Transcript Regulatory Challenges - Global Campaign for Microbicides

Regulatory Challenges
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A Diversity of Considerations
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Ethical
Cultural
Regulatory standards
Strained resources
Competing priorities
Training
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Peter Karlton
The Imperative of Sexual
Autonomy
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Any degree of efficacy is significant if
it provides women with increased
sexual autonomy, especially in
circumstances where a woman has
little or no control over the use of
condoms.
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Peter Karlton
Tenofovir 1% Gel
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Unique mechanism of action
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Absorbed into tissue and blood
• Prevents virus from growing
Applied discretely 12 hours before and after
coitus
 Low dose may reduce chance of resistance
 May slow progression of disease if women
becomes infected
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Peter Karlton
Creams and Gels:
Unique Dosage Forms
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Require specialized training and expertise
Unlike solid-oral dosage forms, e.g.,
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Unique physical-chemical properties
Specialized manufacturing and controls
Compatibility with drug delivery applicators
Complex stability characteristics
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Peter Karlton
Opportunity for Collaboration:
Academia, Regulatory, Industry
Providing regulators with the tools to
assess semi-solid dosage forms
requires a commitment from both
academia and the pharmaceutical
industry.
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Peter Karlton
Collaboration with Developing
World Health Agencies
Major regulatory agencies must work
innovatively with developing world
health agencies to create uniform
guidance on the non-clinical
and clinical development of TMs
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Peter Karlton
FDA Guidance on Non-Clinical
Development
August 20, 2003, Antiviral Drugs Advisory
Committee Meeting (Bethesda, MD)
 Clinical Development of Topical
Microbicides: U.S. Regulatory
Perspective, Teresa C. Wu, M.D., Ph.D.,
FDA, March 28-31, 2004, Microbicides
2004 Meeting, London, UK.
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Peter Karlton
Additional Sources of
Regulatory Significance
Recommendations for the Development
of Vaginal Microbicides, International
Working Group on Vaginal Microbicides.
AIDS. 2001 May 4;15(7):857-68.
 Recommendations for the Nonclinical
Development of Topical Microbicides for
Prevention of HIV Transmission: An
Update. J Acquire Immune Defic Syndr
2004, 36:541-552.
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Peter Karlton
Basic Assumptions About ART
Registration in the Developing World
Abbreviated dossier with summarized
information.
 Known safety and efficacy of Viread and
Truvada.
 Wide use in treatment centers.
 Physicians made repeated requests.
 “Not for profit” price structure.
 FDA approval would have influence.
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Peter Karlton
Impediments to Rapid Review
of Registration Dossiers
• Long delays in review and response
time.
• Iterative and lengthy Q&A process.
• Requests for detailed CMC information.
• The unwillingness to accept approval
by FDA or pre-qualification by WHO.
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Peter Karlton
Thank you
Contact for Peter Karlton:
 [email protected]
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Peter Karlton