Federico Goodsaid is a regulatory strategy consultant at Regulatory Pathfinders and Ariana Data Intelligence. He was, until this year, CEO of MBQ-Pharma, a biotech company licensing IP developed at the University of Puerto Rico. The goal of MBQ Pharma is to commercialize anticancer drugs developed through this license. He is also Principal Consultant at Regulatory Pathfinders LLC, a regulatory consulting practice focused on regulatory strategy and pathways required for precision medicine therapeutic and diagnostic products. Prior to this appointment, he was the Senior Vice President for Product Development and Regulatory Affairs at TOMA Biosciences, where he worked on the preclinical and clinical development and regulatory submissions for a 130-gene targeted NGS oncology panel. His previous work at Vertex focused on therapeutic product submissions in cystic fibrosis which led to the first in-vitro surrogate label expansion for Kalydeco. He 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. Before joining the FDA, he served as a Senior Staff Scientist at Applied Biosystems, where he developed the original TaqMan and SYBR qPCR reagents, Head of the Molecular Toxicology Group at the Schering-Plough Research Institute, Manager of TPD Consumables at Abbott Diagnostics, for the development and launch of the AxSYM Instrument, and at Pacific Biotech, where he worked on the development of the first commercially successful one-step immunodiagnostic pregnancy test. Following his Ph.D. from Yale University in Molecular Biophysics and Biochemistry, he was trained as a Muscular Dystrophy Association Postdoctoral Fellow at Cornell University in Ithaca and at Washington University in St. Louis.
Research
- Biomarker development and validation
- Biomarker integration in clinical trials
- Regulatory strategy for biomarkers
Teaching
- PHAR 6116