TB Alliance: Putting science to work for a faster TB cure

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Open Forum 4

This two-day Open Forum was the fourth in a series of meetings aimed to raise and address key issues in TB drug development, with a special focus on regulatory affairs.

Thank you so much to those participants who were able to join us in Addis Ababa for the Fourth Open Forum meeting from August 18-19, 2010. The event included discussions that tackled a broad range of issues facing TB drug development, delivery, and care and helped map the path forward to bring better and faster TB drugs to those suffering in Africa and around the world. The Open Forum meeting was unique in that it brought a large cross-section of TB stakeholders and key decision makers together, with each group gaining more clarity about how they, individually and collectively, can contribute to ensure rapid uptake of appropriate new TB regimens among patients who need them.

Click here to read more of the event summary

Open Forum 4 was supported in part by grants from Aptuit, AstraZeneca, Bayer Schering Pharma, Celgene, GlaxoSmithKline, Novartis International AG, PharmaNet, Pfizer, sanofi-aventis, and Tibotec.

Day One: 18 August 2010

Day Two: 19 August 2010


Event Summary (continued)
Open Forum 4 brought together a broad cross-section of TB stakeholders: researchers working to develop new TB drugs, managers of National TB Programs that deliver care and their supporters from organizations like WHO, regulators reviewing both clinical trial protocols and drug approval requests, and activists vocalizing the need for new and better treatments. A key outcome of the meeting was an appreciation of the different challenges TB creates for each stakeholder group and the important linkages all groups must build with one another to ensure timely access to new TB drugs.

Participants heard about an innovative approach to TB drug development, where novel drugs from the global pipeline are tested together in combination, instead of one drug at a time. This new regulatory and clinical paradigm, which is embodied by the Critical Path to TB Drugs Regimens initiative, has the potential to reduce the time to develop new TB regimens — from decades to years. Global regulators, such as the European Medicines Agency, the US Food and Drug Administration, and the South African Medicines Control Council, have all shown their support.

The Open Forum event offered updates on the regulatory harmonization efforts in both Africa and Asia, which also have potential for speeding the approval of clinical trials and new drug regimens. Innovations such as regulatory harmonization and the new combination approach to drug development will help the TB community do more with the few resources it has.

After many years of stagnation in TB research, there are now several drugs in late-stage clinical development. Just as countries have begun taking steps to adopt new diagnostics, countries and others involved in TB care must prepare for the approval and introduction of new TB drug regimens. Presentations on treatment programs in Lesotho, South Africa and Ethiopia highlighted the urgent need for new, shorter and — for MDR-TB — more effective treatment, especially for people living with HIV. With Phase 2 studies in drug-resistant disease nearing conclusion, the expectation that new MDR-TB drugs may soon be available for compassionate use, and with other late-stage clinical trials ongoing, there are exciting signals to regulators and program managers to now review and strengthen the systems needed to approve and distribute new TB regimens.

Finally, national TB programs in Africa universally stated that they will look to WHO to recommend new regimens as a prerequisite for changing the country guidelines. This creates a clear opportunity for all members of the TB community to gather the necessary evidence and political will for a thorough yet efficient review by WHO's Strategic and Technical Advisory Group (STAG) so that new regimens may reach patients as quickly as possible.

We welcome your participation in the Open Forum series and we hope you will continue to participate in and support these exciting steps toward adoption of new TB drug regimens. Please be in touch with any feedback and suggestions you may have by e-mailing OpenForum@tballiance.org.

This meeting was sponsored by the TB Alliance, the Bill & Melinda Gates Foundation, the European & Developing Countries Clinical Trials Partnership, the Federal Democratic Republic of Ethiopia Ministry of Health, the Stop TB Working Group on New TB Drugs, and Treatment Action Group.

Open Forum 4 was supported in part by unrestricted educational grants from
Aptuit, AstraZeneca, Bayer Schering Pharma, Celgene, GlaxoSmithKline,
Novartis Institute for Tropical Diseases, Pfizer, PharmaNet, sanofi-aventis, and Tibotec.

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