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Friday, March 28

8:30am Chairperson's Remarks

8:35 Polymerase Chain Reaction: A Quarter Century of Pioneering Discovery and Promises for the Future David H. Gelfand, Ph.D., Chief Scientific Officer, Wafergen BioSystems Twenty-five years ago, Dr. Kary Mullis had the brilliant and insightful idea for the Polymerase Chain Reaction (PCR). Colleagues at Cetus pioneered early applications in molecular biology (田ell-free molecular cloning・, human genetics (launching the first of many human identity/forensics kits), creating the beginnings of the field of molecular diagnostics (HIV proviral DNA and sexually-transmitted infectious diseases), which led to PCR and Taq DNA Polymerase receiving Science magazine's first 溺olecule of the Year・award. Since the earliest days of PCR, major advances have been driven by innovations in Designer DNA Polymerases, chemically modified primers, aptamers for 滴ot Start,・fluorogenic probes and instrumentation and software for harnessing the 鄭wesome Power of PCR.・ My talk will highlight several of these advances, focusing on novel Designer DNA Polymerases and improvements in PCR analytical specificity, which have dramatically improved analytical sensitivity. Future advances in PCR technology will address the need for (1) instrument platforms with increased throughput capability, (2) increasing enzyme extension rate when copying RNA, (3) improvements in specificity in multiplex PCR ・eliminating primer dimer and other unintended, non-specific amplification products and (4) strategies for sensitive detection of rare somatic mutations in peripheral fluids. 9:05 Organizational, Strategic and Technical Considerations for Creating Clinically Differentiated Medicines and Companion Diagnostics: Successes vs. Failures, What Did We Learn? Tim M. Jaeger, M.D., Ph.D., MBA, Head of Divisional Medical and Scientific Affairs, F. Hoffmann-La Roche Ltd, Diagnostics Division  The pharmaceutical, biotechnology, medical device and diagnostic industries are increasingly being pressured by healthcare providers, payers, consumers and regulators to deliver and demonstrate the medical and economic value of innovative methods for diagnosing, treating and monitoring acute and chronic disease. In response to these pressures, researchers and manufacturers are focusing considerable effort on optimizing therapeutic efficacy and safety by 菟ersonalizing・healthcare. The goal of personalization is being pursued through the development and delivery of 妬ndividualized・treatment for patients who are grouped on the basis of clinical differentiators such as genetic, physiologic and disease characteristics. This therapeutic stratification approach depends on the reliable identification and utilization of these differentiators, which in turn relies on the integration of diagnostic and therapeutic strategies and techniques. Key to achieving this integration is the seamless exchange of information throughout the process of care.

9:35 The Increasing Convergence of EHR Data and Clinical Research Data 
Donald T. Mon, Vice President, Practice Leadership, American Health Information Management Association (AHIMA)

10:05 Technology Spotlight (Sponsorship Available)

10:20 Coffee Break in the Foyer

11:00 Expert Panel: MEDICAL INFORMATICS AND MOLECULAR DIAGNOSTICS: Quality Healthcare and EHRs Through Open Collaboration
Moderator: Marc Wine, M.H.A., Co-Author, Medical Informatics 20/20

• What is the implementation plan for introducing EHRs to all Americans by 2014?

• How best to address legal and technical barriers to a more rapid adoption of EHRs, including: security, privacy protection and identity management; incentives; and financial feasibility of project implementation. 

• How to develop practical uses for advanced, high capacity HealthGrid computing and telemedicine to process biomedical, genomic and pharmaceutical research from the lab bench to patient's palm in real time. 

Mary Kratz, MT(ASCP), Executive Vice President, HealthGrid U.S. Alliance, University of Michigan Medical School Information Services 

Bruce Merlin Fried, Esq., Partner, Sonnenschein Nath & Rosenthal LLP

Saul Rosenberg, Ph.D., Associate Clinical Professor Medical Psychology, University of California, San Francisco, and Chief Executive Officer, Neuron Valley Networks Corp. 

Syed Tirmizi, M.D., Director, Health & Medical Informatics, Office of Chief Health Informatics, OI/Veterans Health Administration

12:00pm Luncheon Workshop (Sponsorship Available) or Lunch on Your Own

1:00 Chairperson's Remarks
Brian T. Edmonds, Ph.D., Principal Investigator, Integrative Biology/ Global External Research & Development, Lilly Corporate Center

1:05 Type I Receptor Tyrosine Kinase Interactions in Breast Cancer Using in Situ Proximity Ligation: Potential for Diagnostics?
John Bartlett, Ph.D., Group Leader, Endocrine Cancer Group, University of Edinburgh Cancer Research Centre 
The HER2 oncogene is a key molecular target and driver of aggressive early breast cancer. Data shows that interactions between HER2 and other members of the type I receptor tyrosine kinase family are critical to understanding the biology of breast cancer. Currently, diagnostic detection of HER2 gene amplification provides some information on response to HER2 targeted therapies, but is a poor predictor of patient benefit. Proximity ligation assays (PLA) have the ability to detect homo- and heterodimers at a single-molecule level to investigate numerous biological processes [3]. Using clinical material we are currently exploring in situ kinomic profiling of the type I receptor tyrosine kinases as a potential diagnostic tool for improving the predictive value of HER2 in diagnostics.

1:35 An Integrated Genomic Approach for the Treatment of Patients with Advanced Stage Ovarian Cancer
Holly K. Dressman, Ph.D., Associate Research Professor, Director, Duke Microarray Facility, Duke Institute for Genome Sciences and Policy, Department of Molecular Genetics and Microbiology Duke University Medical Center
An integrated genomic-based strategy for the treatment of patients with advanced-stage ovarian cancer has been developed to identify patients with platinum-resistant disease at the time of initial diagnosis. To further investigate alternative treatments for resistant disease, salvage based therapy response signatures along with oncogenic pathway deregulation were used to identify alternative strategies for developing individualized regimens for the treatment of ovarian cancer.

2:05 Circulating Tumor Cells
Steven M. Rosen Ph.D., Director, Technology Assessment World Wide, Ortho Clinical Diagnostics, Inc. and Veridex LLC, Johnson and Johnson Companies (tentative)

2:35 Oncology Case Study
Caprion Proteomics
It is now possible to profile hundreds to thousands of proteins modulated in plasma by disease using proteomics and bioinformatics in an industrialized and reproducible fashion. Case studies in cancer diagnostic and Alzheimer diagnostic discovery are presented to illustrate the sensitivity, accuracy and precision of the industrialized proteomic workflow and the intelligent selection of putative diagnostics for validation using bioinformatic workflows. Objective assessments of the success of the diagnostic discovery by proteomics are presented as well.

3:05 Close of Conference