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Session Description: After achieving a dramatic triumph over infection in the 20th century with the introduction of antibacterial chemotherapy, the threat of bacterial diseases has resurged with the rise of antibacterial resistance. The Centers for Disease Control and Prevention (CDC) estimate that in the United States, more than two million people are sickened every year with antibiotic-resistant infections, with at least 23,000 dying as a result. The history and contributing factors to the rising trend of antibacterial resistance in the United States will be discussed, as well as recent successes and challenges in the development of novel antibacterial drugs. Efforts to facilitate the development of antibacterial drugs for serious or life-threatening illnesses will be highlighted, including new approaches to the design of clinical trials.

8:30 a.m. – 9:00 a.m.
The Challenge of Antibacterial Resistance: Learned Lessons and New Directions
Edward A. Weinstein, MD, PhD, Medical Officer, CDER, FDA

9:00 a.m. – 9:30 a.m.
Questions and Answers/Discussion

1. Implementation of the Growth Direct™ System: Driving for Greater Accuracy, Speed, and Efficiency in Microbial Enumeration
Ashley Durusky, Senior Supervisor QC Microbiology, Biogen

2. Comparison of Microbial Identification Methods and the Operational Impact in a Drug Quality Control Laboratory in Costa Rica
Franklin Binns, Pharmacist, Microbiología Farmacéutica

3. Discovery of Matrix Interference with an In-Process Production Sample During Method Validation for Endotoxin (LAL): A Case Study
Jennifer Bachner, QC Scientist IV, Pfizer Inc.

4. The Impact of Disposables on Limulus Amebocyte Lysate (LAL) Based Assays and Endotoxin Hold Time Studies
John Brooks, Technical Services Representative, Associates of Cape Cod Inc.

5. Mechanisms of Hidden Endotoxin in Biologic Drug Process Preparations
Kevin Williams, Senior Scientist, bioMérieux, Inc.

6. An LER Case Study for Monoclonal Antibody Drug Product
Lin Chen, PhD, Principal Scientist, Pfizer Inc.

7. Optimization of Data Interpretation Criteria (i.e., Score Cutoffs for Species Confidence) for Bacterial and Yeast Identification Using MALDI-TOF Mass Spectrometry
Prasanna Khot, PhD, Senior Staff Scientist, Charles River Laboratories

8. Recurring Microbial Contamination Disrupts the Cost-Time-Quality Balance: A Case Study 
Joseph McCall, Technical Services Specialist, Life Sciences Formulated Chemistries, STERIS Corporation

9. Evaluation of the New EviSight™ Compact System for the Growth Promotion Testing of Culture Media Used for Water Testing and Environmental Monitoring Using Pharmacopeial Strains and Wild Strain Isolates
Susan McDonagh, QC Analyst, Pfizer Inc.

10. BacT/ALERT as an Alternative Sterility Testing Method of a Cell Therapy Product
Leela Rudrappa, Senior Microbiologist, Kita Pharma

Session Description: Solving problems in the microbiology laboratory often requires collaboration between many individuals and across multiple departments. In addition, laboratory microbiologists often have to work across lines of responsibilities to ensure that projects are completed with involvement from all impacted areas. This session will include three case studies of problem resolution or project implementation with teams of individuals from the front line of the microbiology laboratory.

4:15 p.m. – 4:35 p.m.
Getting Your Product from Fill Line to Clinic (with a Little Help from your Friendly Neighborhood Microbiologist)
Carly Krystopik, Associate Research Scientist II, Bristol-Myers Squibb  

4:35 p.m. – 4:55 p.m.
You Gotta Know When to Hold ‘Em: Microbial Challenge Testing and In-use Hold Times for Non-preserved, Sterile, Single-use Products
Sarah Weiser, MS, Formulation Scientist, Pfizer Inc.  

4:55 p.m. – 5:15 p.m.
How Very Sterile This Johnny Is: The Conundrum of Sterility Testing a Terminally-Sterilized Biodegradable Implant
Melissa Gulmezian-Sefer, PhD, Senior Scientist, SMPD Microbiology, Allergan Inc.

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

Session Description: As a reminder of the importance of our work as pharmaceutical Microbiologists, we will hear directly from a patient, who is also an industry microbiologist, who has benefited from the pharmaceutical and medical device products that our companies manufacture. No one ever plans on becoming ill; but when it happens to someone, that patient relies on the quality, safety, efficacy, and sterility of the products we manufacture in our jobs to aid in their recovery. This patient perspective talk will remind us why we do what we do for a living and will bring together the patient benefits received as a result of our good work.

8:15 a.m. – 9:00 a.m.
When the Microbiologist Becomes the Patient
Marsha Steed (Hardiman), Senior Consultant, ValSource, LLC

9:00 a.m. – 9:15 a.m.
Questions and Answers/Discussion

1. Parameters for Consideration in the Selection of Microspheres Used to Calibrate and Assess Online Water Bioburden Analyzer System Performance
Allison Scott, PhD, Senior Applications Engineer, Azbil North America Research and Development - BioVigilant

2. Validation Results of Nine Different Test Strains Using EZ-Fit™ Filtration Units and Performance Comparison Including Evaluation of Microbiological Recovery of Aspergillus Brasiliensis According to International Standards (US/EP/JP) Using Ten Membrane Filter Products
Claire Fritz Briglia, Technology Specialist, EMD Millipore Corp.

