Dave Hawver
Before becoming a consultant, Dave spent twenty-three years reviewing nonclinical data submitted to the FDA/CDER Divisions of Neurology 1 and 2 in support of 266 commercial INDs, 22 NDA/BLAs, 203 Pre-INDs, and 113 Research INDs. In this role he reviewed nonclinical study reports (pharmacology, safety pharmacology, ADME, toxicology, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and other toxicity studies), draft protocols (carcinogenicity, juvenile animal study, combination toxicity), meeting packages (Pre-IND, EOP1/2/3, pre-NDA), requests for clarification, Investigator’s Brochures, Informed Consent Documents, and responses to full or partial clinical holds.
With a PhD from Columbia University in Neuroscience and Pharmacology and postdoctoral studies at NIH on the mechanisms underlying bipolar disorder and Alzheimer’s disease, in addition to his extensive FDA experience, Dave is uniquely positioned to provide guidance on the non-clinical development of your CNS drug.