Dr. Anne Cropp is Chief Scientific Officer of Early Access Care LLC, a healthcare company focused on facilitating all stakeholders involved in the review and approval of Expanded Access and Compassionate Use requests for investigational drugs.
Prior to founding Early Access Care, Anne was Vice President in the Global Product Development Group at Pfizer Inc. Anne has twenty-five years of experience in the biopharmaceutical industry marked by achievements in innovation and successful development of new drug products. As an innovator, Anne has held a number of global leadership positions in R&D. Anne has led matrixed development teams from Phase 1 through NDA/MAA submission and successful registration and commercialization. Her expertise in drug development spans Phases 1-4, both large and small molecules. She has expertise in planning and executing drug development programs for compounds with multiple routes of administration, including oral, intravenous, subcutaneous and inhalation, as well as devices for inhalation and injection. Anne has partnered extensively with the Regulatory Strategy groups across all therapeutic areas and has a deep understanding of FDA expectations yet vision for opportunity for flexibility in program development that will lead to successful registration.
Anne has been responsible for the strategic planning, development and execution of investigational drugs across a wide spectrum of disease areas in adult and pediatric patients. She has developed and executed very large and mid-sized programs in disease areas that span Alzheimer’s disease, heart failure, hypercholesterolemia, hypertension, Type I and II Diabetes Mellitus and Vascular Surgery. She has an advanced understanding and direct expertise in Advisory Boards, Data Monitoring Committees, Endpoint Adjudication, Interim Analyses, and Safety Committees.
Anne has significant first-hand knowledge and expertise of Pediatric drug development. Anne served as Chair of the Pfizer Pediatric Council for 8 years. She advised pan-therapeutic area teams on issues related to planning for regulatory meetings, pediatric protocols and execution of pediatric clinical trials.
Anne has led multidisciplinary matrixed teams across the full spectrum of product development, including early and late stage development. She has transformed clinical research processes to be highly effective and efficient. Anne is a global expert in Expanded Access/Compassionate Use.