The Bill & Melinda Gates Foundation has issued a multiyear grant to the Critical Path Institute (C-Path), a Tucson, Ariz-based nonprofit organization dedicated to fostering collaborative initiatives to improve the quality and efficiency of the drug development process. The grant will fund the creation and implementation of the institute’s rapid drug susceptibility test data platform, which is expected to catalog a vast amount of genomic data about worldwide strains of tuberculosis (TB).
After infection with human immunodeficiency virus, TB is the second leading cause of death from a single infectious agent. Standard TB therapies are now almost 50 years old, and the disease has now become resistant to many treatments.
The institute’s database will inform the process of correlating TB mutations to instances of clinically relevant resistance to therapy. In turn, such correlations will advance the development of rapid drug susceptibility tests that can be used to speed up the selection of effective TB treatments. The longer-term vision for the database is in facilitating the direct interpretation of patient-sequencing data to guide patient care.
“To create the kinds of tests essential to the effective deployment of novel tuberculosis treatments,” explains Martha Brumfield, PhD, president and CEO of C-Path, “we need a singular data resource that encompasses global resistance trends and markers for resistance that come directly from patients with tuberculosis and their caregivers.”
C-Path is uniquely qualified to work on this initiative, given its history of forging partnerships and developing new tools to shorten drug development cycle time. The institute’s Critical Path to TB Drug Regimens (CPTR) initiative, launched in 2010, is a broad collaboration of industry, civil society, government, and regulatory officials working together to develop regulatory science that can be used to identify, develop, and put through formal regulatory review new methods and tools with specific application in the development of promising TB drug candidate combinations.
To compile international TB data for the institute’s new database, the CPTR program will partner with FIND, the New Diagnostics Working Group, the World Health Organization (WHO), the Centers for Disease Control and Prevention, and the National Institutes of Health. The organizations will assist in the task of compiling data relevant to rapidly diagnosing the specific type of resistant TB present in a patient and, in turn, defining the most effective TB treatment regimen for each patient.
Having this data at the fingertips of researchers will allow for the development of personalized treatment regimens that take into account resistance trends in the patient’s specific locale. “There are a great many different strains of tuberculosis, and diagnosing the specific strain and developing a treatment regimen is currently a time-consuming undertaking,” says Mario C. Raviglione, MD, director of the WHO global tuberculosis program. “With this global partnership in place, a great need is being addressed by putting existing data from around the world to work in developing the fastest and best diagnostic tools to help the patients suffering from the scourge of tuberculosis, which remains an urgent public health threat that kills 1.5 million people each year.”
Established in 2005 with public and private philanthropic support from the Arizona community, Science Foundation Arizona, and FDA, C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. C-Path has established seven global, public-private partnerships that currently include more than 1,000 scientists from government and regulatory agencies, academia, patient advocacy organizations, and dozens of major pharmaceutical companies. For more information, visit C-Path.