I have scientific expertise in small molecule pharmaceutics and practical experience in the pharmaceutical industry after more than 40 years at two large pharmaceutical companies, Upjohn and Eli Lilly. As a product development scientist, I have successfully collaborated with scientists from various disciplines, including toxicology, medical, medicinal chemistry, and ADME, to tackle the challenges of advancing new chemical entities into human clinical studies. In my role as a senior research fellow at Lilly, I implemented the technology strategy for the small molecule development organization and served as the inaugural chair of the first industrially based task force assembled to advance nanotechnology in medicine, the Nanomedicines Alliance.
Since retiring in 2015, I have started a consulting firm, Havel BioPharma, advising the Center for Drug Discovery and Development Accelerator (CD3A) at the IU Simon Comprehensive Cancer Center. My background is in analytical chemistry, regulatory, formulation development, oral biopharmaceutics, and drug delivery. I apply my scientific expertise to advance compounds with appropriate physico-chemical properties into development, evaluating their potential for sufficient absorption after oral administration to achieve therapeutic blood levels in clinical studies. This involves collecting experimental physico-chemical data and integrating those results with in vitro studies of permeability (CaCo-2 cells) and pilot pharmacokinetic and toxicology studies in rodents and dogs. When a compound does not possess adequate physico-chemical properties, I identify means to formulate the compound to achieve desired systemic exposure.
My career at Lilly included scientific positions where I applied my knowledge of analytical, biological, and physical chemistry to drug characterization, delivery, and development of small molecules, peptides, and proteins. Prior to joining Lilly, I worked at The Upjohn Company (now Pfizer) in Kalamazoo, Mich., as a scientist in analytical development and CM&C regulatory departments. I hold a Ph.D. in physical chemistry from the University of Minnesota and a B.S. in chemistry from the University of Rochester.
Key Milestone Expertise in Drug Discovery & Development:
- Lead Optimization
- Predevelopment (candidate selection)
- IND enabling
