BIO Co-Sponsors February FDA/DIA Workshop
It will be held February 2, 2010 8:00AM – February 4, 2010 3:00 pm at the Marriott Bethesda North Hotel.
Some of the featured topics of interest include:
- When PGx 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 PGx
- Translation of genomic information to labels that are useful to prescribers and patients
- Challenges with sample collection for PGx 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
We think this will be a great workshop for members of BIO to attend as well as other industry companies!