PDA Pharmaceutical Microbiology Conference 2024
Bridging Science and Compliance
Educational Sessions | Workshop | Training Course | Networking Opportunities | Exhibit Hall
Become a Sponsor and/or Exhibitor
Step into the future of pharmaceutical microbiology!
For our 19th anniversary, our major focus is “Bridging Science and Compliance” where we’ll dive deep into the crucial nexus between scientific advancement and regulatory adherence.
Join us and a vibrant community of new and seasoned professionals from all facets of the field of pharmaceutical microbiology, including global industry, academia, and regulatory authorities for dynamic discussions and exchange of best practices that will pave the way for a robust future.
There will be many opportunities to listen and directly interact with all of the expert presenters across sessions, roundtables, and plenaries, each including lively Q&A that promise to stimulate discussions and encourage everyone attending to share their thoughts and comments.
Don’t miss the chance to explore cutting-edge research during Poster Presentations covering topics such as animal health, endotoxins, and mold and microbial contamination and remediation, and be sure to visit the Exhibit Hall where leading biopharmaceutical and pharmaceutical companies will showcase the latest technologies, equipment, and applications.
Seize this opportunity to stay ahead of the curve, expand your knowledge, share your voice and help shape the future of our industry. Join us at the forefront of innovation and compliance at the PDA Pharmaceutical Microbiology Conference 2024!
Highlighted Presenters
Key Presenters
Conference Co-Chairs
The Minds Behind the Insights
Schedule
Discover What's Happening Each Day
14:00 – 19:00
Registration Open
07:30 – 17:30
Registration Open
07:30 – 08:30
Continental Breakfast
08:30 – 10:00
P1: Microbes in Microgravity: Navigating Life on a Low Earth Orbit Space Station
Moderator: Erika A. Pfeiler, PhD, Supervisory Microbiologist, OPQ, CDER, U.S. FDA
Step into the extraordinary world of living in a Low Earth Orbit (LEO) Space Station, where every breath, sip of water, and microbe is shared with up to six of your best friends 24 hours a day...the perfect environment for microorganism to thrive.
In the late 1980s, NASA embarked on a pioneering journey to design regenerative life support systems capable of sustaining a crew of six living in a space station. This challenge required unparalleled innovation that introduced NASA’s microbiologist Monsi Román to perplexing questions: What kind of microorganisms lurk in human sweat, are stored in urine, or condensed in humidity? How do you regulate the population of harmful microorganisms? How do you monitor them? How will these organisms behave in micro-gravity, and how might they affect the recycling system?
In this session, Ms. Román offers a comprehensive overview of the groundbreaking work that was performed during the International Space Station design phases to answer these questions, underscoring their significance for future long-duration missions beyond Earth’s orbit. Join us as we orbit into the realm of space microbiology and uncover the intricate web of challenges and solutions that define life beyond our planet.
08:30
Opening Remarks from PDA Leadership and Conference Co-Chairs
- Glenn E. Wright, MA, President and CEO, PDA
- Anil Sawant, PhD, Chair, PDA Board of Directors and Senior Vice President, Merck & Co., Inc.
- Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control,GSK
- Erika A. Pfeiler, PhD, Supervisory Microbiologist, OPQ, CDER, U.S. FDA
08:45
Lessons Learned from the Design of the International Space Station Water Recycling System: A Microbiologist’s Perspective
- Monserrate C. Román, MA, Program Manager, NASA (Supported by Veltek)
09:30
Q&A
10:00 – 18:30
Exhibit Hall Open
10:00 – 10:45
Networking Break and Poster Presentations in the Exhibit Hall
10:45 – 12:15
P2: Navigating the Microbiome: From Fecal Transplants to Next-Gen Therapeutics
Moderator: Lori Daane, PhD, Chief Scientific Officer, Bionique Testing Laboratories
Benefit from exciting insights from two distinguished scientists as they unravel the mysteries of the microbiome’s role in modern medicine.
The microbiome is the newest player in the rapidly changing field of medical treatments and is challenging long-held paradigms of disease treatment. Fecal transplants, initially for Clostridioides difficile infections, have transformed into FDA-approved Live Biotherapeutic Products (LBPs). However, understanding these LBPs remains in its infancy, including their pharmacy, pharmacokinetics, pharmacodynamics, toxicity, and more.
