Appendix BSummary 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 opportunities 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:

  • Russian Federation scientists are highly active in important areas of TB research, and multiple institutions are engaged in drug discovery, diagnostic, immunological, and pathological studies on TB.
  • Sophisticated molecular diagnostics for MDR TB have been developed. However, these diagnostics are not necessarily available at the point of care.
  • MDR 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.
  • Improved sensitivity of TB detection in HIV-positive individuals is needed.
  • Differentiating between non-TB mycobacteria and Mycobacterium tuberculosis at the point of care can be difficult, leading in some cases to inappropriate treatment.
  • Diagnostics and treatment regimens formulated for pediatric TB patients generally are not available.
  • Support for basic science contributing to drug discovery is lacking. Improved connections among medicinal chemists, microbiological laboratories, and clinical investigators could hasten drug discovery.
  • Facilities for the biosafety level-3 laboratories needed for some MDR TB research in Russia are limited.
  • The 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.
  • Diagnostic drug susceptibility testing needs to be harmonized across Russia and, in particular, with new drug developers.
  • Increased 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.
  • Research opportunities supported by the National Institutes of Health and other organizations are open to Russian investigators.
  • The clinical trial infrastructure needs to be strengthened for registration studies.
  • Regulatory and bureaucratic bottlenecks need to be removed for chemical entities in Phase I and Phase II clinical trials.
  • Standards of care and approaches to TB treatment need to be harmonized for multicenter trials.
  • Present clinical sites in Russia and other nations need to be sustained and supported for forthcoming global Phase III trials.