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MATRICS-CT Co-Primary Translation October 27, 2009 Bethesda, MD

. MATRICS-CT Co-Primary

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MATRICS-CT Co-Primary Translation October 27, 2009 Bethesda, MD

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    3.   HOW IT CAME ABOUT  April 2004: FDA - NIMH Advisory Panel (MATRICS Meeting #5) “The current position of the FDA is that concurrent change on a co-primary measure of functional outcome will be required for approval of a neurocognitive drug for schizophrenia.” Buchanan et al. Schizophrenia bulletin 2005 May 2006: Meeting w/ industry & NIMH at APA Meeting to discuss translation and norming of the MCCB Industry expressed preference for a consensus process for co-primary measures (no requirement for single measure) Nov / Dec 2006 MATRICS-CT Charter drafted with Foundation for NIH to cover both work streams Aug 2007 First public MATRICS-CT meeting in Bethesda

    4. MATRICS-CT Deliverables  Translation of the MATRICS Consensus Cognitive Battery (MCCB) into selected languages Selection and validation of intermediate (ie., co-primary) measures of functioning for trials of medications for cognitive impairment associated with schizophrenia (CIAS)

    5. Larry Alphs, M.D., Ph.D. (J&J) Jeffrey Baker, Ph.D. (Abbott) Andrea Baruchin, Ph.D. (FNIH) Robert Buchanan, M.D. (U Md) Raimund Buller, M.D. (Lunbeck) Suresh Durgam, M.D. (Solvay) Sanjay Dube, M.D. (Eli Lilly) Michael Egan, M.D. (Merck) Frederick Frese, III, Ph.D. (NE Ohio) George Garibaldi, M.D. (Roche) Wendy Granberry, Pharm.D. (GSK) Michael Green, Ph.D. (UCLA)

    8. Frederick Frese, III, Ph.D. (NE Ohio) Wendy Granberry, Pharm.D. (GSK) Michael Green, Ph.D. (UCLA) Philip Harvey, Ph.D. (Emory) Craig Karson (Merck) Stephen Marder, M.D. (UCLA) Donna Mayo (NIMH) Nancy Peters, M.B.A. (Sanofi Aventis) Nina Schooler, Ph.D. (Downstate) Michelle Stewart (Pfizer) Ellen Stover (NIMH)

    9. Raimund Buller, M.D. (Lunbeck) Sanjay Dube, M.D. (Eli Lilly) Megan Fredrick (UT SA) Judith Jaeger, Ph.D. (AstraZeneca) Keith Nuechterlein, Ph.D. (UCLA) Donna Mayo (NIMH) Nancy Peters, M.B.A. (Sanofi Aventis) Maureen Rubin (UT SA) Nina R. Schooler, Ph.D. (Downstate) Ellen Stover (NIMH) Dawn Velligan, Ph.D. (UT SA)

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