October 15-17, 2018, Bethesda, MD
James Agalloco is President of Agalloco & Associates, a technical service firm to the pharmaceutical and biotechnology industry. Since the formation of Agalloco & Associates in 1991, Jim has assisted more than 200 health care firms in a wide range of validation, automation and compliance areas. Jim has over 45 years of industry experience and has worked in organic synthesis, pharmaceutical formulation, pharmaceutical production, project and process engineering, validation and process automation during his career at Merck, Pfizer, Squibb and Bristol-Myers Squibb. He received his BS in Chemical Engineering from Pratt Institute in 1968 and his MS, also in Chemical Engineering from Polytechnic Institute of New York in 1979. He received his MBA in Pharmaceutical Studies from Fairleigh Dickinson University in 1983. He is a past President of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993. He is a member of USP’s Microbiology Expert Committee for 2005-2020. He serves on the Editorial Advisory Boards of Pharmaceutical Technology and Pharmaceutical Manufacturing. Jim serves on the scientific advisory boards of MEDInstill and Eniware. He is a frequent author and lecturer on the subject of sterilization, aseptic processing and process validation.
Mr. Frederic B. Ayers earned a bachelor’s degree in Biology, from Franklin College of Indiana in 1999. Before joining Eli Lilly and Company in 2001, he worked in quality control in various industries. Fred has held various quality and technical positions from which he has helped advance Lilly's state of regulatory compliance. Since October 2018, he has served as a Sterility Assurance Steward for Indianapolis Parenteral Manufacturing. He is responsible for developing, influencing and ensuring implementation of the sterility assurance technical and strategic agenda at Lilly’s Indianapolis parenteral manufacturing site.
Fred has multiple professional affiliations (e.g., ISPE, PDA, etc.), and has been an active member in the PDA Midwest Chapter since 2014 currently serving as the President-Elect. Through his local and national affiliations, he has driven solutions for PDA members, along with the development of content and delivery of industry learning sessions for industry colleagues.
Ken Boone has been with Merck and Co., Inc. since 2013 in Global Quality Compliance - Sterile & Microbiology Quality Assurance. He has responsibility for setting Merck’s global standards for process simulations, sterile filtration, and terminal sterilization. He has over 20 years’ experience in aseptic processing and sterility assurance with Pfizer, Cardinal Health, Mallinckrodt, and Novartis. Ken was a founding member of the Missouri Valley Chapter of the PDA.
Justin Boyd is currently an FDA investigator in the Office of Regulatory Affair with Team Biologics. He conducts inspections of licensed biologic products manufacturers and has extensive experience inspecting aseptic manufacturing processes and microbiology laboratories. Mr. Boyd has 10 years of experience conducting pharmaceutical inspections working for the Minneapolis District Office, the dedicated foreign inspection cadre, and the FDA China offices. Mr. Boyd has developed and provided training for FDA investigators for the basic drug, computer aided inspections, and data integrity courses. Mr. Boyd has a Bachelor of Science degree from the University of Wisconsin.
Gretchen Brunner’s 19 year career spans the fields of radiopharmaceuticals, gene therapy, single use bioreactor systems, and biologics. Roles have included positions of increasing responsibility in the areas of microbiological testing, test method development & optimization, laboratory operations efficiency, as well as Project Management within Quality Control. Gretchen’s focus is implementation of continuous improvement of micro testing at her site.
Gretchen’s current work focuses on evaluation and implementation of efficient and reliable test methods for microbiological testing of Critical Utilities Systems, education and training of laboratory staff, and optimization of laboratory work processes in a project management role. She sites on several internal committees within Sanofi, including the Micro Test Method Lifecycle Management Team, Contamination Control Community of Practice, Microbiology Laboratory Error Reduction team and Network Rapid Methods Implementation team.
Reyes Candau-Chacon, PhD is currently Quality Assessment Lead in Branch IV of the Division of Microbiology Assessment (Office of Pharmaceutical Quality, CDER). Branch IV evaluates the microbial quality and sterility assurance of biological license applications. This is conducted in a comprehensive manner and includes reviewing the microbiology aspects of the BLA as well as inspecting the manufacturing facilities. In addition, the branch participates in writing guidelines, policies, and procedures.
Prior to her current position, Reyes worked in the diagnostic industry developing methods to detect genetic biomarkers in blood circulating DNA and before that, she worked in the Biotech industry developing Molecular Biology tools. Reyes hold a PhD in Biology from the University of Sevilla, Spain and conducted post-doctoral research in Marburg, Germany and at the University of Pennsylvania on transcriptional regulation in yeast and mammalian cells.
