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

Global Regulatory Affairs Expert Daniela Drago, PhD Joins NDA Partners

Rochelle, Virginia (February 16, 2015) - Dr. Carl Peck, MD, Chairman of NDA Partners LLC announced today that Daniela Drago, 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. Drago specializes in global regulatory affairs, regulatory strategies, and the management of regulatory projects. She worked in industry for more than a decade and held senior positions in global regulatory and medical affairs at Bausch & Lomb (Zug, Switzerland), Reckitt Benckiser (Zurich), Vifor Pharma (Zurich), and F. Hoffman-La Roche (Basel). Presently, she provides consulting services on the development and commercialization of drugs, biologics, devices, and combination products. Specifically, she prepares global regulatory submissions and advises clients on how to interact effectively with agencies.

Dr. Drago is Assistant Professor and Director of Clinical and Translational Research
at the George Washington University School of Medicine and Health Sciences (Washington, DC). As a faculty member, she teaches regulatory affairs to graduate students. She is a frequent lecturer at international courses and workshops and has published numerous articles in peer reviewed journals. Dr. Drago is fluent in English, German and Italian. She received her PhD in Chemistry from the Swiss Federal Institute of Technology (ETH Zurich).

"Dr. Drago brings additional highly valued talent and experience to our program for assisting clients with their global product development and regulatory strategies", said Dr. Peck. "With her familiarity in both EU and US regulatory requirements, office locations in D.C. and Zurich, Switzerland, Dr. Drago is well positioned to assist EU clients looking to register product in the US as well as to US clients registering in
the EU."

Dr. Drago received her PhD in Natural Sciences from the Swiss Federal Institute of Technology (Zurich, Switzerland) and a Master of Science in Chemistry from the University of Messina (Messina, Italy).

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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