3. Upstream Biosafety: Using Nanofiltration to Prevent Virus and Microbial Contamination of Cell Culture Processes
Corinne Miller, PhD, R&D Manager, MilliporeSigma

4. Cleaning and Disinfection of Bacillus Cereus Biofilm
Jim Polarine Jr., MA, Senior Technical Service Manager, STERIS Corporation

5. The effect of Gamma Irradiation Process Interruption on Microbial Resistance of G. Stearothermophilus
Fatima Hasanain, Polymer Materials Specialist, Nordion Inc.

6. Data-Based Mechanism of Low Endotoxin Recovery
Masakazu Tsuchiya, Senior Research Scientist, Charles River Laboratories

7. Development of R2A Media Optimized for Pharmaceutical Grade Water and Evaluation of Automated Water Testing Using the EviSight™ Compact
Lori Daane, Pharma Microbiology Scientific Director, bioMérieux, Inc.

8. Environmental Control and Maintenance in the Manufacturing of Non-Sterile Drug Products: Kansai Study Group (KSG) of the PDA Japan Chapter
Keisuke Inoue, Associate Director, Analytical Development Pharmaceutical Sciences, Takeda Pharmaceutical Company Limited

Session Description: During this session, FDA will provide an update on the Agency’s regulation and oversight of human drug compounding since passage of the 2013 Drug Quality and Security Act (DQSA), which established a new category of drug compounders called outsourcing facilities. FDA speakers will provide an overview of the Agency’s compounding oversight program and describe relevant policies. Participants will learn about FDA’s inspectional program for outsourcing facilities; quality standards, including current good manufacturing practice requirements, and insanitary conditions, applicable to outsourcing facilities; and guidance documents and regulations that pertain to outsourcing facilities. The session is targeted to participants from all segments of the pharmaceutical industry, and is especially applicable to those working in the newly established outsourcing facility arena.   

4:15 p.m. – 4:35 p.m.
Overview of FDA’s Compounding Program
Julie Dohm, PhD, JD, Agency Lead on Compounding and Senior Scientific Advisor for Compounding, CDER, FDA

4:35 p.m. – 4:55 p.m.
Policies Applicable to Outsourcing Facilities
Sara Rothman, MPH, Senior Policy Advisor, Office of Unapproved Drugs and Labeling Compliance, Office of Compliance, CDER, FDA

4:55 p.m. – 5:15 p.m.
FDA Inspections of Outsourcing Facilities
Justine Tomasso, MBS, Consumer Safety Officer, Pharmaceutical Quality Programs Branch, Division of Pharmaceutical Quality Programs/Office of Pharmaceutical Quality Operations, ORA, FDA

5:15 p.m. – 5:45 p.m.
Understanding CGMP Requirements and Insanitary Conditions
Ian F. Deveau, PhD, Chief, Global Compliance Branch 1, Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance, CDER, FDA

5:45 p.m. – 6:00 p.m.A
Questions and Answers/Discussion

Session Description: Compatible with its overall mission, the role of the 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.

8:15 a.m. – 8:40 a.m.
Current Activities of the USP Microbiology Expert Committee        
David Hussong, PhD, Microbiology and Regulatory Consultant, ValSource, LLC

8:40 a.m. – 9:05 a.m.
Proposed Revisions to USP <1211> and <1222>
Edward Tidswell, PhD, Executive Director, Sterile Quality Assurance, Merck & Co./Merck Sharp & Dohme

9:05 a.m. – 9:30 a.m.
Questions and Answers/Discussion

Session Description: Mutual Reliance Initiative is a new path for Mutual Recognition Agreements between two or more countries to recognize a specific process or procedure of the other country. The intent is to create an expanded inspectorate, one where investigators and inspectors from FDA and trusted partners, such as those in the European Union and beyond, would work together, rely on each other’s inspections, avoid duplicating inspections, and conduct more inspections in areas where the increase in drug manufacturing has greatly increased. The benefit of Mutual Recognition is in strengthening the use of each other’s drug inspection expertise and resources which will result in greater efficiencies for both regulatory systems and provide a more practical means to oversee the large number of drug manufacturing facilities outside of the U.S. and EU.

9:40 a.m. – 10:10 a.m.
FDA's 2017 Mutual Reliance Initiative
Susan F. Laska, Senior Advisor for Medical Products, ORA, FDA

10:10 a.m. – 10:40 a.m.
Questions and Answers/Discussion

Session Description: In the "Ask the Regulators" session, attendees can interact directly with members of regulatory agencies to pose questions and get answers about pressing microbiology issues. This session will provide attendees with a unique opportunity to engage several regulatory speakers in further discussions regarding regulations, trends, solutions, and best demonstrated practices.

Panelists
U.S. FDA ORA Representative Invited
U.S. FDA CDRH Representative Invited
Julie Dohm, PhD, JD, Agency Lead on Compounding and Senior Scientific Advisor for Compounding, CDER, FDA
Lynne A. Ensor, PhD, Director, Division of Microbiology Assessment, CDER, FDA
Laurie P. Norwood, Deputy Director, Office of Compliance and Biologics Quality, CBER, FDA