads the strategic direction for Continuum Clinical clients and oversees a global team of dedicated healthcare marketers, clinical trial experts, and patient advocates.
|Michelle Wetherby, MS, CCRP||Abbott|
Associate Director, Clinical Operations
No bio available
Innovation and Development, Takeda Pharmaceuticals
Lynn is a Senior Manager at Amgen with over 25 years of experience in multiple aspects of clinical trials including bioanalytical testing, clinical drug supplies and specimen management. She currently leads Biological Sample Management and is responsible for managing Amgen’s biobank as well as informed consent tracking related to specimens and use of banked specimens and data for research.
Associate Director, Clinical Site Budgets/CTAs
No bio available
|Laura Whitmore||Cerevel Therapeutics|
Head, Clinical Operations, Oversight
Laura Whitmore is Head, Clinical Operations – Oversight at Cerevel Therapeutics. Prior to this role, she was Director on an Innovation team at a mid-size pharma company. A career-changer, she moved from the Banking industry 10 years ago and has never regretted the shift.
|Kelly Willenberg||Kelly Willenberg LLC|
Kelly Willenberg is the owner of Kelly Willenberg & Associates. Kelly has over 30 years of extensive knowledge and experience in health care with particular focus in clinical trials management and research compliance, including all aspects of clinical trial billing compliance. She has a Bachelor’s Degree in Nursing, a Masters and a Doctorate in Business Administration. Kelly is an experienced oncology nurse with the majority of her experience in oncology, pediatrics, school nursing and cardiac rehab and worked for over twelve years at Vanderbilt University Medical Center, in a variety of roles, including the Director of the Clinical Trials Office for the Cancer Center managing a Community Oncology Research Program. Her consulting practices supports a variety of clients, including large academic medical centers, physician practices and pharmaceutical clients.Kelly is a frequent presenter and speaker at the Oncology Nursing Society, Academy of Health Care Administrators, American Society of Clinical Oncology, Association of HealthCare Internal Auditors, MAGI, The Society of Clinical Research Associates, Association of Clinical Research Professionals, ExL Events, HCCA, and other professional organizations. She is currentlythe managing editor of the new updated Research Compliance Professional’s Handbook for Healthcare Compliance Association (HCCA). She served as an editor for the 3rd Edition of the Manual for Clinical Trials Nurses for Oncology Nursing Society. She has a bi-monthly column in Compliance Today titled “Research Reflections”. She is a Certified Clinical Research Professional (CCRP), Certified as a Healthcare Research Compliance Professional (CHRC) and Certified in Healthcare Compliance (CHC).
|Shaun Williams||Syneos Health|
Vice President, Investigator Management Solutions, Clinical Solutions
Shaun Williams, Executive Director of Investigator Management Solutions at Syneos Health, has more than 15 years’ experience directing a broad spectrum of operational activities in FDA-regulated industries. As the strategic business unit lead over Syneos Health’s investigator payments, transparency reporting and payments forecasting services, he has been instrumental in developing FSP models tailored to customer’s specific needs.
|Kenneth Wilson||Pfizer Inc.|
Director, Sourcing Operations, Portfolio Sourcing
Ken has 27 years of experience in clinical research with varying levels of responsibilities at several CROs as well as 4 years in Outsourcing at Pfizer. Ken began his career at Quintiles in 1987 as a Statistical Programmer and then moved into Statistical Programming line management. He was appointed and served as the Director of Biometrics for Quintiles CNS division until 2000. Following Quintiles, Ken served as Site Director for I3 Statprobe’s San Diego office for a few years with overall business and operational management responsibility. Ken has also worked in Business Development at Clinimetrics/Omnicare selling full-service CRO services in various therapeutic areas as well as helping initiate FSP models with different clients in the industry. Ken has managed many projects from full-service to single service-contracts in many different indications. Ken is currently a Director in Business Operations at Pfizer, Inc. where he is responsible for Clinical Outsourcing of five of Pfizer’s key development programs.
