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Office of Biostatistics Center of Drug Evaluation and Research, FDA Presented at ASA Caucus of Academic Representatives. Ram Tiwari, Ph.D. Office of Biostatistics Center for Drug Evaluation and Research U.S. Food and Drug Administration [email protected] Outline.

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Office of Biostatistics Center of Drug Evaluation and Research, FDAPresented at ASA Caucus of Academic Representatives

Ram Tiwari, Ph.D.

Office of Biostatistics

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

[email protected]


Outline
Outline

  • FDA location and Organizational Charts

  • What FDA statisticians do

    - Review of Drug Products

    - Presentations at Advisory Committees

    - Write Guidance Documents for Industry

    - Regulatory Research and Professional

    Activities

    - Training, Communication and Outreach

  • Career Opportunities at FDA



New

Center

10

70

150

10

40

10

290 Statisticians at FDA and Growing!


Cder organization a condensed version
CDER ORGANIZATIONa condensed version


Cder office of biostatistics director robert t o neill
CDER Office of BiostatisticsDirector: Robert T. O’Neill


Typical activities for an ob statistician
Typical Activities for an OB Statistician

  • Review the statistical aspects of the drug development process

  • Present at the advisory committee meeting

  • Provide the statistical perspective to policy and guidance working groups

  • Continue to develop professionally:

    • Conduct research on regulatory science

    • Participate/ Present at Professional Meetings


Cder drug biologic review team
CDER Drug/Biologic Review Team

  • Clinicians

  • Statisticians

  • Clinical Pharmacologists

  • Chemists

  • Pharmacologists /Toxicologists

  • Microbiologists

  • Safety Reviewer

  • Project Managers

  • Other Scientists, if needed


Communication dynamics between fda and industry

Micro

Chem

Stats

Clinical

Pharm/Tox

ClinPharm

Communication Dynamics between FDA and Industry

Industry

Project Team

Project Manager

Regulatory Affairs


Types of Applications

  • IND: Investigational New Drug Application

  • NDA: New Drug Application

  • BLA: Biologics License Application


Statistical review of nda bla
Statistical Review of NDA/BLA

  • Review study protocol and conduct of trial and sponsor’s analyses

  • Perform additional analyses, if necessary

    • Re-analyze the primary efficacy data

    • Conduct sensitivity analyses

  • Review proposed label


Advisory Committee Meetingshttp://www.fda.gov/AdvisoryCommittees/default.htmhttp://www.fda.gov/ohrms/dockets/ac/acmenu.htm

  • Typical issues at these meetings

    • Safety, efficacy, risk/benefits questions

    • Dosing concerns

    • Target population or labeling issues

    • Guidelines/Study/Protocol designs

    • Appeals of FDA decision


Cder special government employees partial list
CDER Special Government Employees(Partial List)

Victor De Gruttola Thomas Flemming

David Harrington Richard Gelber

James H. Ware Daniel Oakes

Lee-Jen Wei Stephen George

Marvin Zelen Daniel Gillen

Dianne Finkelstein Michael Ginsworld

David Schoenfield Robert Hamer

Scott Evans Joan Hsu

Phillip Lavin Andrew Leon

Janet Anderson James Neaton

John C. Crawley David MeMets

Li Ming Dong Weichung Shih

Dianne Sisfo Thomas Ten Have

Robert Woolson Mary Lindstrom

Ying Lu Warren B. Bilker

Daniel Sargent


Guidance for Industry Adaptive Design Clinical Trials

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document contact Robert O’Neill or Sue-Jane Wang at 301-796-1700, Marc Walton at 301-796-2600 (CDER), or the Office of Communication, Outreach and Development (CBER) at 301-800-835-4709 or 301-827-1800. U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

January 2010

Clinical/Medical


Guidance for Industry Non-Inferiority Clinical Trials

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within ___ days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document contact Robert O’Neill or Robert Temple (CDER) at 301-796-1700, or the Office of Communication

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

January 2010

Clinical/Medical


Guidance for Industry Multiple Endpoints in Clinical Trials

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within ___ days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document contact Mohammad Huque, Robert O’Neill or Robert Temple (CDER) at 301-796-1700, or the Office of Communication

