(Shared Conference with Biomarker World Congress and Digital Health Pharma Congress)

Cambridge Healthtech Institute’s 2nd Annual

Digital Biomarkers: Biosensors, Wearables, and mHealth

Clinical Utility and Emerging Applications in Drug Development

June 19-20, 2019

As the role of biosensors, wearables and mobile health in modern healthcare evolves, the potential of digital biomarkers to continually monitor patient health, rapidly diagnose disease, and accurately predict outcomes becomes increasingly apparent. Physiological data may now be collected via digital devices such as portables, wearables, and implantables. Mobile health, or “mHealth,” promises to transform not only the future of healthcare but also the process of clinical trials. CHI’s 2nd Annual Digital Biomarkers: Biosensors, Wearables, and mHealth conference will focus on the clinical utility of cutting-edge biosensor technology and its impact on drug development.

Final Agenda

Arrive early to attend Tuesday, June 18 - Wednesday, June 19

Digital Health: Pharmaceutical Executive Summit

Wednesday, June 19

12:00 pm Registration Open

12:00 Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:30 Transition to Plenary


2:20 Dessert and Coffee Break in the Exhibit Hall with Poster Viewing


3:05 Chairperson’s Remarks

Wasim Malik, PhD, Chief Digital Strategist, Roivant Sciences

3:10 KEYNOTE PRESENTATION: A Platform Approach to Real-World Evidence and Real-World Population Health Transformation

Ashish Atreja, MD, MPH, Chief Innovation Officer, Icahn School of Medicine at Mount Sinai

The practice of medicine is exponentially evolving. This evolution is fueled by value-based transformation and incentives that are aligning for continuous, proactive care, within and outside the four walls of the hospitals. To address this need, the new generation of startups is leveraging disciplines like data science, informatics, digital medicine, genomics, and AI; but this is creating a problem of plenty. In spite of more than 350,000 mobile apps for healthcare, less than 4% of patients are recommended apps by providers today.

3:40 Digital Biomarkers and Real-World Evidence in Clinical Research

Wasim Malik, PhD, Chief Digital Strategist, Roivant Sciences

The myriad complexities and challenges of the drug development process motivate the rethinking of the entire value chain with the goal of identifying opportunities for radical changes in clinical trial design.This talk will discuss the potential of real-world evidence and digital biomarkers in enabling rapid drug development for the benefit of patients, identifying lessons that can be learned from other data-driven industries and discussing successful examples of technology-enabled approaches to clinical trials.

4:10 Data and Metadata Standards for Real-World Digital Biomarkers

Ida Sim, MD, PhD, Co-Founder, Open mHealth; Professor, Medicine, University of California, San Francisco

The digital health ecosystem would function more effectively if there was judicious standardization of digital biomarkers to facilitate data sharing. Moreover, data and metadata standards are needed to enable efficient real-world monitoring of multitudes of devices at scale for regulatory purposes. This talk will review the current state of digital biomarker standardization and the relationship to electronic health record data standards.

4:40 Sponsored Presentation (Opportunity Available)

5:10 Networking Reception in the Exhibit Hall with Poster Viewing

6:05 Close of Day

5:45 Dinner Short Course Registration

6:15 Dinner Short Course*

*Separate registration required.

Thursday, June 20

7:15 am Registration Open

7:15 Breakout Discussion Groups with Continental Breakfast


8:10 Chairperson’s Remarks

Michael J. Benecky, PhD, Senior Director, Global Regulatory Affairs, Precision and Digital Medicine, R&D Chief Regulatory Office, GlaxoSmithKline

8:15 Challenges and Opportunities in Implementing Digital Biomarkers in Clinical Trials

Balaji Goparaju, Data Scientist, Innovative Digital Endpoints Analytics, Novartis

Digital biomarkers sit in an exciting intersection of the development of biology, novel analytics, and sensor technology. Digital biomarkers have the potential to complete the causal chain using continuous measurements to inform out-of-office behavior. However, much of the hype around transforming clinical trials using sensor technology will have to face the scientific, operational, and financial challenges that need to be addressed before wearables can consistently generate impact for the pharmaceutical industry.

8:45 A Platform Approach to Evaluating Digital Drug Development Technologies

Joshua Cosman, PhD, Quantitative Medicine, Digital Innovation, Biogen

Digital drug development technologies present an opportunity for more frequent, objective functional outcomes across a range of neurological disorders. In this talk, I provide an overview of our ongoing work in the PD and ALS space evaluating wearable and mobile assessments, including operational aspects, precompetitive alignment across industry and academic partners, and our interactions with regulators.

9:15 Transforming Clinical Trials with Objective, Holistic, Continuous and Ecologically Valid Digital Assessment

Jeffrey Kaye, MD, Layton Professor, Neurology & Biomedical Engineering, Director, ORCATECH - Oregon Center for Aging & Technology, Oregon Health & Science University

Trials have been limited by brief, episodic examinations relying on surrogate markers and much subjective data as outcomes. This presentation will describe an integrated, home-based pervasive computing platform deployed to hundreds of homes, and designed to improve trials by capturing objective, holistic, 24/7, and ecologically valid data. The data’s density, reflection of real-world function and person-specificity can reduce sample sizes or time needed to obtain early meaningful signals of clinical efficacy and safety.

