Ironically, the Pfizer-BioNTech Covid-19 vaccine program did not take “Operation Warp Speed” funding. Even more ironic is the fact that Pfizer got there first. For a global public eagerly awaiting approved products, all that really matters is that it happened. But for the clinical research and technology industry, the details of how it happened offer lessons that can change the future of drug development.
Signant Health, a service provider to Pfizer on its COVID-19 vaccine effort, had a front row seat. “It happened because people mobilized around a global problem and found solutions to meet the challenge,” said Scott Connor, Signant’s Chief Marketing Officer. “This is especially amazing when we think about the normal, often plodding course of drug development where conservatism and regulation rule the day, to protect the very people we are trying to serve.”
Pfizer needed to stand up a 30,000-patient study incredibly fast, at a time when more traditional thinking and processes would have required many more months – if not years – to accomplish. Then came an additional challenge: Pfizer’s request to add another 10,000 patients to increase the sample size.
To be successful, this program required the right blend of R&D discipline and industry best practices, combined with regulatory cooperation designed to cut bureaucracy, but not corners. The world was waiting. But nobody involved in the work wanted a vaccine program that was sloppy or hurried. It was the perfect time for everyone to showcase their best selves. And it worked.
Like all the ACRO members involved in this urgent, global effort, Signant had to reflect inwards on what “normal” speed looked like, and ask how the organization could perform better and faster. “This was no ordinary project. The world was literally counting on us to deliver,” said Connor.
For Signant, delivering meant helping Pfizer shave nearly seven weeks off an eCOA initiation timeline. It was a huge lift by any standards. The trial was conducted across six countries, including Turkey, Argentina and Brazil, which pose logistical challenges for distributing clinical study devices. The study also required a faster way of pulling patient outcomes data from the field so that the sponsor could review results more frequently.
“We had to break our own norms and biases about timelines,” explained Connor, likening it to “breaking down old scar tissue to rebuild a body joint.” For Connor, the most important revelation was how everyone pulled together and leveraged their ingenuity and creative spirit “to run our sprint of the relay race. Quite frankly, some of it was a wartime-like, can-do attitude and elbow grease. Everyone did their part and got it done. That was the magic revealed.”
Connor saw urgency and a global sense of purpose get translated into real impacts. “We had finally crossed the chasm from the nebulous world of disruptive innovation that is often the echo chamber at industry conferences, to a world where we have seen the future of what is possible. We did it. And the new challenge is now so very clear: we can never go back.”
Scott Connor is Chief Marketing Officer at Signant Health