Rochelle, Virginia (June 5, 2017) – NDA Partners Chairman Carl Peck, MD, announced today that Sami Karaborni, PhD, senior pharmaceutical executive and former Vice President of Development Operations and Executive Director of Preformulations and Formulation Development at XenoPort Inc., has joined the firm as an Expert Consultant. Dr. Karaborni is an expert in product and process development of new chemical entities (NCEs) and various dosage forms. Over his impressive 20-year career in the pharmaceutical and chemical industries, he served in several senior executive positions. At XenoPort, he led multiple groups active in the areas of chemical, analytical, bioanalytical, formulation development, supply chain and commercial manufacturing. He was formerly Director of Pre-clinical Development Technology, Director of Materials Characterization and Technology Assessment, and Director of Formulation Design and Characterization at Merck Research Labs. In his early career, Senior Research Engineer for the Royal Dutch Shell company in Amsterdam, The Netherlands.
“Dr. Sami Karaborni’s career in the pharmaceutical and chemical industries and expertise in product and process development of new chemical entities will greatly enhance the industry perspective we are able to provide our clients in support of their CMC development programs,” said Dr. David Savello, Partner and Manager, Product Quality & CMC Practice. “We are very pleased to welcome him to NDA Partners.”
Dr. Karaborni earned his PhD and MS in Chemical Engineering from the University of Florida and his BS in Chemical Engineering from Pennsylvania State University. He is a member of the advisory board of the Surfactant Science series and inventor of 19 US published patents and patent applications. He is the (co)author of more than 40 publications in international journals among which Science (Washington), Nature (London), La Recherche Scientifique (Paris) and Mundo Científico (Madrid) and has been a key speaker in several conferences among which, Gordon Conferences (USA), Royal Society of Chemistry (Great Britain) and Rencontres de Moriond (Switzerland).
About NDA Partners
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.
Earle Martin, Chief Executive Officer