Dr. Hawver is an ex-FDA expert in regulatory toxicology and CNS drug development. He earned a BA in Biochemistry from Swarthmore College in 1985 and a PhD from Columbia University in Pharmacology and Neuroscience in 1992 and then conducted postdoctoral research on molecular and cellular mechanisms of bipolar disorder and Alzheimer’s disease at the NIH from 1992 to 1998. From 1999 to 2023, Dr. Hawver worked as a Primary Reviewer for the FDA/CDER Division of Pharmacology/Toxicology, Office of Neuroscience, reviewing 266 commercial INDs, 22 NDA/BLAs (including vutrisiran, aducanumab, donanemab, inotersen, and eteplirsen), as well as countless meeting packages and responses to full or partial clinical hold. His area of expertise was Alzheimer’s disease and related disorders (185 commercial INDs), although projects also included 62 other CNS/PNS indications.

Since retiring from the FDA in January of 2023, Dr. Hawver has worked as a consultant, providing advice on nonclinical strategy and problem-solving to more than 70 pharma/biotech clients. Consulting projects have included review of nonclinical data, draft responses to hold, draft meeting packages, and due diligence analyses for small molecules, oligonucleotide therapeutics, peptides, and biologics targeting disorders in Neurology, Psychiatry, Rare Diseases/Medical Genetics, Immunology/Inflammation, Pain, Obesity, and Cardiology/Nephrology.