The potential of LBPs extend beyond C. difficile infections, impacting diseases influenced by microbiota-host interactions. Yet, realizing their promise requires deep understanding and robust regulations. Developing LBPs poses unique challenges due to the dynamic nature of live microorganisms. Despite these challenges, recent progress fueled by extensive research offers optimism for transformative medical advancements. Don’t miss this opportunity to gain cutting-edge perspectives on the future of microbiome-based therapies and their profound implications for modern medicine.
10:45
From Fecal Transplants to A New Class of Therapeutics
Alexander Khoruts, MD, Professor of Medicine, Division of Gastroenterology, Hepatology and Nutrition, University of Minnesota (Supported by Veltek)
11:15
Developing Live Biotherapeutic Products in a Regulated Environment: Is It Conducting a Well-Arranged Orchestra or Taming an Unpredictable Jungle?
Sathya Janardhanan, Vice President, Development and Manufacturing, Rise Therapeutics
11:45
Q&A
12:15 – 13:45
Networking Lunch and Poster Presentations in the Exhibit Hall
13:45 – 15:15
Concurrent Sessions
A1: Biofilms: Unmasking the Real Culprit in Contamination Events and Its Removal
Moderator: Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK
Join us for an insightful session on tackling the challenges of biofilms in contamination control. Biofilms pose a serious threat, but are often over attributed as the root cause of contamination events.
Through two compelling case studies, we’ll demonstrate how to improve investigation techniques, accurately identify biofilm as the root cause, and streamline corrective actions. Subsequently, we’ll assess the effectiveness of traditional cleaning agents in the actual removal of biofilms from various surfaces, providing you with practical solutions to maintain and improve a clean and safe environment.
13:45 | The Havoc of Non-Existent Biofilms
Jonathan W. Kallay, Scientific Portfolio Specialist, Charles River Laboratories
14:10 | Removal of Biofilm with Cleaning Agents in Pharmaceutical Processes
- Kirsten Høstgaard-Jensen, Senior Principal Scientist, Novo Nordisk
- Thomas B. Rasmussen, Principal Scientist, Novo Nordisk
14:35 | Q&A
B1: Understanding the Challenges and Enhancing Validation Strategies for Rapid and Alternative Microbiological Methods: Insights from PDA TR-33 and FDA CDER
Moderator: Lori Daane, PhD, Chief Scientific Officer, Bionique Testing Laboratories
Short shelf-life products and continuous manufacturing for small and large molecule drugs necessitate the need to shift to alternative and rapid microbiological methods. The implementation of such methods has gained traction among stakeholders and regulatory authorities. Significant challenges in validating these new methods arise when they yield data that differs from traditional methods. Regulatory authorities are keen to understand and address these performance challenges.
This session focuses on the most critical updates to PDA Technical Report 33: Evaluation, Validation, and Implementation of Alternative and Rapid Microbiological Methods, and how stakeholders can practically apply the recommendations when validating alternative methods. The FDA will present a case study on an ATP-based rapid microbial method for biologic drug quality assessment, offering practical insights for CDER-regulated products.
13:45 | A New Guidance on the Validation of Rapid and Alternative Microbiological Methods
- Michael J. Miller, PhD, President, Microbiology Consultants, LLC
14:15 | ATP-Based Rapid Microbial Methods for Product Quality Assessment of Biologic Drug Products
- Talia Faison, Research Scientist, OPQ, CDER, U.S. FDA
14:40 | Q&A
C1: Challenges and Opportunities for Objectionables and Microbial Limits Testing
Moderator: Daniel Bice, Associate Director Microbiologist Quality Compliance, Teva
Tackle the challenges associated with assessing and controlling objectionable microorganisms in non-sterile drug products.
We kick off this session with an engaging, interactive case study highlighting the need for updated practices, drawing from recent recalls, compliance observations, and microbial characteristics studies.
Additionally, we will explore the development of alternative procedures for microbial limits testing of novel dosage forms not covered by standard USP protocols. Practical insights and recommendations will be shared, equipping you with the tools and knowledge necessary to address microbial control effectively in non-sterile drug products.
13:45 | A Contemporary Case Study in the Evaluation of Objectionable Microorganisms
- Edward C. Tidswell, PhD, Executive Director QA, Merck & Co., Inc.
