Bio IT World Expo 2016  
Bio IT World Expo 2016

Track 6 - April 21 – 23, 2015

Clinical & Translational Informatics 

Transforming Biological Data to Clinical Development

Transforming biological insights from drug discovery to clinical development requires innovative techniques for the integration of biological and clinical data. Track 6 explores the integration, analysis and visualization of biological and clinical data with case studies from across pharma and academia.

Final Agenda

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Tuesday, April 21

7:00 am Workshop Registration and Morning Coffee

8:00 – 11:30 Morning Pre-Conference Workshops*

12:30 – 4:00 pm Recommended Afternoon Pre-Conference Workshops*

How Data-Driven Patient Networks are Transforming Biomedical Research

* Separate registration required

2:00 – 6:30 Main Conference Registration


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5:00 – 7:00 Welcome Reception in the Exhibit Hall with Poster Viewing

Wednesday, April 22

7:00 am Registration Open and Morning Coffee


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9:00 Benjamin Franklin Awards and Laureate Presentation

9:30 Best Practices Awards Program

Internet 2

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


10:50 Chairperson’s Opening Remarks
Joy King, Principal Consultant & Practice Lead, Life Sciences, Teradata Corporation 

11:00 Towards Patient-Centered Clinical Trial Eligibility Criteria Design

Chunhua Weng, Ph.D., Florence Irving Assistant Professor of Biomedical Informatics; Co-Director, Biomedical Informatics Core for CTSA, Columbia University

This talk will summarize the patterns in patient selection among > 170,000 clinical trials archived on Clinical and their association with recruitment outcomes. The need and opportunities for data-driven patient-centered eligibility criteria design will be described.

11:30 NIH/NCATS GRDRSM Program: A Model to Accelerate Rare Diseases Research

Barbara W. Brandom, M.D., Professor, Department of Anesthesiology, University of Pittsburgh; Director, North American Malignant Hyperthermia Registry of the Malignant Hyperthermia Association of the United States

NCATS has established the Global Rare Disease Patient Registry Data Repository NIH/NCATS GRDRSM Program. The aim is to develop a Web-based resource that aggregates, secures and stores de-identified patient information from many different registries for rare diseases, all in one place. The ultimate goal is to improve therapeutic development and quality of life for the many millions of people suffering with a rare disease.

Perkin Elmer logo small12:00 pm Integrating Data is the Key to Translational Research and the Future of Personalized Medicine

Jens Hoefkens, Ph.D., Director, Research Strategic Marketing, PerkinElmer, Inc.

Emerging technologies are driving Translational Medicine research and PerkinElmer is developing tools, platforms, and algorithms to generate, analyze, visualize and store those data. This talk will describe how we integrate high-content data with clinical observations to enable our customers to derive and test unique hypotheses.

12:30 Session Break

Teradata sm12:40 Luncheon Presentation I: Implementing Continuous Improvement to Reduce Risks and Speed Clinical & Translational Informatics

Ed Acker, Ph.D., Principal Life Sciences Consultant, Teradata Corporation

Hear how Informatic organizations can innovate by implementing a continuous improvement strategy that reduces the risk of finding the right drug targets, the right treatment attributes for drugs and the right population that best responds to the treatment. Historically siloed research and clinical data repositories, along with today’s large, continuously updated health data repositories, make these programs extremely difficult to implement … until now!

eClinicalOS1:10 Luncheon Presentation II: Big Data in a Small World: Exercising Control in Global Clinical Trials

Don Turner, Senior Vice President, Business Strategy and Commercialization Global Sales, Marketing, and Partnerships with Merge eClinical

This presentation explores how advances in information technology and communications are strengthening researchers’ ability to exercise the control needed to ensure successful and cost-efficient studies on a global stage. In addition, it will examine how digital data management is changing the dynamic of long-standing traditions that hamper global trials and enabling a wider array of research organizations to compete effectively regardless of size or location.

1:40 Session Break


1:50 Chairperson’s Remarks

Alex Sherman, Director, Strategic Development and Systems, Neurological Clinical Research Institute, Massachusetts General Hospital

1:55 Open Source National Network Facilitating Healthcare and Resource Data Sharing

