PDA Alternative Microbiological Methods Workshop 2024

Wednesday, 9 October EDT

• 12:00 – 17:30

  Registration Open
• 14:00 – 15:30

  P1: Evolution of Alternative Microbiological Methods and Regulatory Insights

  • 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.

  Dive into the past twenty-year evolution of alternative microbiological methods and regulatory insights. Explore the change drivers, including modalities and the critical time to result for short-shelf-life release testing, shaping current industry needs. Discuss emerging next-generation scientific technologies and the key enablers facilitating the adoption of alternative methods. The second half of the plenary is focused on a comprehensive understanding of the regulatory advancements and their impact on alternative methods in the pharmaceutical, compounding, and biologics products domain. Current and former health authority regulators will share invaluable insights, including initial observations, concerns, current perspectives, and adaptations of alternative methods.

  • 14:00 – 14:15

    Welcome and Opening Remarks from Workshop Chair

    • 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.

  • 14:15 – 14:40

    Current Industry and Regulatory Drivers for Alternative and Rapid Microbiological Methods

    • 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.

  • 14:40 – 15:05

    Alternative Microbial Methods: Perspectives from Both Sides

    • Presenter: Andrew D. Hopkins, BSc Hons PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie Inc.

      

      Andrew D. Hopkins, BSc Hons PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie Inc.
      

      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.

  • 15:05 – 15:30

    Q&A
• 15:30 – 16:00

  Networking Break in the Exhibit Area
• 16:00 – 17:30

  P2: Real-Life Challenges to Implementing AMM

  • Moderator: Christopher A. Murdock, PhD, CQA, VP, Sterility Assurance and Microbiology Support, Eli Lilly and Company

    

    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.

  During this session, we'll explore the historical and present challenges associated with various Alternative Microbiological Methods (AMM) technologies. We'll highlight key considerations necessary for successful implementation of a specific AMM. Additionally, participants will engage in a case study exercise to identify regulatory risks, technology hurdles, and potential costs involved in the process.

  • 16:00 – 16:15

    Overview and Introduction: Adopting AMMs is Easy, Right?

    • Presenter: Kevin I. Wright, PhD, Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble

      

      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.

  • 16:15 – 17:00

    Simulating the Company Experience of AMMs: Small Working Groups Challenge

    • Presenter: Kevin I. Wright, PhD, Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble

      

      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.

  • 17:00 – 17:30

    Report Out and Discussion
• 17:30 – 18:30

  Networking Reception in the Exhibit Area

Thursday, 10 October EDT

• 08:00 – 09:00

  Continental Breakfast
• 08:00 – 16:45

  Registration Open
• 09:00 – 10:30

  P3: Regulatory Expectations on Alternative Microbiological Methods

  • 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.

  Hear U.S. FDA’s perspective on alternative microbiological techniques proposed for compounded and short shelf-life biologic products. FDA representatives will share the necessary supporting controls, investigations, and validation data required for these alternative methods. Gain additional insights into the complexities of conducting sterility testing for cell-based biologic products and patient safety during the interactive case study discussion.

  • 09:00 – 09:20

    Alternative Sterility Test Methods for Compounded Products: Points to Consider

    • 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, PhD, Division Director (Acting), Office of Manufacturing Quality, 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 holds a Bachelor’s degree in Biology from Buffalo State University; and 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.

  • 09:20 – 09:30

    Q&A with Ian Deveau
  • 09:30 – 10:10

    Interactive Case Study: Short Shelf-life Cell and Gene Products: Assessing Alternatives and Ensuring Patient Safety

    • Presenter: Elizabeth Lessey-Morillon, PhD, Senior Biologist, OTP, CBER, U.S. FDA

      

      Elizabeth Lessey-Morillon, PhD, Senior Biologist, OTP, CBER, U.S. FDA
      

  • 10:10 – 10:30

    Report Out and Discssion
• 10:30 – 11:00

  Networking Break in the Exhibit Area
• 11:00 – 12:30

  P4: Releasing the Power of Alternative Microbiological Methods

  • Moderator: Kevin I. Wright, PhD, Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble

    

    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.

