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Title: Investigational New Drug Applications FDA Trends and Clinical Issues


1
Investigational New Drug Applications FDA
Trends and Clinical Issues
Longmont Life Science ThursdayRadisson
Conference Center May 12, 2005 Jeanne M.
Novak, Ph.D. CBR International Corp. Boulder, CO
80301 ltwww.cbrintl.comgt
2
Current FDA Changes and Issues
  • Reorganization of Centers and addition of
    new offices
  • Congressional pressure to focus on
    facilitating pipeline of new drugs
  • Agency awareness of need for expertise
  • World issues and harmonization of standards
  • Launch of numerous new initiatives

3
Current FDA Changes and Issues Reorganization of
Centers
  • Development of Office of Combination
    Products Dec 24, 2002
  • Transfer of biotechnology products from
    CBER to CDER June 30, 2003
  • Office Drug Evaluation VI (within Office of New
    Drugs)
  • Office of Biotechnology Products (within
    Office of Pharmaceutical Science)

4
Current FDA Changes and Issues Reorganization of
Centers
  • Establishment of
  • Office of Oncology Drug Products
  • July 16, 2004
  • Nation-wide search for a Director

5
Clinical Development - Overview
BLA/NDA/PMA
IND
Drug Discovery
Phase 1
Phase 2
Phase 3
Development
Preclinical
GLP
GMP
6
Recent FDA Initiatives
  • FDAMA - 1997
  • Systems-Based Inspections Feb 1, 2002
  • 21 CFR Part 11 Guidance Nov 12, 2002
  • Pharmaceutical cGMPs for the 21st Century
  • A Risk-Based Approach Aug 21, 2002
  • Process Analytical Technology Aug 2003
  • Critical Path to New Medical Products Mar 04

7
Recent World Initiatives
  • Clinical Trials Directive
  • Effective May 1, 2004 throughout the EU
  • Requires that all material to be used in
    clinical trials be reviewed and certified by a
    Qualified Person (QP) to ensure manufacture
    according to cGMP.

8
Current FDA Changes and Issues Focus on Pipeline
of New Products
  • Congress has asked the Agency to
    evaluate current regulation of generic drugs
  • Congress has taken a special interest in the
    issue of biogenerics and how to
    regulate follow-on biologics

9
Critical Path to New Medical Products
  • March 16, FDA released a report addressing the
    recent slowdown in innovative medical therapies
    submitted to the FDA for approval
  • "Innovation/Stagnation Challenge and
    Opportunity on the Critical Path to New
    Medical Products."
  • Urgent need to modernize the medical product
    development process -- the Critical Path -- to
    make product development more predictable and
    less costly.

10
Critical Path to New Medical Products
11
Critical Path to New Medical Products
12
Critical Path to New Medical Products
13
Critical Path to New Medical Products
14
Critical Path to New Medical Products
15
Critical Path to New Medical Products
16
Critical Path to New Medical Products Impact on
Industry
  • FDA will ask for industry participation in
    identifying areas of medical need
  • FDA will expect industry to increase quality
    standards and efficiency to assist in filling
    the pipeline at an increased rate
  • Some evidence of increasing standards seen in
    recent inspections

17
Clinical Programs for New INDs
  • 1. Choose Clinical Indication(s)
  • 2. Draft Overall Clinical Plan(s) EARLY
  • Develop Nonclinical Studies to Support
    Clinical Studies
  • Consider Timelines for Parallel Program
    Efforts
  • Plan for Both Success and Failure

18
Clinical Programs for New INDs
  • Choose Clinical Indication(s)
  • - As soon as molecular activity known,
    prioritize potential target indications.
  • - Prioritization should match company goals
    consider time to clinic, time to approval, cost,
    enrollment issues, target population.

19
Clinical Programs for New INDs
  • Draft Overall Clinical Plan(s) EARLY
  • - Include the potential target indications
    and timelines
  • - Include list of studies for each
    indication
  • - Prepare CTO for the first two studies
    planned
  • - Consider all countries in which studies
    will be run
  • - Include guidelines for continuation (or
    discontinuation) of program
  • - Prepare a sketch of nonclinical studies
    required

20
Clinical Programs for New INDs
3. Develop Nonclinical Studies to Support
Clinical Studies - DO NOT do every
experiment! Perform Proof of Concept - Plan
for limited nonclinical PK, MIC, toxicology,
ADME programs to support initial clinical -
Get FDA feedback to insure these studies are
adequate
21
Clinical Programs for New INDs
  • Consider Timelines for Parallel Program Efforts
  • - CMC Plan for the amount of product required
    for nonclinical and initial clinical
  • - QC Develop necessary release and
    stability assays
  • - QA Develop QA oversight appropriate for
    the clinical phase of development

22
Clinical Programs for New INDs
  • Plan for Both Success and Failure
  • - Structure the early clinical trials to
    support alternate routes of administration and
    alternate indications
  • - Plan for accelerated development by
    considering limitations in product
    availability site availability etc.

23
Points for Clinical Study Conduct
  • Establish RIGOROUS site selection criteria
  • Consider IRB delays in timeline planning
  • Establish routine oversight and reporting
    mechanisms (AEs SAEs enrollment stats)
  • Develop clinical study documents that not only
    support the trial but support next study
  • Beta test CRF format and content
  • Beta test data collection methods clinical
    tests and outcome measures

24
Clinical Programs for New INDs
  • 1. Choose Clinical Indication(s)
  • 2. Draft Overall Clinical Plan(s) EARLY
  • Develop Nonclinical Studies to Support
    Clinical Studies
  • Consider Timelines for Parallel Program
    Efforts
  • Plan for Both Success and Failure
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