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 Registration Open (Regency Rotunda)
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 (Regency Ballroom S)
6:20 - 7:30
pm SCOPE’s Kick-Off Networking Happy Hour (Upper Pool Deck, 4th Floor)
(Co-Sponsorship Opportunities Available)
7:30 pm Close of Day
Wednesday, February 19
7:15 am Registration Open (Regency Rotunda) and Morning Coffee (Regency Ballroom S Foyer)
8:15 Morning Opening Plenary Keynotes with Light Refreshments (Regency Ballroom S Foyer) provided by 
9:40 Grand Opening Coffee Break in the Exhibit Hall (Windermere Ballroom)
10:40 Chairperson’s Remarks
Michelle Crouthamel, DBA, Director, Digital Health & Innovation, AbbVie
10:55 Mobile Sensors in Clinical Trials and Evidentiary Considerations for Electronic Submissions
Bill Byrom, Vice President, Product Strategy and Innovation, Signant Health
11:20 Regulatory Considerations during Mobile Medical App Development
Michael 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.
11:45 Role of Connected Drug Delivery Devices in Clinical Trials
Michael
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.
12:15 pm Enabling Seamless Recruitment, Increasing Patient Engagement, and Improving Outcomes Through Digital Transformation
Dawn
Anderson, Managing Director, R&D Life Sciences Consulting, Life Sciences, Deloitte
There is a growing body of evidence showing the value of digital trials that share real time data between patients and investigators. Digital trials which utilize mobile apps and the use of connected medical devices can positively transform
the patient experience leading to better recruitment and improved study retention. The use of behavioral insights, by means of nudges and reminders, can improve protocol adherence while real time data sharing can better inform decision
making.
12:45 Transition to Lunch
12:50 Luncheon Presentation: Digital Trials Radically Accelerate and Power New Era Medicines and Therapies
Alison Holland, MS, Head, Virtual Clinical Trials, Medable
1:20 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)
2:15 Chairperson’s Remarks
Philippe Verplancke, PhD, Global Head of Business Development, XClinical GmbH
2:20 Challenges and Opportunities in Deriving Context-Aware Insight
Glynn Dennis Jr., PhD, Senior Director, Digital Health R&D & BioPharma AI, AstraZeneca
Wearable device enabled trials are proliferating in number and complexity. Blending traditional data with data from multiple sensors in real-time holds enormous promise for improving patient experience and safety. This presentation
will touch upon multi-sensor opportunities and highlight challenges in building context aware applications.
2:45 iPREDICT: A Case Study in Applying Digital Sensors Technology and Machine Learning to Predict Asthma Control
R. Alex Barbieri, PhD, Senior Analytics Consultant, Tessella
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.
3:00 Converging Patient-Facing Technology Capabilities: The Pinnacle of Patient-Centricity
Aman
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.
3:25 Wearable Devices in Clinical Trials: AI Methodologies Making an Impact in the Cardiovascular Space
Vanja Vlajnic, Statistician, Clinical Statistics, Bayer
The implementation of wearable devices in clinical trials are of interest due to their ability to continuously capture data, as opposed to traditional data collection methods which only occur at scheduled visits throughout the course
of the trial. A case study examining the utilization of such devices in the cardiovascular space is presented, along with the AI/ML methodologies used to analyze the data.
3:50 Faster
Recruitment, Lower Attrition, and Better Insight – Are you ready for
Decentralized Trials?
Katherine Vandebelt, Global Head, Clinical Innovation, Oracle Health Sciences Global Business
Unit, Oracle, Inc
Decentralized trials reduce patient burden through remote monitoring, minimizing site visits, and in turn reducing attrition. Further, the acquisition of richer datasets in the real world provides greater insight into true outcomes.
Learn about the hurdles of this new approach which we as an industry must jump over, and hear how Oracle are supporting global sponsors to rapidly embed the expanding ecosystem of innovative digital sources and advanced analytics
techniques to fundamentally change clinical research.
4:20 Find Your Table and Meet Your Moderator
For more details on the Breakout Discussions: https://www.scopesummit.com/breakouts
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 (Windermere Ballroom)
(Co-Sponsorship Opportunities Available)
Thursday, February 20
7:15 am Registration Open (Regency Rotunda)
7:45 BREAKFAST PRESENTATION: Navigating the Patient Journey: A Responsibility all Technology Providers Share (Regency Ballroom T)
Mike Nolte, Chief Executive Officer, Signant Health
8:15 Session Break
8:20 Chairperson’s Remarks
Matt Noble, Vice President, Product Management, Medidata, a Dassault Systèmes company
8:25 Digital Medicine 101
Jennifer 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.
8:55 The Development of MVPA as a Clinical Endpoint
Jeremy Wyatt, President & COO, ActiGraph
9:15 Utilizing Digital Tools in Clinical Research for Movement Disorders: Challenges, Successes and the Future
Cindy 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.
9:45 Lessons from Deployment of
a Continuous Multivariate Wearable Sensor Platform for a Heart Failure Trial
Matt Pipke, Chief Technology Officer, physIQ
Continuous wearable sensor data is proving to be a rich source of real world evidence for physicality and cardiopulmonary function in clinical trials. The capture and use of such data to provide analytics and digital
biomarkers is maturing toward a streamlined and standardized approach to deploying continuous sensors in trials. This brief presentation will highlight lessons learned with a cloud platform for long-term robust multivariate
sensor data capture and machine learning analysis in one ongoing interventional study in heart failure, touching on: suitability of sensors, maximizing data yield, subject compliance, machine/deep learning analytics and validation
as biomarkers of outcomes.
10:05 Deploying Digital Biomarkers in Clinical Trials - Uncovering the Operational Advantages
Lauren Sunshine, Associate Director, AiCure
As part of your existing biomarker strategies, the deployment of digital biomarkers offers insights and advantages to the clinical operations team by integrating well-validated digital heath engagement as a seamless part of the
subject’s daily life.
10:25 Coffee Break in the Exhibit Hall (Windermere Ballroom)
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
Sina 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
Moderator: Michelle Crouthamel, DBA, Director, Digital Health & Innovation, AbbVie
Panelists: Jeremy Wyatt, President, ActiGraph
Sina Djali, Head, Clinical and Operations Analytics, Johnson & Johnson
Jennifer Goldsack, Executive Director, Digital Medicine Society (DiMe)
Bill Byrom, Vice
President, Product Strategy and Innovation, Signant Health
- Where do you see the NDE play a role in the drug development process?
- Where are we as an industry regarding novel digital endpoint (NDE) development after 5+ years of exploration?
- What does the successful relationship look like between the sponsor and tech vendors today to achieve NDE development?
- What “infrastructure” have we established and what else still need to be built?
- Your call to action - from sponsor, consortia, vendor’s perspective
12:25 pm Transition to Lunch
12:30 BRIDGING LUNCHEON PRESENTATION: Navigating the Inclusion of Wearables in Clinical Trials: Considerations with Different Patient Populations
Brad Pruitt, MD, Executive Medical Director, Clinical 6, 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 (Windermere Ballroom)
2:00 Close of Conference
Stay on and attend Part 2: Clinical Technology and Innovation