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Heather Astley is Vice President of Health Policy Associates and has over fourteen years of experience in creating and improving workflows for biotechnology companies. Ms. Astley integrates regulatory, clinical, and data management elements when leading teams in developing and executing clinical trials. She has worked across a broad range of therapeutic areas on regulatory submissions including BLAs, PMAs, 510Ks, INDs, NDAs, CE Marks, and post marketing studies.
At Health Policy Associates, Ms. Astley leads teams in designing and conducting clinical trials from animal testing through final analysis. Her expertise encompasses the therapeutic areas of cosmetic procedures, orthopedics, wound care, and biologic injectables used to treat hereditary and acquired diseases. Ms. Astley regularly coaches study sites and sponsors through BIMO audits that result in no findings by the FDA. Additionally, she has extensive experience with compliance cases including FDA Application Integrity Policy (AIP) cases.
She manages project teams which meet and exceed expectations, especially on very tight timelines. Her strengths lie in identifying gaps and correcting them early so that she can assure clients that the issue is under control and that a solution is already in place. She has extensive experience recovering studies from other vendors and salvaging the data and investment for sponsors.
Ms. Astley received her Bachelor of Science from the University of Massachusetts at Amherst in Animal Science / Pre-Veterinary Concentration.
She enjoys equestrian activities and is currently schooling her Morgan in dressage.