Sunday, October 14
3:00 p.m. – 7:00 p.m.
Registration Open
Monday, October 15
7:00 a.m. – 5:30 p.m.
Registration Open
7:00 a.m. – 8:00 a.m.
Continental Breakfast
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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.
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8:00 a.m. – 8:15 a.m.
Welcome and Opening Remarks from Conference Co-Chair
Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company
8:15 a.m. – 8:45 a.m.
Regulatory Challenges to CAR T Commercialization
Yoko Momonoi, Director, Regulatory CMC, Celgene
8:45 a.m. – 9:15 a.m.
CAR T Cell Therapies: Regulatory Considerations for Safety Testing
Kimberly LW Schultz, Gene Therapy CMC Reviewer, CBER, FDA
9:15 a.m. – 9:45 a.m.
Questions and Answers/Discussion
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9:45 a.m. – 10:15 a.m.
Refreshment Break
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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.
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10:15 a.m. – 10:45 a.m.
Microbiological Implications of the EU GMP Annex 1 Revision
Andrew Hopkins, Expert GMDP Inspector, MHRA
10:45 a.m. – 11:15 a.m.
Common Inspection Trends
Justin A. Boyd, Investigator, ORA, FDA
11:15 a.m. – 11:45 a.m.
Questions and Answers/Discussion
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11:45 a.m. – 1:30 p.m.
Grand Opening of Exhibit Hall with Lunch, Poster Presentations, and Tech Talks
1:30 p.m. – 3:30 p.m.
Concurrent Sessions
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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.
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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
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B1: Novel Products, Methods, and Manufacturing Processes
Moderator: Irving Ford, Head of CAR-T QC Laboratories, Celgene
The challenges raised by new products, test methods, and manufacturing processes present great opportunities for innovative approaches in microbiology. The introduction of these new elements is changing the way that we think of microbiology, and forcing the industry and regulators to look at new approaches for process control and product release. This session will explore a novel process, test method, and product to provide unique insights into how the future is quickly becoming the present. |
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1:30 p.m. – 2:00 p.m.
Process Development and Manufacturing: Current and Future Challenges
Vienna Lo, Principal Scientist, Novartis
2:00 p.m. – 2:30 p.m.
The Monocyte Activation Test (MAT) for Pyrogen Detection
Devon Kleindienst, Research Scientist II, Bristol-Myers Squibb
2:30 p.m. – 3:00 p.m.
Microbiological Considerations for Drug Products Derived from Cannabis and Cannabis Components
Marla Stevens-Riley, PhD, Quality Assessment Lead (Acting)/Master Microbiology Reviewer, CDER, FDA
3:00 p.m. – 3:30 p.m.
Questions and Answers/Discussion
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3:30 p.m. – 4:15 p.m.
Refreshment Break and Poster Presentations in Exhibit Hall
4:15 p.m. – 5:45 p.m.
Concurrent Sessions
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A2: Microbial Control
Moderator: Amy McDaniel, PhD, Microbiologist, CDER, FDA
The external environment to a manufacturing process presents a significant source of microorganisms. The potential for microbial ingress from the external environment poses a great challenge for microbial control. This session will focus on controlling a process “from the outside in,” through case studies on equipment contributions and use of EM data to protect a process prior to microbial ingress. The goal of the knowledge sharing will be to incorporate elements into your own microbial control strategies and to improve programs for the future. |
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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
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B2: Small Mold: Big Problem! Case Studies on Mold in a Manufacturing Facility
Moderator: Ebony Arrington, MS, Pfizer Global Supply, Production Operations, Central Support Manager, Pfizer Biotech
In the wide diversity of the microbial world, mold represents a relatively small portion of the possible overall contaminants. However, the presence of mold within a pharmaceutical manufacturing facility creates the need for heightened awareness and response commensurate with the risk that it poses to the process and ultimately the patient. In this session, two case studies will be presented related to the presence of mold either in the environment or in the process of a pharmaceutical manufacturing facility. The impact and response to the situations will be explored to provide insight into the prevention of future recurrence. |
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4:15 p.m. – 4:45 p.m.
