Skip Navigation

Health: Drug development

Key Documents

Reports

Displaying 1-7 of 7 key documents

National policy on traditional medicine and regulation of herbal medicines — Report of a WHO global survey

Source: WHO | May 2005

This WHO report summarises the findings of a global survey on national policy and regulation of traditional medicine in 141 countries. It presents data on existing policies for traditional medicine and regulation of herbal medicines. The report highlights common hurdles to implementing these and provides a profile of each country surveyed.

Promoting R&D in Preventive Health Technologies: Opportunities for the Indian pharmaceutical and biotechnology sector - policy research working paper

Source: International AIDS Vaccine Initiative | January 2005

This report from a workshop on “Promoting R&D in Preventive Health Technologies,” held in India in December 2004 outlines the potential role that the biotechnology sector in India could have in HIV vaccine research and development. India, as other “innovative developing countries” such as Brazil and China, has the research and manufacturing capacity to take a significant role in HIV vaccine research and development. The report strongly advocate’s IAVI’s strategy of promoting public-private partnerships in order to finance such developments.

The Case for Microbicides: a Global Priority

Source: The Population Council / Family Health International | June 2001

This report - the result of a one-year literature review and consultation with experts - provides the case for developing microbicides, and contains a useful account of the recent history of the field. The report notes that although the previous five years had seen a dramatic increase in the number of researchers working on microbicides, progress remains slow.

While there is some overlap with the 2002 reports of the Microbicide Initiative, this document also suggests priorities for stimulating industry investment into research and development of microbicides. These include the need to provide proof of concept (evidence that microbicides can be effective against HIV and other sexually transmitted diseases), and the importance of exploring new sources of investment such as venture capital.

Mobilization for Microbicides: the Decisive Decade

Source: The Microbicide Initiative | February 2002

This short report summarises five different sets of priorities for action on microbicides: development, marketing, public health, consumer access and advocacy. These are the key points of reports from five Working Groups of experts, assembled by the Microbicide Initiative, an umbrella organisation dedicated to the production and global use of microbicides. The full report of the Scientific Working Group is recommended reading, which represents a scientific roadmap for understanding microbicides and accelerating their development.

The key points listed in this summary include the need for further research into preventing the HIV virus from crosssing the mucous membranes of the female genital tract, and the roles of other sexually transmitted diseases. It also outlines the complexities and challenges of pre-clinical and clinical testing, and features a table listing products in clinical trials, as of February 2002.

The Science of Microbicides: Accelerating Development

Source: The Microbicide Initiative | 2002

This 94-page document is an extensive state-of-the-art report by the Science Working Group of the Microbicide Initiative. With individual chapters authored by different scientific experts, it provides a scientific road map for the development of a safe effective vaginal microbicide against infection with HIV and other sexually transmitted diseases.

A microbicide is viewed as "a critical adjunct to condoms, as well as complementing current efforts to develop a therapeutic or prophylactic HIV vaccine", with the added advantage that an effective microbicide is likely to be produced more widely and more rapidly than a vaccine.

The report covers topics ranging from basic research, through the challenges of pre-clinical and clinical testing, to key issues in manufacturing, formulation, acceptability and end use. Highlights of the basic science section includes diagrams showing how HIV infection takes place, the HIV life cycle within an infected cell, and steps where microbicides may act. Also included are tables of microbicides in development, and their many sponsors and developers. Final chapters include a section on the global epidemiology of HIV and other sexually transmitted diseases.

Microbicide to Prevent Heterosexual Transmission of HIV: Ten Years Down the Road

Source: AIDScience | January 2002

This review - which includes a moderate level of technical detail - covers both the progress of microbicides through laboratory and clinical testing, and the social science and market research that supports microbicides as an HIV prevention option.

Particularly useful is the brief information it provides on which companies are developing each product, and the locations of clinical trials. However, it lacks the illustrations and graphic design of other reviews of microbicide development.

Understanding the Results of the AIDSVAX Trial: a Special Update

Source: AIDS Vaccine Advocacy Coalition (AVAC) | May 2003

This report from AVAC is a clear and concise account of the results and implications of the world's first phase III efficacy trial of an HIV vaccine, the results of which were announced in February 2003. It is relevant for anyone engaged in the effort to test vaccine candidates in clinical trials - scientists, health care workers, community groups and policymakers alike.

Produced with the support of influential organisations including the Bill and Melinda Gates Foundation and the International AIDS Vaccine Initiative, the report represents the views of many mainstream vaccine researchers.

The report highlights criticisms about the data analysis and conclusions, and the recent decision by the US National Institute for Allergy and Infectious Diseases and the Centers for Disease Control to hold a series of meetings with VaxGen to independently analyse the trial data. It also underscores lessons to be learned from the trial.