Jason F. Conaty

Jason handles FDA approvals and lifecycle management for complex and advanced therapies. Coming from a 10 year career as a research scientist in nucleic-acid chemistry and rational drug design, he is now a leading authority on issues arising under the Hatch Waxman Act, and the Biologics Price Competition and Innovation Act. He is an expert in applying the principles of lifecycle management to complex drugs, protein-based biologics, and gene therapy products, including novel question of drug and biological product exclusivity, Orange Book patent listings, bioequivalence, therapeutic equivalence, and interchangeability. He is frequently retained on questions of first impression involving antibody-drug conjugates, injectable depots, combination products, RNA-based drugs, digital products, nanotechnology, CAR-T cell therapy, and CRISPR-Cas9 gene editing. Jason works closely with clients to minimize loss of valuable product development time, to evaluate the available regulatory pathways, their benefits and pitfalls, to navigate the pre-approval process, and leverage innovation in the marketplace.

Prior to Hogan Lovells, Jason held positions at Massachusetts General Hospital and Harvard Medical School. He was a Fellow of the Leukemia and Lymphoma Society, and a Fellow in Genetics at the Center for Genomics and Bioinformatics, Indiana University, Bloomington. Jason clerked for the U.S. Senate Judiciary Committee, in the office of Senator Edward M. Kennedy. His pro bono practice centers on refugees and asylum, prisoner’s rights, fair sentencing, amnesty, pardon and parole.