Yuan Xue

VP, Regulatory Affairs @ Aktis Oncology

About

Experienced forward-thinking leader and team builder with solid credentials in research and clinical drug development; diverse experience in both large pharma and small-size biotech. Primarily focus on oncology drug development and regulatory strategy. Successfully led worldwide NDA approvals of 2 first-in-class cancer drugs as well as advancement of pipeline compounds. Highly motivated self-starter who is strategic, agile and result-driven.

Country

United States

City

New York City Metropolitan Area

Industry

Pharmaceuticals

Skill

Due Diligence, Business Development, Biologics License Application (BLA), Investigational New Drug Application (IND), New Drug Application (NDA), Oncology, Commercial Launch, Precision Medicine, Oncology drug development and registration, Global regulatory affairs, Research and Development (R&D), Cancer Research, Strategic Planning, Biotechnology, Clinical Development, Drug Development

Experience

VP, Regulatory Affairs

Aktis Oncology

2025 - Present · 1 yr

Head of regulatory affairs function overseeing regulatory strategy and operation of oncology portfolio.

Senior VP, Global Regulatory Affairs

Accutar Biotech

2022 - 2025 · 3 yrs

Head of the regulatory affairs function overseeing global regulatory strategy and execution. 4 INDs cleared by & 2 Fast Track Designations received from the FDA.

Senior Director, Global Regulatory Affairs - Oncology & in-vitro Diagnostics

Merck

2019 - 2022 · 3 yrs

Greater New York City Area

Global regulatory lead, Keytruda (pembrolizumab) renal cell carcinoma program. Oversaw the first-in-class HIF2a inhibitor Welireg (belzutifan) US and global NDA filings and approvals. Developed regulatory strategy of Phase 1/2/3 oncology clinical trials of mono- and combination therapies, which led to several global approvals. Core member of the commercial launch team of Welireg and the DD team.

Global Regulatory Strategist, Global Regulatory Affairs

Bayer

2013 - 2019 · 6 yrs

Whippany, NJ

Lead regulatory strategist for Vitrakvi (larotrectinib), Xofigo (radium 223), Nexavar (sorafenib) as well as multiple early stage assets; Responsible for developing global regulatory strategy for Bayer oncology portfolio including marketed products (Nexavar & Xofigo) and more than 5 pipeline compounds (e.g. larotrectinib, rogaratinib); Led global regulatory team; Strategic planning for IND and NDA filings; Successfully conducted HA meetings and achieved regulatory milestones with FDA, EMA and NMPA, e.g. global NDA submission & approvals, Orphan Drug Designation, CTA, etc.; Special expertise in companion diagnostics, pediatric oncology drug development and PRO strategy. Core member of commercial launch teams of several products.

Research Fellow

Massachusetts Institute of Technology

2011 - 2013 · 2 yrs

Cambridge, Massachusetts

Conducted postdoctoral research in Dr. Robert Langer Lab in the scope of cancer genome, medical device, nanomedicine, biotechnology, drug delivery, cancer therapy, disease models, antiangiogenesis and diabetes. All research projects are oriented into the clinical applications. Recipient of the Swedish Research Council fellowship. Published 5 scientific publications and 1 U.S. patent in the related fields.