Drugs
Genomics at FDA - Presentations
2009
Pharmacogenomics and Warfarin Testing: The Case for Personalized Medicine, Huang, Shiew-Mei, Ph.D., Academy of Managed Care Pharmacy (AMCP) 21st Annual Meeting and Showcase, Orlando, FL, April 15-18, 2009
2008
Warfarin Pharmacogenetic Testing Is Now Ready for Prime Time, Invited Presentation at the "Warfarin Pharmacogenetics Debate", Huang, Shiew-Mei, Ph.D., AACC Annual Meeting, Washington, DC, July 28, 2008
Pharmacogenomic Research Meets Clinical Practice: Examples of Incorporating Pharmacogenomic Principles into Clinical Practice, Burckart, J Gilbert, Pharm.D., American College of Clinical Pharmacy Meeting, Phoenix, AZ, April 2008
Personalized Medicine: Regulatory Perspective Lawrence J. Lesko, Ph.D., FCP, Washington, DC, January 8, 2008
2007
Warfarin Pharmacogenomics: Translation into Clinical Practice, Lawence J. Lesko Ph.D., FCP, Silver Spring, MD, October 17, 2007
Challenges for Co-Development of New Medical Products: A regulatory perspective, Felix W. Frueh, Ph.D., CDER, Bethesda, MD, October 19, 2007
Personalized Medicine - Quo Vadis? Felix W. Frueh, Ph.D., CDER, Cambridge, MA, October 11, 2007
Principles of Risk-Based Regulatory Decision Making, Lawence J. Lesko Ph.D., FCP, Pittsburgh, PA, October 23, 2007
New Paradigms for Drug Development: A Regulatory Perspective, Felix W. Frueh, Ph.D., CDER, Baltimore, MD, July 31, 2007
The Future of Technology and Regulation: Opportunities in Drug Development, Regulatory Review and Clinical Practice, Shiew-Mei Huang, Ph.D., 10th Annual FDA - Orange County Regulatory Affairs Educational Conference, Irvine, CA, June 11, 2007
Regulatory Perspecive on Warfarin: Relabeling with Genetic Information, Lawrence J. Lesko, Ph.D., FCP, CDER, Ninth Annual Conference of Anticoagulation Therapy, May, 2007
The Transition from Pre-Clinical to Clinical Application of Safety Related Related Genomics, Felix W. Frueh, Ph.D., CDER, IOM/FDA Emerging Safety Science Workshop, April 23, 2007
Update on the Critical Path and Personalized Medicine Initiative Implementation, Felix W. Frueh, Ph.D., CDER, R&D Leaders Forum Spring 2007, March 5, 2007
Clarifying the Current Regulatory Position on the Validation and Standardization of Biomarkers for Approval and Ongoing Patient Care, Felix W. Frueh, Ph.D., CDER, R&D Leaders Forum Spring 2007, March 5, 2007
2006
Pharmacogenetics –Pharmacogenomics in Early Drug Development: Regulatory Expectations, Shiew-Mei Huang, Ph.D., AAPS Annual Meeting, November 2, 2006
The VGDS Process at the US FDA: Lessons Learned and Future Directions, Michael S. Orr, Ph.D., DABT, CDER, American College of Toxicology 27th Annual Meeting, November 6, 2006
Celebrating the Two-Year Milestone and Planning for the Future of Voluntary Genomic Data Submissions (VGDS) to the FDA, Federico Goodsaid, Ph.D., and Felix Frueh, Ph.D., CDER, DIA Webinar, September 28, 2006
Challenges in Biomarker and Drug Co-Development and Regulation: The regulatory view for drugs, Felix W. Frueh, Ph.D., CDER, AACC 2006 Annual Meeting, Chicago, IL, July 24, 2006
Personalized Medicine – Today!, Felix W. Frueh, Ph.D., CDER, Clinical Ligand Assay Society, Louisville, KY, May 22, 2006
Can Pharmacogenomics Help in Psychiatric Drug Development?
Shiew-Mei Huang, Ph.D., CDER
NCDEU 46th Annual Meeting, Boca Raton, FL, June 15, 2006
Pharmacogenomics: Patient Selection for Clinical Trial Participation and Enrichment Strategies
Felix W. Frueh, Ph.D., CDER
Accelerating Anticancer Agent Development and Validation Workshop, May 17, 2006
Co-Development of Drug and Test – Is It a Special Challenge with PGx?
