PDA Alternative Microbiological Methods Workshop 2024
Sunsetting Traditions: The Dawn of Applying and Embracing Change
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Individual Registration
Group Registration
Traditional microbiological test methods may not meet the turnaround time required to release the critical therapies needed by patients based on the rise in novel and compounded therapies.
The EU GMP Annex 1 revision and the recently proposed USP Pharmacopeial Forum draft chapters stress the importance of incorporating alternative microbiological methods in process/facility monitoring and release test methods.
The PDA Alternative Microbiological Methods Workshop 2024 navigates the evaluation and adoption of rapid and alternative microbiological methods with a focus on emerging and alternative technologies and innovations that will push the industry forward.
Why Attend?
This workshop is structured to ensure you are immersed in substance, enlightened by analysis of real-world case studies, and given the opportunity to work and engage with your fellow attendees alongside the experts.
- Our experts will guide you through selecting a test method, implementing the testing platform, and preparing appropriate data packages and methods validation summaries for regulatory submission.
- Hear in-depth presentations featuring solutions to challenges during method selection, regulatory expectations, considerations for cell and gene therapies and short shelf-life products, and best practices for validation.
- Be inspired by case studies highlighting real-life implementation success stories.
- Participate in small group work sessions providing additional takeaways related to cost, overcoming challenges, and the benefits of nontraditional microbiology test methods.
What You Gain
- Comprehensive knowledge of topics ranging from the evolution of alternative microbiological methods to successful implementation strategies.
- Insights into regulatory expectations, provided directly by representatives from U.S. FDA CDER and CBER.
- Immediate application of new knowledge and understanding through group discussions, case studies, role-playing exercises, and interactive polls.
- Multiple opportunities build a professional network and connect with peers and experts across the workshop.
This workshop sells out quickly! Save your seat today.
PROGRAM PLANNING COMMITTEE
- Marc Glogovsky, ValSource, Inc. (Chair)
- Christopher Murdock,Eli Lilly and Company
- Olivia Venhuizen, Amgen Inc.
- Erin Wall, U.S. FDA
- Kevin Wright, Procter & Gamble Company
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Standard Registration
Member Price
$2,095GovernmentMember Only
$995
Health AuthorityMember Only
$995
Early Career ProfessionalMember Only
$1,495
StudentMember Only
$695
AcademicMember Only
$995
Non-Member
$2,495
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to registration@pda.org.
Wednesday, 9 October EDT
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Registration Open
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P1: Evolution of Alternative Microbiological Methods and Regulatory Insights
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Moderator: Marc Glogovsky, MS, Business Unit Manager - Microbiology, ValSource, Inc.
Marc Glogovsky, MS, Business Unit Manager - Microbiology, ValSource, Inc.
Marc Glogovsky is currently managing the microbiology consulting division at ValSource, Inc. His career spans more than 25 years in the pharmaceutical industry, in various microbiology and management roles. In his current position, Marc focuses on development of contamination control strategies, implementation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs. He has been an active PDA member for over 25 years and is presently serving on the Board of Directors and on the planning committee for the PDA/FDA Joint Regulatory Conference. Additionally, Marc has chaired several Technical Reports and Points to Consider publications and served on the Education, Science and ATMP Advisory Boards. In 2020, Marc was the recipient of the James P. Agalloco award for his efforts at PDA's Training and Research Institute, the 2022 Michael Korczynski Award for his support of PDA's international activities and a Service Appreciation Award in 2023 for his time spent as the Microbiology/EM Interest Group Leader. Marc earned his BS in Biology from Monmouth University and his MS in Microbiology & Molecular Genetics from Rutgers University.
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Welcome and Opening Remarks from Workshop Chair
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Chair: Marc Glogovsky, MS, Business Unit Manager - Microbiology, ValSource, Inc.
Marc Glogovsky, MS, Business Unit Manager - Microbiology, ValSource, Inc.
Marc Glogovsky is currently managing the microbiology consulting division at ValSource, Inc. His career spans more than 25 years in the pharmaceutical industry, in various microbiology and management roles. In his current position, Marc focuses on development of contamination control strategies, implementation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs. He has been an active PDA member for over 25 years and is presently serving on the Board of Directors and on the planning committee for the PDA/FDA Joint Regulatory Conference. Additionally, Marc has chaired several Technical Reports and Points to Consider publications and served on the Education, Science and ATMP Advisory Boards. In 2020, Marc was the recipient of the James P. Agalloco award for his efforts at PDA's Training and Research Institute, the 2022 Michael Korczynski Award for his support of PDA's international activities and a Service Appreciation Award in 2023 for his time spent as the Microbiology/EM Interest Group Leader. Marc earned his BS in Biology from Monmouth University and his MS in Microbiology & Molecular Genetics from Rutgers University.
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Current Industry and Regulatory Drivers for Alternative and Rapid Microbiological Methods
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Presenter: Michael J. Miller, PhD, President, Microbiology Consultants, LLC
Michael J. Miller, PhD, President, Microbiology Consultants, LLC
Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology, contamination control and the validation of rapid microbiological methods. He is the President of Microbiology Consultants, LLC (http://microbiologyconsultants.com) and owner of http://rapidmicromethods.com, an educational website dedicated to the advancement of rapid microbiological methods.
For more than 35 years, he has held numerous R&D, manufacturing, quality, business development and executive leadership roles at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb, and his consulting company. In his current role, Dr. Miller advises multinational companies in the areas of pharmaceutical microbiology, quality and regulatory affairs, sterile and non-sterile pharmaceutical manufacturing, contamination control and teh validation of alternative and rapid microbiological methods.
Dr. Miller has authored more than 100 technical publications and presentations and currently serves on the editorial and scientific review boards for American Pharmaceutical Review, European Pharmaceutical Review and the PDA Journal. Dr. Miller is the co-chair for the PDA Technical Report #33 revision team and has served as an advisor to the USP Microbiology Expert Committee.
Dr. Miller holds a PhD in Microbiology and Biochemistry from Georgia State University (GSU), a BA in Anthropology and Sociology from Hobart College.
