The two 'valleys of death' that hold back the fight against TB

TB is now the world’s deadliest infectious disease. Simply put, it kills more people than HIV and malaria combined – three people die every minute, totalling 1.7 million deaths every year, more than 10 million people develop the disease each year, and more than 4 million are missed from case detection annually. TB, however, continues to be a forgotten disease, relegated to the era of Les Miserables and Dickens’ novels.

Because of the relatively low priority historically given to TB on the global and national health agenda, the fight against this treatable and curable disease has lagged behind. Case in point: the only TB vaccine that exists today, Bacillus Calmette-Guérin (BCG), was developed 97 years ago in the same decade that World War I ended, women got the right to vote in the US and the television was invented.

We will absolutely not meet the UN Sustainable Development Goal (SDG) of ending TB by 2030 with the current political support, financing, and innovations available. Current forecasts instead lean toward the disease ending in 2180. Yes, I repeat, in 2180 when I will be 212 years old.

This crisis is rooted, in part, in the sub-optimal scale and coverage of TB services, including the limited rollout of new, quality-assured TB innovations that could help prevent, diagnose, treat and cure TB in an affordable and effective manner. For example, while we have had breakthrough developments in diagnostics and drugs in the past decade, just one country, South Africa, has accounted for 35% of GeneXpert cartridge sales and 60% of bedaquiline use in 2017.

TB is a very complex market that is composed of an archaic labyrinth of structures and actors throughout the product development lifecycle. Innovators with novel ideas and solutions struggle to cross two “valleys of death” and bring their products to market.

The first is encountered between the product development and commercialization stages. Innovators may fail, owing to a variety of factors, including but not limited to: a lack of end-user involvement in research and development, insufficient evaluation of the product in settings of intended use and a lack of funding to conduct independent and appropriate validation studies.

The second “valley of death” is encountered between the commercialization and rollout stages. Innovators that have successfully developed and commercialized their products face additional barriers, including a lack of clarity and/or understanding of the World Health Organization’s evaluation and recommendation processes, weak engagement of country decision-makers and stakeholders, including civil society and community; and a lack of planning and resources for country adoption.

It is critical that the TB and global health community, particularly the public sector, work together with innovators to actively mitigate and/or remove the major barriers they face in bringing products to market, especially as they enter the post-commercialization stages. It is simply useless to generate the supply if we do not generate the demand.

Beyond financing, we need to provide innovators with our guidance, network and capabilities in order to create the necessary conditions for them and their solutions to reach the people who most need them. The Stop TB Partnership, in this vein, launched the Accelerator for Impact (a4i) initiative in late 2016, along with our partners, including the Foundation for Innovative New Diagnostics (FIND), McGill International TB Centre and Unitaid.

In essence, a4i is a synthetic venture capital fund or mechanism which aims to catalyse the rapid rollout of new, quality-assured TB innovations in high burden countries by:

The initiative’s mission is to:

To date, a4i has worked with two innovators, including DNA Genotek Inc, a subsidiary of OraSure Technologies, Inc, and most recently with SureAdhere Mobile Technology. The latter is a start-up formed by researchers from the University of California, San Diego, who have developed a Video Directly Observed Therapy (VDOT) technology, a mobile health solution that provides patients with the autonomy and flexibility to take their TB medication when and where they want.

SureAdhere has already rolled out their technology for TB, Hepatitis C and Opioid Use Disorder patients in several high-income countries, including Mexico, the UK and the US. “Video observed therapy is now a standard of care in many high-income countries,” reflects Dr Kelly Collins, CEO of SureAdhere. “However, SureAdhere’s mission is to deploy this widely in high-burden, low-income settings.”

Given the immense potential of digital adherence technologies, a4i has been working together with SureAdhere and our partners, including the Arcady Group, since October 2017 to map the most efficient pathway to rollout not only their solution but others too, including Everwell’s 99DOTS and Wisepill Technologies’ evriMed pillbox. This effort includes the identification of early adopter countries, organizing focus group discussions with these countries to optimize timely demonstration studies and adoption, and the identification of funding for activities relating to a country’s transition to scale.

The initiative hopes to work with more innovators in the coming months and years and to draw the brightest minds and transformative solutions into the TB and global health market.

At the UN HLM on TB, it will be critical for all heads of state and political leaders to finally commit to being the voice and support for all people affected by TB, and to prioritize the promise of life over unnecessary death.

The TB and global health community, in turn, needs to act with urgency and sophistication on the TB crisis. In fighting this disease, we must become a force with which to be reckoned, which will only be possible by creating a vibrant and thriving environment that catalyses and expedites the rollout of new, quality-assured TB innovations.

I am proud that, as part of this effort, the Stop TB Partnership, Johnson & Johnson, UN Foundation, and the World Economic Forum will organize a TB Innovation Summit on 23 September 2018 in New York City. The event will focus on how we can disrupt business as usual and catalyse novel approaches and innovations across the continuum of care with an emphasis on private sector contributions. It will also celebrate the current solutions that are positively impacting people affected by TB today and look at what we can do to drive progress tomorrow.

It's an opportunity that I am determined to seize. As Eminem put it: