Cambridge Healthtech’s 5th Annual

Data & Tech Driven Clinical Trials

Advancing Clinical Trials with New Tools and Analytics

May 14-15, 2019


Technology and data are at the forefront driving clinical trial decision-making. With further advancements in new technologies (such as mobile devices and wearables) and the rise of online communities, the pharma and biotech industries are poised to capitalize on these advancements to innovate existing clinical trial processes and systems. CHI’s Data & Tech Driven Clinical Trials conference gathers leaders across pharma, biotech and academia for discussions and case studies on leveraging new technologies and clinical trial data to advance clinical research. Special focus will be given to the challenges, solutions, and opportunities that lie in the adoption, use, validation, and data collection of digital technologies.

Final Agenda

Tuesday, May 14

10:00 am Conference Registration

Essex North

PLENARY KEYNOTE SESSION: Enabling Patient-Centric Clinical Trials

10:45 Chairperson Remarks: Patient-Centric Trials: How to Engage the Patients in a Clinical Study

Basker Gummadi, IT Strategy & Digital Transformation, Digital Innovation, Bayer U.S. LLC

Basker will share the results of the patients’ interaction and what is important to them and what keeps them engaged in a trial. He will also share his personal vision of how Digital technologies can help in this space.

10:55 KEYNOTE PRESENTATION: Patient-Centric Trials: Moving from What’s the Matter with Patients to What Matters to Patients

Lisa Shipley, Vice President, Global Digital Analytics, Merck

The overall percentage of potential patients that participate in clinical trial is very low. Engaging patients and removing barriers to patient participation in clinical trials is critically important to the development of new therapies to improve human health. Digital technologies are poised to improve patient participation and experience and shift from a site-centric to a patient-centric model. Pharmaceutical companies and CRO’s are exploring a number of different paradigms deploying technologies such as, telemedicine, wearables, and home-sampling.

11:15 KEYNOTE PANEL DISCUSSION: Going Virtual – Moving towards Patient-Centric, Site-Less Trials

Lisa Shipley, Vice President, Global Digital Analytics, Merck


Linnea Olson, Lung Cancer Patient Advocate


Laura Whitmore, Director, R&D Innovation, Corporate Projects, Otsuka


SHOGREN_MICHELLEMichelle Shogren, Head of Innovation in Portfolio and Operations, Pharma Development, Bayer


With the rise and integration of new technologies into clinical trials – mHealth, wearables, sensors, the internet of things – there is an unprecedented opportunity for revolutionizing how the industry performs clinical trials. New technology can help move clinical trials from sites directly into patient homes.

  • Virtual trials, decentralized trials, remote trials, site-less trials: What are we all talking about?
  • What are the latest successes and failures?
  • What are the barriers and challenges? How is the industry leveraging technology to make this a reality?
  • What are patients saying about their experience with virtual trials?
  • What does this mean for the future of clinical trials?

11:50 KEYNOTE PRESENTATION: Prescription of Digital Therapeutics: The Time has Arrived!

Atreja_AshishAshish Atreja, MD, MPH, FACP, Chief Technology Innovation and Engagement Officer, Medicine, Icahn School of Medicine at Mount Sinai


12:20 pm Networking & Dessert Break in the Exhibit Hall

Essex North

1:45 Chairperson’s Remarks

Tomasz Adamusiak, MD, PhD, Director Medical Informatics Lead, Pfizer Innovation Research Lab, Pfizer

1:50 Incorporating Digital Biomarkers in Clinical Trials

Brian Johnson, Associate Director, Corporate Projects, R&D Innovation, Otsuka

The use of digital technology and biomarkers for healthcare is growing rapidly and represents an opportunity for patient-oriented endpoints in clinical trials with the potential for real-world applications. Digital biomarkers may also represent a more objective, unbiased assessment compared to traditional subjective assessments (i.e., rating scales). Otsuka is actively incorporating digital biomarkers in numerous trials.

