Zhenping Wu
San Diego,USA
Summary
Proven leader in managing CMC teams to support the clinical development of small molecule drugs from IND to approvals with dozens of trials on going and 7 NDAs approved; Results driven executive with strong track record of building robust drug supply chains through in-house facilities or working with CDMO (most in China); Demonstrated expertise in regulatory CMC filings and negotiations and quality management of GMP manufacturing; Strategic thinker with experience in working with senior management team to address complex supply chain issues; Skilled team leader with expertise in working under complex team structures including collaborations with external partners such as Takeda, AstraZeneca, and Eli Lilly
Overview
34
34
years of professional experience
Work History
Executive Vice President
HutchMed
Shanghai, China
01.2008 - 01.2025
- Responsible for all Chemistry, Manufacturing, and Control (CMC) and commercial manufacturing business activities
- Supported the advancement of the company’s clinical development portfolio (~a dozen projects) by developing the manufacturing technologies and providing the supplies for all required human and non-clinical studies in China, US and EU
- Built supply chains for four NDA commercial products in China (Elunate, Sulanda, Orpathys, and Tazverik ) and one in US, EU, and Japan (Fruzaqla)
- Enabled NDA approvals in China, US, EU, and Japan by addressing regulatory questions and passing all regulatory inspections including two from the FDA (with no findings)
- Managed technology transfers for external manufacturing by cultivating close relationships with CDMOs
- Built two drug product manufacturing sites in China with both having passed site inspections by China and US
- Managed a team of over 150 employees and an annual budget of ~$60 millions
- Leading drug development company in China with drugs in clinical development with a pipeline of 11 clinical development portfolio and 4 NDAs approved in China and 1 in US, EU, and Japan
Senior Director, Pharmaceutical Sciences
Phenomix Corporation
San Diego, CA, USA
01.2005 - 01.2008
- Responsible for all Chemistry, Manufacturing, and Control business activities
- Successfully supported the clinical development of two assets, one in phase III and one in phase I by providing manufacturing technology and clinical supplies
- Managed technology transfer for API manufacturing to an EU CMO and drug product to a Canadian CMO
- Supported initiation of phase III clinical study by obtaining agreement with the FDA on key CMC development strategy
Director
Pfizer Global R&D/Agouron
La Jolla, CA, USA
01.1998 - 01.2005
- Responsible for 1)formulation development and drug product manufacturing function activities and 2)overall CMC activities for 2 oncology projects
- Managed a pre-formulation group to provide critical scientific information for formulation development
- Served as a project leader for multiple clinical projects
- Led the technology transfer efforts from R&D lab to manufacturing plant for Sutent, an oncology product
Scientist, Team Leader
Roche Bioscience/Syntex Corporation
Palo Alto, CA, USA
01.1991 - 01.1998
- Managed the CMC activities of development projects
- Directed a working team for selecting clinical candidates in clinical studies
- Manufactured tox and clinical supplies for the osteoporosis project
Education
MBA -
University of California, Irvine
Irvine, CA, USAPh.D. - Organic Chemistry
University of Hong Kong
Hong Kong, Hong KongMS - Organic Chemistry
Sun Yat-Sen (Zhongshan) University
Guangzhou, ChinaBS - undefined
Shangrao Normal College
Jiangxi, ChinaSkills
Strategic planning
Supply chain management
Technology transfer
CDMO relationship
Drug supply technology development
Problem solving
Languages
English
Full Professional
Chinese (Mandarin)
Native or Bilingual
Timeline
Executive Vice President
HutchMed
01.2008 - 01.2025
Senior Director, Pharmaceutical Sciences
Phenomix Corporation
01.2005 - 01.2008
Director
Pfizer Global R&D/Agouron
01.1998 - 01.2005
Scientist, Team Leader
Roche Bioscience/Syntex Corporation
01.1991 - 01.1998
Ph.D. - Organic Chemistry
University of Hong Kong
MS - Organic Chemistry
Sun Yat-Sen (Zhongshan) University
BS - undefined
Shangrao Normal College
MBA -
University of California, Irvine