14:15 | Developing Alternative Procedures for Microbial Limits Testing of Novel Dosage Forms
- Julia Marre, PhD, Principal Consultant, NSF Life Sciences
14:40 | Q&A
15:15 – 16:00
Networking Break and Poster Presentations in the Exhibit Hall
16:00 – 17:30
Concurrent Sessions
A2: Contamination Control Strategy: Guarding Against Contamination
Moderator: Frederic B. Ayers, Senior Consultant – Microbiology, ValSource, Inc.
Developing a robust microbial control strategy is essential for the production of small molecule parenteral products. This session will provide a comprehensive overview of the key components of an effective microbial control strategy, from contamination prevention to detection and response. Experts will share best practices for integrating microbial controls into the overall manufacturing process, ensuring that all potential sources of contamination are identified and managed. In the era of big data, the ability to effectively analyze and utilize microbial data is crucial for ensuring product safety and compliance. This session will delve into advanced techniques for microbial data analysis, including the latest tools and methodologies for data visualization, interpretation, and application. Attendees will learn how to transform raw microbial data into actionable insights that can drive decision-making and improve microbial control strategies.
16:00 | Building a Holistic Microbial Control Strategy for Small Molecule Parenterals
Lindsey Silva, PhD, Director Microbiology, Genentech, a Member of the Roche Group
16:25 | Making the Most of Your Microbial Data: The Importance of Microbial Identification
Michael Loewenstein, VP, Sicientific Consulting, Q Laboratories
16:50 | Q&A
B2: Sterile Manufacturing: Challenges, Novel Technologies, and Regulatory Considerations
Moderator: Vineeta A. Pradhan, PhD, Microbiologist, ONADE, CVM, U.S. FDA
Join us for a deep dive into the various aspects of sterile manufacturing!
Through a detailed case study, you’ll learn about the current challenges identifying a contamination source and the efforts to assign a probable root cause. An FDA representative will then provide insights into regulatory recommendations for current Good Manufacturing Practices (CGMP) to support drug product quality in the post-COVID era. Explore cutting-edge, new technologies and sterilization modalities that will likely enable the conversion of aseptically filled products to be terminally sterilized.
16:00 | Difficulty in Isolating the Contamination Source and Subculturing of a Single Positive Aseptic Processing Simulation Unit
Marcia C. Baroni, MBA, Vice President Enterprise GxP Compliance & Systems, Emergent BioSolutions
16:20 | Microbial Cross-Contamination Control Concerns of Drug Product Filling Lines Post-COVID: An FDA Perspective
Maria Gutierrez-Hoffmann, PhD, Microbiologist, OPQ, CDER, U.S. FDA
16:40 | Evaluation of New Sterilization Modalities that Enable Terminal Sterilization of Parenteral/Injectable Drug Products Traditionally Filled by Aseptic Manufacturing
Terrence Hollis, Global Technology and Engineering, Pfizer Inc.
17:00 | Q&A
C2: Endotoxins in Theory and Practice: Exploring Structure and Detection
Moderator: Josh Eaton, MS, Senior Director, Scientific and Regulatory Affairs, PDA
The detection of endotoxins in complex formulations is a persistent pain point for pharmaceutical manufacturing. Dive into the impact of the variable molecular structure of endotoxins on detection and recovery and the challenges faced in preserving pharmaceutical quality control and safety in compounded medications.
16:00 | Structural Diversity of Lipopolysaccharides Influences Endotoxin Detection and Low Endotoxin Recovery
Luisa Burgmaier, MA, PhD Student, Microcoat Biotechnologie GmbH
16:25 | Implementation of a Recombinant Factor C Technology for Endotoxin Testing at a 503b Compounding Facility
Katie Carroll, Manager, QC Microbiology, QuVa Pharma
16:50 | Q&A
17:30 – 18:30
Networking Reception in the Exhibit Hall
08:00 – 17:45
Registration Open
08:00 – 09:00
Continental Breakfast
09:00 – 10:15
P3: Exploring the Legacy of CAR T Cells
Moderator: Anna F. Lau, PhD, D(ABMM), Chief, Sterility Testing Service, National Institutes of Health (NIH)
Join us for a captivating exploration of CAR T cells, tracing their origins from Dr. Steven Rosenberg’s pioneering work nearly 50 years ago to their widespread impact today.
