With less than a fortnight to go until The World Vaccine Congress in Barcelona we are thrilled to share another pre-Congress interview. Here we meet Dr Amy Shurtleff from CEPI, who will be joining us at the event for a presentation and a panel on Tuesday 17th October. This was a written interview, conducted over email, and we are very grateful to Dr Shurtleff and her team for facilitating the conversation. We hope you enjoy her insights!
Introducing Dr Shurtleff
Dr Shurtleff is the Interim Director of Laboratory Research and Innovations (LRI) Department within CEPI’s Research and Development Division. She also leads the Animal Models Team within the LRI Department. Her work at CEPI draws from experience as lead research investigator and study director for programmes testing DNA vaccines, the Ebola vaccine ERVEBO, and other novel vaccine platforms through “a long tenure” at the United States Army Research Institute for Infectious Diseases (USAMRIID).
She’s going to join us to discuss some of the work that CEPI is doing, so she helpfully offered an overview of CEPI’s mission.
“CEPI is a leading global partnership launched in 2017 with the mission to accelerate the development of vaccines and other countermeasures against epidemic and pandemic threats so they can be accessible to all people in need.”
CEPI has already made investments in over 20 vaccine candidates against its priority pathogens: Lassa, MERS, Rift Valley Fever, Nipah, Chikungunya, and Ebola. It’s also already established itself as a “key global player” in the “rapid development of multiple COVID-19 vaccines”, enabling access to these “lifesaving tools through COVAX”, and has launched an “ambitious plan to better prepare for future epidemics and pandemics”.
Central to this plan, Dr Shurtleff reminds us, is the 100 Days Mission, which has been “embraced” by G7 and G20 to “compress the time taken to develop safe, effective, globally accessible vaccines” against new threats. Working towards this ambition, the LRI Department manages some of CEPI’s key enabling science programmes to “advance our vaccine development efforts”.
“This includes CEPI’s Centralised Laboratory Network – the largest global group using the same methods and materials to standardise and accelerate the evaluation of vaccines against epidemic and pandemic diseases – and the Preclinical Model Network – a group of high containment laboratories for testing of vaccines against our priority pathogens in preclinical models.”
Across this work, Dr Shurtleff and her team are “committed to the principles of the 3Rs and strong ethical research practices”. The team also leads on the development of antibody standards and common assays for priority pathogens, supports each vaccine development project with “pre-clinical expertise”, and leads disease-specific Task Forces. Over the past year they have also expanded their work into “new areas” such as systems immunology and computational predictive modelling.
If you haven’t yet planned your schedule for the event, Dr Shurtleff’s session on Tuesday 17th is one to consider! We asked for a little preview of what attendees can expect. She suggests that the session will give us insight into CEPI’s Centralised Laboratory and Preclinical Model Networks, outlining “objectives, achievements to date, and plans for regional growth, especially in the Global South”.
The networks “support preclinical and clinical research for COVID-19 and other CEPI core pathogens, as well as Disease X”.
“The labs supporting sample testing in clinical trials are expert in assay performance, protocol harmonisation, technology transer, and use of international standards to produce data that are highly comparable.”
“The preclinical modelling and vaccine testing labs are a group of high containment laboratories established for testing of vaccines against our priority pathogens in preclinical models, as performed under high quality research standards and ethical standards.”
Dr Shurtleff will explore the “focus and priorities” of these networks, how they work together, and “why this is an important part of CEPI’s pandemic preparedness plan and is needed to accelerate vaccine development timelines to drive forward the 100 Days Mission”.
Breaking down barriers in preclinical vaccine development
Your next opportunity to hear from Dr Shurtleff is her panel on “challenges in preclinical vaccine development”. We asked about the barriers that CEPI identifies, and how the organisation tries to overcome them. Dr Shurtleff emphasises that preclinical models “play a crucial role” in vaccine and drug development. They serve as a “key bridge and informant” between laboratory studies and in-human trials.
“Emerging out of the peak of the COVID-19 pandemic, the world must leverage our vaccine development learnings during this time to improve and accelerate our practices and better prepare and respond to a future pandemic.”
A “major challenge” that emerged during the COVID-19 pandemic was the “need to rapidly accelerate preclinical research” at the pandemic’s peak, amidst “strict global lockdowns, delays to shipping and receiving laboratory materials, and increased staff sickness or work overload”.
