Federico Goodsaid is an Associate Partner at Opus Three. He worked as Senior Vice President of Clinical and Regulatory Affairs at TOMA Biosciences, where he led the preclinical and clinical development and regulatory affairs for the company’s NGS-based oncology products. His previous work at Vertex Pharmaceuticals focused on regulatory submissions for therapeutic products, as well as diagnostics and biomarker development in rare diseases. Federico was previously Associate Director for Operations in Genomics, and Biomarker Qualification Coordinator in the Office of Clinical Pharmacology, FDA/CDER, working on the regulatory application and development of novel policies genomics and biomarkers at the FDA. His particular focus included the development of a novel biomarker qualification process (now the Biomarker Qualification Program) and the development of policies for companion diagnostics. Before he joined the FDA, he was Senior Staff Scientist at Applied Biosystems and Lead for the Molecular Toxicology Group at the Schering-Plough Research Institute.
Federico Goodsaid received his B.A. in Biochemistry and Biophysics from the University of California at Berkeley and his Ph.D. from Yale University in Molecular Biophysics and Biochemistry. He was a Postdoctoral Fellow at Cornell University and at Washington University in St. Louis.