Cambridge Healthtech Institute’s 3rd Annual

Sensors, Wearables and Digital Biomarkers in Clinical Trials

Technology, Infrastructure and Analytics for Digital Data Sources & Endpoints

February 19-20, 2020


Clinical research industry is moving toward end-to-end digital clinical trials. The data collection should stay in line with this inevitable change and wearables and point-of-care sensors address this need. Furthermore, digital biomarkers translate new data sources into clinically actionable insights. CHI’s 3rd Annual Sensors, Wearables and Digital Biomarkers in Clinical Trials conference is designed to feature case studies of clinical trials that already employ sensors and wearables, as well as to discuss the future steps needed for implementation of digital biomarkers and endpoints in clinical trials.

Stay on and attend Part 2 (Thurs-Fri): Clinical Technology and Innovation

Final Agenda

Tuesday, February 18

9:00 am - 7:15 pm Registration Open

2:00 - 5:00 pm User Group Meetings

2:00 - 5:00 pm The NEW SCOPE China Clinical Development Partnering Forum and The NEW SCOPE Scientific Symposium*

*Separate registration required. Must be a Best Value registered attendee.

5:00 - 6:20 pm Evening Kick-Off Plenary Keynote and Participant Engagement Awards

6:20 - 7:30 pm SCOPE’s Kick-Off Networking Happy Hour

(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

9:40 Grand Opening Coffee Break in the Exhibit Hall

DIGITAL BIOMARKERS AND ENDPOINTS

10:40 Chairperson’s Remarks

Luis Garcia-Gancedo, PhD, Fellow & Director, Digital Biomarkers, GlaxoSmithKline

10:45 Digital Biomarkers: Translating New Digital Data Sources into Clinical Insights to Enhance Drug Development

Garcia-Gancedo_LuisLuis Garcia-Gancedo, PhD, Fellow & Director, Digital Biomarkers, GlaxoSmithKline

The rapid evolution of sensors and mobile devices for the collection of health-related data is laying the foundation for the next revolution in clinical drug development. These technologies not only provide the ability to measure much more detailed disease phenotypes than conventional clinical methods, but also provide the ability to follow patients longitudinally with much higher frequency than is possible through traditional clinical examination. In this presentation, I will explain how we go about introducing novel sensors in our clinical studies, and the impact that the data we are collecting is expected to make in assessing treatment efficacy and adding value to our patients and medicines.

11:10 Digital Medicine 101

Goldsack_JenniferJennifer Goldsack, Executive Director, Digital Medicine Society (DiMe)

From smart pacemakers to diagnostic algorithms and digital therapeutics, medicine is becoming more digitized every year. Digital medicine tools offer the possibility of improved health outcomes, lower costs, and better access to care. But the evidence base for the safety and effectiveness of these new products has not kept pace with their development. Given the great divide between the promised benefits of digital medicine and its potential risks, we need to know — not just believe — that the tools we use are trustworthy. This presentation will provide an introduction to key terms and concepts in digital medicine and reflect on how digital medicine products can advance the quality and efficiency of clinical trials for all medical products.

11:30 Regulatory Considerations during Mobile Medical App Development

Benecky_MichaelMichael 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.

11:55 An Exploration of Effective Regulator Engagement Regarding the Use of Digital Endpoints

Ramachandran_SurajSuraj Ramachandran, Director, Device and Digital Health, Regulatory Affairs, Merck

This session will share and explore a set of best practices for engaging regulators on the use of digital endpoints in clinical trials. The set of shared experiences and best practices is derived from a collective set of experiences by TransCelerate’s members as well as TransCelerate Patient Technology team’s own discussions with the FDA on the topic.

12:15 pm Sponsored Presentation (Opportunity Available)

12:45 Transition to Lunch

12:50 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:20 Coffee and Dessert Break in the Exhibit Hall

ADVANCED ANALYTICS AND CONNECTIVITY FOR DIGITAL BIOMARKERS

2:15 Chairperson’s Remarks

Philippe Verplancke, PhD, Global Head of Business Development, XClinical GmbH

2:20 Ipredict: A Case Study in Applying Digital Sensors Technology and Machine Learning to Predict Asthma Control

Dutta_BhaskarBhaskar Dutta, Principal Scientist, Advanced Analytics Center, AstraZeneca

Use of wearable sensors, home monitoring and smartphone apps have the potential to generate data that can revolutionize clinical trial and disease monitoring. Analysis and interpretation of the large volume of streaming data generated from these novel sources bring a new set of challenges. In a case study applied to severe uncontrolled asthma, we developed a machine learning framework to predict asthma events from the sensor data at population, sub-population and individual levels.

2:50 Converging Patient-Facing Technology Capabilities: The Pinnacle of Patient-Centricity

Thukral_AmanAman Thukral, Assistant Director, Data and Statistical Sciences, AbbVie

Biopharmaceutical sponsors are experimenting with multifold technologies to achieve patient-centricity. This is increasing pressure on patients to use multiple sensors, apps and devices during clinical trials. The goal of this presentation is to provide the framework for converging patient-facing technologies.

