On Demand 15th Annual PDA Global Conference on Pharmaceutical Microbiology

Name: On Demand 15th Annual PDA Global Conference on Pharmaceutical Microbiology
Start: 2020-10-19
End: 2020-11-20

Keeping Microbiology in the Loop

Oct 19 - Nov 20, 2020

Eastern Standard Time | Online

Conference
Virtual

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Online

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Overview
Agenda
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Program Highlights

The 15th Annual Global Conference on Pharmaceutical Microbiology is now available for on-demand viewing.

When you register, you will gain access to all session recordings, including talks and Q&A. These sessions will be available until Friday, Nov. 20, 2020.

Here's what's included in your registration:

Browse the Exhibitor Booths, download information sheets and FAQs, and watch videos. Reach out to Exhibitors for additional information!
Watch the recorded Conference sessions, including all concurrent tracks and moderated Q&A sessions with speakers, at your own speed.
View all the Poster Presentations featuring case studies, new research, and industry insights.

Did you already register for the 15th Annual Global Conference on Pharmaceutical Microbiology? Use your same login information to access the on-demand sessions through Friday, Nov. 20, 2020.

Overview

Virtual Buyer's Guide

The 15th Annual PDA Global Conference on Pharmaceutical Microbiology is going Virtual!

This Conference continues the ongoing tradition of addressing the opportunities and challenges, most relevant, to the future of microbiology in today’s global market. Join new and seasoned professionals from all facets of the field, including global industry, academia, and regulatory authorities, to share insights on how to best prepare for the future through the sharing of best practices, development of standards, and integration of innovative technologies.

Take a look at the many opportunities that will shape the future of the pharmaceutical industry, such as how to best use non-compendial methods for microbial testing of new products, how to overcome challenges with aseptic processing, and what might be in store for the effective use of risk assessment and mitigation in product manufacturing, environmental monitoring, and microbial control. Additionally, the science of biotech microbiology and its impact on the industry in a dynamic fast paced global manufacturing environment will be addressed throughout the Conference.

The comprehensive program agenda will include presentations from global regulatory and industry experts who will share recent case studies and current trends in the field of pharmaceutical microbiology. The Conference will also highlight the following hot topics:

Novel biotechnology processes, including cell and gene therapies
Globalization of aseptic processing
Common microbial deficiencies in regulatory filings and inspections
Contamination control case studies
Innovative technologies, products, and processes

There will be plenty of opportunities to listen to and directly interact with all the speakers, in addition to lively Q&A sessions that promise to stimulate the discussions and encourage attendee participation. Interactive breakfast sessions will feature small group discussions on topics important to the industry.

During the conference, PDA will host many poster presentations and an exhibition of leading bio/pharmaceutical companies that will showcase new technologies and trends for pharmaceutical microbiology strategies.

Agenda

Day 1
Day 2
Day 3

Monday, October 19

8:00 a.m. – 10:00 a.m. | Braindates (2020micro.braindate.com)

10:00 a.m. – 11:30 a.m. | P1: Looping in mRNA-Based Therapies Brings Hope
Moderator: MaryEllen E. Usarzewicz, MS, Associate Director, ASO Microbiology, Bristol-Myers Squibb

During these unprecedented COVID-19 times we kick off the conference with our first plenary speaker who will explore the use of mRNA-based therapies for multiple applications. As the world searches for a long term solution to social isolation and face masks, this session describes how, at “light speed” in a GMP environment, one searches for the best candidate to address treatment of emerging diseases including the one responsible for the current worldwide pandemic. Understanding the criticality of experience in study design, ongoing collaboration with health authorities, identifying key partners and scale up considerations, all resulting in the rapid dosing of patients generating promising phase 1/phase 2 data bringing hope and the possibility of a change to the current state of the universe.

