Fabiola Cervantes-Gomez, Ph.D. Joins Hyman, Phelps & McNamara, P.C. as a CMC Regulatory Expert!

Hyman, Phelps & McNamara, P.C. (HPM) is excited to announce that Fabiola Cervantes-Gomez, Ph.D. has the firm as a CMC Regulatory Expert. Dr. Cervantes-Gomez brings over eight years of experience from the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), where she specialized in chemistry, manufacturing, and controls (CMC) review of biotechnology products including antibodies, antibody-drug conjugates, and biosimilars. At FDA, Fabiola served as primary CMC assessor for numerous biologics license applications (BLAs) and investigational new drug (IND) submissions across oncology, rare diseases, and other therapeutic areas. She conducted manufacturing facility inspections, contributed to FDA guidance development, and most recently led CDER’s Network of Experts Program, managing scientific engagement between FDA offices and external professional organizations.

Fabiola Fabiola is recognized as a subject matter expert in biotechnology product quality assessment. She earned her Ph.D. in Biomedical Sciences from the University of Texas Health Science Center at MD Anderson Cancer Center and her B.S. in Chemistry from the University of Texas at El Paso.

HPM Director Mark Schwartz, who previously served over a dozen years at the FDA in various senior capacities, including as CBER’s Deputy Office Director in the Office of Compliance and Biologics Quality, noted, “Fabiola’s addition strengthens HPM’s team of lawyers and regulatory experts who can assist clients in navigating CMC, cGMP and other quality issues they face both pre and post-approval.  We are thrilled that she has joined our team.”