Project Data Sphere Overview

Transcription

1 Project Data Sphere Overview

2 BACKGROUND AND KEY METRICS 2

3 CEOs committed to the elimination of cancer as a public health problem. Founded in 2001 at the request of President George H.W. Bush, 41 st U.S. President Founding Chairman, Robert A. Ingram, then Chief Executive of Glaxo Wellcome Founding Chief Executive Officer, Dr. Martin J. Murphy Composition: CEOs from major corporations of diverse industries and institutions Non-profit organization: 501(c)(3) under United States IRS code 3

4 CEO Roundtable on Cancer s Life Sciences Consortium (LSC) LSC founded 2004 Mission: Bold and Venturesome Accomplish together what no single company might consider alone Project Data Sphere, LLC, formed in December 2012, is an independent initiative of the CEO Roundtable on Cancer s Life Sciences Consortium 5

5 Data Transparency: NIH Takes a Firm Stand Without access to complete information duplicative studies may be initiated that unnecessarily put patients at risk or expose them to interventions that are known to be ineffective for specific uses. It is time to embrace an era in which transparency and responsible data sharing are Francis S. Collins, M.D., Ph.D. Director, NIH common values. Research participants trust that the data they provide will be used to advance the health of many. It is the responsibility of investigators and funders to guarantee that obligation is fulfilled. -- Hudson, Kathy & Collins, Francis. Sharing and reporting the results of clinical trials. JAMA,

6 Historic Clinical Trial Data 6

7 Project Data Sphere Data Sharing Proof of Principle: 18 Months of Operation Commitment from industry and academia Nearly 30,000 patient lives of data from 13 data providers Strong interest from researchers Over 1,100 researchers who have accessed the data over 3,500 times Completed research challenge with publications forthcoming Prostate Cancer DREAM Challenge had the highest level of participation of any DREAM Challenge to date Demonstrated power of the data to yield impactful research Forthcoming pace-setting publications, using mathematical modeling, predict prostate cancer tumor burden over time; other hormone-driven tumors will now be explored 8

8 Project Data Sphere, LLC Accomplishments 7 Charter Providers: industry, academia 12 Providers: government, industry, academia Concept Approval 2012 Privacy Legal LLC Resources Analytics Formed Launch April Data Initial Data Goal Met April Data

9 Project Data Sphere, LLC Fundamentals Broad access to data has resulted in: 3 peer-reviewed articles and 7 peer-reviewed abstracts with more articles in preparation Demonstrable improvement over the standard prostate cancer prognostic model via a crowdsourced research challenge Work on disease modeling that may change early-stage research De-identification is the responsibility of the data providers Data providers have found that expert certification method offers enhanced usability compared to HIPAA safe harbor Freely accessible analytical tools provide a uniform environment for analysis 9

10 Project Data Sphere, LLC Executive Committee Dr. Victor Dzau; President, National Academy of Medicine Dr. Stephen Friend; President, Sage Bionetworks Sir Dennis Gillings; Retired Executive Chairman, Quintiles Dr. Richard Goldberg; Physician-in-Chief, James Cancer Hospital Dr. Martin J. Murphy, Jr.; Chief Executive Officer, CEO Roundtable on Cancer Dr. Charles A. Sanders; Chairman, Foundation for the National Institutes of Health Dr. Elias Zerhouni; President, Global R&D, Sanofi 10

11 Project Data Sphere People and Technology Digital Library-Laboratory Data Providers Visual Analytics Drug Development Clinical Data Integration SAS Analytic Tools Independent Research Community 11

12 Project Data Sphere Growth

13 Project Data Sphere Key Metrics User Demographics Patient Lives of Data By Tumor Type Geographic Reach By Data Provider Users from 45 countries (highlighted in green)

14 The Power of Access to Patient-Level Data The volume of data available on the Project Data Sphere platform has allowed the development of new models to predict prostate cancer tumor burden over time research that will have real implications for the drug development process and that can be repeated for many other tumor types if the right volume of data is made available. -Tito Fojo, M.D., Ph.D. Director, Neuroendocrine Cancers, Columbia University Data sharing through efforts such as the Project Data Sphere initiative allows new research and new discoveries that no single trial could provide on its own. The Alliance for Clinical Trials in Oncology is proud to cooperate with Project Data Sphere, LLC to make our data available in a responsible manner. -Daniel J. Sargent, Ph.D. Group Statistician, Alliance for Clinical Trials in Oncology 14

