PDA Pharmaceutical Microbiology Conference 2024

PDA Pharmaceutical Microbiology Conference 2024

Bridging Science and Compliance

07 Oct - 09 Oct 2024
Grand Hyatt Washington
Washington, DC

Member Appreciation Week: From 10 to 17 June, members save an additional 10% off the already discounted early registration fees and get a 25% discount for specialized training courses surrounding this event.

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Call for Posters

Closing on 30 June 2024

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Highlighted Presenters

Key Presenters
  • Stephanie Goff, MD

    National Institutes of Health (NIH)

    Senior Research Physician, Surgery Branch, CCR, NCI

    Read Bio
  • Alexander Khoruts, MD

    University of Minnesota

    Professor of Medicine, Division of Gastroenterology, Hepatology and Nutrition

    Read Bio
  • Kenneth Phillips, PhD

    U.S. FDA

    Chief, Laboratory of Analytical Chemistry, OCBQ, CBER

    Read Bio

Conference Co-Chairs

The Minds Behind the Insights
  • Kurt Jaecques, MA

    GSK

    Global Aseptic Technologies Lead Monitoring & Control

    Read Bio
  • Erika Pfeiler, PhD

    U.S. FDA

    Supervisory Microbiologist, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER

    Read Bio

Schedule

Discover What's Happening Each Day
Pre-Agenda06 Oct Day 107 Oct Day 208 Oct Day 309 Oct Workshop09 - 10 Oct Training10 Oct

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 Conference Co-Chairs

  • Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK
  • Erika A. Pfeiler, PhD, Supervisory Microbiologist, OPQ, CDER, U.S. FDA

08:40

Lessons Learned from the Design of the International Space Station Water Recycling System: A Microbiologist’s Perspective

  • Monserrate (Monsi) Román, Program Manager, NASA

09:25

Q&A

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

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 (INVITED)

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, Associate Director, Scientific and Regulatory Affairs, Pocket Naloxone Corp.

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.

Contamination control is paramount in pharmaceutical manufacturing to ensure product safety and efficacy. Join us for an engaging session featuring two presentations related to Small Molecule Contamination Control and the threat posed by Ralstonia pickettii in Sterile Medicinal Products.

In the first presentation, we will explore the intricate challenges surrounding contamination in small molecule parenterals. Challenges in microbial excursions have been observed for small molecules, due to limited guidance on microbial control for upstream manufacturing with organic solvents and downstream purification / concentration under aqueous conditions.

The second presentation will focus on the presence of Ralstonia pickettii in pharmaceutical environments and systems.  Despite its low prevalence, Ralstonia pickettii has emerged as a persistent contaminant with the potential to jeopardize product safety.

Attendees of this session will have a comprehensive understanding of contamination control in both small molecule parenterals and the challenges posed by Ralstonia pickettii.


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 | Ralstonia Pickettii: An Emerging Threat to Sterile Manufacturing Associated with Sterile Products Recalls

Rashid I. Kihwelo, Sr., Executive QC Microbiologist, Shelys Pharmaceuticals Ltd

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 with Additional Panelist

Michael R. Shanks, Senior Biologist, OPQ, CDER, U.S. FDA (INVITED)

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 – 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: Heike Merget-Millitzer, PhD, Microbiology CoE Lead, J&J

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 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 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, Principal Scientist, Pfizer Inc.

11:20 | Machine Learning-Based Detection of Adventitious Agents in T-Cell Therapy Cultures Using Long Read Sequencing

Charley 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, 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 the Intersection of Non-Sterile Production Release 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

  • 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 K. Stevens-Riley, Supervisory Microbiologist, OPQ, CDER, U.S. FDA (INVITED)

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, Associate Director, Scientific and Regulatory Affairs, Pocket Naloxone Corp.

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 (INVITED)

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.
  • Lawrence Curtis, Independent Consultant

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 (INVITED)

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 Micro Expert Committee

  • Liliana Gamboa, MSc, Head of Microbiological Control, Sanofi (INVITED)
  • Jessica V. Hankins, PhD, Associate Scientific Director, Bristol Myers Squibb (INVITED)
  • Brandye Michaels, Senior Director, Microbiology Strategy and Testing, Pfizer (INVITED)
  • Edward C. Tidswell, PhD, Executive Director QA, Merck & Co., Inc.

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
  • Sandra A. Boyd, Drug National Expert, OMPTO, ORA, 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
  • Brooke K. Higgins, MS, Acting Branch Chief, OC, CDER, U.S. FDA
  • Tiffany Lucas, PhD, Gene Therapy CMC Reviewer, OTP, CBER, U.S. FDA

12:25

Closing Remarks from the PDA Pharmaceutical Microbiology Conference 2025 Co-Chairs

Activities and Networking Opportunities

Connect and Collaborate
Tuesday, 08 October 2024

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 Westin Washington, DC Downtown lobby
  • 19:00 Tour departs from Westin Washington, DC Downtown
  • 21:00 Tour returns to Westin Washington, DC Downtown

Program Planning Committee

The Team Behind the Event's Agenda
  • Frederic Ayers

    ValSource, Inc.