  Rapid alternative microbiology methods offer benefits for the timely quality release of the finished product, but one method may not be sufficient to replace the traditional method and fully comply with release specifications. Using examples and a case study, this session provides context for the use of alternative methods in sterile and hygienic manufacturing by employing a data-based approach from a finished product release focus to ensure measured process reliability and risk-managed release.

  • 11:00 – 11:10

    Introduction: Progressing to AMM Use in Quality Manufacturing Versus Quality Release

    • Presenter: Kevin I. Wright, PhD, Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble

      

      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.

  • 11:10 – 11:35

    Integration of Rapid Bioburden Testing into Production Quality Management Systems and Process Control

    • 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.

  • 11:35 – 12:15

    Designing a Risk Strategy Using the Current Regulations to Replace Traditional Methods

    • Presenter: Terra Kremer, Director of Microbiological Quality, Johnson & Johnson

      

      Terra Kremer, 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.

  • 12:15 – 12:30

    A Future of MQL and Managing Risk Release

    • Presenter: John Logar, Director, Radiation Sterilization, Johnson & Johnson

      

      John Logar, Director, Radiation Sterilization, Johnson & Johnson
      

• 12:30 – 13:30

  Networking Lunch
• 13:30 – 15:00

  P5: From Cultures to Code: Alternative Microbiology at the Molecular Level

  • 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.
    
    

  In this session, gain familiarity with the current landscape of available DNA-based products and systems, what to consider when choosing a product or system, the process for implementation including risks and benefits, and the featured applications. Alternative, rapid, and growth-based technologies can be used to support the release of cell and gene therapies in seven days compared to the 14-day compendial sterility test. This accelerated timing still poses challenges to products with the life-saving requirement for immediate administration. Many challenges cannot be foreseen by vendors of molecular kits and technologies. The promising lure of molecular methods and their unique challenges will be discussed and collaboratively debated in an interactive case study.

  • 13:30 – 13:50

    Detecting DNA: Past, Present, and Future

    • Presenter: Cliff Hogan, PhD, Environmental Monitoring Manager, FUJIFILM Cellular Dynamics

      

      Cliff Hogan, PhD, Environmental Monitoring Manager, FUJIFILM Cellular Dynamics
      

    • 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.

  • 13:50 – 14:15

    Implementing Molecular Methods Part 1: Mycoplasma Testing

    • Presenter: Cliff Hogan, PhD, Environmental Monitoring Manager, FUJIFILM Cellular Dynamics

      

      Cliff Hogan, PhD, Environmental Monitoring Manager, FUJIFILM Cellular Dynamics
      

    • 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.

  • 14:15 – 14:25

    Report Out and Discussion: Part 1
  • 14:25 – 14:50

    Implementing Molecular Methods Part 2: Sterility Testing

    • Presenter: Cliff Hogan, PhD, Environmental Monitoring Manager, FUJIFILM Cellular Dynamics

      

      Cliff Hogan, PhD, Environmental Monitoring Manager, FUJIFILM Cellular Dynamics
      

    • 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.

  • 14:50 – 15:00

    Report Out and Discussion: Part 2
• 15:00 – 15:30

  Networking Break in the Exhibit Area
• 15:30 – 17:00

  P6: Future Directions for Alternative Microbiological Methods

  • 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.

  Microbiology laboratories often rely on traditional methods, which can limit efficient contamination control. This session delves into the current state and future potential of rapid alternative microbiology methods (AMM), examining their benefits and the challenges that may hinder their widespread adoption. By understanding these challenges, we can develop strategies to address them and unlock the full potential of rapid AMM. These advanced technologies promise to significantly reduce errors associated with manual processes, thereby enhancing contamination control and product quality. The presentation will also explore the potential role of Artificial Intelligence (AI) in facilitating the adoption and advancement of rapid AMM. AI integration could revolutionize these technologies, making them more accessible and effective. To conclude, we invite you to participate in an open discussion about the future of AMM. Share your thoughts, insights, and ideas on how we can collectively shape the evolution of microbiological methods.

  • 15:30 – 15:50

    Rapid Alternative Microbiology Methods: Stalled Progress or on the Verge of a Breakthrough?

    • 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.

  • 15:50 – 16:45

    The Evolution of Alternative Microbiological Methods: Audience Insights
  • 16:30 – 16:55

    Report Out and Discussion
  • 16:45 – 17:00

    Closing Remarks from Workshop Chair

    • 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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