“While these bottlenecks were overcome and vaccine development advanced at record pace, we need to iron out any of these delays to get ahead of future virus and compress timelines further.”
“Preparedness far outweighs response, so we need to generate important preclinical data in ‘peacetime’ and not when ‘scrambling’ around when faced with an outbreak pathogen.”
Then, if work needs to accelerate during an outbreak, preclinical researchers “need to be given the flexibility to pivot their focus towards the emerging threat”.
Another “noticeable challenge” that Dr Shurtleff identifies is the lack of “common standardised assessment between laboratories documenting preclinical performance of epidemic and pandemic vaccine candidates”. Therefore, members of CEPI’s Centralised Laboratory and Preclinical Model Networks are “purposely positioned to use similar assays and apply internationally approved antibody and antigen standards”. This allows “direct comparability of results”.
“Having uniform and comparable datasets from preclinical or clinical studies can more quickly inform clinical and regulatory progression, and can also help reduce workloads, enhance quality, and improve speed.”
Dr Shurtleff reflects that “many pathogens of potential global pandemic importance are ones for which it is difficult or nearly impossible to plan late-stage clinical trials” because human outbreaks are “sporadic” but disease severe. Vaccine development for some of these diseases, such as MERS or Nipah virus infections, relies on “collection and presentation to regulatory authorities of animal efficacy data collected under high quality research standards”. Although regulators “recognise the need for these laboratory approaches” and are “generally willing to review” as much data as possible, standardised approaches are “not clear across disease models and across national regulatory guidance documents”.
Dr Shurtleff’s final point is that “across all of this work, there is also the need to further build expert preclinical knowledge and capacity in the Global South”.
CEPI describes itself as an “innovative” global partnership, so we asked about novel technologies or techniques that might be of interest. Dr Shurtleff identifies “several novel technologies” that have emerged recently to advance the field of preclinical development.
Some examples that Dr Shurtleff offers are “organ-on-a-chip or tissue modelling innovations”. These can be used “in tandem with more classical approaches” to provide a more accurate representation of human biology. This enhances the data to guide whether a vaccine candidate can enter clinical trials. Another example is artificial intelligence, or AI, which supports preclinically produced data.
“The rise of artificial intelligence is becoming a key component that can rapidly sift through and analyse large preclinical datasets to extract patterns and insights to inform decision-making.”
However, alongside new and innovative technologies, Dr Shurtleff recognises that a “central component of preclinical research advances” come from the “act of having our established networks connecting scientists and science together globally”. These networks could be “quickly utilised in response to an outbreak” and their “faster vaccine candidate data readouts could give the world a head start in generating evidence” on potential candidates, driving forward the 100 Days Mission.
“To shave timelines further, work is also exploring running preclinical and first-in-human studies in parallel, as was done in the COVID-19 response, through using pre-existing supporting evidence and keeping safety paramount.”
Lastly, CEPI offers members of its lab networks and manufacturing network opportunities for collaboration. This ranges from “sharing specific methods, models, protocols, and reagents” to “comparing disease modelling or immunogenicity data collected in similar models”.
“This will help build knowledge, understanding, connection, and capabilities in more and more global regions. CEPI is planning more ways to facilitate communication across global regions through networking”.
Our final question, as always, invites our speakers to share their reasons for joining us at the event. For Dr Shurtleff, and her CEPI colleagues, the Congress provides an “exciting forum to reconnect” with partners and “hear inspiring updates and progress from the broader research sphere”.
“As we get back to a new normal post the pandemic peak, I look forward to catching up in-person with those in my network as well as new researchers in this space to find out more about their work.”
“This year’s agenda looks particularly fruitful, with leading discussions around Disease X and the evolution of RNA Technology – two key topics which are central to CEPI’s pandemic preparedness work.”
Another highlight for Dr Shurtleff will be the “concept of increasing global vaccine production in underserved regions”, explored in the keynote panel discussion. She also looks forward to hearing more on “the future of vaccinology” and “necessary reductions in development times”.
It’s fantastic to hear more about Dr Shurtleff’s work and her enthusiasm for sharing her insights with the community at our event. We hope that you enjoyed this interview and join us in thanking Dr Shurtleff and her team for their commitment. There’s still time to get your ticket to join us at Dr Shurtleff’s sessions here. If you can’t make it, why not subscribe for more interview exclusives?