How TB Alliance’s Mel Spigelman created a promising new anti-tuberculosis drug

In August 2019, TB Alliance’s pretomanid became one of three new anti-tuberculosis drugs approved by the FDA, and the first developed and registered by a nonprofit. When internist Mel Spigelman joined the organization (a product-development partnership, or PDP) as its head of R&D, in 2003, drug-resistant TB was an emerging public health priority, with an estimated 300,000 new cases per year worldwide. TB Alliance had recently licensed rights to develop a promising new drug from the biotech company Chiron. Spigelman jump-started its development, hiring a team with “expertise from early discovery through registration,” he says. “I wanted to be on a basis of equals with drug-development partners” such as Mylan and GlaxoSmithKline, which would enable the organization to move projects forward more quickly, less expensively, and with “a greater ability to guarantee the affordability and conditions of access” to a developed product. Nearly all of the patients in a six-month clinical trial had successful outcomes. TB Alliance is now partnering with major generic drugmakers to get pretomanid to market.