Cambridge Healthtech Institute’s 2nd Annual

Sensors, Wearables and Digital Biomarkers in Clinical Trials

Digital Endpoints and Connectivity

February 19-20, 2019

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. Cambridge Healthtech Institute’s 2nd Annual “Sensors, Wearables and Digital Biomarkers in Clinical Trials” conference is designed as a knowledge and experience exchange for clinical data and clinical operations executives. The conference will feature case studies of clinical trials that already employ sensors and wearables as well as discussions of the future steps needed for digitalization of clinical trials.

Final Agenda

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

Monday, February 18

9:00 am 7:15 pm Registration Open (Convention Level)

2:00 – 5:00 pm User Group Meetings

Shared Investigator Platform User Forum

Trifecta Annual User Group Forum

5:00 – 6:15 pm Pre-Conference Plenary Keynote Panel & Participant Engagement Award (Regency PQ)

6:15 – 7:15 pm SCOPE’s Kick-off Networking Happy Hour Hosted by CHI (Sponsorship Opportunities Available) (Pool Decks)

7:15 pm Close of Day

Tuesday, February 19

7:15 am Registration Open and Morning Coffee (Convention Level)

8:15 Opening Plenary Keynotes

9:35 Grand Opening Coffee Break in the Exhibit Hall (Plaza International Ballroom)

Regency O

10:35 Chairperson’s Remarks

Michelle Crouthamel, Digital Platform Leader, GSK

10:55 Moving beyond Patient Engagement to Human-Centered Design in Digital Health

Silvesti_GregGreg Silvesti, Head, Digital Health & Innovation, AbbVie

Digital health tools, like smart devices and IoT have the power to revolutionize healthcare by unlocking untapped objective data and translating it into clinically relevant information. As the industry is maturing, technology is increasingly getting commoditized and experience is becoming a differentiator. Patient-centricity and “engagement” has taken us so far in digital health, it’s time we start to discuss what it means to be human-centric and why that matters.

11:30 Digital Biomarker Development at Roche: Are Clinical Endpoints from Mobile Sensor Data in Reach?

Timothy Kilchenmann, Digital Biomarker Scientist, Roche

Merging the best of two worlds - clinical trials and real world - is now increasingly possible. Mobile sensors are rapidly becoming a part of everybody’s lives. They allow for objective, precise and continuous measurements. We share our first real world digital biomarker results based on active tests and passive monitoring data - provided by Parkinson’s disease and Multiple Sclerosis patients in clinical trials.

AiCure 12:05 pm Using AI and Computer Vision Technology to Capture, Measure, and Modify Patient Behavior in Clinical Research

Marlborough_MichelleMichelle Marlborough, Chief Product Officer, AiCure

Advances in computer vision and AI technology are allowing us to capture and analyze an unprecedented amount of data from patients around their actions and responses to medical conditions. This is fundamentally changing how drug developers keep their patients engaged and optimized to treatment in clinical trials. Learn how sites and clinical operations teams are leveraging these behavioral insights today to better support patients, improve data quality, and increase the likelihood of trial success.

12:40 Transition to Lunch

Oracle-Health-Sciences 12:45 LUNCHEON PRESENTATION: Plug-Me-In Clinical Research – Innovating at Scale

Palmer JonathanJonathan Palmer, Senior Director, Digital Trials, Oracle Health Sciences

Clinical research is about to change beyond recognition. Simply plugging in the patient to a variety of sensors/wearables/apps can deliver high-quality, objective data, to provide deep understanding of efficacy and safety profiles. This presentation will explore digital trial use cases, and associated enabling technologies, and consider how best to scale adoption of these innovative paths to maximize the resultant new data streams to rapidly gain insight into trial progress and patient outcomes.

1:25 SCOPE Turns 10! Champagne and Dessert in the Exhibit Hall (Plaza International Ballroom)

Regency O

2:05 Chairperson’s Remarks

Luis Garcia-Gancedo, PhD, Director, Clinical Sensors and Data Analytics, GSK

2:10 Implementing Wearable Devices in GSK Clinical Studies

Garcia-Gancedo_LuisLuis Garcia-Gancedo, PhD, Director, Clinical Sensors and Data Analytics, GSK

In this talk I will give an overview of our main considerations for choosing and deploying wearable technologies in clinical trials. As an example, I will explain how we went about introducing a specific wearable in some of our ongoing studies, and the impact that the data we are collecting is expected to make in assessing treatment efficacy and adding value to our medicines.

2:40 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.


3:10 StepWatch™ Accuracy, Reliability, and Adherence Means Greater Probability to Detect Improvements in Real World Walking

Chou_TeriTeri Chou, PhD, CEO, Modus Health

The accuracy of walking monitors vary widely from consumer products such as Fitbit™ to medical devices such as StepWatch™. This presentation emphasizes how monitor accuracy and reliability can affect number of study participants needed to detect walking improvements. Adherence results in an ongoing pharmaceutical trial will also be discussed.

3:40 INTERACTIVE PANEL: Novel Digital Endpoints in Clinical Research: Technology, Infrastructure, Regulatory Considerations

  • Where we are with NDE currently compare to 3 years ago? Are we making progress?
  • What are the barriers?
  • How should industry advance NDE development, standardization, validation, approval
  • Audiences’ thoughts
  • Crouthamel_MichelleModerator: Michelle Crouthamel, Digital Platform Leader, GSK

    Panelists: Timothy Kilchenmann, Digital Biomarker Scientist, Roche

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

    Garcia-Gancedo_LuisLuis Garcia-Gancedo, PhD, Director, Clinical Sensors and Data Analytics, GSK

    Silvesti_GregGreg Silvesti, Head, Digital Health & Innovation, AbbVie

    Regency R

    4:10 Find Your Table and Meet Your Moderator

    4:15 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.