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Alternative Microbial Methods: Perspectives from Both Sides
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Presenter: Andrew D Hopkins, PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie
Andrew D Hopkins, PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie
Andrew Hopkins has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His has worked in the industry over 40 years Currently Andrew is a Director of Compliance at Abbvie with responsiblity for Microbiological contamination the role includes developing long term financial strategy for site investment, assessment of manufacturing sites andTraining and mentoring. Prior to this, Andrew was an Inspector with the MHRA for nearly 14 years. This included: • Inspections across the world, including inspections with a number of other regulators (USFDA, TGA, TFDA and Health Canada) in several areas including, sterile products, biological products, blood components and plasma. • Chairperson of the Inspectorates CMT (working with marginally compliant companies) • Part of the MHRAs inspection Action Group (taking actions regarding non-compliant sites) • Inspector training and mentoring • Invovled in writing of regulatory guidance documents including: o MHRAs Data Integrity guidance o EMA guidance on water systems o Chaired the working group for the revision of Annex 1 • Supporting industry bodies with technical monographs e.g. PDA TR1 and PHSS TM20. Before joining the MHRA Andrew worked for more than 20 years in various areas and technologies in the Pharmaceutical industry.
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Q&A
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Networking Break in the Exhibit Area
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P2: Real-Life Challenges to Implementing Alternative Microbiological Methods
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Christopher A. Murdock, PhD, CQA, VP, Sterility Assurance and Microbiology Support, Eli Lilly and Company
Chris Murdock, PhD holds a BS and MS in Microbiology from the University of Memphis and a PhD from Rutgers University in Molecular Microbiology. Chris has over 35 years of industry experience in microbiology, sterility assurance and sterile quality in both laboratory and operational roles. He has worked in contract manufacturing organizations as well as small, mid-size and large pharmaceutical, biotech and medical device organizations. Dr. Murdock has extensive experience in sterile quality, aseptic processing, nonsterile manufacturing as well as both development and commercial production. Dr. Murdock also has extensive experience in compliance and auditing requirements, has supported and led domestic and international Health Authority inspections and is a ASQ and ISO Certified Auditor and Specialist Microbiologist (NRCM). Chris is the current chair of the Pharmaceutical Microbiology Expert Discussion Group and previously served on the USP Microbiology Water Committee. Chris served as the Co-lead author for the PDA Technical Report TR 13-2, Environmental Monitoring of Facilities Manufacturing Low Bioburden Products, PDA Technical Report TR 88, Microbial Data Deviation Investigations in the Pharmaceutical Industry and PDA Technical Report TR 90 for Contamination Control Strategy Development in Pharmaceutical Manufacturing.
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Overview and Introduction: Adopting AMMs is Easy, Right?
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Kevin I. Wright, PhD, Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble
With 30 years experience in Microbiology and Life Sciences challenges in the Fast Moving Consumer Goods Industry, spanning R&D and industrial microbiology- I have worked across various regulated sectors for non-sterile products (Health, Home and Beauty Care). This journey has involved novel technologies, new products, and new/reapplied methods, covering both upstream and downstream applications and with solutions and innovation enabed through a combination of internal research, external collaborations (Academic & SME) and participation in cross industry groups (Kilmer/Microbiology Modernisation Cross Industry Consortium, PDA, PharMiG). As an industrial microbiologist, this has led to a consideration of a range of interconnected topics including biofilms, traditional, analytical and molecular methods, modelling and the integration of different manufacturing operations to deliver a quality end point. Most recently my focus has been on the application of these alternate approaches and measurements to microbiology in the assessment of the end to end quality of manufactured P&G products to facilitate rapid release, including Solid and liquid phase cytometry, molecular, Raman spectroscopy, guided mode resonance and digital integration in the supply chain as a quality metrics for in line and finished product release testing.
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Simulating the Company Experience of AMMs: Small Working Groups Challenge
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Kevin I. Wright, PhD, Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble
With 30 years experience in Microbiology and Life Sciences challenges in the Fast Moving Consumer Goods Industry, spanning R&D and industrial microbiology- I have worked across various regulated sectors for non-sterile products (Health, Home and Beauty Care). This journey has involved novel technologies, new products, and new/reapplied methods, covering both upstream and downstream applications and with solutions and innovation enabed through a combination of internal research, external collaborations (Academic & SME) and participation in cross industry groups (Kilmer/Microbiology Modernisation Cross Industry Consortium, PDA, PharMiG). As an industrial microbiologist, this has led to a consideration of a range of interconnected topics including biofilms, traditional, analytical and molecular methods, modelling and the integration of different manufacturing operations to deliver a quality end point. Most recently my focus has been on the application of these alternate approaches and measurements to microbiology in the assessment of the end to end quality of manufactured P&G products to facilitate rapid release, including Solid and liquid phase cytometry, molecular, Raman spectroscopy, guided mode resonance and digital integration in the supply chain as a quality metrics for in line and finished product release testing.
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Report Out and Discussion
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Networking Reception in the Exhibit Area
Thursday, 10 October EDT
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Continental Breakfast
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Registration Open
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P3: Regulatory Expectations on Alternative Microbiological Methods
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Moderator: Erin A. Wall, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA
Erin A. Wall, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA
Dr. Erin A. Wall is a Senior Pharmaceutical Quality Assessor at the FDA in the CDER Office of Pharmaceutical Quality, Office of Pharmaceutical Manufacturing Assessment. She is a microbiologist who serves as a subject matter expert on manufacturing process and facility risks to liquid drug products. Dr. Wall has led and co-led division and office-wide trainings on different topics in manufacturing assessment. She has repeatedly volunteered to teach others when new topics are introduced to assessors in her discipline. Dr. Wall organized a data research project with an ORISE fellow to determine common deficiencies in ANDA applications in the Quality Microbiology discipline. This work eventually led to the formation of a working group which proposes collation and analysis of Quality Microbiology assessment data and information requests to inform future assessment. She continues to prioritize data analytics to improve the assessment process. Before joining the FDA, Dr. Wall was a postdoctoral fellow in the lab of Susan Gottesman at the National Cancer Institute where she analyzed protein/protein interactions in a multicomponent signalling pathway in Enterobacteriaceae. Her graduate work under the mentorship of Gail Christie uncovered a novel drug target in Staphylococcus aureus and assessed its structure and function.
