A recent article noted there being some 60 active drug development programs currently underway toward providing treatment options for the current COVID-19 pandemic sweeping the globe. And while biopharmaceutical companies like Gilead Sciences, with its compound remdesivir (a potential treatment previously investigated for Ebola), are providing the world with hope, there are those pointing out that it could take roughly 18 to 24 months to fully complete the clinical development of a COVID-19 vaccine. But let’s get serious for a moment, as the process to actually develop and license a vaccine normally takes six to seven years! And while the U.S. federal government recently implemented various initiatives to remove some of the bureaucracy and red tape surrounding drug and vaccine development for COVID-19, how do you manufacture any viable solution at the necessary scale as fast as possible? Considering the world has roughly 7.8 billion people, we are talking about billions of doses, requiring billions of vials, syringes, and needles coming from an already constrained supply chain.
Fortunately, there is a little-known coalition that has been tasked with figuring this out — and it wasn’t something just cobbled together yesterday. Life Science Leader recently spoke with vaccine manufacturing veteran James Robinson, who got us up to speed on the Coalition for Epidemic Preparedness Innovation (CEPI).
Retirement Has Been Postponed
James (Jim) Robinson got his start in biopharma as a biochemical engineer with GD Searle in 1984. Over the years, he took on positions of increasing responsibility with the likes of Sanofi Pasteur and Novavax. Eventually landing at Merck in 2010, it wasn’t long before Robinson found himself with oversight for technical support of all of Merck’s global vaccine, biologics, and sterile manufacturing business. But in 2015 he was ready to slow down, and he officially retired in June of that year with plans to maybe do some part-time consulting. “At most I wanted to work about 30 hours a month, but right now I’m doing more than 30 hours a week just with CEPI, and there’s no real end in sight,” he concedes. But Robinson doesn’t view his current role with CEPI as a burden, but rather an obligation to do something significant that could have a global impact. “The world’s been good to me, and I need to do the same back.”
For Robinson, COVID-19 is the fifth outbreak in which he has been intimately involved in preparing for. The first was the highly pathogenic Asian avian influenza A (H5N1). First detected in geese in China in 1996, it was detected in humans in 1997 during a poultry outbreak in Hong Kong. “We made a stockpile of vaccine at Sanofi for H5N1, but fortunately that outbreak never spread globally.” He says “fortunately,” because that virus had a fairly high mortality rate, something like 10 times that of the typical flu. Then came the severe acute respiratory syndrome, otherwise known as the SARS coronavirus (SARS-CoV) in 2002/03, followed by the swine flu (H1N1) pandemic in 2009. By then Robinson was at Novavax, and he recalls making clinical material for H1N1 vaccine development in record time. “I was with Merck for Ebola, and making the vaccine for the outbreak that began in West Africa in 2014.” Robinson says it was the lessons learned from that Ebola outbreak that led to the formation of CEPI. “CEPI was formed to close the gaps that would support development of vaccines for known pathogens, but also allow for faster decision making and information flow, thereby providing for faster remediation to unknown or novel pathogens in outbreaks.” (To learn more from Jim Robinson, be sure to check out the additional article links at the end).
Most of the prework for the establishment of CEPI was done in 2016, before officially being launched at DAVOS in 2017 And though Robinson was officially “retired” by then, CEPI was one of the organizations in which he hoped to be involved. “I wanted to engage with CEPI to help the world prepare for events like COVID-19.” This is why he’s been serving on CEPI’s scientific advisory board since its launch and as vice chair since early 2019.
CEPI Key Players And Their Roles
When you think about the complexity of the global public health ecosystem, you are literally dealing with hundreds of regulatory agencies and governments as well as public health organizations, and there is a lack of integration between them. This is why with the COVID-19 outbreak, thus far; we’ve seen different countries take different approaches toward managing the outbreak. But CEPI isn’t necessarily there to do the integration. “They’re there to, I would say, facilitate the discussions, so that ultimately, there are agreements in place for who does what, before the crisis emerges,” Robinson explains. Think about it this way, as we have seen with COVID-19, managing an outbreak at just the country level is a fairly monumental task. Now imagine attempting to do that on a global level without the existence of any borders. “It’s a huge change management project,” Robinson concedes. “At the country level, everyone [involved in pandemic preparedness] pretty much understands what their role is.” But as you move toward trying to manage a pandemic globally, those same people might not understand how their role would change. That uncertainly can cause reluctance or fear, as that person’s role in a global system could be diminished or enhanced. “Both can be scary, so the role of the CEO at CEPI, Richard Hatchett, M.D., is to carefully manage that and the personalities, organizations, and cultures, all across the globe.” Prior, Hatchett served as acting director of the U.S. Biomedical Advanced Research and Development Authority (BARDA), after serving for five years as the organization’s chief medical officer and deputy director. Hatchett came to CEPI to try to make preparedness response better coordinated than various government systems in place for dealing with a pandemic, which is why the organization currently operates under the rules of the Norwegian government. “We still run like a government organization, but with more flexibility.”
