Geographically Integrated CMC Supply China – Speed Your Drug to Market | CPhI North America

 

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Geographically Integrated CMC Supply China – Speed Your Drug to Market

Jingling Chen, Ph.D. (VP, Pharmaceutical Development Services, STA Pharmaceutical, a WuXi App Tec Company)

Xiaoyong Fu, Ph.D. (Senior Vice President API Development & Commercialization, STA Pharmaceutical, a WuXi App Tec Company)

Location: E353b

Date: Wednesday, May 1

Time: 11:45am - 12:30pm

Track: Drug Development

Vault Recording: TBD

The collaboration between a new drug development company and a Contract Development and Manufacture Organization (CDMO) continues to evolve and expand with the growth in the pharmaceutical industry. In some instances, various CDMO functions became consolidated and integrated within a single organization. For example, CMC services, such as API PR&D and manufacturing, formulation development and drug product manufacturing, overall analytical as well as CMC writing to support global regulatory submission, can fall within a single organization. Benefits of this integration include reduced overhead of one-stop shopping and more streamlined project management. Geographically integrated CMC services, with various business units located in the same location, offers additional benefits such as speed, cost and flexibility. In this presentation, the benefits of geographically integrated CMC services, as implemented in China, will be discussed. Case studies from both early phase and late phase projects will be presented to demonstrate its potential to enable further growth in the CDMO business.