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Center for Biologics Evaluation and Research. Applying Regulatory Science to Advance Development of Innovative, Safe and Effective Biologic Products. Carolyn A. Wilson, Ph.D. Associate Director for Research. CBER Mission.

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center for biologics evaluation and research

Center for Biologics Evaluation and Research

Applying Regulatory Science to Advance Development of Innovative, Safe and Effective Biologic Products

Carolyn A. Wilson, Ph.D.

Associate Director for Research

cber mission

CBER Mission

To ensure the safety, purity, potency, and effectiveness of biological products, including vaccines, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions, or injury; and help to defend the public against the threats of emerging infectious diseases and bioterrorism

cber regulates complex products
CBER Regulates Complex Products

Cell & Gene Therapies

Blood, Blood Components and Derivatives

Vaccines: Preventive &

Therapeutic

Xenotransplantation

Products

Tissues

Therapeutic Probiotics

Related Devices

Allergenic Products

cber strategic goals
CBER Strategic Goals
  • Increase national preparednessto address threats from bioterrorism, pandemic and EIDs
  • Improve global public health through international collaboration
  • Enhance ability of science and technologyto 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.pdf

slide5

Regulatory Science:

Development and use of the scientific knowledge, tools, standards, and approaches necessary for the assessment of medical product safety, efficacy, quality, potency,

and performance.

FDA Strategic Plan for Regulatory Science

http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm267719.htm

cber vision for regulatory science and research
CBER Vision for Regulatory Science and Research
  • Proactive, responsive, and collaborative
  • Provide CBER with scientific expertise, tools, and data to support science-based decision making and policy development
role of cber research
Role of CBER Research
  • CBER research occupies a well-defined critical niche at the end of product development pipeline
  • CBER scientists are uniquely positioned to address scientific issues related to safety and efficacy of medicinal products
  • The results remain in public domain and benefit the entire industry
using science and regulation to advance product development
Using Science and Regulation to Advance Product Development

Novel Product

Regulatory

Challenge

Licensed

Product

Public Health

+

Improved

Data –

Benefit/Risk

Regulatory

Science

Discovery

New Tools

Regulatory

Policy/Decision

cber organization
CBER Organization

Communication,

Outreach and Development

Director

Deputy

Associates

Management

Compliance,

Biologics Quality

Biostatistics and

Epidemiology

Cellular, Tissue, and

Gene Therapies

Vaccines Research

And Review

Blood Research

And Review

cber research facilities
CBER Research Facilities
  • Biotechnology Core Facility
    • Oligonucleotide, siRNA, PNA, and peptide synthesis
    • Peptide and DNA sequencing
    • Taqman Probe synthesis
    • HPLC; Capillary electrophoresis
    • Mass Spectrometry/Proteomics
    • Amino acid analysis
  • Core support for
    • Flow Cytometry: Sorting/Analytic
    • Confocal microscopy
  • Vivarium with procedure rooms
    • Rodents, NHP, BSL-2 capacity for infectious agents
  • BSL-3 and ABSL-3 laboratories
scientific expertise
Scientific Expertise
  • Novel technologies: NMR, mass spec, flow cytometry, high throughput sequencing, microarray
  • Microbiology:
    • parasitology, bacteriology, virology
  • Immunology
  • Biochemistry and molecular biology
  • Cell and developmental biology
  • Biostatistics and epidemiology
cber researcher researcher regulator 20 cber staff

CBER researcher =“Researcher-Regulator”~20% CBER Staff

Integration of research and review ensures

Relevance, Expertise, Timeliness, and Usability

cber advances regulatory science through external collaborations

CBER Advances Regulatory Science through External Collaborations

Data from FY11 CBER Research

Reporting Database

annual review of research
Annual Review of Research

PI provides

For each project

Progress report

Future plans

Budget Request

Presentations, Pubs

Other output

Information reviewed

Lab chief, DD, ADR, OD

Relevance

Productivity

Quality

Research Reporting

Database

Funding Allocated

Relevance to priority

Scientific/Reg Output

Feasiblity

the purpose of research management
The purpose of research management

To reconcile investigator-initiated research model with the needs dictated by FDA mission

cyclic peer review of every pi every 4 years
Cyclic Peer Review of Every PI Every 4 Years

External – Site Visits

peer review by scientific experts

Internal – Promotion, Conversion, Evaluation Committee

site visit report
Site-Visit Report
  • Draft report is distributed to full Advisory Committee
  • Final report is approved by full Advisory Committee
  • Final report used in many ways:
    • Internal peer review of research/PI by Promotion, Conversion, Evaluation Committee (PCE) for personnel actions
    • By PIs for improving research program
    • By management, resource allocation decisions may be impacted by report (pending resource availability)
office of vaccines research and review

Office of Vaccines Research and Review

Slides Courtesy of

Konstantin Chumakov, PhD

Associate Director for Research, OVRR

ovrr mission statement
OVRR Mission Statement

Protect and enhance the public health by assuring the availability of safe and effective vaccines, allergenic extracts, and other related products.

ovrr activities
OVRR Activities
  • Review, 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 research
OVRR Research
  • Contributes to regulation of vaccines and related products by addressing scientific aspects of critical regulatory issues
  • Develops and maintains a scientific base for establishing methods and standardsdesigned to ensure the continued safety, purity, potency and effectiveness of vaccines and related products
  • Recruits and maintains highly trained scientistswho possess the expertise necessary for review of regulatory submissions and development of regulatory policies and guidance documents
  • Provides scientific expertise and leadership to vaccine industryto facilitate the development and introduction of new vaccines and related products
ovrr research management process
OVRR Research Management Process

Site visit, Advisory committee recommendations

Research Management Committee

OVRR

CBER

Lab Chief

Principal Investigator

Proposal

Current priorities

Laboratory projects

Current regulatory issues

Division Director

Division research portfolio

Regulatory Division

Annual Research Plan

Budget projection

ovrr rating of research projects
OVRR Rating of Research Projects
  • PUBLIC HEALTH SIGNIFICANCE
    • Public health need — dealing with high priority issue
    • Immediate regulatory relevance — pending applications exist
    • Strategic regulatory relevance — resolving general regulatory challenge of major importance
    • Office/Division needs — fills a gap in the overall research program
  • SCIENTIFIC MERIT
    • Scientific rationale
    • Originality and innovation
    • Feasibility of research approach
    • Budget (affordability)
  • QUALIFICATIONS AND PRODUCTIVITY
    • Necessary qualifications
    • Past productivity of investigator/impact
thank you
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!