NDA Partners' Vice President and General Manager, Eric Fish, announced today that Dr. Michele Schoonmaker, a Market Access and Government Affairs executive, has joined the firm as an Expert Consultant. Most recently, Dr. Schoonmaker served as Senior Vice President with Cephid where she built and led the Government Affairs and Market Access function.
WASHINGTON, Sept. 14, 2023 /PRNewswire-PRWeb/ -- NDA Partners' Vice President and General Manager, Eric Fish, announced today that Dr. Michele Schoonmaker, a Market Access and Government Affairs executive, has joined the firm as an Expert Consultant. Dr. Schoonmaker is a recognized leader in Market Access and Government Affairs strategy and advocacy with over 25 years of experience driving coordinated, innovative solutions to complex reimbursement, regulatory, and other policy issues to accelerate commercialization of and patient access to state-of-the-art molecular diagnostic tests. She joins the firm to provide strategic solutions to complex market access and/or government affairs problems facing companies or laboratories seeking to bring new diagnostic tests to market.
According to Dr. Alberto Gutierrez, Manager of the firm's diagnostic devices practice, "Dr. Schoonmaker brings great value to diagnostic device clients who are developing strategies for market access and government affairs and need expert guidance to navigate complex reimbursement and regulatory pathways for commercialization and patient access."
Prior to joining NDA Partners, Dr. Schoonmaker served as Senior Vice President with Cepheid, a leading molecular diagnostics company, where she built and led the Government Affairs and Market Access function. Her primary responsibilities were to develop and implement global strategic reimbursement plans for the company's molecular diagnostic tests, working with professional associations, federal agencies, and legislative offices on regulatory, reimbursement and disease-specific policies for molecular testing to facilitate the integration of beneficial new technologies into clinical testing. Prior to joining Cepheid, she was a Specialist in Genetics for the Congressional Research Service (CRS), a division of the Library of Congress, and regulatory policy analyst and reviewer of diagnostic tests in the Office of In Vitro Diagnostics (OIVD) at FDA. She also spent 11 years with the National Institute of Aging/National Institutes of Health in the Immunology Laboratory as a Biologist in an earlier role.
Dr. Schoonmaker holds a PhD in Health Services Research, Genetic and Public Policy from The Johns Hopkins University School of Hygiene and Public Health and a bachelor's degree in biology from Goucher College.
About NDA Partners
NDA Partners, a ProPharma company, is a life sciences management consulting and contract development organization focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, product development program design and management, expert consulting, functional teams, project-based solutions, and clinical trial design and management.
Contact
Eric Fish, Vice President & General Manager
Office: 540-738-2550
[email protected]
Media Contact
Eric Fish, NDA Partners, A ProPharma Company, 540-728-2550, [email protected], www.ndapartners.com
SOURCE NDA Partners, A ProPharma Company
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