TB diagnostics in India - Conference Report

Hi Friends!!

I attended the

TB diagnostics in India (From importation and imitation to innovation

In Bangalore last week (25^th-26^th August), representing OSDD at the conference.

It was a wonderful experience to meet over 200 delegates from Industries, Public and Education sector, from around the globe under one roof at St.Johns hospital (beautiful campus and auditorium).

The First day Session started with the Global scenario of spread of tuberculosis and the problems in overcoming this disease. Firstly, the problem is that, the Public Health Centres (PHC) fail to reach the patients. Patients thus, they seek treatment from private health centres. Secondly, India is densely populated so the Public and Private sectors must work together to bring some effective change in the number of patients, which we see ever increasing on India’s TB graph. Lucica Ditiu, Exec. Secretary, Stop TB Partnership, said that India also needs to feel the responsibility to help other needy nations who are struggling to fight TB. Thirdly, Dr.Soumya Swaminathan, NIRT, said the problem is that we do not reach to the grass root level to the people to help them fighting against tuberculosis.

Funding:

One of the main problems which were realized by all is that there is a constant need of Funding and support from various agencies around the globe. Peter Small from BMGF, said that we need to look at the hindrances underlying funding for tuberculosis research. Jay Menon from Xprize foundation said that there is scope for introducing incentive prize model in the development of tuberculosis. Nandita Chopra from NIH said that there are five new announcements on the grants for tuberculosis on their website. VS Chahuan from ICGEB said that government is ready to fund for tuberculosis if there is a proper research model put forwarded to them. Concluding on this issue, Madhukar Pai said that there is need of common portal where all the announcements on tuberculosis funding can be done. In this way, all the working groups/companies working on TB will get updated in a real time.

Market:

In the following sessions, the private companies came up with the issue of the market feasibility in working for tuberculosis diagnostics and tuberculosis as whole. Camila Rodrigues from Hinduja Hospital Mumbai said that, often the patients are not diagnosed properly and given any antibiotics, which further leads to resistant tb. Caroline Bogren from GDF said that, there is no guarantee given to the patient about the quality of drugs they receive, there is a poor regulation in the pharmacy sector in India. There has to be a Standard treatment guideline, so that the correct diagnosis and treatment can be followed. The discussion panel also said that there is a need to build a Cheaper Efficient Fast and Portable Tuberculosis diagnosis tool, to reach to the mass. The High end diagnostics also play a major role in diagnosis, but for the first line of diagnosis there has to be a efficient and cheaper tool.

Education & Research:

On both the days of the meet, there were discussions on how to bring down the costs in research and to accelerate the innovations. Education and Industries need to come up together to bring in innovations in tb diagnostics. Education sector has the fresh talent and enthusiasm to work for a challenge. It was quoted in the meeting that, Indian Education sector needs to have its own niche rather than trying to replicate foreign system of development in education.  The huge gap between innovation and research needs to be filled by the collaboration of industries with the academia.

However there are certain limitations to overcome such as, Industries need to define what kind of expertise they need from the academics. Students should be given credits in the form of publishing the research work. To this, I spoke about the existing Academic-Industry-Government research model which already exists for the tuberculosis drug research by CSIR. Open Source Drug Discovery a consortium led by CSIR and funded by Govt of India is a best epitome of how collaborative research can work wonders. Where in people connect via social networking sites and do collaborative and quality work in limited time. This discussion was further supported by Dr.Anu Aacharya from Ocimum biosloutions.

The two day conference ended with discussions about involvement of media in spreading awareness and combating the disease.

Links:

I am giving the links to the PowerPoint presentations given at the conference

 http://www.tbevidence.org/rescentre/presentations/bangalore.htm

on Twitter: #tbdx2011 and #tbdm2011

Acknowledgment

To,

Director: Zakir Thomas, Open Source Drug Discovery (for giving me opportunity to represent OSDD) www.osdd.net

Chairperson: Madhukar Pai (thanks so much for inviting me for the conference) 

http://www.mcgill.ca/recru/researchers/pai/

Co-Chairperson: John Kenneth (for giving us the opportunity to interact under one roof at beautiful campuu of SJRI) http://www.sjri.res.in/per-pages/per-john.htm

Thanks to all whom I met at the conference for friendly and encouraging interaction.

