2016 Archived Content

Big Data for Clinical Trials Conference


With the increased generation of greater volumes of data from ever more varied data sources, pharma and biotech leaders have the opportunity to streamline and advance the clinical trials process if they can properly harness the information in these big data sets. Harnessing and unlocking the potential in existing data sources, including biomarker, genomic, EHRs, claims data, real world data and clinical trial data, can lead to better informed decision making in all aspects of trial design and more importantly better decision making in drug development. Cambridge Healthtech Institute’s Big Data for Clinical Trials conference gathers leaders across pharma, biotech and academia for discussions and case studies on harnessing existing clinical data to advance clinical trials.


MONDAY, MAY 9

7:25 am Conference Registration and Morning Coffee


Big Data for Clinical Trials

8:25 Chairperson’s Opening Remarks

Greg Koski, Ph.D., M.D., President and CEO, Executive Office, Alliance for Clinical Research Excellence and Safety (ACRES)

8:30 PANEL DISCUSSION: Realizing the Dream: What is the Real Power of Big Data and How Can It Be Unleashed?

Greg Koski, Ph.D., M.D., President and CEO, Executive Office, Alliance for Clinical Research Excellence and Safety (ACRES)

Peter Alterman, COO, SAFE BioPharma Association

Jason Paragas, Director, Innovation, Lawrence Livermore National Laboratory

Ashish Cowlagi, Program Director, IBM Watson Health

J. Scott Lowry, MBA, CEO, HealthIDx

Everyone is talking about big data, but the real question is “what can we do with it that we can’t do now?” Major challenges are posed by data accessibility and data liquidity--the power of big data can only be unleashed by effective application of analytics and a willingness of all parties to share. This requires an enterprise-wide framework for trust and policies for access and utilization, as well as an established infrastructure.

9:30 Designing, Executing and Managing Clinical Trials in the Age of Big Data, an Architect’s Perspective

Manoj Vig, Enterprise Architect Big Data, Information Technology, Shire Pharmaceuticals LLC

Speed of data movement, availability of new data sources and emergence of new technology frameworks have introduced a new world of opportunities in which trials can be designed and executed faster, better and much more economically. This talk will discuss various use cases, available technologies & designs based on big data that can be used in the context of modern clinical trials.

10:00 Networking Coffee Break


Secondary Data Use for Clinical Trials

10:30 Beyond Consent: Overcoming Key Challenges Teams Face When Integrating Clinical and Specimen Derived Molecular Data for Broad Secondary Use

Muzafar Mirza, Director, Global Clinical Trial Execution (GCTE) Development Operations, Global Product Development, Pfizer, Inc.

Catherine Marshall, Director, Clinical Data Science, Pfizer, Inc.

Stuart Pearce, Director, Information Strategy and Analytics, Development Operations, Worldwide Research & Development, Pfizer, Inc.

The secondary use of Clinical and Specimen data has opened up a wealth of opportunities for translating data into quantifiable knowledge. There has been an exponential growth in the quantity of clinical data collected to support trials, alongside this a greater focus on collecting biological specimens to enhance value added research. Research teams wishing to delve in to this bank of data have to overcome a multitude of challenges related to broad data reuse. A key project and multi-disciplinary team at Pfizer was formed to investigate aspects of data reuse and tasked with building a comprehensive solution to this challenge. This talk will provide a summary overview of the team’s activity and introduce some key solutions that are helping research teams at Pfizer utilize data for secondary use.

PPD11:30 Leveraging Data for Better Site Selection

Scott Scarola, Senior Director, Business Analytics, PPD

Maximizing efficiencies is one of the most effective ways to address the rising costs of drug development. Choosing the best possible sites to partner with is a critical area of clinical research where existing data can be leveraged to speed objective decision making and improve the likelihood of long-term trial success. Join us for a discussion on how years of historical experience data can be used to revolutionize study site selection and startup.