Editor’s Note: CEPI is not responsible for trying to coordinate the overall global response to pandemics. Rather, its mission is as an innovative global partnership between public, private, philanthropic and civil organizations toward accelerating the development of vaccines against emerging infectious disease and enable equitable access to these vaccines for people during outbreaks.
Another important role is being played by Nicole Lurie, M.D., MSPH, who previously served as the assistant secretary for preparedness and response at the U.S. Department of Health and Human Services (HHS) during the Obama administration and is a veteran of the H1N1, Ebola and Zika epidemics. Lurie is heading what the U.S. government would call an incident command center,” Robinson elaborates. “But that terminology [i.e., command] doesn’t necessarily work globally.” Together with Dawn O’Connell, she also works with CEPI’s joint coordination group, which is chaired by former FDA Commissioner Margaret Hamburg, and is an institutional roundtable of other global health stakeholders that are needed to regulate, purchase and distribute vaccine.
According to Robinson, one of the people really leading the gauntlet on COVID-19 is Melanie Saville, MBBS, CEPI’s director of vaccine R&D. A physician with clinical virology and research experience, she also has extensive industry experience with Wyeth, Sanofi, and Janssen. “Since this outbreak was officially recognized in late December, she’s been working on setting up contracts with CMOs for a vaccine that will be rapidly developed to deploy,” Robinson elaborates. With eight vaccine development partnerships and counting, Saville is charged with a goal of progressing multiple safe and effective vaccines to licensure for broad use within the next 12-18 months. “This is pretty much unheard of, considering that as of March 13, everything in development for COVID-19 was pretty much all pre-clinical.”
Editor’s Note: while CEPI has been working to identify mass manufacturing capacity for COVID-19 vaccines, it will be up to global health authorities, vaccine manufacturers, and global bodies (e.g., GAVI) to closely coordinate to ensure effective deployment.
What CEPI Has Achieved Thus Far
Robinson says that the speed at which CEPI has been responding is fairly incredible. Consider this. Since its founding, CEPI has launched 19 vaccine development programs for Lassa Fever, Middle East Respiratory Syndrome (MERS), Nipah virus, Chikungunya virus, and Rift Valley Fever, five targets from the WHO’s list of prioritized diseases and pathogens for R&D. “Our target is to develop the products through Phase 2a clinical studies and then manufacture clinical reserves that could be quickly deployed in the event of an outbreak, as we expect we may get an efficacy signal that would support product licensure.”
To achieve its goals, along with responding to the current COVID-19 threat, CEPI has already raised more than $750M from sovereign governments and philanthropic organizations, including the Wellcome Trust and The Bill and Melinda Gates Foundation. And to support CEPI’s portfolio of products and its ability to respond rapidly, CEPI has been conducting outreach for available capacity to support production and clinical reserve needs. “We’ve built a database of more than 200 companies engaged in vaccine, biologics, and/or sterile manufacturing that we will use to solicit bids for manufacturing support.”
CEPI has already launched eight COVID-19 vaccine projects and has plans to announce several additional projects in the coming weeks. “We’re also accelerating our plan to establish this capacity for a significant number of doses [i.e., hundreds of millions of doses] in the next 18 months,” Robinson says. But developing a vaccine, along with having the ability to manufacture it, is an immense challenge. “We don't know where the pandemic is going, and no one really knows how it’s going to turn come summer.” This means spending hundreds of millions of dollars to develop something that may end up not being used, or worse, developing something that no longer works if the virus suddenly mutates. “We know that a lot of our investment could be for naught. But we have to continue moving forward, and do so fast, while still making sure that before we develop something for use in millions of people, we know it is safe. We are at war, and we need to find the right weapons to defend ourselves now, and in the future, because there are roughly 2 million zoonotic diseases lingering in the animal kingdom that have some potential to jump into humans,” Robinson soberingly concludes.
You can learn more from Jim Robinson by checking out the following articles.