E-DRUG: Alliance pledges new cheap TB drug by 2010
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[copied from BMJ website as fair use; WB
http://bmj.com/cgi/content/full/321/7267/981/a\]
BMJ 2000;321:981 ( 21 October )
News roundup
Alliance pledges new cheap TB drug by 2010
Tessa Richards BMJ
A new initiative to tackle tuberculosis (TB), the Global Alliance for
TB Drug Development, was launched last week at the international
conference on health research for development in Bangkok.
The alliance has pledged to have an effective new antituberculosis
drug on the market, at a price developing countries can afford, by
2010. Set up with huge international support, the alliance will
function as a virtual research and development organisation and
outsource its projects to public and private partners.
The catalyst for the formation of the alliance, was a meeting held
earlier this year in Cape Town, South Africa, attended by
international experts who wanted to tackle the escalating
tuberculosis epidemic.
In a declaration after this meeting (International Journal of
Tuberculosis and Lung Disease 2000;4:489-90) the working
alliance set out the scale of the epidemic and the need to
accelerate the development of new drugs to shorten its treatment
time and improve its control.
Currently, a third of the world�s population is infected with
Mycobaterium tuberculosis, and tuberculosis causes two million
deaths a year. A third of all HIV positive people die from the
disease. Although 95% of this burden falls on poor countries�in
India tuberculosis kills one person every minute�globalisation is
fuelling its spread internationally, and no country is immune. This
has been recognised by the G8 countries, who in July issued a
resolution to halve the morbidity from tuberculosis within 10 years.
Treatment with DOTS (directly observed treatment short course)
has increased globally over the past decade, but over half of all
patients are not detected. Of those that are, cure rates over 90%
are possible.
In practice, however, supervision has proved difficult and costly to
administer, and compliance is poor. Less than two thirds of
patients complete treatment. BCG vaccination has had only limited
impact on controlling the epidemic, and there has been a growth in
multidrug resistant disease.
Despite the undisputed need for new and better treatments for
tuberculosis no new antituberculosis drugs have been developed in
30 years. This is largely because pharmaceutical companies have
been reluctant to make the huge investment required because of
the poor prospects of commercial return from the countries where
the disease is common.
Much therefore hangs on the success of what Dr Gro Bruntland,
director general of the World Health Organization, described at its
launch as "this innovatory new partnership."
"Without new drugs to simplify TB treatment and reduce its
duration to less than three months," she warned, "another 50
million people will die over the next 20 years for it will take at least
that time to develop a new more effective vaccine."
Three factors underlie the optimism that was evident at the launch
of the new initiative. Firstly, the alliance, which has unprecedented
international support, has already attracted strong financial
backing. The Bill and Melinda Gates foundation has donated $50m
(�35.7m) and the Rockefeller Foundation has pledged $10m.
Secondly, the alliance has the support of the Hever Group, which
consists of the senior research and development directors of the
worlds 10 largest pharmaceutical companies. Thirdly, Professor
Malegapuru Makgoba, president of the Medical Research Council
of South Africa, emphasised, "The recent advances in molecular
genetics, particularly with the sequencing of the M tuberculosis
genome, means that there has never been a more promising time
for more effective and rational drug design and development."
Details about the Global Alliance for TB Drug Development can be
accessed at www.tballiance.org
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[More info about the Alliance from www.tballiance.org]
The Global Alliance for TB Drug Development
Attn: Di Eckerle
420 Fifth Avenue, 21st Floor,
New York, NY 10018, USA
The Global Alliance for TB Drug Development is a not-for-profit
venture that will accelerate the discovery and development of new
drugs to fight tuberculosis (TB). It is one of a new breed of public-
private partnerships (PPPs) that pursues a social mission by
employing the best practices of the private sector and by drawing
upon resources from both the public and private realms. TB
remains the largest killer of young people and adults in the world
today, and the problem is growing with the spread of HIV/AIDS and
drug resistant strains of TB. Although scientific advancements hold
out great promise for TB drug development, the private sector views
the TB market as relatively unattractive. The Global Alliance will fill
this gap using a lean, virtual research and development (R&D)
operating model that outsources R&D projects to public or private
partners. It will survey the entire universe of TB drug development
and will selectively intervene when its actions will help move a drug
candidate towards registration and use in therapy. It will therefore
build a portfolio of projects with varying levels of funding,
management, and ownership.
