Somerset, New Jersey, May 14, 2007
SommaTech, LLC, helping clients achieve FDA regulated product goals for a fast submission and seamless approval, today announced the addition of John W. Gotto, Ph.D. and D. Amanda Gotto, as Senior Consultants providing clients with access to a combined 50 years of international pharmaceutical and biotechnology industry experience in drug formulation and new product assessment and evaluation...
Sommatech, LLC. Adds Drug Formulation Experts
Somerset, New Jersey, May 14, 2007
SommaTech, LLC, helping clients achieve FDA regulated product goals for a fast submission and seamless approval, today announced the addition of John W. Gotto, Ph.D. and D. Amanda Gotto, as Senior Consultants providing clients with access to a combined 50 years of international pharmaceutical and biotechnology industry experience in drug formulation and new product assessment and evaluation.
"John and Amanda each possess an outstanding track record in evaluating new product development opportunities and their combined experience in working with pharmaceutical companies will be of great value to SommaTech and its clients,” said Russell F. Somma, Ph.D., President. “I am very pleased that John and Amanda have joined SommaTech and I look forward to their contributions.”
With over 25 years of pharmaceutical, biotechnology and vaccine experience, Dr. Gotto joins SommaTech from Wyeth Pharmaceuticals where he held several managerial positions focused on new product development. Most recently, Dr. Gotto was Senior Director, Global Business Development responsible for providing access to new products, technology, intellectual property and business opportunities through licensing, research collaboration and other types of agreements. Prior to Wyeth, he was employed by American Cyanamid Company as Section Manager, Biochemistry, Medical Research Division, overseeing the development of purification processes and characterization of bioactive substances. Within the Lederle Laboratories division, he held several senior research positions and was responsible for the evaluation of bacterial proteins. Dr. Gotto began his career as a Research Assistant Professor in the Department of Biology at the University of South Carolina. Dr. Gotto received his doctorate from the University of Texas at Austin, a Masters of Science from the University of Miami and an undergraduate degree from Wabash College, cum laude, Phi Beta Kappa.
Ms. Gotto’s experience in the international pharmaceutical industry spans over 20 years, primarily in the areas of formulation development and global project management of the drug development activities leading to regulatory approval and commercialization. Her particular area of expertise in formulations is transdermal product development. As Group Leader of Transdermal Process Engineering, she directed the activities of Phase II and III transdermal formulation development, process scale-up through clinical supply manufacture and provided troubleshooting for products in development and on the market. As Director of Global Project Management, Ms. Gotto led international cross-functional teams in designing product-specific strategies for developing, registering, and marketing novel chemical entities, both small molecule and biologics, including Early Development through Phase I and Full Development, Phase II through Phase IV. Ms. Gotto has been an invited presenter at numerous workshops and conferences as well as a member of corporate advisory panels. Ms. Gotto earned a Bachelor of Science in Chemical Engineering from the University of South Carolina, Tau Beta Pi and a Bachelor of Science in Biology from the University of Texas, Phi Beta Kappa.
SommaTech, LLC is a pharmaceutical technology consulting company focused on providing clients with value-added solutions that speed pharma and biopharma products to market as well as helping clients achieve their business goals. SommaTech assists clients with strategic and tactical implementation to bring products to peak sales rapidly and fully realize the potential of the product’s life cycle. Located in Somerset, New Jersey, SommaTech has over 21 successful NDAs and more than 50 product and product assessments. For additional information, please visit www.sommatechconsulting.com.