Crossing the Valleys of Death in TB: From Development to Roll-Out

Ian MatthewsNews

By: Dr. Lucica Ditiu and Dr. Catharina Boehme  

The numbers speak for themselves.  In 2015 alone:

  • 1.8 million died from tuberculosis (TB);
  • 10.4 million people fell ill with the disease; and
  • An estimated 480,000 developed multidrug resistant-TB (MDR-TB).

All of this, combined with the airborne transmission of the disease, makes TB the leading infectious disease killer (surpassing both HIV and malaria) and a global health security matter.  If we are actually serious about ending TB by 2030, as set forth in the Sustainable Development Goals, substantial innovation is required across the whole spectrum of TB diagnosis, treatment, adherence, and prevention.

Although the formation of product development partnerships at the turn of the millennium has been instrumental in building the TB products pipeline, innovators continue to face two “valleys of death” in bringing their promising, new tools to the high burden countries.

The challenge: “Valleys of death”

The first “valley of death” is encountered during the product development to commercialization stage.  Innovators may fail due to a variety of factors, including but not limited to: (1) insufficient evaluation of the product in settings of intended use, (2) lack of end user involvement in product research and development, and (3) lack of alignment in the product design and manufacturing process.[1]

The second “valley of death” is encountered during the commercialization to roll-out stage.  Innovators that have successfully developed and commercialized their products are consequently faced with complex labyrinth of activities and actors that is unique to the global health market.  They face additional barriers, including but not limited to: (1) lack of focus on demand generation, (2) weak engagement of country decision-makers and stakeholders, including civil society and community, and (3) lack of planning and resources for country adoption.[2]

In short, the product launch plans that have been developed for high income markets does not necessarily work for high burden countries.

The opportunity: Accelerator for Impact

In response to this challenge, Stop TB Partnership, FIND, McGill International TB Centre, TB Proof, Unitaid and other key partners launched a public-private initiative called Accelerator for Impact (a4i) in October 2016.

a4i is a coordination platform of key partners and activities that focuses on the downstream end of the product development lifecycle and executes an efficient pathway to rapidly roll-out promising, new TB tools.  The platform’s mantra is: “bringing the right product, with the right performance, at the right cost and ensuring the right uptake, with the right implementation, for the right impact.”

a4i’s core business is to: (1) drive efficient product launches in early adopter countries, (2) catalyze sustainable partnership opportunities between the innovators and early adopter countries, and (3) achieve a return on investment.  The platform hopes to achieve these activities by: (1) leveraging key partners’ expertise and existing platforms, (2) strengthening the feedback loop between innovators, country decision-makers and stakeholders, including civil society and community, and key partners, (3) promoting early engagement with civil society and community, and (4) utilizing the venture capital business model.

a4i consists of six sequential steps, which are underpinned by two strategic enablers – (1) civil society/community engagement and (2) political will.

While the above-listed stages, activities, operating principles, and achievements are critical, it is equally important to highlight some of the values behind a4i.

Creating the future together

When people are asked, “How do you predict the future?” they generally tend to look back to the past and identify lessons learned.  However, we believe, as Abraham Lincoln once said, “The best way to predict the future is to create it.” Thus, one of the first questions we asked ourselves in building a4i was, “How can innovators, country decision-makers and stakeholders, including civil society and communities, and key partners create the future together?”

In answering this question, we realized that we had to jump into pretty complicated and uncharted territory, potentially in ways that global health and international organizations generally avoid. We appreciated the view that all of us needed to put some “skin in the game” and take risks together to achieve our ultimate goal – a TB-free world.

Utilizing the venture capital business model

a4i aspires to become financially sustainable by utilizing the venture capital business model.  We do not want to keep going back to traditional donors and their taxpayers for funding over and over again.

While traditional donors could provide seed funding, we would like to ensure the platform’s sustainability in two ways: (1) by asking innovators supported by a4i to financially contribute back into the platform and (2) by leveraging these royalty streams to launch and securitize a global health bond, a traditional debt instrument that can be publicly traded on market exchanges and sold to impact investors and institutional investors, such as endowment and/or pension funds.

