TUESDAY, APRIL 24
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
4:15 PLENARY KEYNOTES
Martin Leach, Ph.D., CIO, Broad Institute of MIT and Harvard
Jill P. Mesirov, Ph.D., Associate Director and Chief Informatics Officer; Director, Computational Biology and Bioinformatics, Broad Institute of MIT and Harvard
5:00 - 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
WEDNESDAY, APRIL 25
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
8:15 PLENARY KEYNOTE
Eric 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
9:45 Coffee Break in the Exhibit Hall with Poster Viewing
10:50 Chairperson's Remarks
Steve Labkoff, M.D., FACP, Head, Strategic Programs, AstraZeneca Pharmaceuticals LP
11:00 Disease Genomics Studies in situ in the Health Care System
Isaac Samuel Kohane, M.D., Ph.D., Henderson Professor of Health Sciences and Technology, Children’s Hospital and Harvard Medical School; Director, Countway Library of Medicine; Director, i2b2 National Center for Biomedical Computing; Co-Director, HMS Center for Biomedical Informatics
Large numbers of subjects are needed to obtain reproducible results relating disease characteristics to rare events or weak effects such as those measured for common genetic variants. The costs of assembling, phenotyping, and studying these large populations are substantial, recently estimated at three billion dollars for 500,000 individuals. Concurrently the costs of genetic sequencing have plummeted. Tools and methodologies are now available to conduct such research at one order magnitude lower cost and two orders of magnitude faster pace by using the informational and biological byproducts of healthcare delivery rather than requiring a separate set of systems for conducting discovery research. These tools and methods are reviewed and examples of the kinds of previously unrealizable genomic studies are highlighted.
11:30 Perspective of Research and Clinical Data Integration
Keith Perry, Associate Vice President & Deputy CIO, University of Texas MD Anderson Cancer Center
The benefits and obstacles of integrating research data into everyday clinical practice can best be summarized by looking at the perspective of those interested in solving the problem. As the technology and science advances at a rapid pace, addressing the vital needs of the researcher, clinician, administrator, and ultimately the patient, are critical for continued success.
12:00pm Addressing Big Data Challenges to Accelerate Personalized Medicine InitiativesJonathan Sheldon, Ph.D., Global Senior Director, Translational Medicine, Oracle Health SciencesThis presentation will focus on our work to provide a scalable secure platform for personalized medicine that accelerates biomarker discovery, validation and improves point of care delivery. This session will discuss the challenges associated with integrating cross platform ‘omics’ data in a manner that scales to thousands of whole genome sequences and combining with clinical data to provide an integrated view across genotype and phenotype.
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:40 Chairperson's Remarks
Chairperson to be Announced, Oracle
1:45 A Next-Generation Health & Research Informatics Platform
Mark Hulse, R.N., Vice President, Information Technology & CIO, Moffitt Cancer Center
Dana E. Rollison, Ph.D., Vice President & Chief Health Information Officer; Associate Member, Department of Cancer Epidemiology, Moffitt Cancer Center
The Moffitt Cancer Center developed a Health & Research Informatics (HRI) platform to link patient clinical information, molecular profiling and tissue data from one of the world's largest cancer biorepositories. This session will describe Moffitt's HRI and how it is being used for research cohort identification and clinical trial matching.
2:15 Empirical and Pathway-Based Genetic Associations with Subtypes of Metabolic Disorder in the Framingham Heart Study
Marsha A. Wilcox, Ed.D., Sc.D., Director, Epidemiology, Janssen Pharmaceutical Research & Development, a Johnson & Johnson Company
Frank J. DeFalco, Manager, Health Informatics Center of Excellence, Janssen Pharmaceutical Research & Development, a Johnson & Johnson Company
Our goal was to examine the sets of genes associated with an empirically identified subtype of metabolic syndrome in the Framingham Heart Study. There are several approaches to gene set identification. We used both biological pathway-based and empirical approaches and discuss the results with the current understanding of the etiology of the class of disorders. We used non-parametric data reduction and multi-staged clustering to identify subgroups of study participants with similar trait patterns. One was symptom free and served as the control group. Two were clinically interesting with patterns of obesity and metabolic syndrome-like symptoms. The focus of the genetic analysis was the metabolic-syndrome-like group. The genetic analyses began with a standard genome-wide association analysis. This was extended using the Gene Ontology database and the recently described Mean-Log-p statistic (MLP). We also used an ensemble tree-based approach, stochastic gradient boosting (SGB), to empirically identify sets of genes. This was extended using Ingenuity Pathway Analysis. We describe the results of the one-at-a-time GWAS, the pathways identified using the empirical ensemble tree-based approach, and the pathway based approaches: MLP with the GO database, and the IPA analysis based on the SGB results. All of the results are discussed with respect to current understanding of cardiovascular and metabolic disease. The strengths and weakness of the methods are discussed as are the informatics challenges and choices made.
