Our Management Team
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.
Vincent A. Bucci, CEO
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.
Lisa N Cheskin, Senior Vice President of Clinical Affairs
Lisa Norcia Cheskin is Senior Vice President of Clinical Affairs at Health Policy Associates and has over thirty years of experience designing and executing US and European clinical trials in support of various FDA and CE Mark approvals.
At Health Policy Associates, Ms. Cheskin oversees Clinical Affairs activities associated with bringing new medical products to market. She designs and executes clinical trials inclusive of participating in pre‑market FDA negotiations to secure regulatory approval of new technologies.
Her prior experience includes designing and managing the clinical trials leading to an original PMA approval for a cardiovascular device company and two original PMA approvals for a start‑up aesthetics medical device company. These included successful FDA inspections and positive FDA Advisory Panel opinions that ultimately led to an IPO and two acquisitions.
Just before joining Health Policy Associates, Ms. Cheskin served as the Vice President of Clinical Affairs and Co‑Head of R&D for a privately held medical device/pharmaceutical manufacturer where she oversaw all North American clinical research programs. During her time in this role, the company recorded several successful FDA inspections of clinical trials, a positive FDA Advisory Panel opinion where Ms. Cheskin served as the panel moderator, and several PMA and EU approvals supported by clinical trials executed under her direction.
She received her Bachelor of Arts degree from the University of California at Berkeley and a Master of Public Health from Boston University.
Ms. Cheskin is based out of Health Policy Associates’ Silicon Valley office. She enjoys running and is a five‑time marathon finisher. She has a history of volunteering for organizations that promote child advocacy such as Child Advocates of Silicon Valley, where she is a board alumna and a current Court-Appointed Special Advocate.
Brian Young, Vice President of Regulatory Affairs and Quality Assurance
Brian Young is Vice President of Regulatory Affairs and Quality Assurance. He is a senior regulatory, quality, and clinical professional with 30 years of diversified work experience in the medical device and diagnostic industry. He is the former Vice President of Global Regulatory and Clinical Affairs at Kinetic Concepts, Inc.
At Health Policy Associates, Mr. Young works on a wide range of global regulatory, clinical, and quality projects including regulatory strategy, IDE, 510(k), PMA and international submissions, clinical trial development, and quality systems and development.
His experience includes a broad range of clinical and therapeutic areas including orthopedics, wound care, aesthetic products, in vitro diagnostics, general surgery, and cardiovascular surgery.
Mr. Young brings a vast amount of FDA experience including significant face‑to‑face experiences with the agency. He has filed numerous global submissions for Class II and Class III devices, led federal, state and international compliance inspections, and developed quality systems from the ground up.
His extensive experience has led to authored publications in Regulatory Affairs Focus and a textbook chapter on global medical device registration. He has led successful efforts to bring new and highly differentiated products to Canada, Europe, India, China, Japan, and Brazil. His international experience includes obtaining the first approval for a new technology category in Japan and a first foreign approval for a new technology category in China.
He received his Bachelor of Science in Medical Technology from the University of Iowa and his Master’s in Business Administration from Duke University’s Fuqua School of Business.
Mr. Young lives in Boerne, TX with his wife and two children. After years of competitive bike and triathlon racing, he now enjoys recreational swimming and biking. Brian is also a Principal at Parenteau BioConsultants, LLC.
Heather Astley, Vice President
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.
Dan Howell, Vice President of Business Development
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.
Liz FitzGerald, Director of Clinical and Data Operations
Liz FitzGerald is the Director of Clinical and Data Operations at Health Policy Associates where she manages the Data Analysis team. She leads data management projects from protocol, case report form, and database development to the production of analysis tables, listings, and figures for regulatory submission of clinical data. Working directly with clients, she designs Data Management Plans, Statistical Analysis Plans, and produces CDISC-compliant final output.
With a strong background in statistics and biostatistics and with training in CDISC standards, Ms. FitzGerald contributes to many other projects involving clinical data and has experience writing Clinical Summary Reports, supporting 510(k) submissions, and conducting regulatory research.
Ms. FitzGerald has been published in Preventing Chronic Disease on such topics innovations in healthcare and public health, and has presented at organizations such as the American Public Health Association Annual Meeting and Society for Prevention Research Annual Meeting.
She received her Bachelor of Arts in English from the University of Pennsylvania and her Master of Science in Public Health from the Harvard University School of Public Health. Additionally, she earned a certificate in Biostatistics from the University of California San Diego Extension School.
Ms. FitzGerald lives in Cambridge, MA where she enjoys running along the Charles River. She has sailed around the world with her family and has visited forty-one countries.