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Alternative Sterility Test Methods for Compounded Products: Points to Consider
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Presenter: Ian F. Deveau, PhD, Division Director, OC, CDER, U.S. FDA
Ian F. Deveau, PhD, Division Director, OC, CDER, U.S. FDA
Ian Deveau is Deputy Director for Quality in the Office of Compounding Quality and Compliance (OCQC), Office of Compliance, CDER. Dr. Deveau oversees the efforts to protect the American public from poor quality drug products and ensure compliance of firms authorized by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). Dr. Deveau is a subject matter expert on sterile drug production, Current Good Manufacturing Practices (21 CFR 210, 211 & 212), and pharmacy compounding practices (USP <795> and <797>).
Dr. Deveau received a Bachelor’s in Biology at Buffalo State University and holds a PhD in Biology from The Pennsylvania State University with minors in Microbiology, Chemistry, and Biochemistry. Prior to joining CDER, he was a chemist and GLP Study Director at FDA’s Center for Veterinary Medicine, followed by 9 years at the U.S. Pharmacopeia involved in developing standards for microbial control of drug manufacturing, blood and blood products, vaccines, biologics and biotechnology products, radiopharmaceuticals & medical imaging agents, and veterinary drugs.
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Q&A with Ian Deveau
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Interactive Case Study: Short Shelf-life Cell and Gene Products: Assessing Alternatives and Ensuring Patient Safety
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Presenter: Elizabeth Lessey-Morillon, PhD, Senior Biologist, OTP, CBER, U.S. FDA
Elizabeth Lessey-Morillon, PhD, Senior Biologist, OTP, CBER, U.S. FDA
Liz Lessey-Morillon, PhD, is a Senior Biologist in the Office of Cellular Therapy and Human Tissue CMC, Office of Therapeutic Products, CBER, where she reviews manufacturing information for cell therapy products. Dr. Elizabeth Lessey-Morillon received her Ph.D. in Cell and Developmental Biology from the University of North Carolina at Chapel Hill. She did her postdoctoral fellowship at the National Cancer Institute (NCI) at the National Institutes of Health in Bethesda, MD. She then became an NCI/U.S. Food and Drug Administration (FDA) Interagency Oncology Task Force Fellow where she conducted research and regulatory review of cell therapies at the FDA before transitioning to her current role as CMC reviewer.
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Report Out and Discssion
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Networking Break in the Exhibit Area
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P4: Releasing the Power of Alternative Microbiological Methods
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Kevin I. Wright, PhD, Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble
With 30 years experience in Microbiology and Life Sciences challenges in the Fast Moving Consumer Goods Industry, spanning R&D and industrial microbiology- I have worked across various regulated sectors for non-sterile products (Health, Home and Beauty Care). This journey has involved novel technologies, new products, and new/reapplied methods, covering both upstream and downstream applications and with solutions and innovation enabed through a combination of internal research, external collaborations (Academic & SME) and participation in cross industry groups (Kilmer/Microbiology Modernisation Cross Industry Consortium, PDA, PharMiG). As an industrial microbiologist, this has led to a consideration of a range of interconnected topics including biofilms, traditional, analytical and molecular methods, modelling and the integration of different manufacturing operations to deliver a quality end point. Most recently my focus has been on the application of these alternate approaches and measurements to microbiology in the assessment of the end to end quality of manufactured P&G products to facilitate rapid release, including Solid and liquid phase cytometry, molecular, Raman spectroscopy, guided mode resonance and digital integration in the supply chain as a quality metrics for in line and finished product release testing.
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Introduction: Progressing to AMM Use in Quality Manufacturing Versus Quality Release
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Kevin I. Wright, PhD, Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble
With 30 years experience in Microbiology and Life Sciences challenges in the Fast Moving Consumer Goods Industry, spanning R&D and industrial microbiology- I have worked across various regulated sectors for non-sterile products (Health, Home and Beauty Care). This journey has involved novel technologies, new products, and new/reapplied methods, covering both upstream and downstream applications and with solutions and innovation enabed through a combination of internal research, external collaborations (Academic & SME) and participation in cross industry groups (Kilmer/Microbiology Modernisation Cross Industry Consortium, PDA, PharMiG). As an industrial microbiologist, this has led to a consideration of a range of interconnected topics including biofilms, traditional, analytical and molecular methods, modelling and the integration of different manufacturing operations to deliver a quality end point. Most recently my focus has been on the application of these alternate approaches and measurements to microbiology in the assessment of the end to end quality of manufactured P&G products to facilitate rapid release, including Solid and liquid phase cytometry, molecular, Raman spectroscopy, guided mode resonance and digital integration in the supply chain as a quality metrics for in line and finished product release testing.
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Integration of Rapid Bioburden Testing into Production Quality Management Systems and Process Control
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Presenter: Irina Ramos, PhD, Director of Bioprocess Technology and Engineering, AstraZeneca
Irina Ramos, PhD, Director of Bioprocess Technology and Engineering, AstraZeneca
Irina Ramos is a director of downstream continuous manufacturing, in the Bioprocess Engineering and Technology group at AstraZeneca in Gaithersburg, MD, USA. She has been a key driver of the technology development and implementation strategy for continuous biomanufacturing. Her team works to increase fundamental understanding of the various downstream unit operations of drug substance manufacturing. They manage the design, testing and qualification of process equipment and automation on the systems to integrate them. Irina holds a BS/MS in Chemical Engineering from University of Porto (Portugal) and a PhD in Chemical & Biochemical Engineering from University of Maryland, Baltimore County (UMBC). For the past 14 years, Irina’s work in the pharmaceutical industry has spanned from early to late-stage process development and validation, process scalability, CMC and technology transfer to both clinical and commercial manufacturing. With that experience, Irina lead process transfer efforts of the AZ COVID-19 vaccine. She has been involved with NIIMBL Process Intensification program by leading the Control Strategy workstream since 2020. Irina has been teaching a graduate level classes on Biotechnology Master program since 2015. She is passionate about mentorship and developing resources to improve the communication of science.