In this session, Dr. Stephanie Goff, a physician-scientist on the frontlines of Phase I clinical trials at the NIH, shares firsthand accounts of trials and tribulations, the patient journey, and patient wins and losses. She will also report on how the NCI Surgery Branch team utilizes cutting-edge clinical science and basic research in a bench-to-bedside cycle to identify innovative treatment options. Dr. Goff’s expertise in cell-based immunotherapy, particularly in metastatic breast cancer and melanoma, promises an enlightening glimpse into the future of treatment options
09:00
Groundbreaking Discoveries at the NIH and Future Innovations for Cellular Therapies
Stephanie L. Goff, MD, Senior Research Physician, Surgery Branch, CCR, NCI, National Institutes of Health (NIH)
09:45
Q&A
10:15 – 16:15
Exhibit Hall Open
10:15 – 11:00
Networking Break and Poster Presentations in the Exhibit Hall
11:00 – 12:30
Concurrent Sessions
A3: Keep the Microbes Out by Implementing an Appropriate Contamination Control Strategy
Moderator: Vineeta A. Pradhan, PhD, Microbiologist, ONADE, CVM, U.S. FDA
Applying the principles of Quality Risk Management (QRM) as part of the Contamination Control Strategy (CCS) is a clear regulatory expectation, particularly for the manufacturing of sterile products, as stated in EU GMP Annex 1. Gain practical understanding of the risk management of two CCS elements -- personnel monitoring and premises -- to identify, assess, reduce, and control product contamination risk. The first case study provides an example of how to incorporate a risk-based approach into a global personnel monitoring program. It will demonstrate how the strategy can be used across a range of production facilities. The second case study will discuss contamination prevention by separating personnel from process and product through the introduction of barrier technologies for the manufacturing of ATMPs.
11:00 | Design of a Global Risk-Based Personnel Monitoring Assessment for a Multi-Production Operation Company
Luyen T. Nguyen, Global Sterility Assurance and Microbiology Lead, Takeda
11:25 | Contamination Control in GMP Aseptic Manufacturing of ATMPs
Hussein Bachir, Dr. rer.nat, Scientist - GMP Compliance, Franz Ziel GmbH
11:50 | Q&A
B3: Case Studies in the Application of Advanced Rapid Technologies for Adventitious Viral Testing, Sterility Testing, and Bioburden Monitoring
Moderator: Anna F. Lau, PhD, D(ABMM), Chief, Sterility Testing Service, National Institutes of Health (NIH)
Over the last decade, modern technologies such as deep sequencing, metagenomics, and Raman spectroscopy have emerged as novel, rapid alternative methods to gold standard, culture-based release testing. Yet, despite their scientific hype and obvious analytical advantages, the implementation of such technologies in real-life settings is often seen as a daunting task and the ultimate pipe dream.
Join us in this session as we put the pipe dream analogy to rest! Three experts in the field are actively applying these advanced technologies as real-life replacements for adventitious viral culture, traditional sterility testing, and bioburden monitoring. Through their case studies, learn about early method developmental studies, method qualification and validation strategies, and machine learning applications. These solutions utilize 1) next-generation sequencing for viral detection in mammalian host cells; 2) long read nanopore amplicon sequencing with machine learning for unbiased metagenomics for bacterial and fungal detection in T cell cultures; and, 3) Raman spectroscopy for in-line, continuous, quantitative bioburden monitoring during API manufacturing.
11:00 | Application of Next-Generation Sequencing in Adventitious Virus Detection
Nasrin Salehi, Senior Principal Scientist, Pfizer Inc.
11:20 | Machine Learning-Based Detection of Adventitious Agents in T-Cell Therapy Cultures Using Long Read Sequencing
Charles Swofford, Assistant Director, Biomanufacturing Initiatives, MIT Center for Biomedical Innovation
11:40 | Hands Free Detection of Microbial Contamination During Biopharmaceutical API Manufacturing Using Raman Spectroscopy as PAT tool
Karin Balss, PhD, Scientific Fellow, Janssen Pharmaceuticals
12:00 | Q&A
C3: Monocyte Activation Test: A Human(e) Alternative for Pyrogen Testing
Moderator: Simleen Kaur, MSc, Biologist, Team Lead, OCBQ, CBER, U.S. FDA
Dive into pyrogen testing to review how traditional methods face new challenges in the era of complex biological products.
