Center for Biologics Evaluation and Research Applying Regulatory Science to Advance Development of...
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Center for Biologics Evaluation and
ResearchApplying Regulatory Science to
Advance Development of Innovative, Safe and Effective
Biologic Products
Carolyn A. Wilson, Ph.D.Associate Director for Research
CBER Strategic Plan for Regulatory Science Follows
CBER’s Strategic Goals
Increase national preparedness to address threats from bioterrorism, pandemic and EIDs
Improve global public health through international collaboration
Enhance ability of science and technology to facilitate development of safe and effective biological products
Ensure safety of biological products Advance regulatory science and research Manage for organizational excellence
CBER Strategic Plan FY2012-2016: http://www.fda.gov/downloads/aboutfda/centersoffices/cber/ucm266867.pdfCBER’s Strategic Plan for Regulatory Science and Research:http://www.fda.gov/downloads/BiologicsBloodVaccines/ScienceResearch/UCM303542.pdf
Novel Product
Regulatory ChallengePublic Health
Regulatory Science
DiscoveryNew ToolsRegulatory
Policy/Decision
Licensed Product
Improved Data – Benefit/Risk
+
Using Science and Regulation to Advance Product Development
CBER researcher =“Researcher-Regulator”
~20% CBER Staff
Integration of research and review ensures
Relevance, Expertise, Timeliness, and Usability
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Nu
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CBER Advances Regulatory Science through External Collaborations
Data from FY13 CBER ResearchReporting Database
Annual Review of Research
PI providesFor each project
Progress reportFuture plansBudget Request
Presentations, PubsOther output
Information reviewedLab chief, DD, ADR, ODRelevanceProductivityQuality
Research Reporting Database
Funding AllocatedRelevance to priorityScientific/Reg OutputFeasiblity
Cyclic Peer Review of Every PI
Every 4 Years
External – Site Visitspeer review by scientific experts
Internal – Promotion, Conversion, Evaluation Committee
Site-Visit Reporto Draft report is distributed to full Advisory
Committeeo Final report is approved by full Advisory
Committee o Final report used in many ways:
o Internal peer review of research/PI by Promotion, Conversion, Evaluation Committee (PCE) for personnel actions
o By PIs for improving research programo By management, resource allocation
decisions may be impacted by report (pending resource availability)
Office of Vaccines Research and Review
Slides Courtesy of Konstantin Chumakov, PhDAssociate Director for Research, OVRR
Office of Vaccines Research and ReviewDirector
Marion Gruber, Ph.D. Deputy Director
Philip Krause, M.D.
Associate Director for ResearchKonstantin Chumakov, Ph.D.
Associate Director for Medical Policy and Vaccine SafetyKaren Farizo, M.D.
Associate Director For Management and Scientific Affairs
Erik Henchal, Ph.D.
Associate Directorfor Regulatory PolicyTheresa Finn, Ph.D.
Division of Bacterial, Parasitic and Allergenic
Products
Director: Jay Slater, M.D. Deputy: Drusilla Burns, Ph.D.
Division of Viral Products
Director: Jerry Weir, Ph.D.Deputy: Robin Levis, Ph.D.
Division of Vaccines and Related Products
Applications
Director: Wellington Sun, Ph.D.
Deputy: Loris McVittie, Ph.D.
To protect and enhance the public health by assuring the availability of safe and effective
vaccines, allergenic extracts, and other related products.
OVRR Mission Statement:
OVRR Regulatory Portfolio
• Bacterial vaccines (inactivated) – 10• Bacterial vaccines (live attenuated) –
2• Viral vaccines (inactivated) – 10• Viral vaccines (live attenuated) – 15• Combination products (inactivated) –
4• Allergenic extracts (diagnostic and
therapeutic) >2,000• Live biotherapeutic products – INDs
only
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 products
Conducting research related to the development, manufacture, and evaluation of vaccines and related products
OVRR Regulatory Challenges• Emphasis on SAFETY:
– Products for mass use (often universal)– Recipients are healthy individuals, often
children• Short regulatory cycle
– Seasonal influenza vaccines– Response to emerging pathogens
(pandemic vaccines)• Many products are old
– Innovative technologies• Research plays a critical role in
regulation of vaccines
OVRR Research Priorities• Safety
To study factors affecting safety of regulated products, create and validate appropriate methods and standards
• EfficacyTo study biomarkers and introduce new methods and standards to evaluate and improve vaccine efficacy
• AvailabilityTo develop new concepts and methods opening novel regulatory pathways to improve availability of vaccines and related products
Annual Program Review Cycle
Senior Investigat
or
Lab Chief
Division Director
Research Managem
ent Committee
Office IOD
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Looking Forward2014: Moving to White Oak
Campus
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White Oak Lab Facility• State-of-the-Art Vivarium
Imaging facility with MRI, digital X-ray, IVIS, ultrasound Transgenic derivation facility
• Expanded Space for Core Technologies: Flow cytometry Confocal microscopy High throughput sequencing and bioinformatic support
• 10 BSL-3 suites Designed to support work of at least 12 infectious
agents and work of 36 PI’s Many suites with capacity for animal holding rooms 1 suite to support sterile sorts and live cell confocal
microscopy on BSL-3 agents Insectariums (BSL-2 and BSL-3)
• Suites designed to support Microarray and PCR• Expanded NMR facility and Mass Spec Suites
Thank you!
To the Site Visit reviewers and Advisory Committee
Your input improves CBER’s research programs
External review is critical to fulfilling our regulatory mission!