    Senior Consultant - Microbiology

    Read Bio
  • Daniel Bice

    Teva

    Associate Director Microbiologist Quality Compliance

    Read Bio
  • Lori Daane, PhD

    Bionique Testing Laboratories

    Chief Scientific Officer

    Read Bio
  • Kurt Jaecques, MA

    GSK

    Global Aseptic Technologies Lead Monitoring & Control

    Read Bio
  • Simleen Kaur, MSc

    U.S. FDA

    Biologist, Team Lead, OCBQ, CBER

    Read Bio
  • Anna Lau, PhD, D(ABMM)

    National Institutes of Health (NIH

    Chief, Sterility Testing Service

    Read Bio
  • Julia Marre, PhD

    Pocket Naloxone Corp.

    Associate Director, Scientific and Regulatory Affairs

    Read Bio
  • Heike Merget-Millitzer, PhD

    J&J

    Microbiology CoE Lead

    Read Bio
  • Erika Pfeiler, PhD

    U.S. FDA

    Supervisory Microbiologist, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER

    Read Bio
  • Vineeta Pradhan, PhD

    U.S. FDA

    Microbiologist, ONADE, CVM

    Read Bio
  • Dawn Watson

    Merck & Co., Inc.

    Executive Director, Micro Quality & Sterility Assurance

    Read Bio
  • Jason Willett

    Veltek Associates, Inc.

    Midwest Manager

    Read Bio

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

Cancellation Policy
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.
Grand Hyatt Washington

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.

  • Rate: $335+ plus applicable taxes and fees
  • Room Block Opens: Monday, 10 June 2024
  • Cut-Off Date: Friday, 06 September 2024
How to Get Here
By Air The Grand Hyatt Washington is accessible from three major airports: Ronald Reagan Washington National Airport (DCA - approx. 4 miles/6 km), the Washington Dulles International Airport (IAD - approx. 25 miles/40 km), and the Baltimore/Washington International Thurgood Marshall Airport (BWI - approx. 32 miles/51 km).
By Car The Grand Hyatt Washington is located at 1000 H Street, NW, Washington, DC 20001. Both self-parking ($12-45/day) and valet parking ($34-65/day) are available.
By Other Options The Grand Hyatt Washington is easily accessible from the Metro Center Metro stop (Blue, Orange, Red, and Silver Lines - Grand Hyatt/Hotel exit).

Registration

Pricing Options

Early Registration

Register by 14 August 2024

Member Price

$2,195

GovernmentMember Only

$895

Health AuthorityMember Only

$895

Early Career ProfessionalMember Only

$1,395

StudentMember Only

$595

AcademicMember Only

$895

Non-Member

$2,595

Standard Registration

Register after 14 August 2024

Member Price

$2,695

GovernmentMember Only

$995

Health AuthorityMember Only

$995

Early Career ProfessionalMember Only

$1,495

StudentMember Only

$695

AcademicMember Only

$995

Non-Member

$3,095

See Qualifying Criteria for Member Types.

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 registration@pda.org.


 

Presenters

Meet Our Presenters
  • Ziva Abraham, PhD

    Microrite, Inc.

    CEO

    Read Bio
  • Hussein Bachir, Dr. rer.nat

    Franz Ziel GmbH

    Scientist - GMP Compliance

    Read Bio
  • Karin Balss, PhD

    Janssen Pharmaceuticals

    Scientific Fellow

    Read Bio
  • Marcia Baroni, MBA

    Emergent BioSolutions

    VP Quality, Enterprise GxP Compliance & Systems

    Read Bio
  • David Besse, PhD

    U.S. FDA

    Chemist CMC Reviewer, DMT, CVM

    Read Bio
  • Sandra Boyd

    U.S. FDA

    Drug National Expert, OMPTO, ORA

    Read Bio
  • Liz Brockson, MPH VPH

    Takeda

    Aseptic Processing and Sterility Assurance Lead

    Read Bio
  • Luisa Burgmaier, MA

    Microcoat Biotechnologie GmbH

    PhD Student

    Read Bio
  • Renee Buthe

    STERIS Life Sciences

    Technical Services Specialist

    Read Bio
  • Katie Carroll

    QuVa Pharma

    Manager, QC Microbiology

    Read Bio
  • Amanda Curtis

    ValSource, Inc.

