Saturday, October 1, 2011

TB diagnostic innovations: Can India take the lead?

TB diagnostic innovations: Can India take the lead?

Guest article by Madhukar Pai

No country has more cases of tuberculosis (TB) than India. Research from India played a critical role in the development of the global strategy to stop TB.Yet, Indian industry and academics have not developed any new tools (diagnostics, drugs or vaccines) for TB. Why has India has failed to innovate in TB R&D? To understand this better, we recently organized a conferenceat St. John´s Research Institute (SJRI)in Bangalore, India. For the first time, this meeting brought togetherover 200 representatives from industry, government, donors, academia, civil society and the media to discuss what it takes to innovate in TB diagnostics in India and to move from importation and imitation to innovation.The goal was to stimulate industry interest and investments in TB innovations.

Why focus on India? India has already made a big contribution in the area of generic drugs and vaccines, and successes in areas such as information technology and mobile telephony have greatly inspired a burgeoning biotechnology industry. With a strong, growing economy, and a large talent pool, there is great potential for India to contribute to what is called as the “More (value) for less (cost) for more (people) or MLM innovation,” especially in the area of healthcare technologies and delivery innovations.

It is often said that industry interest in TB is low, in part because the disease mostly affects the poor in developing countries. While this is true, should9.4 million TB cases/year not translate into a large global market for companies? What exactly is the size and nature of the TB diagnostics market in India and elsewhere?A preliminary analysis by McKinsey and Company suggested that the TB diagnostics market in India might be in the ballpark of about $100 million, although there was uncertainty surrounding the estimates from the private sector which does not report TB. The Indian TB control program (RNTCP) screens over 7.5 million people with suspected active TB every year, and a similar number is likely to seek care in the private sector. Thus, 15 million persons with suspected TB should translate into a fairly sizeable Indian market. In addition, diagnostics will be needed to diagnose extrapulmonary TB, MDR-TB, childhood TB, and latent TB infection. If a good, point-of-care testwere to be developed, it might open the option of intensive and active case finding. Furthermore, if a new test were to be developed on a platform that can be used for other diseases, then this opens new markets beyond TB. Lastly, there is a large potential market outside of India. Clearly, we need a more detailed TB market size analysis to engage both industry and funders.

The TB community has done a poor job of articulating its needs. ‘What products should we develop, and if we did develop products who purchase them?’ is a key question that industry representatives asked. A presentation by a senior RNTCP official provided some clues: What the RNTCP needs most is a new point-of-care test for active TB that is simple, easy, cheap and can be performed with minimal training at primary healthcare level; in addition, the program needs an indigenous, economical, simple, automated  (battery operated) or manual molecular test to detect drug resistance that can be done in a peripheral lab with minimal training. This wish list is a great place to start, but will need to be converted into clearly defined target product profiles (TPPs) that test developers and funders can aim for.

Other concerns raised by the industry included: lack of access to Indian sample repositoriesfor test development and validation, and limited funding andR&D facilities for TB;poor regulatory mechanisms to evaluate new tests and assure quality; unclear prequalification processfor TB tests by the World Health Organization; lack of venture capital funding for R&D and lack of celebrity/philanthropic support from within India; lack of awareness about funding opportunities, weak or non-existent collaboration between RNTCP and industry, between industry and clinicians, industry and academia. In addition, there are the usual barriers to innovation in India.

Companies, especially those not working in TB, 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 agencies such as WHO (globally) and RNTCP (within India) for advice, possible endorsement or evaluation? What is the procedure for companies to access the government market for TB tests? How will the RNTCP decide on which tests to scale-up, and how much is the RNTCP willing to spend?

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. More importantly, which agency or organization should take on a “honest broker” role to bring together key stakeholders that make up the complete value chain for TB innovations in India?

Increased industry involvement and investment in TB R&D is an important goal. While the Bangalore conference was clearly a first step to begin a dialogue among the various stakeholders,it became clear that a lot more work is needed to address the needs articulated by the industry.Innovations in TB will also require the support of civil society, media, and patient groups which can bring attention to the need for new TB tools, advocating for scale-up of new products that are already available, and advocacy for increased investment in TB R&D. Lastly, if new tools have to be adopted and scaled-up to achieve impact, health system design and delivery innovations are equally important.

Dr Madhukar Pai is a professor and TB researcher based at McGill University, Montreal, Canada. He serves as co-chair of the Stop TB Partnership's New Diagnostics Working Group (NDWG), and as a consultant to the Bill & Melinda Gates Foundation (BMGF). The views expressed in this article are the author's ownanddo notnecessarilyreflect those of NDWG or BMGF. Initially posted on Speaking of Medicine

Saturday, June 11, 2011

TB diagnostics in India: From importation and imitation to innovation (August 25 - 26, 2011, Bangalore, India)