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

January 2010

Clinical/Medical


Work in Progress on Other TWO Guidance Documents

  • Prevention and Treatment of Missing Data in Clinical Trials- National Academy of Sciences Report

  • Meta-Analysis for Safety Evaluation


Professional meetings research activities
Professional Meetings/ Research Activities

  • 4th Annual FDA/DIA Statistics Forum

  • Midwest Biopharmaceutical Statistics Workshop

  • DIA Annual Meeting

  • ICSA 2010

  • Applied Statistics Symposium

  • Joint Statistical Meetings 2010

  • FDA/Industry Statistics Workshop


The critical path to new medical products
The Critical Path to New Medical Products

  • Better Evaluation Tools

  • Streamlining Clinical Trials

    • Adaptive Trial Designs

    • Non-inferiority Trials

    • Multiple Endpoints in Clinical Trials

    • Enriched Trial Designs

  • Harnessing Bioinformatics

  • Moving Manufacturing into the 21st Century

  • Developing Approaches to Address Urgent Public Health Needs

    • Sentinel Initiative*

  • Specific At-Risk Populations -- Pediatrics

http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative


Regulatory science and review enhancement rsr
Regulatory Science and Review Enhancement (RSR)

  • CDER Regulatory Science and Review

  • Enhancement Program

    • RSR MaPP

    • Overview of 2011 RSR Program

  • RSR 2011 Cycle *Updated* (Deadline July 16, 2010)

    • Call for 2011 RSR Applications

    • Guidelines for RSR 2011

    • RSR 2011 Application Form

    • Instructions for Completion, Approval and Submission of RSR Application Form

  • RSR Presentations and Awardees (2007-2009)


Cder science projects and publications databases
CDER Science Projects and Publications Databases

  • The CDER Science Projects Database contains basic information about all CDER science and research projects and programs in a searchable format. The database was developed as an information and research management tool. It provides an opportunity for each investigator to clearly communicate the rationale, impact and relevance of their project/program to a broad audience.

  • All CDER science projects and programs must have an entry in the Research Database. If your project is not in the database, please contact your Division Director. They can contact Jorge Urrutia.

  • The CDER Publications Database captures publications and abstracts from the entire FDA. CDER publications resulting from research projects in CDER link back to the corresponding project description in the CDER Science Project Database.

  • Please check that your publications are in the database by performing a Custom Search using your last name in the Author field. If some of your publications are missing, please click on Add Entry link on the Publications Database page to enter them, or email the citations to Tom Maudru.


Fda commissioner s fellowship program
FDA Commissioner’s Fellowship Program

  • Two-year Program, which provides an opportunity for health professionals and scientists to receive training and experience at the FDA.

  • Designed to provide in-depth understanding of science behind regulatory review, drugs, devices, biologics and cosmetics

  • OB Preceptor: Dr. Ram C. Tiwari, Associate Director

    • http://inside.fda.gov:9003/EmployeeResources/EmploymentOpportunities/CommissionersFellowshipProgram/default.htm


Internship program
Internship Program

  • Oak Ridge Institute for Science and Education (ORISE) Internship program

    • The Office of Biostatistics has contracted with ORISE to administer a summer internship program to enable graduate students in statistics to work with some of our staff on important research projects.

      • http://see.orau.org/

  • Internships through CP and RSR Projects


For more information about careers in statistics at fda
For More Information about Careers in Statistics at FDA:

  • For Links to employment information: http://www.fda.gov/cder/Offices/Biostatistics/

  • http://www.fda.gov/jobs/positions08.html

  • For U.S. Citizens: http://www.usajobs.opm.gov

  • For U.S. Citizens and non-U.S. Citizens, both with and without green cards: Contact/send resumes to S. Edward Nevius, Deputy Director, FDA/CDER Office of Biostatistics: [email protected]


Concluding remarks
Concluding Remarks

  • The Office of Biostatistics, CDER, would welcome academic institutions’ increased participation in:

  • FDA Advisory Committees

  • OB Ambassadors Program

  • Commissioner’s Fellowship

  • Internship Program

  • Sabbatical/Visitors


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