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Critical Path Initiative ONDC Perspective

Critical Path Initiative ONDC Perspective. John Simmons, Ph.D. Office of New Drug Chemistry Office of Pharmaceutical Science. Outline. Critical Path Initiative Current Regulatory Research Risk Based Initiatives Future Programs. Critical Path Components. Critical Path Components.

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Critical Path Initiative ONDC Perspective

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  1. Critical Path InitiativeONDC Perspective John Simmons, Ph.D. Office of New Drug Chemistry Office of Pharmaceutical Science

  2. Outline • Critical Path Initiative • Current Regulatory Research • Risk Based Initiatives • Future Programs

  3. Critical Path Components

  4. Critical Path Components

  5. Critical Path Development

  6. Current ONDC Research • Inefficient • Reactive • Unfocused • Currently Developing New Paradigms Office Reorganization Review focus Research focus • Seeking Input and Guidance

  7. Recent Regulatory Research Activities • Conjugated Estrogens full characterization to establish criteria for pharmaceutical equivalence • Prussian Blue * establish the efficiency of in vitro Cs binding as an efficacy surrogate; free Cyanide safety issue • Inhalation Products develop in vitro methods to establish pharmaceutical equivalence - particle size, spray pattern, chemical imaging • Drug Eluting Stents joint center guidance * shortened critical path

  8. Conjugated Estrogens LC-ESI-MS Total Ion Chromatogram

  9. m/z 349 estrone-3-sulfate 17α-dihydroequilin-3-sulfate 17β-dihydroequilin-3-sulfate

  10. m/z 351 17α-estradiol-3-sulfate 17β-estradiol-3-sulfate

  11. Plume Image

  12. Typical Spray Pattern Major and D D and D Max Max Min Min Minor Axis

  13. Risk-Based CMC Review Benefits of a Risk-Based System • Patients • Increased availability • Faster approval of new products • Continued supply of quality products • FDA • More product and process knowledge shared by industry • More efficient resource allocation for review and inspection • Increased trust and understanding in decision making

  14. Risk-Based CMC Review Benefits of a Risk-Based System • Industry • More efficient, science-based inspections resulting in increased consistency and process understanding • Faster, more consistent reviews • Potential for reduced regulatory burden • Manage changes and nonconformance with less FDA oversight • Focuses resources on critical issues • Flexibility to focus on what should be done, not what can be done • Improves communication with FDA

  15. Pharmaceutical QualityThe New Paradigm (JW) • Need to examine and evaluate linkages between: • Quality attributes and clinical performance? • Values/specifications and safety & effectiveness? • cGMP compliance and safety & efficacy? • Ultimate Goal: The availability to the patient of high quality safe and effective drugs at reasonable cost

  16. The New Quality Assessment Paradigm • CMC specifications to be based on: • Risk-based assessment • Clinical Relevance • Safety Considerations • Process Capabilities • Knowledge gained from Pharmaceutical Development Reports • Better utilization of modern statistical methodologies • Assessment starts with a comprehensive Quality Overall Summary (QOS) • Review practices based on good scientific principles (cGSP) • Increased emphasis on manufacturing science • Peer/critical review of CMC evaluation by FDA scientists • Integration of review and inspection

  17. Benefits of New Quality Assessment Paradigm Less regulatory oversight for post-approval changes More incentive for continuous product improvement Reengineered supplement review More resources for new NDA review Streamlined CMC review of resubmissions Better and less expensive drugs to patients sooner First cycle approval of new drugs Risk-based quality assessment QbD and PDR by applicant Effective communication between FDA and applicant Comprehensive QOS by applicant Less review time

  18. Regulatory Future • CMC only meetings with industry • Quality by Design initiatives • IND Guidances quality sections quality - safety linkage • Process Analytical Technologies (PAT) • Integration of Review-Inspection • Strategies to facilitate 1st cycle approvals • Combination Products • Nano-particle drug products

  19. Next Steps • Regulatory Issues PAT Guidance implementation CMC Guidance Revisions Combination Product Guidances Review-Inspection Integration

  20. Future Goals • Establish a meaningful regulatory science program to support drug development and review • Explore regulatory mechanisms to speed product approval

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