Industrializing Microbicides

24 February 2008│Hotel Ashok, New Delhi, India

Overview

The Alliance for Microbicide Development organized Industrializing Microbicides symposium with the organizers and Scientific Advisory Council for the Microbicides 2008 Conference to:

1. Provide an overview of the microbicide-specific industrialization process so the wider communities of relevance understand the components of that process and how each affects microbicide approval, commercialization, and access; and
2. Among key players in the microbicide and allied fields, present and discuss core industrialization issues, challenges, and opportunities.

Scientific Chairs

Polly Harrison, Alliance for Microbicide Development
Kevin Whaley, Mapp Biopharmaceutical

Scientific Program & Speakers

Session 1: Workshop: GLP Toxicology Studies (9:00-10:00)
Moderator: Liza Solomon (AMD)

• GLP toxicology summary of candidate microbicides
• Challenges encountered by sponsors

Session 2: Manufacturing of Chemical Microbicides (10:00-11:00)
Moderator: Sidney Rubinstein (Regulatory Compliance Initiatives)

• Current manufacturing and formulation capabilities for chemical microbicides

Session 3: Manufacturing of Biological Microbicides (11:00-12:00)
Moderator: Kevin Whaley (Mapp)

• Current manufacturing and formulation capabilities for biological microbicides

Session 4: Intellectual Property (IP) Considerations (13:00-14:00)
Moderator: Anatole Krattiger (Arizona State University)

• IP positions of candidate microbicides in India
• IP agreements

Session 5: Regulatory Considerations (14:00-15:00)
Moderator: Tim Farley (WHO)

• Regulatory status of candidate microbicides in India
• Regulatory challenges and opportunities

Important Documents

Invitation to Attend
General Announcement
Final Scientific Program & Speakers

Important Links

Microbicides 2008 Conference website: http://www.microbicides2008.com/index.asp

General Information

Please direct inquiries to:
Latifa Boyce
Alliance for Microbicide Development
Attn: Industrializing Microbicides
8484 Georgia Avenue, Suite 940
Silver Spring, Maryland 20910 USA
Phone: +1-301-587-9690
Fax: +1-301-588-8390
Email: lboyce@microbicide.org