Kaitlin Christenson is coalition director for the Global Health Technologies Coalition (GHTC), an organization with more than three dozen member-groups that work on neglected diseases, including HIV/AIDS and tuberculosis. The coalition, formalized just two years ago, advocates for more research and backs new U.S. policies to accelerate the development of new drugs, vaccines, diagnostics, and other tools for these diseases.
This is the first in a short series of pieces that look at the research and development issues around HIV and TB. The series begins on International Women’s Day and will continue during a trip to South Africa of two of the U.S. government’s top global health leaders – National Institutes of Health (NIH) Director Francis Collins and Global AIDS Ambassador Eric Goosby. John Donnelly interviewed Christenson Tuesday in Washington, DC.
In the areas of HIV and TB research, what do you see as big news ahead?
About a third of our coalition members are conducting research on a variety of global health diseases, and several of them work in HIV or TB. In general, over the past decade, we’ve made some major advances against HIV and TB, but it’s clear that without new technologies being researched and developed, we do not have the tools we need to fight these diseases.
But there is some excitement now. In HIV, over the last year or so, research has yielded results on the first-ever proof of concept that a microbicide gel could work to prevent HIV infection in women, and there also were a number of exciting advances with HIV vaccines, including the Thai vaccine trials and a number of different efforts taken now to understand neutralizing antibodies.
On the TB front, there are efforts by a number of organizations, including on diagnostics, better TB treatment regimens, and, importantly, a TB vaccine. We have the potential for a much shorter regimen that would be more cost effective in the long run. We are seeing new advances for a TB vaccine. The current vaccine is almost 100 years old and is not effective in many populations that are vulnerable. It’s an urgently needed tool.
Both Francis Collins and Eric Goosby will be travelling Wednesday to one of the microbicides clinical trial sites in South Africa – a CAPRISA site. How important were the findings?
To me, the announcement of the CAPRISA trial results was the highlight of the International AIDS Conference last year. I was sitting in a room surrounded by thousands of people when I heard those results. People stood to applaud the researchers. People had tears in their eyes. I was surrounded by people who had dedicated their entire careers to the field, and it was incredibly moving. What was also moving about it was this was a trial that had taken place in South Africa, by South African researchers, supported by U.S. government resources. It was an example of how you need many partners to develop these tools.
A microbicide gel appears as an example of researchers giving women a tool to protect themselves from HIV infection. What is the expectation of additional breakthroughs through technology to protect women?
There’s certainly no silver bullet for empowering women. To protect women’s health, new technologies will be a critical component of a package of interventions. When you consider HIV, there is a complex web of factors that increase women’s vulnerability to infection. You need new tools like a microbicide or an HIV vaccine that women can initiate or control, alongside other interventions that allow for better access to health care services as well as shifting gender norms and promoting behavior change.
In GHTC – your coalition – are you finding common threads or approaches that lead to success? Is it partnerships that push things along, or is it more common that a brilliant person working alone has an insight that leads to a discovery?
It’s the partnership. In the last two decades, there’s been an emerging organizational model called the product development partnership, or PDP, for neglected diseases, including HIV and TB. That model has brought together the experience from the private sector and the public sector’s will to do good, and we’ve seen successes emerge. Some of the examples are new drugs for malaria, a new vaccine for meningitis, the work in microbicides, diagnostics for TB, and new vaccine and drug candidates for TB.
But haven’t PDPs received low marks by some?
It’s really important to explore a variety of models, and no one size fits every approach. They operate in different ways. But basically the model has worked well. It means not investing all efforts in one single candidate, but investing in a portfolio approach to research and development, with the hope that one or more candidate will work. And it involves bringing together partners that may not otherwise work together on these issues – the U.S. government with European donors, private foundations such as the Gates Foundation alongside the pharmaceutical industry and other private sector players, such as the biotech industry. We need many different players.
Can you give me a good example?
TB drug research is one. The goal is to create cheaper and shorter TB drug regimens. Through the work of the Global Alliance for TB Drug Development, or the TB Alliance, they are bringing together partners who never worked together before – groups like the pharmaceutical industry, global regulatory bodies, and civil society organizations. It also receives support from the FDA, which is playing an increasingly important role in global health diseases.
The FDA is helping support and evaluate new mechanisms to review products for neglected diseases. The regulatory pathways are complex. For U.S. populations, the FDA ensures that products, after they have gone through robust clinical trials, meet its standards. Now FDA’s global health role could be expanding. Later this month, they will release a report to Congress with recommendations for playing a larger role in advancing new products for neglected diseases, including TB. It may involve partnering with countries to help them build regulatory capacity.
What’s next on your agenda?
We’re definitely looking for more funding for research globally. The group Policy Cures recently released the G-FINDER report, which shows a modest increase in funding globally, but funding for HIV research in 2009 essentially held steady. We heard President Obama talk in the State of the Union about the importance of research and innovation and protecting our national leadership in the realm of science and technology, and that it’s critical we continue funding for research and development. Nowhere is that more true than for research for global health technologies. Research and innovation is a cornerstone of the Global Health Initiative, the U.S. Agency for International Development (USAID) has long recognized the importance of science and technology, the NIH director named global health as one of his five priorities, and we’re seeing increased commitment by the FDA on global health issues. Even in this economic climate, we have to make sure that we continue to fully support global health research so we are able to develop the tools needed to make advances against these diseases.