Cambridge Healthtech Institute’s 13th Annual
Enrollment Planning and Patient Recruitment
Predicting and Improving Enrollment through Evidence, Data, New Tech and Creative Engagement
February 19-20, 2020
Patient recruitment and up-front enrollment planning are critical to drug development programs. Patient recruitment, if not adequately planned for, can extend your development timeline by a number of years. Retention of patients throughout the life of a clinical trial is essential in order to have complete data sets for your analysis and subsequent filings. To optimize both, you have to have a plan and effectively leverage analytics and technology without losing site of the participant’s user experience. One must take into account the needs of different patient populations, the importance of diversity, how to use digital tech, challenges of consent processes, direct-to-patient models, and many other factors. CHI’s 13th Annual “Enrollment Planning and Patient Recruitment” will cover the topics one should consider when drafting and strategically implementing a patient recruitment plan for a patient-centric and inclusive clinical development program.
Stay on and attend Part 2 (Thurs-Fri): Patient Engagement, Enrollment and Retention through Communities and Technology
Day 1 | Day 2
Tuesday, February 18
9:00 am - 7:15 pm Registration Open
2:00 - 5:00 pm User Group Meetings
*Separate registration required. Must be a Best Value registered attendee.
5:00 - 6:20 pm Evening Kick-Off Plenary Keynote and Participant Engagement Awards
(Co-Sponsorship Opportunities Available)
7:30 pm Close of Day
Wednesday, February 19
7:15 am Registration Open and Morning Coffee
8:15 Morning Opening Plenary Keynotes
PATIENTS, DATA, DIVERSITY, TECHNOLOGY: OPERATIONALIZING PATIENT-CENTRIC ENROLLMENT USING DIGITAL TECH AND DIRECT-TO-PATIENT MODELS
10:40 Chairperson’s Remarks
Diana Foster, PhD, CEO, Total Clinical Trial Management
10:45 Data and Diversity: The Need for Increased Representation across Clinical Trials
Charlotte Jones-Burton, MD, Vice President, Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc.
Despite known differences in disease prevalence and therapy response across ethnicities and genders, women and minority groups have been historically underrepresented in clinical trials, limiting findings on response from the full breadth of potential patients. How can we ensure that our commitment to addressing unmet need is reflected in complete, diverse patient datasets? The solution begins long before the first patient is enrolled in a trial. This talk will discuss the urgent need for increased diversity within the clinical trials space at every level, from initial study design through final read-out.
11:15 The Intersection of Patients and Technology: Innovating Clinical Trials with Patients in Mind
Michelle Shogren, Director of Innovation, Pharma R&D Clinical Operations, Bayer
We are all working to design and execute truly patient-centered drug development and trials. At the same time we are onboarding a myriad of new technologies, from advanced analytics to wearables. So, how do you innovate while keeping the patient at the center? This presentation will share examples of design thinking principals put to use when bringing in new technology and will suggest how we can set our new way of working up for success.
11:45 SPECIAL CASE STUDY: What’s the Perfect Wearable Device for Research and Patient-Centric Trials?
Joseph Kim, MBA, Senior Advisor, Translational Technology & Innovation, Digital Health, Eli Lilly and Company
Digital approaches can transform research beyond just participant engagement and enrollment. The rapid evolution of wearable devices and mobile health (mHealth) technology in clinical trials combined with patient-centric data generation provides the potential for better science in drug development measures. But which device is the best? They all are – depending on what you’re trying to do. The lack of know-how to understand and validate devices, data, algorithms are slowing the integration as novel endpoints into clinical trials.
12:15 pm Presentation to be Announced
12:45 Transition to Lunch
12:50 LUNCHEON PRESENTATION: The (Not So Distant) Future State of Patient Recruitment
Neil Weisman, President, Continuum Clinical
Join this fast-paced, inspiring presentation that will leave you feeling energized about the future of patient recruitment. Learn about how and when to start incorporating next-gen technology into your patient recruitment strategies.