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Designing a Risk Strategy Using the Current Regulations to Replace Traditional Methods
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Presenter: Terra Kremer, PhD, Director of Microbiological Quality, Johnson & Johnson
Terra Kremer, PhD, Director of Microbiological Quality, Johnson & Johnson
Terra Kremer is the Director, Microbiological Quality at Johnson & Johnson and provides technical, strategic, and leadership support to the Johnson & Johnson Microbiological Quality & Sterility Assurance organization. She is responsible for the acceleration of innovation for microbiological qualify of pharmaceutical and medical devices within Johnson & Johnson. Terra has significant experience in both the Chemistry arena as well as Microbiology. She has authored and co-authored a number of scientific publications and has worked on Tiger Teams in relation to Rapid Micro Methods and Device Processing. Terra is an Analytical Chemist and has 20 years of experience in laboratory testing of medical device, pharmaceutical and tissue products and is a PhD candidate for Microbiology. She is based in New Jersey and routinely collaborates with scientists around the globe to bring innovative new approaches to the industry.
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A Future of MQL and Managing Risk Release
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Presenter: John Logar, Director, Radiation Sterilization, Johnson & Johnson
John Logar, Director, Radiation Sterilization, Johnson & Johnson
John Logar is the Senior Director, Sterility Assurance at J&J Microbiological Quality and Sterility Assurance (MQSA) and is responsible for leading technical subject matter experts (SP6) in support of aseptic processing and sterilization activities across Johnson & Johnson and is responsible for the sterilization operations at the R&D center in Raritan, NJ. John serves as a member of the J&J MQSA Leadership Team and is a co-lead for the Kilmer Collaboration Teams. In addition, he helped to bring back the J&J Kilmer Conference and served as the conference program chair in 2016, 2019 and 2022.
John has 25+ years of experience in sterility assurance of healthcare products and is an industry recognized expert in radiation sterilization as well as a strategic leader in the development and implementation of consensus standards and training programs. He served on the ASTM International Board of Directors for 9 years and served as the Chair of the Board in 2021. Currently, he is the chair of ASTM committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products and serves on the executive committee of ASTM Committee E61 on Radiation Processing: Dosimetry and Applications. In addition, John serves as the Convener of ISO/TC85 WG3 on Radiation Dosimetry.
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Networking Lunch
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P5: From Cultures to Code: Alternative Microbiology at the Molecular Level
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Moderator: Olivia Venhuizen, PhD, Process Development Principal Scientist, Amgen Inc.
Olivia Venhuizen, PhD, Process Development Principal Scientist, Amgen Inc.
Olivia joined Amgen in 2019 as Process Development Principal Scientist in the Cellular Sciences Microbiology group. Her working experiences include research in microbiology and virology as well as quality and manufacturing technical support.
Olivia holds an MS from California State University Northridge, an MPH from Yale University, and a PhD from UCLA. She is a former CDC/APHL Emerging Infectious Diseases Fellow.
Olivia facilitates efforts in the evaluation of innovative microbiological technologies, the development, and improvement of methods, and the development of microbial control strategies. She also supports subjects associated with the manufacturing of drug substances and drug products where microbiology expertise or guidance is needed.
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Detecting DNA: Past, Present, and Future
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Presenter: Cliff Hogan, PhD, Environmental Monitoring Manager, FUJIFILM Cellular Dynamics
Cliff Hogan, PhD, Environmental Monitoring Manager, FUJIFILM Cellular Dynamics
Cliff Hogan joined Fujifilm Cellular Dynamics, Inc (FCDI). in 2023 as the Environmental Monitoring Manager in the Therapeutics Quality Control group. In this role, Cliff manages all aspects of the environmental monitoring (EM) program in FCDI’s Cellular Therapeutics manufacturing facilities, including improvements to the EM program such as implementation of rapid molecular methods. Cliff has over 10 years of experience in diverse roles across the biotech industry including: developing and implementing molecular contamination testing in the agriculture industry, leading quality control for production of molecular biology reagents, and managing risk while guiding a team of R&D scientists developing products to expand the capabilities of next-generation sequencing. Cliff holds a BS in Biology, MS in Bacteriology and PhD in Microbiology, all from the University of Wisconsin- Madison, as well as completing a post-doc with the USDA Agricultural Research Service. Cliff’s PhD research focused on development of tools for analysis of bacterial gene regulation during pathogenesis, and his MS research focused on metagenomic analysis of changes in environmental microbial community structure after exposure to antibiotics. -
Presenter: Amy L. McDaniel, PhD, Director, Microbial Center of Excellence & Operations, Bristol Myers Squibb
Amy L. McDaniel, PhD, Director, Microbial Center of Excellence & Operations, Bristol Myers Squibb
Amy McDaniel is the Microbiology Center of Excellence & Operations Leader at BMS, based in New Brunswick, NJ. In this role she oversees microbiology methods globally, leads the laboratory function for the Clinical Supply Operation at the New Brunswick facility, supports network initiatives on microbiology, and is responsible for bringing new technologies into BMS. Prior to Bristol Myers, Amy worked as a microbiology reviewer at the FDA in CDER, where she assessed applications for sterile pharmaceutical drug products. She also has 18 years of experience in various roles in biotechnology at Pfizer, including QC Microbiology, Manufacturing, Technical Operations, and Quality Assurance. Amy has written numerous articles and given many presentations on rapid microbiology methods and risk assessments in microbiology.
