considerations for the regulatory approval of multipurpose...
TRANSCRIPT
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Cara Chrisman, PhD, AAAS Fellow, USAID ~and~
Martha Brady, M.S., Senior Associate, Population Council
Considerations for the Regulatory Approval of
Multipurpose Prevention Technologies (MPTs)
11‐12 December, 2012 India Habitat Centre ‐ New
Delhi, India
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© The Population Council, 2012
Who Needs MPTs? Diverse groups of women across
geographies, ages, cultures
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Constructing a Critical Path from Product Development to Introduction
Brady, M., Critical Path Framework © 2011 Population Council
© The Population Council, 2012
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CRITICAL ACTIVITIES
• Clarify regulatory pathway(s) for MPTs
• Engage regulatory bodies at global and local levels
• Work with product developers and/or manufacturers to submit dossiers
© The Population Council, 2012
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2
HIV HSV HPV
Pregnancy
Chlamydia BV
Candida Trichomonas
Syphilis Gonorrhea
Adapted from J. Romano presentation, Multipurpose Prevention Technologies for Reproductive Health 2011 Symposium, Washington, DC
INDICATION
HC Non- HC
Pro-biotic
Anti-Microbial
Anti-viral
Anti-fungal
Barrier
MECHANISM OF ACTION
Vaginal gel
Vaginal film
Vaginal tablet
Vaginal ring
Non-IVR device
Implant Injection
FORMULATION & DELIVERY
Topical Daily
Topical Peri-coital
Oral Peri-coital
Topical Sustained
Oral Daily
Systemic Sustained
DOSAGE & ADMINISTRATION
Oral pill
Complexities of developing MPTs:
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© The Population Council, 2012
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MPT Regulatory Puzzle
Specific regulations will vary with each MPT, however
the following perspectives provide a basis: Experimental versus approved Drug versus device Systemic versus topical delivery
© The Population Council, 2012
Thank you!