Digital Health is promising to revolutionize healthcare delivery, optimize personalized and precision medicine, and offer new tools for drug and diagnostic development. The applications of biosensors, mobile devices and wearables, Internet of Things, mobile health platforms, artificial intelligence, and digital biomarkers are quickly expanding into all areas of patient monitoring and disease management, point-of-care diagnostics, and digital endpoints in clinical trials. Cambridge Healthtech Institute’s Inaugural Digital Health: Sensors, Wearables, and IoT conference program will bring together leading experts and thought leaders in digital health to discuss the latest technologies and implementation of digital tools into drug development, diagnostics and healthcare.

Final Agenda

Monday, March 11

10:30 am Conference Program Registration Open (South Lobby)

ENABLING PERSONALIZED MEDICINE WITH DIGITAL HEALTH
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11:50 Chairperson’s Opening Remarks

Adrian Chernoff, Former Worldwide Vice President, Global Head of Research and Development, Johnson and Johnson


12:00 pm KEYNOTE PRESENTATION: Digital Health and the Wired Person

Michael Snyder, PhD, Professor & Chair, Center for Genomics & Personalized Medicine, Stanford University

We have been using wearable devices to detect disease states including infectious disease and glucose dysregulation. A summary will be presented.

12:30 KEYNOTE PRESENTATION: Understanding Disease State through Sensors/Wearables

Subramony_AnandAnand Subramony, PhD, Vice President, Novel Product Technologies, MedImmune

Understanding disease states through the use of wearables, either passive or those that rely on invasive or semi-invasive technologies, helps patients and healthcare providers in disease management. New sensors that monitor sleep disruptions/night-time awakenings, actigraphy, and peak flow assessments at the comfort of patient’s home or remote locations are enabling novel ways to the management of chronic diseases. This talk will provide an overview of emerging opportunities that wearables and sensors are bringing towards richer data-driven clinical studies that might eventually help with the development of patient-centric medications.

1:00 Enjoy Lunch on Your Own

DRIVING DIGITAL HEALTH INNOVATION
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2:30 Chairperson’s Remarks

Adrian Chernoff, Former Worldwide Vice President, Global Head of Research and Development, Johnson and Johnson

2:40 A Multi-Level Approach to Digital Health Innovation

Chernoff_AdrianAdrian Chernoff, Former Worldwide Vice President, Global Head of Research and Development, Johnson and Johnson

Where does one start to innovate and deliver digital transformation in digital health? How does one craft the digital vision and purpose unifying engagement and outcomes? What does it mean to put the patient at the center? How does data and connectivity transform and personalize the user experience? And what can we learn and leverage from other industries to accelerate and advance digital health applications to improve patient outcomes and improve adherence and efficacy?

BostonHealthcare 3:10 Reimbursement for Digital Health Products: What Can We Learn from the Diagnostics Industry?

Girardi_MarkMark Girardi, Vice President, Boston Healthcare Associates

Previous coverage and reimbursement processes for diagnostic testing can provide valuable insights and the start of a blueprint for digital health products.  In this session, we will review several key considerations and recommendations for digital health companies

 

3:40 PANEL DISCUSSION: Strategies for Digital Health Innovation: Investment, Regulation, Reimbursement and Growth Opportunities

Moderator: Adrian Chernoff, Former Worldwide Vice President, Global Head of Research and Development, Johnson and Johnson

Panelists:

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

Jeremy Frank, PhD, Senior Vice President, Digital Medicine, Proteus Digital Health

Anand Subramony, PhD, Vice President, Novel Product Technologies, MedImmune


Topics Include:

  • What are the key drivers behind digital health innovation?
  • What are the key investment opportunities in digital health?
  • How is digital health making healthcare more patient-centric?
  • What are the regulatory and reimbursement issues in implementing digital health?
  • What are the unmet technology needs in digital health adoption?
  • What market areas will see the most rapid growth over the next 5 years?