The compendial rabbit pyrogen test (RPT) is used for the detection of contaminating (fever-causing) pyrogens in parenteral preparations by measuring temperature changes in rabbits following intravenous administration of the test product. It has been the gold standard based on the physiological similarities of rabbits to humans. However, as modern therapeutics have evolved to include RNA-based treatments and novel adjuvants, the RPT often yields inconclusive results due to extraneous inflammatory responses,
The monocyte activation test (MAT), a cutting-edge alternative approach, uses human-derived monocytes to mimic the fever response to pyrogens and provides quantitative data in a system that measures human inflammatory responses. As a more humane approach, MAT also aligns with the ongoing 3Rs initiative aiming to reduce, refine, and replace animal use testing.
Join us on an in-depth exploration of MAT development and implementation, revealing its role in the safety and efficacy of testing innovative products that challenge the conventional RPT
11:00 | Establishment of the Monocyte Activation Test as a Replacement of the Rabbit Pyrogen Test: A Roadmap
Maria Gajewi, Manager Endotoxin Services, Microcoat Biotechnologie GmbH
11:25 | Pyrogen Testing Approaches to Ensure RNA-LNP Product Safety
Mohamad Toutounji, PhD, QC Technical Expert_NL, Lonza
11:50 | Q&A
12:30 – 14:00
Networking Lunch and Poster Presentations in the Exhibit Hall
14:00 – 15:30
Concurrent Sessions
A4: Navigating Batch Disposition After a Bioburden Excursion and Cannabis Quality Consideration
Moderator: Frederic B. Ayers, Senior Consultant – Microbiology, ValSource, Inc.
Join us for a landmark session on biologic manufacturing and cannabis-derived products.
Biologic manufacturing processes are highly susceptible to microbial growth. Learn the importance of rigorous contamination control and in-process monitoring to prevent issues related to microbial impurities. For example, when bioburden limit excursions occur, the impact of microbial by-product impurities can be unclear. The process’s ability to remove these impurities is rarely known, and there is no routine analytical detection strategy covering the full range of microbial impurities.
The FDA has seen a significant rise in human research applications for cannabis and cannabis-derived products encompassing various dosage forms, administration routes, and therapeutic areas. Gain insights into the non-sterile cannabis and cannabis-derived dosage forms, production requirements, and how to meet investigational new drug (IND) requirements and standards used in human clinical research.
14:00 | To Release or Not to Release? Microbial Impact Assessment of Bioburden Limit Excursions
- Cheryl Essex, Head of Contamination Control, R&D Global Quality, Sanofi
- Friedrich von Wintzingerode, PhD, Microbiology and QC Lead, Individualized and Cell Therapy, PTC, Genentech, a Member of the Roche Group
14:25 | Getting into the Weeds: Microbiological Quality Considerations for Non-Sterile Cannabis Intended for Use in Clinical Studies/Trials
Marla Stevens-Riley, Supervisory Microbiologist, OPQ, CDER, U.S. FDA
14:55 | Q&A
B4: Annex 1: Interpretation, Implementation, and Effective Compliance
Moderator: Dawn M. Watson, Executive Director, Micro Quality & Sterility Assurance, Merck & Co., Inc.
Annex 1 became effective in August 2023, with a key focus on the management of contamination risks. “One of the greatest potential sources of contamination” in cleanrooms as per Annex 1 is the transfer of equipment and materials. During this session, we will review key aspects of material transfer validation. Case studies highlighting critical factors associated with the material transfer process and how to objectively analyze the hazards to determine the risk for each factor will be shared. Best practice recommendations and options for the most efficient material transfer methods in compliance with Annex 1 will also be covered.
Additionally, this session will address the risks related to the implementation of single-use systems that are part of closed systems. Annex 1 now includes guidance specific to these systems and introduces the phrase: “intrinsic sterile connection device.” These devices can be used to connect previously sterilized, single-use systems in Grade C and D environments. Join us to explore the results of an industry survey on these innovative devices and receive expert recommendations for validation of intrinsic sterile connection devices.
