Combating Diseases with Limited Investment Incentives: Q&A with Dr. Claire Wagner

Claire Wagner
Head of corporate strategy
and market access
Bill & Melinda Gates Medical Research Institute

In the pharmaceutical industry, both profit and helping patients must be considered as motivators. As head of corporate strategy and market access at the Bill Melinda Gates Medical Research Institute, Dr. Claire Wagner works to get medications produced or developed that are sorely needed but may not fit into the typical profit-structure of a commercial pharmaceutical company.

Pharmaceutical Executive: What are the largest global health concerns for which investment incentives are limited?
Dr. Claire Wagner: The COVID-19 pandemic showed some critical vulnerabilities in health systems across high income countries with strong economies, regardless of income levels. At the Gates MRI, we focus on product development for diseases that primarily impact Low and Middle-Income Countries (LMICs). Weak healthcare infrastructure and limited access to pharmaceutical products is a global health threat, with at least half the world’s population facing critical barriers to essential healthcare services.

At the Gates Medical Research Institute (the Gates MRI) we consider global health as an area of practice that places a priority on improving health and achieving equity in health for all people worldwide. We are driven by the phrase “all lives have equal value,” it is even written on our ID badges! The Gates MRI focuses on programs aimed at reducing the burden of tuberculosis (TB), malaria, diarrheal diseases, and maternal, newborn, and child illnesses in LMICs. The institute works through collaborating partners and organizations, coordinating and driving the full spectrum of biopharmaceutical development activities to address substantial global health concerns, particularly where commercial incentives are not a strong driver for investment.

PE: How does your experience shape your strategy at the Gates MRI?
Wagner: At the Gates MRI, our job is not only to develop novel pharmaceutical products but also to ensure that those products ultimately reach the people that need them. This requires policy alignment, multilateral engagement, innovative financing, market shaping, procurement strategies, product launch and scale planning, and health system integration. A massive ‘job to be done’ with a high bar for success – and a job that only can be done with strong partnerships and collaborations, a depth of knowledge along the access cascade, and keeping front and center the people and patients we serve.

I have had the opportunity in my career to work across this cascade, and I leverage those experiences to advance the mission of our organization and that of the Gates Foundation. For example, a key need for Gates MRI is to ensure our products are aligned within global and national normative bodies. In coordinating the expansion of the WHO Model List of Essential Medicines in 2014-15 followed by translation to national formularies, I saw first-hand how policy changes happen. It also demonstrated that policy change is often more of a floor than a ceiling: a changed policy does not mean a medicine is now accessible to a patient in need in rural Rwanda. Experiences that I had working for the Ministry of Health of Rwanda taught me the importance of political will, multilateral engagement with organizations like Gavi, the Global Fund, and PEPFAR, and how to advance partnerships and agreements to scale up access. The case is no different at the MRI: we also need to build effective coalitions and leverage global health mechanisms for our products in development.

A keystone to effective launch and scale beyond product, policy, and partnerships is resource mobilization, particularly in low-income settings. At Gates MRI we work to understand what kind of market conditions will enable products to reach those in need. For example, what kind of investments may be needed to scale manufacturing infrastructure; or what kind of advance market commitments may be warranted to incentivize companies to increase supply volumes at launch before demand is well characterized? My experience working in collaboration with financial institutions has afforded me insights into diverse ways that money can solve problems: whether through transactions or financial architecture. We work closely with our partners and our colleagues at the Gates Foundation to create a conducive environment for our innovations to be accessible, affordable, and available at the point of care.

These elements are all of course at the mercy of health systems: without the right infrastructure, talented healthcare professionals, and strong health systems, a product may never make it to the person who needs it. As my longtime mentor Dr. Paul Farmer used to say, we need the “Staff, Stuff, Space, and Systems” to all be in place. Supporting Rwanda’s Ministry of Health in advancing national health system priorities – like specialty training programs, cancer care, radiation oncology, and the rollout of novel vaccines – stays with me every day. I rely on those experiences to guide our approach to integrated access and launch strategies so that we are not just delivering products but creating lasting impact on clinical outcomes and public health overall.

PE: How important is it for groups like the Gates MRI to focus on areas where there are limited investment incentives?

Wagner: The Gates Medical Research Institute is a non-profit organization dedicated to the development and effective use of novel biomedical interventions addressing substantial global health concerns, for which investment incentives are limited. Many of our development programs include vaccines or therapeutic agents that were developed at-risk by for-profit companies. We get to partner with those companies to drive forward further product development in line with the mission and values of our funders. It is a privilege to be able to do the work we do without certain constraints that a publicly listed company may have, like quarterly earnings calls. We are able to license a compound or vaccine and then take responsibility of the ongoing development through to phase 3 clinical trials and potential licensing. The institute has a different risk profile compared to a for-profit organization. We consider scientific attributes, potential impact on global health and our ability to develop a usable, competitive product–we can take on risks that many organizations could not consider.

PE: What are some of the drugs that Gates MRI is developing at the moment?
Wagner: The institute is supporting and investing in multiple vaccines and therapeutics programs. The institute’s TB vaccine program has a workstream focused on development of a candidate vaccine M72/AS01 (under an exclusive license with GSK) indicated for the prevention of tuberculosis disease in adolescents and adults. In a phase 2b clinical study, the investigational vaccine demonstrated potential in preventing TB disease among Mtb infected individuals. The first clinical trial Gates MRI initiated with M72/AS01 was a trial in South Africa to evaluate the safety and immunogenicity of the vaccine candidate in people living with HIV, referred to as the MESA-TB trial (supported by both The Bill & Melinda Gates Foundation and The Wellcome Trust). The trial was completed and demonstrated that the vaccine was well tolerated by people living with HIV.

In anticipation of a phase 3 trial efficacy trial of the investigational vaccine, the institute conducted a TB epidemiology study to document the prevalence of latent Mtb infection and the incidence of TB disease in populations with a high TB disease burden. The study was intended to build the required clinical trial capacity to support the investigational vaccine’s phase 3 trial evaluation. The phase 3 trial with up to 20,000 participants started earlier this year, involving up to 60 sites in Africa and Asia.

We serve as sponsors for the clinical trials of the Project to Accelerate New Treatments for Tuberculosis (PAN-TB) collaboration (the collaboration comprises Evotec, GlaxoSmithKline, Janssen, Otsuka, TB Alliance, the Bill & Melinda Gates Medical Research Institute and the Bill & Melinda Gates Foundation). This group of philanthropic, non-profit and private sector organizations is working together to expedite the development of a pan-TB regimen: a novel TB regimen capable of treating nearly all TB patients, even those with drug-resistant forms, to enable a simpler “test and treat” paradigm. Within the collaboration, the MRI is responsible for the execution of a Phase 2b/2c clinical trials intended to evaluate promising new regimens constructed with TB drugs from the PAN-TB partners in order to identify the best regimen for subsequent Phase 3 evaluation, in close coordination and joint governance with the partners. A pan-TB regimen that is expected to be significantly shorter than current standard TB treatments (2-3 months) would allow more TB patients to be cured, resulting in less transmission of infection, and a reduced burden on health systems that treat TB.

Earlier this year we initiated the first stage of a phase 3 clinical evaluation of a probiotic supplement to assess its potential to positively impact weight gain in malnourished children. Our earlier stage programs include the development of a monoclonal antibody with the potential of providing seasonal protection in children against Plasmodium falciparum malaria–we will soon start a phase 1 clinical trial.