2:45 Sponsored Presentation (Opportunity Available)
3:00 Patient-Centered Solutions for Translational MedicineIlya Kupershmidt, Co-Founder & Vice President, Products, NextBioHigh-efficiency ‘omics’ data generation combined with clinical profiles of patients can potentially transform the current translational medicine paradigm. Here, we describe NextBio’s secure, cloud-based platform that integrates the largest collection of patients and cell lines with molecular, clinical and drug sensitivity data to enable discovery of biomarkers, patient stratification for clinical trials and development of more effective, targeted therapies.
3:15 Refreshment Break in the Exhibit Hall with Poster Viewing
3:45 Using IT to Improve the Clinical Genetic Testing Process
Sandy Aronson, Executive Director, IT, Partners HealthCare Center for Personalized Genetic Medicine
Genetic testing can introduce powerful new clinical workflows into the care delivery process. However, scaling these workflows requires in-depth IT support. This talk will describe IT infrastructure that has been deployed inside and outside of Partners HealthCare to support the genetic testing process. This infrastructure has been used to gather statistics on the clinical genetic knowledge management process.
4:15 Enterprise-Wide Biobanking: Converging Research and Clinical IT Infrastructure
Natalie Boutin, Director IT - Biobanking & Personalized Medicine, Partners HealthCare
As whole genome sequencing enters the clinical space, the lines between clinical and research efforts are increasingly blurred when it comes to IT infrastructure. The biobanking infrastructure required for broad-based research is proving essential to the translation of genomic data into information for productive clinical use.
4:45 Connected Health meets Personalized Medicine
Joseph C. Kvedar, M.D., Center for Connected Health, Harvard Medical School
Connected health is time and place independent health care. As wireless and monitoring technologies become ubiquitous, it is possible to envision a unique phenotypic/behavioral map equivalent to one’s genetic map. This presentation will cover three related topics: the interplay between this unique genetic map and one’s unique phenotypic map, a more detailed example using obesity, and the use of communications technology to extend genetic counseling expertise to broad geographies.
5:15 Best of Show Awards Reception in the Exhibit Hall
6:15 Exhibit Hall Closes
THURSDAY, APRIL 26
8:40 Chairperson's Opening Remarks
Hui Cao, M.D., Ph.D., Director, Personalized Healthcare, Strategic Programs, AstraZeneca Pharmaceuticals LP
8:45 Real World Evidence Data for Real World Insight
Hui Cao, M.D., Ph.D., Director, Personalized Healthcare, Strategic Programs, AstraZeneca Pharmaceuticals LP
The life sciences industry faces unprecedented challenges to its long term sustainability with mounting competition, slowing pipelines, soaring R&D costs and tightened scrutiny on drug safety. Front runner LS companies are looking into Real World Evidence (RWE) data for “real-world” insight into their drug development and product lifecycle strategies. We will discuss the LS industry’s expectation for RWE data and then examine the breadth and scope of data available across the health care eco-system. Finally, we will present a case study of mining hospital discharge data and claims data for business insight to support R&D, marketing, commercial planning, and HEOR.
9:10 The Role of HIT in Implementing Personalized Medicine
Michael Cantor, M.D., Senior Director, Biomedical Informatics Services, Pfizer; Assistant Professor of Medicine, NYU Medical Center
Healthcare IT is an important tool for translating discoveries related to personalized medicine into clinical practice. This talk will explore the range of HIT's role in PM, including clinical decision support, real world data for evaluating personalized medicine in practice, linking clinical phenotypes to genetic data, and improving patient education.
9:35 Opportunities for Pharmaceutical Application of Real World Healthcare Data
Jason Johnson, Executive Director, Informatics IT, Merck
The rapidly changing healthcare landscape has made it both possible and necessary for pharmaceutical companies to make use of “real world” data outside of clinical trials to position and demonstrate value of new products. Merck has made use of such data for years, but the nature and scope of available data types are increasing substantially. Here we will present examples of mature and emerging opportunities for use of health data with accompanying challenges.
9:55 Achieving Personalized Healthcare in Real World using Real World Data
Zhaohui (John) Cai, Ph.D., Biomedical Informatics Director, RWE Biomedical Informatics Lead, AstraZeneca
Personalized Medicine has been tightly associated with and benefited from genetics and molecular biomarkers in relation to disease understanding and treatment outcomes, especially from diagnostic and prognostic markers in oncology areas. However, in many other disease areas where such biomarkers are not readily available or applicable, different approaches have been explored. Particularly, utilizing healthcare data, which is now available with unprecedented breadth and depth, will provide numerous opportunities of developing personalized medicine or patient care. For examples, segmenting patient population using clinical characteristics and understanding different treatment pathways in relation to patient outcomes both could help identify the right treatment to the right patient at the right time, as well as reduce healthcare cost and improve quality of care overall.
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
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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