Bio IT World Expo 2016  
Bio IT World Expo 2016
Archived Content

eClinical Solutions 

Final Agenda


7:00 am Workshop Registration and Morning Coffee

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

*Separate Registration Required

2:00 - 7:00 pm Main Conference Registration

4:00 Event Chairperson’s Opening Remarks

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

4:05 Keynote Introduction

Sanjay Joshi, Solutions Architect, Life Sciences, EMC Isilon Storage Division



Martin LeachMartin Leach, Ph.D., CIO, Broad Institute of MIT and Harvard


Jill MesirovJill P. Mesirov, Ph.D., Associate Director and Chief Informatics Officer; Director, Computational Biology and Bioinformatics, Broad Institute of MIT and Harvard


Hitachi Data Systems5:00 - 7:00 Welcome Reception in the Exhibit Hall with Poster Viewing

Drop off a business card at the CHI Sales booth for a chance to win 1 of 2 iPod touches® or 1 of 2 Xbox 360s®*!

*Apple® is not a sponsor or participant in this program



7:00 am Registration and Morning Coffee

7:55 Chairperson’s Opening Remarks

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

8:00 Keynote Introduction

Bas Burger, President, Global Commerce, BT Global Services


Eric PerakslisEric D. Perakslis, Ph.D., CIO and Chief Scientist of Informatics, U.S. Food and Drug Administration


8:45 Benjamin Franklin Award & Laureate Presentation

9:10 Best Practices Award Program

Cycle Computing small9:45 Coffee Break in the Exhibit Hall with Poster Viewing

Integrating Systems to Improve Trial Design and Operations

10:50 Chairperson’s Remarks

Aaron Kamauu, M.D., CEO, Healthcare Data Analytics, Anolinx LLC; former Head, Healthcare Data Strategy, Roche and Genentech

11:00 Enabling Innovation and Decision Making Electronically in Clinical Trial Design and Interpretation

Laszlo Vasko, Director, R&D Information, AstraZeneca

What makes innovative companies effective? How can innovation & effective decision making be landed in clinical trial design & interpretation so that it’s effective, consistent and repeatable? This session will explore how integrative thinking can be tailored to suit the clinical design & interpretation process, with the help of process execution, collaboration, and search technologies.

11:30 Overcoming Challenges in Integrating Systems (EDC, IVRS, CTMS) and Clinical Operations Data

Christine Gibson, Associate Director, Clinical Business Systems, Biogen Idec and Garen Avetissyan, Senior Manager, Clinical Business Systems, Biogen Idec

As functionalities of different clinical systems expand and intermingle, pharmaceutical companies seek to increase efficiencies and reduce costs by connecting these systems through integrations and data interchanges. At Biogen Idec, integrated solutions have been implemented across clinical platforms: IXRS, EDC, CTMS and internal drug distribution systems, presenting technical and non-technical challenges. This session will explore the integration approaches implemented, along with the development challenges and operational benefits of the strategy.

Clear_Trial_201212:00 pm Collaborating in the Cloud: Breaking Down Silos in Clinical Development

Andrew Grygiel, Chief Marketing Officer, ClearTrial

Leading life sciences companies are leveraging cloud-based systems as collaboration platforms in clinical development, integrating and connecting siloed functions to ensure data consistency and increase operational efficiency. This presentation will examine real-world examples, such as how a Top 20 biopharmaceutical company is relying on a web-based SaaS application to link clinical operations, finance, outsourcing and project management to compress development cycle-times and reduce project cost and risk.

Booz_Allen_Black12:15 The Sepsis Interventions Outcomes Research Project: An Analytics Approach

Mark Adams, Ph.D., Principal, Booz Allen Hamilton

12:30 Luncheon Presentation or Lunch on Your Own

(Sponsorship Opportunity Available)

Data Integration to Enable Clinical Operations and Pharma Development

1:40 Chairperson’s Remarks

Mark Adams, Ph.D., Principal, Booz Allen Hamilton

1:45 IxRS & EDC to CDR & MSP: An Integrated Platform to Promote Data Exchange, Collaboration, and Advanced Analytics

Bernd Doetzkies, Director, Informatics, Daiichi Sankyo Pharma Development

Integrating a Modeling & Simulation Platform (MSP) with the Clinical Data Repository (CDR) extends functionality to also support advanced and predictive analytics to optimize clinical trial planning and project execution. This results in a significant competitive advantage by minimizing risks & maximizing benefits to subjects and patients, improving trial design and execution, reducing costs and timelines, scaling back number/size of trials, improving decision making processes and developing effective contingency plans.

