The theme for the PDA annual meeting this year is “Agility in the New Normal.”  The plenary address kicked off the meeting with an interesting presentation by Dr. Jeffrey Baker, Senior Fellow, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), titled “Pandemic Response, Regulatory Rubric, and the Nature of Rubber Bands.”  He spoke about the intrinsic nature of rubber bands being that they only work when stretched or stressed; even after they are removed from use, it takes less stress each time to stretch them out and they never quite hold things together as tightly.  Finally, when they break, they sting indiscriminately, don’t work anymore, and have to be replaced at a time and place not of your choosing.  He then related this to the four “rubber bands” of industry today: people, policy, process, and pipeline.  He pointed out that when any one of these areas are metaphorically stretched, it puts stress on the other three, even if they are in control within their own areas.  Likely, we can all relate to this metaphor as industry tries to balance a new way of working while maximizing efficiencies and meeting corporate timelines.

Donna Boyce, Pfizer’s SVP of Global Regulatory Affairs, followed with an in-depth look at how Pfizer was able to navigate multiple regulatory bodies to receive approvals for its Covid vaccine and another, subsequent antiviral.  Her presentation, “Regulatory Expediency and Flexibility Fit for a Pandemic, but what Endures Will Drive Future Breakthroughs Globally,” detailed some takeaways from this experience that could be advantageously applied, even in post-pandemic times:

  • Using decentralized trials;
  • Using real-world evidence to support the EUA of some dosing studies;
  • CMC flexibilities, including real-time data submissions and reviews of CMC, and remote facility inspections;
  • No CBER batch releases; and
  • Digital labeling, especially in cases where the drugs are administered by healthcare providers.

Having had this type of expedited-approval experience for any drug in a non-pandemic setting is likely zero.  Pfizer and CBER worked around the clock to accomplish the work needed to get to the end goal of vaccine approval.  Pfizer was still obligated to provide all requisite data and information, but on a rolling basis and in (near) real time.  Going back to the rubber bands, they were all stressed and it is unlikely that they will return to their pre-pandemic shape after all that time with the continuous pull-on resources.  Many of us will not.  The question that will always come from management:  Well, you managed to do that once, why not get that approval in that timing again, or you managed to do something else, why can’t you do it again?  However, the cost of this has been witnessed over and over again, i.e., work was stopped or delayed on other pipeline products and personnel burnout is rampant, not just because of the additional stresses at work but because of the additional stresses in life.

What can the industry take away from these learnings to make it more agile and can the regulatory bodies keep up the pace?  This question was asked during the Q&A and the most favored answers from the list above were digital labeling, which some other countries have already embraced, and remote inspections, which are slowly, but surely, being integrated into the FDA’s toolkit.  Here’s to hoping that we, industry and the FDA, can move forward with the implementation of some of these changes without stretching our rubber bands until they break.  Not just a new way of working – but also a new way of thinking!