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Committee & Speaker Biographies

Committee & Speaker Biographies

2020 PDA Rapid Microbiological Methods Workshop

October 21-22, 2020, Washington, DC

  • Michael J. Miller, PhD

    Microbiology Consultants, LLC

    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. 

  • Sven Deutschman

    Sven M. Deutschmann, PhD

    Roche Diagnostics GmbH
    Sven M. Deutschmann studied biology at the University of Brunswick where he obtained his PhD in cell culture technology. In 1995 he joined Roche Diagnostics GmbH. In the past years he took over increasing local and global responsibilities within the Roche Biologics QC Network. Currently, Sven Deutschmann is responsible for the microbiological, molecular and cell biological analytics of QC- and In-Process-Control-samples in the production of biotechnological derived commercial and clinical active pharmaceutical ingredients. Beginning of 2012 he was appointed as Global Head of a Corporate Function called “Method Management and Technology” within the Biologics Operational Unit of Roche with special focus on PCR-based technologies and Rapid Microbiological Methods. Besides his local and global responsibilities in the Biologics QC Network he is involved in External Interaction. Sven Deutschmann is member of the German Pharmacopeia Commission, the Microbiology Committee and the Working Party “Pyrogentests” of the German Pharmacopeia Commission as well as Germany’s representative in the Working Parties “Bacterial Endotoxins”, “Mycoplasmas” (whose chairman he is) and Expert Group 1 “Biological Methods and Statistical Analysis” of the European Pharmacopeia Commissions in Strasbourg, France. In 2009 he was appointed as commissioner of the Central Commission for Biological Safety, a brains trust of the Federal Office of Consumer Protection and Food Safety. In addition, he is member of the PDA “Mycoplasma Task Force” and chairman of the Advisory Board of the ECA “Rapid Microbiological Methods Group”.
  • Irving Ford

    Irving Ford, MSc

    Bristol-Myers Squibb
    Irving Ford is currently the Head of CAR T QC Laboratories at BMS. Prior to joining BMS, Irving was a significant contributor for activities supporting the BLA, PAI, and commercial approval of Novartis’ CAR T product Kymriah®.

    Irving has over 28 years of QA/QC experience in the pharmaceutical/biotechnology and cell and gene therapies industries including, but not limited to, non-sterile, sterile, and low bioburden manufacturing production. Irving has also designed, implemented and managed paperless laboratories.

    Irving has a successful track record developing personnel and working with laboratory, facilities, validation, manufacturing, regulatory, QA, R&D, and compliance personnel to manage and resolve complex quality and manufacturing issues.

    Irving served on the planning committee for the 2019 PDA Global Conference on Pharmaceutical Microbiology and 2019 PDA ATMP Conference. Irving is also a co-author/contributor for the PDA’s TR for EM of Low Bioburden Facilities. Irving is also a co-author of a White Paper for appropriate microbiological controls for ATMPs manufacturing that is being published in the PDA Journal.

    Irving is a member of a task force creating an ISO Standard for apheresis collection.
  • Andrew Hopkins

    Andrew D. Hopkins

    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 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:

    • Inspections across the world, including inspections with a number of other regulators (USFDA, TGA, TFDA and Health Canada) in a number of 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
    • Involved in writing of regulatory guidance documents including:
      • MHRAs Data Integrity guidance
      • EMA guidance on water systems
      • Chair for the working group for the revision of Annex 1
    • Supporting external industry bodies with technical monographs e.g. PDA TR1 and PHSS TM20.

    Prior to joining the MHRA Andrew worked for more than 20 years in various areas and technologies in the Pharmaceutical industry.

  • Erika Pfeiler

    Erika A. Pfeiler, PhD

    U.S. FDA

    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

    Lisa A. Wysocki, MS

    GlaxoSithKline

    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.

  • Lori Daane

    Lori L. Daane, PhD

    bioMérieux

    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

    Wayne I. DeHaven, PhD

    Pharmetric Lab

    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

    CDR James L. Kenney, DSc

    U.S. FDA

    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

    Yoko Nakai, MS Engineering

    HORIBA Advanced Techno, Co., Ltd.

    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

    Stacey N. Ramsey, MS, SM(NRCM)

    Charles River Laboratories

    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.

  • Kevin Wright

    Kevin I. Wright, PhD

    Procter & Gamble Technical Centres Ltd.

    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.