Heather Ignatius

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.