(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

Wednesday, June 19

12:00 pm Registration Open

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

Elnaz AtabakhshElnaz Atabakhsh, Product Manager, Regional Sales & Marketing, 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

3:05 Chairperson’s Remarks

Wasim Malik, PhD, Assistant Professor, Harvard Medical School


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

Malik_WasimWasim Malik, PhD, Assistant Professor, Harvard Medical School

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

Sim_IdaIda 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 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

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

Goparaju_BalajiBalaji 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

Cosman_JoshusJoshua 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

Kaye_JeffreyJeffrey 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.

PhysIQ 9:45 Using Deep Learning to Generate Novel Digital Biomarkers: A Wearables-Based Proxy for VO2max

Economos_ChrisChris Economos, Vice President, Business Development, physIQ


Pipke_MattMatt 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

Benecky_MichaelMichael 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

Chan_Yu-Feng_(Yvonne)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

Tavassoly_ImanIman 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

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

Vertes_GergelyGergely 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

Northcott_CarrieCarrie 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

Munro_JanetJanet 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

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.

4:25 Close of Conference

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

Digital Health: Pharmaceutical Executive Summit