Cambridge Healthtech Institute’s Fourth Annual
Data & Tech Driven Clinical Trials
Advancing Clinical Trials with New Tools and Analytics
May 8-9, 2018 | Aloft Boston Seaport | Boston, MA
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 industry are poised to capitalize
on these advancements to innovate existing clinical trial processes and systems. Cambridge Healthtech Institute’s Data & Tech Driven Clinical Trials 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 8
10:00 am Conference Registration
10:45 PLENARY KEYNOTE SESSION
Transformation through Digital Medicine: The Time is Now!!
Ashish Atreja, MD, MPH, FACP, Chief Technology Innovation and Engagement Officer, Medicine, Icahn School of Medicine at Mount Sinai
Value based healthcare and outcome based contracts are reshaping the entire health industry and major players including health systems, payers and pharma. Digital Medicine is an emerging discipline that can enable transformation of health systems to support
both patient centered clinical care and research. Dr. Atreja, will provide an overview of current state of the art of digital medicine, review the challenges faced in digital medicine adoption and demonstrate how prescription of digital medicine can
support care and research transformation.
As Chief Technology Innovation and Engagement Officer, Medicine, Dr. Atreja leads the Sinai AppLab (www.sinaiapplab.org), a one-of-a-kind collaborative hub to build and test disruptive mhealth technologies. Dr. Atreja leads scientific registries for the
American Gastroenterology Association and serves on the Innovation Advisory Board for American College of Cardiology. As an intrapreneur, Dr. Atreja has won innovation awards at Cleveland Clinic and Mount Sinai, successfully licensed technologies
from academic centers and advises startups, accelerators and Fortune 500 companies in digital medicine. More recently, Dr. Atreja launched the first enterprisewide app curation and prescribing platform (www.rxuniverse.com) and established Network
of Digital Medicine (www.nodehealth.org) to connect innovation centers worldwide and share best practices for digital medicine innovation and implementation.
11:50 Walking Lunch & Dessert Break in the Exhibit Hall
1:45 Chairperson’s Remarks
John Reites, Chief Product Officer & Partner, THREAD
1:50 Taking eCOA to the Enterprise: Paving the Way for Remote Trials and Transitioning to BYOD
Joe Dustin, Principal, Mobile Health, Medidata Patient Cloud
The market landscape of eCOA is changing rapidly. As clinical trials are becoming more patient centric, there are new opportunities to empower all patients with technology to engage them in traditional, in-clinic and remote settings. This presentation
will use current and past examples of how the changing trends in eCOA are making it easier for sponsors and CRO's to adopt a platform approach and take the capabilities they already have and transition to a virtual trial design to be implemented at
global scale.
2:20 What to Do (and Not to Do) When Incorporating Technology in Your Upcoming Trial
Georgia Mitsi, Senior Director, Search & Evaluation, Digital Healthcare, Sunovion Pharmaceuticals
Almost everybody gets excited when new, exciting technology is being incorporated into a clinical trial. However, the initial excitement can turn into a logistics nightmare due to lack of digital experience and preparation. In a world that moves so fast
when it comes to technological advancements, how can traditional pharma and CRO keep up? This presentation contains a survival kit for new entrants (and not only) in the digital space.
2:50 An Easy 4-Step Process That Will Make You a CTMS Evaluation Hero
Jens B. Thuesen, CTMS Business Development, BSI Business Systems Integration AG
Pamela Penman, CTMS Business Development, BSI Business Systems Integration AG
Is your CTMS evaluation process outdated? Using scorecards to evaluate solutions based on features alone can be frustrating. And knowing the right questions to ask that go beyond basic features can be daunting. You don’t have to be an IT expert
to choose a CTMS that will serve you well for years to come. Learn how a concise 4-step process can get you on your way to a solution that fits your organization perfectly.
3:20 Refreshment Break in the Exhibit Hall
4:05 Patient Centric and Siteless Clinical Trials
Nina Spiller, Vice President Clinical Management, Otsuka Pharmaceutical Development and Commercialization
(OPDC)
With the advent of telehealth technologies, a traditional clinical trial model can be challenged to address some current limitations of site-centric trials. Siteless trials may provide an option for clinical trial participation not currently available
to a substantial number of patients, while decreasing burden for those active in traditional site-centric trials. An example from an active pilot will be used to frame scientific and operational considerations when working in the siteless model.
Implications for rethinking clinical trial conduct will be explored.
4:35 People behind the Tech - Change Management to Aid Innovation
Michelle Shogren, Head of Innovation in Portfolio and Operations, Pharma Development, Bayer
As technology continues to provide new and wonderful opportunities for clinical trials it is important to plan for the people that will be using and supporting it. While we often think of the patient and try to answer the question "will this population
embrace technology?" we sometimes forget about the sites that will need to support it. Lessons learned from a user experience data flow study using a multi-functional app and connected devices will be presented.
