SUNDAY, 01 OCTOBER
14:30 – 19:00 | Registration Open
MONDAY, 02 OCTOBER
07:00 – 17:30 | Registration Open
07:30 – 08:30 | Continental Breakfast
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08:30 – 10:00 | P1: A Cancer Journey as Seen through the Patient Lens
Moderator: Mitch B. Garber, RPh, Head of Quality Services & Compliance, 2seventy bio
Rob Weker worked his entire career in healthcare and is a three-time cancer survivor, including pancreatic cancer. He will share his journey from diagnosis through the different treatment options of his pancreatic cancer. Rob will provide a special perspective from the patient’s lens on how he and his family made many difficult treatment decisions while having continuous challenges from his medical insurance company. Rob will share his thoughts on going against his family and several doctor’s advice and entered a clinical trial study which he believes ultimately saved his life. Everyone has been touched somehow by cancer either directly or indirectly which drives Rob’s passion to share his learnings and journey with everyone he can. He also hopes his message will influence and motivate the scientists and regulatory professionals at the PDA event.
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08:30 | Welcome Remarks
08:40 | Rob Weker, MBA, Principal, Weker Advisors
09:20 | Q&A
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10:00 – 10:45 | Networking Break
10:45 – 12:15 | Concurrent Sessions
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A1: Optimizations in Decontamination and Sterilization
Moderator: Dawn Watson, Director, Micro Quality & Sterility Assurance, Merck & Co., Inc.
Aside from HEPA filters, no other advancement in the aseptic processing industry has more effectively addressed the issue of environmental contamination of critical zone processes than isolators. For such an impactful technology with decades of history, implementation of isolators has been regrettably slow. One of the major obstacles to isolator technology is validation of the Vapor Phase Hydrogen Peroxide (VPHP) decontamination cycle. This session will provide insights into recommended best practices for VPHP cycle development from an industry collaboration, an introduction to enzyme indicators and optimization of validation approaches that deliver effective and more efficient decontamination cycles.
While the use of isolators limits the risk of contamination, aseptic processing areas are still in use today. It is imperative to maintain strict control of these environments, which is in part accomplished through a robust cleaning and disinfection program that utilizes sterilized or pre-sterile disinfection agents. This session will also provide the essential elements of sterility validation for gamma-irradiated disinfection agents and how to reduce the risk of contamination while considering their chemical stability once opened.
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10:45 | Optimizing Decontamination Cycles for Aseptic Processing Isolators
Joseph E. McCall, SM (NRCM), Director, QA Technical Services, ADMA Biologics
11:05 | BioPhorum Isolator Good Operating Practices Team: Industry Guidance for Vapor Phase Hydrogen Peroxide Cycle Development
Terrence Hollis, Senior Manager, Global Technology and Engineering, Pfizer Inc.
11:25 | Sterility, Sterilants, and Sterilization
Kenneth M. Wiencek, BS, MS, PhD, Principal Microbiologist, Contec, Inc.
11:55 | Q&A
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B1: Elements of Effective and Robust Microbiology Laboratory Investigations
Moderator: Heike Merget-Millitzer, PhD, Microbiology CoE Lead, Janssen Pharmaceutical Companies of Johnson & Johnson – J&J
Inadequate performance and documentation of investigations represent a large proportion of observations from health authorities. In this session, the presenters will discuss best practices and examples for conducting effective and robust Microbiology Laboratory Investigations in support of a thorough root cause analysis. Elements to consider for aseptic process simulation or sterility test failures as well as for environmental monitoring limit excursions will be addressed. The importance of identifying the type of contaminant to determine the root cause and to define respective remediation measures will also be highlighted.
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10:45 | Points to Consider for Complex Microbiological Investigations Involving the Aseptic Process
Angie L. Bragdon, Senior Principal Scientist, Eli Lilly and Company
11:05 | Get Out from Behind your Computer to Conduct Comprehensive EM Investigations
Jaime Kaho’ohanohano, BS, Senior Microbiology Consultant, Microrite Inc.
11:35 | Investigating Cleanroom Contamination and Disinfection Strategies
Dan A. Klein, Sr. Technical Service Manager, STERIS Corporation
11:55 | Q&A
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C1: Endotoxins and Pyrogens: Next Generation Testing Platforms
Moderator: Simleen Kaur, MSc, Biologist, Team Lead, OCBQ, CBER, U.S. FDA
It is time to remove barriers and adopt innovative platforms for detection of Endotoxins and Pyrogens during production and testing of pharmaceutical products. The proven efficacy of the modern methods provides an opportunity for the pharmaceutical industry to modernize traditional procedures and contribute significantly to the conservation of animals. This session will focus on evaluation of Recombinant Factor C and Monocyte Activation Test for safety testing during manufacturing and release of products.
