Mark Verdecia
Biological Reviewer @FDA
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WORK HISTORY
Biological Reviewer @FDA
Silver Spring, MD, US
EDUCATION
UC San Diego
Doctorate, Biology
University of Southern California
B.S., Biology and Chemistry
The Johns Hopkins University - Carey Business School
Master of Business Administration (M.B.A.), Entrepreneurship/Entrepreneurial Studies
SKILLS
ABOUT MARK VERDECIA
As a CMC Reviewer for gene therapies, I play a crucial role in evaluating and ensuring the safety, quality, and efficacy of gene therapy products. My key responsibilities include conducting in-depth CMC reviews of regulatory submissions, assessing product quality, analyzing risks, and proposing mitigation strategies. To accomplish this, I work within a multidisciplinary team, collaborating with scientists, clinical reviewers, and regulatory affairs personnel to provide recommendations on gene therapy submissions.Additionally, I contribute to policy and guidance development at the FDA and outside standard-setting organizations, such as the United States Pharmacopeia. Staying current with advances in gene therapy manufacturing and analytical techniques is essential for improving review practices and regulatory frameworks.I hold a PhD in Biology from the University of California, San Diego and an MBA in Entrepreneurship from the Johns Hopkins Carey Business School. With over 20 years of research experience in academic, industry, and government settings, I have a strong background in biotechnology, including multiple patents and publications in prestigious journals. I\'m also passionate about teaching and mentoring the next generation of biotech professionals and have served as an adjunct faculty member at Johns Hopkins University.
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