ADNI-Private Partner Scientific Board Update

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ADNI-Private Partner Scientific Board Update Robert Dean (Lilly), PPSB Chair ADNI Steering Committee Meeting Boston, April 24, 2017

Current PPSB Partners for ADNI3 2

Benefits of PPSB Partnership Membership in the ADNI Private Partner Scientific Board (PPSB) Independent, pre-competitive forum for study-related scientific exchange among partners; convened monthly by the FNIH Receive latest updates on ADNI progress/status Representatives attend annual face-to-face ADNI Steering Committee meeting Chair serves as liaison to ADNI Executive Committee Participate in ADNI Core open discussions (Biomarkers, Biostatistics, Clinical, Genetic, Informatics, MRI, Neuropathology, PET, Publications) Interact with NIH, FDA, ADNI PI/Core Leaders and industry colleagues Participate in industry-initiated Working Groups Participate in annual PPSB face-to-face meetings (Spring and Fall) 3

PPSB Face to Face Meetings Spring Meeting / 23 April 2017 ADNI Core Updates Readouts on ADNI-related innovation activities DNA Methylation Study (Andy Sakin) Metabolomics & Systems Biology (Rima Kaddurah-Daouk) CSF Biofluid Biomarkers Elecsys Platform (Sandra Rutz) ADNI 1, 2 & GO data output (Les Shaw) Standardization & next steps (Roundtable) Fall Meeting / Date TBD Tentative theme: How PPSB member organizations have utilized ADNI data in trial design 4

ADNI Cores PPSB Core Liaisons PPSB chartered working groups Biochemical Biomarker Les Shaw and John Trojanowski Biosta@s@cs Laurel BeckeA Clinical Ron Petersen & Paul Aisen Susan DeSanti Jerry Novak Veronika Logovinsky P PET Endpoints WG (2010 present) Mark Schmidt, Gregory Klein Biofluid Biomarkers WG (2012 present) Susan DeSan@, Johannes Streffer Gene@cs Andy Saykin MRI Cliff Jack Neuropathology John Morris PET Bill Jagust Aparna Vasanthakumar Adam Schwarz Susan DeSanti Mark Schmidt P S Clinical Endpoints WG (2013 present) Veronika Logovinsky, Nandini Raghavan rsfmri WG (21012-2013) Mark Schmidt, Holly Posner ADAS-Cog Plus WG (2009 2014) Mark Schmidt, Holly Posner Publica@ons Robert Green Informa@cs Art Toga RARC John Hsaio Lee Honigberg Open Jerry Novak B Aβ as a Biomarker WG (2009 2015) Jeff Waring InformaKcs WG (2010 2013) Victor Lobanov ADNI PI Mike Weiner PPSB Chair (transitioning) Robert Dean (Veronika Logovinsky) 2017

PPSB Working Groups PET Endpoints Working Group Chair: Mark Schmidt, J&J (Deputy: Gregory Klein, Roche) IdenKfy & control sources of PET imaging variability to improve deteckon of treatment effects PotenKal tau ligand alternakves to AV1451 Discussion of early frame amyloid imaging for vascular flow (not chartered) Biofluid Biomarker Working Group Chair: Susan De SanK, Piramal (Johannes Streffer) Access to residual ADNI biological specimens for assay manufacturers Efforts to standardize pre-analykcal specimen colleckon & handling - Roundtable discussion (not chartered) 6

PPSB Working Groups Clinical Endpoints Working Group Chair: Veronika Logovinsky (Deputy: Nandini Raghavan) Four previous workstreams collapsed into one funckoning group Monitoring implementakon and data quality for the Financial Capacity Instrument Short Form (FCI-SF) Monitoring colleckon of Cog State data Finishing a comparison of composite scales developed by different sponsors Finalizing manuscripts on earlier work completed by separate workstreams 7

Coordination and Organization by FNIH Joseph Menetski, PhD Deputy Director, Research Partnerships (301) 594-6596 jmenetski@fnih.org Dinetta Parrot Development Officer (301) 594-2103 dparrot@fnih.org 8

Back ups 9

PPSB: Leadership Chair Chair-elect FNIH Past PPSB Chairs Core Team Extended Team Robert Dean, Lilly Veronika Logovinsky, Eisai Joseph Menetski, Deputy Director* Rosa Canet-Aviles, Scien@fic Program Manager DineAa ParroA, Partnership Development Officer # Meredith Donnelly, Partnership Development Officer Eric Barese, Partnership Development Officer Julie Wolf-Rodda, Director of Development Gerald Novak, J&J; Susan De San@, Piramal; Jesse Cedarbaum, Biogen; Adam Schwarz, Eli Lilly; Johan Luthman, Eisai; Enchi Liu, Prothena; Mark Schmidt, J&J; Holly Soares, BMS; Patricia Cole, Takeda; Eric Siemers, Eli Lilly; Bill PoAer, NIMH; Pete Snyder, Lifespan Hospital System PPSB company / organiza@on primary representa@ves Addi@onal PPSB representa@ves *Indicates primary Scientific contact # Indicates primary Development contact 10

ADNI-PPSB 2017 Spring F2F Mee@ng Agenda 11