Committee & Presenter Biographies

Fred was a student-athlete at Franklin College of Indiana and participated in the college’s Leadership Program while graduating in 1999 with a Bachelor of Arts (BA) in Biology.  After graduating, he spent time in the contract manufacturing industries, prior to joining Eli Lilly in 2001. Mr. Ayers has held various roles within the Quality and Technical Services organizations. In each position Fred has helped advance Lilly's state of regulatory compliance and is regarded as a Sterility Assurance Subject Matter Expert. For Lilly's Indianapolis Parenteral Manufacturing site, he had the responsibility of the development, implementation, and continuous improvement for the site's sterility assurance programs. As an Advisor for the Global Quality Standards organization, Fred is responsible for ensuring the Lilly Quality Standards for the Sterility Assurance Programs evolve with global regulatory expectations. He is driving technical leadership through external focus and engagement throughout the bio-pharmaceutical industry to influence the direction of regulatory expectations. Fred has been a strong supporter and contributor to local and national PDA events including being a PDA Midwest Chapter Board Member since 2014, serving as the President from 2020-2021, and is a current PDA Science Advisory Board member.

Liz Brockson is an Aseptic Processing and Sterility Assurance Lead in Global Sterility Assurance and Microbiology at Takeda and is based out of Minneapolis, MN. Liz has a background in benchtop microbiology and immunology, as well as over 7 years of experience in FDA-regulated businesses as a quality assurance and quality control technical professional. In her current role, Liz is responsible for leading the design and implementation of Takeda's global manufacturing sterility assurance program. Liz holds a Bachelor’s degree in Animal Sciences and a Master’s degree in Public Health, both from The Ohio State University.

Phil Duncanson is the Chief Microbiologist for AstraZeneca has over 20 years of experience in pharmaceutical, industrial and clinical microbiology. Phil has a Bachelor’s degree in Genetics with Microbiology from The University of Leeds and obtained a Doctoral Degree in Parasitology from The University of Salford, both in the United Kingdom. At AstraZeneca, Phil is responsible for global strategy and standardization for QC labs. Phil is currently a member of the U.S. Pharmacopeia Microbiology Expert Committee, part of the USP 2020-2025 Council of Experts.

Irving Ford is currently the VP of Quality at Adaptimmune and has over 29 years of QA/QC experience in pharmaceutical/biotechnology and cell/gene therapies industries.

Prior to joining Adaptimmune, Irving was a significant contributor for activities supporting the regulatory filings and commercial approval of BMS’ CAR T products Abecma and Breyanzi as well as Novartis’ CAR T product Kymriah.

Irving is an active member of PDA and has served on several planning committees for various PDA Conferences. Irving is a co-author of PDA TR-13- EM of Low Bioburden Facilities, PDA Points to Consider for ATMPs, and for the published White Paper – Risk Assessment Approach to Microbiological Controls of Cellular Therapies.

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 20 years and is presently serving on the Board of Directors, both the Science and ATMP Advisory Boards and is the co-chair of the Microbiology/EM Interest Group. Marc is also co-chairing the Microbial Data Deviation Investigations conference and participating on the planning committee for PDA/FDA and Global Microbiology conferences. Additionally, Marc has chaired several Technical Reports and Points to Consider publications and is currently supporting multiple PDA global chapters.

In 2020, Marc was the recipient of the James P. Agalloco award for his efforts at PDA’s Training and Research Institute, and the 2023 Michael Korczynski Award for his work with PDA’s international chapters.

Marc earned his BS in Biology from Monmouth University and his MS in Microbiology & Molecular Genetics from Rutgers University.

Anthony Grilli holds a graduate degree in Microbiology from Rutgers University and has worked with industry laboratories for 40 years. Tony has leveraged his technical experience, compliance history and lean sigma knowledge to bring several CRO's to regulatory and commercial success, including SGS Life Science Services NJ, IL and Canada and Celsis Laboratory Group NJ and MO operations. He has hosted dozens of successful regulatory audits, designed and executed RMM validations, developed EM qualification programs and identified root cause of contaminated products. He has consulted for companies globally. Tony is Owner and Laboratory Director of FOCUS Laboratories, a harmonized network of microbiology laboratories in Lehigh Valley PA and Tampa Bay FL, where over 40 staff bring first in class customer service to microbiological lab support. FOCUS's recent acquisition of Microbiology Network brings additional expertise and consulting experience to FOCUS customers. Tony shares his experience as a presenter at conferences, and recently authored the Microbiology Laboratory Validation chapter for CRC Handbook of Validation in Pharmaceutical Processes, a reference he also co-edited. He is past President of New Jersey Society of Industrial Microbiology, past President of PDA's Metro Chapter. He is still active in these organizations as well as ASTM and CETA.

