Microbicide Development Strategy Unveiled At International AIDS Conference

Today, leading microbicide experts
unveiled the Microbicide Development Strategy, a plan to accelerate the
development of a safe and affordable microbicide that could help women
reduce their risk of acquiring HIV and other sexually transmitted
infections. Microbicides are recognized as a promising new prevention
approach that could potentially turn the tide of the global HIV/AIDS
epidemic, and have been highlighted in speeches by Bill and Melinda Gates,
Bill Clinton, and other prominent speakers at the XVI International AIDS
Conference in Toronto.

The Microbicide Development Strategy (MDS) is the result of
consultation with more than 100 experts in the microbicide, HIV/AIDS, and
reproductive health fields over the past 18 months, and was initiated by
the Microbicide Donors’ Committee, supported by the Bill & Melinda Gates
Foundation, and coordinated by the Alliance for Microbicide Development.

The MDS will help guide donor decisions for investing in microbicide
research and development, and ensure that resources are used as effectively
as possible. The effort marks the first time that major donors have agreed
on a shared strategy for investing in microbicide development.

The MDS captures critical issues that have arisen in the rapidly
growing field of microbicide development, and identifies opportunities to
ensure that promising microbicide research moves forward as quickly as
possible. Key priorities in the MDS include:

— Developing improved scientific models and markers to help researchers
more quickly identify the most promising microbicide candidates

— Increasing capacity in developing countries to conduct clinical trials
of microbicides by increasing funding for recruiting, training, and
retaining trial staff, and facilitating communication among trial sites

— Expanding market research to better understand consumer preferences
regarding potential microbicide products

— Engaging experts to map regulatory pathways, including strategies to
obtain rapid approval of a microbicide that can be provided without a
prescription

— Developing combination microbicides with multiple mechanisms of action
“An effective microbicide would help put the power of HIV prevention in
the hands of women,” said Renee Ridzon, senior program officer at the Bill
& Melinda Gates Foundation. “This report provides a clear way forward on
microbicides, and it will be an invaluable guide for policymakers, funders,
and researchers.”

“With the widening pipeline of microbicide candidates, there is an
urgent need to build and expand clinical trial capacity in countries with
high HIV incidence rates,” said Professor Salim Abdool Karim, Director of
the Centre for the AIDS Programme of Research in South Africa (CAPRISA).
“Current capacity to conduct microbicide trials is inadequate to ensure
rapid studies of this next generation of microbicide candidates.”

Professor Abdool Karim also emphasized the importance of preparing to
ensure access to microbicides. “Those waiting for this product, especially
women in resource-constrained settings who most need microbicides, must
have access,” he said. “Just as much as we need to learn from failure, we
need to prepare for success. A successful trial that finds an effective
microbicide will need to be translated into public health action. This will
require innovation to address the range of logistical, financial, and
ethical issues involved in manufacturing and distributing this new form of
HIV prevention.”

Polly Harrison, Director of the Alliance for Microbicide Development,
said the creation of the MDS reflects that the microbicide field is at a
new stage. “What do we know now that we didn’t ten or even five years ago?
We didn’t talk about gaps then because, frankly, it was one big gap,” she
said. “Now, we have a real ‘fabric’ of research, development, and advocacy
as well as five pivotal trials currently in place from which we are
learning a great deal. We have candidates with unique mechanisms of action,
a set of theories and reasons for how a microbicide can interact with
target cells, and a variety of delivery mechanisms, formulations, and
evaluation approaches that are being developed and tested. And very
importantly, we have meaningful efforts at coordination which is
illustrated by the MDS.”

A copy of the MDS is available on microbicide.
The Alliance for Microbicide Development is a member of the Caucus for
Evidence-Based Prevention. Comprised of dozens of diverse organizations,
the Caucus for Evidence-Based Prevention was created for the specific
purpose of promoting HIV prevention supported by sound science at the XVI
International AIDS Conference. The Alliance defines itself as a catalyst,
communicator, convener, and problem-solver. It is a global coalition of
representatives from biopharmaceutical companies, nonprofit research
institutions, and health advocacy groups. It is the authoritative source of
information on microbicide development, convener of dialogue on key policy
issues, educator about the public health potential of microbicides, and
advocate for the resources needed to develop them.

Alliance for Microbicide Development
microbicide

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