14:00 | "Intrinsic Sterile Connection Devices": New Language in Annex 1 Supporting Sterile Connections of Single-Use, Closed Systems
William Peterson, Associate Director, Global QA, Merck & Co., Inc.
14:20 | Annex 1: Contamination Control Strategy for Material Transfer in the Aseptic Area: Best Practice for Packaging and Surface Disinfection
Renee Buthe, Technical Services Manager, STERIS Corporation
14:40 | Case Study: A Risk-Based Approach to Material Transfer Validation
Liz Brockson, Aseptic Processing and Sterility Assurance Lead, Takeda
15:00| Q&A
C4: Quality by Design Begins with Testing
Moderator: Julia Marre, PhD, Principal Consultant, NSF Life Sciences.
Ready to manufacture a quality drug product? Master Quality by Design principles to design the drug product and the manufacturing process. It all begins with testing!
Join this session to explore tests used to understand microbial quality concerns of both the drug product and the manufacturing process. We’ll cover critical topics such as integrity testing of the container closure system and testing of the bulk solution for bioburden during the manufacturing process.
14:00 | Considerations for Pre-Sterilization Bulk Solution Bioburden Analysis: Limits, Identification, and Microbial By-Products
Stephen E. Langille, PhD, Senior Microbiology Consultant, ValSource, Inc.
14:30 | Container Closure Integrity Test (CCIT) for Sterile Products
Yan Zheng, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA
14:55 | Q&A
15:30 – 16:15
Networking Break, Passport Drawing, and Poster Presentations in the Exhibit Hall
16:15 – 17:45
Concurrent Sessions
A5: Innovative Strategies in Mold and Microbial Remediation
Moderator: Jason L. Willett, Midwest Manager,Veltek Associates, Inc.
Explore the limitations of common mold investigation methods and the differences between remediation techniques used in the pharma/biotech industry and those in the cleaning and restoration sector.
We’ll examine the complexities of contamination remediation and discuss the importance of science-based corrective actions to move beyond prescriptive methods for remediation.
The session will conclude with a panel Q&A featuring our esteemed presenters, offering you the chance to engage directly with industry experts. Don’t miss this engaging session packed with valuable insights on mold and microbial remediation.
16:15 | Growth in the Workplace: Assessment of Restoration Industry Standards for Complete Mold Remediation in the Pharmaceutical Cleanroom
- Amanda Curtis, Microbiology Consultant, ValSource, Inc.
16:40 | Microbial Mischief: Navigating Remediation Challenges
Ziva Abraham, PhD, CEO, Microrite, Inc.
17:10 | Q&A
B5: Pharmacy Compounding – Best Practices for Quality Preparations
Moderator: Erika A. Pfeiler, PhD, Supervisory Microbiologist, OPQ, CDER, U.S. FDA
Pharmacy compounding plays a critical role in meeting drug supply needs in the United States. Updates to FDA regulations and USP chapters require many compounders to familiarize themselves with new requirements while working to meet increased demand for their preparations.
Gain insights on how to understand and meet these new requirements from both a technical and a regulatory perspective. Deepen your understanding of microbiology lab best practices for sterile compounders and hear updates from the U.S. FDA regarding the intersection of compounding with both FDA-approved drugs and those in clinical trials. Following the presentations, a question-and-answer period with the experts will address the audience’s questions about best practices for these crucial medicines.
16:15 | Incubators = Lab: Applying USP <1117> to the Sterile Compounding Microbiology Lab
Abby A. Roth, CME/OE, Owner/Microbiologist, Pure Microbiology, LLC
16:45 | Pharmacy Compounding and FDA Regulated Drugs: A CDER Microbiologist’s Perspective
John W. Metcalfe, PhD, Master Microbiology Reviewer, OPQ, CDER,U.S. FDA
17:15 | Q&A
C5: The Vital Impact of Training on Industry Excellence
Moderator: Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control,GSK
Without effective training, the ability to navigate complex procedures, foster innovation, and ensure operational efficiency is compromised. Training also ensures continuous improvement and ethical responsibility. Ultimately, investing in training not only mitigates legal and financial risks but also reinforces the industry's commitment to deliver safe, effective medication to patients. This session presents how to train global sterility assurance professionals and explores how to bridge the gap between theory and practice.