2:15 Extension of the Data Warehouse Concept to meet the Needs of Clinical Operations and Pharma Development

Norbert Fritz, Development Leader Business Information Warehouse, Pharma Operations, PDGI, F. Hoffmann-La Roche Ltd.

Data integration for reporting and analysis is generally considered the core task of any data warehouse. In pharma development, however, data warehouses are part of a much wider technical and information landscape. This presentation will examine data quality management across different data sources, as well as management of patient recruitment to clarify the impact of pharma business needs on data warehouse functions.

2:45 Transform Clinical Specimen Management to Empower Clinical Research

Robert Stelling, Program Manager for Clinical Genomics & Biomarker IT, Merck & Co., Inc.

Management of clinical specimen and consent information provides a foundation for translational research.  It takes an organization, strategic partners, a process and an IT platform to effectively: plan, collect, monitor, track, govern, and destroy clinical specimen and related information. Benefits include reduced cycle time, reduced compliance risk, reduced inventory costs, and improved decision making ability.

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

Optimizing Trial Monitoring and Safety through Technology

3:45 Impact of New Business Models Made Possible by IT and the Implications for Drug Safety

Michael Celeste, Associate Director, Pharmacovigilance Information Management, Pfizer, Inc.

Healthcare data digitization is a fundamental change in the current drug safety/pharmacovigilance business model. Many industries have felt the impact of adopting digital technologies, and drug safety is finally undergoing its own radical changes. Theoretically framing current changes and observing the recent attempts to formulate new models point us toward a future vision for drug safety, and helps us to discover far-reaching implications for the way we do business and how it’s regulated.

4:15 Improving Clinical Trial Monitoring through Technology

Mark Apgar, Senior Manager, Clinical Informatics, Allergan

Intelligent implementation and integration of clinical trial technologies is critical to delivering efficiencies to study monitors. Providing information quickly and conveniently allows monitors to provide better service to the sites and sponsor. The integration of IVR/IWR, CTMS, EDC, and CSMS applications will be discussed as a way to reduce non-value added activities for monitors and allow them to better manage their resources for site activities.

TessellaNEW4:45 Optimizing Drug Development: Simulating the Drug Development Process in Order to Optimize Development Choices and Decision Making

Tom Parke, Head, Clinical Trial Solutions, Tessella, Plc

More and more drug developers are building models of diseases and their drugs in order to address the increasing difficulties and complexities of drug development. By modeling the process itself we can explore how much these models can be relied on for decision making during the process and we can evaluate different development choices in terms of the likelihood of overall business benefit and risk. This talk will look at what this modeling process involves and the opportunities it offers for better decision making.

5:15 Best of Show Awards Reception in the Exhibit Hall

6:15 Exhibit Hall Closes



Clinical Data Aggregation and Visualization to Improve Trial Operations

8:40 Chairperson’s Opening Remarks

Andrew Grygiel, Chief Marketing Officer, ClearTrial

8:45 Case Study: A Clinical Systems Data Aggregation and Visualization Journey

Ted Snyder, Analyst, Clinical Informatics, Infinity Pharmaceuticals

This talk will share lessons learned from Infinity’s efforts to empower clinical development teams with innovative visualizations and integrated data. It will include examples of using data visualization to improve understanding, quality of data, and operational performance, and will provide some tips for gaining adoption with data management, clinical operations, safety, and medical monitors.

9:05 Using Data Visualization to Improve the Efficiency and Quality of Clinical Trial Monitoring

Dimitris Agrafiotis, Vice President, Informatics, Johnson & Johnson PRD

Data visualization is a powerful analytic technique that can greatly enhance the efficiency and quality of the clinical monitoring process. However, many visualization applications are aimed at computer-savvy experts and place a high technical burden on the typical end user. In this talk, we describe the approach to developing such a solution by learning from previous successful efforts in drug discovery and process development.

9:25 Case Study: Electronic Trial Master Files (eTMF)

Jean-Remy Behaeghel, Head, GIS Client Account Management, Vertex 

Icon Corporation9:45 Leveraging Technology to Achieve Optimal Success at Investigator Sites

Adrian Pencak, Vice President, Strategic Development, Data Technology Services, ICON Clinical Research

10:00 Sponsored Presentation
(Opportunity Available)

10:15 Coffee Break in the Exhibit Hall and Poster Competition 

10:45 Plenary Keynote Panel Chairperson’s Remarks

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

10:50 Plenary Keynote Panel Introduction

Geoffrey Noer, Senior Director, Product Marketing, Panasas

11:00 Plenary Keynote Panel:
A special plenary session featuring trends and challenges in cancer research:

Julian Adams, Ph.D., President, Research and Development, Infinity Pharmaceuticals, Inc.

