13th Annual PDA Global Conference on Pharmaceutical Microbiology

8:00 a.m. – 9:45 a.m.
P1: The New Frontier of Personalized Medicine: Regulatory Expectations and Microbiological Challenges
EU Moderator: Kerstin Wilken, PhD, PMP, Director, Programs and Education, PDA Europe
US Moderator: Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company

Imagine using your own body’s cells to cure cancer – the idea has recently been made tangible and has been shown to be successful with new discoveries in the field of immuno-oncology. CAR T (Chimeric Antigen Receptor T-Cell) therapy is a novel cellular therapy that supercharges a patient’s own immune system T-cells and programs them to attack designated cancer cells in the body. Significant challenges with facility design, room classification, manufacturing, testing, and regulatory approval have been brought forth as several of these personalized “living drug” therapies have achieved commercialization. This opening plenary session will explore CAR T product manufacturing challenges from an industry perspective and discuss regulatory challenges for commercialization as well as the use of non-compendial microbiology methods.

10:15 a.m. – 11:45 a.m.
P2: Current Regulations in EU and US
EU Moderator: Michael J. Miller, PhD, President, Microbiology Consultants, LLC
US Moderator: Julie Barlasov-Brown, MBA, Associate Director Sterile and Microbiology QA, Merck & Co., Inc.

Current regulatory and inspection trends will be the focus of this very popular session and this year we are fortunate to simulcast presentations from both European and FDA representatives. Renowned MHRA microbiology expert and GMP inspector, Andrew Hopkins, will provide an update on the long-awaited revision to Annex 1, Manufacture of Sterile Medicinal Products. Justin Boyd, an investigator in the Office of Regulatory Affairs with FDA's Team Biologics will present an overview of recent investigational findings and discuss some of the most significant non-compliance issues facing the industry.

A1: The Trouble with Sterility
Moderator: Edward Tidswell, PhD, Executive Director, Microbiology QA, Merck & Co., Inc.    

Sterility is an absolute and binary concept – we categorize therapeutics either sterile or non-sterile. Yet the modality of imparting sterility, sterile manufacturing, and the method of proving sterility remain challenging and possibly one of the greatest potential risks to patient safety. Regulatory expectations, compliance observations, and the cadre of contemporary microbiological tools all used to assure sterility will be discussed to provide a picture of how to avoid trouble with sterility.         

1:30 p.m. – 2:00 p.m.
Avoiding Regulatory Trouble with Sterility: Drug Product Sterilization
Stephen E. Langille, PhD, Acting Division Director, Division of Microbiology Assessment, CDER, FDA

2:00 p.m. – 2:30 p.m.
The Problem with Sterility: Aseptic Processing, The Things We Don’t Talk About (Enough)
Hal Baseman, Chief Operating Officer, ValSource LLC

2:30 p.m. – 3:00 p.m.
The Problem with Sterility: Aseptic Processing, The Open Flaw in Using Humans in Your Critical Process
David Keen, Senior Global Microbiology Consultant, ECOLAB LIFE SCIENCES

3:00 p.m. – 3:30 p.m.
Questions and Answers/Discussion

A2: Microbial Control
Moderator: Amy McDaniel, PhD, Microbiologist, CDER, FDA

4:15 p.m. – 4:45 p.m.
What’s in Your Equipment?
Cheryl Essex, Head of Biologics Microbiological Control, Sanofi

4:45 p.m. – 5:15 p.m.
Bioburden Intensity: An Integrated Approach to Environmental Monitoring Data Trending
Austin W. Kuo, Principal Research Scientist - Sterility Assurance, Eli Lilly and Company

5:15 p.m. – 5:45 p.m.
Questions and Answers/Discussion

7:15 a.m. – 8:15 a.m.
Breakfast Roundtable
Moderator: Julie Barlasov-Brown, MBA, Associate Director Sterile and Microbiology QA, Merck & Co., Inc. 
Hosted by the Microbiology/Environmental Monitoring Interest Group

This session will focus on electronic notebooks (ELN), data integrity, and capturing data in the microbiology laboratory. As we move into the future, expectations on data capture and integrity are becoming more of a question. The discussion will focus on how the industry can prepare to meet these expectations as well as what can be done at the laboratory level to provide excellent product quality.

Tessa Patton will provide a presentation on the implementation of ELN at Eurofins Lancaster Laboratories followed by roundtable discussion about current practices and lessons learned.

