Innovation must go hand-in-hand with responsible use of antibacterials and assurances that patients who need life-saving products will have access to them 

Stewardship and Access Plan Development Guide is a ‘first’ and represents progress for developers of antibacterial products

(BOSTON/LONDON: March 22, 2021) – Leading funders of research and development of new antibiotics and other products targeting antibiotic-resistant bacteria, often called ‘superbugs’, have just released a document providing comprehensive guidance on strategies and activities to support Stewardship and Access for companies bringing new antibacterial products to market.

The Stewardship and Access Plan Development Guide provides companies with a framework to develop plans so that their product will be used responsibly, minimizing the spread of antibiotic-resistant bacteria while helping patients get access to life-saving products.

The Guide sets a new benchmark for the responsible use of antibiotics, other therapeutics, preventatives including vaccines, and diagnostics to address antibiotic-resistant bacterial infections. Overuse and misuse of antibiotics around the world are major contributors to the global drug-resistant bacteria crisis. The World Health Organization (WHO) estimates that 700,000 people die each year from infections caused by bacteria that have developed resistance to antibiotics.

“Antibacterial innovation must go hand-in-hand with responsible use and access. Otherwise, innovative drugs that are meant to help patients risk contributing to the global burden of antibiotic-resistance,” said Kevin Outterson, Executive Director of CARB-X, which is led by Boston University and is investing $480 million in 2016-22 to accelerate the early development of innovative antibacterial products including antibiotics, vaccines and rapid diagnostics. “We all must do our part to see that antibacterials are used responsibly and that patients who need them have access to them. From a public health, a health security and economic perspective, it is the right approach.”

Companies funded by CARB-X, a global non-profit partnership that supports the world’s largest early development pipeline of new products, are required to develop a Stewardship and Access Plan for their CARB-X-funded project, when it reaches clinical trials. The plan outlines what strategies will be deployed to help ensure responsible stewardship globally and access in low- and middle-income countries.

It is hoped that the Guide will also serve to inspire product developers everywhere, and governments and other organizations involved in antimicrobial resistance (AMR), to be more proactive in integrating Stewardship and Access principles into their activities.

A new benchmark for developers of innovative antibacterial products

“Responsible stewardship and equitable access to antibiotics is critical so that these vital products are available to patients who need them and safeguarded for future generations. The Guide represents a new benchmark for what can be expected from companies preparing to market innovative antibiotics, as they should proactively develop robust plans enabling worldwide stewardship and equitable access alongside market entry plans. We are delighted to see the publication of the guide and hope that these insights inform the wider pharmaceutical, scientific and global health community, as well as CARB-X awardees,” said Tim Jinks, Head of Drug-Resistant Infections Program at Wellcome Trust, which led the development of the Guide.

World AMR leaders welcome the guide as a step forward

Dame Sally Davies, UK Special Envoy on AMR, said: “Sound Stewardship and Access Plans are key to the success of new products in the AMR space, because they ensure global accessibility to new treatments while also preventing inappropriate antimicrobial use in healthcare settings and beyond. But what does a good plan look like? This Guide will be made available to all developers, to help them articulate and formulate their own activities when they bring much-needed products to market, enabling us to achieve that goal of “access, not excess” to these essential medicines.”

Dr. Hanan Balkhy, Assistant Director General on AMR at the WHO, said: “Public and private funded innovation to tackle antimicrobial resistance becomes meaningless if it does not benefit all patients wherever they live, and if products are not used responsibly. WHO welcomes CARB-X’s initiative to integrate the principles of stewardship and access into the funding of antibacterial R&D, and to do so early in the R&D process with transparency and purpose.”

The Guide was developed by a cross-sector working group led by Wellcome Trust, one of CARB-X’s major funders. It included several other CARB-X funders – the United States Department of Health and Human Services (HHS) Office of Global Affairs (OGA) and Biomedical Advanced Research and Development Authority (BARDA), the UK Department of Health and Social Care (DHSC) Global AMR Innovation Fund (GAMRIF), and the Bill & Melinda Gates Foundation (BMGF) – as well the Global Antibiotic Research and Development Partnership (GARDP), the Access to Medicine Foundation (ATMF), and the Biotechnology Innovation Organization (BIO). 

Click here for the Stewardship and Access Plan Development Guide

Click here to visit CARB-X’s new Stewardship and Access webpage

Information:
CARB-X:
Jennifer Robinson carbxpr@bu.edu

About CARB-X
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a global non-profit partnership dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X is led by Boston University and funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the US Department of Health and Human Services (HHS), the Wellcome Trust, a global charity based in the UK working to improve health globally, Germany’s Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).  CARB-X is investing up to $480 million from 2016-2022 to support innovative antibiotics and other therapeutics, vaccines and other prevention approaches, and rapid diagnostics. CARB-X supports the world’s largest and most innovative pipeline of preclinical products against drug-resistant infections. CARB-X is headquartered at Boston University School of Law. carb-x.org/.  Follow us on Twitter @CARB_X.

Supporting global antibacterial innovation to address drug resistance
The CARB-X portfolio is the world’s largest and most diverse antibacterial R&D portfolio with 55 active projects focused exclusively on drug-resistant bacteria. Since its launch in 2016, CARB-X has announced 81 awards in 11 countries and has committed more than $303.3 million in non-dilutive funding, with the potential of additional funds if project milestones are met and subject to available funding. These funds are in addition to investments made by the companies themselves. CARB-X funds only projects that target drug-resistant bacteria highlighted on the Center for Disease Control and Prevention (CDC)’s Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO, with a priority on those pathogens deemed Serious or Urgent on the CDC list, or ranked Critical or High on the WHO list.