Tom Moran is the President of Access Therapeutics Inc. specializing in clinical development, regulatory and public policy counsel, and commercialization strategies. Mr. Moran is an experienced senior executive, having served for 20 years as the Chief Executive Officer (CEO) for prominent national health foundations including the Sudden Infant Death Alliance and the Immune deficiency Foundation before founding Access Therapeutics Inc. to focus on expanding medical knowledge and guiding new therapies from development through clinical trials to licensure and successful commercialization
Access Therapeutics’ clients are international manufacturers, US specialty distributors and national patient advocacy organizations. A partial list of significant engagements includes ASD Healthcare, CSL Behring, Prolong Pharmaceuticals, Kamada (Israel), Kedrion (Italy), Green Cross Corporation (Korea), Grifols and Octapharma. Mr. Moran has organized pivotal clinical trials for his clients enabling them to enter the N. American market and introduce novel therapeutics.
Mr. Moran has collaborative relationships with the US FDA involving initiatives designed to address critical product shortages, to streamline licensure requirements for therapies intended for rare disease populations and to manage clinical trials for non-US manufacturers seeking to meet these needs. He has testified and provided key data to FDA, HHS, and CDC advisory committees and senior staff. Mr. Moran has worked closely with the US Congress and with key legislators and staff on public health issues resulting in legislative directives and grant support to his related organizations.
On behalf of the organizations he has led, Mr. Moran has worked with Congress and the NIH to establish multi-year and multi-center medical research programs and consortia. Mr. Moran’s therapeutic experience includes plasma derivatives (e.g. IGIV, clotting factors, and hyperimmunes), transgenic and biotech proteins, small molecules and novel gene therapy approaches.
He has served on the Business Advisory Board for the Canadian Immunodeficiency Society; Board of Directors of Save One Life; National Public Policy Chair for the US Hereditary Angioedema Association; Associate Member of the Clinical Immunology Society; past member of the National Corporate Advisory Council for The Neuropathy Association; current Board Chair for the Foundation for Sickle Cell Disease Research and is a recent Past President of the Board of Trustees for a private, college preparatory K through 12th school serving 1,000 students in Baltimore, Maryland.