9:45 Sponsored Presentation (Opportunity Available)

10:15 Coffee Break in the Exhibit Hall with Poster Viewing


11:00 Regulatory Considerations During Mobile Medical App Development

Michael J. Benecky, PhD, Senior Director, Global Regulatory Affairs, Precision and Digital Medicine, R&D Chief Regulatory Office, GlaxoSmithKline

This presentation will cover: 1) Mobile Medical Apps (MMAs) are defined as medical devices from its intended use shown through labeling claims, advertising, oral or written statements; 2) MMA regulation is health risk based to balance patient safety and regulatory barriers to technological innovation, 3) Patient risk analysis is a critical activity prior to sensor/app inclusion within a clinical trial; 4) Digital Safety Risks include Data Privacy, Data Cybersecurity, Software Malfunction and Clinical Risk from app/sensor use.

11:30 The Asthma Mobile Health Study Latest Research Findings

Yu-Feng (Yvonne) Chan, MD, PhD, Associate Professor, Genetics & Genomics Sciences, Icahn School of Medicine; Director, Digital Health & Personalized Medicine, Icahn Institute for Genomics and Multiscale Biology at Mt. Sinai

The Mount Sinai Asthma Mobile Health Study powered by Apple’s ResearchKit framework is a remote observation study that enrolled >10,000 participants from 3 countries. Yvonne Chan, MD, PhD, principal investigator of the study and Director of the Center for Digital Health at Icahn School of Medicine at Mount Sinai, will share the latest lessons learned from this pioneering mobile health research study.

12:00 pm Precision Medicine on the Cloud

Iman Tavassoly, MD, PhD, Physician-Scientist, Icahn School of Medicine at Mount Sinai

Computational and mathematical models of human physiological and pathological processes can be used as a platform to monitor and control disease conditions by cloud computing. Input data are provided by biosensors and wearables, and the data processing using mathematical models is done on the cloud. In this talk I will give an overview and details of cloud computing strategy for precision medicine.

12:30 Sponsored Presentation (Opportunity Available)

1:00 Transition to Lunch

1:05 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:35 Dessert and Coffee Break in the Exhibit Hall with Poster Viewing


2:20 Chairperson’s Remarks

Carrie Northcott, PhD, Research Project Lead, Digital Medicine and Translational Imaging (DMTI), Early Clinical Development, Pfizer, Inc.

2:25 Inspiration from the Unmet Patient Need and Our Long-Term Vision

Gergely Vértes, MBA, Solution Accelerator Lead, Wearable for Epilepsy, UCB Pharma

Epilepsy is a complex disease affecting 65 million people with one commonality: seizures. The number of seizures is the basis of any medical decision to select or alter the right treatment and for approving drugs for their efficacy. Despite its clear importance, there is no objective solution for outside of the hospital (besides patient reported via pen and paper resulting in less than 50% accuracy).

2:55 The Verification and Use of Digital Wearable Technology to Evaluate Scratching and Sleep in Atopic Dermatitis

Carrie Northcott, PhD, Research Project Lead, Digital Medicine and Translational Imaging (DMTI), Early Clinical Development, Pfizer, Inc.

Atopic dermatitis is often accompanied by unrelenting nighttime pruritus resulting in reduced sleep. Quantitatively evaluating nighttime scratch and sleep via accelerometry using digital wearables to continuously monitor patients in their “home environment” would provide insight into the disease and effectiveness of treatments. A key aspect to provide value in these assessments is that the methods and devices are vetted and verified to detect clinically meaningful changes.

3:25 Actigraphy in Clinical Trials – Learnings and Prospects

Janet Munro, MBBS, MRC, Psych, General Manager Digital Development, Novartis

Actigraphy devices enable the collection of continuous real-world data that provide valuable new insights into the impact of diseases and treatments on patients’ everyday lives. As the implementation of actigraphy devices in clinical trials increases, reflecting on case studies and the lessons learned will allow us to overcome the challenges and embrace the opportunities.

3:55 Shaping the Future of Digital Health Technologies in Parkinson’s Research

Lauren Bataille, MS, Senior Associate Director, Research Partnerships, Michael J. Fox Foundation

The Michael J. Fox Foundation for Parkinson’s Research collaborates with leading researchers, industry partners, and the data science community to generate and analyze robust sensor-based datasets. In this talk, Lauren will report on results and best practices that are bringing us closer than ever to developing clinically meaningful endpoints and using them to support Parkinson’s disease clinical development.

4:25 Close of Conference

Arrive early to attend Tuesday, June 18 - Wednesday, June 19

Digital Health: Pharmaceutical Executive Summit

* The program is subject to change without notice, due to unforeseen reason.

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