Responding to In-Process Contaminations: A Case Study
Brian Lloyd, PhD, Senior Validation Engineer/Clinical Manufacturing Scientist, Pfizer
4:45 p.m. – 5:15 p.m.
Antimicrobial Effectiveness Test Failure: A Case Study for Nasal Spray Product
Mark P.J. Nabuurs, BASc Medical Microbiology, Merck & Co./Merck Sharpe & Dohme
5:15 p.m. – 5:45 p.m.
Questions and Answers/Discussion
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5:45 p.m. – 7:00 p.m.
Networking Reception and Poster Presentations in Exhibit Area
Tuesday, October 16
7:00 a.m. – 5:30 p.m.
Registration Open
7:00 a.m. – 8:30 a.m.
Continental Breakfast
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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.
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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.
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8:30 a.m. – 9:00 a.m.
Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and Cell Therapy Products
Michael J. Miller, PhD, President, Microbiology Consultants, LLC
9:00 a.m. – 9:30 a.m.
Case Studies with Burkholderia Cepacia Complex (BCC)
Jeanne Moldenhauer, Vice President, Excellent Pharma ConsultingA
9:30 a.m. – 10:00 a.m.
Questions and Answers/Discussion
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10:00 a.m. – 10:45 a.m.
Refreshment Break, Passport Drawing, and Poster Presentations in Exhibit Hall
10:45 a.m. – 12:15 p.m.
Concurrent Sessions
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A3: Environmental Monitoring
Moderator: Christine Sherman, Director, Global Microbiology and Aseptic Network, Takeda
In order to assure control of manufacturing facilities, environmental monitoring (EM) programs are critical to evaluate the effectiveness of disinfection programs, operator’s aseptic practices, and the engineering controls in place which provide appropriate conditions for manufacture. These programs generate large amounts of data which can make it difficult to determine the best focus of valuable resources. This session will highlight a case study which provides guidance and tools to evaluate personnel gowning data to assess trends and risks. The second case study evaluated the impact of facility changes on sterility assurance and how to determine the most efficient and effective EM performance qualification after modification of the facility. |
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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
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B3: Biotech Products
Moderator: Bo Chi, PhD, Microbiologist, CDER, FDA
Microbial control and sterility assurance during manufacture of biotech products are critical to ensure product quality and patient safety. In this session, FDA and industry will present microbial control strategies and case studies in the context of current challenges encountered by the biotech industry. |
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10:45 a.m. – 11:15 a.m.
Microbiology and Biologic Manufacturing are Interdependent!
Jean Stuckey, Senior Principal Microbiologist, Patheon Biologics, LLC, part of Thermo Fisher Scientific
11:15 a.m. – 11:45 a.m.
Current Challenges for Biotech Products
Reyes Candau-Chacon, PhD, Quality Assessment Lead, Division of Microbiology Assessment, Branch IV, CDER, FDA
11:45 a.m. – 12:15 p.m.
Questions and Answers/Discussion
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12:15 p.m. – 1:15 p.m.
Exhibit Hall with Lunch, Passport Drawing, Poster Presentations, and Tech Talk
1:15 p.m. – 3:15 p.m.
Concurrent Sessions
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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.
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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
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B4: Predictably Irrational Microbiology
Moderator: MaryEllen E. Usarzewicz, MS, Parenteral Manufacturing Support Lead, Analytical & Bioanalytical Operations, Microbiology, Bristol-Myers Squibb
Despite best efforts at performing testing in a consistent, predictable fashion, the nature of microbiology is such that the living organisms sometimes do not provide rational results. Predictability also includes the repetitive nature of performing an action in the same way, even if the action (or test) does not seem rational. This session will focus on the predictably irrational nature of microbiology (from the perspective of both testing and results), including case studies on disinfectant efficacy evaluation and recovery of an anaerobic microorganisms from an aerobic aseptic process simulation.
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1:15 p.m. – 1:45 p.m.
