News

Heather Ignatius is the senior policy manager for the TB Alliance, a not-for-profit, product development partnership dedicated to discovering, developing, and ensuring access to better, faster-acting, and affordable drugs to fight tuberculosis (TB) and drug-resistant TB. She is also a member of the GHTC’s Steering Committee. The most recent WHO TB Control report noted that rates of TB declined this past year for the first time in decades. However, even with such progress, TB remains one of the most devastating global health crises today, with ripple effects that extend beyond health to cripple prosperity and development of regions overwhelmed by the disease. New and improved tools to prevent, diagnose, and treat TB in its many forms—including MDR-TB and XDR-TB—are vital to eradicate the disease, but a reinvention of such an arsenal can’t be achieved by any single organization. To this end, last week marked another notable achievement for TB: the launch of a collaboration between four pharmaceutical companies, along with the TB Alliance and the World Health Organization (WHO), which enables information-sharing on TB drug candidates within their respective pipelines. The partnership aims to bring these groups together to quickly and collaboratively identify and develop the most promising new TB drug regimens, regardless of sponsor. Representatives from (left to right) TB Alliance, Tibotec, Sanofi, Bayer, Sequella, and AstraZeneca gather at the CPTR Workshop to discuss new approaches to TB drug R&D. The collaboration was brokered under the Critical Path to TB Drug Regimens (CPTR), a cross-sector initiative designed to speed the introduction of shorter, safer, and more effective new TB drug regimens. The partners include AstraZeneca, Bayer, Sanofi, Tibotec, the TB Alliance, and the WHO. Combinations of drugs are required to treat TB to avoid the development of resistance. Since the launch of CPTR in March 2010, regimen development—testing and seeking the approval of combinations of new TB drugs as opposed to developing individual drugs, one at a time—is emerging as the gold standard within the field. Regimen development can telescope the time it takes to develop novel drug combinations, which show promise to shorten, simplify, and create safer and more affordable treatment. In the context of appropriate drug-sensitivity testing, novel regimens can treat both TB and MDR-TB, and truly transform the tools to fight the epidemic. CPTR and this agreement establish mechanisms for cross-sponsor information-sharing and begin to chart the course for cross-company collaborations on new TB drug regimens. Those who signed onto the agreement represent the majority of global sponsors with TB drugs in clinical development. Earlier this year, the combination of PA-824 (a novel chemical entity), moxifloxacin (an existing antibiotic not yet approved for treating TB), and pyrazinamide (an existing TB drug) completed a Phase II clinical trial. Meeting this milestones further confirmed both its potential as a regimen and the co-development approach to TB drug development. With this “proof of concept” trial completed, the door is now open to bring forward additional multi-drug combinations. Progress to develop novel drug regimens also requires advances in regulatory science to enable regulators to support and evaluate clinical trials that use this paradigm. This theme was echoed at the CPTR Workshop where this announcement was made, which featured a keynote address from the Director of the Center for Drug Evaluation and Research at the US Food and Drug Administration (FDA), Dr. Janet Woodcock. “I congratulate all of you coming together to solve what was previously perceived as an intractable problem,” said Dr. Woodcock. “Working together, we can take the steps needed to control this disease worldwide. We at the FDA, we will do everything we can do ensure that the regulatory process is not a barrier to getting this problem solved.” It is uplifting to see such a collaborative approach being to TB drug development adopted by its stakeholders, including the pharmaceutical industry. While harnessing the resources necessary to conduct future regimen trials remains a challenge, there is justifiable optimism surrounding the scope and pace of TB drug development, and in turn, the impact that the introduction of new and improved TB therapies can have on the health and prosperity of millions.

