The world needs more science to tackle tuberculosis and in order to get that science to patients, the global health community needs to help incentivize others to get involved, according to Rogerio Ribeiro, senior vice president and head of the global health unit at pharmaceutical company GSK.
In 2017, of the 10 million people who contracted TB, 1.6 million people died from the disease. While a vaccine exists — the bacillus Calmette-Guérin, or BCG — it doesn’t provide consistent protection for adults. And the treatment available — an 18-24 month regimen consisting of 14,000 pills and 240 injections made up of seven different drugs — often causes severe side effects, while resistance to the treatment is also on the rise.
GSK believes that without more effective vaccines and medicines, it will not be possible to achieve the World Health Organization’s target of decreasing the number of new cases globally by 90 percent and the number of tuberculosis deaths by 95 percent between 2015-2035.
“One of the challenges is that there are few companies developing medicines or vaccines for TB,” Ribeiro said. “How do we create incentives for more biotech companies, startups, big companies to do this research? And how do we encourage local organizations and middle-income countries to be involved?”
GSK has been working on the research and development of a vaccine and medicines for TB for 16 years, and in 2018, announced the interim phase two results of a trial for a developmental new vaccine. Phase two assesses the efficacy of the vaccine against the disease. However, Ribeiro said they cannot make progress alone and urged the global health community to find a way to incentivize others to join the efforts.
“We have the science, but the science alone will not make these medicines available.”— Rogerio Ribeiro, senior vice president and head of the global health unit, GSK
Speaking to Devex, Ribeiro explained what’s needed to make progress in TB prevention and treatment, the challenges the community is up against, and how these go beyond TB itself.
This conversation has been edited for length and clarity.
What are the key ingredients of a sustainable model that translates scientific discoveries into significant benefits for the most vulnerable?
At GSK, we are united behind a core purpose of helping people to do more, feel better, live longer, regardless of where they live.
The first way in which we do that is with our commercial vaccines and medicines. We develop them to benefit patients and drive return to shareholders, but medicines and vaccines are not only important in developed countries, they’re equally important for the poorest countries in the world. For those countries, we focus on access and affordability.
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One example is our partnership with Gavi, the Vaccine Alliance, where we have committed to provide more than 850 million vaccine doses at reduced prices to help protect 300 million children in developing countries by 2024. We ensure that Gavi always has the lowest price of our vaccines and we benefit from a guaranteed purchase mechanism.
Another good example is in HIV, where we make antiretrovirals. A strong business in developed markets enables us to offer voluntary licenses to generic manufacturers in all lower-middle-income, low-income, least developed, and sub-Saharan Africa countries. This is one way that we are bringing our science to the most vulnerable patients, but there’s another more challenging level.
In some disease areas, while we have the science, the know-how and the technology, there is often no clear route to market and innovative products fail to be made available. That’s because, in the developing world, in many cases, there are no markets for the creation of some of the science and technology that tackles prevalent diseases like tuberculosis and malaria.
There’s no commercial attractiveness or linkages to incentivize the developers of the research. We’ve been developing a roadmap to allow us to do that, but clearly, we cannot do it alone. We need partnerships, they are critical. We have the science, but the science alone will not make these medicines available.
We’ve been developing our malaria vaccine for 30 years and are donating the vaccine for three WHO pilots in Ghana, Malawi, and Kenya. But even with these pilots, there are still some challenges in moving forward. If the pilots are successful, how will vaccine delivery be scaled up and who is going to purchase the vaccine even if it’s made available at low cost? We need to work with partners to answer these questions.
How and why does GSK use its scientific expertise to tackle TB in low- and middle-income countries?
It’s all science-led. Today, while at GSK we don’t currently have any TB vaccines or medicines available, we have a strong pipeline — two compounds already moving to phase two. We’ve also recently published promising interim results on our TB vaccine candidate.
Science is about helping people and a lot of that comes from collaboration. We have the GSK Tres Cantos Open Lab Foundation, which allows visiting scientists from around the world to use our laboratories, our technologies, and our library of more than 2 million compounds to advance their science.
It is extremely important that our team is constantly engaging with others like the Bill & Melinda Gates Foundation, the Wellcome Trust, other funders, NGOs, and researchers to try to make the development of this science sustainable.
What are some of the challenges you’ve faced in tackling TB?
One key challenge today is finding the right hospitals and clinics that have the patients and the capacity to take part in clinical trials. I think another complexity is that the bar is high in trying to find new medicines that can be combined together to deliver shorter treatment regimens that are safe and effective for patients.
Another challenge is the increase in resources required once a development program moves from phase two to three. These confirmatory studies are necessarily large, and the associated costs of conducting a study for a medicine for TB is similar to that for other medicines, for example for cancer.
The resources here are scarce in the area of global health, although regulatory incentive mechanisms and the availability of co-funding can help address this gap. The complexities of treatment, availability of funding to scale, and then — once developed — the ability of resources for the countries to purchase the medicines, pose the biggest challenges.
I think that TB is a great example of a disease around which, in recognition of the huge need, different companies and organizations — both scientific and delivery-focused — are really coming together now to address some of these challenges collectively.
In research and development, the level of cooperation across pharma companies, for example, is almost unique, with broad recognition from those at the forefront that when it comes to TB research, commercial interests cannot undermine or delay the scientific progress that we need to achieve.
What we need is for this collective thinking to continue and to grow across all partners and stakeholders. If we can do that, we can not only develop the new interventions in partnership but then can also work collectively and with the right urgency to implement end-to-end plans to ensure that once approved and available, the innovations reach people who need them.