Most project managers know that feeling of time pressure and having dependencies that must align. But not every project has the lives of billions hanging on the result.
Sophie Weston is one of several project managers working on the Oxford R21/Matrix-M malaria vaccine. If you’ve followed the news, you might know it’s the project that’s developed the first vaccine against malaria with an efficacy of more than 75%. It was approved by the World Health Organization (WHO) in October.
Malaria is one of the biggest killers in the world. R21/Matrix-M is the result of 30 years of malaria vaccine research at the University of Oxford's Jenner Institute, where Weston works. “I joined about two-and-a-half years ago to help run phase III, which is a large multicentre trial with 4,800 participants,” she explains. “There had been some work done to get phase III set up, but we picked up some really tight timelines.”
The real heroes
Project managers are no strangers to deadline pressure. The start of the malaria season at two of the five test sites in Mali and Burkina Faso was a non-negotiable (the other non-seasonal sites are in Burkina, Kenya and Tanzania). Getting up to speed quickly on the existing work was critical. But the real challenge was hitting those deadlines while co-ordinating a huge range of stakeholders, regulators and sponsors.
“For example, we work with trial monitors, who make sure that everything is being done according to the protocols,” Weston says. “Or there’s the data management company in India doing the safety medical monitoring for the trial. So it was crucial to work out who all these people are, their responsibilities and how to keep everything aligned.”
Add contracts, funding, insurance and vaccine shipments (which need to be temperature-controlled) to the sites, as well as all the clinical and pharmacy supplies — and it’s a huge job.
“There’s big team in Oxford,” Weston says. “I'm the only Oxford project manager here working on the phase III trial; there are project managers at each trial site, too. Then we have a lead clinician and a senior research nurse in Oxford, plus a big lab team; a team doing all the immunology work; and people at the trial sites and in India handling data management and safety.”
That’s not to mention the finance, grants and information security teams. “The people doing all the real hard work are working at the sites,” she says. “They’re doing all the participant recruitment, vaccination and follow-up. They’re the real heroes of the story.”
What made the project a little different from the normal phase III trials was the WHO requirements. That meant the intrinsic time pressures were compounded with a crunch around the data the WHO required.
“WHO wanted to see data on the R21 vaccine in combination with other childhood vaccines,” she says. “So we had to set up a brand-new trial quickly, find a trial site and get the data to WHO, all against the clock.”
When the request came through to test the vaccine for safety and immunogenicity on children with HIV, for example, setting up that trial in time to include them in the rollout added another workstream.
Says Weston: “For the HIV trial, the vaccine didn’t need to be given seasonally so that wasn’t an issue. But we wanted to get the data from this trial to WHO soon so we can confirm that the vaccine can also safely be given to kids with HIV and they can be included in the rollout.”
Ways of working
Weston’s appointment in early 2021 came in the middle of the Covid pandemic. That sucked up resources and capacity Jenner and its trial sites were relying on.
“We struggled, for example, to get needles and syringes,” she says. “We get a huge amount from the NHS and they had strict controls on how many you could order because they were making sure there was enough for Covid vaccinations and trials — understandably!”
And as every project manager knows, getting to grips with a team at headquarters — plus a huge range of suppliers, funders, local coordinators and more — is much easier when you’re able to meet face to face. Weston is happy to have hybrid working — ideal for being close to the teams in Oxford, but also perfectly suited to days when the main contacts are in, say, India.
The team’s efforts to hit deadlines and keep everything aligned paid off in September 2022, when the data came back on efficacy from the initial phase III trials.
“We knew it looked good because the key readouts for safety are 28 days after vaccination and we’d been getting that data through continuously during the trial,” says Weston. “But you don't really know for sure what the final efficacy readout is going to be. So that was a really exciting moment, when we saw the compiled efficacy data submitted to the WHO.”
In the year since, a succession of follow-on submissions and requests for data and analysis has occupied the team’s time. Although even after the WHO’s big announcement this October, clinical work has continued as the team explores the optimum booster regimes and test performance in edge-case recipients. The aim now is for mass rollouts for mid-2024. “Serum Institute has already manufactured a lot of vaccines,” Weston says. “They’re waiting to go, stored in a fridge in India.”
What’s next? “Things will definitely become a bit calmer in terms of the R21 vaccine, but there are trials testing the various different vaccines in combination with each other,” she says.
Director Sir Adrian Hill and the teams at Jenner have a big portfolio and there are plenty of exciting developments in other vaccines — in part hastened by the heft brought to the field thanks to Covid.
“I’ve learnt a lot about project management,” Weston says. “Everything needs to be super-thorough, well-documented and done according to good clinical practice. And working with people from lots of different places, with different working cultures and language barriers – that’s really emphasised the importance of building connections with people… and meeting in person if you can.”
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