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© Giulio Donini / UNI- TAID SPEEDING TREATMENTS TO END PEDIATRIC TB: Repairing the market, improving child survival For more information, visit www.tballiance.org/children Tuberculosis (TB) is one of the leading killers of children. Despite the extent of the problem – and the fact that young children are very vulnerable to illness and death from TB – appropriate TB treatments for children simply do not exist. TB Alliance, in partnership with the World Health Organization (WHO), UNITAID, and others, is working to lower market barriers that currently prevent appropriate and affordable TB treatments from reaching children. We hope to facilitate the availability, access, and use of improved pediatric TB medicines—for today’s treatments, and tomorrow’s—and make a sustainable global health impact. Childhood TB has long been a neglected crisis. To jumpstart the field and create ongoing access for new and improved drugs for children, interventions are needed throughout the lifecycle of product development and delivery. Our work is designed to deliver new, correctly formulated, child-friendly drugs of existing TB treatments, while enhancing the market understanding needed to accelerate the time in which new and better treatments will be available and taken up by countries. This global effort can be best understood by focusing on a number of strategic goals. DEFINE THE MARKET The burden of childhood TB has not been adequately studied or quantified. Gaps in information exist at many levels, including incidence and treatment rates, which obscure the true size of the market. The lack of information acts as a disincentive to manufacturers. TB Alliance operates with the support of the Bill & Melinda Gates Foundation, AIDS Clinical Trial Group, UK aid, Irish Aid, UNITAID, the United States Agency for International Development (USAID), Australia Department of Foreign Affairs and Trade (DFAT), European Commission, Global Health Innovative Technology (GHIT) Fund, National Institute Of Allergy And Infectious Diseases (NIAID), and the United States Food and Drug Administration (FDA). For more information on TB drug development and TB Alliance, please visit www.tballiance.org.
TB MEDICINES FOR CHILDREN ARE NEEDED: No pediatric TB treatments currently exist in the correct formulation and dosage. In 2010, the WHO released revised guidelines for childhood TB drug doses; however, no such treatments have reached the marketplace. In the absence of proper drugs, those treating children with TB must grind or cut adult drugs to approximate an appropriate dose for a child. This leads to improper treatment, contributing to poor health outcomes and the development of drug-resistant TB. PHOTOGRAPHY: DARBY FILMS (FIRST PAGE AND LEFT); DESMOND TUTU, TB CENTRE, DEPARTMENT OF PAEDIATRICS AND CHILD HEALTH, STELLENBOSCH UNIVERSITY (RIGHT) »» TB Alliance and the WHO are working to obtain an accurate understanding of the childhood TB burden, and in so doing, understand the real demand for pediatric TB treatment. Equally important is to understand the market dynamics that influence uptake and appropriate use of products. CLARIFY REGULATORY REQUIREMENTS A key challenge to development of child-friendly formulations for TB has been the lack of clarity on regulatory requirements for developers and manufacturers. Additionally, there are no data available on the correct dosages for TB medicines for newborns and infants weighing 5 kg or less. With these data, manufacturers will be able to make formulations available to treat all children, rather than leaving clinicians to take their best guess on appropriate treatments for babies. »» We are building consensus among industry, clinicians, researchers, and regulators to determine the clinical trial standards and data required for submission of new childhood TB treatments. Clear regulatory requirements are an incentive for developers and could help speed new treatments through clinical testing. This should decrease the current time gap between availability of adult and pediatric formulations so vulnerable children can benefit from TB innovations. COLLABORATE TO DEVELOP NEW DRUGS AND FACILITATE UPTAKE Development of new policy and treatment guidelines at a global level is not sufficient to ensure uptake of new medicines within countries. Manufacturers are understandably reluctant to embark on the development of new formulations. »» The aim is to catalyze change that prioritizes care and treatment of children and ends the neglect of this highly vulnerable group. TB Alliance, in partnership with WHO, will survey current treatment guidelines and practices in countries to understand the obstacles to uptake. Additionally, TB Alliance will prepare a case for donors and governments to sustain and expand investment in procurement of childhood TB medicines, particularly for low-income countries, so that changes in guidelines can be paired with availability of product. »» Our initial goal is to encourage the development, manufacture and stable supply of high quality, affordable pediatric formulations of today’s existing first-line TB drugs meeting the updated WHO guidelines. For future treatments, TB Alliance will work to shorten the regulatory pathway to accelerate the approval of pediatric formulations of new drugs. RESHAPE THE INFORMATION LANDSCAPE Information surrounding the market for pediatric TB treatments, the process of developing and manufacturing them, and the case for their procurement and distribution is woefully lacking. »» By organizing existing information and disseminating critical new data revealed through our efforts, a clearinghouse for data and intelligence necessary to advance pediatric TB product development and use can be created. Providing this information will transform the current chaos of pediatric TB treatment into a clearly defined marketplace that addresses manufacturers’ barriers and meets the needs of children. Working with our partners, our goal is an ambitious one—to stop the neglect and create a sustainable supply of new and improved treatments for children with TB. To find out more, visit tballiance.org/children.
Page 1: A FAMILY DISEASE, A FORMIDABLE BURD
Page 5 and 6: TB OFTEN INFECTS CHILDREN IN ITS DE
Page 7: “ THERE CONTINUES TO BE A HUGE GA

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