Working against the ‘hard’ vaccines with patient capital
Bill and Melinda Gates Foundation has taken up the opportunity to provide funding to projects deemed too ‘risky’ to support research on a global scale. It is one of the largest providers of science funding in the world, having the ability to support projects with longer timelines but outsized impact.
BioPharma-Reporter had the chance to meet Lynda Stuart, deputy director for Vaccines and Human Immunology for the Foundation, during the BIO Convention in Philadelphia, and discussed the current challenges in vaccine discovery and what needs to change across the industry.
Among other areas of focus, the Foundation encourages R&D of vaccines that would have significant impact on reducing mortality of those under five years, maternal deaths, prevalence of HIV, tuberculosis (TB) and malaria, as it has been investing in the ‘Sustainable Development Goals’ set by the UN.
“Our funding is in really innovative, transformational approaches and in biologics for global health indications,” Stuart commented.
However, she argued that vaccine research remains ‘empirical’ and “there is a lot of work we can do to make it a much more rational, predictable modality than it is at the moment.”
She explained that although previous research on vaccine development have provided scientists with valuable facts and knowledge, today’s vaccinology is still a ‘black box’, an area which can only be examined through its inputs and outputs and but is still not completely understood.
“I think for the vaccines that worked, they worked and people didn't need to understand why they worked. But now that we're coming up against the ‘hard ones’, people don't know how to make them,” Stuart said.
Therefore, focus is being put on reverse vaccinology, where scientists try to understand the mechanism of action by developing either vaccines or antibodies that will recapitulate the protective phenotypes.
Answering a question regarding the challenges that the Foundation faces during their work with partners, Stuart said, “We ‘hit barriers’ in the partnerships when we don't fully understand each other's motivations and what each side needs to get out of the partnership.”
However, she explained that there can be a win-win position between industry and research – this is what the Foundation is working on through its partnerships and by the research it is funding.
Providing an example, she told us that the Foundation was an early investor on antibody discovery platforms, which are now being used heavily in oncology because they were ‘frantically’ looking for antibody interventions for HIV.
Asked about what would help the research improve further, Stuart mentioned the need to increase the ‘patient capital’ and the ‘risky’ investments, which might not have short-term profit, but will bring ‘outsized impact’ after long-term funding.
“You need to give things enough time to be ready. The challenge is to find the balance – patiently taking a product to the right pre-clinical proof of concept and to ensure the sufficient runway and capital to get there,” Stuart said.
“This might not work for individual companies but in the Foundation we're very much in ‘fail fast, fail often’ and we can do that because we have a large portfolio,” she added.
Referring to drug pricing, and the recent approval of Novartis’ Zolgensma (onasemnogene abeparvovec), priced at $2.1m (€1.87m) per patient, Stuart pointed out the need to encourage the industry to return to ‘where the impact is’, rather than addressing small patient populations that generate profit.
Asked to comment on the statement made by the CEO of Merck at the conference about the need for return on investments and that capital markets “don’t go to church on Sunday,” Stuart responded, “Well, we are still making investments to benefit the poorest.”
She added that this ‘trend’ of the industry is ‘unfortunate’.