Bridging Diagnostic and Drug Development
May 5, 2009
1:00 p.m. – 3:00 p.m. EST
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1:00-1:10 Chairperson’s Opening Remarks
1:10-1:40 Strategies for Companion Diagnostic Development in a Pharmaceutical Research & Development Setting
John C. Bloom, V.M.D., Ph.D., Executive Director, Diagnostic & Experimental Medicine, Eli Lilly & Co.
The development and commercialization of novel diagnostics that enhance the value of drugs to patients, payers and prescribers is increasingly critical to “personalizing” medicines and differentiating new drugs in the marketplace. Strategies for building the capability to address such anticipated and unforeseen opportunities entail understanding the regulatory process and options for approval; and ensuring access to the appropriate specimens required for development, intellectual property rights and mutually profitable business partnerships. This presentation will review the challenges that building the required virtual technical and process diagnostic development expertise entail in today’s rapidly changing research & development environment.
1:40-1:50 Sponsored Presentation
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1:50-2:20 OIVD Outlook: Biomarker-Based in vitro Diagnostic Assays
Reena Philip, Ph.D., Scientific Reviewer, DIHD/OIVD/CDRH/FDA
Recent scientific and technological advances have provided a large inventory of candidate DNA, RNA, and protein biomarkers which could be potential candidates for disease risk assessment, screening, diagnosis, prognosis, or selection. These advancements in the development of new and cutting edge biomarkers and their associated in vitro diagnostic technologies have also raised a number of regulatory questions. This talk is intended to provide the current perspective of the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) in the FDA's Center for Devices and Radiological Health (CDRH) on the issues related to assessing analytical and clinical performance of biomarker-based in vitro diagnostic assays for use in clinical practice or medical product development.
2:20-2:30 Biomarker Imaging: From Molecules to Man, Discovery to Diagnostics
Richard A. Frank, M.D., Ph.D., FFPM (RCP), Vice President, Global Medical Affairs and Clinical Strategy, GE Healthcare
Molecular imaging enables translational medicine from drug discovery to pre-clinical, to clinical research and development and finally, to diagnosis in clinical practice. Imaging biomarkers have proven utility in the spectrum of in vivo cell, small animal, and clinical imaging. Biomarkers are not only useful in quantifying the natural history of pathophysiology but also in early identification and stratification of patients and subsequently monitor treatment effect. Monitoring treatment effect requires longitudinal quantification, in this regard, clinical research and development for novel therapeutics is converging with clinical practice. However, the success of biomarkers depends on how effectively we can pair a specific biomarker to a specific disease condition and the mechanism of action of the therapy. This presentation will explore several paths of translational research that GE Healthcare is pursuing.
2:30-3:00 Circulating Oncology Biomarkers to Guide Targeted Therapies: Companion Diagnostics for Personalized Medicine
Walter P. Carney, Ph.D., Head, Oncogene Science, Siemens Healthcare Dx
About the Speakers:
John C. Bloom, V.M.D., M.D., Executive Director, Diagnostic & Experimental Medicine, Lilly Research Labs, Eli Lilly & Co.
John C. Bloom holds a B.S. degree in biology from the University of Pittsburgh and doctorates in veterinary medicine and experimental hematology from the University of Pennsylvania. He completed his postdoctoral training at Lankenau Hospital (Jefferson Medical College) in hematology/oncology and served on the Faculty of the University of Pennsylvania School of Veterinary Medicine as Chief, Clinical Laboratory Medicine before joining Smith Kline & French Laboratories in 1981 as Associate Director of Pathology. Dr. Bloom is a past president of the American Society for Veterinary Clinical Pathology and has been active in the fields of hematotoxicology and immunotoxicology within the pharmaceutical industry. He has authored several manuscripts, chapters and reviews on these topics and edited texts on toxicology and clinical biomarkers in drug development. He joined Lilly Research Laboratories in 1989 as Head, Clinical Pathology in the Toxicology Division, and in 1991 moved to the Medical Division, where he established the department of Clinical Laboratory Medicine, and later the departments of Experimental Medicine and Clinical Diagnostic Services. As Executive Director, Diagnostic and Experimental Medicine, he is responsible for routine laboratory, ECG, imaging and specimen banking support for global clinical development, and novel clinical biomarker discovery, validation and application in the Division of Translational Medicine. Dr. Bloom holds adjunct academic appointments at the University of Pennsylvania and Purdue University.
Reena Philip, Ph.D., Scientific Reviewer, Division of Immunology and Hematology Device evaluation, Office of In Vitro Diagnostics, CDRH/FDA
Reena Philip, Ph.D., has with the FDA’s Office of In Vitro Diagnostics Evaluation and Safety (OIVD) in the Division of Immunology and Hematology Device evaluation (DIHD) since September 2004. She received her Ph.D. in molecular biology from University of Illinois at Urbana-Champaign in 1997, followed by post-doctoral training. Prior to joining OIVD, she spent three years in the biotechnology sector. At OIVD, she is an active member of the ‘Omics’ working group, serves as a scientific reviewer on Immunology, Genetics, Genomics, In Vitro Devices (IVD) and participates in drafting guidances. She is the author of many peer-reviewed articles.
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