Janet Iles, MD, MPH

Advisor, Clinical Development & Drug Safety

Providing innovative thinking and leadership in clinical development and pharmacovigilance

Expertise

Janet combines her years of clinical development, drug safety, and pharmacovigilance experience to advise clients developing CNS-active drugs, including psychedelics and cannabinoids. She specializes in:

  • Clinical development plans and trial design
  • Study feasibility
  • Clinical trial safety
  • IND and NDA/BLA filing strategy
  • Development and negotiation of product labeling
  • Postmarketing pharmacovigilence

Experience

Janet is board certified in both Internal Medicine and Occupational Medicine and spent more than 15 years in clinical practice followed by more than a decade of experience and leadership in industry. She began consulting with Pinney Associates in 2021.

The scope of Janet’s industry expertise includes therapeutic areas in multiple indications involving all phases of clinical development (preclinical through Phase 4) covering gene therapy, enzyme replacement, biologics, and small molecules. She has a successful track record of regulatory activities including multiple filings, approvals, and face-to-face interactions with global regulatory agencies. She also has a strong background in pharmacovigilance working in both the clinical development and post-approval settings.

Education

  • MPH, School of Public Health, University of California Los Angeles
  • Chief Resident, Internal Medicine, Santa Barbara Cottage Hospital
  • MDCM, Faculty of Medicine, McGill University
  • BA magna cum laude, Biology, University of California Santa Barbara

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