This post is by Global Center Director Christine Lubinski.
The excitement in the room was palatable today as FDA Commissioner Margaret Hamburg joined representatives from the Global Alliance for TB Drug Development, the Bill & Melinda Gates Foundation, the Treatment Action Campaign, and representatives from the pharmaceutical industry to announce a new collaboration to accelerate the development of combination treatments for tuberculosis.
Known as the Critical Path to TB Drug Regimens (CPTR), the initiative will test promising combinations of individual TB drug candidates from different companies early in the development pipeline—and identify the best new treatment regimens.
“We are here today because every year almost two million people die from a disease we have known how to cure for decades,” Dr. Hamburg said in opening remarks at the event. She went on to describe the scientific enterprise in TB as stagnant and characterized TB research as the “only field in medicine where you could go into hibernation for decades and emerge to find that nothing has changed.”
She also spoke about her experience leading the effort to combat resurgence in TB, including MDR-TB in the early 1990s in New York city, and noted that $1 billion in costs associated with that effort might have been saved if appropriate resources had been marshaled to control TB in the first place. She articulated her commitment–and that of the FDA–to advancing regulatory processes that bring urgently needed advances in the treatment of drug-susceptible and drug-resistant TB.
Mario Raviglione, MD, the lead on TB for the World Health Organization, noted that 4,500 people who die of tuberculosis every day. And he pointed out that while there is a disproportionate burden of TB in some parts of the world—notably Asia and Africa—no country has even come close to eliminating tuberculosis. He described the coalition of companies coming together to develop new, more effective combinations of drugs for TB treatment as “unprecedented” and pledged that the WHO would move forward rapidly to develop policies relevant to getting new treatments to the field.
Dr. Regina Rabinovich, head of infectious diseases for the Bill & Melinda Gates Foundation, said the CPTR the initiative was groundbreaking and forged “a new pathway.” She also noted that the Gates Foundation could not do this alone and said it’s is essential that industry and governments step up to help finance this effort.
Paul Stoffels, MD, head of global research and development for Johnson & Johnson, talked about clinical trials under way for a new drug for MDR-TB in South Africa and said it’s been so long since there have been major TB clinical trials, that both capacity and know-how are a problem.
Professor Charles Mgore, executive director the the European and Developing Countries Clinical Trials Partnership (EDCTP) pledged the cooperation of his organization in the implementation of this initiative. EDCTP aims to accelerate the development of new or improved drugs, vaccines and microbicides against HIV/AIDS, malaria and tuberculosis, with a focus on phase II and phase III clinical trials in sub-Saharan Africa. Dr. Mcgore noted the imperative of conducting trials in high burden countries but highlighted the challenges that exist from poor infrastructure to personnel in need of training.
Mark Harrington, executive director of the Treatment Action Group, offered himself as a living example of what can be achieved when there is an effective collaboration among government, pharmaceutical companies and activists, as there was in the HIV context. He also said he never thought he’d find himself in a room with five pharmaceutical companies interested and willing to invest in TB drug development, while highlighting the incredibly modest level of resources being invested today in TB research and development—only $178 million on drug development worldwide.
This collaboration, with its promise of game changing new tools to combat tuberculosis, challenges those of us who are advocates to press even harder for an allocation of resources from the U.S. and other wealthy countries for research and development and TB programming at a level commensurate with the impact of this ancient and deadly disease on the poorest people on earth.
More information on this exciting project can be found here: http://www.tballiance.org/newscenter/view-brief.php?id=904. And for a Q&A with Dr. Mel Spigelman, president and CEO of the Global Alliance for TB Drug Development, about this project, click here.