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Implementing Molecular Methods Part 1: Mycoplasma Testing
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Presenter: Cliff Hogan, PhD, Environmental Monitoring Manager, FUJIFILM Cellular Dynamics
Cliff Hogan, PhD, Environmental Monitoring Manager, FUJIFILM Cellular Dynamics
Cliff Hogan joined Fujifilm Cellular Dynamics, Inc (FCDI). in 2023 as the Environmental Monitoring Manager in the Therapeutics Quality Control group. In this role, Cliff manages all aspects of the environmental monitoring (EM) program in FCDI’s Cellular Therapeutics manufacturing facilities, including improvements to the EM program such as implementation of rapid molecular methods. Cliff has over 10 years of experience in diverse roles across the biotech industry including: developing and implementing molecular contamination testing in the agriculture industry, leading quality control for production of molecular biology reagents, and managing risk while guiding a team of R&D scientists developing products to expand the capabilities of next-generation sequencing. Cliff holds a BS in Biology, MS in Bacteriology and PhD in Microbiology, all from the University of Wisconsin- Madison, as well as completing a post-doc with the USDA Agricultural Research Service. Cliff’s PhD research focused on development of tools for analysis of bacterial gene regulation during pathogenesis, and his MS research focused on metagenomic analysis of changes in environmental microbial community structure after exposure to antibiotics. -
Presenter: Amy L. McDaniel, PhD, Director, Microbial Center of Excellence & Operations, Bristol Myers Squibb
Amy L. McDaniel, PhD, Director, Microbial Center of Excellence & Operations, Bristol Myers Squibb
Amy McDaniel is the Microbiology Center of Excellence & Operations Leader at BMS, based in New Brunswick, NJ. In this role she oversees microbiology methods globally, leads the laboratory function for the Clinical Supply Operation at the New Brunswick facility, supports network initiatives on microbiology, and is responsible for bringing new technologies into BMS. Prior to Bristol Myers, Amy worked as a microbiology reviewer at the FDA in CDER, where she assessed applications for sterile pharmaceutical drug products. She also has 18 years of experience in various roles in biotechnology at Pfizer, including QC Microbiology, Manufacturing, Technical Operations, and Quality Assurance. Amy has written numerous articles and given many presentations on rapid microbiology methods and risk assessments in microbiology.
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Implementing Molecular Methods Part 2: Sterility Testing
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Presenter: Cliff Hogan, PhD, Environmental Monitoring Manager, FUJIFILM Cellular Dynamics
Cliff Hogan, PhD, Environmental Monitoring Manager, FUJIFILM Cellular Dynamics
Cliff Hogan joined Fujifilm Cellular Dynamics, Inc (FCDI). in 2023 as the Environmental Monitoring Manager in the Therapeutics Quality Control group. In this role, Cliff manages all aspects of the environmental monitoring (EM) program in FCDI’s Cellular Therapeutics manufacturing facilities, including improvements to the EM program such as implementation of rapid molecular methods. Cliff has over 10 years of experience in diverse roles across the biotech industry including: developing and implementing molecular contamination testing in the agriculture industry, leading quality control for production of molecular biology reagents, and managing risk while guiding a team of R&D scientists developing products to expand the capabilities of next-generation sequencing. Cliff holds a BS in Biology, MS in Bacteriology and PhD in Microbiology, all from the University of Wisconsin- Madison, as well as completing a post-doc with the USDA Agricultural Research Service. Cliff’s PhD research focused on development of tools for analysis of bacterial gene regulation during pathogenesis, and his MS research focused on metagenomic analysis of changes in environmental microbial community structure after exposure to antibiotics. -
Presenter: Amy L. McDaniel, PhD, Director, Microbial Center of Excellence & Operations, Bristol Myers Squibb
Amy L. McDaniel, PhD, Director, Microbial Center of Excellence & Operations, Bristol Myers Squibb
Amy McDaniel is the Microbiology Center of Excellence & Operations Leader at BMS, based in New Brunswick, NJ. In this role she oversees microbiology methods globally, leads the laboratory function for the Clinical Supply Operation at the New Brunswick facility, supports network initiatives on microbiology, and is responsible for bringing new technologies into BMS. Prior to Bristol Myers, Amy worked as a microbiology reviewer at the FDA in CDER, where she assessed applications for sterile pharmaceutical drug products. She also has 18 years of experience in various roles in biotechnology at Pfizer, including QC Microbiology, Manufacturing, Technical Operations, and Quality Assurance. Amy has written numerous articles and given many presentations on rapid microbiology methods and risk assessments in microbiology.
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Networking Break in the Exhibit Area
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P6: Future Directions for Alternative Microbiological Methods
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Moderator: Marc Glogovsky, MS, Business Unit Manager - Microbiology, ValSource, Inc.
Marc Glogovsky, MS, Business Unit Manager - Microbiology, ValSource, Inc.
Marc Glogovsky is currently managing the microbiology consulting division at ValSource, Inc. His career spans more than 25 years in the pharmaceutical industry, in various microbiology and management roles. In his current position, Marc focuses on development of contamination control strategies, implementation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs. He has been an active PDA member for over 25 years and is presently serving on the Board of Directors and on the planning committee for the PDA/FDA Joint Regulatory Conference. Additionally, Marc has chaired several Technical Reports and Points to Consider publications and served on the Education, Science and ATMP Advisory Boards. In 2020, Marc was the recipient of the James P. Agalloco award for his efforts at PDA's Training and Research Institute, the 2022 Michael Korczynski Award for his support of PDA's international activities and a Service Appreciation Award in 2023 for his time spent as the Microbiology/EM Interest Group Leader. Marc earned his BS in Biology from Monmouth University and his MS in Microbiology & Molecular Genetics from Rutgers University.
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Rapid Alternative Microbiology Methods: Stalled Progress or on the Verge of a Breakthrough?
