Mikael Dolsten, M.D., Ph.D., Pfizer’s chief scientific officer and president for worldwide R&D and medical, is clear: The company's COVID-19 vaccine is here because of a decade of R&D work and taking major risks itself while not asking for government handouts.
Speaking to Fierce Biotech after the annual J.P. Morgan healthcare conference, Dolsten said: “This didn’t just happen by pure chance. We have been working on building an R&D organization for the future for more than a decade, and this has included sharpening our focus on several areas, including vaccines, and working with the best and most innovative partners, like BioNTech.”
He said Pfizer has grown a “breakthrough” R&D culture, and it is this that allowed the pharma—alongside its sheer size and capacity—to help deal with the “enormous challenge” of COVID-19. “This is the worst pandemic in 100 years; Pfizer should be one of the companies that can stand up and help stop it.”
He said, with a glancing eye at rival vaccine maker Moderna, which was offered billions of dollars from the Trump administration, that it is “not about seeking funding from the (U.S.) government,” as it is “our job to put our capital at risk if we think we can do something extraordinary.”
“R&D should be rewarded with risks,” he said, but added that when companies such as Moderna are given huge lump sums, “we are doing R&D without the risks. For a pandemic, that may be OK, but it really isn’t the way we should use resources as a society.”
“We funded $2 billion at risk (to work with BioNTech and develop/produce their never-before-used mRNA COVID-19 vaccine technology), but it allowed us to move faster, be more nimble, be less dependent on bureaucracy, and a huge chain of structures.
“At the same time, we said we wanted to be transparent and collaborative: We published within days so our data was available for the rest of the world. When you put all of these pieces of the puzzle together, it allowed us to accomplish what we did: Creating and producing a new COVID vaccine for so many countries.”
That deal with the German biotech was one of the quickest Pfizer has ever made, and probably one of the most important in living memory, should their vaccine’s efficacy prove out in the real world and get to enough people.
“It was clear at the start of March (2020) there was a dialogue going on between myself, Albert (Bourla, Ph.D., Pfizer’s CEO) and a few others, about how we should help. We already had work in place for antivirals as well as the vaccine effort,” explained Dolsten.
“From that, we had a meeting at the White House, which under such historic circumstances in such an historic place, made everyone feel the importance of this moment. I remember on the way back, talking to Albert, we said, 'Let’s see if we can expand the alliance with BioNTech'; we had our vaccine team on board with that.
“But, if we’re going to do a fast deal, that would still take months. Let’s do something that’s beyond fast, and we said: 'Look, let’s do it in seven to 10 days, and have at least a letter of intent.' 10 days later, this was signed. Then we started pouring resources into (BioNTech) because we had the ‘scientific handshake,’ and, I think around a month later, with significant levels of our resources already allocated, the final deal was signed. There was still detail to sort out but the pandemic made us find solutions: trust each other; have a common, central goal; and move much swifter.”
He said he found a similar philosophy at the FDA. “We approached each other mutually, and discussed: How would you address this pandemic? And we were able to run a seamless phase 1, 2 and 3 program in less than a year. This was never thought about or possible before in vaccines, where we had real-time feedback from the FDA; not just putting big reports back and saying ‘hey, you’ll hear from us in a month’; this turned months to weeks, and weeks to days, days to hours.
“They were willing to take phone calls from us; it sounds strange, but normally it was just letters sent weeks later. Not everything in R&D can be in this warp speed setting, but this shows we can come together and mount battles against some of the most threatening medical conditions.”
Being in the right place
Dolsten reiterates that this doesn’t just happen: Pfizer pushed itself to be in the right place, and this was only helped by a preexisting pact with BioNTech and its continued push into infectious disease, such as with its pneumonia vaccines, when so many others had dropped out of researching this area.
Pfizer’s R&D budget in 2019 was $8.65 billion, up 8% on the year before and coming from a $51.8 billion total sales ledger, showing its R&D budget as percentage of revenue as 16.7%—not the highest among Big Pharma, but respectable.
2019 was a transitional year for Pfizer, with CEO-elect Bourla charged with overseeing the implementation of a revamp of the company—started under his predecessor Ian Read—to refocus it on innovative drug discovery and development.
That revamp of R&D is already paying off in terms of phase 2 project success rates—now more than 50% versus 15% a few years ago—and the number of new molecular entities reaching the market.
Part of that improvement has come from reorganizing all its business units into biotech-like organizations, each responsible for all things from early R&D to commercial and competing for capital allocation. That success is continuing, Dolsten said, and asked that I look out for its annual results in a few weeks to see a boost in its overall success rates.
“There is a three-phase approach that got us here,” Dolsten said. “We have built that breakthrough approach throughout the organization; we took the chance and the risk; and we’re now trying to leverage, not just to continue the war against COVID-19; we won the battle maybe, but there is a longer lasting war.”
In nine months, Pfizer and BioNTech went from having no deal on COVID-1 to a sped up “gentleman’s agreement” within a few weeks after the pandemic surged in the West, to phase 3 trials and emergency uses across a number of countries, including the U.S.
Dolsten wants to see more of this, noting it will use its experience from COVID-19 to help create new R&D projects at speed, including for influenza but also in areas such as cancer and gene therapy, a relatively new area for Pfizer but one in which it is hoping to do big things.
These include its late-stage hemophilia B candidate fidanacogene elaparvovec as well as Pfizer’s Duchenne muscular dystrophy gene therapy, also late-stage, and a Wilson’s disease candidate is also approaching the clinic.