Russell F. Somma, Ph.D.
Research and Development
Russ Somma is an industry veteran with over 30 years of product development experience, primarily at Ciba-Geigy / Novartis. While at Novartis he held a series of positions in early and late stage product development as well as process introduction which culminated in his position as Technical Project Leader responsible for several novel oral solid dosage forms. He is currently President of SommaTech, LLC a consulting firm focused on helping clients meet the manufacturing and quality control requirements for FDA new product approvals. He has assisted several clients in overcoming FDA Consent Decrees that required total cessation of all manufacturing operations. With Dr. Somma’s help, several have resumed full production operations.
Over the span of his career, Dr. Somma has been involved with every phase of product development from bench top formulations and pilot scale manufacturing to the establishment of full commercial scale operations. Multi-particulate systems are a particular expertise for Somma.
He has been involved in the development, approval and PAI 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 the “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 equipment similarities and process technology.
Dr. Somma has more than 30 publications and presentations in the area of development, manufacturing and quality by design. He is Past Chairman of the International Society of Pharmaceutical Engineers (ISPE) Product Quality Lifecycle Implementation (PQLI) Committee.
He received his BS, MS and Ph.D. in Pharmaceutical Science from Rutgers University. He is a registered pharmacist, as well.