Appendix B

Summary of a Joint Meeting of the
National Institute of Allergy and
Infectious Diseases, National Institutes
of Health, and Indian Biomedical
Research Agencies,
Held April 20-21, 2011,
New Delhi, India

On the two days following the workshop summarized in this volume, the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, held a forum in collaboration with the Indian Council of Medical Research (ICMR) and India’s Departments of Health Research (DHR) and Biotechnology (DBT) entitled “Indo-NIAID Tuberculosis Drug Discovery Forum—Exploring Opportunities for Research Collaboration.” The forum brought together scientists from the United States, Europe, and India to explore collaborative opportunities in TB drug discovery and development. Participants included researchers and administrators from government and university laboratories, not-for-profit product development organizations, and the pharmaceutical industry. The goals of the joint workshop were to:

• share the latest state-of-the-art scientific information on drug discovery research designed to help combat MDR and extensively drug-resistant (XDR) TB;
• summarize TB drug development projects of the pharmaceutical industry and the public sector currently under way;
• discuss TB drug development needs and ways in which biomedical research can contribute;
• identify partnership opportunities to advance and accelerate new drug discovery efforts so that therapeutic options for drug-resistant TB can be advanced and accelerated;

• explore potential connections for bioinformatics related to systems biology and the genomics of Mycobacterium tuberculosis (M.tb.); and
• discuss current gaps in translational research and how opportunities in the United States and India can be leveraged to help address these gaps.

At the conference, during a session convened by the Institute of Medicine (IOM), Barbara Laughon, NIAID; Gail Cassell, Harvard Medical School and Infectious Disease Research Institute; and several participants cited conclusions and recommendations emerging from the meeting that were especially important in the context of the recently completed workshop summarized herein.

DRUG SUSCEPTIBILITY ANALYSIS

• All countries affected by TB should conduct surveys to determine the strains of M.tb. prevalent in different regions and patterns of drug susceptibility. In India in particular, coordinated and systematic analysis of genomic variations in M.tb. across the country and across population groups should be performed.
• An important question is whether certain strains are more infectious and virulent. Drug-resistant strains may be more likely to spread rapidly and infect both children and adults.
• Genomic surveys should be accompanied by phenotypic screening and cohort studies to identify effective treatments and investigate how drug susceptibility patterns may change. This will be especially important to monitor as new classes of TB drugs are introduced. Such studies could contribute valuable information to lay the foundation for registration clinical trials of new anti-TB drugs.

THE RESEARCH INFRASTRUCTURE

• Important research ideas emerging from the conference could be supported by investigator-initiated research grants. NIAID, the lead agency supporting research on TB, has several program announcements for competitive research projects and welcomes applications.
• Research involving TB within India and between India and international partners is rich in opportunities and could draw on successful models in other disease areas of concern and other countries.
• Academic researchers and industrial drug developers in India may need to accelerate coordinated efforts to build on recent progress in combating drug-resistant TB.

• Meetings such as the workshop summarized in this volume and the Indo-NIAID forum create opportunities for collaboration.

DRUG DEVELOPMENT

• Translational efforts are needed to advance drug discovery candidates. These efforts should include examination of physiochemical properties, pharmacokinetics, efficacy, and formulations. Research resources for these activities are available within India. NIAID offers product development assistance for high-priority research areas such as TB.
• Evaluations of compounds against virulent M.tb. in animal models and in vitro are particularly promising, and NIAID can provide technical preclinical assistance in this area.
• Although it is a notable research challenge, new approaches to identifying and eliminating dormant mycobacteria are greatly needed and should be given high priority by the research community.
• Future workshops and forums for the exchange of information, along with collaborative efforts centered on anti-TB drug development, would be welcomed by Indian investigators and are recognized as critically important.

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