William Salminen

Dr. Salminen has over 20 years of drug development experience for an array of drug products and indications. He is board-certified in toxicology (DABT) and project management (PMP) and a subject matter expert in nonclinical safety and toxicology support for drug product development. His experience includes regulatory strategy and advice, nonclinical safety and toxicology strategy and advice, US FDA pre-Investigational New Drug (pre-IND) meetings, IND applications and maintenance, and New Drug Application (NDA) and Biologics License Application (BLA) submissions.

Dr. Salminen has significant experience with 505(b)(2) NDAs and the unique regulatory, nonclinical, and clinical strategies involved with developing drugs under this pathway. He also has FDA-applied research experience with developing new biomarkers of drug-induced liver injury.