Genomics and Personalized Medicine at FDA

1
Genomics and Personalized Medicine at FDA

• Elizabeth Mansfield, PhD
• OC/FDA
• elizabeth.mansfield_at_fda.hhs.gov
• ACLA May 7, 2009

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Role of Senior Genomics Advisor

• Now Senior Genomics and Personalized Medicine
  Advisor
• Report to Chief Science Officer (CSO), FDA
  (Dr.Goodman)
• New role at FDA
• Recommendation of FDA internal symposium on
  genomics
• Omics coordination suggested by Science Board

3
Overview

• Central internal view of FDAs omics activities
  and needs
• Represent omics with one voice
• Forge and maintain ties to appropriate external
  groups/programs
• Provide recommendations to CSO regarding omics
• Needs
• Options
• Build analytical capacity for cross-center access

4
FDA omics Activities Clear Overlap

• Centers

ORA
CDER
CBER
CDRH
CFSAN
NCTR
CVM
Basic
Basic
Basic
Invstgn
Basic
Basic
Basic
BMQ
BMQ
BMQ
Invstgn
Infor
Infor
Infor
Infor
Infor
Infor
Infor
Product Review
Product Review
Product Review
Product Review
Testing
VXDS
VXDS
VXDS
VXDS
Not intended to limit or be complete
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FDA omics Needs

• Easy intra/inter-center interaction
• Database capabilities
• Analytical capabilities
• Technology (arrays, reagents, etc)
• Common approach to validation

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Scientific Infrastructure

• Consider scientific needs across the Agency
• Address
• Common technology needs
• Consumables budgeting
• IT/scientific computing needs

7
Collaborations

• Identify and promote FDA scientific
  collaborations
• Intra-agency
• External HHS IAA
• External CRADA

8
Guidances

• Process
• Co-development/combination products
• Submission
• Etc
• Policy
• Genetic testing
• Genomics
• Labeling
• Use of information
• Etc

9
Informatics

• Assess and organize informatics needs
• Database structure/capacity
• Analytical tools
• Hardware
• Standards
• Staff

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A Face

• Represent certain aspects of omics and
  personalized medicine from point of view of FDA
• Serve as point of contact for internal and
  external interests
• Provide consolidated view of omics and PM to
  upper level agency staff

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Genomics in the ClinicWhat I See

• FDA has limited view
• Few FDA cleared/approved products
• CLIA validation packages
• VXDS packages
• Small steps, confusing messages
• Most providers dont understand
• Pharma and device industries not on same page
• Outcomes available to show improvement in care?

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What you should know

• Laboratory developed test Test developed by the
  laboratory offering it
• Clear implication of internal knowledge,
  validation, responsibility
• Not applicable to tests obtained through
  agreements, purchase, from others
• RUO means For research use only
• Not a regulatory loophole
• Proceed at your own risk
• Supply/demand equation

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More that you should know

• Consider who will be HARMED in addition to who
  will benefit
• Good science will drive good healthcare
• No shortcuts to the finish line

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Taking Suggestions
elizabeth.mansfield_at_fda.hhs.gov