Jose Baselga, M.D., Ph.D., Chief and Bruce A. Chabner Chair, Division of Hematology/Oncology, Massachusetts General Hospital; Associate Director, Massachusetts General Hospital Cancer Center; Professor of Medicine, Harvard Medical School

Sir John Burn, MD, FMedSci, Professor of Clinical Genetics, Institute of Genetic Medicine, Newcastle University, UK; Genetics Lead, National Institute of Health Research, UK; Medical Director, QuantuMDx Ltd

John Quackenbush, Ph.D., Professor, Biostatistics and Computational Biology, Cancer Biology Center for Cancer Computational Biology, Dana-Farber Cancer Institute

12:15 Luncheon in the Exhibit Hall with Poster Viewing

EHR/EMR Data & Clinical Trials

1:55 Chairperson’s Remarks

Joel White, Executive Director, Health IT Now Coalition

2:00 Creating World-Class HIT Capabilities for Global Clinical Trials

Gary Keith Mallow, Ph.D., Director, Healthcare Information Technology, Merck Research Labs IT/Global Clinical Development IT

The value proposition for Life Sciences companies in the area of clinical trial planning and operations includes the potential for improved identification of patients who qualify for a study and their subsequent enrollment, improved site identification and assessment of country feasibility, and improved protocol refinement processes.  For global clinical trials, enabling new informatics, information acquisition and IT solutions that are fit for purpose in the areas of information architecture and computational technology, content identification, acquisition and management, and informatics, analytics and IT solutions that create actionable knowledge are the new normal in the effort to realize that potential.  This talk will explore lessons learned and being learned from experiments and pilots in the area of aggregating and harmonizing EHR suitable for this secondary use of healthcare data in planning and prosecuting clinical trials on a global basis.

2:30 Facilitating Comparative Effectiveness Research through the Use of EHR Data and Clinical Trial Results

Victor Lobanov, Ph.D., Director, Informatics Center of Excellence, Johnson & Johnson

It is essential for patients, clinicians, and payers to make health-care decisions based on the evidence on the effectiveness, benefits, and harms of different treatment options. Traditionally such evidence is acquired through conducting expensive and time consuming research studies and systematic reviews. Mining EHR databases and applying meta-analysis techniques to clinical trial results has a potential of dramatically reducing the cost and increasing availability of the comparative effectiveness research. This presentation will discuss methods and approaches for leveraging commercial EHR data and publically available clinical trial results for CER purposes.

3:00 Integrating a Clinical Trial into the Electronic Medical Record: The Department of Veterans Affairs Point-of-Care Clinical Trial Program

Leonard D’Avolio, Ph.D., Associate Center Director, Biomedical Informatics, MAVERIC, Department of Veterans Affairs

Louis Fiore, M.D., Executive Director, Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), Dept of Veterans Affairs

Today in the VA hospitals in Boston and Providence, the first "order" option for physicians ordering insulin regimens is "randomize the patient to a clinical trial." Once selected, a clinical trial unfolds behind the scenes of routine care in effect combining the scientific power of an RCT with the low cost of an observational study. We believe such a model has the power to transform the way science is conducted and can generate much needed evidence for understudied areas such as comparative effectiveness of the effectiveness of "personalized" bio-markers.

3:30 Closing Featured Speaker:
Platform for Clinical Research Networks: Novel Approach towards Discoveries in Rare Diseases

Alex Sherman, Director, Systems, Neurology, Massachusetts General Hospital

In rare disease research community there is a recognized need to develop better disease progression models, optimize designs of clinical trials, and discover biomarkers to better understand the disease, expedite diagnosis, facilitate therapy development and predict patient outcomes. Collaboration is essential to obtain a sufficient number of data and samples to allow statistically meaningful studies. A TREAT ALS™ software platform is currently deployed to support a clinical research network in Lou Gehrig’s disease and allows investigators from 100+ academic institutions around the world to collaborate and share data and biological specimen. This is a unique solution and approach in managing disease-specific research networks as it promotes common practices, standards, processes and improves the integrity and homogeneity of data and biosamples, and may serve as a model for academic and industry collaboration in finding cures for rare diseases.

4:00 Conference Adjourns


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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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