015 - Outsourcing in China: How far can it go? episode artwork

EPISODE · Nov 13, 2020 · 33 MIN

015 - Outsourcing in China: How far can it go?

from CMC Live - Chemistry, Manufacturing & Controls · host Edward Narke, David Blasingame, Brian Lihou, Meranda Parascandola

What We Covered00:55 – Ed, Brian and Meranda welcome to the show David Blasingame who speaks to his extensive background as a process chemist as well as the advantages and disadvantages of manufacturing drugs in China  10:20 – The importance of person in-plant activity and the White Coat Effect  11:29 – David speaks to the issues he’s experienced with employee turnover  17:11 – Facts and myths about America’s dependence on medicine from China, overcoming communications issues and the process of dealing with CMOs  23:41 – David talks about the benefits of staying with the same drug substance manufacturer and expounds on the reasons why not every program is a fit for China  31:55 – Ed, Brian and Meranda thank David for joining the show  Tweetable Quotes“One of the key activities for any oversight of manufacturing and any CMO is person in-plant activities.” “You better make sure you have an easy to manage process…easily transferable, and you really do have to budget to have a presence on that floor. All these things have to be factored into your decision to move into China.”“If you’re looking for a commercial process that you might be able to take anywhere, I’m not necessarily sure that [China] is the place that you would go.” “We found it actually paid for itself in having somebody on staff who can speak the language because the communication style and the communication was very different than when we didn’t have one.”“I think if you’re planning on doing manufacturing in China, plan on being hands on.” Relevant LinksDesign Space InPharmatics - LinkedInDesign Space InPharmatics - TwitterEdward Narke on LinkedInDavid Blasingame on LinkedIn

David Blasingame is a Director of CMC at Rigel Pharmaceuticals and former Senior Consultant at Design Space InPharmatics. David is an accomplished process chemist with over twenty years of experience in process research and development, API and drug product manufacturing and developing cross-functional and external CMO relationships. In this episode, David, Ed, Meranda and Brian discuss the advantages and disadvantages of outsourcing drug manufacturing to China, the value of person in-plant approach, and the importance of communication and trust in building good partnership relationships.

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015 - Outsourcing in China: How far can it go?

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This episode was published on November 13, 2020.

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What We Covered00:55 – Ed, Brian and Meranda welcome to the show David Blasingame who speaks to his extensive background as a process chemist as well as the advantages and disadvantages of manufacturing drugs in China  10:20 – The importance of...

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