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

Marianne Mann, MD

Practice Area Focus

  • Clinical Development Strategy
  • Regulatory Strategy
  • Inhaled Drug Development
  • Pulmonology

Biography

Dr Mann is a drug development and regulatory expert, with the majority of her work in the area of pulmonary drug development for conditions such as asthma, COPD, and cystic fibrosis, as well as allergy. As a consultant, Dr Mann has worked on inhaled drug delivery for a variety of non-respiratory indications. Her work extends from pre-IND meetings to approval and post-approval commitments. Dr Mann brings strong FDA experience, having served as Deputy Director for the Division of Pulmonary and Allergy Drug Products, and the Division of Reproductive and Urologic Drug Products, CDER. She was also the Branch Chief, Respiratory Disease Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases at the National Institutes of Health. While at the FDA, Dr Mann was responsible for review of clinical protocols from the early phases of drug development through post-marketing for drugs to treat asthma, allergic rhinitis, chronic obstructive pulmonary disease, cystic fibrosis, and other respiratory/allergic conditions. She also represented the Agency at meetings with industry, Congress, the media, and the public.