The presentation will describe the challenges of developing recombinant salmon calcitonin (rsCT) from a CMC and drug development perspective; ranging from early phase development through the results of the phase 3 program and NDA submission. The strategy and CMC development issues associated with a 505(b)(2) NDA dealing with a change in the route of administration (nasal to oral) as well as API manufacturing will be discussed. In particular, the strategy for bridging a peptide manufactured using recombinant DNA technology to the reference listed drug (RLD) manufactured by chemical synthesis will be presented.
An overview of the development and scale up issues encountered for the oral delivery technology of a peptide in a high potency modified release tablet, as well as issues related to the unique properties of peptide based therapeutics versus small molecules will be addressed. The topline results from the clinical development program (Phase I-III) will be presented.
Currently Dr. Gilligan is Chief Scientific Officer and Co-Founder of Tarsa Therapeutics Inc. located in Philadelphia, PA. Tarsa was founded in late 2009 with the goal of developing innovative therapies for the treatment and prevention of osteoporosis and related bone diseases. Tarsa is developing TBRIA™ an oral formulation of salmon calcitonin, a peptide hormone that inhibits bone resorption, a key process underlying the development of osteoporosis. Tarsa has submitted it’s 505(b)(2) NDA application for TBRIA to the FDA which is currently under review.
Prior to joining Tarsa, Dr. Gilligan held positions of increasing responsibility for nearly 30 years at Unigene Labs, where he led the development of the oral calcitonin product now licensed to Tarsa. He served as vice president of product development at Unigene, where he was project leader for the oral and nasal calcitonin programs, as well as the oral parathyroid hormone and site-directed bone growth programs. Dr. Gilligan was responsible for leading the clinical programs and successful U.S. and European regulatory registrations for the nasal calcitonin product Fortical® Nasal Spray and the injectable calcitonin product Forcaltonin® Injection.
Dr. Gilligan holds a Ph.D. in pharmacology & toxicology from the University of Connecticut, performed his post-doctoral research at the Roche Institute of Molecular Biology and received a master’s degree in international business from the Stillman School of Business at Seton Hall University.