PROVEN METHODOLOGIES FOR CONNECTING PATIENTS WITH TRIALS & SUPPORTING RECRUITMENT AT PROGRAM AND STUDY LEVEL
2:15 Chairperson’s Remarks
Chair to be Announced, Clariness
2:20 Let’s Talk Options and Scalability: Exploring the Evolution of Patient-Centric Technologies in Clinical Trials
Hassan Kadhim, Director, Clinical Trial Business Capabilities, GCO, Bristol-Myers Squibb
Patient technology is proliferating at a fast pace in the healthcare industry, but it is still slow at scaling in the clinical research arena. This talk will explore strategies at scaling patient-centric technologies in clinical trials to enable wider adoption while benefitting patients in the way they want to be engaged.
2:50 Talk Title to be Announced
Kristina Wolfe, DrPH, Director of Strategic Accounts, EVERSANA
3:05 Patients are a Virtue: How to Find the Right Participants for Your Trial
Mark Joing, MBA, Vice President, Clinical Operations, Menlo Therapeutics Inc.
Leading patient recruitment experts and organizations are finding new ways to connect patients to trials and are tackling the thorniest of patient recruitment challenges. What hurdles do they have in common and what solutions are worth investing time and money in? This talk will share qualitative research, consisting of interviews with leading patient recruitment experts, innovators, and service providers to understand the trends, latest tools, technologies, and other recent innovations impacting the patient recruitment landscape. It will also share a simple yet powerful framework, called S4, as a tool for anyone looking to improve patient recruitment in any trial.
3:20 Supporting Clinical Trial Recruitment – Program versus Study Level
Melanie Goodwin, Director, Patient Recruitment Programs, Clinical Development & Operations, Pfizer
This presentation will discuss the pros and cons of supporting clinical trial enrollment efforts at the program level versus the study level. It will look at how operational and financial efficiencies are impacted, as well as the risks involved in these approaches.
3:50 CO-PRESENTATION: Talk Title to be Announced
Kyle Cunningham, Chief Product Officer, Greenphire
Denisa McKnight, Senior Operations Insights Analyst, Business Insights & Analytics (Clinical Development), Roche Products Limited
INTERACTIVE BREAKOUT DISCUSSION GROUPS
4:20 Find Your Table and Meet Your Moderator
4:25 Interactive Breakout Discussion Groups
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions. To get the most out of this interactive session and format, please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and most importantly, participate in active idea sharing.
(Co-Sponsorship Opportunities Available)
6:45 Close of Day
Day 1 | Day 2
Thursday, February 20
7:15 am Registration Open
7:45 BREAKFAST PRESENTATION: Navigating the Patient Journey: A Responsibility all Technology Providers Share
Mike Nolte, Chief Executive Officer, Signant Health
8:15 Session Break
IMPROVING TRIAL PLANNING AND ENROLLMENT UTILIZING AI/ANALYTICS & ENGAGING PATIENTS FOR DIGITAL HEALTH TRIALS
8:20 Chairperson’s Remarks
Chair to be Announced, WIRB Copernicus Group
Aaron Fleishman, Director, Market Development, BBK Worldwide
Jessica Kim, Director, Research, Digital Strategy, BBK Worldwide
This session will leverage findings from BBK’s Study Voices survey, designed to gain insight into the new healthcare consumer. Market Development Director Aaron Fleishman will share findings from more than 1,000 survey respondents and provide insight into what drives healthcare consumer behavior and how study sponsors can harness it for enrollment success Research and Digital Strategy Director Jessica Kim will share ways to leverage insight in the planning and execution of recruitment and engagement campaigns.
8:55 CASE STUDY: Operationalizing Patient-Centric Enrollment Using Digital Tech and Direct-to-Patient Models
Eric Hajjar, Associate Director, Clinical Technology & Innovation, Global Development Operation, Novartis
Medicines can spend years in the development pipeline held back by a lack of suitable patients at clinical sites, yet we know that there many more potential patients out there desperately waiting for the right medicines. Digital approaches can transform recruiting by adopting direct-to-patient models, enabling access to a wider pool of potential patients and the ability to accelerate clinical trials. We will share our vision for an end-to-end clinical trial recruitment capability based on a modular and partnership approach, and also highlight the key challenges and pitfalls that that can be encountered along the journey.
