PDA Letter Article

Macro Impacts from the Micro-Universe

by Kurt Jaecques, GSK, and Vineeta A. Pradhan, U.S. FDA

The theme’s title for the 18th PDA Pharmaceutical Microbiology Conference, Macro Impacts from the Micro-Universe, accurately summarizes the challenges we currently face in microbiology. Microbiologists and regulators are tasked with answering big and difficult questions, and this can only be achieved by continuing to build our competence, sharing experiences and challenges, and keeping the discipline of pharmaceutical microbiology strong and vibrant. For this year’s conference, PDA and the Program Planning Committee are proud to present a robust program that tackles both current and future issues that will impact pharmaceutical microbiology.

Day one will open with a plenary presentation by Rob Weker, who will share his patient perspective. The story of his incredible journey will remind us of the overall purpose of our work by keeping us patient focused.

A pair of blue latex gloved hands holding a petri dish that holds the image of a galactic scene with stars and nebula in purple

The remainder of the day is packed with concurrent sessions covering multiple topics, including a dedicated track on endotoxins. Other sessions will focus on decontamination and disinfection, managing complex investigations and good practice sharing. Moreover, we will conclude our first day with a plenary presentation on spillover, presented by David Kennedy, MD, Assistant Professor of Biology at the Penn State University, who will be sharing insights on a model that will be able to predict the likelihood of microbial transmission. 

Day two will kick off early with a Microbiology/Environmental Monitoring Interest Group breakfast session, where the discussion will be audience-led. Next on the agenda is the plenary session, Critical Thinking in a Regulated Environment, which focuses on risk management and data governance. We will continue with three concurrent session tracks covering many topics such as contamination control strategies, case studies on the implementation of the new European Union Annex 1: Manufacture of Sterile Medicinal Products, advanced therapeutics medicinal products and environmental monitoring.

Day three will start with the second breakfast session, providing an overview and update on the future plans for the United States Pharmacopeia microbial standards. An eye-opening plenary session follows, featuring Elisabeth Bik, PhD, a scientific integrity consultant and founder of the Science Integrity Digest blog, who will share some insights on image duplication, manipulation and other problems in biomedical research. Bik, PhD, is known for her work on detecting photo manipulations in scientific publications.

We will finish our two-and-a-half-day conference with the interactive Ask the Regulators session, where U.S. Food and Drug Association (FDA) representatives will provide insight into questions posed by the audience. This will be unique opportunity to interact with regulators in an open forum focused exclusively on your microbiology concerns!

People who have attended previous PDA Micro Conferences will be familiar with some of the other features that make this conference a can’t miss event. The poster presentations, tech talks and the Exhibit Hall present the perfect forum for attendees and suppliers to connect for open discussion on products, technology and solutions.

On behalf of the Program Planning Committee, we are really looking forward to welcoming you to the 2023 PDA Pharmaceutical Microbiology Conference, 02-04 October, in Washington, DC! We have been working hard on this upcoming conference to keep you current with advances in pharmaceutical microbiology and the ever-changing regulatory landscape.

We hope to see you there!

About the Authors

Kurt JaecquesKurt Jaecques, MA, is the Global Aseptic Technologies lead for Monitoring and Control at GSK Vaccines and has been working within the pharmaceutical Industry for more than 28 years. He holds a master's in biochemistry and has been working in different quality control and quality assurance roles, focusing on pharmaceutical microbiology in general and environmental monitoring and clean utilities in particular. He recently co-chaired the update of the PDA Technical Report No. 13: Fundamentals of an Environmental Monitoring Program.

Vineeta PradhanVineeta Pradhan, PhD, received her PhD in Microbiology from The Ohio State University. She joined the U.S. FDA in 2016 and works as a Microbiologist in the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation at the Center for Veterinary Medicine (CVM). However, prior to joining the U.S. FDA, Vineeta worked as an Assistant Professor at the Northern Virginia Community College, Loudoun Campus in Sterling, Virginia.

Pradhan, PhD, also reviews the pre- and post-approval chemistry, manufacturing and controls information of generic sterile injectable drugs for the entirety of the drug application lifecycle. She has experience in moist steam sterilization, aseptic processing, media fills and microbiological testing.