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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Rapid Microbiological Methods Workshop

October 23-24, 2019, Rockville, MD

  • Tony Cundell

    Tony Cundell, PhD

    Microbiological Consulting, LLC

    Dr. Tony Cundell consults with a number of pharmaceutical, consumer health and dietary supplement companies, microbiology instrument manufacturers, contract testing laboratories and sterile compounding pharmacies in the areas of microbial risk assessment, regulatory affairs, and microbiological testing. Prior to November 2013 he worked for Merck Research Laboratories in Summit, New Jersey, as the Senior Principal Scientist in early phase drug development. Earlier in his career, Tony Cundell worked at a director level in Quality Control and Product Development organizations at the New York Blood Center, Lederle Laboratories, Wyeth Pharmaceuticals and Schering-Plough.

    Tony Cundell chaired the PDA Task Force responsible for the publication of the original 2000 PDA Technical Report N0. 33.  He is a member of the 2015-2020 U.S.P. Microbiology Committee of Experts where he takes a leadership role in the area of modern microbiology methods, co-chairing the USP Expert Panel that published a stimuli article in the Sept-Oct. 2017 Pharmacopeial Forum entitled The Development of Compendial Rapid Sterility Tests.

  • 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.
  • Frederic Ayers

    Frederic B. Ayers

    Eli Lilly and Company

    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.

  • Bill Carpenter

    Bill M. Carpenter, MS

    Biogen, Inc.

    William (Bill) Carpenter is currently a Sr. Manager in QC Microbiology with Biogen, Inc. He is responsible for the EM/UM programs and all aspects of Microbiology laboratory management at the drug substance manufacturing facility in RTP, NC. His team is currently supporting the manufacture of and release and stability testing of drug substance material ranging from toxicology material to commercial batches of multiple parenteral products. Of particular interest to the team and currently being deployed are: rapid microbial methods, electronic lab notebooks (ELN), automated colony counters and low endotoxin recovery (LER) testing and mitigations strategies.

    Bill graduated from NC State University with a Master's degree in Zoology in 1997 and has held increasing levels of responsibility in QC Microbiology over the last 20 years, 17 of which have been with Biogen, Inc. In addition to his day job, Bill enjoys process improvement and building effective teams. He is a father of two and enjoys reading, hiking and playing softball and golf with his son and wife and volleyball with his daughter.

  • John Duguid

    John Duguid

    Vericel Corporation

    John Duguid is Senior Director, Research & Development at Vericel Corporation in Cambridge, MA. As a Principal Scientist, Mr. Duguid was responsible for developing, validating, and transferring molecular biology assays for rapid microbiology and cell differentiation applications, managing complex projects to implement process changes, and using statistical process control tools to implement process analytical technology for cell therapy products.

    Before taking on his current role in R&D, Mr. Duguid managed quality control cell therapy operations for over 10 years. He participated as a subject matter expert during FDA inspections and audits from international regulatory authorities for material inspection and release, biopsy accessioning, endotoxin testing, mycoplasma testing, analytical methods, flow cytometry, laboratory failure investigations, assay validation, and data management.

    Mr. Duguid received his Bachelor of Science degree in chemistry in 1986 from the University of Michigan in Ann Arbor. Previously, he worked in analytical research at Abbott Laboratories and then as a scientific consultant for Massachusetts biotechnology companies at Arthur D. Little. Involved with the pharmaceutical and biotechnology industries for over 20 years, Mr. Duguid has technical and management experience spanning all phases of the product lifecycle from early research and development through cGMP commercial operations.

  • Andrew Finnerty

    Andrew A. Finnerty, BSc, Grad. Dip, MBA

    Centre for Cell Manufacturing Ireland (CCMI) – REMEDI at NUIG Galway Ireland

    Andrew Finnerty is the General Manager for The Centre for Cell Manufacturing Ireland (CCMI) in NUI Galway. He has over 30 years’ experience in the pharmaceutical manufacturing industry having worked for Warner Lambert, Schering Plough, Organon and Merck Sharpe and Dohme. He has worked extensively in the areas of quality, development, validation and production and has significant experience in the areas of aseptic manufacturing and operational management. Andrew oversaw the process by which CCMI was the first ever facility in Ireland to be granted a licence from the Health Products Regulatory Authority (HPRA) – (formerly the Irish Medicines Board) to manufacture culture-expanded stem cells for human use. He has a degree in Biochemistry and an MBA.