9:10 “Patients didn’t join my trial.” We asked 4,000 patients why
Laurent Schockmel, DVM, MBA, CEO, Antidote
Finding the right patients at the right time requires a deep understanding of the patient experience. This presentation will share results of a groundbreaking survey examining motivations for and barriers to participation in research, and dive into what these findings mean for your recruitment strategies.
IMPROVING ENROLLMENT AND OUTCOMES FOR UNDERSERVED AND OTHER PATIENT POPULATIONS VOLUNTEERS BY LISTENING
9:25 CO-PRESENTATION: Listening to Representative Patient Populations Matters: How Co-Creating with Patients Creates Better Outcomes
Cassandra Smith, MBA, Associate Director, Diversity and Inclusion in Clinical Trials Lead, Janssen R&D
Lauren Gadsby, MBA, Program Manager, Investigator and Patient Engagement, Janssen R&D
To improve enrollment of underserved and underrepresented populations in clinical trials and to ensure that all patients have access to innovative and high quality care regardless of race or ethnicity, it is important to actually ASK what patients need so they feel comfortable joining a trial. Ensuring the patient population in a trial is representative of the actual incidence of the disease itself is vital to understand the impact on patient lives. We will share a case study, where we co-created with patients and made significant changes to our approach in order to better deliver a better experience. We will also be able to share results as a result of asking, listening, and acting on what we learned.
PRACTICAL DATA-DRIVEN APPROACHES TO PARTICIPANT RECRUITMENT & LEVERAGING RWD TO OPTIMIZE ELIGIBILITY CRITERIA
11:20 Chairperson’s Remarks
Ivor Clarke, President & CEO, SubjectWell
11:25 Utilizing RWD to Enable Data-Driven Enrollment Planning and Recruitment
Cathy Critchlow, PhD, Vice President, Center for Observational Research, Amgen
Using a data-driven approach, investigators can optimize recruitment activities and efficiently reach potential participants. This talk will discuss tools available to collect data on recruitment activities, including: claims data, EHR data, Google analytics, Facebook pixel, trackable links and phone numbers and survey data. There is no shortage of data sources! Turning that into knowledge and a guide to improved recruitment is the challenge. This talk will share a few successes and failures that informed our RWD strategy at Amgen.
11:55 How to Use RWD to Optimize Eligibility Criteria and Enhance Recruitment
Jack Sheehan, MBA, PhD, Director, Real-World Value and Evidence, Neuroscience, Janssen Scientific Affairs (JSA)
This presentation will outline best practices to leverage EHR and claims data for recruitment and eligibility in clinical trials. Attendees will learn about CTTI’s newly released recommendations that provide practical models and operational guidance for the use of RWD to facilitate RCT planning and execution.
12:25 pm Transition to Lunch
12:30 BRIDGING LUNCHEON CO-PRESENTATION: Putting Patients & Caregivers First: An In-Depth Look at Strategic Partnerships in Executing a Successful Clinical Trial
Samantha Rogers, Patient Recruitment & Retention Lead, Takeda
Tricia Barrett, Senior Vice President, Managing Director, Praxis Communications, LLC
Join us as we pull back the curtain to review strategies from a case study that highlights a patient-centric approach to drug development. We’ll discuss how to craft a strategic plan that resonates with both the patient and caregiver. This session will focus on tactics that were successfully executed as well as mid-study adjustments that were implemented in order to optimize patient recruitment and retention.
2:00 Close of Conference
Stay on and attend Part 2: Patient Engagement, Enrollment and Retention through Communities and Technology
Tuesday Evening, Wednesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:
SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization
INTERACTIVE BREAKOUT DISCUSSION GROUPS
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing: breakouts
* The program is subject to change without notice, due to unforeseen reason.