10:00 a.m. | Welcome from Program Planning Committee Co-Chairs
Yeissa M. Chabrier-Rosello, PhD, Senior Pharmaceutical Quality Assessor, CDER, U.S. FDA
MaryEllen E. Usarzewicz, MS, Associate Director, ASO Microbiology, Bristol-Myers Squibb

10:08 a.m. | mRNA-Based Therapeutics for Oncology and Viral Infections
Andreas N. Kuhn, PhD, Senior Vice President RNA Biochemistry & Manufacturing, BioNTech RNA Pharmaceuticals GmbH

10:45 a.m. | Q&A

11:30 a.m. – 12:30 p.m. | Virtual Exhibit Hall

11:30 a.m. – 11:57 a.m. | Exhibitor Tech Talks

11:30 a.m. | Tech Talk 1: A Novel, At-Line, Pharmaceutical-Grade Mycoplasma Testing Solution: Sample to Results in Less than One-Hour
Brian Whitehouse, MBA, Global Marketing Manager, Product and Process Solutions, bioMérieux

11:45 a.m. | Tech Talk 2: Data Integrity in Endotoxin Testing
Josiah B. Hosie, Product Strategist, Lonza

12:30 p.m. – 1:45 p.m. | Concurrent Sessions

A1: Aseptic Manufacturing Challenges, Mistakes, and Robotic Technologies
Moderator: Mitch B. Garber, BS, RPh, Director Sterile & Bio Pharm Product Quality, GlaxoSmithKline

There are many technologies to fill aseptic products in a traditional cleanroom RABS or isolator and common mistakes occur with the design and integration of these technologies. Morgan Polen will share his insights into some of these mistakes while Joseph McCall will provide a case study and his thoughts on the qualification of a fully robotic isolator for aseptic filling of sterile products.

12:30 p.m. | Common Mistakes in Cleanroom, RABS and Isolator Design and Integration
Morgan Polen, Cleanroom, Particulate and Airflow Expert, Microrite, Inc

1:03 p.m. | Case Study - Qualification of a Fully Robotic Isolator for Aseptic Filling of Sterile Drugs
Joseph E. McCall, SM (NRCM), Associate Director, QA Technical Services, ADMA Biologics, Inc

1:38p.m. | Q&A

B1: The Microbiologist's Role – A Day in the Life
Moderator: Christine Sherman, BA, Global Microbiology, Takeda

Have you ever wondered what a Microbiologist contributes to well executed Container Closure studies or Contamination investigations? Two Microbiologist SMEs will share their expertise in these fields. Don Singer will provide his insights on the technical requirements for container closure integrity. Christopher Murdock will provide his thoughts on one of the more challenging events in a Microbiologist’s career, providing support for a contamination investigation.

12:30 p.m. | The Microbiologist's Role in Container Closure Integrity - USP/PDA Technical Guidance
Donald C. Singer, MA, (NRCM), Senior Microbiology Technical Consultant, N.A., Ecolab Life Sciences

12:53 p.m. | The Microbiologist’s Role in Microbiological Deviation Investigation
Christopher A. Murdock, PhD, Murdock Advisors, LLC

1:18 p.m. | Q&A

1:45 p.m. – 2:15 p.m. | Virtual Exhibit Hall

1:45 p.m. – 1:55 p.m. | Exhibitor Tech Talks

1:45 p.m. | Tech Talk 6: Brighten up your Bioburden Testing while Improving your Workflow
Michel W. van Musschenbroek, Field Marketing Manager, MilliporeSigma

2:15 p.m. – 3:30 p.m. | Concurrent Sessions

A2: Effective Environmental Monitoring Programs using One-Medium/Single-Incubation Conditions
Moderator: Kim Sobien, MBA, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company

The Environmental Monitoring (EM) session will describe the effectiveness of optimal medium/incubation conditions for viable EM samples based on literature search, empirical data and regulatory requirements. The first presentation describes the studies performed to evaluate the capability of a one-medium / single-incubation conditions for detecting microbial diversity in EM samples. The second presentation will provide an update on PDA Environmental Task Force’s efforts to evaluate the effectiveness of a one-medium/one-incubation condition for optimal detection of bacteria and fungi.

2:15 p.m. | Selection of Incubation Conditions for Environmental Monitoring Samples at TCF04Kite Pharma EU
Linda C.L Boele, BSc, Senior Manager - QC Microbiology, Kite Pharma EU
Arabela X. Cuirolo, PhD, QC Specialist III – Microbiology, Kite Pharma EU B.V.

2:39 p.m. | Effectiveness of One Media/One Incubation Condition for Functional Environmental Monitoring Program: An Update
Scott E. Weiss, BS, Director, Industrial Microbiology, Johnson & Johnson

2:55 p.m. | Q&A

B2: Monocyte Activation Test – Teenage Years are Over
Moderator: Friedrich von Wintzingerode, PhD, QC Lead iNeST (individual Neoepitope Specific Therapy), Genentech Inc

It has been 10 years since the Monocyte Activation Test became a compendial test in the EU. MAT has the potential to replace Rabbit Pyrogen Testing but is still awaiting its global acceptance. Two industry experts share their experiences and provide a user perspective of MAT.

