Pfizer: Improving the Pace of Innovation

The COVID-19 pandemic spawned an unprecedented challenge to modern medicine. It also showed how innovative biopharmaceutical companies like Pfizer can respond and dramatically accelerate the clinical development of medicines and vaccines while ensuring safety and rigor remain a key component to the process.¹

The extraordinary speed of the 269-day Pfizer-BioNTech COVID-19 vaccine development was the most prominent example of how clinical trials can move quickly while maintaining focus on quality and safety.² But the changes that researchers made to adapt to pandemic times also make sense for the post-pandemic world, industry leaders say.³

Those changes could result in trials that better serve patients and increase the speed, efficiency and innovation in clinical development. And that could help ensure the $9.4 billion Pfizer spent in R&D in 2020 will deliver strong results.⁴

$9.4 Billion R&D Investment

This combination of breakthrough science and speed that maintains safety and quality bodes well for Pfizer’s growth.

Clinical trials, reimagined for the digital world

COVID-19 caused major disruptions in clinical trials and posed a challenge to researchers: how could they keep participants safe while keeping studies going?

Prior to the pandemic, teams at Pfizer were already thinking creatively and swiftly to shift many study activities online. Patients in the COVID-19 vaccine trial, for example, only needed to show up at the clinic site twice to receive injections. They signed digital consent forms and filled out app-based e-diaries to record, track and measure how they felt afterward.⁵

Meanwhile, trial researchers who previously needed to travel to remote sites to review participant records and other study data switched to secure data storage platforms, allowing them to review patient data remotely.

“Our hope is that use of technology in this way is the new normal,” said Rob Goodwin, Pfizer’s Vice President, Head of the Operations Center of Excellence for Global Product Development.

Participating from home

Clinical trials are continuing during the pandemic for potential treatments for diseases ranging from cancer to autoimmune conditions with adaptations that allow patients to participate from home.

Patients get the candidate medicine or a placebo in the mail and have home health visits with a nurse for blood draws and additional monitoring.

Making science faster

The biopharmaceutical industry and regulators around the world worked together to safely bring COVID-19 vaccines from the lab to the public in historic time. In the U.S., the FDA waived new drug and clinical trial application waiting periods while providing near-real-time advice and virtual meetings with companies to speed the regulatory process.

Trial sponsors, meanwhile, shared what usually is generally viewed as competitive information with each other. It turns out that such collaboration is good for the drug-making ecosystem because it accelerates safe and effective drug development.

“Our industry’s focus has, and always will be, patient need,” Pfizer’s Rod MacKenzie, Executive Vice President of Global Product Development, wrote in Nature. “But COVID-19 is redefining what our response to urgent patient needs must be. As a biomedical community, we have a significant opportunity to carry forward and further accelerate the improvements made during the pandemic.”

[1] Nature. Covid-19 Must Catalyze Changes to Clinical Development. Available here.
[2] See “A Letter from Pfizer’s Chairman and Chief Executive Officer”. Proxy Statement for 2021 Annual Meeting of Shareholders. Available here.
[3] COVID-19 as a Catalyst for Modernizing Clinical Trials. Available here.
[4] Breakthroughs That Change Patients Lives. Proxy Statement for 2021 Annual Meeting of Shareholders. Available here.
[5] Politico.com. Breakthroughs at the Speed of Science: Applying lessons from COVID-19. Available here.