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

Former Amgen Executive Mary Ellen Cosenza Joins NDA Partners as a Premier Expert Consultant

Rochelle, Virginia (February 9, 2015) - Dr. Carl Peck, MD, Chairman of NDA Partners LLC announced today that Mary Ellen Cosenza, PhD, 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. Cosenza is a senior executive and business team leader, with broad US and international drug development experience. She has lead successful teams in both early-stage and full development of new drugs in a variety of therapeutic areas and modalities. She is a recognized expert in preclinical biologic drug development, and her experience includes implementation of a Corporate Integrity Agreement for a US regulatory organization.

Dr. Cosenza was formerly the Executive Director for US Regulatory Affairs for Amgen, where she led the development and execution of regulatory strategy and plans for a pipeline of over 40 products. She has also served as Amgen's Executive Director for Emerging Markets, in which she led the team in the development of processes and organizational alignment for regions including Latin America, Asia Pacific, Middle East, Africa, Eastern Europe, Russia, and CIS countries. She was a member of the Expert Working Group for ICH M3(R2) and teaches Food and Drug Toxicology at the University of Southern California.

"Dr. Cosenza's experience in interacting with and preparing complex regulatory submissions for numerous global regulatory authorities, deep knowledge of preclinical development, and solid industry experience, will bring significant value to our clients", said Dr. Peck, "especially to those who are pursuing registration of their products on a global basis."

Dr. Cosenza received an MS and PhD in Toxicology from St John's University (Queens, NY), an MS in Regulatory Science from The University of Southern California School of Pharmacy, and a BA in Biology from Queens College (CUNY). She is Board Certified by the American Board of Toxicology in General Toxicology and was recently selected to be a Fellow of the Academy of Toxicological Sciences (ATS).

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.

Contact
Earle Martin, General Manager
+01 540-738-2550
MartinEarle@ndapartners.com