2:10 Bringing Innovation to Clinical Trials: Lessons Learned

Georgia Mitsi, Senior Director, Frontier Business, Sunovion Pharmaceuticals

2:30 Smartphones as Clinical Trial Measurement Tools

Daniel Karlin, MD, CEO, HealthMode; Former Head of Clinical, Informatics, and Regulatory Strategy, Digital Medicine and the Pfizer Innovation Research Lab

The ubiquity of mobile technologies that contain sensors capable of collecting clinical quality data, the emergence of novel analytical techniques, the availability of transmission and storage resources to support the collection of huge amounts of data, and computational resources to execute demanding models have brought us toward the integration of latent and trial data. HealthMode is leading this effort in several therapeutic areas. Dan will discuss the opportunities and obstacles we have encountered on this journey.

2:50  Refreshment Break in the Exhibit Hall

Data Analytics
Essex North

3:35 The Devil is in the Metadata - Lessons Learned from Data Acquisition in Digital Medicine Studies

Tomasz Adamusiak, MD, PhD, Director Medical Informatics Lead, Pfizer Innovation Research Lab, Pfizer

The mission of the Digital Medicine and the Pfizer Innovation Research (PfIRe) Lab is to solve key business problems using dynamical measures, advanced-STEM platforms and a collaborative network of external stakeholders, regulators and internal enterprise-wide colleagues to support a digital therapeutic pipeline. PfIRe Lab is an industry-leading mobile/digital technology initiative striving to utilize digital continuous remote monitoring of patients’ symptoms as novel endpoints for disease diagnosis and health state assessment. This talk will focus on the takeaways from our multi-year experience of data quality management of heterogeneous non-CRF data.

4:05 Clinical Analytics Innovation 2.0 - Measurement that Matters

Ankit S. Lodha, MS, MBA, Associate Director, Clinical Analytics & Innovation, Global Development Operations, Shire, part of Takeda Pharmaceuticals

Clinical analytics and insight can be leveraged to address a wide range of operational questions in a variety of settings. It is often utilized for purposes that are beyond the original intent of these data points. At Shire, we have developed industry best practices in measuring multiple CROs’ performance consistently, i.e. apple to apple comparison for all our CRO partners. We are applying best practices, but also taking a fresh approach to develop world-class clinical analytics metrics that will enhance our partnerships across our therapeutic areas. The goal of this presentation is to review the capability of several analytical approaches and to demonstrate how these insights can be incorporated into all phases of a clinical development program. This presentation will also share advances from previous analytical solutions and from scaling up our clinical analytics suite of metrics in developing KPIs to measure clinical trial performance.

4:35 Session Break

Essex North

5:00 Start-Up Showcase and Networking Reception

As a part of the Clinical Trial Innovation Summit, attendees are welcome to attend Tuesday night’s Start-Up Showcase and Networking Reception. As technological advances rapidly enter the market, it may become a challenge to keep up and ensure that your organization is effectively leveraging these technologies for improved clinical trial efficiency. Come listen to and network with new, emerging companies in the digital tech space as they provide brief descriptions of their companies and their services or products. Over cocktails in our open reception, connect with emerging products and service providers in the clinical trial space with special focus on the wearable and digital tech space.

7:00 Close of Day

Wednesday, May 15

8:30 am Interactive Breakout Discussion Groups with Continental Breakfast

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. 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.

9:25 Session Break

Operational & Technical Aspects of Virtual Trials
Essex North

9:40 Chairperson’s Remarks

Kamaljit Behera, MBA, Industry Analyst, Transformational Health, Frost & Sullivan

9:45 Enabling Patient Centricity and Remote Trials in Clinical Development through At Home Sample Collection

Kevin Bateman, Scientific Associate Vice President, Merck

Traditional approaches for measurement of drug exposure in clinical trials involves having the patient travel to a clinical site for collection of venous blood. This puts a burden on the patient while also limiting the opportunities for assessment of drug exposure or other measurements to these clinical visits. The ability to collect samples at home would provide a more patient-centric approach, enabling remote trials. At home collection would provide benefit for 1) disease areas associated with episodic events (e.g. asthma, migraine, etc.), 2) long half-life compounds, 3) assessment of adherence, 4) developing understanding of adherence patterns for new dosing regimens (i.e. QWeekly, QMonthly), and 5) more frequent assessment of biomarkers of efficacy and toxicity. This talk will share results from recent clinical pilot studies employing at home sampling technologies.