  • Anthony Grilli

    Anthony T. Grilli, MS

    FOCUS Laboratories / Atlas Analytical Inc.

    Tony holds an MS in Microbiology from Rutgers University. He is owner of FOCUS Laboratories and Atlas Analytical Inc., two laboratories dedicated to state-of-the-art microbiology testing supporting all segments of the Life Science Industry. He has over 30 years of industrial microbiology experience and has managed contract laboratory operations for Celsis Laboratory Group and SGS. He has worked with and validated various rapid microbiological methods. He is currently active in PDA, serving as President Elect for the Metro Chapter, and contributes to ASTM and CETA.

  • Haijing Hu

    Haijing Hu, PhD

    U.S. FDA

    Haijing Hu joined the FDA in 2010 and has served in several roles and positions. Her most current role is as staff directory in Office of Dietary Supplement Program at CFSAN. She was a senior microbiologist in CDER’s Office of Compliance, Office of Manufacturing Quality, with a focus on pharmacy compounding. She also conducted microbiological assessments for sterile drug manufacturing in CDER’s Office of Pharmaceutical Quality.  Before joining CDER, she evaluated sterile and non-sterile medical devices at CDRH.

    Haijing Hu obtained her Ph.D. in 2003. She has more than 10 years of experience in microbiological research prior to joining the FDA.

  • Luis Jimenez

    Luis E. Jemenez, Sr., PhD

    Bergen Community College

    Dr. Luis Jimenez is currently Associate Professor of Microbiology at Bergen Community College in Paramus, New Jersey, where he teaches medical microbiology and environmental microbiology. Dr. Jimenez runs a laboratory where students perform research and development of biotechnological applications to industrial, environmental, and medical problems.

    Dr. Jimenez completed his Ph.D. in Environmental Microbiology at the University of Puerto Rico and performed his dissertation research under the supervision of Dr. Terry Hazen at the Savannah River Plant in South Carolina under predoctoral fellowships in Bioengineering and Microbiology from the Department of Energy of the United States and the National Institutes of Health. He completed Post-Doctoral studies in Environmental Biotechnology at the University of Tennessee, Knoxville under the supervision of Dr. Gary Sayler. Dr. Jimenez has 20 years of industrial experience in the biotechnology and pharmaceutical industry. He has developed or participated in the development of several products for clinical and environmental applications. His expertise in these areas is reflected by 66 publications, 12 book chapters, 1 book, 1 patent, and 138 presentations.

  • Simleen Kaur

    CDR Simleen Kaur, MSc

    U.S. FDA

    CDR Kaur has a Masters in Biotechnology from Johns Hopkins University and Bachelors in Biology from the University of Delhi (India). She is currently stationed in Food and Drug Administration, under Center for Biologics and Evaluation and Research, Office of Compliance and Biologics Quality. She serves as a Team Leader for Laboratory of Microbiology In-vivo Testing and Standards where she manages production and distribution of CBER Reference materials used in potency testing of biological products such as vaccines prior to release to public. In addition, she reviews microbiological test methods used in the lot release of biological products as submitted in Biological License Applications and Supplements to ensure they are validated in accordance with Code of Federal Regulations and different pharmacopeia requirements.

  • 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 11 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.

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    Yutaka Kikuchi, PhD

    Chiba Prefectural University of Health Sciences

    Dr. Yutaka Kikuchi is Professor of Department of Nutrition, Faculty of Healthcare Sciences at Chiba Prefectural University of Health Sciences, Japan. He holds a PhD (1991) in pharmacy and a BSc (1983) from the Hoshi University. From 1983 to 1986, he was a Researcher in the Research Institute of Life Science, Snow Brand Milk Products Co. Ltd., Japan. From 1991 to 2019, he is Lead Scientist of Division of Microbiology at the National Institute of Health Sciences, Japan. In 1991, he joined the National Institute of Health Sciences as Researcher and was promoted to Lead Scientist in April 2009. He was a Visiting scientist of Mycotoxin Research at USDA/ARS, NCAUR, USA (1994 to 1995) and a Postdoctoral fellow of Biochemistry at University of Alberta, Canada (1995 to 1996). He was also an Administrative officer of Health Sciences Division at Ministry of Health, Labor and Welfare, Japan (1999 to 2000). He has been extensively engaged in the preparation of the Japanese Pharmacopoeia since 2009 to present.