4:00 pm Event Chairperson’s Opening Remarks
Cindy Crowninshield, Conference Director, Cambridge Healthtech Institute

4:15 Informatics: Integration & Convergence
John Reynders, Ph.D.,Vice President & Chief Information Officer,Johnson & Johnson, Pharma R&D

5:00 Welcome Reception in the Exhibit Hall
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7:30 am Registration and Morning Coffee

8:15 Event Chairperson’s Opening Remarks
Phillips Kuhl, Co-founder and President, Cambridge Healthtech Institute 

8:20 Drug Development: Evolving Challenges and Opportunities
Joshua Boger, Ph.D., President & Chief Executive Officer, Vertex Pharmaceuticals, Inc.

9:00 Keynote Presentation & 2008 Benjamin Franklin Award
Robert Gentleman, Ph.D., Head of Program in Computational Biology, Fred Hutchinson Cancer Research Center

9:30 Coffee Break, Exhibit and Poster Viewing in the Exhibit Hall

10:50 Track Chairperson’s Remarks

11:00 CDISC Today and Tomorrow
This talk reviews the industry’s efforts to establish a standard platform for data capture and its impact on EDC-based studies. Our CDISC task force for the Society of Clinical Data Management has the goal of educating mem-bers on CDISC and contributing to the organization’s reference material on the application of the data standard to good clinical practices. We will present an overview of CDISC standards adoption in clinical research, discuss the relationship between CDISC and other data interchange standards. Also discussed: approaches to importing and exporting ODM data sets in clinical trials, privacy and security requirements exchanging CDISC data; and the fu-ture of CDISC as an industry-wide data standard.
Khaled El Emam, Ph.D., CTO, TrialStat Corporation; Canada Research Chair in Electronic Health Information, Uni-versity of Ottawa
Sally Cassells, Vice President of Clinical Systems, Lincoln Technologies

11:30 Electronic Data Capture and Data Integration 
This presentation will discuss an approach we are using at the Dana-Farber Cancer Institute for electronic collec-tion and aggregation of clinical trial results data. The ‘bench to bedside and back’ paradigm for achieving person-alized medicine requires the seamless and timely exchange, sharing, aggregation, integration and analysis of clinical research data across the cancer research community. However, even when sources of large datasets ex-ist, data integration is challenging because of the lack of completeness of information or lack of semantic integrity and resulting ambiguity. We will describe the problem and present an example strategy to resolve some of the issues.
Jomol Mathew, Ph.D., Director, Clinical Research Information Technology, Dana-Farber Cancer Institute

12:00 pm Collaborative Visualization: Getting the Most from EDC and Data Integration
Transforming clinical trials data into cost savings requires a decision-support system that empowers human interpretation. Common dashboards or portals that centralize reporting only offer a partial solution; data volume and complexity still overwhelm decision-makers. We have leveraged battle-hardened collaborative visualization software and created a radically different environment for exploring and analyzing integrated clinical trials data. Information objects are liquid, pliable, and transferable among display elements, enabled by a semantically-rich information model. We will show how partners Array BioPharma and the Immune Tolerance Network have used collaborative visualization for project management, financial tracking, and clinical data analysis to accelerate drug development and clinical trials.
Jake Kolojejchick, Ph.D., Chief Scientist, General Dynamics

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

1:45 Now What? Are We Using EDC to Create Its Fullest Possible Business Benefits? Can organizations fully realize the larger business benefit that EDC and eClinical trials can bring? Most sponsors are using EDC so that standard, current-state IT can correct basic clinical trial process inefficiencies. Few compa-nies have learned how to really shorten development timelines or accelerate decision-making — two other as-sumed EDC benefits. But even more is made possible by the catalyst that eClinical Development provides: re-considering clinical development governance and resourcing; radically altering protocol design and development; routinely designing for and benefiting from interim analyses and adaptive design; re-examining the relationships between medical affairs, clinical research and marketing; cultivating higher-quality sites; reducing overall IT ex-pense through cross-application integration; changing fundamental assumptions in site monitoring philosophies; increasing investigational drug supply efficiency; and more. This session will present perspectives and case study examples of organizations that have successfully leveraged their use of EDC and the actionable knowledge it cre-ates.  Moderator: Ronald Waife, President, Waife & Associates, Inc. Steve Shevel, Manager eSolutions, Allergan Greg Moody, Associate Director, Clinical Systems, Clinical Data Management, Millennium Pharmaceuticals Andrew Worley, Associate Vice President, Clinical Information Services, Wyeth

3:15 Refreshment Break, Exhibit and Dedicated Poster Viewing

3:45 Linking Clinical Data, Laboratories, and Providers: Establishing Application Networks to Enable Personal-ized Medicine 
As more genetic and genomic-based diagnostics are preformed, it will be increasing difficult for clinicians to track and fully leverage these test results. Clinical decision support systems can assist in this area. Genetic based clini-cal decision support systems require the integration of genetic data, phenotypic data and genetic knowledge. At times, all of this information exists within a single institution. We will discuss examples of self-contained clinical decision support that operates within our institution. However, the information required for these systems to meet their potential is often spread out across multiple databases in multiple institutions. We will also discuss the types of secure data networks that need to be established to provide broader clinical decision support.
Samuel (Sandy) Aronson, Executive Director of IT, Harvard Partners Center for Genetics and Genomics (HPCGG)

