|
Russell F. Somma, Ph.D.
Senior VP, New Products and Commercial Development
 Russell Somma is an industry veteran with over 25 years of product development experience, primarily at Ciba-Geigy then at Novartis. At Novartis he held a series of positions in product development and manufacturing which culminated in his position as Director of Novel Oral Solid Dosage Forms. His most recent position was President of Somma Tech a consulting firm focused on helping clients meet the manufacturing and quality control requirements for FDA new product approvals. He has also recently assisted some high profile clients in over coming FDA Consent Decrees that required total cessation of all manufacturing operations. With Dr. Somma’s help, several have resumed full production operations, obviously a very valuable service.
Over the span of his career, Dr. Somma has been involved with every phase of product development from bench top formulation and pilot scale manufacture ring to the establishment of full commercial scale operations. Multi-particulate systems are a particular expertise for Somma.
He has been involved in the development and approval of over 25 NDAs so has considerable experience working with the FDA. Indeed, he received a “Special Recognition Award” from Janet Woodcock, MD of FDA for his work in developing the SUPAC-IR Equipment Guidance. Further, he was awarded a “Golden Hammer” by then VP Al Gore for his efforts to reduce red tape and help improve through put at FDA in the area of manufacturing validation.
Dr. Somma has more than 30 publications and presentations in the area of manufacturing and quality control. He is Chairman of the International Society of Pharmaceutical Engineers (ISPE) Quality and Life Cycle Committee. He is also a member of the New Jersey Pharmaceutical Association for Science and Technology.
He receivd his BS, MS and Ph.D. in Pharmaceutical Science from Rutgers University. He is a registered pharmacacist, as well.
|