Director, Clinical Pharmacology Operations
Kristi is a global drug development professional with over 14 years of industry experience and an expertise in early development. Her clinical research career began in patient safety at a CRO and has since advanced to directing study operations at Allergan. For the past 4 years, Kristi has led the Clinical Operations study team within the department of Clinical Pharmacology at Allergan, providing technical expertise for strategic planning, oversight, and conduct of early development studies to align with program development. Kristi and her team manage early phase studies (Phase 0, Phase 1, and Phase 2a/b) in multiple therapeutic areas from conception to close-out, on time, and within budget.
|Liz Wool, RN, BSN, CCRA, CMT||Wool Consulting Group|
Liz has over 25 years in clinical research specializing in Vendor Oversight since 2010 and is a recognized industry expert and international speaker/trainer on Vendor Oversight, GCP Compliance, Clinical Quality Management Systems, and Resource Management and Training. Liz is a certified CRA®, instructional designer and master trainer. The Wool Training Institute, a division of Wool Consulting Group, Inc., provides on-line, advanced GCP training for investigators/sites and sponsors/CROs for researchers around the globe that includes a Vendor Oversight curriculum.
Jeremy Wyatt is President of ActiGraph, a leading global provider of physical activity and sleep monitoring solutions for pharmaceutical and academic industries. Jeremy has 20 years of experience with low-power micro-electro-mechanical systems and related cloud technology, giving him a unique perspective on the challenges and opportunities of deploying wearable technology to produce meaningful patient data. He earned an MBA from the University of West Florida and is a member of the Digital Medicine (DiMe) Society.
|Rich Wzorek||Almac Group|
Director, New Products & Service
Since joining the Almac Group in 2011, Rich has been instrumental in the creation and implementation of today’s most highly configurable and customizable Interactive Response Technology, IXRS® 3, used in both simple and complex adaptive clinical trials around the globe. Rich also currently manages the development teams who enhance and maintain this intuitive platform
|Brenda Yanak||Clinical Transformation Partners|
Ms. Yanak is an award-winning, cross-functional Pharmaceutical and Central Lab executive who has held leadership positions in laboratory, technology, clinical operations, and innovation domains. Recognized in the industry as a subject matter expert in consent management, specimen management, and virtual specimen tracking, she has been responsible for enterprise wide specimen and technology strategy at more than one company. She was one of the first to pilot uses of artificial intelligence within clinical trials, and drove the operationalization of precision medicine at one of the world’s largest pharmaceutical companies, enabling value capture of advancements in genetics and biomarkers. Brenda is often asked to speak at conferences and chair panels to discuss innovative ways to translate scientific strategy into clinical trial operations.
|Yue Yang, PhD||Shenyang Pharmaceutical University|
Director, International Center for Food and Drug Policy and Legal Research
Yue Yang, Ph.D. is Director at the International Center for Food and Drug Policy and Legal Research at Shenyang Pharmaceutical University. She is a Professor, member of the 14th Degree Committee of Shenyang Pharmaceutical University, Chairman of the Pharmaceutical Management Branch. She is also a representative of the 16th National People's Congress of Shenyang City, member of the Legal Affairs Committee of the Shenyang Municipal People's Congress. She was awarded China's first pharmaceutical management doctoral degree in pharmacy. She was mainly engaged in pharmaceutical regulations and drug policy research. Dr. Yang participated in the revision of the Drug Administration Act and the enactment of the Vaccine Management Act.
Systems, Analytics & Reporting Administrator
Joseph has worked in the Analytics department in Business Operations at Allergan for 2 years, developing reporting and analytics solutions for clinical trial management and site monitoring. He has a bachelor’s degree in Biochemistry and marched tuba for UCLA.
Manager, Digital Clinical Trials
John has 20 years of experience working in the pharmaceutical industry the last 5 years focused in digital clinical discovery and development. John is a member of the GSK Digital Clinical Trials team which aims to transform how GSK conducts its drug development through the use of digital, data, and analytics tools. His work in this space includes the evaluation of wearables and sensors, leading development of mobile applications, and development of custom platform solutions for trial data collection and analysis. As a member of the Digital Clinical Trials team at GSK John is focused on how GSK’s development organization captures, ingests, processes, analyzes, interprets, and reports its data across the organization. He holds a BS in Biology from The Pennsylvania State University and an MS in Clinical Pharmacology from Thomas Jefferson University.
|Richard Young||Veeva Systems|
Vice President, Vault CDMS Strategy
Richard Young is VP, Strategy, Vault CDMS at Veeva Systems. Young has over 25 years of expertise in data management and clinical strategy. His broad experience includes roles at Medidata where he focused on adaptive trials, risk-based monitoring, mobile health, and big data. He has also held operational roles at leading pharma and CRO organizations including GlaxoWellcome, Novo Nordisk, and PAREXEL. Young holds a Bachelor of Science degree in biochemical sciences from Coventry University.