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:45 Session Break


Secondary Data Use for Clinical Trials

1:25 Chairperson’s Remarks

Greg Koski, Ph.D., M.D., President and CEO, Executive Office, Alliance for Clinical Research Excellence and Safety (ACRES)

1:30 Facilitating Secondary Use of Clinical Data - One Company’s Approach

Liz Roberts, Senior Director, Global Lead, Transparency and Data Sharing, UCB

The ecosystem of care is evolving radically, one such area being greater transparency of clinical trial data and results. This presentation will describe the approach taken by UCB, a global, biopharmaceutical company, including: 1. Involvement and alignment with TransCelerate model approaches to patient-level data (PLD) anonymization and document redaction, and 2. Joining a multi-sponsor request-management system through which researchers can submit proposals for anonymized PLD and redacted study documents.

2:00 PANEL DISCUSSION: Clinical Trial Data Sharing and Data Privacy

Liz Roberts, Senior Director, Global Lead, Transparency and Data Sharing, UCB

Muzafar Mirza, Director, Global Clinical Trial Execution (GCTE) Development Operations, Global Product Development, Pfizer, Inc.

Robin Jenkins, Head, Clinical Trial Data Sharing & Disclosure, Sanofi

With increased clinical data sharing for secondary use and novel analyses, the questions of informed consent, how much data to share, best practices on managing data requests and patient privacy are paramount. This panel offers insights on data de-identification (where and when it should be used), the types of data to share, managing data requests, and data privacy issues.

2:30 Refreshment Break in the Exhibit Hall

3:15 Interactive Breakout Discussion Groups

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.

4:15 Welcome Reception in the Exhibit Hall

5:15 Close of Day

5:15 pm Dinner Short Course Registration


TUESDAY, MAY 10


Data Visualization & Analytics Techniques for Clinical Trial Insights

7:55 Chairperson’s Remarks

Scott Scarola, Senior Director, Business Analytics, PPD

8:00 Data Visualization Approach to Clinical Studies Data

Mukta Tripathi, Clinical Science Visual Analytics, Genentech

The presentation will focus on implementation of a data visualization approach for safety signal detection while study is ongoing, as well as visualization approach for scenario building for analyses that will be carried out for dose escalation, and final analysis, to name a few. At Genentech/Roche, the process of individual as well as aggregate reviews has been revolutionized by implementing Spotfire for Clinical and Safety Scientists. This talk focuses on advantages of an innovative approach to clinical data visualization using Spotfire.

8:30 Clinical Visualizations Drive Decision Making in Clinical Trials and Translational Research

Philip C. Ross, Director, Data Sciences TR&D, Clinical Pharmacology and Pharmacometrics, Exploratory Clinical and Translational Research, Bristol-Myers Squibb

Clinical trials generate large amounts of data that require rapid review to identify emerging signals and trends. These signals and trends are most effectively identified using visualizations. Using the information revealed in the visualizations, clinicians and scientists can make faster, better informed decisions driving translational research and development. The integration of this data and knowledge drives the development of new treatments that will be beneficial for patients.

ifa9:00 Big Data Analytics and Cognitive Computing in Ophthalmology: Innovation in Clinical Research and Development

P. Lloyd Hildebrand, MD FACS P-CEO, Professor, Department of Ophthalmology, University of Oklahoma

Big Data Analytics and cognitive computing create knowledge that can improve clinical decisions in clinical trials, drug development and direct patient care. Eye care industry providers Topcon (diagnostic imaging), ifa (EHR), and Inoveon (telemedicine) are partnering with the leading Big Data Analytics specialist to create the world’s first cognitive computing engine in Ophthalmology.

9:30 Raising the Bar for Central Medical Review

Victor Lobanov, Ph.D., Executive Director, Data Sciences, Covance Inc.

Periodic review of clinical data is critical for the patient safety and data quality. Covance’s Medical Review is aligned with the FDA guidance for a greater role of central monitoring and provides timely, integrated views of all relevant clinical data along with the unique, interactive capabilities to detect outliers and trends, create and analyze cohorts, execute review workflows, annotate clinical data, and communicate observations.

10:00 Coffee Break in the Exhibit Hall


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 Close of Conference


Pair this program with Data & Tech Driven 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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