Bio IT World Expo 2016  
Bio IT World Expo 2016


Track 7: eClinical Solutions - Header 


Final Agenda: 

Track 7 explores how to leverage technology to optimize speed, quality and cost of clinical trials. Themes covered include best practices in data collection and analysis, systems integration across multiple vendor and internal platforms, clinical imaging, utilization of informatics for drug safety surveillance, and utilization of EHRs to accelerate patient recruitment.


7:00 am Workshop Registration and Morning Coffee

8:00 - 4:00 pm Pre-Conference Workshops*

*Separate Registration Required.

2:00 - 6:00 pm Main Conference Registration

4:00 Event Chairperson’s Opening Remarks

Cindy Crowninshield, RD, LDN, Conference Director, Cambridge Healthtech Institute

Sponsored by
Isilon Systems
4:05 Keynote Introduction
Chris Blessington, Life Sciences Solutions Architect, Isilon 

Plenary Keynote
4:15 Making the World’s Knowledge Computable

StephenWolframStephen Wolfram, Ph.D., CEO, Wolfram Research; Creator of Wolfram|Alpha




Sponsored by

5:00 Welcome Reception in the Exhibit Hall and Poster Viewing




Wednesday, April 13

7:00 am Registration and Morning Coffee

8:00 Event Chairperson’s Opening Remarks

Phillips Kuhl, Co-Founder and President, Cambridge Healthtech Institute

Sponsored by
8:05 Keynote Introduction
Grant Stephen, CEO, Tessella, Inc.

Plenary Keynote
8:15 Interacting with Complex Information Landscapes: Integration and Next Generation User Interfaces

Bryn RobertsBryn Roberts, Ph.D., Global Head, Informatics, Pharma Research and Early Development, F. Hoffmann-La Roche Ltd.





8:45 Benjamin Franklin Award/Presentation: Jonathan Eisen, Ph.D., Professor, Genome Center, University of California, Davis

9:10 Best Practices Awards Program

Sponsored by

9:45 Coffee Break in the Exhibit Hall and Poster Viewing



10:50 Chairperson’s Remarks

James Weatherall, Ph.D., Global Director, Biomedical Informatics, Clinical Information Management, AstraZeneca

11:00 Efficient Integration and Analysis of Clinical Trial Data

Steve Sweeney, Head, Clinical Operations, Infinity Pharmaceuticals

Co-Developed with John Keilty, Vice President, Informatics, Infinity Pharmaceuticals

Infinity’s integrated clinical systems, consisting of custom CTMS, Pharmacovigilance, EDC and a CDISC-compliant data warehouse enables the timely analysis of clinical data to meet strategic and tactical needs. The platform’s automated reporting and a progressive approach to data visualization and analysis has led to broad and effective use throughout the company. The team utilizes a variety of mechanism for data review, transforming all aspects of clinical operations and medical review. This approach to data integration and reporting has increased company-wide productivity while dramatically reducing the dependency on traditional programming efforts.

11:30 Merck/Schering-Plough Merger: R&D Master Data Harmonizing Program

Dan Serretti, Program Manager and IT Lead, Reference Data and Vocabulary Rationalization, Merck Research Labs

As Merck and Schering-Plough move forward to create one combined company, we are focusing on rationalizing the complex R&D Application Landscape to define and implement the New Merck Application Roadmap. Foundational to that roadmap is defining and implementing master data that will be utilized across research and research systems. This session will outline the approach utilized to assess, rationalize, define and, as necessary, implement Reference Data and Vocabularies in support of the New Merck Clinical environment. Topics to be covered include: Clinical Master Data Information Architecture and Modeling; Information and Program Governance & Stewardship; Solution Architecture and Planning; and Reference Data solution and Application Transition Planning.

Sponsored by
Icon Corporation
12:00 pm Leveraging Integrated Clinical Research Data

Adrian Pencak, Vice President, Data & Technology Services, ICON Clinical Research
In this presentation we ask the question; are we leveraging our safety and clinical data to get the most out of it?  This presentation will describe the benefits of using a central warehouse for all clinical data.  The central data warehouse can enable the integration, management, reporting, visualisation and analysis of that data. The concept will be explained and how it can provide; intelligence to support more timely decision making, more transparency to the sponsor and improved chain of custody for clinical data.


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



1:40 Chairperson’s Remarks

Joan Chambers, COO, CenterWatch

1:45 Case Study: Data Integration across Multiple Vendor and Internal Platforms in Support of eClinical Trial Setup

Ramzi Najm, Vice President, R&D Information and Technology Management, Allergan

SOA integration of internal systems can be a challenge. When eClinical operations are distributed across multiple vendors’ SaaS platforms as well as internally managed applications, integration can present unique challenges. This discussion will review our unique SOA integration approach for internal and multiple external environments and share a case of collaboration across multiple stakeholders.

