October 21-22, 2020, Washington, DC
Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology and the validation and implementation of rapid microbiological methods (RMM). He is currently the President of Microbiology Consultants, LLC (http://microbiologyconsultants.com) and owner of http://rapidmicromethods.com, a website dedicated to the advancement of rapid methods within healthcare related industries.
For 30 years, he has held numerous R&D, manufacturing, quality, business development and executive leadership roles at multinational firms such as Johnson & Johnson, Eli Lilly and Company and Bausch & Lomb. In his current role, Dr. Miller provides technical, quality and regulatory solutions in support of RMMs, sterile and non-sterile pharmaceutical manufacturing, contamination control and GMPs.
Dr. Miller has authored more than 100 technical publications and presentations and is the editor of PDA’s Encyclopedia of Rapid Microbiological Methods. He currently serves on the editorial and scientific review boards for American Pharmaceutical Review, European Pharmaceutical Review and the PDA Journal of Science and Technology. Dr. Miller was the chairperson for PDA's Technical Report #33 and currently serves as an advisor to the USP Microbiology Expert Committee in the area of rapid sterility testing.
Dr. Miller holds a Ph.D. in Microbiology and Biochemistry from Georgia State University.
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 35 years. Currently Andrew is a Director of Compliance at Abbvie the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies. Prior to this, Andrew was an Inspector with the MHRA for nearly 14 years. This role included:
Prior to joining the MHRA Andrew worked for more than 20 years in various areas and technologies in the Pharmaceutical industry.
Dr. Erika Pfeiler is a microbiologist and Branch Chief in the FDA/CDER Division of Microbiology Assessment, where she performs and oversees microbiology reviews of ANDAs, NDAs, and INDs. She joined CDER in 2012. Her areas of particular interest in pharmaceutical microbiology include rapid microbiological testing methods, pharmacy compounding, and the microbiological aspects of nonsterile products. Dr. Pfeiler has an educational background in food microbiology, and received a B.S. from the University of Tennessee and a Ph.D. from North Carolina State University.
Lisa Wysocki is a Microbiology Technical Lead and Associate Fellow at GlaxoSmithKline, Upper Providence, PA, in the CMC Analytical group. She has a BS degree in Microbiology from the Pennsylvania State University and an MS degree in Molecular Biology from Drexel University, and has worked at GSK since 1988. Lisa provides microbiology support for sterile products and also leads an effort on Microbiology Testing Modernization, driving evaluation and implementation of rapid microbiology methods. She has previous experience in molecular biology, microbial genetics, mammalian cell culture and biological sample management.
Fred received a B.A. degree in Biology from Franklin College of Indiana in 1999. After graduating, he spent two years working in the contract manufacturing industries (pharmaceutical, food) and joined Eli Lilly and Company in 2001. Since joining Eli Lilly, Mr. Ayers has held various quality and technical positions from which he has helped advance Lilly's state of regulatory compliance. He is regarded as a Subject Matter Expert in Sterility Assurance for the companies Indianapolis Parenteral Manufacturing site. Fred has the responsibility of developing, implementing and continuous improvement for the site’s sterility assurance related strategies. Additionally, Fred is involved been a PDA Midwest Chapter Board Member since 2014 and is currently serving as the chapter’s President.
Michael Blackton is responsible for the global quality organization at Adaptimmune inclusive of Quality Control, Analytical Development, Quality Assurance, and Quality Lifecycle Management spanning sites in the Philadelphia Navy Yard and Oxford, UK. Michael's career spans over 25 years in biotechnology, medical device and pharmaceuticals where he has held leadership positions in manufacturing, quality, operations, and engineering. Prior to joining Adaptimmune, he spent 11 years with Eli Lilly and Company and ImClone in roles of increasing responsibility directing facilities maintenance operations, qualification, cleaning validation, multi-product strategies, regulatory documentation, and technology transfer initiatives supporting a portfolio of products and approvals, including CYRAMZA® (ramucirumab). Prior to joining Lilly, Mr. Blackton served in various quality management roles at Millennium Pharmaceuticals and Inhale Therapeutics. He earned his Master of Business Administration degree from New York University.
