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
Ram.tiwari@fda.hhs.gov
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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
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FDA White Oak Campus, Silver Spring, MD
OB/Building 21
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New
Center
290 Statisticians at FDA and Growing!
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CDER ORGANIZATION
a condensed version
CDER
Pharmaceutical
Sciences
New Drugs
Surveillance &
Epidemiology
Translational
Sciences
Clinical
Pharmacology
Biostatistics
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CDER Office of Biostatistics
Director: Robert T. O’Neill
DB1
Cardiovascular & Renal; Neurological; Psychiatric
DB2
Pulmonary & Allergy; Metabolism & Endocrine; Analgesics &
Anesthetics
DB3
Gastrointestinal; Reproductive & Urologic; Dermatologic &
Dental
DB4
Anti-Infective & Ophthalmology; Anti-Viral; Special Pathogen &
Transplant
DB5
Oncology Biologics; Oncology Drugs; Imaging & Hematology
DB6
Generics; Pharmacology & Toxicology; Chemistry &
Manufacturing; Special Projects
DB7
Quantitative Safety & Pharmacoepidemiology
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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
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CDER Drug/Biologic Review Team
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Clinicians
Statisticians
Clinical Pharmacologists
Chemists
Pharmacologists /Toxicologists
Microbiologists
Safety Reviewer
Project Managers
Other Scientists, if needed
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Communication Dynamics between FDA and
Industry
Chem
Micro
Project Team
Stats
Pharm/
Tox
Clinical
Clin
Pharm
Project
Manager
Regulatory
Affairs
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Types of Applications
• IND: Investigational New Drug Application
• NDA: New Drug Application
• BLA: Biologics License Application
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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
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Advisory Committee Meetings
http://www.fda.gov/AdvisoryCommittees/default.htm
http://www.fda.gov/ohrms/dockets/ac/acmenu.htm
• Typical issues at these meetings
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Safety, efficacy, risk/benefits questions
Dosing concerns
Target population or labeling issues
Guidelines/Study/Protocol designs
Appeals of FDA decision
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CDER Special Government Employees
(Partial List)
Victor De Gruttola
David Harrington
James H. Ware
Lee-Jen Wei
Marvin Zelen
Dianne Finkelstein
David Schoenfield
Scott Evans
Phillip Lavin
Janet Anderson
John C. Crawley
Li Ming Dong
Dianne Sisfo
Robert Woolson
Ying Lu
Daniel Sargent
Thomas Flemming
Richard Gelber
Daniel Oakes
Stephen George
Daniel Gillen
Michael Ginsworld
Robert Hamer
Joan Hsu
Andrew Leon
James Neaton
David MeMets
Weichung Shih
Thomas Ten Have
Mary Lindstrom
Warren B. Bilker
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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
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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
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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
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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
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Professional Meetings/ Research Activities
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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
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The Critical Path to New Medical Products
1.
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Better Evaluation Tools
Streamlining Clinical Trials
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Harnessing Bioinformatics
Moving Manufacturing into the 21st Century
Developing Approaches to Address Urgent Public Health
Needs
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Adaptive Trial Designs
Non-inferiority Trials
Multiple Endpoints in Clinical Trials
Enriched Trial Designs
Sentinel Initiative*
Specific At-Risk Populations -- Pediatrics
http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative
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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)
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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)
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CDER Science Projects and Publications
Databases
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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.
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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.
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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.
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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.
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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/EmploymentOpport
unities/CommissionersFellowshipProgram/default.htm
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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
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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: SEdward.Nevius@fda.hhs.gov
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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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