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William Salminen

Vice President, Nonclinical Safety and Toxicology

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. He has authored or co-authored numerous scientific publications and presented his work through multiple channels, with topics including:

  • “Streamlining nonclinical drug development using the US FDA 505(b)(2) New Drug Application regulatory pathway” — Drug Discovery Today
  • “Nonclinical Study Considerations”SAAMnow Demystifying 505(b)(2) Development conference
  • Nonclinical Study Contracting and Monitoring: A Practical Guide, 1st edition
  • “Continuing Education Course: Nonclinical/Toxicology Study Contracting and Monitoring: Practical Considerations”American College of Toxicology annual meeting

Dr. Salminen earned a Bachelor of Arts degree in Biology from the University of Rochester, New York, and a PhD in Toxicology/Pharmacology from the University of Florida.

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