2:15 Case Study: Lessons Learned from EDC Implementation at the Dana Farber Cancer Institute

Marina Nillni, EDC Program Manager, Dana Farber Cancer Institute

This presentation will share the story of EDC implementation at the Cancer Center. Details to be shared include how the journey started and where we are today. Lastly, the presentation will summarize what we consider to be the key challenges and benefits.

Sponsored by
2:45 Emerging Clinical Trial Data Integration Requirements and Technologies

Bruce Chen, M.Sc., CTO, Liaison Technologies
In many industries integration services and solutions have reached maturity, though incremental improvement and evolution does occur. Recent developments in eClinical data integration have generated a higher order of requirements that are unique to the pharmaceutical industry. In this session Bruce Chen will describe emerging technologies and trends that will define integration for clinical trials over the next several years including semantic integration, expert matching, pattern recognition, and the combination of health care and pharmaceutical data.

Sponsored by
Clear Trial 2011 
3:00 Utilizing SaaS-based Clinical Trial Operations Software to Optimize Clinical Development

Andrew Grygiel, Vice President, Marketing and Product Management, ClearTrial

Biopharmaceutical and medical device companies are turning to new types of software to accelerate clinical development while reducing IT infrastructure costs. Attendees will discover how Clinical Trial Operations (CTO) software delivered as Software-as-a-Service (SaaS) is enabling study sponsors to reduce study cycle-times and costs—while maintaining study feasibility.

3:15 Refreshment Break in the Exhibit Hall and Poster Viewing



3:45 ImagEDC - Clinical Trial Imaging Integration Using Service-Oriented Architecture, Grid Computing and Open Source

Josh C. Snyder, Imaging Infrastructure Expert, Biomarker Development/Clinical Imaging & Thierry Cladé, Solution Architect, IT & Automation, Novartis Pharma AG

Co-Developed with Stefan Baumann, Head, Imaging Infrastructure, Biomarker Development/Clinical Imaging, Novartis Pharma AG

Novartis has released ImagEDC, an open source tool based on the National Cancer Institute’s grid computing platform “caGrid”. The software enables machine-to-machine integration between partners involved in a Clinical Imaging Trial. As a reference implementation for service-oriented architecture (SOA), and being free from license costs, ImagEDC can help to integrate both academic and commercial partners using a shared communication standard. Key advantages of the proposed SOA standard include archive federation to avoid large bulk data transfers.

4:15 Sorting Out eTrial Solutions for the Clinical Operations Professional: Which is Right for You?

Adam Ruskin, Ph.D., D.V.M., M.P.H., Director, Clinical Affairs, Gentura, Inc.

With many eTrial solutions for various tasks now on the market, how does the Clinical Trial Manager decide what they really need for their trial? How does a company decide what technologies are needed to optimize their overall efficiency? With so many choices, decision points based on cost, performance and efficiencies need to be made. This presentation will help to sort out the ever growing variety of eSolutions for the Clinical Operations professionals who use these systems to help make informed technology-based decisions.

4:45 Bridging Patient Care and Clinical Research through Biomedical Informatics

Aaron Kamauu, M.D., M.S., M.P.H., Head of Healthcare Data Strategy, Genentech

Massive amounts of rich patient-level clinical data is generated by electronic health information systems (including EHR/EMR) as they are increasingly used to assist healthcare providers in providing quality patient care. At the same time these data sources are also increasing in both depth and breadth of clinical information collected. This change in the healthcare environment provides new opportunities in how these data can be used to support a variety of drug development activities. I will present some unique ways we have leveraged these healthcare data to support clinical research and clinical trials in Roche and Genentech, focusing on examples that have strengthened assumptions in clinical trial strategy, protocol design and site identification.

5:15 Best of Show Awards in the Exhibit Hall

6:15 Exhibit Hall Closes


Thursday, April 14

8:45 am Event Chairperson’s Opening Remarks

Kevin Davies, Ph.D., Editor-in-Chief, Bio-IT World


Sponsored by
Keynote Introduction
A special plenary session featuring a series of succinct, forward-looking presentations by:

Ken Buetow, Ph.D., Associate Director, Bioinformatics and Information Technology, National Cancer Institute

Debra Goldfarb, Senior Director, Strategy, Microsoft

Martin D. Leach, Ph.D., Executive Director, MRL IT for Discovery & Pre-Clinical Sciences, Merck & Co.