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Presenter: Kumbirai Dhliwayo, MS, Founder and Principal Consultant, Kumby Consulting
Kumbirai Dhliwayo, MS, Founder and Principal Consultant, Kumby Consulting
Kumbirai (Kumby) Dhliwayo is a pharmaceutical microbiologist with over 14 years of experience in Quality Control, Validation, and Contamination Control. As the Founder and Principal Consultant of Kumby Consulting, Kumby provides strategic guidance based on his comprehensive experience. His background includes various analyst and management positions within the Bio-pharmaceutical, Biotech, and Medical device industries. This experience provides him with a well-rounded perspective that he brings to his consulting work. Kumby holds a Bachelor of Science in Microbiology with a Minor in Economics, a Master of Science in Operations and Project Management and a Master of Science in Regulatory Affairs & Health Policy.
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The Evolution of Alternative Microbiological Methods: Audience Insights
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Report Out and Discussion
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Closing Remarks from Workshop Chair
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Moderator: Marc Glogovsky, MS, Business Unit Manager - Microbiology, ValSource, Inc.
Marc Glogovsky, MS, Business Unit Manager - Microbiology, ValSource, Inc.
Marc Glogovsky is currently managing the microbiology consulting division at ValSource, Inc. His career spans more than 25 years in the pharmaceutical industry, in various microbiology and management roles. In his current position, Marc focuses on development of contamination control strategies, implementation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs. He has been an active PDA member for over 25 years and is presently serving on the Board of Directors and on the planning committee for the PDA/FDA Joint Regulatory Conference. Additionally, Marc has chaired several Technical Reports and Points to Consider publications and served on the Education, Science and ATMP Advisory Boards. In 2020, Marc was the recipient of the James P. Agalloco award for his efforts at PDA's Training and Research Institute, the 2022 Michael Korczynski Award for his support of PDA's international activities and a Service Appreciation Award in 2023 for his time spent as the Microbiology/EM Interest Group Leader. Marc earned his BS in Biology from Monmouth University and his MS in Microbiology & Molecular Genetics from Rutgers University.
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Presenters
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Ian F. Deveau, PhD
Division Director, OC, CDER, U.S. FDA
Presenter
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Ian F. Deveau, PhD
U.S. FDA
Ian Deveau is Deputy Director for Quality in the Office of Compounding Quality and Compliance (OCQC), Office of Compliance, CDER. Dr. Deveau oversees the efforts to protect the American public from poor quality drug products and ensure compliance of firms authorized by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). Dr. Deveau is a subject matter expert on sterile drug production, Current Good Manufacturing Practices (21 CFR 210, 211 & 212), and pharmacy compounding practices (USP <795> and <797>).
Dr. Deveau received a Bachelor’s in Biology at Buffalo State University and holds a PhD in Biology from The Pennsylvania State University with minors in Microbiology, Chemistry, and Biochemistry. Prior to joining CDER, he was a chemist and GLP Study Director at FDA’s Center for Veterinary Medicine, followed by 9 years at the U.S. Pharmacopeia involved in developing standards for microbial control of drug manufacturing, blood and blood products, vaccines, biologics and biotechnology products, radiopharmaceuticals & medical imaging agents, and veterinary drugs.
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Kumbirai Dhliwayo, MS
Founder and Principal Consultant, Kumby Consulting
Presenter
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Kumbirai Dhliwayo, MS
Kumby Consulting
Kumbirai (Kumby) Dhliwayo is a pharmaceutical microbiologist with over 14 years of experience in Quality Control, Validation, and Contamination Control. As the Founder and Principal Consultant of Kumby Consulting, Kumby provides strategic guidance based on his comprehensive experience. His background includes various analyst and management positions within the Bio-pharmaceutical, Biotech, and Medical device industries. This experience provides him with a well-rounded perspective that he brings to his consulting work. Kumby holds a Bachelor of Science in Microbiology with a Minor in Economics, a Master of Science in Operations and Project Management and a Master of Science in Regulatory Affairs & Health Policy. -
Marc Glogovsky, MS
Business Unit Manager - Microbiology, ValSource, Inc.
Chair
Moderator
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Marc Glogovsky, MS
ValSource, Inc.
Marc Glogovsky is currently managing the microbiology consulting division at ValSource, Inc. His career spans more than 25 years in the pharmaceutical industry, in various microbiology and management roles. In his current position, Marc focuses on development of contamination control strategies, implementation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs. He has been an active PDA member for over 25 years and is presently serving on the Board of Directors and on the planning committee for the PDA/FDA Joint Regulatory Conference. Additionally, Marc has chaired several Technical Reports and Points to Consider publications and served on the Education, Science and ATMP Advisory Boards. In 2020, Marc was the recipient of the James P. Agalloco award for his efforts at PDA's Training and Research Institute, the 2022 Michael Korczynski Award for his support of PDA's international activities and a Service Appreciation Award in 2023 for his time spent as the Microbiology/EM Interest Group Leader. Marc earned his BS in Biology from Monmouth University and his MS in Microbiology & Molecular Genetics from Rutgers University. -
Cliff Hogan, PhD
Environmental Monitoring Manager, FUJIFILM Cellular Dynamics
Presenter
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Cliff Hogan, PhD
FUJIFILM Cellular Dynamics
Cliff Hogan joined Fujifilm Cellular Dynamics, Inc (FCDI). in 2023 as the Environmental Monitoring Manager in the Therapeutics Quality Control group. In this role, Cliff manages all aspects of the environmental monitoring (EM) program in FCDI’s Cellular Therapeutics manufacturing facilities, including improvements to the EM program such as implementation of rapid molecular methods. Cliff has over 10 years of experience in diverse roles across the biotech industry including: developing and implementing molecular contamination testing in the agriculture industry, leading quality control for production of molecular biology reagents, and managing risk while guiding a team of R&D scientists developing products to expand the capabilities of next-generation sequencing. Cliff holds a BS in Biology, MS in Bacteriology and PhD in Microbiology, all from the University of Wisconsin- Madison, as well as completing a post-doc with the USDA Agricultural Research Service. Cliff’s PhD research focused on development of tools for analysis of bacterial gene regulation during pathogenesis, and his MS research focused on metagenomic analysis of changes in environmental microbial community structure after exposure to antibiotics. -
