Medical Device Innovation Consortium Selects Sandra Siami to Lead National Evaluation System for health Technology Coordinating Center

As SVP of NESTcc, Ms. Siami will guide the strategy and operations for NESTcc programs to advance the goals of stakeholders including patients, providers, payers, industry, regulators, and others. She will lead NESTcc’s efforts to become a trusted platform in the timely generation of real-world evidence (RWE) and a key partner in solving pre- and post-market challenges in the medical technology space.

“NESTcc has a vital role to play in the market, and it is poised to expand as high-quality evidence becomes increasingly critical to ensuring public health and supporting clinical, regulatory, and coverage decisions,” said Siami. “I’m honored to join the great team at NESTcc and work with its expert Network Collaborators to change the paradigm of clinical research and help drive continued innovation for the benefit of patients and all medical device stakeholders.”

Ms. Siami joins NESTcc from HealthCore, Inc., a subsidiary of Anthem Inc., where she most recently served as staff vice president of Clinical Research, Regulatory Affairs, and Quality Assurance. At HealthCore, she led the Clinical Research business unit that directed early- and late-phase trials utilizing the real-world data ecosystem, with a specific interest in rare, orphan, and underserved diseases, as well as pediatric, elderly, and minority populations. Ms. Siami also oversaw the business unit’s pharmacovigilance and medical device activities, quality system administration, and domestic and international regulatory affairs efforts in 31 countries.

“I am thrilled to welcome Sandi to MDIC as the leader of NESTcc,” said Pamela Goldberg, MBA, president and CEO of MDIC. “Her commitment to clinical research, focus on quality, and business expertise align perfectly with our mission and vision. We’re excited to build on the strong foundation at NESTcc and take our impact and growth to the next level.”

Ms. Siami’s 25-year career spans roles in corporate management, clinical and RWE research, and strategy and business development. She served in leadership positions for 15 years at New England Research Institutes, Inc. (acquired by HealthCore in 2017), including as the Scientific Integrity Officer, and oversaw the NERI Institutional Review Board. She was also involved in the Boston Pediatric Device Consortium funded by the FDA and served as Principal Investigator of the Data & Statistical Coordinating Center for several NIH-funded medical device studies. In addition, Ms. Siami has a proven history in leading multi-stakeholder collaborations for clinical and regulatory decision-making in the medical device industry for abdominal aortic aneurysms, thoracic aortic dissections, carotid stenting, and inferior vena cava filters. She has given over 45 scientific presentations and has over 50 publications in major medical journals and book chapters.

“Sandi is an innovator and accomplished leader, and I’m excited to collaborate with her to guide NESTcc’s strategic priorities, deliver on its vision, and demonstrate its value for stakeholders across the medical device ecosystem,” said Adrian Hernandez, M.D., MHS, chair of the NESTcc Governing Committee, professor of Medicine at Duke School of Medicine, and vice dean and executive director of the Duke Clinical Research Institute.

About the National Evaluation System for health Technology Coordinating Center

In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) $3 million in seed funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc). The Coordinating Center seeks to support the sustainable generation and use of timely, reliable, and cost-effective Real-World Evidence (RWE) throughout the medical device lifecycle, using Real-World Data (RWD) that meets robust methodological standards and is generated in the course of clinical care and everyday life by patients, providers, or payers, and for the purpose of enhancing regulatory and clinical decision-making. For more information, visit http://www.nestcc.org.

About the Medical Device Innovation Consortium

Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s mission is to promote public health through science and technology and to enhance trust and confidence among stakeholders. MDIC works in the pre-competitive space to facilitate the development of methods, tools, and approaches that enhance understanding and improve evaluation of product safety, quality, and effectiveness. Its initiatives improve product safety and patient access to cutting-edge medical technology while reducing cost and time to market. For more information, visit http://www.mdic.org.

Funding for NESTcc was made possible, in part, by the Food and Drug Administration through grant (1 U01 FD 006292-01). Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.

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