William F. Hodnick, Ph.D., DABT

Product Development Champion

William (Bill) Hodnick, Ph.D., DABT, is a regulatory and product development expert with extensive experience guiding drug, biologic, device, and combination product programs from IND through post-market requirements. He provides strategic regulatory insight, submission leadership, and scientific expertise for a diverse range of therapeutic innovations.

Bill is a subject-matter expert in allelopathy, nonclinical and clinical pharmacology, toxicology, pharmacognosy, and natural products. To learn more, jump to:

Regulatory & Development Experience

  • Serving as U.S. Agent and leading FDA interactions, including meeting requests, briefing documents, and responses
  • IND and NDA strategy, including gap analyses, submission leadership, and special regulatory designations (Orphan drug, RPD, iPSP, waivers)
  • Radiation-emitting devices and radiopharmaceuticals for both therapy and diagnosis (i.e., microdose radiopharmaceutical diagnostic drugs)
  • Designed and directed IND-enabling studies: in vitro/in vivo pharmacology, pharmacokinetics, safety pharmacology, and toxicology
  • Member of an Institutional Review Board (IRB)
  • Post-Marketing Requirement/Commitment (PMR/PMC) tracking and reporting

Therapeutic Experience

  • Analgesia ā€” abuse deterrent opioid products, drug products to treat opioid side effects (e.g., opioid-induced constipation), local anesthetics (e.g., ketamine for opioid-resistant pain), drug/device combination products (e.g., bupivacaine infusion pump);
  • Anesthesiology ā€” inhalation anesthesia products
  • Cardiothoracic and Vascular Surgery ā€” biologic, small molecule, and small molecule drug/device combination products
  • Endocrinology ā€” biologic and small molecule drug products
  • Gastrointestinal ā€” small molecule drug product
  • General Surgery ā€” hemostatic and suture devices
  • Hematology ā€” small molecule drug products
  • Infectious Diseases ā€” antibacterial and antiviral small molecule drugs, small molecule drug/device combination products
  • Interventional Radiology ā€” device product, small molecule drug/device combination products
  • Microdose Radiopharmaceutical Diagnostic Drugs ā€” small molecule (direct and chelate labeled)
  • Neurology/Psychiatric ā€” small molecule drugs (e.g., ketamines for mood disorders), small molecule drug/device combination products
  • Ophthalmology ā€” biologic and small molecule drug products
  • Otolaryngology ā€” device products
  • Oncology ā€” biologic, small molecule drugs +/- device products, radiopharmaceuticals, combined modality therapy (chemotherapy plus radiation)
  • Pulmonary ā€” small molecule drug product
  • Reproductive Health ā€” small molecule drug product, drug/device combination products (e.g., drug-eluting IUD)
  • Rheumatology ā€” biologic, small molecule drugs, small molecule drug/device combination products
  • Transplantation ā€” small molecule drug products
  • Ultra-Rare (orphan) Diseases ā€” small molecule drug/device combination products
  • Urology ā€” devices and small molecule drugs

Education, Training, & Affiliations

  • California Polytechnic State University at San Luis Obispo, B.S. in Biochemistry
  • University of Nevada ā€“ Reno, Ph.D. in Biochemistry (focus in Biochemical Pharmacology and Toxicology)
  • Diplomat of the American Board of Toxicology (DABT), 2018 to present