Pfizer’s Rod MacKenzie says the collaborations and accelerated timelines taking place during COVID-19 are causing introspection in pharmas for how they operate, and for how they can push for regulators to continue the pace of interactions they’re setting during the pandemic into its aftermath.
Pfizer Inc. (NYSE:PFE) administered the first dose of the COVID-19 mRNA vaccine it’s co-developing with BioNTech SE (NASDAQ:BNTX) two hours after FDA approved the trial, MacKenzie, EVP and chief development officer at the pharma, told BioCentury. In an audio interview that was part of a series of conversations with industry leaders for BioCentury’s Back to School 2020 package, MacKenzie described steps companies and regulators have taken to speed the development of COVID-19 medicines. These efficiencies must be applied in the future to all drug development for serious unmet needs, he said. The COVID-19 experience “has taught us what we're all capable of when the chips are really, truly down.”
At the same time, MacKenzie said, it raises the question: “Why just COVID-19, because there are so many other people in dire need from other serious diseases. It is not that their conditions are any less deserving or their needs any less urgent.” The speed of interactions with regulators must be maintained, he said. “It would just be extremely difficult to go back to waiting months for a meeting with a regulator after what we’ve had here.” Aspects of drug development that have been accelerated by the COVID-19 response include the “use of wearables, electronic diaries for real-time data capture image collection, using smartphones,” and telemedicine, MacKenzie said (see Cover Story: “The Imperative of COVID-19”). He also discussed the importance of overcoming vaccine hesitancy. To bolster public confidence in the COVID-19 medicines it is developing, Pfizer has said it will not describe results in press releases before data are made available to the scientific community
While the development of medicines to prevent and treat COVID-19 is breaking speed records, advance planning would have saved months — and many lives — MacKenzie said. “If we had worked from a putative virus like this years ago, we could have been much further ahead. In fact, we may even have [had] vaccines in place.” He added that this level of preparedness is a “very expensive proposition that requires a huge commitment of governments, particularly, because they will be the ones to coordinate all this and then ultimately taxpayers would have to fund it.”
A transcript of the interview follows here.