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Jiwen Zhang
SVP, Regulatory Affairs & Quality Assurance at Renovacor, Inc.
Jiwen Zhang, Ph.D., is the Senior Vice President of Regulatory Affairs and Quality Assurance at Renovacor, an early-stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for cardiovascular and central nervous system diseases.1 Dr. Zhang brings over 20 years of experience in regulatory affairs, with more than a decade specifically in the cell and gene therapy space.12
Prior to joining Renovacor, Dr. Zhang held several notable positions:
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Vice President and Head of Regulatory Affairs at Passage Bio, Inc., where she built a regulatory affairs function that led to three original IND applications and obtained Fast Track and Orphan Drug designations for AAV products.1
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Executive Director and Head of Regulatory Affairs at Tmunity Therapeutics, Inc., where she led successful meetings with the FDA and the company's first IND filing for gene-modified CAR T cell therapy.1
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Worked at GE Healthcare for over seven years, building a regulatory affairs function for the cell technology and regenerative medicine business.1
Dr. Zhang has also held roles at Merck and Co. Inc., Wyeth Pharmaceuticals (now Pfizer), and Sanofi.1 Additionally, she served as the President of the Standards Coordinating Body for Regenerative Medicine (SCB) and continues to serve on its board of directors.1
Dr. Zhang holds a Ph.D. in physiology and neurobiology from Rutgers University and a bachelor's degree in biology from the University of Science and Technology of China.1