Andrew D Hopkins, PGDip
Director, Operation Quality QA Audit and Compliance, AbbVie
Presenter
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Andrew D Hopkins, PGDip
AbbVie
Andrew Hopkins has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His has worked in the industry over 40 years Currently Andrew is a Director of Compliance at Abbvie with responsiblity for Microbiological contamination the role includes developing long term financial strategy for site investment, assessment of manufacturing sites andTraining and mentoring. Prior to this, Andrew was an Inspector with the MHRA for nearly 14 years. This included: • Inspections across the world, including inspections with a number of other regulators (USFDA, TGA, TFDA and Health Canada) in several areas including, sterile products, biological products, blood components and plasma. • Chairperson of the Inspectorates CMT (working with marginally compliant companies) • Part of the MHRAs inspection Action Group (taking actions regarding non-compliant sites) • Inspector training and mentoring • Invovled in writing of regulatory guidance documents including: o MHRAs Data Integrity guidance o EMA guidance on water systems o Chaired the working group for the revision of Annex 1 • Supporting industry bodies with technical monographs e.g. PDA TR1 and PHSS TM20. Before joining the MHRA Andrew worked for more than 20 years in various areas and technologies in the Pharmaceutical industry. -
Terra Kremer, PhD
Director of Microbiological Quality, Johnson & Johnson
Presenter
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Terra Kremer, PhD
Johnson & Johnson
Terra Kremer is the Director, Microbiological Quality at Johnson & Johnson and provides technical, strategic, and leadership support to the Johnson & Johnson Microbiological Quality & Sterility Assurance organization. She is responsible for the acceleration of innovation for microbiological qualify of pharmaceutical and medical devices within Johnson & Johnson. Terra has significant experience in both the Chemistry arena as well as Microbiology. She has authored and co-authored a number of scientific publications and has worked on Tiger Teams in relation to Rapid Micro Methods and Device Processing. Terra is an Analytical Chemist and has 20 years of experience in laboratory testing of medical device, pharmaceutical and tissue products and is a PhD candidate for Microbiology. She is based in New Jersey and routinely collaborates with scientists around the globe to bring innovative new approaches to the industry. -
Elizabeth Lessey-Morillon, PhD
Senior Biologist, OTP, CBER, U.S. FDA
Presenter
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Elizabeth Lessey-Morillon, PhD
U.S. FDA
Liz Lessey-Morillon, PhD, is a Senior Biologist in the Office of Cellular Therapy and Human Tissue CMC, Office of Therapeutic Products, CBER, where she reviews manufacturing information for cell therapy products. Dr. Elizabeth Lessey-Morillon received her Ph.D. in Cell and Developmental Biology from the University of North Carolina at Chapel Hill. She did her postdoctoral fellowship at the National Cancer Institute (NCI) at the National Institutes of Health in Bethesda, MD. She then became an NCI/U.S. Food and Drug Administration (FDA) Interagency Oncology Task Force Fellow where she conducted research and regulatory review of cell therapies at the FDA before transitioning to her current role as CMC reviewer. -
John Logar
Director, Radiation Sterilization, Johnson & Johnson
Presenter
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John Logar
Johnson & Johnson
John Logar is the Senior Director, Sterility Assurance at J&J Microbiological Quality and Sterility Assurance (MQSA) and is responsible for leading technical subject matter experts (SP6) in support of aseptic processing and sterilization activities across Johnson & Johnson and is responsible for the sterilization operations at the R&D center in Raritan, NJ. John serves as a member of the J&J MQSA Leadership Team and is a co-lead for the Kilmer Collaboration Teams. In addition, he helped to bring back the J&J Kilmer Conference and served as the conference program chair in 2016, 2019 and 2022.
John has 25+ years of experience in sterility assurance of healthcare products and is an industry recognized expert in radiation sterilization as well as a strategic leader in the development and implementation of consensus standards and training programs. He served on the ASTM International Board of Directors for 9 years and served as the Chair of the Board in 2021. Currently, he is the chair of ASTM committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products and serves on the executive committee of ASTM Committee E61 on Radiation Processing: Dosimetry and Applications. In addition, John serves as the Convener of ISO/TC85 WG3 on Radiation Dosimetry.
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Amy L. McDaniel, PhD
Director, Microbial Center of Excellence & Operations, Bristol Myers Squibb
Presenter
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Amy L. McDaniel, PhD
Bristol Myers Squibb
Amy McDaniel is the Microbiology Center of Excellence & Operations Leader at BMS, based in New Brunswick, NJ. In this role she oversees microbiology methods globally, leads the laboratory function for the Clinical Supply Operation at the New Brunswick facility, supports network initiatives on microbiology, and is responsible for bringing new technologies into BMS. Prior to Bristol Myers, Amy worked as a microbiology reviewer at the FDA in CDER, where she assessed applications for sterile pharmaceutical drug products. She also has 18 years of experience in various roles in biotechnology at Pfizer, including QC Microbiology, Manufacturing, Technical Operations, and Quality Assurance. Amy has written numerous articles and given many presentations on rapid microbiology methods and risk assessments in microbiology. -
Michael J. Miller, PhD
President, Microbiology Consultants, LLC
Presenter
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Michael J. Miller, PhD
Microbiology Consultants, LLC
Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology, contamination control and the validation of rapid microbiological methods. He is the President of Microbiology Consultants, LLC (http://microbiologyconsultants.com) and owner of http://rapidmicromethods.com, an educational website dedicated to the advancement of rapid microbiological methods.
For more than 35 years, he has held numerous R&D, manufacturing, quality, business development and executive leadership roles at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb, and his consulting company. In his current role, Dr. Miller advises multinational companies in the areas of pharmaceutical microbiology, quality and regulatory affairs, sterile and non-sterile pharmaceutical manufacturing, contamination control and teh validation of alternative and rapid microbiological methods.
Dr. Miller has authored more than 100 technical publications and presentations and currently serves on the editorial and scientific review boards for American Pharmaceutical Review, European Pharmaceutical Review and the PDA Journal. Dr. Miller is the co-chair for the PDA Technical Report #33 revision team and has served as an advisor to the USP Microbiology Expert Committee.