Doug Macfadden, Chief Informatics Officer, Harvard Catalyst

Bhanu Bahl, Director of Informatics, Harvard Catalyst

In the era of personalized medicine there is an ever increasing need to match patients with clinical trials specific to their indications. In the absence of a common way to describe, organize and query the data, the information is silo-ed and fractured across healthcare providers and hospitals. Recognizing this gap, Accrual to Clinical trials (ACT) project supported by NCATS was launched with the goal of creating a network of 60 Clinical Translational Science Center Award (CTSA) sites. The network will facilitate investigators to query EHR data across all these sites for cohort exploration and subsequently engage and enroll identified patients into clinical trials. SHRINE (Shared Health Research Information Network) is a system developed by Harvard Catalyst for enabling clinical researchers to query across distributed hospital electronic medical record systems. SHRINE is built on top of i2b2 a widely used and robust platform for clinical research. In the immediate future for the ACT project the plan is to scale SHRINE functionality to establish a national network of CTSA sites, to facilitate more sophisticated querying and allow users to trigger detailed review of potential trial subjects at each site. Biomedical researchers spend lot of time and money finding necessary resources for their research. There is a need for a common way to describe and publish resource information which will allow search of all published resources. Some of the resources maybe created by small-labs in remote locations and thus hidden from the research community. The goal of eagle-i project is to make all aspects of research resources as transparent as possible, putting all information into the public domain and enabling scientists to easily find and obtain resources from the groups that make them. Launched as a consortium of 9 universities in 2010 funded by NIH grant, today eagle-i network spans 40 sites nationwide and publishes resources for reagents, antibodies, bio-specimens, stem cell lines, mice etc.

2:25 NeuroBANK™, Accelerated Research Environment as a Model for Collaboration and Cooperation in Clinical Research

Alex Sherman, Director, Strategic Development and Systems, Neurological Clinical Research Institute, Massachusetts General Hospital

NeuroBANK™, a patient-centric platform that allows clinicians and investigators to aggregate and cross-link clinical and research information from clinical visits, clinical studies, health records, and self-reported patient outcomes, and to connect it to biospecimen, images and genetic files. Will discuss how to find or create incentives for collaborations. The system is also utilized in two patient-centered research networks (PPRNs) of PCORnet. Utilization of the Global Unique Patient Identifier (GUID), first ever in ALS research, allows to link information in NeuroBANK™ to biospecimen, image banks and genetic material collections. Comparative effectiveness research and practice quality improvement become a standard and achievable objective.

2:55 Data Access Models for Genetic Data Sharing – GSK SHARE and the GA4GH Beacon

Karen King, Head, Genetic Data Sciences, GlaxoSmithKline

3:25 Refreshment Break in the Exhibit Hall with Poster Viewing


4:00 Making Visualization and Exploration Tools Truly Useful in the Regulatory Setting

Timothy Kropp, Ph.D., Associate Director for Innovation, Office of Computational Science, US FDA/CDE

As FDA applies tools and technologies to regulatory data (“big” data as well as “little”) a lot is being learned about what is truly useful and in what contexts (not what is pretty or simply interesting). This talk will provide an overview of what informatics approaches FDA/CDER is using for visualization and exploration of scientific/clinical review data, how we are modifying what we use for better usefulness, what our biggest challenges and opportunities are, and where we want to go.

4:30 Feeding the Analytics Engine: Targeting Optimal Clinical Trial Sites, a Case Study

James Gill, Ph.D., Director, Analytics Tools and Technology, Bristol-Myers Squibb R&D

Balazs Flink, Feasibility Analytics Lead, Bristol-Myers Squibb R&D

It is no surprise that as soon as an analytical approach is proposed, access to data becomes a hurdle. In this talk we review a successful approach to improving our clinical trials site selection process by leveraging unique data in a dashboard format. Our keys to success included a clear understanding of the impact of different factors on site performance, how we can find surrogates for non-existing data and using an exploratory process with our scientists.

5:00 Delivering Standardized Clinical and Preclinical Data to Scientists in Guided Analysis

Baisong Huang, Principal Statistical Analyst, Novartis Institutes for BioMedical Research, Inc.

As visualization tools evolve and become widely accepted in investigating and monitoring drug safety and efficacy, rapid access to standardized, interpretable data views is becoming essential. We will present some examples how we standardized and aggregated data in both translational and clinical settings and provided guided analysis to visualize the data in real-time.

5:30 Best of Show Awards Reception in the Exhibit Hall with Poster Viewing

6:30 Close of Day

Thursday, April 23

7:00 am Registration Open and Morning Coffee


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10:00 Coffee Break in the Exhibit Hall and Poster Competition Winners Announced


10:30 Chairperson’s Remarks

Yuriy Gankin, Ph.D., Chief Life Science Officer, EPAM Systems

10:40 Translational R&D Analytics: Delivering ‘Big Insights’ to Drive Translational Research

Kaushal Desai, Associate Director, Translational R&D Analytics and Decision-Support, Research Informatics & Automation, Bristol-Myers Squibb

The emergence of immunotherapy and a focus on systems approaches has led to an unprecedented surge in translational research opportunities for discovery and development of newer treatment paradigms. Organizations leading the race for scientific breakthroughs in patient treatment have accumulated overwhelming quantities of efficacy, survival, safety and biomarker data from decades of preclinical studies and clinical trials. Translational R&D organizations face the arduous task of mining this data to deliver insights that drive translational research. This session will explore case studies demonstrating how translational R&D analytics can inform patient stratification and trial design in early clinical and translational research. The talk will focus on the journey from a lack of discoverability for disjointed datasets to insights that drive key decisions in translational research. Challenges associated with delivering actionable information at the point of decision-making will be highlighted and opportunities to deliver business value will be outlined using real examples from multiple disease areas.