    5:00 Welcome Reception in the Exhibit Hall (Plaza International Ballroom)

    6:30 Close of Day

    Wednesday, February 20

    7:15 am Registration Open (Convention Level)

    7:45 BREAKFAST PRESENTATION: ICF Authoring - The Next Evolution of Informed Consent (Regency P)

    Delente_EricEric Delente, Head, Patient Consent, IQVIA Technologies

    This session will explore how the recent introduction of informed consent form (ICF) authoring systems, including IQVIA ICF Author, have evolved the informed consent process by allowing sponsors and CROs to create, distribute, and track ICFs from a centralized portal, whether using paper forms or eConsent. It will also explore the features and benefits of these portals, showing why sponsors and CROs should consider adoption.

    8:15 Session Break

    Regency O

    8:20 Chairperson’s Remarks

    Daniel Karlin, MD, Director of Biotech Ventures, CEAi, Inc.

    8:25 Regulatory Considerations during Mobile Medical App Development for Commercial and Clinical Trial Use

    Benecky_MikeMichael Benecky, PhD, Senior Director, Global Regulatory Affairs, Precision & Digital Medicine, GSK

    Mobile medical apps are defined as medical devices from their intended use. Mobile medical app regulation is health risk-based to balance patient safety and barriers to technological innovation. Medical device patient risk analysis is a critical prerequisite prior to sensor/app inclusion within a clinical trial. Key components of quality management systems for mobile medical apps include: software requirements/specifications, user acceptance testing, software post-market surveillance, software version control and medical device adverse event reporting.

    8:55 Data Integrity Playbook: Risk-Based, Analytics-Driven Approach to Monitor Data Integrity

    Prakash_GianGian Prakash, Assistant Director, Data and Statistical Sciences, Abbvie

    Technology is changing the paradigm of how clinical data is collected and analyzed, with the increase in the volume of data and complexity of clinical technologies, there is a need to ensure appropriate controls are in place to govern and monitor the data integrity throughout the life cycle of the clinical data. Data Integrity Playbook provides a solution to implement a cross-functional technical approach to perform audit trail reviews for ensuring data integrity.

    9:25 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.

    KPMG 9:55 CO-PRESENTATION: Re-Imagine Clinical Trials with Trust

    Ghosh_ArunArun Ghosh, Principal, US Blockchain Leader, KPMG LLP

    Bergstrom_RichardRichard Bergstrom, Vice President, Life Sciences, Guardtime

    Digital technologies provide significant opportunity to modernize clinical trials. During this session, KPMG will provide its perspective on applying the Internet of things (IoT) and Blockchain technologies for clinical trials to validate the precision and accuracy of patient data captured from smart sensors, improve consistency and reliability of data to garner insights and provide the trust trial participants, clinicians and regulators need for transparency and compliance with data privacy and security regulations. KPMG will also present a framework to enhance the efficacy of patient care, improve reporting cycles, optimize drug development lifecycle, and advance innovation in Life Sciences.

    10:25 Coffee Break in the Exhibit Hall (Plaza International Ballroom)

    Regency Q

    11:20 Chairperson’s Remarks

    Hugh Levaux, PhD, Founder & CEO, Protocol First

    11:25 The Future of Healthcare: Humans and Machines Partnering for Better Outcomes

    Fombu_Emmanuel Emmanuel Fombu, MD, MBA, Global Commercial Strategy and Digital Innovation, Johnson & Johnson

    We live in a world where data can help us make more informed decisions about how to navigate traffic, who to date, what to buy, who to network with and how to better manage our finances. But when it comes to our personal health and wellness, we have no roadmap. We need something to show us where we are in terms of our health, with landmarks for risks and opportunities. A GPS that makes it easier to move toward our personal health goals. A new way to look at health and life.

    11:55 The Digital Health Ecosystem: The “New” People, Technologies and Processes Needed to Scale Up the Use of Digital Health in Pharmaceutical Development

    Mark Sapp, Product Line Owner, Digital Health, Janssen R&D

    It is becoming increasingly valuable to leverage digital technology in a clinical trial environment to differentiate therapy, provide rapid insights and provide patient-centric solutions. This talk will aim to discuss how to move beyond ongoing digital health “pilot-itis” and describe the ecosystem of functions and capabilities that are needed to scale the use of digital technologies in clinical operations.

    12:25 pm Transition to Lunch

    12:30 BRIDGING LUNCHEON PRESENTATION: Configuration in ePRO: Making Design More Collaborative and Delivering Better Results (Regency O)

    Kyle Hogan, Director, eClinical Solutions, Clinical Ink

    You will learn how the authoring tool allows Clinical Ink project managers to focus on continuous collaboration in design and iterative improvements starting with early decisions and regular feedback. You will see how rapid and regular prototyping supports that feedback cycle, improves sponsor study team confidence and delivers better quality ePRO solutions with fully integrated patient engagement experiences.

    1:10 Coffee and Dessert Break in the Exhibit Hall (Plaza International Ballroom)

    2:10 Close of Conference

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