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Appendix B Summary of a Meeting of the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Held May 24–25, 2010, Moscow, Russian Federation During the workshop, Barbara Laughon of the National Institute of Allergy and Infectious Diseases summarized a meeting on research oppor- tunities in TB drug discovery and diagnostics held on the 2 days before the workshop. The goals of that meeting, said Laughon, were to exchange information among researchers from the United States, Europe, Russia, China, and other countries and explore opportunities for collaborative research. Laughon focused in particular on how to increase cooperation among countries. The following are highlights of the discussions at the meeting: • R ussian Federation scientists are highly active in important areas of TB research, and multiple institutions are engaged in drug dis- covery, diagnostic, immunological, and pathological studies on TB. • S ophisticated molecular diagnostics for MDR TB have been devel- oped. However, these diagnostics are not necessarily available at the point of care. • M DR and XDR TB strains are highly prevalent in Russia, but drug susceptibility testing for second-line drugs, as in the rest of the world, has yet to be standardized. • I mproved sensitivity of TB detection in HIV-positive individuals is needed. • D ifferentiating between non-TB mycobacteria and Mycobacterium tuberculosis at the point of care can be difficult, leading in some cases to inappropriate treatment. 121
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122 DRUG-RESISTANT TUBERCULOSIS IN RUSSIA • D iagnostics and treatment regimens formulated for pediatric TB patients generally are not available. • S upport for basic science contributing to drug discovery is lacking. Improved connections among medicinal chemists, microbiological laboratories, and clinical investigators could hasten drug discovery. • F acilities for the biosafety level-3 laboratories needed for some MDR TB research in Russia are limited. • T he TB strains used as standards in the West differ somewhat from those used as standards in Russia. These differences should be considered in comparing results of tests of diagnostics and drug effectiveness. • D iagnostic drug susceptibility testing needs to be harmonized across Russia and, in particular, with new drug developers. • I ncreased communication and collaboration among investigators within and outside of Russia could be beneficial to all participants. For example, the importation of reagents, equipment, and microbes is currently a barrier to collaborative research. • R esearch opportunities supported by the National Institutes of Health and other organizations are open to Russian investigators. • T he clinical trial infrastructure needs to be strengthened for regis- tration studies. • R egulatory and bureaucratic bottlenecks need to be removed for chemical entities in Phase I and Phase II clinical trials. • S tandards of care and approaches to TB treatment need to be har- monized for multicenter trials. • P resent clinical sites in Russia and other nations need to be sus- tained and supported for forthcoming global Phase III trials.