5:05 Close of Day
5:05 Dinner Short Course Registration
Wednesday, May 9
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
9:40 Chairperson’s Remarks
Michelle Shogren, Head of Innovation in Portfolio and Operations, Pharma Development, Bayer
9:45 Methods to Measure the Impact of Digital Health Innovations as Part of a Clinical Trial
Nnamdi Ezeanochie, MD, DrPH, Manager, Behavior Science, Johnson & Johnson
This presentation introduces digital-compatible research designs and analytic methods to ensure that digital solutions used in clinical trials are efficiently and accurately measured. These research methods include: Continuous Evaluation of Evolving
Behavioral Intervention Technology, Multiple Optimization Strategy, and Sequential Multiple Assignment Randomized Trials. The presentation describes each research design/analytic method, and discusses how these methods can be used concurrently
to achieve the accurate and reproducible evaluation results.
10:15 Wearables in Clinical Trials
Elena S. Izmailova, PhD, Senior Director, Novel Data Streams and Devices, Takeda
Pharmaceuticals International, Inc.
This presentation will cover the following topics: 1. The current state of wearables in the field: the promises and challenges; 2. Meaningful principles for the adoption of wearables in clinical trials: analytical, technical, and clinical;
and 3. Examples of wearables in use at Takeda.
10:45 Understanding the Future of Data Interoperability for Clinical Trial Excellence
Sina Adibi, MA, CEO and President, Adaptive Clinical Systems
Join us as we take a few minutes to examine our collective journey of clinical trial data flow then and now and how data interoperability impacts clinical trial success. We will share innovation strategies that your peers are implementing
and the technology and processes that are significant for the future.
11:00 Coffee Break
11:30 Regulatory Aspects for Mobile Medical App Development for Commercial and Clinical Trial Use Cases
Michael J. Benecky, PhD, Senior Director, Global Regulatory Affairs, Precision
and Digital Medicine, R&D Chief Regulatory Office, GlaxoSmithKline
The presentation will focus on the following points: 1. Mobile Medical Apps are defined as medical devices from its intended use shown through labeling claims, advertising materials, or oral or written statements by manufacturers or their
representatives; 2. Mobile Medical App regulation is health risk based to balance patient safety and barriers to technological innovation; 3. Quality management of Mobile Medical Apps; including legal manufacturer (the specification developer)
software as a medical device quality management system responsibilities; software requirements/specifications and user acceptance testing; Software version and change control; post-market surveillance includes software incident handling,
software recalls/field corrective actions and medical device adverse event reporting procedures.
12:00 pm Elevating Clinical Research - How Innovation in Technology Will Drive the Clinical Trial Process Into a New Era
Tony Rees, Director, SQN Clinical
Adoption of new technology across a range of sectors has improved processes and efficiencies in significant ways. The clinical space is acknowledging that technology can have an impact on data quality, reduced timelines and savings in costs.
With a drive towards patient centricity, the data collection paradigm has to shift to meet regulatory, clinical and commercial needs. Enabling cloud based and mobile technology will remove historical constraints and liberate data collection,
reporting and management processes.
12:30 Luncheon Presentation: Where’s My *&!@$ Credential? Solving the Site User Identity Challenge with Community SSO
Chris McCarthy, Director, Sales, Exostar
The e-enablement of clinical studies has created a burden on site users and researchers across the industry. Individuals supporting multiple clinical initiatives must access numerous system accounts and maintain literally dozens of credentials
in order to do their jobs. In this presentation, attendees will learn about an innovative Community Single Sign-On solution that truly solves the problem with a single trusted credential. We’ll describe how Merck, AstraZeneca, Pfizer,
and TransCelerate are participating in the community.
1:15 Session Break
2:15 Chairperson’s Remarks
Michelle Shogren, Head of Innovation in Portfolio and Operations, Pharma Development, Bayer
2:20 A Case Study on Wearables & Machine Learning in the PIONEER-HCM Study
Charles Wolfus, Vice President, Digital Health, Technology and
Business Operations, MyoKardia
2:50 PANEL DISCUSSION: Moving beyond Adoption - Challenges and Considerations When Using Digital Solutions (Wearables, Apps, etc.) in Clinical Trials
Moderator:
Jennifer Turgiss, Vice President, Behavior Science & Analytics, Johnson &
Johnson
Panelists:
Elena S. Izmailova, PhD, Senior Director, Novel Data Streams and Devices,
Takeda Pharmaceuticals International, Inc.
Georgia Mitsi, Senior Director, Search & Evaluation, Digital Healthcare, Sunovion
Pharmaceuticals
Margaretta Nyilas, MD, Senior Vice President Clinical and Business Operations,
Otsuka Pharmaceutical Development and Commercialization (OPDC)
Charles Wolfus, Vice President, Digital Health, Technology and Business Operations, MyoKardia
As pharma ventures into using more digital solutions within their clinical trials, there remains many technical and data challenges that may be overlooked. The panel will discuss how to ensure the adoption of digital solutions and involving
stakeholders cross departmentally to address concerns around consent, evolving technology and user experience as the study progresses, and integrating wearable/app data into the trial.
3:50 Close of Conference