Senior Advisors
Federico Goodsaid, PhD
EXPERTISE
- Regulatory Strategy
- Orphan Indications
- FDA expert
Senior Advisor Regulatory Affairs
Former FDA Associate Director
Federico Goodsaid, PhD, was Vice President for Strategic Regulatory Intelligence at Vertex Pharmaceuticals. His work at Vertex focused on early and effective interaction and collaborations on exploratory and product biomarkers with regulatory agencies.
Biography
Federico was previously Associate Director for Operations in Genomics and Biomarker Qualification Coordinator at the Office of Clinical Pharmacology/Office of Translational Sciences/ Center for Drug Evaluation and Research/ U.S. FDA, working on the regulatory application and development of genomics and biomarkers at the FDA.
Before he joined the FDA, he was Senior Staff Scientist at Applied Biosystems and Lead for the Molecular Toxicology Group at theSchering-Plough Research Institute.
Education
- University of California at Berkeley
- Yale University
- Cornell University
- Washington University in St. Louis
Experience
- Vertex
- FDA
- Schering-Plough
Previously with the FDA, Dr. Goodsaid has insider knowledge of the federal agency to help you navigate the regulatory process.