Mark Goldberger is an independent consultant at Mark Goldberger MD MPH LLC Maryland, USA, where he advises pharmaceutical and biotech companies on the development of infectious diseases products.
Before retiring in 2014 and becoming a consultant, Mark spent seven years at AbbVie – formerly part of Abbott – in various senior positons including vice president of regulatory affairs and senior advisor. In these roles he provided regulatory guidance and strategic advice with a focus on US Food and Drug Administration (FDA) and European Medicines Agency (EMA) activities and submissions.
While at Abbott/AbbVie, Mark was involved in product and policy development, provided regulatory advice across a broad range of therapeutic areas and, was personally involved in the preparation of new drug applications (NDAs) for Duopa™ used to treat Parkinson’s disease and Viekira Pak™ used for hepatitis C.
He also participated in Pharmaceutical Research and Manufacturers of America (PhRMA), and European Federation of Pharmaceutical Industries and Associations (EFPIA), working groups on antibiotic resistance and twice presented on this subject to the EMA, as well as the FDA.
Mark joined Abbott/AbbVie following an 18-year career at the FDA where he served as a primary reviewer, medical team leader and a director of various divisions including the Office of Antimicrobial Products within the FDA’s Center for Drug Evaluation and Research (CDER). During his time at the CDER, Mark served as its acting deputy center director, coordinated its drug shortage-related activities and as acting associate center director for quality assurance – where he developed the concept of the regulatory briefing.
Mark was also an FDA lead in an assessment of the readiness of the pharmaceutical industry for Y2K and was medical director for Emerging and Pandemic Threat Preparedness within the FDA’s Center for Biologics Evaluation and Research (CBER).
Mark conducted or participated in over 500 meetings with the regulatory industry while at the FDA. He has also been involved in the review and approval of dozens of NDAs including antibacterials, antifungals, antivirals, antiparasitics and drugs for tuberculosis.
Mark received his medical degree from the Columbia University College of Physicians and Surgeons in New York and his Master of Public Health from George Washington University in Washington, DC. He completed his postgraduate training at the Presbyterian Hospital in New York and the Centers for Disease Control in Atlanta. He is board certified in internal medicine and infectious diseases and is a fellow of the Infectious Diseases Society of America.
Mark was on the faculty of Columbia University between 1979 and 1988 practicing and teaching internal medicine and infectious diseases.