Global Alliance CEO gets drugs moving
Global Alliance CEO gets drugs moving
Transferring ideas to real cures
[Editor’s note: Maria Freire, PhD, former head of the National Institutes of Health’s Office of Technology Transfer, took over last September as head of the Global Alliance for TB Drug Development. Under her guidance, the nonprofit group has already identified five compounds that hold promise as new anti-TB drugs, one of which was licensed for development by the group last month. Freire recently spoke with TB Monitor about the concept of technology transfer and how it can facilitate TB drug development.]
TB Monitor: You have the reputation of being a consummate artist in a field the average person has never heard of. Exactly what is technology transfer?
Freire: It means moving technology from conception to wider use. Sometimes that can be a fairly simple process. For example, let’s say you’re a surgeon who’s come up with a new surgical procedure. To get it more widely used, you give it a name and put it in every medical journal. That way, you get all the surgeons to use it. But it’s not always that easy. Suppose you’ve come up with a chemical that you notice can kill TB mycobacterium. Getting it from that point to a pill people can swallow may take eight to 10 years’ time, plus a lot of technology and investment. Plus, you’re talking about technology that can affect the lives of millions of people, which makes it even more complicated.
TB Monitor: What hurdles related to technology transfer exist in TB research?
Freire: In the past, whenever we tried to transfer technology for diseases that affect mostly people in poor countries — like TB, malaria, dengue fever, or cholera — there were never many takers. Two things worked against us: First, TB is unique in that drugs to cure the disease already exist (even though they take six to nine months to work). And until very recently, the market for these drugs in the developing world was considered too poor. So for the past 30 years, research has been underfunded, and promising compounds that did turn up languished on the shelf.
TB Monitor: How do you reverse that trend?
Freire: Let’s say that you’re a company or university that’s developed a compound which seems to work against TB. You may not be interested in moving it forward, or you may not able to. So you decide to seek a partner. The Alliance tells you, "Look, we acknowledge that this new compound is your intellectual property. We’ll respect your patent on it and not try to work around it. What we’d like to do is in-license your compound for development, under terms agreeable to both of us."
Or in a second kind of situation, let’s say your group has found something interesting, but your work is at such an early stage that it’s too soon to license it. There, we might fund the research needed to move it along. We’d negotiate a specific contract for a clear, deliverable good, and the intellectual property would flow to us. These are both the kinds of things business understands, and it’s a win-win deal for both sides.
TB Monitor: The Alliance’s goal is to find a new TB drug by 2010 that will shorten therapy to two months or less. Have you made any progress so far?
Freire: We’ve already identified five compounds with potential as new drugs, and our hope is to come up with more. (Editor’s note: One of the compounds, PA-824, was in-licensed by the Alliance in a deal struck shortly after this interview took place.) If you look at our goal as that of putting horses into the race, then we need to find as many horses as possible — since, realistically speaking, not all the horses will finish.
TB Monitor: How exactly do you find these horses?
Freire: In two ways. First, the Alliance puts out a request for applications, where we ask businesses, universities, or others to come to us with things we might use. Second, our staff conducts proactive inquiries to see who’s developing what. If we go ahead with the decision to license and develop something, the drug’s progress is monitored by Dr. Giorgio Roscigno, our scientific director, working closely with our Scientific Advisory Board.
TB Monitor: From the Alliance’s standpoint, aren’t some of these deals riskier than others?
Freire: Certainly. So, like any good investor, we diversify our approach, with what I call our stock-and-bond strategy. First, we have what I call our government bonds. They’re the derivatives or analogs of a current compound, things we can in-license which only need to tweaked or modified a bit. They’re our good, solid investments. Then there are the stocks — the quantum-leap compounds that are novel and that have never been seen before by the TB organism. Not only might they possess bactericidal and sterilizing properties, but, because they’ve never been seen before by the TB organism, they have the potential also to work against multidrug-resistant TB. So they carry a much higher risk, but they offer the potential for much higher returns.
Two of our five new compounds are "stocks," and three fall into the "bond" category. I should mention that not all five come from the United States; after all, we’re a global organization, so our task is to search very broadly.
TB Monitor: What else is the Alliance doing besides looking for new drugs?
Freire: Well, getting back to that racetrack analogy again, we need to make the racetrack as smooth as possible for the horses. So we’re working with the TDR [the Special Program for Tropical Disease Research, sponsored by the World Bank, the United Nations Development Programme, and the World Health Organization] to codify and simply the rules for registering a compound. That way, when it’s time to register a drug, you won’t have to provide multiple sets of data and abide by many different sets of rules. We’re also looking for new surrogate markers, since finding them will help minimize investments of time, money, and impact on clinical trials.
TB Monitor: Would you call this a hopeful time for TB drug development?
Freire: Definitely. For one thing, we have a number of new tools at our disposal. The sequencing of the TB mycobacterium genome has opened a whole new set of doors and given us a whole new set of tools. Genomics, the new field of molecular modeling, combinatorial chemistry — all these fields are going to have an enormous impact on our work. We can now design drugs on the computer. We can take existing drugs and modify them using these new tools. So while the cornerstone of our work is still traditional science, we now have the chance to leverage new tools and technologies from multiple disciplines.
Also, I think there are two other things working in our favor. One is a growing recognition that there is a great need for new TB drugs. Also, marketplace economics are beginning to be seen as much more feasible than before. All these things place us at a unique moment in history where I believe we’re primed to achieve our goal of developing new, better TB medicines.
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