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  • Innovation Through Collaboration: Why the CSS Working Groups are Important to the FDA Steve Wilson, DrPH, CAPT USPHS Director, FDA/CDER/OTS/OB/DBIII 2014
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Innovation Through Collaboration: Why the CSS Working Groups are Important to the FDA Steve Wilson, DrPH, CAPT USPHS Director, FDA/CDER/OTS/OB/DBIII 2014 Computational Science Symposium March 16 th – 18 th , 2014 Silver Spring Civic Center, Silver Spring, MD

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  • Innovation Through Collaboration: Why the CSS Working Groups are Important to the FDASteve Wilson, DrPH, CAPT USPHSDirector, FDA/CDER/OTS/OB/DBIII2014 Computational Science SymposiumMarch 16th 18th, 2014 Silver Spring Civic Center, Silver Spring, MD

  • Our Grand Experiment in Collaboration: Opportunities Disguised as Problems in this Fast-Paced, Complex Scientific/Regulatory/Technical Decision-Making WorldSteve Wilson, DrPH, CAPT USPHSDirector, FDA/CDER/OTS/OB/DBIII2014 Computational Science SymposiumMarch 16th 18th, 2014 Silver Spring Civic Center, Silver Spring, MD

  • DisclaimerThis presentation reflects the views of the authors and should not be construed to represent FDAs views or policies

  • Computer-Assisted Review of Safety (CARS)

  • Computer-Assisted Review of Safety (CARS)

  • OutlineMission/VisionThe LandscapeMotivationPDUFA/FDASIA21st Century ReviewCDER says -- Show Me the DataOur Computational Science: Is Something Missing?How Are We Going To Get There CDER/OTS and Pre-competitive CollaborationConsortia and Institutional CollaborationComputational Science Symposium (CSS)The Experiment Some ChallengesProgressBottom Line

  • Mission / VisionFDA's mission is to protect and advance public health by helping to speed innovations that provide our nation with safe and effective medical products and that keep our food safe. The Agency achieves this by applying the latest technology and science-based standards to the regulatory challenges presented by drugs, biologics (vaccines, blood products, cell and gene therapy products, and tissues), medical devices, food additives, and, since 2009, tobacco Innovation

  • PDUFA / FDASIAEfficiency/Predictability of processes Promote innovationGoals Letter: B. Assessment of the Program be evaluated by an independent contractor with expertise in assessing the quality and efficiency of biopharmaceutical development and regulatory review programs.XII. IMPROVING THE EFFICIENCY OF HUMAN DRUG REVIEW THROUGH REQUIRED ELECTRONIC SUBMISSIONS AND STANDARDIZATION OF ELECTRONIC DRUG APPLICATION DATA

  • 21st Century Review

  • 21st Century Review

  • CDER says --Show Me the Data

  • Copyright CDISC 2008*Cooper, 2008

  • *CDER says Show me the data!Assessing Potential Liver Injury [by Analyzing Increases in Serum Alanine Aminotransferase (ALT) and Total Serum Bilirubin (TBILI)]X-axis: Days into StudyIndividual Patient Profile:Linkage of several data tables using the same timelineDrug experience DataAdverse Event DataConcomitant DrugsLaboratory DataCooper, 2010

  • The Critical PathData Standards

  • Our Computational Science: Is Something Missing?

    Tool development / standards on-goingData quality / documentation / languageSubmission processes Application: Relevant Science and Decision-MakingTrainingAcceptance by Regulatory Agencies, Industry, Academia

  • How Are We Going to Get There?

    CDER/OTS and Pre-competitive Collaboration

    SO

  • Examples of Public-Private Partnerships with CDER ParticipationBiomarker Consortium (BC)fNIHInternational Serious Adverse Events Consortium (iSAEC)Pediatric Anesthesia Safety Initiative (PASI)Analgesic Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) InitiativeCardiac Safety Research Consortium (CSRC)Critical Path Institute (CPath)Coalition Against Major Diseases Consortium (CAMD)Patient Reported Outcomes Consortium (PRO)Predictive Safety Testing Consortium (PSTC)Polycystic Kidney Disease Consortium (PKD)Critical Path to TB Drug Regimens Consortium (CPTR) Clinical Trials Transformation Initiative (CTTI)McCune, 2012

  • Computational Science Symposium(CSS)2014 CSS is the 5th in a Series of Annual Computational Science Meetings established to support the work of FDAs Center for Drug Evaluation and Research (CDER), Office of Computational Science (OSC)3rd Year working with PhUSE (first two were with the DIA)Intention: To work collaboratively with industry, vendors and regulators in a non-competitive space to find solutions and advance the computational sciences/technology associated with the development and regulation of new medical products (drugs, biologics, etc.)

  • Meetings 2.0 Computational Science SymposiumA different kind of conference: A Collaborative Workgroup SymposiumOrganizing Committee: Currently defined 4 working groups to continue the work throughout the yearSupporting collaborative workgroups that will continue until all of the work is done.Technical Stakeholder Workgroups but we are asking you to move beyond your stake act as knowledgeable professionals seeking solutionsWork Products, timelines, next stepsJob much bigger than these workgroups this is a start

  • The Experiment:Tom Sawyer & The Fence

  • The Experiment ProgressSome Challenges

  • Progress: Current WorkgroupsOptimizing the Use of Data Standards Development of Standard Scripts for Analysis and Programming Non-Clinical Road-map and Impacts on Implementation Emerging TechnologiesEmerging Technologies

  • Progress: Deliverables

  • Progress: The Wiki

  • Some ChallengesVolunteer / Co-LeadRight Projects Transparency/OpticsRecognition/AppreciationFDA Involvement Disclaimer & LiaisonWiki and Agile CommunicationTesting and Socialization of Deliverables

  • [email protected] from Oliva,, 2007

    ***


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