We shall Work Hard to ERRADICATE TUBERCULOSIS

Smiles J

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Following is the brief note from Madhukar Pai on the conference:

Discussions during the conference (and subsequently) has outlined several areas (and needs) that require follow-up and some coordinated action:

1.       Industry folks and academics expressed a need for clearly defined target product profiles (TPPs) on what type of TB tests need to be developed for various indications (active TB, latent TB, MDR-TB, extrapulmonary disease, point-of-care testing, etc.) and what the performance benchmarks ought to be.

2.       In particular, they seemed keen to know exactly what the RNTCP perceives as their biggest diagnostic needs, and how new products get endorsed and scaled-up with the programme.

3.       While the business case analysis by McKinsey was very valuable and timely, it is clear that a more fleshed out, in-depth analysis is required, and would be greatly appreciated by the industry. We have noted all the suggestions that were made on how such an analysis can be refined.

4.       Other specific needs that came up were: 1) TB specimen banks or standardized panels for validation studies; 2) list of possible sources of funding for TB innovations; 3) methodological advice on how to conduct validation and demonstration studies for WHO endorsement; 4) advice on WHO prequalification for TB diagnostics; 5) guidance on what quality standards to meet.

5.       Companies, especially those not working in TB, seem to want “mentorship” or technical advice on TB, and it is not clear who they can approach for issues specific to TB. When and how should companies engage with the RNTCP for advice, possible endorsement or evaluation?

6.       As more TB products get developed, it is not clear which agency or organization can conduct head-to-head validation studies to identify the best products for scale-up.

7.       Which agency or organization should take on a convening role to pull together key stakeholders that make up the complete value chain for TB innovations in India? Who can serve as the “honest broker” to bring stakeholders together (“match-making”)? How can we increase governmental participation to support TB innovations, especially since more governmental funds are now available for R&D? How can industry bodies such as CII and ABLE facilitate this?

8.       Can similar efforts to engage industry and stakeholders be made in other BRICS countries, especially China and Brazil?

9.       What sorts of innovative delivery models will be needed to drive access to innovative diagnostics, and how can we get the private sector to play a bigger role in TB control?

10.   How can we engage Indian celebrity/philanthropic individuals and groups to raise awareness about TB, and to specifically raise resources for TB innovations (e.g. for an India TB Diagnostics Prize)? What role can media and civil society play in supporting this?

Clearly, there are no easy solutions, and our conference was merely a first step in this direction. Do send us suggestions on how to address the needs identified.

We take this chance to point out some resources that might be particularly helpful:

1.       The Stop TB Partnership’s New Diagnostics Working Group has published a scientific blueprint for new TB diagnostics development and is available at: http://www.stoptb.org/wg/new_diagnostics/assets/documents/BluePrintTB_annex_web.pdf

2.       The “Evidence-based TB Diagnosis” website provides access to information on all current TB tests, new diagnostics pipeline, systematic reviews of test accuracy, WHO guidelines, research agendas, etc.: www.tbevidence.org

3.       Funding opportunities in TB are often posted on the TB Research Movement website: http://www.stoptb.org/global/research/

4.       FIND and TDR/WHO have published a global TB diagnostics market analysis report: http://www.finddiagnostics.org/export/sites/default/resource-centre/find_documentation/pdfs/tbdi_full.pdf

5.       Bio Ventures for Global Health has published a “Diagnostics Innovation Map: Medical Diagnostics for the Unmet Needs of the Developing World”: http://bvgh.org/LinkClick.aspx?fileticket=-a1C6u2LE4w%3d&tabid=91

6.       A recent publication “Towards Lab-Free Tuberculosis Diagnosis” by MSF, TAG, Stop TB Partnership and others provides an overview of work being done to develop POC tests for TB, including an assessment of resources such as specimen banks available for TB diagnostics research: http://www.msfaccess.org/content/towards-lab-free-tuberculosis-diagnosis

7.       Results for Development Institute recently published an analysis on innovation prizes for TB diagnostics:http://healthresearchpolicy.org/assessments/prizes-global-health-technologies Additional information on prizes is available on the X Prize Foundation home page: http://www.xprize.org/

8.       The WHO prequalification program is described at: http://apps.who.int/prequal/default.htm

We take this chance to thank all our partners and sponsors;  special thanks to St John’s Research Institute for the excellent conference facility, logistics and support.

We thank you again for your contribution and enthusiastic participation. We succeeded in bringing together a large number of stakeholders and hope the spark has been lit. Much more needs to be done, and we hope all of you will continue to stay engaged.

Best regards

Madhukar Pai & John Kenneth

Conference Co-Chairs

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PUSHPDEEP MISHRA