4:40 Refreshment Break and Transition to Plenary Session


5:00 Plenary Keynote Session (Room Location: 3 & 7)

6:00 Grand Opening Reception in the Exhibit Hall with Poster Viewing

7:30 Close of Day

Tuesday, March 12

7:30 am Registration Open and Morning Coffee (South Lobby)


8:00 Plenary Keynote Session (Room Location: 3 & 7)

9:15 Refreshment Break in the Exhibit Hall with Poster Viewing

INTERNET OF MEDICAL THINGS: CONNECTED HEALTHCARE WITH SENSORS AND WEARABLES
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10:15 Chairperson’s Remarks

Christopher M. Hartshorn, PhD, Program Director, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health

10:25 IoT Wearables: Understanding and Applying New Technologies in Research

Rich Brancaccio, Founder & CEO, Revibe Technologies

10:55 Widgets to Cancer Patient-Specific Digits: The Case for Remote Patient Monitoring via Sensors and Connected Health Solutions for Precision Oncology

Hartshorn_ChristopherChristopher M. Hartshorn, PhD, Program Director, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health

Albeit the case for long-term, out-of-clinic monitoring has been obvious for many chronic diseases, the case for cancer has not been as clear. The National Cancer Institute has begun piloting and funding various aspects to enable an Internet of Cancer Medical Things. This talk will focus on these efforts currently/prospectively as well as the coordination of a broader initiative to improve our understanding of cancer progression and the delivery of cancer care.

11:25 Sensing Life Kinetics: Building the Evidence Base for Digital Health

Kaye_JeffreyJeffrey Kaye, PhD, Professor, Neurology & Biomedical Engineering, Oregon Health & Science University

Advances in pervasive computing, sensing devices, wireless communications, and data analytics have promised to transform healthcare. Despite this growing evolution of technology, the value of these technologies for health has not been fully realized. This presentation will address pathways forward emphasizing the need for trusted evidence and include a description of a new national initiative (“CART”) to create a technology agnostic, scalable, flexible system for evidence building across the research enterprise.

11:55 Ingestible Sensors

Van_Hoof_ChrisChris Van Hoof, Senior Director, Connected Health Solutions, imec

12:25 pm Enjoy Lunch on Your Own

1:35 Refreshment Break in the Exhibit Hall with Poster Viewing

AI AND MACHINE LEARNING FOR IoT BIG DATA: ENABLING ACTIONABLE REMOTE PATIENT MONITORING AND CARE
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2:05 Chairperson’s Remarks

Kamal Jethwani, MD, MPH, Assistant Professor, Dermatology; Senior Director, Connected Health Innovation, Massachusetts General Hospital

2:10 Humanizing Care through AI

Jethwani_KamalKamal Jethwani, MD, MPH, Assistant Professor, Dermatology; Senior Director, Connected Health Innovation, Massachusetts General Hospital

Health systems and healthcare industries are eagerly diving into AI and machine learning technologies, allocating significant resources toward validating and refining predictive algorithms for a range of applications, including diagnostic tools and aids to clinical decision making. However, we need to understand the human users of these algorithms, and how their clinical workflows, decisions, and relationships with patients will be affected, and how best to position AI for success in the delivery of care.

2:40 Supporting Personalized Health with AI and IoT

Rogers_JeffreyJeffrey Rogers, PhD, Global Research Leader, IBM


3:10 Integrating Wearable Sensors and AI into Automated Drug Delivery and Decision Support Systems for People with Type 1 Diabetes

Jacobs_PeterPeter G. Jacobs, PhD, Assistant Professor, Department of Biomedical Engineering, Artificial Intelligence for Medical Systems (AIMS) Lab, Oregon Health & Science University

Wearable glucose sensors are being used to drive automated insulin delivery and decision support systems for people with type 1 diabetes (T1D). Physical activity and other IoT sensors combined with AI can augment these drug delivery systems to achieve better performance and personalized care. This talk will describe how the AIMS lab at OHSU is using sensors and AI to develop new drug delivery and decision support systems for T1D.

3:40 Remote Patient Monitoring for Neurological Disorders

Wasim Malik, PhD, Assistant Professor, Harvard Medical School

4:10 St. Patrick’s Day Celebration in the Exhibit Hall with Poster Viewing

5:00 Breakout Discussions in the Exhibit Hall

6:00 Close of Day

Wednesday, March 13

7:30 am Registration Open and Morning Coffee (South Lobby)


8:00 Plenary Keynote Session (Room Location: 3 & 7)

10:00 Refreshment Break and Poster Competition Winner Announced in the Exhibit Hall

DIGITAL BIOMARKERS FOR INNOVATIVE CLINICAL TRIALS
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10:50 Chairperson’s Remarks

11:00 The Value of Digital Endpoints: Case Studies in Innovation and Novel Insights

Clay_IeuanIeuan Clay, PhD, Group Lead, Digital Endpoints, Translational Medicine, Novartis Institutes for BioMedical Research

Emerging capabilities in sensors and analytics are increasing our ability to understand how our patients’ lives are affected by their disease. We present several case studies across multiple indications to illustrate how we identify and address clinical needs by leveraging connected digital devices to capture novel, QoL relevant insights on a population and patient level.

