NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Former FDA Pharmacology and Toxicology Expert David Jacobson-Kram Joins NDA Partners as a Premier Expert Consultant

Rochelle, Virginia (April 25, 2014) - NDA Partners LLC announced today that David Jacobson-Kram, former Associate Director of Pharmacology and Toxicology in the US Food & Drug Administration Office of New Drugs (CDER), has joined the firm as a Premier Expert consultant. NDA Partners Premier Experts are top tier consultants whose expertise and professional stature enable them to bring extraordinary value to the company's clients. Premier Experts collaborate to design and implement critical solutions to help clients successfully develop their medical products, pursue optimal regulatory pathways, build companies that are attractive to professional investors, and initiate access to global markets.

"Dr. Jacobson-Kram further strengthens our international roster of highly-experienced medical product development experts and will fulfill a critical role in the expert advice we deliver to our drug development clients", said Dr. Peck, Chairman of NDA Partners. "We are pleased to welcome Dr. Jacobson-Kram as a key member of the NDA
Partners team."

Prior to his 11 years at FDA, Dr. Jacobson-Kram was Vice President of Toxicology and Laboratory Animal Diagnostics at BioReliance Corporation; Associate Professor of Oncology, Department of Radiobiology, The Johns Hopkins University Oncology Center; and Acting Branch Chief, Genetic and Molecular Toxicology Assessment Branch, Office of Health and Environmental Assessment, Office of Research and Development, U.S. Environmental Protection Agency. Over the past twenty years, he has served as principal and co-principal investigator on several NIH grants and government contracts and published widely in the areas of genetic and molecular toxicology. He has served as council member, treasurer and chairman of the Genetic Toxicology Association, executive council member to the Environmental Mutagen Society, and Editor of Cell Biology and Toxicology. In 1996 he became a Diplomate of the American Board of Toxicology (DABT).

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 two former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of approximately 40 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, 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, General Manager
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