Clinical Genomics Sub-team

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Clinical Genomics Sub-team

• Sub-team is one of three that evolved out of the
  DIA Pharmacogenomics Standards Workshop.
• Workshop was product of collaborative effort
  between DIA, FDA, and several industry
  organizations (PWG, PhRMA, and BIO) and in
  follow-up to an earlier workshop (May 2002) that
  focused implication of PG and issues and
  application of these technologies in drug
  development and regulatory decision-making.
• Intent of this workshop was to provide forum for
  detailed review of the PDA proposal and draft
  guidance for PG Data Submissions. This guidance
  is intended to encourage voluntary submissions as
  well as submission of data in support of a
  regulatory decision-making.

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Clinical Genomics Sub-team

• Broad sponsorship and involvement HL7, CDISC,
  I3C, FDA
• Started with the use cases that were included in
  Backgrounder document from this meeting (put
  together to guide and stimulate discussion around
  FDA draft guidance document).
• Created a flow chart that based on a selected use
  case.

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Key Issues

• Standards are important for pharmacogenomics
  submission data because
• a) there is a large amount of data to handle
• b) it is necessary and desirable to compare
  across trials and
• c) need for consistency in review by various
  organizations (biotechs, CROs, FDA).
• In order to develop a recognizable standard in a
  short timeframe, subteam has agreed we should not
  develop something totally new but rather adapt
  existing standards to our needs
• We need to increased our understanding of what
  the FDA wants to review.
• Should we focus on the FDA required submissions
  or the voluntary submissions? Is there a
  difference in scope?

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Next steps

• Increase our understanding of what the FDA would
  like to see.
• Focus on one scenario (the microarray scenario).
• Review and leverage work already done by SEND and
  CDISC groups. FDA will likely want to integrate
  data from different sources through their viewing
  tools.
• Identify other existing standards that can be
  used.
• Provide comments to FDA relevant to Draft
  Guidance
• Harmonize with other relevant models