We are pleased to announced the expansion of the unique NDA Advisory Board with the appointment of Dr Mark Goldberger, Infectious Disease Expert.
Mark brings with him a wealth of experience in and in-depth knowledge of infectious diseases and antimicrobial products as well as extensive FDA expertise. For the clients of the reputable drug development consultancy this means high calibre advice to move such products swiftly through development and to regulatory success.
Dr Goldberger has unparalleled insight in these fields, working at the FDA as an expert within the Center for Drug Evaluation and Research (CDER), for which he held various roles of increasing responsibility, including five years as the Director of the Office of Antimicrobial Products. He also spent one year in the Center for Biologics Evaluation and Research (CBER) as Medical Director for Emerging and Pandemic Threat Preparedness.
Following his time at the FDA, Mark joined Abbott as Divisional Vice President involved in multiple areas of both product and policy development, before becoming VP Regulatory Affairs and Senior Advisor following the AbbVie split, providing both regulatory and scientific input into multiple development programs.
Mark is board certified in internal medicine and infectious disease and is a fellow of the Infectious Diseases Society of America.
Dr Werner Van den Eynde, Vice President NDA Advisory Board, commented on the appointment:
”The NDA Advisory Board is one of a kind – no other professional body comes as close to reflecting the current opinions and practices of the world’s regulatory and reimbursement agencies. I am very excited to welcome Dr. Goldberger on board. With his in-depth knowledge of infectious diseases and antimicrobial products as well as his FDA experience he will be able to add tremendous value to clients in these areas and help them to make new and promising medicines available to patients.”
Dr Goldberger is joining an increasing number of former FDA thought leaders at NDA, who since announcing its expansion into the US in 2016, has grown a team of more than 30 regulatory, drug development and scientific communications specialists in their locations in Boston, Princeton and San Francisco.
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NDA is an independent consulting group with offices in Stockholm, London, Zürich, Munich, Paris, Princeton, Boston and San Francisco. Its mission is to ensure that good medicines reach patients without unnecessary delay. It accomplishes this by providing the pharmaceutical industry with a comprehensive range of professional drug development services focusing on regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. NDA’s team of more than 150 full time professionals is comprised of more than 25% ex-regulators from major EU Agencies, and a specialist Advisory Board consisting of Europe’s leading regulatory and HTA experts. The NDA Advisory Board provides scientific advice to pharmaceutical companies supporting them in gaining fast and constructive assessment of applications from regulatory agencies and HTA bodies. www.ndareg.com