Presentation on theme: "Center for Biologics Evaluation and Research"— Presentation transcript:
1 Center for Biologics Evaluation and Research Applying Regulatory Science to Advance Development of Innovative, Safe and Effective Biologic ProductsCarolyn A. Wilson, Ph.D.Associate Director for Research
2 CBER Strategic Plan for Regulatory Science Follows CBER’s Strategic Goals Increase national preparedness to address threats from bioterrorism, pandemic and EIDsImprove global public health through international collaborationEnhance ability of science and technology to facilitate development of safe and effective biological productsEnsure safety of biological productsAdvance regulatory science and researchManage for organizational excellenceCBER Strategic Plan FY :CBER’s Strategic Plan for Regulatory Science and Research:
3 Using Science and Regulation to Advance Product Development Novel ProductRegulatoryChallengePublic HealthScienceDiscoveryNew ToolsPolicy/DecisionLicensedProductImprovedData –Benefit/Risk+Opportunity to use WO move to re-engage scientific staff in the mission of CBER and that includes the critical role that research plays to support our regulatory mission.CBER research is filling gaps in scientific knowledge in order to overcome obstacles to product development3
4 CBER researcher = “Researcher-Regulator” ~20% CBER Staff Integration of research and review ensuresRelevance, Expertise, Timeliness, and Usability
5 CBER Advances Regulatory Science through External Collaborations Data from FY13 CBER ResearchReporting Database
6 Annual Review of Research PI providesFor each projectProgress reportFuture plansBudget RequestPresentations, PubsOther outputInformation reviewedLab chief, DD, ADR, ODRelevanceProductivityQualityResearch ReportingDatabaseFunding AllocatedRelevance to priorityScientific/Reg OutputFeasiblity
7 Cyclic Peer Review of Every PI Every 4 Years External – Site Visitspeer review by scientific expertsInternal – Promotion, Conversion, Evaluation Committee
8 Site-Visit ReportDraft report is distributed to full Advisory CommitteeFinal report is approved by full Advisory CommitteeFinal report used in many ways:Internal peer review of research/PI by Promotion, Conversion, Evaluation Committee (PCE) for personnel actionsBy PIs for improving research programBy management, resource allocation decisions may be impacted by report (pending resource availability)
9 Office of Vaccines Research and Review Slides Courtesy of Konstantin Chumakov, PhDAssociate Director for Research, OVRR
10 Office of Vaccines Research and Review DirectorMarion Gruber, Ph.D.Deputy DirectorPhilip Krause, M.D.Associate Director for ResearchKonstantin Chumakov, Ph.D.Associate Director for Medical Policyand Vaccine SafetyKaren Farizo, M.D.Associate Director ForManagement and Scientific AffairsErik Henchal, Ph.D.Associate Directorfor Regulatory PolicyTheresa Finn, Ph.D.Division of Bacterial, Parasitic and Allergenic ProductsDirector: Jay Slater, M.D.Deputy: Drusilla Burns, Ph.D.Division of Viral ProductsDirector: Jerry Weir, Ph.D.Deputy: Robin Levis, Ph.D.Division of Vaccines and Related Products ApplicationsDirector: Wellington Sun, Ph.D.Deputy: Loris McVittie, Ph.D.OVRR Mission Statement:To protect and enhance the public health by assuring the availability of safe and effective vaccines, allergenic extracts, and other related products.
12 OVRR Core ActivitiesReview, evaluate, and take appropriate actions on INDs, BLAs, amendments and supplements to these applications for vaccines and related products, conducting inspections, etc.Develop policies and procedures governing the pre-market review of regulated productsConducting research related to the development, manufacture, and evaluation of vaccines and related products
13 OVRR Regulatory Challenges Emphasis on SAFETY:Products for mass use (often universal)Recipients are healthy individuals, often childrenShort regulatory cycleSeasonal influenza vaccinesResponse to emerging pathogens (pandemic vaccines)Many products are oldInnovative technologiesResearch plays a critical role in regulation of vaccines
14 OVRR Research Priorities SafetyTo study factors affecting safety of regulated products, create and validate appropriate methods and standardsEfficacyTo study biomarkers and introduce new methods and standards to evaluate and improve vaccine efficacyAvailabilityTo develop new concepts and methods opening novel regulatory pathways to improve availability of vaccines and related products
16 Looking Forward 2014: Moving to White Oak Campus 16
17 White Oak Lab Facility State-of-the-Art Vivarium Imaging facility with MRI, digital X-ray, IVIS, ultrasoundTransgenic derivation facilityExpanded Space for Core Technologies:Flow cytometryConfocal microscopyHigh throughput sequencing and bioinformatic support10 BSL-3 suitesDesigned to support work of at least 12 infectious agents and work of 36 PI’sMany suites with capacity for animal holding rooms1 suite to support sterile sorts and live cell confocal microscopy on BSL-3 agentsInsectariums (BSL-2 and BSL-3)Suites designed to support Microarray and PCRExpanded NMR facility and Mass Spec Suites17
18 Your input improves CBER’s research programs Thank you!To the Site Visit reviewers andAdvisory CommitteeYour input improves CBER’s research programsExternal review is critical to fulfilling ourregulatory mission!
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