8:30 a.m. – 10:00 a.m.
P3: Creative Solutions for Contamination Detection and Control
EU Moderator: Olivier Rocher, Head, QC Microbiology and Sterility Assurance, GSK Vaccines
US Moderator: Renée Blosser, Master Microbiology Reviewer, CVM, FDA

In this session, we will look at alternative solutions to present contamination detection and control issues. Our two speakers are well-known on both continents for their long experience in pharmaceutical microbiology, investigations and troubleshooting, and their passion for alternative micro methods. Dr. Michael Miller will present an overview of the more recent revision to regulations and guidances to define strategies for short-shelf lives medicines such as cell and gene therapy products. Jeanne Moldenhauer will give a focus on the infamous Burkhoderia cepacia complex and novel methods for eradication of this contamination as well as preventative measures. These two passionate speakers will enrich their presentations with real case studies.

A3: Environmental Monitoring
Moderator: Christine Sherman, Director, Global Microbiology and Aseptic Network, Takeda

10:45 a.m. – 11:15 a.m.
Leveraging Gown Monitoring Data to Improve Employee Performance
Joe McCall, SM (NRCM), Technical Service Specialist, STERIS Life Sciences
Jennifer Longstaff, Manufacturing Manager, Aseptic, Bausch + Lomb

11:15 a.m. – 11:45 a.m.
A Case Study of Environmental Monitoring Performance Qualification (EMPQ) Risk Analysis
Frederic B. Ayers, Consultant Scientist, Eli Lilly and Company

11:45 a.m. – 12:15 p.m.
Questions and Answers/Discussion

A4: Risk Identification, Assessment, and Mitigation
Moderator: Yeissa M. Chabrier-Roselló, PhD, Microbiology Reviewer, CDER, FDA

A microbiological risk assessment is the scientifically-based process to estimate the likelihood of exposure to a microbial hazard and the resulting impact from this exposure. While the overall tools for quality risk management have been well described (ICH Q9), the practical applications for microbiology continue to present opportunities. This session will present three unique case studies on microbiological risk identification, assessment, and mitigation. It will include real-life perspectives on reactive microbiological risk assessment reports, improvements in aseptic processing to prevent microbial contamination, and manufacturing situations where the shelf life of the product influences the need to build risk reduction into the overall manufacturing processing. This session will emphasize the importance of design with a risk in mind for manufacturing operations upstream and downstream of the final drug product.

1:15 p.m. – 1:45 p.m.
Specific Problems and Advice Associated with Writing Microbiological Risk Assessment Reports
Dennis E. Guilfoyle, PhD, Senior Director, Microbiology Regulatory Compliance, Johnson & Johnson

1:45 p.m. – 2:15 p.m.
Case Study on Quality Risk Management
Mitchell B. Garber, RPh, Director, Clinical Global Supplies Sterile, GlaxoSmithKline

2:15 p.m. – 2:45 p.m.
Risk Reduction in a Novel Aseptic Manufacturing Process
Jessica G. Chiaruttini, PhD, Microbiologist, CDER, FDA

2:45 p.m. – 3:15 p.m.
Questions and Answers/Discussion

4:00 p.m. – 5:30 p.m.
P4: Future Leaders
Moderator: Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company

Solving regulatory and process problems in the small world of microbiology can seem overwhelming in the grand scheme of product control and quality. Yet sharing of these challenges by the leaders who have experienced them first hand will ensure future success. This session will include four exciting case studies of problem resolution, project implementation, or deficiency awareness from the front lines of the microbiology laboratory or product review division.

7:15 a.m. – 8:15 a.m.
Breakfast Roundtable
Moderator: Julie Barlasov-Brown, MBA, Associate Director Sterile and Microbiology QA, Merck & Co., Inc.  
Hosted by the Microbiology/Environmental Monitoring Interest Group

This session will concentrate on environmental monitoring samples around incubation conditions. There are several approaches in the industry on how samples should be incubated, including latest trends of single temperature incubation. To address these considerations, the PDA sanctioned a task force to evaluate single temperature incubation and provide industry with guidance.

This session will begin with a short presentation by Scott Weiss on initiation of this PDA Task Force, followed by roundtable discussions about current practices, filing information, and regulatory expectations.

8:30 a.m. – 10:00 a.m.
P5: USP Updates
Moderator: Radhakrishna S. Tirumalai, PhD, Principal Scientific Liaison, US Pharmacopeial Convention

10:30 a.m. – 12:00 p.m.
P6: Ask the Regulators
Moderators:
Amy McDaniel, PhD, Microbiologist, CDER, FDA
John W. Metcalfe, PhD, Quality Assessment Lead, CDER, FDA 

During this interactive session, FDA will provide insight into questions posed by audience participants. The session is targeted to participants from all segments of the pharmaceutical industry and will provide valuable perspectives from agency experts from reviewers of compounding, sterility assurance, aseptic processing, and terminal sterilization of small molecules. In addition, biotechnology professionals can seek input from agency experts on biosimilars and new molecules manufactured using biotechnology processes. Finally, expert field inspectors will provide their perspectives on inspection-related questions. Don't miss this unique opportunity to interact with regulators in an open forum focused exclusively on your microbiology concerns!