Lori Daane is the Director of Scientific Affairs at bioMérieux and has experience in clinical, environmental and industrial microbiology. She is a technical expert on rapid and alternative methods and provides scientific support to the Healthcare Business in North America. Prior to joining bioMérieux, Lori worked for 11 years at Celsis in a variety of technical roles including VP of Scientific Affairs and Reagent Development. Lori received her PhD from the University of Minnesota in Microbial Ecology and performed postdoctoral research at Rutgers University and Los Alamos National Laboratory. She also holds a Master’s degree in Limnology and a Bachelor’s degree in Medical Technology.
Wayne DeHaven earned his Bachelor's degree from the University of Florida, and his PhD in Pharmacology and Therapeutics from the University of South Florida. He joined the Food and Drug Administration in 2009 where he worked until 2015 when he left as acting director of the division of bioequivalence to join Pharmetric Laboratory as Director of Quality. As Director of Pharmetric, Wayne provides innovative solutions for microbiological and analytical testing of pharmaceutical products.
James Kenney, D.Sc. is a Commander in the U.S. Public Health Service and has worked for the U.S. Food and Drug Administration for 12 years. He is currently the Chief of the Laboratory of Microbiology, In-vivo Testing and Standards in the Center for Biologics Evaluation and Research's Office of Compliance and Biological Quality's Division of Biological Standards and Quality Control. Dr. Kenney oversees the production and distribution of FDA biological standards and reagents; and the regulatory review of microbiological analytical methods and their quality control related to product lot release.
Yoko Nakai is the project manager for hardware and application development of RMM system at HORIBA Advanced Techno, Co., Ltd. She received her Bachelor's degree in engineering and Master’s degree in energy science from Kyoto University. In 2006, she joined HORIBA, Ltd., a manufacturer of measurement and analysis instruments. She has worked as a R&D and application engineer for UV-NIR spectroscopic in-line chemical concentration monitor for semiconductor manufacturing process for 10 years. As an application engineer, she organized and experienced various projects collaborating with industrial customers to implement the monitoring systems while she worked in Taiwan. After joining the RMM technology group, her main focus has been on hardware system development and implementation project with her colleagues including Senior Biologist Hideki Nakayama, PhD, a member of RMM Study Group of PDA Japan.
Stacey Ramsey is a career microbiologist with more than 15 years of experience in the pharmaceutical industry. Originally from Wichita, KS, Stacey completed her BS in Biological Sciences from Wichita State University before completing a Master of Science degree at Friends University, also located in Wichita. Stacey worked for the generics and contract pharmaceutical manufacturing company, Hospira, where she gained experiences in environmental monitoring, drug product testing, endotoxins testing, and process and method development and validation. Stacey relocated to North Carolina where she has also worked in contract laboratory testing, focusing on implementation of new processes, including rapid microbiology. Stacey joined Charles River as an Associate Product Manager for the Celsis rapid microbial detection platform in 2019.
Bryan Riley is a Branch Chief in the Division of Microbiology Assessment in the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research at the Food and Drug Administration. He is also a member of the CDER/OPQ Emerging Technology Team which is entrusted with facilitating the adoption of innovative technologies for pharmaceutical manufacturing. Prior to coming to FDA in 1998, he directed a clinical microbiology laboratory specializing in molecular diagnostic methods. He holds B.S. and M.S. degrees in Microbiology from Texas Tech University and a Ph.D. in Microbiology from the University of North Texas. He completed his formal scientific training as a post-doctoral fellow at the University of Texas Southwestern Medical Center at Dallas.
Alex van der Meer is a subject matter expert for Mycoplasma PCR tests at Janssen Biologics B.V. steadily working toward rapid mycoplasma testing since 2019. He graduated from the university of Groningen, with a bachelor’s degree in pharmacy and a master’s degree in medical pharmaceutical sciences. In the past year he developed himself as an expert in the field of rapid mycoplasma testing by validation of biopharmaceuticals at the Mycoplasma testing center of excellence for the Janssen Supply Chain.
Dr. Kevin I.T. Wright,Director Corporate Quality Assurance- Industrial MIcrobiology, Procter & Gamble Technical Centres Ltd.
With 25 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, facilitated through a combination of Internal research, external collaborations (Academic & SME) and participation in cross industry groups (Kilmer/Microbiology Modernisation Cross Industry Consortium). 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 Confocal Raman Spectroscopy as a quality tool.