15 THE PROSTATE CANCER DREAM CHALLENGE 15

16 Prostate Cancer DREAM Challenge Foundation 15 institutions: Project Data Sphere, LLC and Sage Bionetworks (which uses the proven DREAM project methodology) Data Providers (AstraZeneca, Celgene, Memorial Sloan Kettering, Sanofi) Additional support from Advocacy and Academia First crowd-sourced research challenge in Prostate Cancer Guided by the PCDC Scientific Steering Committee: Drs. Charles Ryan, Oliver Sartor, Howard Scher, Howard Soule, Chris Sweeney Ran from March 16 to July 27,

17 Prostate Cancer DREAM Challenge Research Questions The Challenge asked solvers to use curated data from four Phase III clinical trials in the Project Data Sphere platform to: 1A: Predict overall survival for metastatic, castrate-resistant prostate cancer patients using patients clinical variables at baseline 1B: Predict time to death (bonus question) 2: Predict treatment discontinuation for metastatic, castrateresistant prostate cancer patients treated with docetaxel due to adverse events (AE) at early time points (<3 months) 17

18 Prostate Cancer DREAM Challenge Data 2,070 mcrpc patients from the Project Data Sphere platform Curated baseline clinical covariates were modeled: demographics comorbidity prior treatment laboratory lesion prior treatment vital signs 18

19 Prostate Cancer DREAM Challenge Research Questions and Incentives Recognition for top solvers included: $75,000 NCI contract to enhance prognostic model performance $30,000 educational grant sponsored by AstraZeneca Collaboration opportunity with the American Joint Committee on Cancer Speaking opportunities at the PCF Scientific Retreat and DREAM Conference Co-authorship of a publication in Nature Biotechnology to be submitted for peer review 19

20 TYTDreamChallenge Prostate Cancer DREAM Challenge Best Performers Team Cornfield PC LEARN Motoki Shiga Jayhawks CAMP Brigham Young Univ. Bmore Dream Team A Bavarian Dream FIMM-UTU Turku University; Turku, Finland Abo Akademi University; Turku, Finland Univ. of IL; Urbana-Champaign, United States University of Alberta; Alberta, Canada Hebrew Univesrity; Jerusalem, Israel Gifu University; Gifu, Japan Univ. of KS Medical Center; Kansas City, USA Technische Universität; Munich, Germany Brigham Young Univ.; Provo, United States Johns Hopkins Univ.; Baltimore, United States Helmholtz Zentrum; Munich, Germany Technische Universitaet; Munich, Germany University of Turku; Turku, Finland Univ. of Helsinki, Helsinki Univ. Hosp.; Finland

21 Prostate Cancer DREAM Challenge Results 559 registrants on >60 teams more than any other DREAM Challenge Best performers were announced in mid-august Strong participation with over 1,200 model submissions Over 160 final submissions were received Global collaboration with participations from >20 countries Backgrounds in stats, data modeling, data science, bioinformatics, machine learning, engineering, and other disciplines Publications are in development; expected early 2016

22 Prostate Cancer DREAM Challenge Question 1A: Scoring and Results Team Submissions Scoring Method for Question 1A Integrated AUC (6-30 months) Teams must perform better than existing benchmark model Top teams must be within a Bayes Factor of 3 from top performer Benchmark 22

23 CONTACT INFORMATION 23

24 Project Data Sphere More Information Martin J. Murphy, DMedSc, PhD Chief Executive Officer Project Data Sphere, LLC O: M: Joseph K. Morrell Program Management Office Project Data Sphere, LLC M: John N. Dornan, Jr. Chief Operating Officer Project Data Sphere, LLC O: M: Liz Zhou, MD, MS Director, Scientific Analytics Project Data Sphere, LLC Sanofi Oncology O: Gregory A. Curt, MD Co-Chairman Life Sciences Consortium Task Force AstraZeneca Oncology M: Mace L. Rothenberg, MD Co-Chairman Life Sciences Consortium Task Force Pfizer Oncology O:

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