I know many of you feel like you have been racing all year—some without leaving home—and the 2020–2021 course has included difficult twists and turns, but the results have been amazing. Congratulations to all of pharma for unprecedented speed in development, manufacturing, and distribution of high-quality COVID-19 vaccines and treatments, and for enabling us to start once again participating in the opportunities we love.
Regulatory Speeds Up
We see speed in recent regulatory trends as well. As of 1 November 2020, the FDA had issued 60 new COVID-19-related guidances. ICH Q12 affords us the realization of many flexibilities outlined in ICH Q8 and supports efficient implementation of manufacturing and analytical innovation. The pandemic has taught us we can do clinical trial steps in parallel, collaborate with regulators throughout the development process, and submit rolling submissions to increase speed of approval.
Knowledge management and appropriate implementation of quality risk management also enable speed by facilitating quicker, accurate decisions and knowledge and product transfers as outlined in ISPE’s recently published Good Practice Guide: Knowledge Management in the Pharmaceutical Industry. ICH Q9 and appropriate application of risk management, as discussed at ISPE’s 2021 Asia Pacific Pharmaceutical Manufacturing Conference, enable identification and efficient application of resources to mitigate and prevent potential manufacturing issues.
ISPE’s Focus On Speed
The ISPE Strategic Plan also contains focus on speed. We strive to make technical information available to our members at the time it is most valuable (and relevant). This is often when concepts are new, when innovation occurs, and/or when new regulatory expectations are established. We have made significant progress with quicker publication of our guidance documents and concept papers, partially due to the Content Priorities plan, which reflects member input and has just completed its first update. The plan enables integration and coordination across all of our product delivery platforms, including Pharmaceutical Engineering®, guidance documents, training, conferences, and webinars.
The theme of speed is also reflected in the 2021 ISPE Annual Meeting & Expo. Keynote presentations include Robin Kumoluyi, VP and Chief Quality Officer at Johnson & Johnson, presenting on “Leading with Agility: How the COVID-19 Pandemic Was a Catalyst for New Collaboration and Innovation.” Planned educational session presentations and topics include “Applying Warp Speed Lessons to the Next Manufacturing Facility,” “Driving Efficiencies Through Continuous Manufacturing,” “Pivoting to Multiple Product Platforms to Treat COVID,” and “Discovery Mindset: Benefits to Patients through Fast Speed to Market.”
Thanks to all of our members who have continued to volunteer during this fast-paced and, at times, chaotic year. In some of my other volunteer work, I feel like folks give what is left over, when and if convenient. But many ISPE volunteers give “off the top,” the very best they have to offer, with the passion to help their colleagues and contribute to moving the pharma industry forward. THANK YOU!
The 2021 Indy 500 was the 105th running but with a 140,000-fan limit (40%) and I don’t think I will ever have greater appreciation for the oppor-tunity to attend the race. Forty-six-year-old Helio Castroneves (a fan favorite for many years) won the race in dramatic fashion passing Alex Palou with two laps to go, becoming one of only four drivers to win the 500 four times. It was indeed spectacular!
Is 2021 the greatest spectacle in pharma? I cannot think of a more impactful year in my lifetime, but I am confident the innovation and speed expe-rienced this year will lead to many more exceptionally impactful years. Thank you for all that you do to support patients around the globe and please consider sharing your passion with a student or Emerging Leader. I look forward to seeing many of you at the upcoming 2021 ISPE Annual Meeting & Expo. Stay safe!