Vision and Mission
Vision: To provide new medicines with equitable access for the
improved treatment of TB.
Mission: To accelerate discovery and/or development of cost-
effective new TB drugs that will:
Shorten the duration of TB treatment or otherwise simplify its
completion, Improve the treatment of latent TB infection, or Be
effective against multi-drug resistant TB (MDR-TB)
Operating Model
The Alliance will accelerate drug discovery and development by
following a series of operating principles:
It will act as a public-private partnership (PPP) that employs the
practices and dynamism of the private sector in pursuit of a social
mission, building partnerships among both public and private
partners and donors It will conduct virtual drug research and
development, optimizing the cost and speed of development by
outsourcing specific research and development activities to
academic or public researchers, contract research organizations,
private companies, or non-governmental organizations (NGOs) The
Global Alliance will track the progress of all international TB drug
development efforts and will intervene selectively when its efforts
will help advance promising drug candidates. If a compound already
has momentum, the Alliance will focus its efforts and resources
elsewhere. To maintain control and accountability for its
investments, the Alliance will set clear, pre-defined milestones for
its contracting partners and assign a dedicated project manager to
each project It will model itself after an "incubator" in the e-
commerce space, providing staged funding, expert scientific and
management guidance, and some limited infrastructure (project
management, legal support, etc.). It will also be interested in
retaining some rights to the compound in exchange for its support
The ownership of intellectual property rights (IPR) will help the
Alliance pursue two complementary goals, namely, retaining the
ability to deliver new TB drugs equitably to those areas most in
need, and encouraging private industry to help develop new TB
indications. To pursue these goals, the Global Alliance will be free
to pursue any form of control or ownership of IPR The Alliance will
have a relatively small, high quality, active Board of Directors,
whose membership will be based upon specific areas of expertise
(rather than representation from founding organizations or donors)
The Alliance will be global in scope and maintain active offices in
three locations: Brussels, Cape Town, and New York City The
Alliance will focus its initial fundraising efforts on about 50 high-
priority donors and will place considerable emphasis on securing
resources from public sources around the globe
Organization
The Global Alliance will have a lean organization with three
functional areas, each run by a Director:
Advocacy will handle education, communications, relationships
with other TB organizations, and fundraising Business Development
will be responsible for forming relationships and negotiating
contracts with Alliance partners, protecting Alliance intellectual
property rights, tracking important regulatory issues and concerns,
and providing financial analysis and accounting support for senior
management and the Portfolio Committee The R&D Department
will employ and empower project managers to directly oversee a
portfolio of TB R&D projects and will seek out potential projects for
investment
The Alliance will also have the services of a Scientific Advisory
Committee, which will:
Consist of 9-12 scientific experts drawn from a wide array of
relevant disciplines, in addition to the CEO and R&D Director as ex
officio members, Survey the TB environment and select projects
that have strong potential to advance TB treatment Evaluate these
candidates along scientific and technical lines and make a
recommendation on funding to the Portfolio Committee, which has
the final investment decision Assist the Alliance in other scientific
endeavors, including crafting an ideal product profile, assisting with
requests-for-proposals (RFPs), and representing the Alliance at
conferences and seminars
Governance
The Board of Directors will assume fiduciary responsibility for the
Global Alliance and is expected to guide the business strategy by
advising on and consenting to the Alliance�s strategy, actions, and
budgets. It will also be responsible for setting performance
objectives and monitoring management performance.
The Board will consist of 7 to 9 Directors. An initial slate of six has
been nominated by the stakeholders in the Alliance on the basis of
the skills and experience they can bring to the venture. The Board
will be expected to select additional members to round out its
complement.
The various stakeholders who helped form the Alliance will be
represented in a Stakeholder Association and certain measures
have been taken to ensure that the Board remains accountable to
the stakeholders.
Additional details on the Board structure, functions, and
composition are included in the governing documents of the
corporation.
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