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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.
  • Erika Pfeiler

    Erika A. Pfeiler, PhD

    US 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.