FDA Role in Medical Error Prevention by fdshsdhs


									               Update From FDA:
Office of the Commissioner and Center for Drug
            Evaluation and Research

             Janet Woodcock, M.D.
             Acting Deputy Commissioner for Operations
             Food and Drug Administration
             April 7, 2005
    Medical Imaging and The
     Critical Path Initiative

   Central focus of critical path is
    developing new biomarkers and
    other evaluative technologies
   Imaging is seen as a key
    technology for assessing,
    accelerating development and
    guiding use of new therapeutic
    Development of Imaging Technologies as
       Biomarkers and Surrogate Markers

   Developing these data involves significant time and

   Lack of clear commercial pathway limits enthusiasm

   However, absence of data curtails evolution of medical
    practice as well as medical product development: this
    situation is very frustrating for therapeutic developers as
    well as for those working on biomarkers

   Similar conundrum for in vitro diagnostics
      FDA Critical Path Initiative

   FDA seeks mechanisms for qualifying such
    new biomarkers for regulatory use

   Imaging technologies are at the forefront of
    our efforts

   We believe that synergy between current
    drug development programs and imaging
    networks can be created to get this work
    done in a cost effective manner
      FDA Critical Path Initiative

   FDA will also begin an initiative to
    describe the general processes for
    biomarker and surrogate marker
    qualification for regulatory use

   This effort should help clarify the
    pathways for development of these
                 Critical Path Focus:
           Better Utilize Imaging as a Tool
                in Drug Development

   Overall evaluation of use of imaging in drug

   Facilitating use of molecular probes and other
    imaging techniques in early clinical trials

   Use of imaging in development of cancer
          Use of Imaging in Drug

   FDA conducted internal survey: broad use of imaging
    in multiple therapeutic areas

   Workshop: DIA Co-sponsored; May 5 & 6, 2005

   Hope to develop specific qualification projects in
    promising areas
 Facilitating Use of Molecular Probes and
other Imaging Techniques in Early Clinical

   Meeting on RDRC process

   Master file concept for probes

   Draft “Exploratory IND” Guidance

   Draft guidance on laboratory production of
    clinical supplies
             Exploratory IND

   “Phase 0” studies – prior to traditional
    drug development Phase 1 trials

   Microdose or low dose-limited period of
          Exploratory IND     (cont.)

   Toxicology to support use may be
    similarly abbreviated

   May be used for proof-of-mechanism,
    screening multiple compounds,
    microdose, imaging
     Laboratory Production – Draft

   Appropriate methods and quality control for
    small scale production

   Explain what should be filed in IND vs.
    records kept at site
    • Reflects FDA’s longstanding position – not
      previously articulated
    • Developed in collaboration with NCI
Use of Imaging in Development of
        Cancer Treatments

   Critical Path issue: Lack mechanism to rapidly incorporate
    new science/technology into evaluations (e.g. response)
    done in development trials

   Measurements of tumor size as a surrogate for response

   Measurement of other tumor parameters (e.g. glucose
    uptake) as a response surrogate

   Combination measurements in composite EPs
       Collaborations with NCI

   Evaluation of use of FDG-PET in
    therapeutic cancer trials

   Evaluation of molecular probes

   Review of use of RECIST criteria in
    cancer trials
                Desired Outcomes

   “Gap analysis” : Current data on technology used
    in a particular tumor vs needed data for adoption as
    response measure in trials

   “Trial analysis” : What trials, using what active
    agents, would be needed to fill in these gaps?

   Mechanisms to conduct such studies
     How to Get Such Work

   New opportunities for collaboration
   Many stakeholders will have to
    participate: FDA, NCI, drug and
    biologic developers, ?payors,
    medical imaging industry
   Hope studies can be designed to
    synergize with ongoing trials or with
    clinical care so that expense will not
    be prohibitive
        Reorganizations within CDER

   Creation of Office of Oncology Drug Products within CDER

   Medical Imaging will be one of three Divisions

   Consolidation of monoclonal antibody imaging agents &
    other biologics with traditional drug imaging agents

   Progress ongoing – should be complete by summer
 Reorganization: Facilitate
 Movement of New Science
into Cancer Drug Evaluation

    We believe that new imaging
     technologies as well as
     pharmacogenomics will be
     taken up first in cancer drug
    We hope that this will
     happen in a deliberate way
     rather than haphazardly

   Imaging technologies are currently
    very important, and will become even
    more crucial to cancer therapeutic
   FDA, under its critical path initiative,
    is seeking to advance development of
    these imaging biomarkers in an
    organized fashion

   Accomplishing this will require
    extensive collaboration across
    many stakeholders—and close
    attention to IP issues
   NCI and FDA are collaborating
    in this effort

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