4:15 Informatics Solutions for Translational Research 
An information management system has been developed to assist clinical and translational researchers in storing, querying and integrating such diverse data sets efficiently. We have also developed analysis tools to help bio-medical researchers and those in the pharmaceutical industry to manage and analyze large volumes of data ef-fectively. This talk will help researchers and clinicians how to: 1) efficiently manage and track laboratory samples, chips, gels and biospecimens; 2) effectively analyze, and interpret high-throughput data from microarrays; 3) visualize microarray, proteomics and sequence data; 4) integrate data and annotations from disparate data sources; and, 4) correlate patient data with experimental data as well as annotations from public databases.
Rakesh Nagarajan, Ph.D., Assistant Professor, Pathology and Immunology, Division of Laboratory and Genomic Medicine, Washington University School of Medicine 
Aditya Phatak, Strategic Relationship Manager, Life Sciences, Persistent Systems Inc.

4:45 Leveraging Biorepositories and Correlative Clinical Data to Drive Translational Medicine
Alicia Sable-Hunt, MBA, RN, CCRC, President, Edwards-Hunt Group LLC; Former Program Manager, Multiple Myeloma Research Consortium
Steven Young, Executive Director, Multiple Myeloma Research Consortium
With translational medicine at the forefront of its approach to multiple myeloma research, in 2006 the Multiple Myeloma Research Consortium (MMRC) selected LabVantage, Inc. as the preferred partner to establish a central MMRC Tissue Bank designed specifically to span the lifecycle of samples, and provide centralized access to all of its then 11 member sites. Due to the complexity of the research, an automated process was necessary to ensure the timely collection and processing of samples combined with the capture of correlative clinical data. Moreover, scientists needed the ability to query the data to identify trends and locate samples based upon specific criteria. The scope of the tissue bank is extensive and requires numerous solution components including participant registration, sample collection, sample shipment, tissue bank processing, and inventory/location management of biospecimens. Additionally, the solution captures correlative information, tracking participant data, study enrollment details, and health history. This session will cover an overview of how the MMRC’s Tissue Bank is enabling Translational Medicine through interdisciplinary collaborations among patients, researchers, pharmaceutical companies, biotech firms, and the National Cancer Institute as well as numerous academic and community institutions.

5:15-6:15 2008 Best of Show Awards/Reception in the Exhibit Hall 

6:15 Exhibit Hall Closes 

7:00 2008 Bio-IT World’s Best Practices Awards/ Dinner 

7:30 am Registration and Morning Coffee

8:00 Event Chairperson’s Opening Remarks
Kevin Davies, Ph.D., Editor-in-Chief, Bio-IT World 

Keynote Introduction: 
Ron Ranauro, President and CEO, GenomeQuest, Inc. 

8:05 Personalized Genetics: Advancements & Driving Change
Linda Avey, co-Founder, 23andMe, Inc..

8:45 The Future of Personal Genomics George Church, Ph.D., Professor of Genetics and Director of the Center for Computational Genetics, Harvard Medical School Dietrich Stephan, Ph.D., Co-founder and Chief Science Officer, Navigenics, Inc. Jeffrey M. Drazen, M.D., Editor-in-Chief, New England Journal of Medicine; Distinguished Parker B. Francis Professor of Medicine, Harvard Medical School Fred D. Ledley, MD, Professor and Chair, Bentley College; Founder and Chairman, My Genome John Halamka, MD, MS, CIO, Harvard MedicalSchool Linda Avey, co-Founder, 23andMe, Inc.

9:45 Coffee Break, Exhibit Viewing, Vendor Theater Presentations, and Poster Competition in the Exhibit Hall

10:45 Track Chairperson’s Remarks
Dan McDonald, Vice President, Business Strategy, Excel Life Sciences

11:00 Enabling the Molecular Medicine Revolution: Getting Connected with caBIG 
Joint with Track 1
This talk will explore strategies for embracing evidence-based patient care using the cancer Biomedical Informat-ics Grid, or caBIG. caBIG is an unprecedented initiative led by the NCI to create a seamless technology network that accelerates information and data translation, and enables molecular approaches to research, as well as adaptive clinical trials. caBIG connects its collaborators as a voluntary, open-source network of infrastructure, tools, and ideas that enables the collection, analysis, and sharing of data and knowledge along the entire re-search pathway from laboratory bench to patient bedside. This discussion will illustrate how IT is bridging the gap between clinical and research informatics.
Kenneth Buetow, Ph.D., Director, NCI Center for Biomedical Informatics and Information Technology, National Cancer Institute 