Mark Boguski, M.D., Ph.D., Founder, Resounding Health Incorporated

Jamie Heywood, Co-founder and Chairman, PatientsLikeMe
Yury Rozenman, Global Head of Marketing, Pharmaceutical and Life Sciences Sector, BT Global Services

10:30 Coffee Break in the Exhibit Hall with Poster Competition



10:55 Chairperson’s Remarks

Aaron Kamauu, M.D., M.S., M.P.H., Head of Healthcare Data Strategy, Genentech

11:00 Rising Protocol Design Complexity and Its Impact on Clinical Trial Performance

Ken Getz, Senior Research Fellow, Assistant Professor, Tufts Center for the Study of Drug Development, Tufts University Medical School

This session explores how protocol designs have changed during the past decade and discusses the dramatic negative impact that rising protocol complexity has on clinical trial cycle time, cost and efficiency. Variability by phase and therapeutic area will be presented with insights into targeted areas where protocol complexity is the highest and where it has grown the fastest. Sponsor approaches and technology solutions used to simplify and streamline protocol designs will also be discussed.

11:30 Case Study: Approach and Experiences Implementing Structured Protocol Authoring at Genzyme

A. Brooke Hinkson, Associate Director Program Management, Global Biomedical Informatics, Genzyme

There is significant pressure to streamline business processes, increase reuse of clinical information, produce high quality clinical documentation and decrease overall development timelines. This presentation will share the approach and experiences to date implementing topic-based structured content at Genzyme..

12:00 pm The Application of Text Analytics to Drug Safety Surveillance

James Weatherall, Ph.D., Global Director, Biomedical Informatics, Clinical Information Management, AstraZeneca

This presentation will: Outline the fundamental challenges of conducting routine post-marketing surveillance on the published literature; Explain why the utilization of informatics approaches such as text analytics potentially addresses some of these challenges; Describe how an agile internal project succeeded in delivering a system to employ such an approach within 6 months; Report on the business impact of the new system so far; Look ahead to possible future enhancements, and alternative applications of the approach.

12:30 Luncheon in the Exhibit Hall and Poster Viewing

2:00 Exhibit Hall Closes



Solutions for Personalized Medicine and eClinical Solutions
(shared session between Tracks 7 and 8)

1:55 Chairperson’s Remarks

Presented by
caBIG sm
2:00 Creating a Research Infrastructure to Support Cancer Personalized Medicine

Gregory C. Bloom, Ph.D., Assistant Professor, Biomedical Informatics, H. Lee Moffitt Cancer Center and Research Institute

Sorena Nadaf, Director, Translational and Biomedical Informatics and CIO, Helen Diller Family Comprehensive Cancer Center Translational Informatics, University of California, San Francisco

Kenneth Buetow, Ph.D., Associate Director for Bioinformatics and Information Technology, National Cancer Institute

The personalized medicine paradigm requires data liquidity so that information and knowledge can be freely exchanged among stakeholders at all stages of the bench-to-bedside continuum. In this approach to biomedicine, research and clinical care are seamlessly linked in a virtuous circle that enables the collection and analysis of information on clinical outcomes of large populations. This session will discuss how caBIG® technology is being leveraged to build and extend capabilities that will support a rapid learning system of healthcare.


3:00 Interactive Presentations and Panel Discussion

The Partnership to Advance Clinical electronic Research (PACeR) is a broad-based health care collaborative that is led by the Healthcare Association of New York and comprised of New York State hospitals, healthcare providers, patients and pharmaceutical and technology companies. Since its inception in early 2010, PACeR has been working to identify new approaches for the collection and use of clinical information to accelerate evidence-based medical research. Its long-range goal is to improve the delivery and outcomes of patient care by effectively and efficiently leveraging electronic clinical data for research-related activities through a sustainable model.
Key goals of this broad public-private participation are to:

  • Support improvements in patient care and facilitate the research missions of participating institutions
  • Promote large-scale integrated electronic health capability across multiple institutions and organizations
  • Assist medical institutions to meet their objectives regarding the primary and secondary use of clinical data
  • Accomplish these objectives in a way that is economically sustainable; and serve as a viable, practical model for other states and regions that takes into account
  • Resolves relevant legal, regulatory, economic, and operational issues

David A. Krusch, M.D., Chief Medical Information Officer, University of Rochester Medical Center

Terri Straub, Consultant, Healthcare Association of New York State
David Leventhal, Director, Healthcare Informatics, Pfizer

Jeff Kraut, Senior Vice President, Strategic Planning and Marketing, North Shore-LIJ Health System

John Murphy, Dr.P.H., Head, Clinical Analytics, Quintiles

4:00 Conference Adjourns

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Elsevier R&D Solutions


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Precision for Medicine


 Seven Bridges Genomics

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  • Making the World's Knowledge Computable
  • Bioinformatics in the Cloud
  • The Application of Text Analytics to Drug Safety Surveillance

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