We believe such a model is the future and will transform TB and global health financing.  It will allow us to better optimize the use of traditional donor funding to catalyse innovation, subsequently leverage market investors to scale successful projects, and, more importantly, help fill the annual $2 billion resource gap for TB.[3]

Going forward

While a4i has identified TB diagnostics/adjunct diagnostics as the first area of investment, the platform will broaden its scope to include adherence technologies, drugs, and vaccines in the near future.  As such, the 1st Innovators & Adopters Workshop will be organized in October 2017 in Guadalajara, Mexico, on the sidelines of the 48th Union World Conference on Lung Health, to:

  • Foster evidence-based discussions between innovators, country decision-makers and stakeholders, including civil society and community, and key partners to accelerate the roll-out of current and new TBDx;
  • Provide country decision-makers and stakeholders, including civil society and community, early visibility to the TBDx pipeline;
  • Plan for the development of country tailored roadmaps to product introduction for TBDx; and
  • Achieve better balance between supply and demand in the TBDx space.

We are excited about working hand-in-hand with innovators, country decision-makers and stakeholders, including civil society and community, and our key partners in a different and new way to successfully cross the valleys of death.

[1]Engel et al. Addressing the challenges of diagnostics demand and supply: insights from an online global health discussion platform. BMJ Global Health. 2016; 1:e000132.

[2] Diagnostics 2017, 7, 8; doi:10.3390/diagnostics7010008 www.mdpi.com/journal/diagnostics.

[3] The Global Plan to End TB, 2016-2020: The Paradigm Shift.

About the Authors

 

Dr. Lucica Ditiu

Dr. Lucica Ditiu is the Executive Director of the Stop TB Partnership since January 2011. A native of Romania, Dr. Ditiu is a physician and a public health expert, who has devoted her career to helping those affected by TB and people living in communities heavily burdened by tuberculosis (TB).

In the last few years, Dr. Ditiu has been instrumental in developing a clear identity for Stop TB Partnership, in ensuring a strong voice of TB Community in international arena and a great advocate for all those marginalized and vulnerable and suffering because of TB. She led the process in the transformation of the coordinating board to enable greater representation from constituencies. She has deepened engagement with The Global Fund working with the board, the secretariat and at the country level.

She has worked to ensure the provision of continued access of quality-assured TB drugs and diagnostics through the Global Drug Facility. A strong believer in innovation and change, Dr. Ditiu is restless in pushing for more ambition in TB work and in challenging status quo.

Looking ahead, Dr. Ditiu hopes that she will see all stakeholders coming together to fight against the TB epidemic, within countries health system

Dr. Catharina Boehme

As CEO of FIND, Dr. Catharina Boehme oversees the operations of the organization together with the assistance of the heads of programme and supporting staff.

In her previous roles at FIND, as Chief Medical Officer (CMO) and Head of the TB programme, Catharina was responsible for the clinical evaluation of new tools for diagnosis for TB, malaria and neglected diseases. She also oversaw FIND’s downstream activities, which focused on laboratory strengthening, in-country validation and implementation. Catharina managed the R&D projects for several new point of care technologies and molecular diagnostic approaches, which required close interaction with the diagnostics industry, academia and WHO.

Since 2013, Catharina has been serving as co-Chair of the New Diagnostics Working Group of the Stop TB Partnership, and in April 2015 she became a member of the WHO Strategic and Technical Advisory Group (STAG-TB).

Catharina has an extensive background in clinical evaluation and has managed over 30 early-stage trials, and five late-phase large-scale trials, including those for five diagnostic tools recently endorsed by WHO. She played a key role in FIND’s Xpert MTB/RIF feasibility, evaluation and implementation studies in 12 high-burden countries, with a focus on identifying ways to adapt the device for use in low-resource settings.

Prior to joining FIND in 2005, she worked as programme coordinator for the Department of Infectious and Tropical Diseases in Munich, Germany and established a TB research unit at Mbeya Medical Research Program in Tanzania.

Catharina holds a Doctor of Medicine degree in Internal Medicine (Ludwig Maximilians University Munich, Germany) and diplomas in Public Health (Charite, Berlin, Germany) and in Management & Leadership (University of Heidelberg, Germany).

 

Ian MatthewsCrossing the Valleys of Death in TB: From Development to Roll-Out