After Secretary of State Hillary Clinton’s speech at the NIH earlier this week, GHTC asked our member organizations involved in HIV and AIDS why the US should continue to prioritize HIV and AIDS research. Here are answers from three of our members working on this issue: Elizabeth Glaser Pediatric AIDS Foundation: GHTC members stress the importance of prioritizing HIV and AIDS research in order to save lives around the world. Photo: Wendy Stone/PATH Discovering the medical interventions to prevent mother-to-child transmission of HIV (PMTCT) is one of the great success stories in the thirty-year fight against HIV and AIDS. But we cannot finish the job of eliminating pediatric AIDS worldwide without continued research. To implement the science that we do know, operations research is needed to address the global gaps in PMTCT coverage. Further clinical research is also needed to understand why approximately 60% of babies who are exposed to HIV from their mothers and receive no medical interventions still do not become infected. Answering this question could help in the development of an HIV vaccine that is safe and effective for children and adults, and provide lifetime immunity to the virus. International AIDS Vaccine Initiative: US support of HIV and AIDS research, including new HIV prevention tools, is vital to bringing an end to a pandemic that has taken and affected millions of lives in the US and worldwide, as well as cost the global economy billions of dollars. These investments also keep the US on the frontier of scientific innovation, as the lessons learned in trying to stop one most formidable foes ever encountered by scientists hold potential across many areas of medicine. Global Campaign for Microbicides/PATH: The generosity of the American people invested in HIV research can not only help to save the lives of poor people in other countries most greatly affected by HIV—but that same generosity can benefit the American people whose lives can also be saved by the same innovations. The world is a small place. As good global neighbors, prioritizing HIV research can help save the lives of poor people in not-so-distant lands. The same innovations in HIV treatment and prevention can save the lives of our neighbors much closer to home.

In this regular feature onBreakthroughs, we highlight some of the most interesting reads in global health research from the past week. Several cases of drug resistant tuberculosis (TB) are reported in India, underscoring the need for new treatment and prevention options. In related news, GHTC member Aeras enters into a partnership to develop new TB vaccines. GHTC member the American Society of Tropical Medicine and Hygiene urges against cuts to vital medical research that protects American troops from tropical diseases. New research could lead to the production of more affordable antimalarial drugs. GHTC member Medicines for Malaria Venture also seeks projects to propel malaria drug discovery. A Congressional delegation’s trip to see development projects in Tanzania included visits to global health projects. A candidate for the first-ever vaccine against hookworm enters into a clinical trial in Brazil.

Last week, Dr. Nathan Wolfe, Stanford biology professor and director of the Global Viral Forecasting Initiative (GVFI) joined Stephen Colbert on The Colbert Report to discuss GVFI’s work in developing a system to detect future pandemics before they happen. GVFI focuses on monitoring infectious diseases that could ‘jump’ from animals to humans in the future, and maintains field sites in more than fifteen countries. Through its research, GVFI has created a pilot global early warning system for new diseases. During the interview, Colbert described how his 91-year old mother used to decide as a child whether or not to go to school each year based on whether polio was present in her community at the time, and questioned whether that scenario could happen again. Polio, which has been eradicated from the United States due to innovations in health technologies like vaccines, may never return to the US, but Dr. Wolfe stressed that there is an incredible amount that scientists do not yet know about how viruses evolve and move from animals to humans. He added that diseases we have never heard of may one day be in our backyard. Amid jokes about Ebola in the movies and who gets to name the next new disease, Colbert and Wolfe got serious about the need for heightened attention to the interconnected environment we live in and its effect on how disease spreads. Dr. Wolfe noted that “if you look at airplane routes, and the way we move boats, and animals around, we’re this sort of large mixing vessel of microorganisms, and it means that a virus that pops out of Central Africa or Southeast Asia has the potential to get here to New York or Tokyo in a matter of days. And that’s something that we should all be very concerned about and take very seriously.” While Colbert knows how to joke about any subject, it’s clear that this issue is not a laughing matter. Global diseases know no borders. Groundbreaking research and development into technologies to combat the diseases of today—coupled with surveillance of the possible pandemic threats of tomorrow—are critical resources for providing us with the knowledge and tools to be ready for whatever is ahead.