11:10 Integrated Genomics Platform: Putting Patients and Their Genomes into the Focus of Our Research

Nora Manstein, Ph.D., IT Project Manager, Bayer Business Services GmbH

The fast progress in the generation of genomic data has reached the patient. Especially the advent of next generation sequencing and high resolution microarrays enable accurate descriptions of diseases with a strong genetic component ultimately leading to novel therapeutic approaches. Application of these technologies, however, leads to large amounts of data in need of effective storage and analysis. As now several data types (mutation, expression, microRNAs) become available for each patient, patient-centric views and analyses become mandatory. Consistent data handling and storage is a scientific and technological challenge towards both the research organization and the IT infrastructure. We have established the Integrated Genomics Platform (IGP) as a central tool for genomics research in Cardiology, Oncology and Clinical Sciences. The platform supports advanced data analysis and is intended to simplify discovery processes, e.g. for novel therapeutic targets and genetic biomarkers. In this strategic project, we have overcome known bottlenecks and enabled true translational research by establishing a company-wide mandatory repository and toolbox for storage and analysis of genomics data as well as common standards for data annotation, privacy & security.

Bina Technologies11:40 Building a Globally Distributed, Hybrid NGS Sequence Analysis and Integration Infrastructure for Oncology Discovery and Translational R&D

Justin H. Johnson, Principal Scientist, AstraZeneca

Next-Generation Sequencing is changing the way pharmaceutical companies develop drugs, perform patient stratification, and evaluate treatment efficacy. However, managing the massive amounts of NGS data has introduced fundamental IT challenges. Here we discuss the implementation of a fast, flexible, scalable and validated IT infrastructure that can streamline the upkeep of the NGS analysis workflow and the distribution of genomic information throughout an organization for translational discovery.

12:10 pm Session Break

12:20 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:20 Dessert Refreshment Break in the Exhibit Hall with Poster Viewing

1:55 Chairperson’s Remarks

Brenda Yanak, Ph.D., Director, Precision Medicine Leader, Clinical Innovation, Pfizer

2:00 GenISIS: Powering the Establishment of a Mega Scale National Resource for Biospecimens and Linkable Longitudinal Clinical and Genomic Data

Saiju Pyarajan, Scientific Director, MAVERIC, VA Boston Healthcare System

Veterans Administration (VA) embarked on the Million Veterans Program (MVP) in 2011 to collect and store consented biosamples from a million Veterans with the goal of creating a national resource of clinically linkable biosamples that can be used for next generation translational research including discovery of prognostic and diagnostic markers of disease and treatment responses. GenISIS is the data integration and mining platform that powers MVP. GenISIS provides the framework for integration of longitudinal clinical & molecular data and the analytical platform & tools for performing genome-phenome analysis. Unlike many platforms targeted for specific diseases GenISIS allows for building analytical cohorts for a large number of diseases. The talk will give an overview of the MVP project and GenISIS platform and the lessons learned.

2:30 Technology Framework to Operationalize Biomarker-Focused Clinical Research

Brenda Yanak, Ph.D., Director, Precision Medicine Leader, Clinical Innovation, Pfizer

3:00 Optimizing Clinical Biomarker Data Collection for Translational Research

Al Wang, Associate Director, Exploratory Clinical & Translational Research IT, Bristol-Myers Squibb

The objectives of translational research & development have led to increasingly complex biomarker assay panels for clinical studies, both in terms of the number of assays and the complexity of the assays themselves. Study teams are asked to plan and execute protocols that involve complex biological sample handling and distribution requirements, and significant effort is required to track those samples across multiple external partners to ensure high quality data. There are also real challenges in receiving the data back from these high-dimensional assays in a format that is consistent and ready for analysis. This talk will dig deeper into this problem, and offer some suggestions on possible solutions for real-time monitoring of sample collection and automation of data formatting.

3:30 Panel Discussion: How Has Translational Medicine Benefited from Big Data?

Moderator: Anastasia Christianson, Head, Translational R&D IT, Bristol-Myers Squibb


Justin H. Johnson, Principal Scientist, AstraZeneca

James Cai, Head, Data Science, Roche, Translational Clinical Research Center (TCRC)

Matthew V. St. Louis, Data Scientist, Predictive Informatics, R&D BT Business Insights, Pfizer

Heidi L. Rehm, Ph.D., FACMG, Chief Laboratory Director, Laboratory for Molecular Medicine, Partners HealthCare; Associate Professor, Pathology, Brigham & Women’s Hospital and Harvard Medical School

4:00 Conference Adjourns

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