11:30 Remote Data Capture for the Cancer Cooperative Groups and caBIG for Drug Development
The NCI is implementing a nationwide interoperable remote date capture solution of clinical trial information for cancer drug development. This talk will explore the major NCI efforts to harmonize clinical trial data amongst the broader cancer research community to enable better collaboration to improve the clinical trials process and accel-erate drug development. 
George Redmond, M.Sc., M.B.A., Bioinformatician, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI)

12:00 pm Implementing Ontology Based Reasoning Services to Guide Clinical Trial Protocol Compliance 
The Immune Tolerance Network (ITN) has been in collaboration with Stanford Medical Informatics for the last 2 years to increase support for automated clinical trials management. At the core of such efforts is formal modeling of knowledge found in clinical protocols. We are modeling this knowledge in the Epoch clinical trial ontologies de-veloped at Stanford, to encapsulate the knowledge in a computable formalism. Managing protocol compliance, and the large amounts of data associated with a clinical trial requires a study design beyond that of a traditional CTIS. We believe that the work being done with Clinical Trial Ontologies provides such a design. We will present ways of actively using the trail design to support ontology and non-ontology based applications.
Keith Boyce, Associate Director, Bioinformatics, Immune Tolerance Network / UCSF

12:30 Luncheon in the Exhibit Hall

2:00 Exhibit Hall Closes

2:00 Improving Drug Development Using Patient Adherence Technology & Data in Clinical Trials 
Patient compliance (adherence) to long-term therapy is emerging as a critical challenge across the drug devel-opment and commercial continuum. Implications of poorly characterized patient adherence in clinical trials affect interpretation of PK, dosing, efficacy, and safety. Opportunities exist for new technologies to improve our under-standing of patient adherence in clinical trials, as well as to favorably influence adherence. This talk will review existing and emerging technology for monitoring adherence (RFID, printed electronics, drug tagging, etc.), as well as the range of applications of the resulting data.
Craig Lipset, Director, Health Technologies, Pfizer Inc.

2:30 A Complex Protocol Design to Accelerate Clinical Trials: How to Implement Multiple Database Lock in an EDC System 
One of the ways pharma companies can simultaneously reduce time and costs of clinical trials is to conduct sev-eral studies or portions of a study as “one protocol”. In this scenario, it is common that part of the trial is being locked, unblinded, analyzed and reported, while subjects continue to participate in the study and the data con-tinue to be collected. This approach makes scientific and business sense and will likely become the main stream of protocol design. Such complex protocol design brings new challenges to current EDC structure, especially the external data import, common data management process such as database (db) lock. There are enormous impli-cations in clinical and regulatory affairs. In order to prevent inadvertent or unauthorized changes of data once the final analysis and reporting of the trial data have begun, db lock has become a well-defined process for closing a database and change control procedures in data management of a clinical trial. In a protocol with multiple stud-ies, the traditional db lock occurring once at the end of the trial is not sufficient because the data is usually un-blinded, analyzed and submitted in the middle of the trial. Therefore, implementing multiple db locks is neces-sary. We will discuss new requirements for multiple db locks and present a case study to illustrate the challenges and solutions. We have implemented three partial locks for a very complex study, which is comprised of four dis-tinct parts to answer different clinical questions.
Olive Yuan, Ph.D., Senior Clinical Data Manager, Regeneron Pharmaceuticals. Inc.

3:00 Connecting Two Worlds: Electronic Health Record Systems and Clinical Research 
eClinical Forum, formed in 2000 by members of the pharmaceutical industry, has been partnering with the PhRMA EDC/eSource Taskforce to address requirements needed to determine how electronic health record (EHR) systems can be used for clinical research. The EHR clinical research profile team is producing a set of functions and criteria in order for EHR systems to be used as a source of data for clinical research. A first draft of this pro-file was produced in 2007, with work continuing toward HL7 and QRec submissions in 2008. We will describe the EHR/CR Functional Profile and its importance to industry, as well as certification, applications of use cases in real world environment, and lessons learned. 
Catherine Celingant, Director, Clinical Data Management, Millennium Pharmaceuticals

3:30 Clinical Observations Interoperability: Using EHRs for Patient Recruitment 
Clinical Data acquired in the patient care process and stored in Electronic Health Records (EHRs) can be re-used for a variety of applications such as Patient Recruitment, Drug Safety Surveillance, Post Launch Drug Use and Virtual Phase IV Clinical Trials. A critical component is the ability to interoperate and exchange clinical observa-tions across clinical research, trials and practice. This presentation will focus on the problem of patient recruit-ment and illustrate, with the help of detailed examples, the use of Semantic Web Technologies for enabling interoperability between the EHR and Clinical Trials applications. Results of an ongoing collaborative effort in the framework of the W3C Healthcare and Life Sciences Interest Group will be presented.
Vipul Kashyap, Ph.D., Senior Medical Informatician, Clinical Informatics R&D, Partners Healthcare System

4:00 Conference Adjourns