Funding Extended For Reagan-Udall Foundation for the FDA Tuberculosis Drug Regimen Development Project

Top Quote Extension of grant from the Bill & Melinda Gates Foundation to facilitate community engagement in TB drug development; education for regulatory scientists. End Quote
  • (1888PressRelease) December 17, 2014 - WASHINGTON - The Reagan-Udall Foundation (RUF) for the Food and Drug Administration (FDA) announced that the Bill & Melinda Gates Foundation will extend its funding of RUF's role within the Critical Path to Tuberculosis Drug Regimens (CPTR) initiative. The funding will facilitate two key efforts: new training and fellowship opportunities in pressing regulatory science challenges related to tuberculosis (TB) drug regimen development and better community engagement in TB research.

    TB is a contagious, airborne illness second only to HIV as a cause of death from disease via a single infectious agent; the growing prevalence of drug-resistant strains has prompted increasing alarm. In 2013, 9 million people around the world contracted TB. Almost half a million of these were infected with drug-resistant strains, a situation the World Health Organization has called a "global crisis" amidst a climate of shrinking investment in TB research.

    CPTR is a cross-sector collaboration, co-founded by the Critical Path Institute, the Gates Foundation, and the Global Alliance for TB Drug Development, that aims to address this urgent issue by greatly reducing the time needed to develop and share new drug regimens for TB. In March 2011, RUF was provided with a three-year grant to provide regulatory science research support to CPTR. RUF's work with CPTR to date has been aimed at creating more efficient global regulatory pathways to speed the testing and review of much-needed treatment options, as well as in promoting stakeholder and community engagement in TB treatment research.

    "RUF's unique statutory relationship with the FDA combined with our expertise convening multi-stakeholder groups to achieve complicated health goals has already been very helpful to CPTR's much-needed work. We are grateful for the funds that will allow this work to continue and we're particularly excited about the prospect of offering a new fellowship in TB regulatory science," said Jane Reese-Coulbourne, M.S., ChE. executive director of RUF.

    The new funding will allow RUF to sustain their efforts in CPTR, working to address critical regulatory scientific challenges that currently impede TB research and development. A newly proposed component of this work includes the development of a regulatory science fellowship for a mid - to senior - level scientist to be placed within the FDA to work on addressing some of these challenges. RUF is currently working with FDA and CPTR partners to refine the focus of the proposed fellowship, additional details are forthcoming.

    "Though the USA's rate of tuberculosis is now comparatively low, TB continues to take a major toll around the world. I am pleased that the United States is playing a leadership role in the development of drugs and drug regimens for TB. The FDA approved the first drug to treat multi-drug resistant TB in 2012 and welcomes new opportunities to advance product development and share our expertise with other nations' regulatory authorities," said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs for the FDA.

    Historically, due to a limited pipeline of new drugs for TB, there has been little patient or community involvement in TB drug development, but community and stakeholder engagement can critically impact the outcomes of clinical trials. The new funding will help RUF build on its successful work to date in defining and developing a framework for the practice of community engagement for the TB research community. Next steps include the creation of practical implementation tools and training materials to facilitate more effective community engagement and bolster participatory approaches throughout the research process.

    About the Reagan-Udall Foundation for the FDA
    The Reagan-Udall Foundation for the FDA is an independent 501(c)(3) not-for-profit organization created by Congress to advance the mission of the FDA by advancing regulatory science and research. With the ultimate goal of improving public health, the Foundation provides a unique opportunity to bring all parties to the table (FDA, patient groups, academia, other government entities and industry) to work together in a transparent way to create exciting new regulatory science.

    About the Critical Path to Drug TB Regimens (CPTR) Initiative
    The Critical Path to Drug TB Regimens Initiative (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 a specific application in the development of promising tuberculosis (TB) drug candidate combinations. CPTR was formally launched on March 18, 2010, in Washington, D.C., with a keynote address by U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg. Its mission is to address an urgent public health need-with the goal of saving millions of lives.

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