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Winners of 2012 AIChE Awards for QbD

    Winners of 2012 AIChE Awards for QbD

    AIChE has announced the Winners of the 2012 AIChE Award for Outstanding Contribution to QbD for Drug Substance and 2012 AIChE Award for Outstanding Contribution to QbD for Drug Substance, both of which will be presented at the 2012 Annual Meeting in Pittsburgh.

    Each award is worth $1500 and a commemorative plaque.  The awards will be presented at the AIChE 2012 Annual Meeting, in the session, Awards Ceremony On Comprehensive Quality by Design – Monday, October 29, 2012: 6:30 PM,Allegheny II (Westin).

    AIChE is grateful to the award sponsors, Scale-up Systems Inc (Drug Substance) and Pfizer Inc (Drug Product), respectively.

    The 2012 Annual Meeting once again features a QbD Topical Conference, in which best practices are discussed by industry leaders and practitioners in 14 sessions over 4 days.  For more information and to register for the Annual Meeting, visit https://aiche.confex.com/aiche/2012/webprogram/TI.html and http://www.aiche.org/Conferences/AnnualMeeting/index.aspx.

    About the Awards Process
    Nominations for the AIChE QbD Awards are invited through a public website.  After the nomination period has closed, the AIChE QbD Awards Chair compiles the nominations and coordinates the award voting via a blinded judging panel consisting of senior members of the AIChE Pharma community.The blinded judging system was established so that the award sponsor does not direct to whom the award is given.

    Criteria taken into account by the blinded judging panel include contributions to the state of the art in the public domain (e.g. thought leadership presentations, articles, publications, best practices).  Nominees may be working in Industry, Academia, Regulatory or other relevant working environment, and be from any nation, working at any location.  There are no age or experience limits.  Preference is given to work that features chemical engineering.

    Information on previous winners may be found here: http://www.pharmaqbd.com/tag/aiche/ and http://www.pharmaqbd.com/tag/aiche/page/2/

    2012 AIChE Award for Outstanding Contribution to QbD for Drug Substance
    Winner: Dr John Lepore, Merck & Co.
    Dr LePore nominated and received votes on the basis of:

    • many contributions to advancing QbD in the pharmaceutical community;
    • your work helping to author key elements of the ICH guidance on such topics as design space, criticality, modeling, control strategy
    •  ICH Q11 – Contributor and reviewer for ICH Q11
    • ICH IWG – Provided answers for ICH Q&A specific to design space, knowledge management, and impact to PQS;
    • ISPE – Led Design Space team and contributed to Criticality team which produced an illustrative real example of QbD for drug substance and drug product.
    • being a recognized thought leader by both industry professionals and regulators around the globe, having delivered many presentations at premier scientific conferences and regulatory meetings such as IFPAC, AIChE, ISPE, PhRMA, ICH IWG Training.

    2012 AIChE Award for Outstanding Contribution to QbD for Drug Substance
    Winner: Dr ChristineMoore, FDA.
    Dr Moore nominated and received votes on the basis of:

    • many contributions to advancing QbD in the pharmaceutical community
    • support of AIChE  and many presentations at AIChE meetings as well as other premier scientific conferences around the world
    • process development accomplishments at Pfizer, Searle and Pharmacia.

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