(BOSTON: November 19, 2021) – A joint blog post by Richard Alm, Ph.D, Chief Scientist, CARB-X; Cameron Bess, Ph.D, Interdisciplinary Scientist, BARDA; Alfred Tonelli, Ph.D, Head External Innovation, Global Public Health R&D, The Janssen Pharmaceutical Companies of Johnson & Johnson
Johnson & Johnson Innovation (JJI) recently convened an international panel of experts for a webinar discussing the increasing global threat of antimicrobial resistance.The panel was comprised of Richard Alm, CARB-X; Sofka Brown, UK Science & Innovation Network; Yohann Lacotte, Inserm; Natalie Ma, Felix Biotechnology (a BLUE KNIGHT™ resident at Johnson & Johnson Innovation – JLABS @ South San Francisco); Mark McClellan, Margolis Center for Health Policy at Duke University; and Alfred Tonelli, The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). Now, Richard Alm and Alfred Tonelli have teamed up with BARDA to share further perspective and encourage innovators to get involved. Here’s what they shared:
Each year, more than 700,000 deaths worldwide are attributed to “superbugs” that are resistant to antibiotic treatment – and this figure is projected to rise to 10 million per year by 2050. The increasing global threat of antimicrobial resistance (AMR) is a potential risk to people of all age groups and geographies, but especially our most vulnerable populations: those who are immunocompromised, elderly, and/or impacted by health inequities.
Ever since the discovery of penicillin, bacteria have found ways to overcome and pose a threat to our health and wellbeing. With all the capabilities of 21st century healthcare, how can we better support a pipeline of solutions to prevent this crisis from continuing to grow and threaten populations on a global scale?
Keeping Pace with Pathogens
To change the trajectory of this global crisis, the development of novel antibiotics must reach the market at rates that exceed the emergence of drug-resistant bacteria. However, we currently have too few antibiotics in clinical development to keep pace due to a failed market for new antibiotics.
Many factors are at play in the lack of a viable antibiotic market. Some key factors raised by experts include the sparing use of new antibiotics required to preserve their effectiveness; the fragility and poor commercial sustainability of the antibiotic pipeline (partially driven by the abundance of cheaper and still effective generics); and the shortage of late-stage investments that help bridge the valley of death for startups (the gap between federal support for basic research ending and a company earning revenue). Clinical stage antibiotic development is long and complex – and many compounds fail along the way. For those that do succeed, they are typically prescribed for short durations of 7-14 days resulting in a poor return on investment as compared to drugs that treat chronic diseases. And history has shown that bacteria will eventually become resistant to any new drug. Thus, a significant part of this issue is that traditional volume-based payment systems are not fit for supporting effective antibiotic development.
A webinar convening international experts allowed us to explore the barriers to building a robust pipeline of next generation AMR innovation. The key message: AMR is a global challenge, and we must work together as an international community to spur innovation, support whole-of-ecosystem changes, and learn from one another’s different approaches.
Envisioning Solutions, Encouraging Action
To enable conditions for sustainable investment in the antibiotic pipeline, the panelists agreed that the AMR challenge demands market-based policy reforms, including new “pull” incentives, reimbursement reforms, and other post-market financial support that may create conditions that accelerate antibiotic research and development. The webinar discussed recent proposals for these incentive programs, with one example being the PASTEUR Act in the United States, introduced to offer support to potentially lifesaving AMR drugs in later stages of development. There is also global leadership on the issue, such as the inclusion of AMR on the G7 ministers of health and finance agenda in the UK this year; and through the European Joint Action on Antimicrobial Resistance and Healthcare Associated Infections (EU-JAMRAI), which has studied these incentives.
Additionally, the public and private sector seem to agree on the need to offer “push” incentives that help ignite early-stage innovation by offering funding, mentorship, facilities, and education for navigating the path to successful commercialization. The private sector has demonstrated a commitment to addressing this challenge through the formation of the AMR Action Fund, of which Johnson & Johnson is a founding member, alongside more than 20 participating pharmaceutical companies and with support from the World Health Organization, the European Investment Bank, and the Wellcome Trust. The Fund aims to bring two to four new antibiotics to patients by 2030.
BARDA and the private sector are also collaborating to spur the early development pipeline. One of these partnerships is Blue Knight, BARDA’s joint initiative with Johnson & Johnson Innovation – JLABS (JLABS) that supports eligible early-stage companies by offering access to incubation, mentorship, and resources (including facilities and fee assistance) within the global JLABS innovation ecosystem. Blue Knight creates an avenue for even earlier stage startups to engage and access support. Blue Knight encourages innovators to explore strategies across the product development pathway to identify gaps and address inefficiencies related to platform development, supply chain, manufacturing, distribution and so on. Johnson & Johnson also brings to the collaboration a commitment to combatting the growing threat of AMR.
Over the past five years CARB-X has developed a large, innovative, early development pipeline of new antibiotics, vaccines, rapid diagnostics, and other products to prevent, diagnose and treat life-threatening bacterial infections, with a focus on the pathogens on the World Health Organization’s Priority Pathogen List and in the Centers for Disease Control and Prevention’s Antibiotic-Resistant Threats Report. CARB-X has funded 92 projects, graduated nine programs, led eight projects to ‘First-in-Human’ Phase I studies with a significant number of projects in the current pipelines poised to start Phase I. These early-stage CARB-X graduates can transition to BARDA for late-stage clinical development, regulatory approval, manufacturing and procurement.
Pushing for Progress on AMR
Now, more than ever, is the time to elevate the ongoing dialogues and increase critical investments while simultaneously promoting innovation in the AMR space. This pandemic world has created an environment primed for action. At the recent webinar, Mark McClellan stated, “What’s different now than a decade ago, is that awareness is growing – even more so in the last year through COVID-19. We know it costs a lot of money to maintain a product on the market, especially for small companies… and we’ve learned we need to build out advanced manufacturing capacities, distribution capabilities and supply chains proactively, so that if we do need to surge a product against an emerging threat, we have the capacity to do that.”
Could your innovation or support help prepare the world to address the next superbug or public health threat? Become a part of the answer today.
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