The world of drug development is littered with early-phase failures: drugs that were shown to be safe in Phase I trials, but which failed to show efficacy later on. The failure of a drug at this early phase might not mean that there’s anything wrong with the compound. Rather, a failure might mean that the mechanism by which the drug acts was not of benefit in the disease against which it was tested.
A handful of these drugs are being pulled from the shelves and given a second chance in a new initiative announced earlier this month. NIH’s new National Center for Advancing Translational Sciences (NCATS) is partnering with Pfizer, AstraZeneca, and Eli Lilly, which have agreed to make select compounds available for a pilot initiative to test promising compounds for new indications.
A total of $20 million will be used from NCATS’ budget to fund the initiative. Scientists may apply for research grants of up to three years duration for preclinical and clinical feasibility. Industry partners will supply around 20 compounds to participating researchers, as well as access to related data. The program also incorporates template agreements designed to streamline the legal and administrative process for participation, and a framework for handling intellectual property used or developed within the program.
In times of shrinking pharma R&D budgets, this is just the type of project by which industry can capitalize on relationships with academia. In the release, Jan Lundberg, PhD, executive vice-president, science and technology, and president, Lilly Research Laboratories, sums it up. “Discovering and developing new medicines, regardless of the therapeutic area being studied, is a complex and expensive process and we look forward to collaborating with the NIH and academia for the benefit of the patients we all serve.”