    Microbiology Consultant

    Read Bio
  • Lawrence Curtis

    Independent Consultant

    Read Bio
  • CDR Donald Ertel, MS, MT (ASCP)

    U.S. FDA

    Branch Chief / Program Manager, OCBQ, CBER

    Read Bio
  • Cheryl Essex, MSc

    Sanofi

    Head of Contamination Control, R&D Global Quality

    Read Bio
  • Talia Faison

    U.S. FDA (INVITED)

    Research Scientist, OPQ, CDER

    Read Bio
  • Maria Gajewi

    Microcoat Biotechnologie GmbH

    Manager Endotoxin Services

    Read Bio
  • Photo coming soon

    Liliana Gamboa, MSc

    Sanofi (INVITED)

    Head of Microbiological Control

    Bio Coming Soon
  • Stephanie Goff, MD

    National Institutes of Health (NIH)

    Senior Research Physician, Surgery Branch, CCR, NCI

    Read Bio
  • Candace Gomez-Broughton, PhD

    U.S. FDA

    Supervisory Microbiologist, OPQ, CDER

    Read Bio
  • Maria Gutierrez-Hoffmann, PhD

    U.S. FDA (INVITED)

    Pharmaceutical Scientist, OPQ, CDER

    Read Bio
  • Jessica Hankins, PhD

    Bristol Myers Squibb (INVITED)

    Associate Scientific Director

    Read Bio
  • Brooke Higgins, MS

    U.S. FDA

    Branch Chief, OC, CDER

    Read Bio
  • Terrence Hollis

    Pfizer Inc.

    Global Technology and Engineering

    Read Bio
  • Kirsten Høstgaard-Jensen, PhD

    Novo Nordisk

    Senior Principal Scientist

    Read Bio
  • Photo coming soon

    Sathya Janardhanan

    Rise Therapeutics

    Vice President, Development and Manufacturing

    Read Bio
  • Jonathan Kallay

    Charles River Laboratories

    Scientific Portfolio Specialist

    Read Bio
  • Alexander Khoruts, MD

    University of Minnesota

    Professor of Medicine, Division of Gastroenterology, Hepatology and Nutrition

    Read Bio
  • Rashid Kihwelo

    Shelys Pharmaceuticals Ltd

    Executive QC Microbiologist

    Read Bio
  • Stephen Langille, PhD

    ValSource, Inc.

    Senior Microbiology Consultant

    Read Bio
  • Tiffany Lucas, PhD

    U.S. FDA

    Gene Therapy CMC Reviewer, OTP, CBER

    Read Bio
  • Julia Marre

    Pocket Naloxone Corp

    Read Bio
  • John Metcalfe, PhD

    U.S. FDA

    Master Microbiology Reviewer, OPQ, CDER

    Read Bio
  • Photo coming soon

    Brandye Michaels

    Pfizer (INVITED)

    Senior Director, Microbiology Strategy and Testing

    Bio Coming Soon
  • Michael Miller, PhD

    Microbiology Consultants, LLC

    President

    Read Bio
  • Luyen Nguyen

    Takeda

    Global Sterility Assurance and Microbiology Lead

    Read Bio
  • Ken Paddock

    Baxter Healthcare

    Quality Director, Sterility Assurance

    Read Bio
  • William Peterson

    Merck & Co., Inc.

    Associate Director, Global QA

    Read Bio
  • Kenneth Phillips, PhD

    U.S. FDA

    Chief, Laboratory of Analytical Chemistry, OCBQ, CBER

    Read Bio
  • Thomas Rasmussen, PhD

    Novo Nordisk

    Principal Scientist

    Read Bio
  • Abby Roth, CMQ/OE

    Pure Microbiology, LLC

    Owner/Microbiologist

    Read Bio
  • Nasrin Salehi

    Pfizer Inc.

    Senior Principal Scientist

    Read Bio
  • Mark Schweitzer, PhD

    Mark Schweitzer Consulting LLC

    Principal

    Read Bio
  • Michael Shanks

    U.S. FDA (INVITED)

    Senior Biologist, OPQ, CDER

    Read Bio
  • Lindsey Silva, PhD

    Genentech, a Member of the Roche Group

    Director Microbiology

    Read Bio
  • Photo coming soon

    Marla Stevens-Riley, PhD

    U.S. FDA (INVITED)

    Supervisory Microbiologist, OPQ, CDER

    Read Bio
  • David Talmage, MBA

    PDA

    Vice President, Education

    Read Bio
  • Edward Tidswell, PhD

    Merck & Co., Inc.

    Executive Director QA

    Read Bio
  • Photo coming soon

    Mohamad Toutounji

    Lonza

    QC Technical Expert_NL

    Read Bio
  • Friedrich von Wintzingerode, PhD

    Genentech, a Member of the Roche Group

    Microbiology and QC Lead, Individualized and Cell Therapy, PTC

    Read Bio
  • Yan Zheng, PhD

    U.S. FDA (INVITED)

    Senior Pharmaceutical Quality Assessor, OPQ, CDER

    Read Bio

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