Good Morning Colleague,
Welcome to Day 3 of the PDA Pharmaceutical Microbiology Conference 2025!
Yesterday marked another fantastic day of the conference! The sessions were filled with incredible content and engaging discussions, offering plenty of opportunities to connect, collaborate, and network. A special thank-you to our exhibitors for their continued support, willingness to share ideas and approaches, and for providing valuable perspectives that enrich the conference experience.
Yesterday's Key Moments
The morning plenary set the stage for an inspiring day. In The Path to Discovery of the Hepatitis C Virus session, Lori Daane, PhD (Chief Scientific Officer, Bionique Testing Laboratories), reflected on the moving and memorable presentation delivered by Dr. Harvey J. Alter, Nobel Laureate and Distinguished NIH Scholar Emeritus at the National Institutes of Health. With a rare blend of humor, humility, and poetry, Dr. Alter transformed complex science into captivating storytelling emphasizing how careful observation, collaboration across disciplines, and a relentless curiosity led from puzzling transfusion-related infections to the discovery of the hepatitis C virus.
His persistence and human-centered approach ultimately inspired one of medicine’s most pivotal changes: the shift from purchased- to volunteer-blood donations, a decision that redefined patient safety and illustrated how empathy and collaboration can drive the greatest scientific breakthroughs.
Midday, we heard about critical industry aspects in the From Standards to Solutions: Enhancing Microbial Control with USP’s Latest Chapters session. Conference Planning Committee Member Kurt Jaecques (GlaxoSmithKline Biologicals S.A.) introduced the engaging and insightful presentation featuring Edward C. Tidswell, PhD (Merck & Co., Inc.), Huiping Tu, PhD, and Leslie A. Furr, MS (both from USP).
Together, the speakers explored the intent and rationale behind USP Chapters <1119> and <1119.1> on bioburden monitoring and testing, offering attendees a rare look into the decision-making process that shapes microbial control strategies. The discussion highlighted the importance of collaboration and open dialogue with regulators, understanding both the flexibility and limitations of mandatory and informative chapters, and seeking guidance when uncertainties arise. Through practical examples and open discussion, the session empowered participants to translate strategies into solutions to advance low-bioburden manufacturing and environmental monitoring practices with greater confidence and regulatory alignment.
Innovation and integrity took center stage in Digital Integrity and Intelligent Automation: Microbial Quality in the Modern Age, where Moderator Julia Marre, PhD (Regulatory Affairs, Principal Consultant, NSF) guided a dynamic conversation with Peniel Ortega, PMP (PharmAllies) and Camilla Giardini (Copan Newlab). Ortega emphasized that true data integrity begins with culture wherein leadership models accountability and teams adopt a risk-based approach rather than chasing every data point.
Giardini highlighted the power of static AI in automating colony counting, revealing how carefully trained systems can match or exceed human accuracy while maintaining control and validity. The discussion left attendees envisioning a future where thoughtful leadership and intelligent automation work hand-in-hand to advance microbial quality and strengthen trust in digital data.
Poster Presenters Shined This Week
Leaders and innovators across the industry showcased 23 posters yesterday, each highlighting groundbreaking research and emerging technologies. Thank you to all our presenters for sharing your expertise and creativity.
Tracy Radcliffe of Mettler Toledo shared insights from her poster, Overcoming Biofilm Detection and Mitigation Challenges to Improve Process Control of a Pharmaceutical Water-for-Injection System. She noted that this event has been the most exciting in her eight years of attending, with strong attendance, great energy, and interest from professionals representing emerging facilities.
Radcliffe emphasized the importance of addressing challenges in microbial detection—particularly with organisms that don’t readily grow in Petri dishes—and highlighted the need for emerging technologies to strengthen the industry’s quality toolbox. You can revisit her poster—and all 46 posters presented this year—on the conference poster page for continued learning well beyond the event.
Final Day Lineup
We’re setting the tone for the day with an impactful session, Beyond Blame: A Systems Approach to Understanding and Preventing Human Error, featuring Dr. Patrice Tremoulet, a leader in human factors engineering, as she explores how shifting from a “human error” mindset to a systems-based approach can improve quality, safety, and compliance. Learn how to identify systemic contributors to error, design resilient processes, and build a culture of continuous improvement.
Carrying that spirit of curiosity and progress forward, we’ll wrap up the conference with an engaging panel focused on career growth in pharmaceutical microbiology in the closing plenary, From Classroom to Cleanroom: Navigating a Career in Pharmaceutical Microbiology. As Josh Eaton, PDA’s Sr. Director, Scientific and Regulatory Affairs, shared, “Attendees can expect candid stories, practical advice, and a look ahead at the evolving opportunities shaping the next generation of pharmaceutical microbiologists.”
Sincerely,
Glenn E. Wright, MA
President and CEO, PDA
