PhD Career Stories panel – Regulatory Affairs
Join us Wednesday, March 5, 10am in Light Hall 208 to hear about the career journey of Dr. Kelly Gordon and Dr. John Brogan.
PhD Career Stories: Regulatory Affairs
Wednesday, March 5
10:00am
Light Hall 208
Registration requested.
J.T. Brogan Ph.D., R.A.C., is a regulatory affairs and biopharmaceutical professional with a background spanning scientific research, drug development, and regulatory strategy. Dr. Brogan received a B.S. in Chemistry and English and a Ph.D. in Chemical and Physical Biology from Vanderbilt University. After his time in Nashville, Dr. Brogan completed a postdoctoral fellowship at Biogen Inc. in Cambridge, MA, where his work focused on Biopharmaceutical Manufacturing Sciences and Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls).
In his early career, Dr. Brogan joined Biogen’s Regulatory Affairs CMC team, where he led the CMC lifecycle maintenance of Biogen’s commercial product portfolio across various emerging markets in Central and Eastern Europe. His role expanded when he moved to Seattle, WA and joined Seagen Inc., where he served as the Regulatory CMC lead for Adcetris, Seagen’s flagship antibody-drug conjugate (ADC), and played a pivotal role in developing clinical trial applications for numerous ADCs. Following Seagen’s acquisition by Pfizer in 2023, Dr. Brogan transitioned to the Pfizer Oncology Regulatory Affairs CMC team, where he is supporting late-phase CMC clinical development for disitamab vedotin, an ADC being investigated in a range of different cancers. Throughout his career, Dr. Brogan has built a track record of navigating complex regulatory challenges, advancing clinical development, and ensuring the successful delivery of innovative biopharmaceutical products to patients worldwide.
Dr. Gordon is the founder of Boudicca DX, a global precision medicine consulting firm that supports global regulatory strategies for innovative precision medicine products. She received a B.S. in Molecular and Cellular Biology from the University of Arizona and a Ph.D. in Pharmacology from Duke University. After completing two years of postdoctoral training in translational oncology at the Translational Genomics Research Foundation (TGEN) and Arizona Cancer Center, she worked at the Southern Arizona Veterans Affairs (VA) hospital’s CAP-certified and CLIA-accredited laboratory developing molecular diagnostic Laboratory Developed Tests (LDTs) hands-on as an ASCP-certified molecular technologist. Dr. Gordon developed Companion Diagnostic (CDx) IVDs for oncology therapies working at Roche Tissue Diagnostics. She held several executive roles at Pharma companies developing precision therapies (Loxo Oncology & Kura Oncology). Dr. Gordon has worked in Regulatory Affairs for over 10 years and holds a Regulatory Affairs Certification (RAC) in Devices from the Regulatory Affairs Professional Society (RAPS).