PDA Letter Article

Chair’s Message: Continuing to Shape the Future of Pharmaceutical Manufacturing

by Anil Sawant, PhD

As I embark on my new role at PDA, Chair, Board of Directors, I took a moment to think about my long association with PDA and my fellow volunteers, which began in 1992. It struck me that belonging to PDA has been by far the longest association I have had with any institution. More than any other institution, PDA has helped me focus on the science and the patients we serve, along with the knowledge I acquired at PDA helped me fulfill my quest to learn and advance my professional goals.

PDA is an industry leader with a rich 78-year history of serving patients through its members. PDA was founded in 1946 to provide the fledgling parenteral drug industry a place for the pioneers in our industry to come together and develop practical solutions and best practices, provide training, and help establish patient-centric standards. Right from its onset, PDA helped developed the “workforce of the future” to make sterile products; although I admit I don’t know whether the pioneers used the phrase “workforce of the future.”

Today, PDA continues to develop the digitally savvy workforce of the future needed to manufacture cell and gene therapy products, biologics and vaccines using newer technologies.

As I looked back at my professional journey, I was reminded how many mentors like Dan Gold, Ray Shaw, Tony Cundell, and others hoisted me on their shoulders, and experts like Jim Akers, Jim Agallaco, Ron Tetzlaff, Rich Levy, and Becky Devine taught me that researching sterilization, lyophilization, and quality systems could be fun. I also realized my journey was buoyed by PDA friends like Richard Johnson, Michael Miller, Hal Baseman, and Martin VanTrieste who opened my mind, of course over a drink, to looking at problems from different angles. I benefited from the camaraderie and community that PDA offered.

Now that the pandemic is behind us, I am sure today’s Early Career Professionals (ECPs) will be able to benefit from mentorship, just like their predecessors did. The members of our advisory boards and board of directors, past and present, are willing to help those that will one day replace them to carry the torch of our industry forward.

I recognize times have changed, and we live in the era of social media likes and AI-driven responses, but I am still betting, the age-old approach of apprenticeship and mentorship which fueled industrial revolutions will continue to be the major vehicle of knowledge transfer. I am still betting industry professionals will continue to benefit, just as in the past, from PDA’s time-tested formula of camaraderie, community, and connections which makes accessing knowledge and learning the nuances much easier. There is also the added benefit of…. phone a friend available when you need to talk through an issue.

Over the last 78 years, PDA has become an industry leader in disseminating knowledge through its technical reports, the PDA Journal of Pharmaceutical Science and Technology, and the Training and Research Institute. Throughout its history, PDA has not shied from addressing cutting-edge, important, or controversial topics in an objective, unbiased, and open manner.

Thanks to the subject-matter experts who volunteer their time and the robust review process, PDA publications help establish the ‘C’ in CGMP. PDA’s focus on the quality of science is very important in the current, increasingly confusing environment. The internet is loaded with journals that have eliminated the review process, to be the first to post. I understand, the old adage, ‘Science will correct itself’ still holds. However, unreliable science can do a lot of damage, especially in the fast-decision-making environment, before science self corrects.

The strength and quality of PDA’s technical reports became apparent to me last March during a Q&A session with U.S. FDA at the PDA India Chapter. The audio mics were busy with questions for the regulator, and many of the Agency’s responses were, “Have you read the PDA Technical Report xyz? If not, go read it, and you will find the answers.”

Post-pandemic, there is heightened concern about drug and vaccine shortages and increased awareness about lack of access to life saving medicines, especially in low- and middle-income countries. The causes for shortages are many, including quality issues, supply chain disruption, economics, and raising the bar quickly without a patient-focused, risk-benefit assessment which sometimes precipitates a capacity problem. PDA has been working on this issue with regulators and will continue to do so by focusing on what it does best. Simplifying adoption of digital technology to be more predictive, plan better, and increase speed and agility.

In 2024, my fellow board members and I, along with PDA’s President and CEO, Glenn Wright, and his highly talented and motivated team, will be working on becoming more efficient at disseminating knowledge without sacrificing quality, more proactive and efficient at creating more opportunities to be mentors and mentees, expanding opportunities to develop talented workforce to meet the needs of low-income countries, and rebuild the scientific community the pandemic dared to disrupt.

I invite you all to join me in this journey of growth and collaboration. Let us continue to shape the future of pharmaceutical manufacturing, ensuring the availability of life-saving medicines and vaccines for all who need them.