In one of the greatest scientific accomplishments of our generation, mRNA technology has demonstrated the ability to change the timeline for developing and delivering a new vaccine from years to months. And the entire world was witness to that demonstration. The development of an mRNA-based vaccine for COVID-19 took just 63 days from release of the virus sequence to first dosing in humans, leading to accelerated clinical trials and ultimately billions of doses manufactured. The new mRNA vaccines have demonstrated efficacies in the high 90s, with minimal side effects, and have been manufactured by two different RNA technology firms to date, with others adding further production capacity.
The scale of this on-going achievement was made possible because, unlike the established existing vaccine manufacturing techniques, RNA technology shifts the most difficult and complex parts of manufacturing — the key proteins needed for a vaccine — to the natural bioreactor that is the human body. This shift meant the mRNA vaccine could deliver the instructions for how to make the antigen, or spike protein, needed to train our immune systems rather than the antigen itself. The development of lipid nanoparticles (LNPs) ensured that instructions would arrive intact to our cells – a critical element of the mRNA vaccine delivery and effectiveness. Importantly, this RNA-based approach holds promise for treatments beyond vaccines and infectious diseases to diverse biologics as treatments for cancer, metabolic disorders, cardiovascular conditions, and autoimmune diseases.
Given this vaccine breakthrough, it would be reasonable to expect a wave of activity to discover, develop, and deliver new RNA-based biologics – a diversity of organizations; academic, small biotech, private and public research centers around the world flooding clinical facilities with novel, investigational products. All these products could then be tested against diseases that cause millions of deaths per year; thus providing access to these new products, while also securing protection against the next pandemic.
While we see continued and increasing global investments to scale existing mRNA manufacturing capabilities, such investments alone will not be enough to increase the number, diversity, affordability, and pace of discovery for these new biologic treatments, or to provide continuing access to agile, state-of-the-art manufacturing processes likely needed for rapid response to another pandemic.
The R3 program has two goals: one, to increase exponentially the number of biologic products that can be designed, developed, and produced every year, reducing their costs and increasing equitable access; and two, to create a self-sustaining network of manufacturing facilities providing globally distributed, state-of-the-art surge capacity to meet future pandemic needs.
Deadline: August 13, 2021 (for first-stage applications, including 5-page Executive Summary and 1-page cost estimate and timeline)
Duke applications are being coordinated by Foundation Relations, in conjunction with the leaders in the Office of Research and Innovation. Interested Duke applicants should contact Jennifer Gallina or Vera Luck (jennifer.gallina@duke.edu; vera.luck@duke.edu).
We are soliciting abstracts and proposals for work over three (3) years (with a potential additional one-year option) in one or more of the following thrust areas, to either develop the platform, develop products, or demonstrate the platform implementation.
Proposers should clearly relate work in these thrust areas to one or more of the program goals, but are not required to provide both platform technologies and end-to-end demonstrations. Synergies among performers will be facilitated by Wellcome Leap.
