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

Cambridge Healthtech Institute’s 2^nd 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 2^nd 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.

Wednesday, June 19

12:00 pm Registration Open

12:00 Bridging Luncheon Presentation: Advancing High-Throughput Screening Using FirePlex-HT Immunoassays

Elnaz Atabakhsh, PhD, Senior Product Manager, Multiplex Assays, Abcam

To address the need for high-throughput and sensitive quantification of protein biomarkers from biological samples, we at Abcam have developed FirePlex®-HT immunoassays: a high-throughput multiplex platform that can quantify 10 protein analytes per well in a 384-well format. FirePlex-HT is ideally suited to drug discovery projects screening large compound libraries, safety assessment and toxicity screening in large sample sets, and clinical focused studies for disease identification, patient stratification or therapy responses in large patient cohorts.

12:30 Transition to Plenary

12:50 PLENARY KEYNOTE SESSION

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

2:25 Meet the Plenary Keynotes

REAL-WORLD EVIDENCE: UTILITY OF DIGITAL BIOMARKERS
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3:05 Chairperson’s Remarks

Wasim Malik, PhD, Assistant Professor, Harvard Medical School; Managing Partner, Iaso Ventures

3:10 The Use of RWE and AI to Improve Patient Outcomes

Bernard Hamelin, MD, Head, Medical Evidence Generation, Sanofi

Data is the currency of drug research and development and medical knowledge. The huge technical advances that have been evolving about evidence generation, analyzing and sharing data are allowing drug companies to better respond to physicians, regulators, payers and patients' requirements. At the same time, there are risks that come along with these advances which makes it important to develop a structured approach to help companies deal with various cultural, administrative and legal complexities.

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

Wasim Malik, PhD, Assistant Professor, Harvard Medical School; Managing Partner, Iaso Ventures

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 NEW: Digital Biomarkers: A Path to Meaningful Real-World Evidence

Jamileh Jemison, MS, MD, Head of Clinical Development, HealthMode

Successful clinical development and post-approval adoption hinge on clean, relevant data. With continuous, tailored data-measurement tools emerging, the future looks bright for focused passive data collection using latent technologies. Using examples from our work, I will discuss the future applications of continuous, customizable measurement in clinical research.

5:10 4th of July Celebration in the Exhibit Hall with Poster Viewing

5:30-5:45 Speed Networking: Oncology

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

DIGITAL BIOMARKERS AS CLINICAL ENDPOINTS
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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 Using Deep Learning to Generate Novel Digital Biomarkers: A Wearables-Based Proxy for VO2max

Chris Economos, Vice President, Business Development, physIQ

Matt Pipke, CTO, physIQ

There are many “gold standard” clinical assessments that, while accepted by industry and regulators, are far from ideal.  They are either too expensive (polysomnography), too inaccurate (6 minute walk), or too burdensome (VO2max).  Physiology data from wearable sensors, when coupled with deep-learning artificial intelligence, provide the opportunity to replicate these assessments at home.  In this presentation physIQ will review their latest proprietary deep learning tool as a potential replacement for VO2max in clinical trials.

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

10:45 Poster Winner Announced

mHEALTH PLATFORMS FOR DIGITAL BIOMARKERS: MOBILE DEVICES AND APPS

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 Enjoy Lunch on Your Own

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

1:45-2:00 Speed Networking: Last Chance to Meet with Potential Partners and Collaborators!

BIOSENSORS AND WEARABLES AS NOVEL DIGITAL BIOMARKERS

2:20 Chairperson’s Remarks

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

2:25 Talk Title to be Announced

Ariel V. Dowling, PhD, Associate Director, Clinical Devices, Data Science Institute, Takeda Pharmaceuticals

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

Julia Keefe, Associate Director, Research Programs, 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.

3:55 Close of Conference