Russ Somma, Phd Email & Phone Number

Dr. Somma has more than 30 years of experience working in the pharmaceutical industry, specifically in the areas of production troubleshooting, dosage form development, manufacturing scale up, technology transfer and project management. He has a particular technical interest in the area of solid dosage forms and the physical pharmacy associated with them. He has had direct responsibility for senior staff, both domestically and internationally, as well as technical development and life cycle management support for a variety of oral solid dosage, novel formulations and therapeutic groups. Additionally, he has served as an invited investigator trainer and liaison for the FDA on various projects and initiatives, affording a unique perspective within Pharmaceutical Regulatory Affairs. He has a strong background in implementation of SUPAC IR/MR equipment guidance with society associates and colleagues within FDA/CDER, and will work to share his expertise with SommaTech’s clients.Considered a subject matter expert in technology transfer and Quality by Design, Dr. Somma has been a welcomed keynote speaker and presenter at many association meetings and conferences and has written and co-authored numerous technical papers and studies throughout his career. Additionally, Dr. Somma has written and co-authored several technical papers and studies, most recent being “In vitro Dissolution and In vivo Bioavailability of Methylphenidate from a Bi-modal Release Formulation and an Immediate Release Formulation in Healthy Volunteers,” with L. Lee, et al.Dr. Somma is the Past Chairman of ISPE’s Product Quality Lifecycle Implementation (PQLI) project and the Past Chair of the Professional Certification Commission, CPIP. Dr. Somma is a “Hammer Award” winner, presented by Vice President Al Gore’s Committee for National Performance Review. In addition, Dr. Somma was recently awarded ISPE’s prestigious 2007 Max Seales Yonker Member of Year Award.Specialties: Solid Oral Dosage Forms Liquids Sterile Medical Devices Combination Products Diagnostics Fixed Dose Combinations Food Supplements Natural Products

Listed skills include Technology Transfer, Pharmaceutical Industry, Fda, Drug Development, and 21 others.