Sterility Test Recoveries and Process Simulation Design
Kenneth Boone, Associate Director, Sterile & Microbiology Quality Assurance, Merck & Co., Inc.
1:45 p.m. – 2:15 p.m.
Principles to Consider for Setting Appropriate Bioburden Sample Hold Times
Gretchen Brunner, Scientist, QC Science and Technology, Sanofi
Mark J. Kapeckas, Biologics Corporate Quality Global Program Manager, Sanofi Biologics
2:15 p.m. – 2:45 p.m.
Disinfectant Efficacy: Expect the Unexpected
Jeffrey W. Heiser, Director, Microbiology, Boston Analytical
2:45 p.m. – 3:15 p.m.
Questions and Answers/Discussion
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3:15 p.m. – 4:00 p.m.
Refreshment Break, Passport Drawing, and Poster Presentations in Exhibit Hall
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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.
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4:00 p.m. – 4:15 p.m.
Free Range Facility Parenting: Challenges in Establishing Contamination Control, Environmental Monitoring, and Microbiological Testing Strategies for CAR T Therapies
Joseph R. Sondej, Associate Director, QC Microbiology, Celgene
4:15 p.m. – 4:30 p.m.
It’s A Small World After All: Microbial Biogeography of a Manufacturing Facility
Emily Elizabeth Castelloe, Rotational Development Program Associate, Pfizer Inc.
4:30 p.m. – 4:45 p.m.
Facility Fitness: Tracking Steps to Sterility Assurance
Joshua Schmitz, Principal Engineer Sterility Assurance, Advanced Sterilization Products (ASP), Johnson & Johnson
4:45 p.m. – 5:00 p.m.
Common Deficiencies for Drug Substance Manufacturing
María José López Barragán, PhD, Microbiologist, CDER, FDA
5:00 p.m. – 5:30 p.m.
Questions and Answers/Discussion
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Wednesday, October 17
7:00 a.m. – 12:15 p.m.
Registration Open
7:00 a.m. – 8:30 a.m.
Continental Breakfast
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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.
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8:30 a.m. – 10:00 a.m.
P5: USP Updates
Moderator: Radhakrishna S. Tirumalai, PhD, Principal Scientific Liaison, US Pharmacopeial Convention
Compatible with its overall mission, the role of USP in microbiology and sterility assurance is to develop public standards pertaining to microbiology that, along with other requirements, ensure the consistent quality of products. This session will provide an overview on current and proposed activities of the USP General Chapters-Microbiology Expert Committee, with emphasis on revisions to existing chapters and new chapter proposals; discussion of a proposed new chapter proposal on a test for absence of B.cepacia complex; and, discussion of bioburden resistance in materials being terminally sterilized and a simple method to determine this. |
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8:30 a.m. – 8:50 a.m.
Current Activities of the USP Microbiology Expert Committee
David Hussong, PhD, Chief Technical Officer, Eagle
8:50 a.m. – 9:10 a.m.
Burkholderia Cepacia – Prominent Recalls, Screening Methods, and Controls
Tony Cundell, PhD, Principal Consultant, Microbiological Consulting, LLC
9:10a.m. – 9:30 a.m.
The Boil Test: Estimating Microbial Resistance to Sterilization
Edward Tidswell, PhD, Executive Director, Microbiology QA, Merck & Co., Inc.
9:30 a.m. – 10:00 a.m.
Questions and Answers/Discussion
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10:00 a.m. – 10:30 a.m.
Refreshment Break
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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!
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Panel Discussion
Justin A. Boyd, Investigator, ORA, FDA
Patricia F. Hughes, PhD, Branch Chief, CDER, FDA
Stephen E. Langille, PhD, Acting Division Director, Division of Microbiology Assessment, CDER, FDA
Anthony F. Lorenzo, Lead Consumer Safety Officer, CBER, FDA
Kimberly LW Schultz, Gene Therapy CMC Reviewer, CBER, FDA
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12:00 p.m.
Closing Remarks from the Conference Co-Chair
Amy McDaniel, PhD, Microbiologist, CDER, FDA