Felix W. Frueh, Ph.D., CDER
Annual DIA EuroMeeting, March 8, 2006
Qualification of Genomic Biomarkers for Regulatory Decision Making
Felix W. Frueh, Ph.D., CDER
Annual DIA EuroMeeting, March 7, 2006
Voluntary Genomic Data Submissions: Review and Analysis of Toxicogenomic Data in Preclinical Drug Safety Assessment
Felix W. Frueh, Ph.D., CDER
Pharmacogenomics Grand Rounds, January 31, 2006
Creating a Network to Study the Effect of Genomics on Clinical Outcomes: The View from FDA
Felix W. Frueh, Ph.D., CDER
Group Health Cooperative – CDC Meeting, December 14-15, 2005
Voluntary Genomic Data Submissions at the U.S. FDA
Felix W. Frueh, Ph.D., CDER
International Conference on Harmonization, November 9-10, 2005
Presentations from FDA, DIA, PhRMA, BIO, & PWG Workshop on “Applications and Validation of Genomic Biomarkers for Use in Drug Development and Regulatory Decision Making” Bethesda, MD, October 6 – 7, 2005. Download zip file of all presentations (6.71 MB). Individual presentations.
Voluntary Genomic Data Submissions: One Year Later
Felix W. Frueh, Ph.D., CDER
41st Annual DIA Meeting
Pharmacogenomics and Biomarkers: Current role in drug development
Felix W. Frueh, Ph.D., CDER
Accelerating Anticancer Agent Development and Validation, June 2, 2005
Personalized Medicine: What Is It? How Will It Affect Health Care?
Felix W. Frueh, Ph.D., CDER
11th Annual FDA Science Forum, April, 2005
Translation of Pharmacogenomics and Pharmacogenetics: A Regulatory Perspective
Lawrence J. Lesko, Ph.D., FCP
11th Annual FDA Science Forum, April, 2005
Pharmacogenomics, Personalized Medicine and the Role of FDA
Lawrence J. Lesko, Ph.D., FCP
Bio-IT World Conference, May 18, 2005
[Rat Mixed Tissue RNA Reference Material (MTRRM) for Microarrays]
Application of a Cross-Platform RNA Standard for Assessing Microarray Data Comparability
P. Scott Pine, CDER
Karol Thompson, Ph.D.
11th Annual FDA Science Forum, April, 2005
Pharmacogenomics: Experience with Voluntary Submissions and Regulatory Development
Felix W. Frueh, Ph.D., CDER
International Conference on Drug Development, February 15, 2005
Toxicogenomic Data Submissions: Regulatory Considerations
Felix W. Frueh, Ph.D., CDER
The Toxicology Forum: February 1, 2005
2004
Pharmacogenomic Data Submissions: Review of Guidances and Goals
Felix W. Frueh, Ph.D., CDER
Pharmacogenomics Working Group, December 14, 2004
Education in Pharmacogenomics: Closing the Gap between Possibility and Reality
Felix W. Frueh, Ph.D., CDER
Drug Metabolizing Enzymes and Pharmacogenomic Testing Workshop September 13-14, 2004
Regulatory Perspective on Integrating Pharmacogenomics into Drug Development and Regulatory Decision Making
Lawrence J. Lesko, Ph.D., F.C., CDER, May 18, 2004
2003
Regulatory Issues in Genotyping Metabolizing Enzymes-CDER Perspective
Shiew-Mei Huang, Ph.D., CDER
FDA/Johns Hopkins University/PhRMA Educational Workshop, September 13-14, 2003, Rockville, MD
Effect of Pharmacogenetics and Drug-Drug Interactions on Exposure-Response: What Needs to be Done?
Shiew-Mei Huang, Ph.D. CDER
American College of Clinical Pharmacology Exposure-Response (E-R) Relationships, September 21, 2003, Tampa, FL,
2002
2002 Workshop on Pharamacogenetics/Pharmacogenomics in Drug Development and Regulatory Decision-Making
Lawrence J. Lesko, Ph.D., CDER
May 16-17, 2002, University of Maryland