10:15 The Next Generation of Clinical Trials

Laura Whitmore, Director, R&D Innovation, Corporate Projects, Otsuka

In 2016, Otsuka implemented an end-to-end electronic trial, reducing site burden and increasing Otsuka's access to data, enabling real time data and real time decisions. As of January 2018, 24 clinical trials have been initiated using this new ePlatform. Laura Whitmore will share Otsuka’s experience and lessons learned, and how Otsuka is going farther by designing the next generation of clinical trials.

10:45 Sponsored Presentation (Opportunity Available)

11:00 Coffee Break

Digital Approaches to Clinical Trial Awareness & Patient Engagement
Essex North

11:30 Strategies for Digital Patient Engagement in Clinical Trials

Melaina Boyce, Director, Clinical Applications & Innovation, Biopharma, Global Clinical Operations, EMD Serono

12:00 pm A Model for Defining and Measuring User Engagement in Digital Behavior Change Interventions

Nnamdi Ezeanochie, MD, DrPH, Senior Manager, Behavior Science, Johnson & Johnson

Researchers and practitioners of Digital Behavior Change Interventions (DBCIs) use varying and oftentimes incongruent definitions of the term engagement; thus, leading to lack of precision in DBCI measurement and evaluation. The objective of this presentation is to propose nuanced definitions for various types of user engagement and explain why precision in the measurement of these engagement types is integral to ensuring intervention effectiveness. Additionally, this presentation will describe a framework and practical steps for how engagement can be measured in practice and used to inform DBCI design and evaluation especially in the context of clinical trials.

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:15 Session Break

Digital Approaches to Clinical Trial Awareness & Patient Engagement (cont.)
Essex North

2:15 Chairperson’s Remarks

Kamaljit Behera, MBA, Industry Analyst, Transformational Health, Frost & Sullivan

2:20 Growing Adaptation of Connected Technologies and Platforms in Clinical Trials

Raj Pallapothu, mHealth Solutions Global Lead, Bayer

This presentation will cover 1. Emergence of wearables, sensors, bio-markets in clinical trials, 2. Patient adaptation, challenges at site level, 3. Data transfers, privacy, portability growing need and associated challenges, 4. Operational challenges, 5. Value proposition, and 6. Market trends.

Clinical_Pipe 2:50 Leveraging EHR Data in Clinical Research

Hugh Levaux, PhD, Founder & CEO, Protocol First

The speaker will describe relevant regulatory requirements and standards that enable the use of EHR in clinical research. The speaker will then show a short demo video (3-4 minutes) describing the EHR-to-EDC workflow. Finally, the speaker will address some of the institutional hurdles to widespread adoption at sites and sponsors.

3:05 Panel Discussion: Digital Strategies for Patient Engagement & Recruitment

Jiao Song, Associate Director, Janssen Clinical Innovation

Dennis Salotti, COO, The Avoca Group

David Sall, President & CEO, Patient Enrollment Advisors

Digital advances have made it easier for patients to find information about clinical trials online. How is pharma engaging with this digital audience and how is the industry integrating digital solutions into their clinical trial recruitment strategies? This discussion will address:

  • How is pharma engaging patient and caregiver communities to enhance trial awareness and recruitment?
  • How should pharma leverage social media for patient engagement and clinical trial recruitment? Are some social media platforms better than others (ex. Facebook, Instagram, Twitter, etc.)?
  • What digital strategies (mobile apps, gamification, etc.) should pharma focus on to enhance and accelerate trial recruitment?

3:50 Close of Conference. Arrive early to attend Big Data Analytics, Machine Learning and Artificial Intelligence for Clinical Trials.

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