HCP Engage: A Square Peg in a Round Hole – What’s the Problem?

Kays Sawaged is the Founder of a Compliance Consulting Group and a seasoned compliance and risk management leader with over 15 years of experience in the Pharmaceutical, MedTech, and Biotech industries. His career spans global organizations and high-growth companies, including Novartis, Meta, Sanofi, and Daiichi Sankyo.Kays has a proven track record of developing strategic compliance frameworks, driving operational efficiencies, and aligning compliance initiatives with business objectives. With deep expertise in building and optimizing healthcare compliance programs, he has guided organizations through complex regulatory landscapes with a pragmatic, business-focused approach that ensures sustainable compliance while fostering innovation and growth.

Maria Villanueva leads Ethics and Compliance function at BioTissue, a pioneering company in regenerative medicine that develops innovative products derived from human amniotic membrane tissues. As head of Ethics & Compliance, she is responsible for the design and execution of the company’s comprehensive compliance program and regularly reports to the Audit Committee. With a strategic and pragmatic approach, Maria ensures that compliance is embedded into the fabric of the organization, enabling sustainable growth while upholding the highest ethical standards.

Prior to joining BioTissue, Maria served as Vice President and Compliance Officer at Ra Medical, a publicly traded medical device company. There, she successfully built and managed a compliance program under a Corporate Integrity Agreement (CIA), ultimately negotiating a release from CIA obligations with the Department of Health and Human Services following a corporate merger. Her earlier career includes progressive leadership roles at Zimmer Biomet, GE Healthcare, Micrus (acquired by Johnson & Johnson), Abbott, and Motorola. She has led compliance efforts during a DOJ monitorship, developed global compliance operations, and advised on high-risk areas such as FCPA, transparency reporting, HCP engagement, international trade, and government contracting. A Certified Fraud Examiner with a background in public accounting and forensic auditing, Maria is also a frequent speaker on anti-corruption, FCPA, and healthcare compliance topics. She holds a B.S. in Accountancy from DePaul University and an MBA from the University of Miami.