Christoph Hansy has 16 years of experience in the pharmaceutical industry. He is currently member of the Global Sterility Assurance and Microbiology Management Team at Takeda and based in Vienna, Austria.

In his current role he provides subject matter expertise as well as technical leadership on microbiological matters, such as method related projects, microbial control strategies, and contamination/investigation support in a global role. The Bacterial Endotoxin Test (BET) as well as the traditional Rabbit Pyrogen Test have been key focus areas for many years in his career, as well as technical operator, but also as leader of these laboratories, including the participation in multiple global projects and studies in this field. In his current global role, the viewpoint moved more to the strategic component of Endotoxin and Pyrogen testing. Recently the evaluation of a global Pyrogen control/testing strategy became one of his core tasks.

Djamila Harouaka is the Senior Scientific Advisor in the Office of Quality Surveillance (OQS) in the Office of Pharmaceutical Quality (OPQ) in FDA’s Center for Drug Evaluation and Research (CDER). In her current role, she provides scientific and technical advice and consultation regarding program matters and complex issues related to pharmaceutical quality surveillance. Djamila also served as a microbiologist in CDER’s Office of Compliance (OC) where she assessed the compliance status of compounding facilities and performed high-priority inspections. In addition to her routine work, she also led the development of technical training courses delivered through the Compounding Quality Center of Excellence including the courses on Environmental Monitoring and Aseptic Process Simulations. Djamila began her FDA career in the Office of Regulatory Affairs (ORA), where she worked as a certified Drug Investigator. She earned her PhD in Microbiology from the University of Alabama at Birmingham.

Chris Knutsen received his PhD in biochemistry and microbiology from Rutgers University. After spending time working at various contract testing laboratories, running both microbiology and chemistry laboratories, he started at Bristol Myers Squibb 16 years ago. Initially Chris was responsible for developing a microbiology laboratory that supported new parenteral and oral solid dosage clinical manufacturing facilities. This role involved developing GMP compliant laboratory practices, as well as hiring and training staff as the responsibilities of the laboratory expanded. Chris is currently serving as Scientific Director for the Microbiology Center of Excellence. In this role, he is responsible for keeping on the lookout for new and emerging techniques for rapid microbiology, assisting sites in complex investigations, serving on industry organizations, including working with PDA either as an author on technical reports, or as a reviewer on nascent TR's as well as submitted articles to the PDA Journal of Pharmaceutical Science and Technology. Most recently, he has been active in working cross-functionally on the implementation of the requirements of Annex 1.

Peter has over 18 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various roles within the industry, primarily around process solutions and engineering for drug substance facilities. He has extensive knowledge of bioprocess manufacturing and has helped design new facilities and retrofit existing facilities. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their cGMP facilities utilizing G-CON’s pre-fabricated autonomous clean rooms by capitalizing on his process and regulatory know-how.

Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received his MEng in Chemical Engineering from Cornell University. He is also very active within PDA where he currently sits on the PDA BioAB, co-Leads the Biopharmaceutical Manufacturing IG, and Mobile Manufacturing Task Force.

Dr. John Metcalfe holds a BA in biology from Merrimack College in Andover, MA, and a PhD in microbiology from the University of Rhode Island. John spent 14 years teaching college microbiology courses prior to beginning a career in CDER in 2003. At FDA, John is a Senior Pharmaceutical Quality Assessor (SPQA) where he performs a microbiological quality assessment of both sterile and non-sterile drug products. He is an FDA Liaison to the USP Expert Committee on Pharmacy Compounding and is a published author in the area of drug product microbiological quality.

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 30 years of industry experience in microbiology 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 Certified Quality Auditor. 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 as well as the PDA Technical Report TR 88, Microbial Data Deviation Investigations in the Pharmaceutical Industry. Chris is also a participating author on the new PDA Technical Report for Contamination Control Strategy Development in Pharmaceutical Manufacturing.

Paula Peacos, MS possesses over 30 years of practical industry experience as a Microbiologist. She has worked in contract manufacturing organizations as well as small, mid-size and large pharmaceutical organizations. Her extensive experience encompasses aseptic processing, API/drug substance, ATMP and nonsterile production, both clinical and commercial, as well as microbiological laboratory management.

Ms. Peacos has conducted compliance audits internationally as a microbiological subject matter expert. She is also an experienced trainer and has developed and implemented customized developmental and remedial programs both in the US and abroad.

In recent years, Ms. Peacos has published several articles and delivered presentations at major industry meetings on topics such as microbiological data integrity, root cause analysis, environmental monitoring, contamination control, and trending analysis.

Ms. Peacos is currently employed as a Senior Consultant with ValSource, Inc.