2:15 p.m. | The Monocyte Activation Test – A Reliable Alternative to the Rabbit Pyrogen Test?
Johannes M. Reich, MA, PhD, Managing Director, Microcoat Biotechnologie GmbH
Ruth Roeder, PhD, Devision Manager, Microcoat Biotechnologie GmbH

2:46 p.m. | Considerations for Development of the Monocyte Activation Test as an In-Vitro Replacement for the Rabbit Pyrogen Test
Jessica A. Campbell, PhD, Principal Scientist, Pfizer

3:19 p.m. | Q&A

3:30 p.m. – 5:00 p.m. | Braindates (2020micro.braindate.com)

3:30 p.m. – 4:00 p.m. | Virtual Poster Hall

The following posters will be presented from 3:30 p.m. - 4:00 p.m.

“Error-Proofing” and “Future-Proofing”: Updating the Bacterial Endotoxins Test with Automation and Recombinant Reagents
Allen L. Burgenson, MS, Global SME - Testing Solutions, Lonza Walkersville, Inc.

Case Studies on the Environmental Monitoring for Biologics using Automated TSIA - Practical, Acceptable, and Easier Option for QC Test
Yasuhito Sugawara, MS, Member, ONO Pharamaceutical CO., LTD
Shoji Narutaki, MS, Senior Director, ONO Pharmaceutical Co., Ltd./Graduate School of Science, Technology and Innovation, Kobe UniversityD

Case Studies: How Rapid Microbiological Methods Enable Operational Efficiencies – from Routine Product Quality Testing to Process Failure Investigations
Julie Yang, MS, MBA, Program Director – Rapid Microbiological Methods, bioMerieux Inc.

Comparing Sequence-Based Microbial Identification Methods
Emily N. Huang, Senior Global Data Manager, Charles River Laboratories

Comparison Study of 177 Clinical Isolates of Gram Negative Bacteria Tested with LAL and rFC
Kevin L. Williams, BS, Senior Scientist, bioMerieux Inc.

Continuous Bioburden Monitoring of your Water System for Better Process Control and Reduced Cost
Arundhati Samanta, MA, MBA, Global Product Manager, Mettler Toledo

Data as Clean as Water: The Criticality of Detecting Relevant Endotoxins in Global Pharmaceutical Water Samples
John A. Dubczak, BS, Executive Director, Charles River Laboratories

Disinfectant Neutralization using Membrane Covered Culture Media
Courtney M. Russell, Senior Applications Microbiologist, Rapid Micro Biosystems

Introduction to a New Standardized Methodology to Evaluate Environmental Monitoring Petri Dishes Visual Inspection Quality
Diara D. White, R&D Senior Scientist, bioMerieux Inc.

Mitigating Contamination Risk of Viable Air Samplers in Cleanrooms
Anne Connors, Senior Field Marketing Manager, MilliporeSigma

Operational Impact of Accurate Microbial Identification
Christine E. Farrance, PhD, Senior Director of Scientific Affairs, Charles River Laboratories

Pyrogens - The Efficacy of Depyrogenation
Johannes M. Reich, MA, PhD, Managing Director, Microcoat Biotechnologie GmbH
Peter Kitschmann, MBA, Head of Pharma Compliance and Aseptic Processing, Bausch&Ströbel

STAT Results for STAT Samples: Implementing Rapid Micro Methods for Sterile Compounded Product Testing
Wayne I. DeHaven, PhD, Director, Pharmetric Lab

The Monocyte Activation Test: Applications for Rapid Release of Safer COVID-19 Treatments
Djikolngar Maouyo, PhD, President, Pyrodex LLC

The Monocyte Activation Test: The Road Forward for Pyrogenicity Test and Replacing the Animal Testing
Shabnam Solati, CEO, CTL-MAT

Use of a Bio-Fluorescent Particle Counter to Support a Reduction in Water Loop Sanitization Frequency
Allison A. Scott, PhD, Senior Principal Scientist, Azbil North America Research and Development

