Innovation goes hand-in-hand with stewardship and access
CARB-X’s primary focus is accelerating antibacterial innovation. CARB-X also actively supports stewardship and access to ensure that products funded and supported by CARB-X are used responsibly and are made accessible to patients who need them. Stewardship and access principles must exist alongside the research and development of new products, so that these vital products are available to patients who need them, used responsibly, and safeguarded for future generations. This is essential to addressing the global antibiotic-resistant bacteria threat.
Stewardship and Access Plan Development Guide provides a new benchmark for product developers around the world
The Stewardship and Access Plan Development Guide, developed and endorsed by cross-sector stakeholders, is the world’s first comprehensive guidance to support developers of therapeutics, diagnostics and preventatives to produce Stewardship and Access Plans. The Guide outlines what is reasonably expected of product developers in relation to stewardship and access. CARB-X-funded product developers are contractually obligated to develop a Stewardship and Access Plan for their funded product, outlining what strategies they will deploy to ensure responsible stewardship and appropriate access in low- and middle-income countries (LMICs). The Plan must be developed within 90 days of their product entering pivotal Phase 3 clinical development, or the equivalent for diagnostics. The Plan would be shared publicly if the product obtains regulatory approval. It is our hope that the contents of this Guide will inspire product developers everywhere, and governments and other organizations, to develop their own plans and to integrate Stewardship and Access principles into their activities.
To view our Stewardship and Access FAQ click here.
To view a 10-minute interview with Kevin Outterson and John Rex, focusing on background to the Guide and practical approaches for product developers, click here.
To view a 50-minute webinar, led by Kevin Outterson and featuring Wellcome’s Tim Jinks, on Stewardship and Access principles and practical approaches for product developers, click here.