As Chief Scientific Officer for CluePoints, Steve oversees the research and development of advanced methods for data analytics, data surveillance and risk management, along with providing guidance to customers in RBQM methodology and best practices. Steve worked for three bio-pharmaceutical companies over a span of 15 years where he assumed leadership positions in clinical data management and led the successful enterprise roll-out of EDC at both J&J and Centocor.
Vice President and Global Head, Data Monitoring and Management
Demetris is currently Vice President and Global Head of Data Monitoring and Management at Pfizer. Demetris started his career as a Laboratory Scientist in 1991 at Schering Plough Research Institute. He transitioned into the Clinical Development space and held roles of increasing responsibilities in Trial Management and Monitoring and led the implementation of the company’s first Clinical Trial Management system. In 2000, Demetris was a member and eventually the leader of the team which executed the industry’s first Tech-Transfer of a web-based EDC system. He eventually led the Data Management and Standards organization and continued onto Merck & Co. following the merger in 2009. Subsequently Demetris was Vice President of Data Management at Novartis AG since 2014.
|Dan Zhang, MD||Fountain Medical Development Ltd.|
Before founding Fountain Medical Development Ltd. In 2007, Dr. Zhang was the Head of Clinical Development and Safety Assessment at Sigma-Tau Research Inc. Prior to that he was the Vice President at the Quintiles Transnational Corp. and Chairman of Quintiles Medical Development (Shanghai) Company Ltd. Dr. Zhang is a member of grant review committee for National Drug Development Fund of China, and is also a consultant for the National Medical Products Administration (NMPA). He is a member of ICH E19 Expert Working Group. He was a member of the Overseas Expert Committee on New Drug R&D for the Ministry of Science and Technology of China and was the secretary-general of the Association of “Thousand Talent” Expert from 2011-2017. Dr. Zhang was the former board of director for the Sino-American Pharmaceutical Association (SAPA) and was the former president of Chinese Biopharmaceutical Association-USA (CBA), Dr. Zhang is chairing the government relationship committee of Bayhelix - an organization hosting senior executives from life science organizations in USA and China.
|Sean Zhao, MD, PhD||AstraZeneca|
Head, US Patient Safety, AstraZeneca Pharmaceuticals LP, US Medical Affairs
Dr. Zhao is a senior pharmaceutical executive with over 20 years of diverse working experience. He possesses proven abilities in clinical development, pharmacovigilance, pharmacoepidemiology, observational study, post marketing evidence generation, risk evaluation, management and mitigation, post marketing safety studies, safety process development and refinement, and health economic and outcome research. Dr. Zhao has successfully built and led a global safety department, safety surveillance teams, and pharmacoepidemiology teams, as well as effectively managed safety business alliances and outsourcing vendors in various mid- and large-size biotech and pharmaceutical companies. He possesses deep knowledge of the safety regulations and guidance, and experience of appropriate regulatory interactions with FDA, EMA, CFDA, Health Canada, and Japan Regulatory Authorities. He has participated in pharmaceutical industry wide and regulatory agencies’ safety initiatives, activities, working groups, and expert panels. Most recently, has been invited by Chinese FDA to provide input to its post marketing research guidance development. He is also a member of US PhRMA Safety and Pharmacovigilance Work Group since 2017. Dr. Zhao currently leads US Patient Safety Department in AstraZeneca
|Maya Zlatanova||FindMeCure Foundation|
A health tech entrepreneur with 10 years of experience in the clinical research industry. Developed training on regulations and how to improve the clinical research industry for the United Nations, the NHS, and the pharmaceutical companies. In the last few years, passionate patient advocate heading FindMeCure and the Patient Empowerment Initiative with focus on solving the biggest problems within patient recruitment and engagement.
|Mary Zuniga||Eli Lilly and Company|
Consultant, Translational Science, Immunology
Mary Zuniga, BS in Biology, is the Operational Consultant in the Translational Science, Immunology department at Eli Lilly and Company. Mary has worked at Lilly for the past twenty-two years. During her career, she collaborated both internally and externally to establish the first Lilly long term sample storage process and IT infrastructure for the collection and management of clinical trial samples across more than 30 countries. In her current role, her focus encompasses BioSpeciman sample strategy, standardization, process improvement, and operational support for outsourcing pharmacodynamic biomarkers for assets in Lilly’s immunology pipeline.