President’s Message: A Bittersweet Farewell

This message will be my last to you as the President of PDA. After 13+ years as President, I will be retiring March 1, 2023. I joined PDA as President in the firm belief that PDA is an important resource for our community. As I look back on this period, I am reminded of all the things that this organization has accomplished since 2009.

Strategy

Over the past 13 years, I have participated in the development of three strategic plans, all of them furthering the focus on “connecting people, science and regulation.” Proudly, I must say that we have accomplished many of our goals while continuing to pursue others.

Since then, we have updated our mission: to advance pharmaceutical/ biopharmaceutical manufacturing science and regulation so members can better serve patients.

Our values are published, which include “science based, integrity and Inclusion.” These things constantly guide our activities.

People

PDA is, at its heart, a volunteer-based organization. Thousands of you have contributed to the mission of PDA in so many ways. As a result, our membership has expanded to be truly global, with about 45% of our members outside the U.S. This has been further demonstrated by adding new PDA chapters in India, Singapore and Brazil, as well as new chapters in the U.S. regions in Missouri Valley, Texas and the Pacific Northwest. Our chapters are supported by hundreds of volunteer leaders worldwide.

One of PDA’s core activities has been bringing people together at high-quality conferences. Since 2009, we have hosted more than 55,000 people at more than 440 conferences and workshops in the United States, Europe, Latin America and Asia. Each of these has been supported by hundreds of planning committee members, thousands of speakers and dedicated staff members. Some of our signature events are more than 30 years old and highlight key and emerging topics to help attendees better understand and navigate the complexities of pharmaceutical sciences and technology.

Also, education has been a core focus for PDA for many years and, during my tenure, we have trained more than 23,000 people. Many of these were hands-on courses at our state-of-the-art Training and Research Institute (TRI) and represent industry-leading training. We have also trained thousands of health authority members from around the world.

Science

Science is the foundation of our organization. We utilize a scientific approach to meet challenges and to continuously improve. It is not subjective or emotional but rather a logical, open, rational and transparent process. Through our multistep process, we have published more than 120 PDA technical publications since 2009. These documents cover various topics from sterilization and aseptic processing to biotechnology, cold chain and risk management. Every document we have produced has had volunteer experts who contributed their time and knowledge as contributors, reviewers and approvers.

We continue to publish a peer-reviewed scientific journal that is highly referenced and brings forward the latest science and technology to advance pharmaceutical manufacturing. This sets PDA apart from many other organizations.

Regulation

PDA is a highly regulated industry, and PDA’s strategy has enabled global harmonization of regulatory requirements and industry standards to drive compliance, quality performance and innovation. Many of our conferences involve health authority members as planning committee members and speakers, and we have continued with the industry-leading PDA/FDA Joint Regulatory Conference since 1990.

PDA, through our volunteer experts and reviewed by our leaders, has commented on hundreds of regulatory documents from the U.S. FDA, EMA, WHO, ICH and PIC/S, as well as major pharmacopoeias. Additionally, we have invited regulators to be participants in our technical documents, either as contributors or reviewers.

Leadership and Business Management

In 2009, we recognized that we also needed to focus on management of the organization. We formalized this with a strategy that PDA “will maintain strong organizational leadership to promote teamwork, an environment of sustainable growth and excellence in business management.”

We rebuilt our financial strength, and then used that to expand our facilities in TRI and our offices in Bethesda and Berlin. We added an office in Singapore to meet the needs of our members in the Asia-Pacific region, and we established and maintained strong financial controls that positioned us to navigate the global pandemic with substantial reserves.

It has been my delighted honor to lead this organization. Our staff has undergone so many changes in the past 13+ years, but we have maintained the functions upon which so many continue to utilize. Our staff, past and present, have worked hard to provide this service to you, and we could not have accomplished what we have without them.

I have met thousands of you at conferences, chapters and meetings. I have enjoyed getting to know the plethora of individuals that I could not possibly name you all. I want to thank all of you for making PDA the organization it is today, and I feel confident that PDA will continue to be a strong, valuable and inclusive organization for many years to come.

Thank you!