Emily Elizabeth Castelloe is a Rotational Development Program Associate for Pfizer Inc. in Sanford, NC where she has participated in the Student Worker Program since the summer of 2017. She is a recent graduate of Clemson University with a Bachelor of Science degree in Microbiology and a concentration in Biomedicine. Currently, she works in Quality Operations with a focus on the impact of microbes in critical vaccine processing areas. She is conducting ongoing microbial mapping assessments for both new and preexisting manufacturing sites on the Sanford campus.
As a Senior Microbiology Reviewer in FDA’s Center for Drug Evaluation and Research Division of Microbiology Assessment, Jessica Chiaruttini is responsible for the review of Investigational New Drug Applications (INDs), New and Abbreviated Drug Applications (NDA/ANDAs), and combination drug products. Dr. Chiaruttini has extensive experience with regulation of novel manufacturing platforms and test methods, as well as traditional aseptic and terminal sterilization procedures, and control of non-sterile drug products. She routinely consults to CDER’s Office of Compliance on microbiology-related inspectional and contamination events in the industry. She obtained a BS in Microbiology from the University of Georgia and a PhD in Emerging Infectious Diseases at the Uniformed Services University of the Health Sciences. Other work experience includes collaboration with Mozambique’s Ministry of Health and CDC to expand HIV viral load testing capacity and clinical microbiology testing at the CDC’s National Reference Laboratory for Escherichia coli and Shigella. Dr. Chiaruttini holds the rank of Commander in the United States Public Health Service Commissioned Corps and has nine years of commissioned service.
Ms. Essex is the recognized expert in Contamination Control for Sanofi Biologics manufacturers. She leads a community of Contamination Control and Sterility Assurance leaders from across the global Sanofi network.
Ms. Essex’s undergraduate education focused on Biology and Microbiology and she holds two graduate degrees in Bioengineering. Over the past 15 years, she has held various positions in Contamination Control and Microbiological Quality Control at established biologics companies, biologics contract manufacturers, and emerging biotechnology firms working in mammalian, microbial and stem cell systems.
Through the course of her career, Ms. Essex has built strong technical expertise in all aspects of contamination control including facility, utility, and process design, and cleaning validation. She is also well versed in microbiological test methodology and Quality Risk Management.
Cheryl believes that good control requires a solid foundation of rules, but excellent control requires an understanding of principles applied with good judgment. For this reason, she puts a strong emphasis on awareness and education for front-line staff.
Brian Fitch is a Quality Control Associate III for the Microbiology group at Biogen in Research Triangle Park, North Carolina. He has been a member of the Biogen team since 2014, where he has spent considerable time evaluating rapid microbial methods including water and air. Brian is an active member of the OWBA (Online Water Bioburden Analyzer) workgroup representing Biogen with a goal to develop and promote the use of OWBAs in Pharmaceutical/Biotech utilities monitoring. Brian has over eighteen years of experience in Biotech environmental and utilities monitoring. He earned his Bachelors in Biology at Campbell University and his Masters of Public Health at the University of North Carolina Chapel Hill.
For the last five years, Dr. Guilfoyle has been happily employed as the Senior Director, Microbiology & Analytical Regulatory Compliance with Johnson & Johnson, Corporate Compliance and Quality Control. He is responsible to provide scientific and compliance expertise to the corporate GXP audit teams, compliance remediation, and regulatory Intelligence and outreach functions. Dr. Guilfoyle serves as the expert on matters related to laboratory test standards, compendia requirements, cGMP and rapid microbiological methods. Collaterally he helps foster meaningful, credible and strong partnerships with health authorities ensuring that J&J is at the frontline in developing appropriate global microbiological laboratory requirements. Prior to working in industry, he had worked for over 40 years with the U.S. Food & Drug Administration (FDA) and was classified as an international expert in the field of pharmaceutical microbiology. He is currently serving his 19th year as a member of the USP expert Microbiology committee and is a member of the PDA Science Advisory Board. Dr. Guilfoyle has been an Associate Professor for two Graduate courses entitled “cGMP” and “Process Validation”
Jeffrey Heiser is the Director of Microbiology at Boston Analytical in Salem, NH. His previous roles have been in Microbial Sciences and Technology at Pfizer in Andover, MA and Quality Control Operations at Genzyme Biosurgery in Cambridge, MA. He has over ten years’ experience in Quality Control Microbiology and Development and his current focus is client testing design in a contract lab environment.
David Hussong is the Chief Technical Officer at Eagle Analytical Services (Houston, TX). He also had been a consultant with ValSource, LLC., specializing in regulatory microbiology issues. In 2014, David retired from the Commissioned Corps Officer of the US Public Health Service after 30 years with the Food and Drug Administration (FDA). In addition, David is currently the chair of the USP Microbiology Expert Committee for the 2015 – 2020 cycle.
David earned his Ph.D. in microbiology from the University of Maryland (UM) and has served as a research microbiologist at UM, the US Department of Agriculture and the US Naval Medical Research Institute. Dave has been a member of the Parenteral Drug Association since 1993, and a member of the American Society for Microbiology since 1975.
