Project Data Sphere Overview - ceo-lsc.org · PDF fileProject Data Sphere, LLC, formed in...
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Project Data Sphere Overview
Transcript of Project Data Sphere Overview - ceo-lsc.org · PDF fileProject Data Sphere, LLC, formed in...
Project Data Sphere Overview
BACKGROUND AND KEY METRICS
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CEOs committed to the elimination of cancer as a public health problem.
• Founded in 2001 at the request of President George H.W. Bush, 41st 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
CEO Roundtable on Cancer’sLife 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
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Francis S. Collins, M.D., Ph.D.Director, NIH
Data Transparency: NIH Takes a Firm Stand
that the data they provide will be used to advance the health of many. It isthe responsibility of investigators and funders to guarantee that obligationis fulfilled.”
-- Hudson, Kathy & Collins, Francis. Sharing and reporting the results of clinical trials. JAMA, 2014
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“Without access to complete information …duplicative studies may be initiated thatunnecessarily put patients at risk or exposethem to interventions that are known to beineffective for specific uses.
“It is time to embrace an era in whichtransparency and responsible data sharing arecommon values. Research participants trust
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Historic Clinical Trial Data
● Commitment from industry and academia Nearly 30,000 patient lives of data from 13 data providers
Project Data Sphere® Data SharingProof of Principle: 18 Months of Operation
● 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
● Strong interest from researchers Over 1,100 researchers who have accessed the data over 3,500 times
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ConceptApproval
Privacy Legal Resources Analytics
201420132012
Launch
2015
Data+ Initial Data Goal Met
Data++
2016
Project Data Sphere, LLCAccomplishments
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April April
LLCFormed
7 Charter Providers: industry, academia
12 Providers: government,
industry, academia
Project Data Sphere, LLCFundamentals
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● 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
Project Data Sphere, LLCExecutive Committee
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• 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
Data Providers
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Project Data Sphere®People and Technology
Digital Library-Laboratory
SAS Analytic Tools
Visual Analytics Drug Development Clinical Data Integration
Community
IndependentResearch
Project Data Sphere® Growth
Project Data Sphere® Key Metrics
Geographic Reach
Users from 45 countries (highlighted in green)
User Demographics Patient Lives of DataBy Tumor Type
By Data Provider
The Power of Access to Patient-Level Data
“The volume of data available on the Project Data Sphere platformhas allowed the development of new models to predict prostatecancer tumor burden over time – research that will have realimplications for the drug development process and that can berepeated for many other tumor types if the right volume of data ismade available.”
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-Tito Fojo, M.D., Ph.D.
Director, Neuroendocrine Cancers, Columbia University
“Data sharing through efforts such as the Project Data Sphereinitiative allows new research and new discoveries that nosingle trial could provide on its own. The Alliance for ClinicalTrials in Oncology is proud to cooperate with Project DataSphere, LLC to make our data available in a responsiblemanner.” -Daniel J. Sargent, Ph.D.
Group Statistician, Alliance for Clinical Trials in Oncology
THE PROSTATE CANCERDREAM CHALLENGE
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Prostate Cancer DREAM ChallengeFoundation
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● 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, 2015
Prostate Cancer DREAM ChallengeResearch Questions
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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, castrate-resistant prostate cancer patients treated with docetaxel due to adverse events (AE) at early time points (<3 months)
Prostate Cancer DREAM ChallengeData
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● 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
Prostate Cancer DREAM ChallengeResearch Questions and Incentives
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● 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
Prostate Cancer DREAM ChallengeBest Performers
Turku University; Turku, FinlandAbo Akademi University; Turku, Finland
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Univ. of IL; Urbana-Champaign, United States
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University of Alberta; Alberta, CanadaHebrew Univesrity; Jerusalem, Israel
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Gifu University; Gifu, Japan
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Univ. of KS Medical Center; Kansas City, USAJa
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Technische Universität; Munich, Germany
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Brigham Young Univ.; Provo, United States
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.Johns Hopkins Univ.; Baltimore, United States
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Helmholtz Zentrum; Munich, Germany Technische Universitaet; Munich, Germany
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University of Turku; Turku, FinlandUniv. of Helsinki, Helsinki Univ. Hosp.; Finland
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Prostate Cancer DREAM ChallengeResults
● 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
Prostate Cancer DREAM ChallengeQuestion 1A: Scoring and Results
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Benchmark
Team
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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
CONTACT INFORMATION
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Project Data Sphere®More Information
www.ProjectDataSphere.org
www.CEO-LSC.org
www.CEORoundtableOnCancer.org24
Mace L. Rothenberg, MD
Co-Chairman
Life Sciences Consortium Task Force
Pfizer Oncology
Gregory A. Curt, MD
Co-Chairman
Life Sciences Consortium Task Force
AstraZeneca Oncology
Martin J. Murphy, DMedSc, PhD
Chief Executive Officer
Project Data Sphere, LLC
O: +1-919.402.8750
John N. Dornan, Jr.
Chief Operating Officer
Project Data Sphere, LLC
O: +1-919.531.0966
Joseph K. Morrell
Program Management Office
Project Data Sphere, LLC
Liz Zhou, MD, MS
Director, Scientific Analytics
Project Data Sphere, LLC
Sanofi Oncology
