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Trisha is a versatile biomedical engineer and recognized subject matter expert with more than 15 years of diverse experience (industry, academia, and government) in the development and regulation of medical products (drugs, devices, biologics, and combination products) and implementation of scientific and regulatory policy. Her areas of expertise include biocompatibility, animal-derived materials, and nanotechnology.
Trisha joined Parexel in November 2018 and uses her recent FDA experience to assist medical device and combination product clients in developing their nonclinical and clinical testing plans and regulatory strategies to achieve their company objectives. At the FDA, she worked as a Commissioner’s Fellow at the National Center for Toxicological Research (NCTR) for two years developing novel nanotechnology characterization and detection methods, as a lead premarket reviewer for three years at the Center for Devices and Radiological Health (CDRH), Office of Device Evaluation (ODE) (now the Office of Product Evaluation and Quality (OPEQ)) reviewing devices that run the gamut of the benefit-risk spectrum, as well as a policy analyst for over one year creating new policies, regulations, and guidances for devices and combination products in accordance with the 21st Century Cures Act. Trisha has extensive experience in developing novel methodologies in support of regulatory science and reviewing the broad spectrum of CDRH submissions, including 510(k)s, PMAs, IDEs, De Novos, 513(g)s, and Q-Submissions, especially Breakthrough Device submissions. Prior to working at the FDA and Parexel, Trisha worked in both small start-up as well as large and established biotech companies. She has co-authored numerous scientific and educational publications and has represented FDA at several conferences and meetings as a technical expert.
Trisha has a Ph.D. in Biomedical Engineering from Purdue University and a B.S. in Bioengineering with a Minor in Mathematics from the University of California, San Diego.
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