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by Joe Hannon -
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Congratulations to Kevin Seibert and Sal Garcia Munoz for winning the 2010 AIChE QbD (Quality by Design) Awards for Outstanding Contribution to Drug Substance QbD and Drug Product QbD respectively.
The awards were presented Tuesday evening at the AIChE Annual Meeting in Salt Lake City, at the Pharma/QbD Mixer, by Dr. Mike Thien, Senior Vice President at Merck & Co.
Tuesday morning featured four Vice Presidents from leading pharma companies in a discussion of challenges facing CMC organizations in the changing business and regulatory climate. John Dillon (Pfizer), Howard Morton (Abbott), Bret Huff (Lilly) - all chemists by training - and Mike Thien (Merck) - a chemical engineer - described how their companies are adapting to and leveraging the QbD framework. The good news for chemical engineers is that they need to play a major role in the transformation and some companies are hiring to fill gaps in their capability.
In total, 24 sessions at AIChE directly addressed pharma process development and scale-up, covering drug substance, drug product and biologics. 2010 Programming Chair Joe Hannon (Scale-up Systems) noted that 'AIChE is attracting attention from the wider pharma community for its leadership role in QbD; we intend to continue to raise the quality of our programming in future years while adapting the program to meet emerging challenges where chemical engineers can add value".
AIChE's Pharma Division is building an online community to facilitate year-round discussion of programming and related issues. All are welcome to join the LinkedIn group: AIChE Pharma Open Forum .