Meet the Commissioners
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Dr. Russ Somma |
Dr. Russ Somma has been involved in production support, scale-up, pilot plant as well as early and full development activities of pharmaceutical products, which include novel as well as traditional dosage forms during his 29 year tenure with Novartis. He has provided support for 21 NDAs in the chemistry, manufacturing and control area from submission through the pre approval inspection phase. As president of SommaTech, an affiliate company of IPS, his focus is on pharmaceutical technology and helping clients achieve their FDA regulated product goals for a fast submission, seamless approval as well as assuring a cost effective product and a secure supply chain. He is the past chairman of ISPE’s SUPAC Equipment Guidance Steering Committee. He currently chairs the ISPE-PCC. Russ earned his Ph.D. in Pharmaceutical Technology under N.G. Lordi at Rutgers University College of Pharmacy in 1987. Prior to this he earned his BS degree in Pharmacy in 1974 and an MS degree in 1980 from Rutgers University.
Dr. Somma has been a welcomed keynote speaker and presenter at many pharmaceutical industry association meetings. Among them is the FDA/s Pharmaceutical cGMPs and Process Analytical Technology (PAT) Symposium, where his topic was “Current Industry Practices in Manufacturing Process Validation.” Other topics include “Technology Transfer or Knowledge Transfer for Products and Processes: Which Expedites the Process Most?”, “Life Cycle Management – the Way of the Future?” and “Aspects of Technology Transfer.”
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., currently in review.
