When: January 24, 2001
“Clearing the Drug Development Hurdle-It is Time to Take Biotech Concepts to Commercial Reality”
Prabhavati B. Fernandes
(CEO, Ricerca, LLC)
Prabhavathi B. Fernandes, Ph.D.is the Chief Executive Officer of Ricerca LLC. Ricerac is a pre-clinical drug development company. Dr. Fernandes brings to Ricerca her experience in discovering and developing drugs that she learned at three major pharmaceutical companies as well as the experience of founding and developing a biotechnology company. Prior to joining Ricerca she was the Chief Executive and Chief Scientific Officer as well as co-founder of Small Molecule Therapeutics. In March 2000, she merged her company with Morphochem AG.
Prior to founding Small Molecule Therapeutics, Dr Fernandes gained broad experience in drug discovery and development working as the Vice-President of Biomolecular Screening Drug Discovery at Bristol Myers Squibb, leader of the microbiology program at Abbott laboratories and as the leader of the in vivo Microbiology group at Squibb. During the two decades of her career in three major pharmaceutical companies she was directly involved in the development of many drugs, of which four have been approved. Dr. Fernandes’ industrial career was preceded by an NIH post-doctoral fellowship at the Fox Chase Cancer Center and she was an assistant professor at Temple University. She was also an Associate Scientist in Immunochemistry at the University of Ghent, Belgium. She received her Ph.D. in Microbiology from Thomas Jefferson University.
Dr. Fernandes has authored many publications, edited three books and is an editor of several journals. She served on the United States Congressional Panel for Assessment of Impact of Antibiotic Resistant Bacteria and was a member of the American Society for Microbiology Advisory Panel on Antibiotic Resistance. She has served as the President of the Society for Biomolecular Screening and on NCI and NIAID panels. She has received many awards recognizing her achievements.
Abstract of the Talk
Despite advances in the sciences and a growing market demand, time and costs are major limiting factors in profitable new drug commercialization. Discovery and development can take 10-15 years, and development costs that are high, are increasing. Today, the expected assurance of safety at the approval stage is higher, especially for life-style drugs. Genomics is expected to yield many hundreds of potential drug targets. Validation of these targets will not be simple or easy. Here, development is faced with two unknowns: the pharmacological effect of interfering with a new target in addition to testing new chemical agents with unknown effects in man.
Large numbers of lead molecules continue to fail after entering the development pipeline. Common causes include: poor pharmacokinetics, metabolism, drug-drug interactions and unacceptable toxicity. Thus, a compound may be effective against a target in vitro but may not show efficacy in animals or man. Tightening economics in the industry will not permit this to continue.
Unanticipated problems in development leading to project discontinuation is the primary determinant of time and cost overruns. This key concern can be visualized as an opportunity, that of: advancing selection criteria earlier in development, during lead optimization. The newer selection criteria will, by definition, include downstream parameter limits and will be anticipatory and predictive in nature.
Biotechnology companies have been the source of innovative technologies, programs and early stage leads to the major pharmaceutical companies. These deals have helped their valuation. However, partnering these early stage leads minimizes the true value of the biotechnology companies after having taken the risk in developing new drug treatment strategies. This will involve limiting access to major pharma to these innovative products until they ready for human use. True value will be derived from products that biotechnology companies develop themselves, instead of licensing to a major company partner to fuel their drug development. Biotechnology companies with no experience in drug development can develop their lead molecules into drugs by partnership with drug development companies, such as Ricerca. The risks and rewards can be shared by the partners to maximize the value of each company. Product-dependent value can sustain the biotechnology industry in the future.
The speaker will share her experience, which spans over two decades, during which she has been involved in the discovery and development of many drugs.