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10:45 | Characterization of Endotoxin Detecting Recombinant Factor C Products for Evaluation of Manufacturing Quality and Assay Performance
Talia Faison, MS, CQA, Biologist, CDER, U.S. FDA
11:05 | Suitability of rFC-Based Endotoxin Tests: A Comparison Study Including Different Pharmaceutically Relevant Grades of Water
Andre Kriegeskorte, PhD, Global Expert Microbiology, GSK
11:25 | Monocyte Activation Test: A Case Study from Method Development and Validation to Release Testing of Drug Products
Maria Gajewi, Manager Endotoxin Services, Microcoat Biotechnologie GmbH
Jonas van den Berg, Global Quality Manager, Roche Diagnostics GmbH
11:55 | Q&A
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12:15 – 13:45 | Grand Opening of the Exhibit Hall and Networking Lunch
13:45 – 15:15 | Concurrent Sessions
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A2: Reflecting on “Microbiology Testing of the Future”
Moderator: Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK
Reflecting on microbiology testing of the future, our first thoughts guide us towards implementation of Rapid Microbial Methods (RMM) to allow fast release of microbial QC testing results. Whilst this should indeed be one of the main goals, it is not the only one. Of equal importance is the immediate access to data in the right format. Finally, within this lab of the future, we will need competent microbiologists, able to follow this evolution and able to make the right decisions fast and effectively. Within this session, we will be covering these three aspects by looking at a RMM for mycoplasma, how we efficiently can access and trend our data, and finally how we can build and ensure the right competencies for our microbiology experts for the future.
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13:45 | Implementation of a Novel Mycoplasma Testing Technology which Facilitates the Evolution Towards Increased Automation and Real-Time-Release in Microbiology Labs
Heike Merget-Millitzer, PhD, Microbiology CoE Lead, Janssen Pharmaceutical Companies of Johnson & Johnson – J&J
14:05 | A Novel Method to Extract Environmental Monitoring Data from Paper Records for Use in EM Monitoring and Trending
Jon R. Voss, MS, VP, Head of Quality, Abeona Therapeutics
Liz Maida, BSE, President and Co-Founder Fathom
14:30 | Pharmaceutical Microbiologists: Training for Competency in the Next Decade and Beyond
Donald C. Singer, MA, ASQ Fellow, CPGP, Senior Microbiology Technical Consultant, North America, Ecolab
Radha Tirumalai, PhD, Director, Merck & Co., Inc.
14:55 | Q&A
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B2
Moderator: Yeissa M. Chabrier-Rosello, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA
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13:45 | Sterile Compounding: Clarity from Chaos
Abby A. Roth, CMQ/OE, Owner/Microbiologist, Pure Microbiology, LLC
14:05 | Reyes Candau-Chacon, PhD, Quality Assessment Lead, OPQ, CDER, U.S. FDA
14:25 | U.S. FDA Representative Invited
14:45 | Q&A
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C2: Endotoxin Masking
Moderator: Moderator: Josh Eaton, MS, Director, Scientific and Regulatory Affairs, PDA
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13:45 | Overcoming Low Endotoxin Recovery: From Theory to Practice
Jessica V. Hankins, PhD, Associate Scientific Director, Bristol Myers Squibb
14:10 | The Impact of Endotoxin Masking on the Removal of Endotoxin during Manufacturing of a Biopharmaceutical Drug Product
Jessica Stolzenberger, Associate Director Late Stage Downstream Development, Boehringer Ingelheim GmbH & Co. KG
14:30 | Endotoxin Masking: Dependency on Container Type and Material
Bernhard Illes, PhD, Project Leader Endotoxin Services, Microcoat Biotechnologie GmbH
14:55 | Q&A
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15:15 – 16:00 | Networking Break in the Exhibit Hall
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16:00 – 17:00 | P2: Spillover
Moderator: Frederic B. Ayers, Advisor - Sterility Assurance, Global Parenteral Products Network, Eli Lilly and Company
Dr. David Kennedy is an Assistant Professor of Biology studying pathogen ecology at Penn State University. Dr. Kennedy will be presenting an educational session on pathogen spillover into humans and the challenges associated with experimentally studying spillover in the lab. According to Dr Kennedy, pathogens spill over into humans frequently but understanding “the likelihood that a virus will be transmissible in a new host is hugely challenging, especially with the replication needed to gain scientific insight”. Dr. Kennedy will present his research model of using nematodes as a unique host organism and how this model has promise to predict future crossovers before they develop into global pandemics.
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16:00 | David Kennedy, Assistant Professor of Biology, University of Pennsylvania
16:30 | Q&A
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17:00 – 18:00 | Networking Reception in the Exhibit Hall