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

10:40 Use of Novel Sensors in Understanding Disease States toward Patient-Centric Therapies

Subramony_AnandAnand Subramony, Vice President, New Product Technologies, MedImmune, a member of AstraZeneca

Enabling improved patient outcome will dictate the development of new therapeutics in the digital era. In addition to providing patient centricity through right dosage forms, ability for patients to monitor vital signs, quality of life indicators, and other biomarkers will be key to obtain desired outcome. This presentation will focus on how the use of breathomics and other wearable sensor technologies and the use of data analytics is emerging to help patients better manage disease states.

11:10 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.

11:40 Digital Biomarker Development at Roche: Are Clinical Endpoints from Mobile Sensor Data in Reach?

Gossens_ChristianChristian Gossens, PhD, Global Head Early Development Workflows, Roche Pharmaceutical Research & Early Development

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 12:10 pm Presentation to be Announced

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

Chairperson to be Announced

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.

2:30 Validating Novel Digital Endpoints: What’s the Right Development Model?

Erb_KelleyMichael Kelley 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.

2:50 Application of Digital Health Solution in the Context of Asthma Disease Management

Bhaskar Dutta, PhD, Principal Scientist, Advanced Analytics Center, AstraZeneca

Use of wearable sensors has the potential to revolutionize the clinical trial process by allowing us to measure new endpoints, continuous monitoring of the efficacy and safety signals, and improve medication adherence. We designed an integrated digital health solution consisting of wearable sensors, patient home measurements, and cell phone based app to collect streaming data from asthma patients. The goal of the pilot study is to reveal the feasibility of developing and deploying digital health solutions for better disease management.

3:10 INTERACTIVE PANEL: Novel Digital Endpoints in Clinical Research: Technology, Infrastructure, Regulatory Considerations

Crouthamel_MichelleModerator: Michelle Crouthamel, Digital Platform Leader, GSK

Bhaskar Dutta, PhD, Principal Scientist, Advanced Analytics Center, AstraZeneca

Erb_KelleyMichael Kelley Erb, PhD, Director, Digital Medicine, Early Clinical Development, Pfizer

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

Gossens_ChristianChristian Gossens, PhD, Global Head Early Development Workflows, Roche Pharmaceutical Research & Early Development

Silvesti_GregGreg Silvesti, Head, Digital Health & Innovation, AbbVie

Subramony_AnandAnand Subramony, Vice President, New Product Technologies, MedImmune, a member of AstraZeneca

  • 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


3:40 StepWatch™ Accuracy, Reliability, and Adherence Means Greater Probability to Detect Improvements in Real World Walking

Teri 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.

3:55 Sponsored Presentation (Opportunity Available)

Regency O

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, President, Patient Consent, DrugDev, An IQVIA Company

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, Former Head of Clinical, Informatics, and Regulatory Strategy, Digital Medicine and the Pfizer Innovation Research Lab

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

Amato_StephenStephen Amato, PhD, Global Product Development, 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 Re-Imagine Clinical Trials with Trust

Arun Ghosh, Principal, US Blockchain Leader, KPMG LLP

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 O

11:20 Chairperson’s Remarks

Chairperson to be Announced, Protocol First

11:25 Where Is the Internet of Medical Things Taking Clinical Research?

LaPorte_JacobJake LaPorte, PhD, Vice President, Global Head, Digital Development, Novartis Pharmaceuticals Corporation

The Internet of Medical Things (IoMT)–the network of physical healthcare devices that are able to generate and exchange data remotely–is one of the fundamental driving forces of the digital transformation in healthcare. IoMT will have significant implications for how clinical research is conducted including the development of digital endpoints and evidence to measure the effects of medicines in new ways. Where is clinical research heading and how can we harness these new technologies to develop better, more effective medicines faster?

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

Rowe_AnthonyAnthony Rowe, PhD, Director, Business Technology Leader, R&D IT, 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

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


SCOPE 2019 is dedicated to the life and memory

Christine K. Pierre
September 8, 1958 - October 23, 2018

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“SCOPE Featured Author”
Emmanuel Fombu, MD,
Director, Digital Health Solutions

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