Yizhen Xu

About Yizhen Xu

Harvard trained physician scientist and accomplished drug developer, specialized in endocrinology and cardio-renal-metabolic diseases with extensive clinical development experience both in pharmaceutical and biotech setting, committed to develop innovative therapies to help patients improve their lives. • Passion and commitment to improve the lives of patients; dedication to clinical research: deep understanding of diseases and unmet needs and business acumen.Knowledge and expertise in multiple therapeutical areas, including common diseases, such as diabetes, obesity, NASH, Cardiovascular, CKD, as well as rare diseases such as Pompe disease, neuromuscular and CNS diseases, etc. • Knowledge and expertise in multiple therapeutical areas, including common diseases, such as diabetes, obesity, NASH, Cardiovascular, CKD, as well as rare diseases such as Pompe disease, neuromuscular and CNS diseases, etc. • Extensive knowledge and experience in clinical strategy and clinical trials, including phase 1-4 clinical trials, IND and NDA submissions, blockbuster launch preparation, label negotiation and FDA advisory committee meeting preparation, life cycle management, publication planning, IIS (Investigator initiated studies), KOL management, scientific advisory board meetings, • Leadership in cross-functional project team to develop and execute program related strategies, including clinical development plan (CDP), medical product plan (MPP), product development plan (PDP) and evidence generation plan (EGP). • People management experience: recruiting and retaining talents to build high-performing Clinical Development team, and mentoring and coaching junior employees and interns.

Experience

1. Vice President Clinical Development

   AskBio Inc.

   Mar 2021 — Present · Research Triangle Park, NC

   At AskBio, we are making history with every clinical advancement and aspire to turn hope into cures by unraveling new possibilities for genetic medicine. Our scientific co-founder, Jude Samulski, PhD, was the first to demonstrate that adeno-associated virus (AAV) could be cloned for therapeutic purposes. His groundbreaking research inspires our world-leading gene therapy platform that is bringing new therapeutics to patients. Our preclinical and clinical pipeline covers a broad range of genetic and pathway diseases including CNS, neuromuscular, metabolic, and cardiac disorders. We are expanding our product portfolio in multiple therapeutic areas.

Education

• Shanghai Medical College of Fudan University

  Doctor of Medicine (M.D., Ph.D.), Endocrinology and metabolic diseases, internal medicine

  1988 — 1998