Mark Ammann, Pharm.D.
President, Catalyst Regulatory Services, LLC
Mark Ammann is the owner and President of Catalyst Regulatory Services. Prior to founding Catalyst, Mark established and built a successful Regulatory Affairs consulting practice at United BioSource Corporation where he served as Vice President of Regulatory Affairs and provided strategic regulatory consulting to a range of clients from start-up pharmaceutical companies to large multinational corporations. Prior to starting his consulting career, Mark held positions with increasing levels of responsibility within Regulatory Affairs for 18 years at three major pharmaceutical companies (Novartis, Pharmacia and Pfizer).
Mark is a recognized leader in the regulatory affairs community with an extensive knowledge of regulatory issues and the overall pharmaceutical development process. His excellent analytical, communication and negotiation skills have been used to effectively prepare and lead teams through many challenging health authority interactions.
Mark received his Doctor of Pharmacy degree from the University of Michigan.
- Regulatory Affairs experience: >25 years
- Therapeutic Areas: Cardiovascular, Psychiatry, Neurology, Diabetes, Metabolic, Inflammation, Oncology, Dermatology, Nephrology
- Development Phases: Pre-IND, IND, Phase 1-3, NDA submission/approval and post-approval
- Organizer and chair of a highly successful collaborative industry presentation at the FDA Psychopharm Advisory Committee (Oct 2005) on long-term data requirements for chronic psychiatric disorders; founder and chairperson of a 25+ company consortium on abuse liability assessment of pharmaceuticals that organized two Dialogue Sessions with FDA’s controlled Substance Staff (Feb 2008 and Nov 2010)
- Coordinator of PhRMA workgroup on suicidality evaluation for pharmaceuticals that prepared an influential “white paper” submitted to FDA
- Led dozens of meetings with health authorities in both US and Europe including pre-IND, end-of-phase II, pre-NDA and final labeling negotiations
- Member of governance teams for psychiatry, neurology, oncology and inflammation deciding overall project and portfolio strategy
- Led regulatory strategy development for several novel atypical antipsychotic compounds
- Led regulatory activities for novel agent to treat multi-drug resistant tumors
- Directly submitted more than 20 INDs
- Supervised NDA submission and review for 8 products