TB diagnostics in India: From importation and imitation to innovation

  • August 25 - 26, 2011, Bangalore, India
  • Host : St. John’s Research Institute, Bangalore, India
  • Sponsors : McGill University & Global Health Strategies
  • Technical partners : Bill & Melinda Gates Foundation, Foundation for Innovative New Diagnostics, International Centre for
  • Genetic Engineering and Biotechnology (ICGEB), India & Stop TB Partnership
  • Industry partners : Association of Biotechnology Led Enterprises (ABLE) & Confederation of Indian Industry (CII)
  • Media partners: BioSpectrum Asia, Express Pharma & Express Healthcare

Context and rationale

The scale up of DOTS in India is a great public health accomplishment, and yet undiagnosed and poorly managed TB continues to fuel the epidemic. Recognizing these challenges, the Government of India has set an ambitious goal of providing universal access to quality diagnosis and treatment for all TB patients. Innovative tools and delivery systems in both the public and private sectors are critical for reaching this goal. The current in-vitro diagnostics market in India is dominated by imported and generic products, with virtually no innovations. But India has the potential to solve its TB problem with “home-grown” solutions. Just as Indian pharma and biotech companies revolutionized access to high-quality, affordable AIDS drugs and hepatitis vaccines through generic production, Indian diagnostic companies could also become the world’s hub for high-quality generic diagnostics. India also has the potential to lead the world in developing innovative TB diagnostics. For this to happen, Indian industry must move from the import and imitation approach to genuine innovation in both product development as well as delivery. This will require permissive policies, enhanced funding, and greater collaboration between government, donors, researchers and the private industry.

Content and themes

This conference will convene industry leaders, innovative thinkers, researchers, funders, and policy makers, to stimulate increased industry/biotech engagement in diagnostic innovations that can help TB control in India and elsewhere. Sessions will focus on topics such as market size for TB diagnostics, IVD market analysis and value chain, target product profiles and market needs, frugal innovation and affordable diagnostics, intellectual property issues, regulation of diagnostics, sources of funding, prize models, business models for engaging private sector, scientific obstacles for R&D, barriers to innovation in India, academia-industry relations, and role of emerging economies and BRICS in the next wave of TB innovations.

Confirmed speakers & panelists

  • Anu Acharya, Ocimum Biosolutions, Hyderabad, India
  • Ramnik Ahuja, Confederation of Indian Industry, India
  • Tanjore Balganesh, AstraZeneca, Bangalore, India
  • Steven Buchsbaum, Bill & Melinda Gates Foundation, USA
  • Sanjeev Chaudhry, SRL, India
  • Vir S. Chauhan, ICGEB, New Delhi, India
  • Anand Daniel, Accel Partners, Bangalore, India
  • Satya Dash, Association of Biotechnology Led Enterprises, India
  • Dhananjaya Dendukuri, Achira Labs, Bangalore, India
  • Pradip Desai, Span Diagnostics, Surat, India
  • Bindu Dey, Department of Biotechnology, New Delhi, India
  • Puneet Dewan, WHO, SEARO, New Delhi, India
  • Gopi Gopalakrishnan, World Health Partners, New Delhi, India
  • Sami Guzder, Avesthagen, Bangalore, India
  • Rekha Hemrajani, Exelixis Inc. & Omidyar Network, USA
  • Szymon Jaroslawski, IBAB, Bangalore, India
  • Nalini Krishnan, REACH, Chennai, India
  • Rishikesha Krishnan, IIM, Bangalore, India
  • Ashok Kumar, Central TB Division, DGHS, New Delhi, India
  • Blessi Kumar, TB/HIV activist and consultant, Delhi, India
  • BV Ravi Kumar, XCyton Diagnostics, Bangalore, India
  • Bala S Manian, ReaMetrix, Bangalore, India
  • Jaykumar Menon, X Prize Foundation, USA
  • Shirshendu Mukherjee, Wellcome Trust, India
  • Chandrasekhar Nair, BigTec Labs, Bangalore, India
  • Anjali Nayyar, Global Health Strategies, India
  • V Raja, GE Healthcare, Bangalore, India
  • Viveka Roychowdhury, Express Pharma & Express Healthcare, India
  • Camilla Rodrigues, Hinduja Hospital, Mumbai, India
  • Gayatri Saberwal, IBAB, Bangalore, India
  • Sandeep Sen, Sen Labs, Patna, India
  • Anand Sivaraman, Remidio, Bangalore, India
  • Narayanan Suresh, BioSpectrum Asia & Technology Review, India
  • Peter Small, Bill & Melinda Gates Foundation, USA
  • Natarajan Sriram, Tulip Group, Goa, India
  • Soumya Swaminathan, TRC, Chennai
  • Javid Syed, Treatment Action Group, New York, USA
  • Jaya Tyagi, AIIMS, New Delhi, India
  • Brad Tytel, Global Health Strategies, India & New York
  • Suresh Vazirani, Transasia Biomedicals, Mumbai, India
  • Suri Venkatachalam, Connexios, Bangalore, India
  • Gene Walther, Bill & Melinda Gates Foundation, USA

Space is limited. Industry participants from India will get preference.Registration form available at:

Meeting coordinators

  • Dr John Kenneth, MD, SJRI, Bangalore []
  • Dr Madhukar Pai, MD, PhD, McGill University, Montreal []