Mark has been with NDA since 2018 and is an Infectious Disease Expert. Providing regulatory and technical advice to development teams in multiple therapeutic areas including metabolic, pain, immunologic and antiviral therapies.
His understanding of the FDA’s policies and procedures are instrumental when advising companies on how to best engage with them.
Key Areas Of Expertise
- Clinical pharmacology and therapeutics
- Board-certified in internal medicine and infectious disease and is a fellow of the Infectious Diseases Society of America.
- Extensive expertise in the inner workings of the US regulatory systems
- FDA policies, procedures & interpretation of FDA actions
- Regulatory strategy
- Quality Assurance
- Product development in multiple therapeutic areas
- Antibacterial and antiviral therapeutics, Immunologic and Inflammatory Disease and Parkinson’s disease
Clinical medicine & clinical development
Preparation of companies for FDA interactions
Before Joining The NDA Advisory Board
Mark held multiple leadership positions within the Center for Drug Evaluation and Research (CDER) at the FDA including Director of the Office of Antimicrobial Drugs Products and Director of the Division of Immunologic and Transplant Drug Products. He was also Acting Deputy Director of CDER for six months. Mark also spent a year in the Center for Biologics Evaluation and research as Medical Director for Emerging and Pandemic Threat Preparedness. While in CDER he was responsible for coordinating drug shortage activities and also spent 8 months as the acting Associate Center Director for Quality Assurance in CDER. Mark was a VP of Regulatory Affairs at both Abbott and Abbvie where his responsibilities included both interpreting and preparing FDA correspondence and preparing project teams for Agency meetings.
Gold.berger MJ Beyond the Gain Act: Some Thoughts on Expediting Antibacterial Development to Address the Problem of Antimicrobial Resistance. Pharmaceutical Medicine (2016) 30: 71. doi:10.1007/s40290-016-0137-7
Rex JH, Talbot GH, Goldberger MJ et.al. Progress in the Fight Against Multidrug-Resistant Bacteria 2005-2016: Noninferiority Trial Designs Enable Antibiotic Development in Advance of Epidemic Bacterial Resistance. Clinical Infectious Diseases. 2017; 65(1): 141-146.
Dr Mark Goldberger