Advisory Committee Role in Facilitating FDA Scientific Collaboration Concept and Proposal for a Pharmaceutical Science Subcommittee Science Advisory Board to the NCTR June 11, 2001 James T. MacGregor, Ph.D., D.A.B.T. Deputy Director, NCTR Washington

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Advisory Committee Role in Facilitating FDA
Scientific CollaborationConcept and Proposal
for a Pharmaceutical Science Subcommittee
Science Advisory Board to the NCTRJune 11,
2001James T. MacGregor, Ph.D., D.A.B.T.Deputy
Director, NCTR Washington Operations C\advc
omm\nctrsab\jtm61101

• cmydocs\advcomm\ncss\ncsslssp.ppt

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How can FDA focus and leverage resources to
capitalize on new scientific opportunities?

• Use Advisory (Sub)Committee Structure to
• Identify and recommend focus areas
• Identify experts in focus areas form expert
  working groups (EWGs) with nominations from
• Federal Register announcements (Public)
• FDA and Stakeholders (Collaborators)
• Professional Societies
• Steer collaborative projects
• Convene workshops, symposia
• Facilitate reporting recommendations

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History of the Nonclinical Studies Subcommittee,
Advisory Committee for Pharmaceutical Science

• CDDI Concept (1996-98)
• Nonclinical Studies Subcommittee (NCSS),
  Advisory Committee for Pharmaceutical Science
  (ACPS)
• 8/31/99 Meeting to develop concept
• 9/99 ACPS endorsed concept
• 12/00 Focus areas selected (accessible biomarkers
  noninvasive imaging)
• 3/00 Specific EWGs endorsed (cardiotoxicity
  vasculitis)
• 10/00 Nominations for EWGs received
• 1/01 FDA selected EWG members
• 5/3-4/2001 NCSS/EWG joint meeting, EWGs begin
  working

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Nonclinical Studies Subcommittee

• Functions
• To provide advice on improved scientific
  approaches to nonclinical drug development
• To foster scientific collaboration among FDA,
  industry, academia, and the public

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Objectives

• 1. To recommend approaches and mechanisms to
  improve
• Nonclinical information for effective drug
  development
• Predictivity of nonclinical tests for human
  outcomes
• Linkage between nonclinical and clinical studies
  
• and
• 2. To facilitate collaborative approaches to
  advancing the scientific basis of drug
  development and regulation

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Current participants

• FDA
• CDER
• CBER
• NCTR
• Industry
• PhRMA
• BIO
• Academia
• Public Research Institutions
• NIH (NIEHS NTP)

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Subcommittee Composition

• John Doull, Univ. Kansas (Chair)
• Jim MacGregor, NCTR (FDA Coordinator)
• Dave Essayan, CBER (CBER Liaison)
• Jack Reynolds, PhRMA (DruSafe Chair)
• Joy Cavagnaro, BIO
• Jack Dean, ACPS (Sanofi-Synthelabo)
• Gloria Anderson, ACPS (Morris Brown Univ.)
• Jay Goodman, Michigan State University
• Raymond Tennant, NIH, NIEHS
• Daniel Casciano, NCTR

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Future of the Nonclinical Studies Subcommittee?

• Focus is on nonclinical safety assessment
• NCTR has mandate and structure to lead in this
  area
• FDA Subcommittee Liaison now at NCTR
• ICCVAM process for Agency adoption of new
  methodologies now at NCTR
• Should Subcommittee be affiliated with the NCTR
  SAB?
• Is this a good model for implementation in other
  Advisory Committees?