Collaboration and passionate sharing of solutions are woven into Mark Kapeckas’ fabric. There are too many patients to serve, and unmet medical needs to work in a less efficient way. Mark Kapeckas’ career spans the fields of traditional pharmaceuticals, electronic materials, contract manufacturing, and biologics. Roles have included positions in R&D for test methods and new products, Project and Program Management, Quality Control, Quality Assurance, Quality Engineering. Mark has focused this unique experiential perspective on Biologics Quality for the past 10 years. Mark currently leads several global initiatives within the Sanofi Biologics Quality organization. Relevant micro-focused leadership roles include the Sanofi Global Working Group and Quality Commission responsible for all aspects of Low Endotoxin Recovery (LER). Also head of the Micro Test Method Lifecycle Management Group globally, Mark drives continuous improvement of micro testing and compliance globally. Externally, Mark is an active member of the BioPhorum Operations Group (BPOG) Rapid and Reliable Micro Methods sub-team.
Devon Kleindienst is a Research Scientist II at Bristol-Myers Squibb Company. Currently part of the Analytical Strategy and Operations team, she is a microbiologist specializing in endotoxin and pyrogen detection. She holds a B.S. degree from the University of Pittsburgh and a M.S. in Microbiology from Seton Hall University.
Mr. Kuo brings 16 years of experience in parenteral manufacturing, with a focus on sterility assurance and environmental monitoring programs. Most recently, for the past 3 years, he has led an organization supporting aseptic process simulations (media fills), aseptic manufacturing technique, gowning and hygiene, aseptic interventions, sterile filtration validations, sanitization programs and agent validation, and sterility assurance risk assessments supporting parenteral operations.
Brian J Lloyd is a New Products Manager at Pfizer’s Biotechnology site in Sanford, North Carolina. In this role he is responsible for managing the technical transfer of new vaccines into full scale production including clinical trial material production, validation and licensure. Brian previously served as Principle Validation Engineer developing policies and procedures for cleaning validation, multiproduct operations, and process validation. Brian has the served as team lead for numerous microbial contamination responses for commercial and clinical products within process equipment and the environment. Brian has been with Pfizer for 15 years. Brian has a Ph.D. degree in Food Process Engineering from North Carolina State University and a minor degree in microbial food safety.
Ms. Lo has been with Novartis since 2013 in the Cell & Gene Technical Development & Manufacturing, Analytical & Process Science unit, responsible for the process development of commercial and pipeline projects.
Today, Ms. Lo manages the media project that is responsible for serum replacement, media alternative, media collaboration, as well as optimize the T-cell expansion using the AMBR 250 automated bioreactor system.
Jennifer is the Manufacturing Manager for the Aseptic Department at Bausch & Lomb. She is responsible for the filling activities, Prep activities and Gowning classes/qualifications. Jennifer has over 18 years of experience in the pharmaceutical and medical device industries, specializing in aseptic processing, aseptic process redesigns, Aseptic simulation processing (media fills), and cleanroom qualification, six sigma and risk management. Jennifer holds a MS in Pharmaceutical Manufacturing from Stevens Institute of Technology and is certified Six Sigma Green Belt.
María José López-Barragán currently acts as a Quality Assessment Lead in the Division of Microbiology Assessment, within the Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research. Her current responsibilities focus on the review of Biologic License Applications from microbiology product quality and sterility assurance perspectives, as well participating and leading pre-license inspections of manufacturing sites. Dr. López-Barragán joined the FDA in 2015 after holding several private sector positions as Senior and Principle Scientist, both in Europe and the U.S., spanning from the discovery of new drugs against infectious diseases to the interpretation and discovery of novel genetic variants associated with complex clinical syndromes. Dr. López-Barragán received her PhD in Biochemistry and Molecular Biology from Complutense University of Madrid (Spain) and completed a five-year postdoctoral research program at the U.S. National Institute of Allergy and Infectious Diseases, authoring over twenty peer-reviewed scientific publications.
Joe McCall, SM (NRCM) is the Associate Director of Quality Assurance Technical Services at ADMA Biologics in Boca Raton, FL. He has over 25 years of experience as a professional microbiologist at such companies as Bausch & Lomb, Genzyme, DSM Pharmaceuticals, STERIS Life Sciences, and Mass Biologics. Joe has been an active industry member throughout his career, teaching courses at PDA TRI, the University of Tennessee HSC, and providing training at FDA CBER Division of Product Quality and Manufacturing. Joe has developed and delivered numerous training seminars on pharmaceutical microbiology at companies and conferences across Europe, Asia, South America, and the US. He has been a proud member of PDA for over 15 years and is one of the few ASM Certified Specialists in Pharmaceutical and Medical Device Microbiology on the National Registry of Certified Microbiologists.
