Tiffany Lucas

Tiffany Lucas, PhD brings over 20 years of scientific development expertise — 10 years in commercial biotechnology and over 6 years as a CMC Senior Reviewer in cell and gene therapy at the FDA in CBER. At the FDA, she managed product lifecycle review from pre-IND through licensing and post-licensure changes, chairing the BLA review for an approved gene therapy, and reviewing multiple approved BLAs. Her work includes review of comparability, potency, inspections, commercial product specifications, and special designations. As Principal Consultant at ELIQUENT, Tiffany advises on regulatory strategy and CMC development to accelerate CGT product advancement.