16:15 | Sterility Assurance Competency: A Community of Practice and Training Program that Actively Develops and Promotes Best Demonstrated Practice Through Science and Engineering
Ken Paddock, Quality Director, Sterility Assurance, Baxter Healthcare
16:40 | Beyond Read and Understand: Building a Curriculum that Supports Working in a Cleanroom Environment
David Talmage, Vice President, Education, PDA
17:05 | Q&A
07:30 – 12:30
Registration Open
07:30 – 09:00
Continental Breakfast
07:45 – 08:45
Breakfast Session: USP Updates
Moderator: Lori Daane, PhD, Chief Scientific Officer, Bionique Testing Laboratories
Don’t miss this exclusive opportunity to dive deeply into USP documents and their timelines with guidance from the chair of the USP Microbiology Expert Committee! This session will provide an overview of key components including monographs, general chapters, and general notices. Gain valuable insights into the journey of producing a document, from the commenting period to its publication and eventual implementation.
Following the presentation, participate in an interactive Q&A panel with members of the USP Microbiology Expert Committee. Explore technical nuances and seek clarification on recent chapters (including 72, 73, 86, and 1119).
Take advantage of this opportunity to enhance your comprehension of USP standards and processes.
07:45
Overview of the USP Standard Setting Process and Summary of Microbiology Chapters Under Development
Mark G. Schweitzer, PhD, Principal, Mark Schweitzer Consulting LLC
08:15
Q&A Panel Discussion with the USP Microbiology Expert Committee
- Leslie Furr,Associate Scientific Liason, USP
- Brandye Michaels, PhD, Senior Director, Microbiology Strategy and Testing, Pfizer
- Marsha Steed, Founder & President, Steed MicroBio
- Edward C. Tidswell, PhD, Executive Director QA, Merck & Co., Inc.
- Huiping Tu, PhD, Senior Principal Scientist, Compendial Science and Standards, USP
- Friedrich von Wintzingerode, PhD, Microbiology and QC Lead, Individualized and Cell Therapy, PTC, Genentech, a Member of the Roche Group
09:00 – 10:00
P4: Microbial Biofilms: Resistant Enemies and Hidden Threats
Moderator: Simleen Kaur, MSc, Biologist, Team Lead, OCBQ, CBER, U.S. FDA
Many labs face the same challenge: microbial biofilm formation on environmental surfaces. With most microbiologic tests relying on simple methods (e.g., test tubes and agar plates), it is important to consider how microbial biofilms may impact the applicability and accuracy of said testing.
This session will share illuminating and shocking discoveries about microbial biofilms and their role in medical device-associated infections (e.g., endoscopes, contact lenses, dermal fillers, orthopedic implants, etc.). Participants will gain insight into improved test methods, method failures, the biological mechanisms behind antimicrobial resistance and persistent microbial threats, and the implications for pharmaceutical microbiology.
09:00
Biofilms: A Microbial Paradigm Shift
CDR Kenneth Phillips, PhD, USPHS, Chief, Laboratory of Analytical Chemistry, OCBQ, CBER, U.S. FDA
09:30
Q&A
10:00 – 10:45
Networking Break
10:30 – 12:30
P5: Ask the Regulators
Moderator: John W. Metcalfe, PhD, Master Microbiology Reviewer, OPQ, CDER, U.S. FDA and Erika A. Pfeiler, PhD, Supervisory Microbiologist, OPQ, CDER, U.S. FDA
Seize
the opportunity to engage directly with regulators at this interactive closing session. U.S. FDA representatives, including expert field investigators, will share insights and regulatory perspectives on participant-posed questions.
This exclusive open forum is dedicated solely to addressing your microbiological concerns, from sterilization to aseptic processing to compounding, and more.
