New Products, New Paradigms:
Combination Products for Women
Satellite Session at AIDS 2012
Thursday, 26 July
Location: Mini Room 1
Co-Conveners: Population Council and CAMI, along with AVAC, CONRAD, USAID, and WHO
- Dr. Helen Rees, Founder and Executive Director, Wits Reproductive Health and HIV Institute (WRHI), University of the Witwatersrand, Johannesburg, South Africa
- Dr. Debra Birnkrant, Director, Division of Antiviral Products, US Food and Drug Administration (US FDA)
Satellite Moderator: Ms. Martha Brady, Senior Associate, Population Council
Unprotected sex puts women worldwide at simultaneous risk of unintended pregnancy and sexually transmitted infections (STIs), particularly HIV, herpes simplex virus (HSV) and human papillomavirus (HPV)—all of which impose heavy burdens on morbidity and mortality. Multipurpose prevention technologies (MPTs) that integrate the prevention of unintended pregnancy, HIV, and other STIs, would address these combined risks, and thus enhance public health impact.
A dynamic, conversation-style session is envisioned, which will consider the need, the challenges, and the opportunities for multi-indication products.
- New products, new paradigms: Combination products for women (PDF)
Dr. Debra Birnkrant, US FDA
- The case for multipurpose prevention technologies (PDF)
Dr. Helen Rees, WRHI
- From ideal to real: What's in the MPT pipeline? (PDF)
Dr. Judy Manning, USAID
Description of first-generation MPTs currently in development.
- Regulatory concepts for dual indication combination products (PDF)
Dr. Charu Mullick and Dr. Daniel Davis, US FDA
Review of the potential regulatory pathways for dual-indication products.
- Prequalification process at WHO
Dr. Manjula Lusti-Narasimhan, WHO
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