Using Swabs and Growth Direct™ System as Environmental Monitoring Application
Feng Jin Liew, MS, Microbial Field Scientist, Rapid Micro Biosystems

Validation and Approval for Lot-Release Testing of a Rapid Mycoplasma Assay
Darren J. Bauer, Product Manager, Thermo Fisher Scientific

Tuesday, October 20

8:30 a.m. – 9:45 a.m. | Breakfast Session: Contamination Control Strategy Tech Report
Moderator: Christine Sherman, BA, Global Microbiology, Takeda

PDA has SMEs working on a draft TR to provide guidance on preparing a Contamination Control Strategy and risk assessment for your manufacturing process. This is an excellent opportunity to chat with the authors and get a preview of the process and content for a thorough and well-documented strategy risk assessment.

8:30 a.m. | Panel Discussion
Reyes Candau-Chacon, PhD, Microbiologist, CDER, U.S. FDA
Cheryl E. Essex, MS, Head of Microbiological Control, Sanofi
Jeanne M. Mateffy, MS, Director Quality Sciences, GPO Contamination Control, Amgen, Inc.
Ed C. Tidswell, PhD, BSc, Executive Director QA, Merck & Co., Inc.

10:00 a.m. – 11:15 a.m. | P2: The Pathway to the First FDA-Approved Ebola Vaccine
Moderator: Yeissa M. Chabrier-Rosello, PhD, Senior Pharmaceutical Quality Assessor, CDER, U.S. FDA

The Ebola virus disease (EVD) was discovered in 1976 in the Democratic Republic of the Congo (formerly Zaire). EVD is a rare and often fatal illness characterized by causing a hemorrhagic disease in those infected, leading to a 50-90% fatality rate. Since its discovery over 10 outbreaks have occurred, mostly in Central and West Africa, with the most recent occurring in June 2020. These outbreaks were declared public health emergencies by the World Health Organization. The declaration of a public health emergency for EVD led to the formation of global partnerships and collaborations among the private sector, regulatory agencies and world governments to embark on the quest of finding new drugs, therapies and treatments to combat this deadly viral disease. This session will tell the story of the development and final approval of the first FDA-approved vaccine for the prevention of Ebola virus disease (ERVEBO® by Merck) in 2019, from a pharmaceutical microbiology perspective.

10:00 a.m. | Opportunities in Pharmaceutical Microbiology: Use of Recombinant Vesicular Stomatitis Virus Genetically Modified with the Ebola Virus Surface Glycoprotein to Combat Ebola Virus Infection
William Lapps, Jr., PhD, Director/Liaison, Vaccines & Infectious Diseases, Global Regulatory Affairs, Merck & Co., Inc.

10:40 a.m. | Q&A

11:15 a.m. – 12:15 p.m. | Virtual Exhibit Hall and Braindates (2020micro.braindate.com)

11:15 a.m. – 12:10 p.m. | Exhibitor Tech Talks

11:15 a.m. | Tech Talk 8: Automating the Microbiology Lab: The Past, Present, and Future
Matthew P. Paquette, MBA, Manager, Operational Excellence, Microbial Solutions/Charles River

11:30 a.m. | Tech Talk 9: Core2Scan - RFID Tracking for Asset Management & Compliance Support
Kevin J. McMurtrie, MBA, Global Business Manager, Veltek Associates, Inc.

11:40 a.m. | Tech Talk 10: Real-Time Equipment Release using Online Total Organic Carbon (TOC) Monitoring
Michelle A. Neumeyer, BA, Global Product Applications Specialist, SUEZ

11:50 a.m. | Tech Talk 11: A Look at How the Sievers Eclipse BET Platform Automates Endotoxin Test Setup Without the Cost or Complexity of Robotics
David E. Wadsworth, Global Product Manager, Bio-Detection, SUEZ WTS Analytical Instruments, Inc.

12:00 p.m. | Tech Talk 12: Rapid Detection of Bacteria and Fungi in ATMPs Prior Treatment – Validation of a Real-Time PCR-Based Test
Kai Nesemann, MA, Product Manager, Microbiology, Sartorius Lab Instruments GmbH & Co KG

12:15 p.m. – 1:40 p.m. | Concurrent Sessions

A3: The Role of Quality Risk Assessment in the Development of a Contamination Control Strategy
Moderator: Lydia Troutman, Director Sterile and Microbiology QA, Merck & Co., Inc.