11:30 Introducing Digital Health into Clinical Trials

Sindhya Govind, Specialist Business Systems Analyst, Amgen

12:00 pm Consumer Digital Health Wearables in Interventional Clinical Studies: A Case Study from Pioneer-HCM

Wolfus_CharlesCharles Wolfus, Vice President, Digital Health and Business Operations, MyoKardia, Inc.

Ensure the adoption of digital solutions by involving cross-functional stakeholders to address concerns around consent, evolving technology and user experience. You will learn: 1) how MyoKardia’s cross-functional team rapidly deployed sensors in the Phase II PIONEER-HCM study; 2) why Phase II studies uniquely position companies using exploratory endpoints to develop digital biomarkers; 3) how to apply wearable technologies combined with machine learning to better understand disease state and disease burden.

12:30 Enjoy Lunch on Your Own

1:10 Refreshment Break in the Exhibit Hall and Last Chance for Poster Viewing

MOBILE HEALTH: CLINICAL UTILITY OF SMARTPHONES AND MOBILE MEDICAL APPS
9

1:50 Chairperson’s Remarks

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

2:00 Lessons Learned from the Asthma Mobile Health Study

Chan_Yu-Feng_YvonneYu-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 lessons learned from this pioneering mobile health research study.

2:30 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 the following topics: 1) Mobile Medical Apps (MMAs) are defined as medical devices from their intended use shown through labeling claims, advertising, or oral or written statements; 2) MMA regulation is health risk based to balance patient safety and 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.

3:00 From Design to Digital Biomarkers: App-Based Research Using ResearchKit and ResearchStack

Webster_DanielDan E. Webster, PhD, Principal Scientist of Digital Health, Sage Bionetworks

The smartphone has become a useful platform for large-scale, remote studies of human health. The accelerometers, camera, GPS, microphone, touch screen and emerging sensors serve as a versatile toolkit to longitudinally measure health outside of a clinical setting. Here, I will discuss successes and instructive failures from the past few years of performing app-based research studies with the ResearchKit (iOS) and ResearchStack (Android) frameworks. Vignettes will span from the importance of iterative, user-centric design to the discovery and validation of digital biomarkers. Included will be a discussion of our work on the mPower Parkinson’s Disease Study, the Mole Mapper Melanoma Study, the All of Us Research Program CardioRespiratory Fitness Study, the Samsung/UCSF Stress Study, and others.

3:30 Session Break

DIGITAL THERAPEUTICS
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3:40 Chairperson’s Remarks

Joel Sangerman, Chief Commercial Officer, Click Therapeutics, Inc.

3:45 Transforming Care Models and Business Models with Digital Medicine

Jeremy Frank, PhD, Senior Vice President, Digital Medicine, Proteus Digital Health

The US FDA approved the world’s first NDA for a medicine including an ingestible sensor and an associated digital care management offering: ABILIFY MYCITE®, developed by Otsuka Pharmaceutical and Proteus Digital Health®, which supports patients with severe mental illness. This emerging business model for the pharmaceutical industry, based on integration of medications with hardware, software, analytics and services, is directly linked to patient-specific outcomes measuring pharmaceutical value and pricing. David will provide insights into the digital medicines category and associated pipeline of products in development and commercialization.

4:15 Prescription Digital Therapeutics: Three Key Outcomes That Will Transform Healthcare Delivery

Sangerman_JoelJoel Sangerman, Chief Commercial Officer, Click Therapeutics, Inc.

Smartphones are in constant use, making them ideal devices to deliver prescription digital treatments. Clinical studies indicate that apps treat certain diseases as effectively as prescription drugs. What traditionally is provided in a doctor’s visit is digitized to a highly engaging user experience enabling effective treatment via a smartphone. Apps will be prescribed by doctors as stand-alone or concomitant drug treatments, transforming the three pillars of healthcare delivery.

4:45 Close of Conference Program

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