The Drug Information Association (DIA) and US FDA, in collaboration with BIO, PhRMA, Industry Pharmacogenomics Working Group, will host the 5th Workshop in a Series on Pharmacogenomics: Generating and Weighing Evidence in Drug Development and Regulatory Decision Making from February 2-4, 2010 in Bethesda, MD.
This workshop will develop and advance approaches and ideas to improve the value of pharmacogenomics and other biomarker studies during clinical development and for regulatory decision making. Session topics will include:
- When pharmacogenomics data will be required during clinical development
- Defining parameters that allow retrospective/prospective analyses to be conducted for regulatory approval of compounds in biomarker defined cohorts
- Case studies in efficacy, safety, and dosing which have integrated Pharmacogenomics
- Translation of genomic information to labels that are useful to prescribers and patients
- Challenges with sample collection for Pharmacogenomics in global development programs and ways to overcome them
- Critical analyses and recommendations for drug-diagnostic co-development paradigms which are feasible in the competing hurdles to develop new medicines
- Discussion panel of stakeholders including regulators, industry, third party payers, medical researchers and practitioners
“The field of genetics and its applications continue to evolve rapidly with the publication of multiple genome-wide association studies, the availability of new DNA sequencing technologies, and examples of biomarkers that are being used to help define patient response in myriad diseases,” says Steering Committee Co-chair Issam Zineh, PharmD, MPH, Associate Director for Genomics, Office of Clinical Pharmacology, CDER/FDA. This fifth major workshop will provide stimulating learning and networking opportunities with colleagues from academia, regulatory authorities, industry, payors, and providors who work on personalized medicines.”
ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.