I have extensive experience with FDA regulations governing the development and registration of pharmaceuticals, as well as deep expertise in pharmaceutical manufacturing process development and technology transfer. My strong working knowledge encompasses formulation development, analytical method development, preparation of clinical trial materials, and supply chain strategy. With more than 35 years of industry experience in drug product development and regulatory affairs, I have served both large and small companies and am frequently called upon to assist in the development of regulatory strategies for both pharmaceutical and medical device projects.
As a research scientist at Eli Lilly and Company, I led CMC development activities for several cancer drugs in development and 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 been a leader of numerous CMC development teams, delivering process/product development objectives in full integration with preclinical, clinical, marketing, and regulatory strategies. As a consultant, I have helped clients advance several oncology drugs toward clinical trials. More recently, 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.
My specialties include FDA Regulatory Affairs, API process development, formulation development, project management, technology transfers, working with third parties, CMC due diligence assessments, and a particular depth in the development of oncology drugs. I have also served as vice president of chemistry at Walden Biosciences, Inc., where I have been focused on developing novel therapies for treating renal diseases since 2019.
Key Milestone Expertise in Drug Discovery & Development:
- IND enabling