3:20 Role of Connected Drug Delivery Devices in Clinical Trials

Song_MichaelMichael Song, PhD, Senior Manager, Device Functionality Safety and Digital Connectivity, AstraZeneca

Explore connected drug delivery devices for clinical trials, as well as pitfalls and approaches in selecting and developing connected devices. With connected devices come additional considerations and regulations. We will discuss approaches to minimize organizational burden and expedite development/implementation. Not all connected devices are the same; we will explore what to consider when choosing the technology platform for your therapeutic area.

3:50 Sponsored Presentation (Opportunity Available)

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.

5:10 Welcome Reception in the Exhibit Hall

6:45 Close of Day

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

IMPLEMENTATION CASE STUDIES

8:20 Chairperson’s Remarks

Joe Mather, Executive Director, Head of Advanced Science and Collaboration Group, Pfizer

8:25 A Standardized Approach for Assessing Endpoints through Mobile Technology Collection: A Pfizer Perspective

Mather_JoeJoe Mather, Executive Director, Head of Advanced Science and Collaboration Group, Pfizer

This presentation will take a brief look at the standardized approach that Pfizer has developed to build remote monitoring platforms using biosensors to quantitatively assess disease relevant physical and physiological phenomena. A review of this methodology will focus on endpoint identification, biosensor and device evaluation, and analytics development.

8:55 Utilizing Digital Tools in Clinical Research for Movement Disorders: Challenges, Successes and the Future

Casaceli_CindyCindy Casaceli, Director, Clinical Trials Coordination Center, University of Rochester Medical Center

Research has traditionally involved in-person visits at a limited number of research centers. As approved digital tools become mainstream in clinical research, distance to a participating research site is no longer a barrier to participation. Digital tools are also creating volumes of continuous data as compared to the data collected from a traditional in-clinic, episodic research visit. This presentation will provide an overview of our experience at CHeT utilizing a wide variety of digital tools in our research, which include smartphone applications, tele-health, remote visits, watches, sensors and video.

9:25 Validating Novel Digital Endpoints: What’s the Right Development Model?

Erb_KelleyKelley Erb, PhD, Director, Digital Medicine, Early Clinical Development, Pfizer

Novel digital endpoints are transforming drug development. Their successful validation in time to impact clinical development requires the right evidence, from the right studies, at the right time. With the range of options including clinical trial pilots to large multi-stakeholder collaborations, what’s the right model to deliver fit-for-purpose outcome measures? Data, experiences, and key lessons learned from Pfizer’s efforts to develop and validate novel outcomes for Parkinson’s disease will be discussed.

PhysIQ9:55 Presentation to be Announced

10:25 Coffee Break in the Exhibit Hall

AN INTERSECTION OF CLINICAL RESEARCH, ENGINEERING AND DATA SCIENCES

11:20 Chairperson’s Remarks

Fred Martin, Chief Product Officer, Medrio

11:25 FEATURED PRESENTATION: Digital Biomarkers: An Intersection of Clinical Research, Engineering and Data Sciences

Djali_SinaSina Djali, Head, Clinical and Operations Analytics, Johnson & Johnson

Clinical and outcome-based research are rapidly moving away from relying on traditional sources of data, such as Electronic Data Capture/Case Report Forms and laboratory outputs, to collecting data continuously in real time using different digital media. This is achieved through the use of wearables and invisible (e.g. Bluetooth) miniaturized devices, and a corpus of existing images that can collect, track and predict behavioral and physiological outcomes. These innovations have given rise to digital biomarkers as a new discipline in clinical research. Many companies and academic research institutions have dedicated Digital Biomarker teams and projects solely focused on defining digital genotypes and phenotypes relevant to their specific areas of research. This new discipline takes advantage of new deep learning models, such as convolutional (imaging) recurrent neural networks that can be used for both detection and prediction of a particular clinical outcome. The aim of this session is to provide an overview of some of the advances in this field.

11:45 PANEL DISCUSSION: Novel Digital Endpoints in Clinical Research: Technology, Infrastructure, Relationship with Technology Providers

Crouthamel_MichelleModerator: Michelle Crouthamel, DBA, Director, Digital Health & Innovation, AbbVie


Wyatt_Jeremy_PanelistPanelists: Jeremy Wyatt, President, ActiGraph

This panel will discuss managing relationships with technology providers.


12:25 pm Transition to Lunch

12:30 BRIDGING LUNCHEON PRESENTATION: Navigating the Inclusion of Wearables in Clinical Trials: Considerations with Different Patient Populations

Fawcett_ChristinaChristina Fawcett, Senior Director, Operations, PRA Health Sciences

What types of studies do wearables seamlessly integrate and when do the complications outweigh the benefits? Are all types of patients ready to embrace wearables and are we ready to support the change?


1:00 Coffee and Dessert Break in the Exhibit Hall

2:00 Close of Conference


Stay on and attend Part 2: Clinical Technology and Innovation

PLENARY KEYNOTES

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

For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award

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: www.scopesummit.com/breakouts