Where and when should biomarkers be incorporated into drug development?
CDER Director Janet Woodcock and Office of Clinical Pharmacology Director Lawrence Lesko, and others from industry and academia, addressed these questions October 21 and 22 at a workshop held at the FDA's White Oak Campus. Adaptive Pharmacogenomics' Michael Palmer organized and chaired the workshop. Join Michael at a one day course in New Jersey, Boston, San Diego or San Francisco in February to learn how the workshop answered the "where" and "when" questions about incorporating biomarkers into drug development.
CDER Director Janet Woodcock, M.D. opened the "Workshop on the Impact of Biomarkers on the Complexity and Cost of Drug Development" and noted the agency's continuing commitment to supporting the use of biomarkers in drug development. Lawrence Lesko, Ph.D., Director of the Office of Clinical Pharmacology chaired a panel discussion. Over the two day workshop, FDA and industry representatives finalized two benchmark therapeutic area scenarios, in oncology and Alzheimer's Disease. The benchmarks are the results of an eight month effort by FDA, MIT, Adaptive Pharmacogenomics, and several major pharma companies. They will be used to evaluate software tools for assessing the complexity and cost of clinical development with biomarkers.
For more information, download the course brochure (http://www.adaptivepharmacogenomics.com/users/FebruaryFDAbiomarkerWorkshopCourse01.pdf).