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for over twenty years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, the Middle East, Asia, and Latin America on issues related to cleaning and disinfection, microbial control in cleanrooms, and validation of disinfectants. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active on the PDA’s COVID-19 Task Force. He was a co-author on PDA’s Technical Report #70 on cleaning and disinfection and Technical Report 88. Mr. Polarine teaches industry regulators with FDA, MHRA, HPRA, ANVISA, and ANMAT as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine is current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. His main hobby is tornado chasing and severe weather safety.

Stacey Ramsey is a QC microbiologist with more than 15 years of direct laboratory experience in pharmaceutical quality control. Through her years of method and process development, Stacey focuses to bring robust quality processes to the laboratory through continual improvement and change in order to deliver safe and effective products to patients. She received her Bachelor of Science and Master of Science degrees in Wichita, Kansas, and began her career in QC microbiology in parenteral contract manufacturing in McPherson, KS. Having worked in both contract manufacturing and laboratory services, she has a broad background in laboratory testing, including environmental monitoring, microbial identification, endotoxin testing, and rapid detection. Stacey is currently based out of Charleston, South Carolina, working for the Microbial Solutions division of Charles River Labs.

Abby Roth, founder of Pure Microbiology, has over 18 years of experience in supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring. Abby served as a USP Compounding EC member during the 2015-2020 cycle. She is an involved member of the Controlled Environment Testing Association (CETA), serving on the Board of Directors, speaking at its annual meetings, and chairing committees for the revision of four CETA Application Guides. Abby has been invited to speak for state boards of pharmacy and for national organizations.

Christine Sherman is a member of the Takeda Global Sterility Assurance & Microbiology team and is based in Cambridge, Massachusetts. Within Takeda, her role is supporting Sterilization and Aseptic Processing at the sterile manufacturing sites. Her newest assignment is implementing a Sterility Assurance program at Takeda's sites in Japan. Her background in Microbiology consists of supporting facilities that manufacture pharmaceutical products (sterile and non-sterile), biologics, cell therapies, and vaccines.  Prior to joining Takeda in 2017, she worked for Johnson & Johnson and then Pfizer in the QC microbiology laboratory, and later, at Merck in a Sterility Assurance role for the Durham, NC vaccine facilities. In these roles, she was responsible for ensuring product sterility by supporting environmental and utility monitoring, programs, process simulation of bulk and finished product, and smoke studies, well as facilitating internal Microbiology Communities of Practice focused on bioburden control. She has experience supporting Microbiological investigations for environmental and utility monitoring, sterile and non-sterile products, and process simulation positives. Throughout her career, she has interacted with various regulatory agencies and supported internal audits as a Microbiology SME. She is currently active in PDA Technical Report revisions and a member of the South East Chapter.

Kim Sobien is a Microbiology Senior Consultant with ValSource, Inc. Her pharmaceutical industry career encompasses a breadth of Quality, Compliance, and technical experience with injectable pharmaceutical products, including parenteral pharmaceutical contract manufacturing, pre-filled syringe generics, radiopharmaceuticals, and biologics. Previously she has served as MSAT Contamination Control Lead and a GSK Fellow at GSK, Principal Sterility Assurance Engineer for PETNET Solutions, Associate Director of Regulatory Compliance at Merck, Regulatory Compliance Lead at BD Rx, Inc., and Microbiology Laboratory Manager at Oso BioPharmaceuticals (now Curia).

Kim has a BS in Microbiology from the University of Wisconsin–La Crosse and a Master of Business (MBA) degree with an emphasis in Global Management from the University of Phoenix. She is an active member of the Parenteral Drug Association (PDA), the PDA Southeast Chapter, and a past co-chair of the PDA Annual Global Conference on Pharmaceutical Microbiology.

Vanessa Vasadi Figueroa, Chief Executive Microbiologist, and Independent Consultant, has almost 20 years combined experience in the life sciences industry, supporting Pharmaceutical, Biotechnology and Medical Device companies. Mrs. Figueroa’s core expertise is rooted in sterility assurance, contamination control, environmental and utilities monitoring programs and quality control laboratory management. Her consulting experiences have spanned both domestic and international top ten pharmaceutical companies, applying both US and global regulatory standards of quality. She has authored several publications, and co-developed Virtuosi®, the world’s premier, revolutionary and one of a kind education and training product for the life sciences. Mrs. Figueroa has a Bachelor’s degree in Molecular Biology from State University of New York at New Paltz, and a Master’s degree in Molecular Biology and Microbiology from San Jose State University. She is an active and publishing member of several professional organizations, such as the Parenteral Drug Association, American Society of Microbiology and Association for Women in Science.