Dr. Miller holds a PhD in Microbiology and Biochemistry from Georgia State University (GSU), a BA in Anthropology and Sociology from Hobart College. -
Christopher A. Murdock, PhD, CQA
VP, Sterility Assurance and Microbiology Support, Eli Lilly and Company
Committee Member
Moderator
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Christopher A. Murdock, PhD, CQA
Eli Lilly and Company
Chris Murdock, PhD holds a BS and MS in Microbiology from the University of Memphis and a PhD from Rutgers University in Molecular Microbiology. Chris has over 35 years of industry experience in microbiology, sterility assurance and sterile quality in both laboratory and operational roles. He has worked in contract manufacturing organizations as well as small, mid-size and large pharmaceutical, biotech and medical device organizations. Dr. Murdock has extensive experience in sterile quality, aseptic processing, nonsterile manufacturing as well as both development and commercial production. Dr. Murdock also has extensive experience in compliance and auditing requirements, has supported and led domestic and international Health Authority inspections and is a ASQ and ISO Certified Auditor and Specialist Microbiologist (NRCM). Chris is the current chair of the Pharmaceutical Microbiology Expert Discussion Group and previously served on the USP Microbiology Water Committee. Chris served as the Co-lead author for the PDA Technical Report TR 13-2, Environmental Monitoring of Facilities Manufacturing Low Bioburden Products, PDA Technical Report TR 88, Microbial Data Deviation Investigations in the Pharmaceutical Industry and PDA Technical Report TR 90 for Contamination Control Strategy Development in Pharmaceutical Manufacturing. -
Irina Ramos, PhD
Director of Bioprocess Technology and Engineering, AstraZeneca
Presenter
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Irina Ramos, PhD
AstraZeneca
Irina Ramos is a director of downstream continuous manufacturing, in the Bioprocess Engineering and Technology group at AstraZeneca in Gaithersburg, MD, USA. She has been a key driver of the technology development and implementation strategy for continuous biomanufacturing. Her team works to increase fundamental understanding of the various downstream unit operations of drug substance manufacturing. They manage the design, testing and qualification of process equipment and automation on the systems to integrate them. Irina holds a BS/MS in Chemical Engineering from University of Porto (Portugal) and a PhD in Chemical & Biochemical Engineering from University of Maryland, Baltimore County (UMBC). For the past 14 years, Irina’s work in the pharmaceutical industry has spanned from early to late-stage process development and validation, process scalability, CMC and technology transfer to both clinical and commercial manufacturing. With that experience, Irina lead process transfer efforts of the AZ COVID-19 vaccine. She has been involved with NIIMBL Process Intensification program by leading the Control Strategy workstream since 2020. Irina has been teaching a graduate level classes on Biotechnology Master program since 2015. She is passionate about mentorship and developing resources to improve the communication of science. -
Olivia Venhuizen, PhD
Process Development Principal Scientist, Amgen Inc.
Committee Member
Moderator
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Olivia Venhuizen, PhD
Amgen Inc.
Olivia joined Amgen in 2019 as Process Development Principal Scientist in the Cellular Sciences Microbiology group. Her working experiences include research in microbiology and virology as well as quality and manufacturing technical support.
Olivia holds an MS from California State University Northridge, an MPH from Yale University, and a PhD from UCLA. She is a former CDC/APHL Emerging Infectious Diseases Fellow.
Olivia facilitates efforts in the evaluation of innovative microbiological technologies, the development, and improvement of methods, and the development of microbial control strategies. She also supports subjects associated with the manufacturing of drug substances and drug products where microbiology expertise or guidance is needed.
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Erin A. Wall, PhD
Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA
Committee Member
Moderator
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Erin A. Wall, PhD
U.S. FDA
Dr. Erin A. Wall is a Senior Pharmaceutical Quality Assessor at the FDA in the CDER Office of Pharmaceutical Quality, Office of Pharmaceutical Manufacturing Assessment. She is a microbiologist who serves as a subject matter expert on manufacturing process and facility risks to liquid drug products. Dr. Wall has led and co-led division and office-wide trainings on different topics in manufacturing assessment. She has repeatedly volunteered to teach others when new topics are introduced to assessors in her discipline. Dr. Wall organized a data research project with an ORISE fellow to determine common deficiencies in ANDA applications in the Quality Microbiology discipline. This work eventually led to the formation of a working group which proposes collation and analysis of Quality Microbiology assessment data and information requests to inform future assessment. She continues to prioritize data analytics to improve the assessment process. Before joining the FDA, Dr. Wall was a postdoctoral fellow in the lab of Susan Gottesman at the National Cancer Institute where she analyzed protein/protein interactions in a multicomponent signalling pathway in Enterobacteriaceae. Her graduate work under the mentorship of Gail Christie uncovered a novel drug target in Staphylococcus aureus and assessed its structure and function. -
Kevin I. Wright, PhD
Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble
Committee Member
Moderator
Presenter
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Kevin I. Wright, PhD
Procter & Gamble
With 30 years experience in Microbiology and Life Sciences challenges in the Fast Moving Consumer Goods Industry, spanning R&D and industrial microbiology- I have worked across various regulated sectors for non-sterile products (Health, Home and Beauty Care). This journey has involved novel technologies, new products, and new/reapplied methods, covering both upstream and downstream applications and with solutions and innovation enabed through a combination of internal research, external collaborations (Academic & SME) and participation in cross industry groups (Kilmer/Microbiology Modernisation Cross Industry Consortium, PDA, PharMiG). As an industrial microbiologist, this has led to a consideration of a range of interconnected topics including biofilms, traditional, analytical and molecular methods, modelling and the integration of different manufacturing operations to deliver a quality end point. Most recently my focus has been on the application of these alternate approaches and measurements to microbiology in the assessment of the end to end quality of manufactured P&G products to facilitate rapid release, including Solid and liquid phase cytometry, molecular, Raman spectroscopy, guided mode resonance and digital integration in the supply chain as a quality metrics for in line and finished product release testing.
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