Community News Quarterly | January 2025

Insights from a Graduate Student: The 33rd Annual PDA/FDA Joint Regulatory Conference

By Jennifer Bates

Hi, my name is Jennifer Bates, and I do not currently work in the drug manufacturing regulatory industry. “So,” you may ask, “Why are you writing this article?” I am a graduate student in regulatory affairs at George Washington University in Washington, D.C. I work in the Clinical Research regulatory industry, where I am a clinical research associate at a contract research organization. “But that doesn’t answer my question!” I am getting to that. My regulatory affairs course tasked us with attending a regulatory conference and writing about it; this article was just a bonus for me. So, dear reader, let me start with my first impressions.

The Event Ecosystem

Upon walking into the Westin Conference Center, I immediately noticed dozens of booths, professionals recognizing each other and catching up, and the schedule of lectures posted in multiple places. I picked up my badge and began introducing myself to everyone I could, interested in seeing the parallels in careers between drug manufacturing and clinical research regulations. A little while later, I sat down to hear the first few speakers. I listened while the U.S. Food and Drug Association’s Center for Drug Evaluation and Research, Center for Biologics Evaluation, and Research and Office of New Animal Drug Evaluation, along with several other agency representatives. They discussed major updates to their organizations over the past year, policy differences, how they affect the previous workflow, etc.

I recognized much of the vocabulary and concepts from my past regulatory affairs courses. I appreciated how they were applied in real life instead of a scenario in a discussion board. I will readily admit I spent a good amount of time googling different acronyms to keep up. Several people around me saw my open search engine tabs and happily filled me in on the abbreviated meanings and how they related to the topic of discussion. Throughout the sessions, I learned more than possible about completely new topics in one day. I learned about the Office of Regulatory Affairs (ORA) restructuring, how to apply evaluation of a risk to manage a partnership with your contract development and manufacturing organization, the differences between tacit and explicit knowledge, and so much more.

Connections

Between sessions, I met with hundreds of industry professionals, some there to present, some to catch up on the past year’s changes and some to network. By speaking with different people at different levels within the industry, I was able to make many parallels between drug manufacturing and clinical research regulations. The main intersections were the Code of Federal Regulations, the bread and butter of regulation in the United States. I met some rather interesting professionals, both seasoned and brand new.

I spoke with Michael Rogers, the Associate Commissioner for ORA (whose eloquent speech I thoroughly enjoyed), about his new graduate program in North Carolina designed to help break young professionals into the industry. I also spoke with two college students, George Kwiecinski and Zephaniah Odidika of Global Key Solutions, who noticed a distinct gap in how FDA 483s are received and interpreted and created affordable software to assist companies. In the three days I attended the conference, I handed out over 200 business cards and returned with over 75 from other attendees, took 6 pages of notes and snapped about 50 pictures of various slides. Above all, I now know how to keep up in a conversation about the newest regulation changes in the industry.

Unexpected Benefits

Before the 33^rd Annual PDA/FDA Joint Regulatory Conference, I never thought I could walk into sessions on topics I could only slightly relate to and depart with more than a basic understanding of the regulatory industry. I also walked away with the contact information of many esteemed professionals in my pockets and the pride of knowing some of my classmates will most likely graduate and enter such an interesting field.

Thank you PDA for an unforgettable experience!

The Student Experience of Attending the 33^rd Annual PDA/FDA Joint Regulatory Conference: Insights into Biologics Manufacturing

By Ellie Masserrat

Attending the 2024 PDA/FDA Conference in Washington, D.C., was a transformative experience as a student pursuing a graduate certificate in Regulatory Affairs at George Washington University in the District of Columbia. The three-day event featured numerous sessions, ample networking opportunities and various expo booths where representatives from different companies shared their journeys and personal experiences while showcasing their innovative tools and products. It was an enriching environment for insightful conversations about the industry.

Biologics' Leadership

Industry leaders addressed various topics, including historical perspectives, current issues, emerging trends and problem-solving skills. The conference captivated a large audience of dedicated professionals eager to learn and stay current in their respective fields. It deepened my understanding of the complexities within the medical device and pharmaceutical industries and highlighted the crucial role of manufacturing in the development of biologics.

Key topics that stood out during the sessions were the importance of advanced manufacturing processes, regulatory programs and available resources for product developers. Biologics, including products like vaccines, monoclonal antibodies and cell therapies, are vital in modern medicine. Developing these products comes with unique challenges that require advanced manufacturing techniques. One particularly interesting session I attended focused on advanced technologies, such as continuous manufacturing and automation, which are changing how biologics are produced. Traditional batch manufacturing can be slow and lead to inconsistencies affecting product quality. In contrast, continuous manufacturing streamlines the process, improving consistency and reducing production times. This innovation boosts efficiency and enables better scalability, which is essential as the demand for biologics continues to rise.

Best Practices

The conference also covered different regulatory programs that oversee the development of biologics. The U.S. Food and Drug Administration (FDA) understands the importance of a strong framework promoting innovation while ensuring safety and effectiveness. Programs such as the Breakthrough Therapy designation and Fast Track designation offer developers faster pathways to market their products.

In one particular session, a panel of experts discussed the significance of these regulatory incentives, highlighting how they support the development of new therapies and encourage collaboration between the industry and regulatory agencies. This dialogue is crucial for creating policies that keep up with advancements in manufacturing technology. One key takeaway from the conference was the focus on a risk-based approach to regulation. This means that the lowest-risk operations can be subject to a lower oversight threshold, preserving time, human capital and other resources for higher-risk operations. This approach provides flexibility and encourages companies to use advanced technologies while still maintaining safety standards. Balancing innovation with patient safety is an important theme in regulatory affairs, and it was inspiring to see how this is being actively addressed in the field.

Solution Providers

The exhibition hall featured numerous organizations showcasing their latest technologies and services, including analytical testing solutions, advanced manufacturing equipment and consulting services. It highlighted robust programs, innovative tools and various services designed to improve operations and effectively address regulatory challenges in manufacturing. The atmosphere was friendly and inviting, creating a sense of community among professionals committed to advancing the field of biologics. As a student, interacting with experienced professionals and learning about their real-world applications of advanced manufacturing techniques was invaluable. I met many professionals who took pride in their contributions to developing life-saving biologic therapies.

Attending the PDA/FDA Conference Joint Regulatory Conference was pivotal in my educational journey. The discussions on advanced manufacturing technologies, regulatory programs and available resources deepened my understanding and inspired me to become more actively engaged in this field. As I continue my studies, I look forward to applying the knowledge I gained at the conference to contribute meaningfully to the development and regulation of biologics, ensuring they remain safe, effective and accessible to those in need.