Contamination control is a challenging and significant issue for the pharmaceutical industry. It requires steps to be taken to identify, assess and evaluate controls that will minimize risk of the sources of microbial and particulate contamination. The importance of quality risk management approaches has been recognized in the pharmaceutical industry and has become a valuable component supporting contamination control. Updates to Annex 1 calls for the implementation of a Contamination Control Strategy across the facility to define all control points and assess and monitor the effectiveness of all the controls. The utilization of quality risk management approaches can be applied for the development of an end to end contamination control strategy. This section will include a risk assessment approach to contamination control for cleaning and disinfection and a case study on the development of a contamination control strategy using the QRA FMEA tool.

12:15 p.m. | Risk Assessment Approach to Cleanroom Contamination Control - Influencing Cleaning and Disinfection Standards
Helen Gates, BSc, Global Technical Consultant, Ecolab Life Sciences

12:47 p.m. | Case Study: Leveraging a FMEA to Create a Contamination Control Strategy
Karen S. Ginsbury, BPharm, MSc, Consultant, PCI Pharmaceutical Consulting Israel

1:26 p.m. | Q&A

B3: Microbiology Laboratory Data and Inspection Trends
Moderator: Leslie A. Furr, MS, SM (NRCM), Associate Scientific Liaison, US Pharmacopeia

Microbiology data collection for manual methods presents unique challenges for ensuring data integrity. This session will focus on points to consider for implementing second analyst verification in a cGMP facility. This session will also include current FDA inspection findings and trends that will highlight recent industry quality challenges.

12:15 p.m. | Points to Consider When Implementing Second Operator Verification of Microbiological Laboratory Data
Paula J. Peacos, MS, Senior Consultant, ValSource, Inc.

12:43 p.m. | Current Microbiological Inspectional Findings and Trend Analysis: A Pharmaceutical Perspective
Simone E. Pitts, Consumer Safety Officer, ORA, U.S. FDA

1:21 p.m. | Q&A

1:40 p.m. – 2:15 p.m. | Virtual Exhibit Hall

11:40 a.m. – 1:49 p.m. | Exhibitor Tech Talks

1:40 p.m. | Tech Talk 14: Genotypic Microbial Identification-Ready to Implement In-house Solution for Same Day Accurate
Michael Brewer, Director, Global Principal Consultant, Regulatory BioProduction, Thermo Fisher Scientific

2:15 p.m. – 3:30 p.m. | Concurrent Sessions

A4: Automated Microbial Test Technologies for Water and EM: Are you in the Loop?
Moderator: Amy L. McDaniel, PhD, Director, Microbial Center of Excellence & Operations, Bristol-Myers Squibb

Automating assays in the area of environmental monitoring and water testing in a pharmaceutical manufacturing facility poses great advantages in efficiency, data integrity and ability to react faster to atypical events, ultimately leading to better control of the facility. This session takes us through two case studies of the use of automated technologies for EM and water testing and will provide the audience with a chance to hear firsthand from users of the technologies.

2:15 p.m. | Automated Environmental Monitoring: THE Solution for the Next Decade
Niels JF Visschers, Specialist Operations, MSD

2:46 p.m. | From Fiction to Reality: Lessons Learned from 8 Months of Continuous Water Monitoring Using Bio-Fluorescent Particle Counter
Joanny Salvas, Manager, Pfizer

2:57 p.m. | Q&A with Additional Panelist
Maria R. Flores, PhD, Scientific Technical Specialist, MSD

B4: Microbiological Attributes and Testing Considerations for Radiopharmaceuticals
Moderator: Lynne A. Ensor, PhD, Vice President, Technical, PAREXEL International

This session will focus on the challenges encountered from a microbiology perspective when developing, manufacturing, and/or testing radiopharmaceuticals. Implementable solutions for meeting potentially challenging regulatory expectations for the microbiological attributes of radiopharmaceuticals, as well as maintaining compliance with radiation safety standards while doing so, will be discussed.

2:15 p.m. | Radiopharmaceuticals: A Microbiologists Challenge
Keira F. Anderson-King, Sterility Assurance Specialist ANZ, Baxter

2:39 p.m. | Microbiological Regulatory Perspective for PET Drug Products
Laura R. Wasil, PhD, Microbiologist, CDER, U.S. FDA

3:07 p.m. | Q&A