Extraordinary times, such as the global COVID-19 pandemic, require extraordinary actions. One such action initiated by the PDA Board of Directors was to swiftly approve the formation of a Coronavirus Task Force. The singular objective of the Task Force was to find ways to help our members do what they do best: Serve patients by ensuring minimal disruption to the supply of critical medicines.
I have had the privilege to be part of PDA’s call to action and to help assemble and lead the Task Force composed of dedicated volunteers and PDA staff with diverse experiences and expertise. The Task Force met weekly with the goal of quickly and efficiently suggesting actions on GMP processes and controls, surveying and benchmarking best practices, creating awareness about the impact on supply chains, and providing rapid feedback to health authorities who were developing important regulatory guidance using emergency powers and processes.
Thanks to excellent project management support from Adam Caruso, Merck and Co., Inc., one of PDA’s many enthusiastic early-career volunteers, meeting participants were strongly engaged and collaborated unreservedly, driven by a sense of urgency and purpose—beat SARS-CoV-2.
Our first task was to build a COVID-19 webpage that could become a one-stop shop for communication with our membership. The second task was to start addressing important benchmarking questions our membership was asking related to the impact of COVID-19 on manufacturing activities, preapproval inspections, and remote audits and assessments.
The Task Force work was expertly enabled by the PDA staff who helped arrange webinars, published articles, and developed podcasts, all while working remotely. Adjusting to the new “remote working” reality involved a lot of trial and error, experimentation and, if we failed in one direction, expeditious work to agree on a different approach.
Despite the heavy workload, regulators at the U.S. FDA and UK MHRA made themselves available to participate and help our mission. I remember the late evening and weekend calls to plan the webinars and test the technology to ensure cybersecurity firewalls did not block speakers from joining.
Together we accomplished a great deal and, as I look in the rearview mirror, this is what I see:
- I see a PDA Coronavirus Pandemic Survey, April/May 2020, that helped industry benchmark practices and adjust to new ways of working.
- I see a paper in the PDA Journal of Pharmaceutical Science and Technology, entitled “Controls to Minimize Disruption of the Pharmaceutical Supply Chain During the COVID-19 Pandemic,” authored by virologists, pharmaceutical microbiologists, and GMP experts. This paper provides insight into how industry could continue to make critically needed medicines. The misinformation about the longevity of the coronavirus that spread through social media was leading some companies to question the adequacy of existing controls and contemplating extreme measures, such as sanitizing every pallet of packaged product before it was shipped out. Now that the dust of misinformation has finally started to settle, the value of good scientific rationale stands validated.
- I see many timely webinars: One that created awareness of the impact of the COVID-19 pandemic on the pharmaceutical supply chain. Another on regulators’ perspectives on remote assessments and inspections during the COVID-19 pandemic that addressed how they would manage preapproval inspections and PDUFA/GDUFA dates. And a complementary webinar to share industry perspective on remote assessments and inspections. A fourth webinar on applying the June 2020 FDA Guidance on Responding to COVID-19 Infection in Employees in Manufacturing. A fifth on modular manufacturing to enhance or scale-up manufacturing capacity for COVID-19 products, and a sixth on mitigating shortages of critical manufacturing supplies during a global pandemic. These webinars helped regulators provide critical guidance using their emergency powers and enabled industry to provide direct feedback in lieu of the normal commenting process, which was not readily available during the pandemic.
- I see podcasts on topics that included working remotely, travelling during COVID-19, and preventing coronavirus transmission from employees to GMP facilities.
Looking forward, the Task Force is now focused on recording the lessons learned. A team of dedicated volunteers is working on a Points-to-Consider document that will help prepare us for a future pandemic. After all, this might not be the last time a new infectious agent threatens humankind. Hopefully, the next time, our industry will be armed with more agile processes to react to global patient needs and counter misinformation, fear mongering and supply chain disruptions. Also, we can better address why it takes so long to develop vaccines and how we can expedite further vaccine and therapeutics development and scale-up.
On a personal level, working on the COVID-19 Task Force with a group of highly committed individuals has been one of my most gratifying experiences. I have made new friends and strengthened my friendships with others. Through numerous heated debates, I have learned to appreciate different points of view in this polarized world. Best of all, the last 18 months has redoubled my faith in PDA’s mission of Connecting People, Science and Regulation®.
It has been almost 20 months since we set out to do our bit to fight COVID-19. Thanks to the valiant efforts of our industry, we have numerous vaccines and therapeutics available for use. A sense of normalcy, albeit a new normalcy, is our current reality and our hope for a better future has returned.