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To find an effective malaria vaccine, know when to say no

A vaccine against one of the world's most debilitating diseases, malaria, has been notoriously elusive. But the PATH Malaria Vaccine Initiative (MVI) is bringing one promising candidate closer than ever before to reality while continuing to advance other candidates through the stages of development.

MVI has all the preclinical and clinical expertise of a biotechnology or pharmaceutical company. But the program does not have laboratories that actually build vaccines. Instead, we identify promising ideas from all sources. Then, we form partnerships to pursue approaches for producing vaccines that promise affordable and accessible protection from malaria in the developing world.

Not every idea achieves its promise. As projects move forward, they eventually come to a crossroads, and MVI staff must decide: Is it worth continuing support, or should we pull the plug? A committee of a dozen MVI staff members makes the difficult call.

Cynthia Lee, director of portfolio management and translational projects, and Ashley Birkett, director of research and development, explain how we decide to end a project or move it forward.

Coming to consensus

Cynthia Lee

Cynthia Lee says consensus is crucial in deciding which projects move ahead.

Cynthia:

We make decisions through a team, not through individuals. We oversee what comes into the portfolio and how the money is being spent. The committee operates by consensus decision rather than by majority rule. We debate until everybody buys into one or the other opinion.

The principle behind consensus agreement is to ensure that all voices, especially dissenting voices, are heard. There are very few occasions where there’s a holdout who stands his or her ground.

Ashley:

Ashley Birkett

Ashley Birkett helps decide which malaria vaccine projects continue to receive support.

We want everybody to get behind the decision, whether it’s their favorite project or not. We debate it. Everybody gets behind the decision and then we all go in the same direction.

Cynthia:

We set go/no go criteria prior to getting the data. You have to do this. And you need to have not just the internal team buy into this, but you also need the external partners’ buy-in. Once the data are in, there won't be a debate—oh, maybe it did work, or there's a hint of it working so we should go on. We have to set those criteria at the beginning.

Good decisions, quickly

Ashley:

We both faced it in our previous roles at companies. It’s very easy to keep things moving. It’s much harder to kill things. But that’s really what we need to do because we have a limited amount of resources and we have to apply them in the best way possible. If we’re not prepared to make the tough decisions and terminate programs, then we’re not going to have the resources to apply to those more promising new approaches.

So our philosophy is to try to make good decisions as quickly as possible, as cost-effectively as possible, so that we can kill things if they’re not looking promising.

“Consensus agreement is to ensure that all voices, especially dissenting voices, are heard.”

We are very data-driven. There are other product development partnerships similar to ours that are not totally virtual. For example, you might have your own manufacturing facility or your own internal programs that compete with similar ones you are supporting via an external partner. There are some advantages to that. But I think one of the big challenges is being impartial. For example, let’s say we have a portfolio of ten projects and two of them are being developed in our own lab. Ensuring that we’re impartial and purely data-driven and not biased toward those two programs that we might have more of a vested interest in because they're the ones we work on every day in the lab—that would be a challenge.

So, we actually think this virtual model where our partners do all the work and we’re absolutely data-driven enables us to be the best organization we can be. Several years ago we decided not to get into the manufacturing business and I think it’s a decision we feel very good about.

An objective view

Cynthia:

We can be a lot more objective. Ashley and I have both had labs in the past. And it is really hard to kill projects you have such a vested interest in. You may have to lay-off your staff. It’s very difficult to remain objective.

Next Transferring the technology

Photos, from top: Virginia del Rosario, PATH.