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

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 with Light Refreshments provided by Clinical_Ink_NoTagline

9:40 Grand Opening Coffee Break in the Exhibit HallHighthink_Med

ENABLING DIGITAL BIOMARKERS AND ENDPOINTS

10:40 Chairperson’s Remarks

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

10:55 Presentation to be Announced

11:20 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.

11:45 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.

12:15 pm Enabling Seamless Recruitment, Increasing Patient Engagement, and Improving Outcomes Through Digital TransformationDeloitte

Anderson DawnDawn 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

Medable 12:50 Luncheon Presentation to be Announced

 

1:20 Coffee and Dessert Break in the Exhibit HallAbond

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

Speaker to be Announced

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 Wearable Devices in Clinical Trials: AI Methodologies Making an Impact in the Cardiovascular Space

Vlajnic_VanjaVanja 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.

OracleHealthsciences_new 3:50 Faster Recruitment, Lower Attrition, and Better Insight – Are you ready for Decentralized Trials?

Vandebelt KathleenKatherine 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.

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 Halld_wise_NEW

(Co-Sponsorship Opportunities Available)

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

Chairperson to be Announced

8:25 Digital Medicine 101

Goldsack_Jennifer 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

Casaceli_Cindy 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.

PhysIQ 9:45 Talk Title to be Announced

Matt Pipke, Chief Technology Officer, physIQ

 

10:05 Deploying Digital Biomarkers in Clinical Trials - Uncovering the Operational AdvantagesAiCure

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 HallAris_Global_New

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_Sina

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

Crouthamel_Michelle Moderator: Michelle Crouthamel, DBA, Director, Digital Health & Innovation, AbbVie


Panelists: Jeremy Wyatt, President, ActiGraph

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

12:25 pm Transition to Lunch

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

Fawcett_Christina Christina 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 HallBioTelResearch

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