Formal Meetings between IND Sponsors and FDA in Clinical Drug Development

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Formal Meetings between IND Sponsors and FDA in
Clinical Drug Development
Food Drug Administration in the
U.S. Copenhagen, Denmark November 5, 2008 Martin
M. Kaplan, MD, JD Drug Regulatory Affairs
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Main Objective of Presentation

• Provide overview of formal meetings with FDA in
  clinical drug development
• Review IND sponsor interactions with FDA for
  fast track products

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Collaboration between IND Sponsors and FDA

• IND sponsors and FDA share the common goal of
  seeking to advance the public health by helping
  to speed innovations that make medicines more
  effective or safer
• Meetings should be conducted in a spirit of
  mutual respect and cooperation based on this
  shared drug development goal

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Categories of Formal FDA Meetings

• Type A meeting a meeting that is immediately
  necessary for an otherwise stalled drug
  development program to proceed
• Type B meeting pre-IND, certain End-of-Phase 1,
  End-of-Phase 2 and pre-NDA/BLA meetings
• Type C meeting any FDA and sponsor meeting
  other than a Type A or Type B meeting regarding
  development of an investigational drug

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Type A meeting

• Immediately necessary for a stalled development
  program to proceed (e.g., IND clinical hold)
• Sponsor requests after receipt of FDA special
  protocol assessment
• Dispute resolution
• Timing scheduled to occur within 30 days of FDA
  receipt of written request
• Information package at least 2 weeks prior to
  formal meeting

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Pre-IND meeting (Type B)

• Focus on preclinical and clinical data supporting
  the design of the clinical protocol for the
  opening trial of the IND application
• Need to ask specific, answerable questions and
  present sound data-driven development proposals
• Agency advice based on information provided
• Timing scheduled to occur within 60 days of FDA
  receipt of meeting request letter
• Submission of meeting information package at
  least 4 weeks prior to formal meeting date

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End-of-Phase 2 Meeting (Type B)

• Most important meeting in drug development
• Determine safety for proceeding into Phase 3
• Reach agreement on clinical studies that will
  provide definitive support for product efficacy
  and safety
• Review draft labeling claims ensure that Phase
  3 clinical trial design supports labeling goals
• Timing scheduled to occur within 60 days of FDA
  receipt of meeting request letter
• Information package at least 4 weeks prior to
  formal meeting date

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Pre-NDA Meeting (Type B)

• Primary purpose uncover any major unresolved
  development issues
• Discuss adequacy of evidence of effectiveness in
  pivotal trials
• Review status of ongoing or needed pediatric
  studies
• Secure agency feedback on approach to
  presentation and formatting of data in NDA
• Identify and discuss any risk management issues

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Guidance Meeting (Type C)

• Discuss issues raised during the course of
  clinical development
• Questions and proposals need to be data driven
• FDA may, at its discretion, invite one or more
  Drug Advisory Committee members or other
  consultants to attend the meeting
• Sponsors may bring their own consultants
• For major scientific and medical policy issues,
  FDA may refer the matter to its Drug Advisory
  Committee for consideration and recommendations

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Guidance Meeting (cont.)

• Timing scheduled to occur within 75 days of FDA
  receipt of meeting request letter
• Information package submitted at least 2 weeks
  (preferably 4 weeks) prior to scheduled meeting
  date

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FDA Meetings General Comments

• Minutes of meetings are provided by FDA in 30
  days
• Minutes provided by sponsor are optional only
  useful if submitted promptly
• Disagreements about FDA written minutes sponsor
  sends letter to Division Director, citing
  recommended revisions and rationale
• If agency agrees, an addendum is made to the
  official FDA meeting minutes

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IND Sponsor and FDA Interactions on Fast Track
Products

• Definition of fast track products drugs
  intended to treat life-threatening and/or
  severely debilitating illnesses that demonstrate
  the potential to address unmet medical needs
• Early consultation (FDA Division of Anti-Viral
  Drug Products approach)
• IND sponsor sends pre-IND submission with
  specific questions to the Division
• Division internal review team holds meeting
  within 3 weeks of receipt of submission
• Division sends IND sponsor written letter with
  answers to questions and comments

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Fast Track Products (cont.)

• Pre-IND meeting
• End-of-Phase 1 meeting
• Review and reach agreement on design of Phase 2
  controlled clinical trials
• Goal is that Phase 2 trial data may be adequate
  to support early approval

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Fast Track Products (cont.)

• End of Phase 1/2 meeting some early clinical
  testing results available for review as important
  background for discussion of design of proposed
  new Phase 2 clinical trials
• Conventional End-of-Phase 2 meeting as previously
  described

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Summary

• IND sponsors are strongly encouraged to develop a
  mutually respectful, interactive relationship
  with the FDA
• For investigational drug developmentimportance
  of reaching agreement with FDA on proposed Phase
  3 clinical trial program at End-of-Phase 2
  meeting cannot be overemphasized

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