Health Policy Associates’ staff comprises highly accomplished individuals with extensive experience in regulatory strategies, quality systems and compliance, clinical trial design and execution, product manufacturing, and program management. Collectively they form a team that can tackle the most complex and novel regulatory and clinical challenges within the medical device and biotech fields.
We will work with you to identify the area of support that is required and build the appropriate team around your needs and to work seamlessly with your existing personnel.
Mr. Bucci has over 30 years of international management experience in the medical device industry. Mr. Bucci served as Chairman of AngioDynamics (NASDAQ:ANGO) for 10+ years, having retired from that position in March 2014. Prior, Mr. Bucci served as Chairman of the board of, Rita Medical Inc., which was acquired in January 2007. In addition, Mr. Bucci has served as Chairman of the Board of IMI Intelligent Medical Implants GmbH and as a director of Northwood Medical Implants, a London based company. Since 1992, Mr. Bucci has been President of Health Policy Associates Inc., a consulting company he founded. Prior to that, Mr. Bucci spent 11 years with Pfizer Hospital Products Group. Mr. Bucci holds a B.A. from Bates College and a graduate degree in Law and Government from Georgetown University.
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.
Mr. Olsen is a senior Quality and Regulatory professional with 35 years of diversified experience in the device industry. Russ previously served as VP of QA/RA and Engineering for Stanmore Implants in the UK and prior to that was the VP of QA/RA for Mindray DS USA Inc. Russ’s device experience includes orthopaedic implants and capital equipment, most notably, Intra-Aortic balloon pumps, Patient Monitoring devices, Diagnostic Ultrasound, and Anesthesia delivery systems. Russ has significant Regulatory and Quality experience in the US, Canada, and Europe. He has developed and implemented Quality Systems to meet the US and global requirements. Russ has successfully led numerous regulatory body inspections in the US and in Europe. He has cleared numerous class II and class III devices through the FDA, Health Canada and CE marking process.
Dan Howell is Vice President of Business Development at Health Policy Associates and has over fifteen years of experience in the medical device industry. Before joining HPA Inc. in 2014, Mr. Howell led the Sales and Marketing team at CBSET, a preclinical contract research organization (CRO) where he assisted large and small medical device companies in developing Class II and Class III technologies.
During his tenure in the Cardiology Department at Brigham & Women’s Hospital, he developed novel marketing efforts working with some of the world’s leading interventional cardiologists.
Mr. Howell currently works with Health Policy Associates’ sponsors on their on-going projects, programs, and leading business development initiatives. In this capacity, he provides guidance to clients and assists with their business needs, identifies opportunities for companies to work with Health Policy Associates, and assists clients with navigating a project idea to a finalized plan and budget.
He received his Bachelor of Arts in Communication from the University of Massachusetts in Amherst.
Mr. Howell lives in Scituate, MA with his wife and two children. He enjoys basketball, golf, tennis, movies, and music.
Annie Kim is Regulatory Affairs Manager at Health Policy Associates, where she leads the Regulatory Affairs department and advises companies on regulatory strategy, preclinical and clinical development, and market authorization pathways. She works closely with clients to navigate complex FDA interactions and advance challenging programs for successful regulatory outcomes. Her experience includes PMAs, 510(k)s, IDEs, Breakthrough Device Designations, 513(g) Requests, and Q-Submissions across a diverse range of medical technologies, including neurology, cardiovascular, orthopedic, wound care, clinical chemistry, hematology, plastic surgery, and human cell and tissue products (HCT/Ps).
Ms. Kim holds a MSc in Sport and Exercise Nutrition from the University of Roehampton in London and a BA in Art History and Business from the University of California, Riverside. She was recognized by the California State Senate as a 2024 Woman of Distinction in Healthcare and is a Life Science Scholarship awardee of VC University, a program of the UC Berkeley School of Law and the National Venture Capital Association.
Based in Austin, Texas, she enjoys culinary travel, scenic Vespa rides, and fishing with her fiancé. She is a proud Pi Beta Phi alumna.
Dr. Jocelyn Sawaji leads the Data and Analytics Department at Health Policy Associates, where she oversees all data management aspects of clinical studies for our clients. With over 12 years of experience in clinical research analytics, she manages a team of SAS programmers delivering end-to-end data services, from study design and CRF/EDC development through CDISC conversion, statistical programming, and analysis for regulatory submissions. Her work has supported many regulatory approvals.
Dr. Sawaji works closely with clients to align data strategy with study milestones, providing hands-on oversight of deliverables. She is skilled at translating complex technical and regulatory requirements into clear guidance for study teams and clients alike. Dr. Sawaji is a SAS-certified Base Programmer and holds a certificate in Biostatistics from UC San Diego Extension and a PhD from Durham University.
