2016 Archived Content

Data & Tech Driven Clinical Trials

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.


10:00 am Conference Registration

Leveraging EHRs for Protocol Feasibility
& Patient Recruitment

10:40 Chairperson’s Remarks

Scott Scarola, Senior Director, Business Analytics, PPD

10:45 Using Advanced Software Applications to Leverage EHRs to Support Protocol Feasibility and Patient Identification

Sameer Tandon, Clinical Trial Intelligence Manager, Clinical Sciences & Innovation, Novartis

This presentation will cover the use of a software application to mine EMRs with leading academic institutions with the ability to arrange consultation and identify patients for referral into a clinical trial.

11:15 Integration of Clinical Trials into Clinical Care Using the Electronic Health Record

Mary T. Brophy, M.D., MPH, Director, Maveric Core Laboratory, VA Boston Healthcare System

This session will review efforts by the Department of Veterans Affairs to conduct clinical research as an extension of quality improvement efforts in the clinical care ecosystem. Alternatively termed pragmatic or point-of-care clinical trials, these studies are conducted less expensively and yield results that are more generalizable than traditional study designs. The session will review the Department’s efforts in cardiovascular and medical oncology investigations.

11:45 A Technology Platform for Delivering Pragmatic Clinical Trials within a Primary Care Setting in the UK, Using Electronic Healthcare Records

Tim Williams, Ph.D., Head, Research, Clinical Practice Research Datalink (CPRD), Medicines and Healthcare Products Regulatory Agency (MHRA)

The ability to use Electronic Healthcare Records (EHR) as part of a randomized interventional study has been identified as a novel paradigm to manage and deliver clinical data in a real-world setting. Our challenge was to design and build a system to deliver pragmatic trials based on primary care EHR. This resulted in the development of an integrated suite of EHR-centric tools to enable trial design, feasibility and data management to CDISC-ODM standard EDC interfaces, enabling recruitment, minimum data collection, and patient reported outcomes (PROs). The resulting technology platform has benefits in terms of speed, costs and generation of real-world evidence.

12:15 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:00 Dessert Break in the Exhibit Hall

1:30 Session Break

New Digital Technologies for Clinical Trials: Mobile Health, Apps and Wearables

1:55 Chairperson’s Remarks

Anita Zubak, Executive Director, Global Clinical Trial Operations IT, Merck

2:00 Co-Presentation: Use of Digital Mobile App to Keep Clinical Trial Participants Engaged

Kamal Abbassi, BS, MS, Information Manager / Project Manager Early Development Workflows, pRED Informatics, Roche Innovation Center New York

Margaret Chan, Study Leader, Operations, Roche Innovation Center New York

Learn how to improve the clinical trial experience for patients through the use of digital technologies. Digital technologies can improve efficiencies in clinical trials and retention of study subjects. I will share key insights from the making of patient-centric mobile app to keep clinical trial participants engaged, supported and connected.

3:00 Endpoints To Insights: Integrating External Data Feeds Into The Broader eClinical Ecosystem

Nick Neri, Platform Manager, ERT

Effective data surveillance is critical for ensuring safe and cost-effective clinical trials. With safety and efficacy endpoints often being captured outside of the primary study database, the increased use of patient reported outcomes, and the emergence of wearable’s in research, we are experiencing the tip of the spear in a new research paradigm. The ability to harmonize these data into actionable information and unlock the power behind your data is critical for success. In this presentation, Mr. Neri will share real-world use cases on the integration and analysis of these data using cloud technologies, and explore the approaches being taken by different research organizations as they prepare for this “new normal.”

3:30 Refreshment Break in the Exhibit Hall

4:00 The Use of Mobile Health Technology in Improving Clinical Trials

Michelle Crouthamel, Project Manager, ID, NS, Digital PPU, Projects Clinical Platforms & Science, GlaxoSmithKline

The ability to efficiently develop new medicines for patients with unmet needs is limited by the current model for clinical development. Fundamentally, the conduct of clinical trial has not changed significantly over the last few decades. Emerging digital and mobile health technologies have the potential to improve the conduct of clinical trials, allowing for more efficient development of new medicines for patients. Seeking patients’ input into the design and conduct of clinical trials is now possible via mobile devices, sensors and remote technologies that can enhance recruitment, retention, adherence and clinical endpoint measurement. Data and experiences from a number of clinical trials will be summarized, highlighting the opportunities and challenges in this new area of clinical development.

4:30 Wearables in Health: In Theory and in Practice

Samuel Volchenboum, M.D., Ph.D., Associate Professor, Pediatrics and Fellow of the Computation Institute; Director, Center for Research Informatics; Associate Chief Research Informatics Officer, Biological Sciences Division; Associate Director, Institute for Translational Medicine, University of Chicago Medical Center

The way in which clinical trials are deployed is rapidly evolving. With FDA-approved use of wearables, physicians and researchers are realizing an opportunity to meaningfully improve patient experience and outcomes by generating and analyzing rich and objective data at the point of experience. Using real-world use cases, Dr. Samuel Volchenboum will explore the process of passively collecting patient data and evaluate the impact of wearables on the effectiveness and accuracy of clinical trials.

5:00 Close of Day


8:30 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.

Emerging Technologies for Clinical Trials

9:25 Chairperson’s Remarks

Nick Neri, Platform Manager, ERT

9:30 Co-Presentation: Experimenting with Emerging Technologies in Clinical Research – Case Study Examples

Omar Ceren, Senior Specialist, Global Development Architecture & Innovation IT, Merck

Anita Zubak, Executive Director, Global Clinical Trial Operations IT, Merck

Jeffrey R. Sachs, Senior Principal Scientist, Merck

This presentation will review Merck’s approach to innovation experiments, with review of specific case studies including wearable technology, “smart sampling” using dried blood samples, electronic informed consent. The presentation will cover selection, structure, results analysis, and lessons learned of the experimentation with emerging technologies.

10:30 Sponsored Presentation (Opportunity Available)

10:45 Coffee Break in the Exhibit Hall

11:30 PANEL DISCUSSION: Using Wearables to Accelerate Clinical Trials

Jeremy Sohn, Vice President and Head, Digital Business Development & Licensing; Ad-Interim Global Head, Digital Development, Novartis

Hamid Najafi, CTO and Co-Founder, Sensoplex, Inc.

Haiming Wu, Principal Engineer, Technical Development, Biogen

Patrick Hankey, Principal Platform Adoption, Patient Cloud & mHealth, Medidata

Marc Sebes, Vice President, Product Management, Validic

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

1:15 Session Break

1:55 Chairperson’s Remarks

Nick Neri, Platform Manager, ERT

2:00 Remote Trials to Drive Patient Centricity

Hassan Kadhim, Business Consultant, IS BP R&DM, Boehringer Ingelheim

With the emergence and increasing ubiquity of digital technology in several industries, and with the increasing need of patient-centric trial design, several initiatives have been recently launched within the pharmaceutical industry to promote change in clinical research towards a more patient-centric approach. This talk will describe one potential initiative to conduct clinical trials in a remote fashion, and will propose a remote clinical trial model for the pharmaceutical industry to perform clinical research. We will also discuss several considerations in order to apply this model, and address challenges and benefits of the model.

2:30 A Guide & Lessons Learned: From Innovation Island to Innovation Mainland

Jeremy Sohn, Vice President and Head, Digital Business Development & Licensing;Ad-Interim Global Head, Digital Development, Novartis

3:30 Close of Conference

Pair this program with Big Data for Clinical Trials and a Dinner Course on Expectations of Risk-Based Monitoring to maximize your time at the Clinical Trial Innovation Summit!

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