Yoko joined Regulatory CMC at Celgene in March 2018 and works on a late phase CAR-T product. Prior to Celgene, Yoko was at Novartis Pharmaceuticals where she was responsible for the initial process characterization of Kymriah. Subsequently, in her role as Head of Late Stage Process Development at Novartis, she was responsible for the process development, process characterization, and comparability studies of late phase cell and gene therapy products. Before joining the cell and gene therapy unit at Novartis, she was in Regulatory CMC at Novartis Japan where she gained broad regulatory experience in cell and gene therapy products, monoclonal antibodies, and small molecules. She started her career in biotechnology at Genentech, where she worked on drug substance manufacturing site design and site startup as a process engineer.
Mark Nabuurs has worked at Merck for over 9 years covering multiple roles within the quality organization. Upon graduation from University, Mark started in the microbiological development group at MSD Oss. Mark is a subject matter expert on method suitability testing of all compendial Microbiological methods. Three years ago he joined the global Center of Expertise Microbiology. Within the field of Pharmaceutical Microbiology he is mainly responsible for the method validation and transfer of Rapid Microbiological Methods and site support on microbiological issues ranging from test to production processes. In addition, he is responsible for the design and execution of microbiological studies. Mark holds a Bachelor of Applied Science degree in Biological and Medical diagnostics from the HAN University of Applied Science.
Tessa Patton joined the Eurofins Lancaster Laboratories, Inc. team in 2015 as an Associate Microbiologist. She has performed testing and accumulated knowledge in multiple of areas including Microbial Limits Testing and Anti-Microbial Effectiveness Testing. She is currently is a Group Leader in the Non-Sterile Product testing group and oversees Microbial Limits testing as well as assists in the development of ELLI’s electronic laboratory notebook system. In this role she assists clients with their testing to meet compendial requirements and as well as support the design and implementation of non-compendial studies. Tessa earned her BS in Micro/Molecular/Cell Biology from Kutztown University of Pennsylvania.
Joshua Schmitz is a Principal Engineer of Sterility Assurance at ASP and provides technical knowledge and expertise in the areas of spore production, biological indicator manufacturing, sterilization and disinfection. In addition to managing the biological Product Management team, Joshua supports the terminal sterilization programs, long term strategic business initiatives and connecting with Industry and the Global Sterility Assurance organization. Joshua brings over 12 years of industry experience in infection prevention, project management, process and product validations, terminal sterilization, spore development and BI production and governing medical device standards; ISO, AAMI, and QSR. He holds a Bachelors of Science in Chemical Engineering from the University of Minnesota and is a trained auditor and a six sigma green belt.
Kim received her PhD from the University of Wisconsin and conducted postdoctoral studies at Johns Hopkins Bloomberg School of Public Health. Her research has focused on virology and immunology. She joined the FDA in 2015 as a Commissioner’s Fellow to conduct an analysis on CAR T cell CMC data. She joined the Gene Therapy Branch in 2016 as a CMC reviewer.
Joseph is leading the QC Microbiology group at Celgene in support of commercial CAR T manufacturing. His experience has been focused on QC Operations in support of cell therapy manufacturing for the duration of his career.
Jean Stuckey is a Senior Principal Scientist specializing in Microbiology at Patheon Biologics, LLC. (part of Thermo Fisher Scientific). She has been in industrial microbiology for over twenty five years. Her experience has been with several major pharmaceutical companies as an employee and then as clients through CMO employment. Jean has supported her site, other biologic sites and clients in the areas of microbiology and contamination control. She has a passion for Microbiology and believes that collaboration between microbiologists, manufacturing, quality and clients will dramatically improve the life of patients receiving these life-changing medicines!
Scott earned a Bachelor of Science degree in Microbiology from Texas Tech University and has over 25 years of experience in microbiology and sterility assurance. Scott's experience is with medical devices, combination products, and tissue products. He has developed and established methods with internal and external laboratories for product evaluation including endotoxin testing, bioburden recovery, environmental monitoring and control for manufacturing, qualification and control of aseptic processes, troubleshooting environmental and bioburden failures. His sterilization experience includes cycle development, validation and routine control of steam, dry heat, vaporized hydrog! en peroxide, ethylene oxide, gamma, e-beam, and liquid chemical processes. He has worked on facility design for clean room / controlled environment and sterilization construction, which included design and validation of isolator technology for aseptic transfer. The Director Industrial Microbiology provides overall direction of the Industrial Microbiology function globally for Johnson & Johnson Microbiological Quality & Sterility Assurance (JJ MQ&SA). He leads and directs research related activities in the area of Industrial Microbiology to support the technical needs for Enterprise wide initiatives, as well as those of MD, Pharma and Consumer.