I have just short of 30 years of experience with Lilly Research Laboratories, Eli Lilly and Company, in the department of Toxicology, ADME, and Pharmacokinetics. When I joined Eli Lilly, I set up and operated a laboratory that conducted in vitro receptor, ion channel, and enzyme assays to demonstrate the selectivity of chemical series progressing to development. In addition to my laboratory responsibilities, I served as the toxicology project leader on both small and large molecule projects to progress compounds into development. This required collaborating with scientists ranging from medicinal chemists, discovery biologists, pharmaceutical scientists, and process chemists. I also served as the functional area technical expert in CNS Safety Pharmacology and Drug Abuse Liability, which involved study design, peer review of documents, conduct of due diligence reviews, service on intra- or inter-departmental committees, authorship of regulatory submission documents and regulatory responses, and consultation with global regulatory agencies. As part of my role in abuse liability assessment for CNS active compounds, I had been a member of the Cross Company Abuse Liability Council (CCALC) since its initiation.
Since retiring from Eli Lilly, I have served as a toxicology consultant for Karuna Therapeutics before they were purchased by Bristol Myers Squibb. I am also a member of the Tau Consortium (non-profit) committee, reviewing grant proposals and providing recommendations for programs the consortium funds to assist in compound development.
Throughout my career, I have developed chemical processes for preparing clinical materials and commercialization of new pharmaceutical agents. My scientific leadership has included roles as head of discovery chemistry, bioprocess, and technical service groups. I have led numerous CMC development teams, delivering process/product development objectives in full integration with preclinical, clinical, marketing, and regulatory strategies. My strong technical background has become a key component of my service to clients as a pharmaceutical Regulatory Affairs specialist, assisting clients in achieving successful INDs, orphan drug designations, 505(b)(2) submissions, and guiding them through successful meetings with the FDA.
Key Milestone Expertise in Drug Discovery & Development:
- Predevelopment (candidate selection)
- IND enabling
- Phase I- trials