10:30
Panel Introduction
John W. Metcalfe, PhD, Master Microbiology Reviewer, OPQ, CDER, U.S. FDA
10:45
Panel Discussion and Q&A
- David Besse, PhD, Chemist CMC Reviewer, DMT, CVM, U.S. FDA
- CDR Donald B. Ertel, MS, MT (ASCP), Branch Chief / Program Manager, OCBQ, CBER, U.S. FDA
- Candace Y. Gomez-Broughton, PhD, Supervisory Microbiologist, OPQ, CDER, U.S. FDA
- Tiffany Lucas, PhD, Gene Therapy CMC Reviewer, OTP, CBER, U.S. FDA
- Simone E. Pitts, MS, National Expert, Pharmaceutical, ORA, U.S. FDA
- Timothy Pohlhaus, Consumer Safety Officer, OMQ, CDER, U.S. FDA
12:25
Closing Remarks from the PDA Pharmaceutical Microbiology Conference 2025 Co-Chairs
PDA Alternative Microbiological Methods Workshop 2024
09 Oct - 10 Oct
Activities and Networking Opportunities
Connect and Collaborate
Monuments by Moonlight Trolley Tour
See DC’s most popular monuments in a different light! On the Monuments by Moonlight Trolley Tour, be transported to many of the city’s most famous sights while enjoying the tranquil night and evening breeze.
Date and Time
Tuesday, 08 October / 18:45 – 21:00 ET
Cost
$52 per person, includes private trolley tour and professional live tour guide.
Limit
35 people Max.
Note
A jacket or sweater is recommended as evening temperatures can dip as low as 55°F (13°C)
About This Tour
See DC’s most popular monuments in a different light! On the Monuments by Moonlight Trolley Tour, be transported to many of the city’s most famous sights while enjoying the tranquil night and evening breeze. Along the way, a professional tour guide will take you back in time as they share historic tales and anecdotes about the city’s fascinating history. Learn about the curse of the Hope Diamond and its legacy of death and despair and hear about the Medal of Honor winner who donated his amputated leg to a museum (and often visited it!). You haven’t seen DC until you’ve seen it at night!
Monuments include the Franklin Delano Roosevelt Memorial, the Korean War Veterans Memorial, the Lincoln Memorial, the Marine Corps War Memorial, the Martin Luther King, Jr. Memorial, the Thomas Jefferson Memorial, the United States Capitol, the Vietnam Veterans Memorial, and the Washington Monument.
Timeline
- 18:45 Tour participants meet PDA staff in the Grand Hyatt Washington Lobby
- 19:00 Tour departs from the Grand Hyatt Washington
- 21:00 Tour returns to the Grand Hyatt Washington
Program Planning Committee
The Team Behind the Event's Agenda
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Anna Lau, PhD, D(ABMM)
National Institutes of Health (NIH)
Chief, Sterility Testing Service
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Location and Travel
Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Conference Venue & Hotel Accommodations
Grand Hyatt Washington
1000 H Street, NWWashington, DC 20001, United States
Individual reservations cancelled within seventy-two (72) hours prior to arrival will forfeit one night’s room deposit. Individuals will be responsible for payment of their own cancellation fees.
Located near many of DC’s most famous landmarks and museums, Grand Hyatt Washington places you only steps from all the action. Immerse yourself in the iconic sights, unlimited shopping and alluring nightlife of the nation's capital. Whether you're visiting for business or pleasure, you'll enjoy exceptional comfort and service and a direct connection to the city via the Metro Center station.
How to Get Here
Registration
Pricing Options
Standard Registration
Register after 14 August 2024
Member Price
$2,695GovernmentMember Only
$995
Health AuthorityMember Only
$995
Early Career ProfessionalMember Only
$1,495
StudentMember Only
$695
AcademicMember Only
$995
Non-Member
$3,095
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].
Presenters
Meet Our Presenters
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Stephanie Goff, MD
National Institutes of Health (NIH)
Senior Research Physician, Surgery Branch, CCR, NCI
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Alexander Khoruts, MD
University of Minnesota
Professor of Medicine, Division of Gastroenterology, Hepatology and Nutrition
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Charles Swofford, PhD
MIT Center for Biomedical Innovation
Assistant Director, Biomanufacturing Initiatives
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Friedrich von Wintzingerode, PhD
Genentech, a Member of the Roche Group
Microbiology and QC Lead, Individualized and Cell Therapy, PTC
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Promotion and Press
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Exhibitors
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Amplify Your Presence and Reach Your Customers!
Elevate your brand and maximize your exposure by becoming a sponsor at the PDA Pharmaceutical Microbiology Conference 2024! Connect with industry leaders, showcase your products and services, and establish your company as a key player in the field.
Become a SponsorBoost your brand and visibility by becoming an exhibitor at the PDA Pharmaceutical Microbiology Conference 2024! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.
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