The Need for Not-For-Profit: Q&A with Dr. Emilio Emini

Dr. Emilio Emini
The Bill and Melinda Gates
Medical Research Foundation

The Bill and Melinda Gates Medical Research Institute recently announced that its CEO, Dr. Emilio Emini, would retiring, with Dr. Patrice Matchaba taking his place. Dr. Emini spoke with Pharmaceutical Executive about his work at the institute and the importance of not-for-profit organizations.

Pharmaceutical Executive: What led you to your decision to retire?
Dr. Emilio Emini: We have completed the CEO transition, so I am now formerly an advisor to the foundation. I was the CEO there from August 2021 up until last week (June, 2024). Why did I decide to retire? There’s a number of reasons, but the most predominant one is that at the very end of last year, I turned 70. I’ve been doing this for 45 continuous years across multiple organizations, including Merck and Pfizer. I joined the Bill and Melinda Gates Foundation in 2015 as the director of the global HIV and Tuberculosis programs. I did that for a number of years, and then I started doing work on COVID during the pandemic.

I completed what I wanted to do, and there’s comes a point when it’s a good idea to move on, retire, and do the things that I never had the time do while working full-time for 45 years.

PE: Can you discuss the transition of Gates MRI from a translational discovery organization to a fully integrated biopharmaceutical product development organization?
Emini: When Gates MRI was founded in the latter part of 2017, I was on the board. As you may know, it’s a fully owned subsidiary of the foundation, so it has an independent board. It was originally intended to be a transactional research organization which would take potentially interesting novel products and would move them from either academic institutions or companies that had been funded by the foundation to do the early work, and then the institute would do the middle work of determining if these products had potential clinical importance. We would also determine if they could be further developed and perform the early development research work.

It became clear that what’s really missing from the pharmaceutical ecosystem is a not-for-profit organization that could do fully integrated biopharmaceutical integration and fully develop a product. For a lot of the products that are needed by diseases that are significant in the global south, the commercial potential is not there. These products, which would normally be developed by large biopharmaceutical companies, didn’t make commercial sense.

There needs to be someone that can do that on a not-for-profit level with not-for-profit funding. That’s why we morphed the company. We licensed the development from GSK of a potentially effective Tuberculosis vaccine. The institute is now doing the full phase III development of that vaccine. It’s not just clinical development, it’s working with potential backend partners who could potentially manufacture the vaccine.

It's working in areas such as that, and it’s also working in areas of novel drugs for the treatment of a number of diseases. It became a true not-for-profit product development organization.

PE: What were some of the most notable novel collaborations that you helped develop for advancing research into public health challenges?
Emini: The collaborations are across the board. We are involved as a partner on a large collaboration that is focused on the development of novel combinations of novel TB drugs. That includes companies such as J&J and not-for-profit organizations like the TB Alliance. We’ve also had independent collaborations with Merck and a number of other companies.

We have a number of company and not-for-profit collaborations where we do the phase II or III development. It’s an entire development program that we’ve built. We’ve also worked with a number of smaller companies developing monoclonal antibodies, along with collaborations on the backend with larger manufacturing companies. This way, if we do successfully develop these interventions, they will take on the responsibility for manufacturing, licensing, and distribution.

PE: Can you discuss some of the treatments that are in the works at the moments?
Emini: We’re working on a Malaria monoclonal antibody. The hope is to be able to deliver this once to children who are high risk for Malaria during the transmission season, which occurs during the wet season when mosquitos show up and become more abundant. That has not started clinical studies, but is in the planning phase.

We also have two large TB programs and a probiotic program where we are assessing the potential of giving a probiotic to improve the outcome of malnourished children.

PE: How important is it that organizations like the Bill and Melinda Gates Foundation get involved in areas that big Pharma may not find profitable, but there is still a desperate need?
Emini: For a lot of these companies, the kinds of diseases we talk about are difficult. The concern for companies that they need to develop a way for products to come out of their laboratories that would be potentially useful. The commercial viability may not be there, at least not at the level that big Pharma companies would need. There’s always an investment element: investment in people, time, and other resources.

From their perspective, it doesn’t make sense. That’s why there was a need to put a not-for-profit biopharmaceutical development organization. That’s what the Gates MRI is, to do what the big Pharma companies do but on a not-for-profit basis.