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TB to enter 3rd Revolution,’ says Roscigno
Giorgio Roscigno, MD, is the new CEO of the newly created Global Alliance for TB Drug Development. His resume includes wide-ranging experience in both public health and private industry; his reputation is that of someone who has functioned as a conscience for the drug industry, continually encouraging it to do better by the poor.
Certainly, the facts bear that role out. On the (very) short list that might be called "Big Pharma’s Contributions to Tropical Medicine," thanks are owed chiefly to the U.S. military for developing three anti-malarial compounds; the veterinary industry, which invented six more drugs that have proven useful in humans; and to Roscigno, who oversaw the development of eflornithine, a drug used to treat African trypanosomiasis (sleeping sickness), and rifapentine, the only new compound developed for TB treatment in the past 25 years.
Says Ariel Pablos-Mendez, MD, scientific director of the Rockefeller Foundation: "You can see why we think we have gotten the right man for the job."
Following are excerpts from a TB Monitor interview with Roscigno:
Q: How did you become interested in public health?
Roscigno: I am an Italian born in Eritrea, the breakaway part of Ethiopia. My mother’s family emigrated there the end of the last century; it was there my elder daughter was born. I worked in Ethiopia, Sudan, Nigeria, and Zaire, and that’s how I came to have a passion for public health and tropical diseases. [Editor’s note: After a two-year stint in private practice in Italy, Roscigno joined one of the precursors to Aventis, where he survived a steady succession of mergers, and where he served first as medical director in both Africa and in Asia, and later as director of clinical research in Europe.]
I always hoped my work in private industry would bring me back to my original interests, and in that way, I’ve been quite lucky. Being in charge of eflornithine development, being on the decision team with rifapentine — these things are like children to me in that I’ve always hoped they would mean more than just commercial success.
Q: Some people say Big Pharma has seriously underestimated the potential of the TB drug market; others say that given their shareholders’ priorities, the drug industry can never be persuaded to gamble on drugs tailored to meet the needs of people living in poor countries. What do you think?
Roscigno: Certainly the TB drug market is poorly understood by industry. Small- and medium-scale industry are often unaware of potential markets, and big industry is reluctant to believe they will ever make any return on investments. That’s why the Alliance is preparing a report which will discuss the scope of this market, its nuances, its size, and how to segment and access it.
At about $500 million to $600 million, this market is quite substantial; the tricky part is that it’s widely spread throughout many countries, and a lot of it’s in the public sector, so it is not easy to access. And despite the fact that current TB research is very active, both in academia and in the public sector, industry often fails to pick up many good ideas and leads. So there is this gap, this void that needs to be filled.
We can fill that gap first by elucidating the market size, and so creating some interest; and second, by establishing an alliance of partners and stakeholders, which can help move some of these products from early discovery to development.
Q: Besides the market report, what other activities are already under way at the Global Alliance?
Roscigno: As you know, 25 scientists from all over the world have contributed to the Alliance’s Scientific Blueprint [for new drug development], a state-of-the-art document full of insights that should prove valuable to anyone interested in the current research on TB. We’ve also put out a call for proposals, and we expect the first round to come in by Dec. 15. In addition, we’re proactively going out and provoking discussions about development of various promising compounds — carrying on both active and passive case-finding, you could say.
Q: You say that by 2010 the Global Alliance will have produced a new TB drug that will shorten therapy to two to three months. You also say that such a discovery will amount to a "third revolution" in TB control, equal in importance to the development of short-course therapy and the DOTS strategy. Where in current research activities do you believe that new drug is most likely to emerge?
Roscigno: Although we still have no drug in therapeutics that has gone the genomic route and made it onto the market, I have very strong faith in genomic research. So does most of Big Pharma, which is why they’re investing heavily right now in genomics. Theoretically, the genomic route is the easiest way to go. For example, the discovery of the gene that induces latency would bring us very close indeed to our goal of a drug that works in just two or three months. Still, I would never rule out exploring other uses for existing drugs.
One other thing the Alliance is working on is how to shorten the period of time needed to register a drug — the clinical trials, the years spent waiting for relapses — which is now quite a long and tedious exercise. That’s why we’re encouraging activities aimed at finding some sort of surrogate marker that can be used to predict relapse rates.