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Committee & Speaker Biographies

Committee & Speaker Biographies

14th Annual PDA Global Conference on Pharmaceutical Microbiology

October 21-23, 2019, Rockville, MD

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    MaryEllen E. Usarzewicz, MS

    Bristol-Myers Squibb

    MaryEllen E. Usarzewicz received her B.S. in Microbiology from Wagner College in 2000. After several years working in CRO’s, she joined BMS in 2007, eventually ending up, through various roles as Associate Director, Microbiological Support Operations.  She oversees a group of 17 who are responsible for providing microbiological support of non-sterile and sterile clinical manufacturing operations including environmental monitoring, drug product testing and facility qualifications.  She is active in several teams in the Parenteral Drug Association.  In her spare time, she is busy raising 2 children.

  • Ebony Arrington

    Ebony S. Arrington, MS

    Pfizer, Inc.

    Ebony Arrington is a Manager within Production Operations at the Pfizer Sanford, North Carolina site. She works with the Central Support team responsible for cell banking, weigh and dispense operations, investigations, change controls, electronic batch record system, and document lifecycle management among other support functions for daily manufacturing operations at the Sanford facility. She also supports aseptic training to manufacturing colleagues, as well as microbial contaminations and environmental excursions. In her previous role, Ebony served as the site Cell Bank Lead managing production of starting material for vaccines such as Prevenar 13 and Trumenba. Prior to joining the Operations team, Ebony was a scientist within the QC Microbiology group responsible for the analytical development and implementation of new assays and technologies. Her past experience also includes environmental monitoring, product testing, as well as extensive knowledge and experience with fungal and microbial identification. She holds a Bachelor of Science in Biology with a concentration in Genetics from Duke University and a Master of Science degree in Clinical Research from Campbell University.

  • Renee Blosser

    Renée S. Blosser, MS

    FDA

    Renée Blosser joined the FDA in 2004 and is currently a Master Microbiology Reviewer in the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation at CVM. She has extensive experience in aseptic processing for finished drug products and review of media fill and sterility failure investigations. She also serves as a Quality Assessment Lead for review of pioneer and generic injectable drug products. Prior to joining the FDA, Renée worked in the field of antimicrobial drug development and surveillance of antimicrobial resistance.

    Renée received a Bachelor of Science in Biology from Florida State University and a Master of Science in Microbiology from the University of South Florida.

  • Bo Chi

    Bo Chi, PhD

    FDA

    Bo Chi is currently a reviewer in Branch IV in the Division of Microbiology Assessment, Office of Process and Facilities, Office of Product Quality in CDER/FDA. The branch is responsible for microbiology quality review and pre-license and pre-approval inspections of biotech products. Bo has been with the FDA for more than 15 years. She has a Ph.D. in Microbiology.

  • Irving Ford

    Irving Ford, MSc

    Celgene, Biotechnology Company

    Irving Ford is currently the Head of CAR T QC Laboratories at Celgene. Prior to joining Celgene, Irving was a significant contributor for activities supporting the 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 designed, implemented and managed paperless laboratories.

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

    Irving has served as the subject matter expert during numerous contract service provider audits as well as for regulatory inspections/filings. Irving was also involved in a successful consent decree remediation.

    Irving is an active member of PDA and recently served on the planning committee for the 2018 PDA Global Conference on Pharmaceutical Microbiology. Irving is also a co-author/contributor for the PDA’s TR for EM of Low Bioburden Facilities.

    Currently, Irving is working on a task force for creating an ISO Standard for the apheresis collection. Irving is also co-authoring a White Paper for appropriate microbiological controls for ATMPs manufacturing.

  • Leslie Furr

    Leslie A. Furr, MS, SM (NRCM)

    US Pharmacopeia

    Leslie Furr is an Associate Scientific Liaison to the Compendial Sciences-General Chapters group at the United States Pharmacopeial Convention.  She has been with USP since 2018 where she is a liaison to the Packaging and Distribution and Microbiology Expert Committees.  Before becoming a liaison at USP she was an Expert Committee volunteer for the Chemical Medicines group with expertise in antibiotic testing.   She holds a certification from the American Society for Microbiology as a Specialist Microbiologist in Pharmaceutical and Medical Device since 2012.  Prior to working at USP, she was a Senior Microbiologist in the pharmaceutical industry where she spent 14 years in method development, R&D, and manufacturing support for non-sterile products.  She obtained her B.S. in Microbiology from the University of North Carolina at Charlotte and her M.S. in Pharmaceutical Sciences at the University of Florida.

  • Mitch Garber

    Mitch B. Garber, BS, RPh

    GlaxoSmithKline

    Mitch Garber is a Director of Sterile and BioPharm Product Quality with GlaxoSmithKline, where he provides technical and quality support for the manufacture of BioPharm bulk and sterile commercial and clinical products used worldwide.  He obtained his Bachelor of Science in Pharmacy from the University of Sciences in Philadelphia (formerly Philadelphia College of Pharmacy and Science) and is a registered pharmacist.  Mitch has over 34 years of professional experience in regulatory compliance, aseptic manufacturing, validation, GMP auditing, and sterile product/process development and quality.    

    He is active in the field of aseptic manufacturing and compliance and has served on committees within Parenteral Drug Association (PDA) and GSK including GSK’s Aseptic Manufacturing Taskforce Group.  Mitch has presented in several countries for PDA and GSK. He was also the Program Committee Chairman of the Delaware Valley Chapter of the PDA. 

  • Christine Sherman

    Christine Sherman, BA

    Takeda
    Christine Sherman is a member of the Takeda Global Microbiology Management team and is based in Cambridge, Massachusetts.  Her background in Microbiology consists of supporting facilities that manufacture pharmaceutical products (sterile and non-sterile), biologics, and vaccines.  Prior to joining Takeda in 2017, she worked for several microbiology laboratories in the pharmaceutical industry including Johnson & Johnson, Pfizer and later, Merck in Sterility Assurance roles in the vaccines facilities.  In these roles, she was responsible for ensuring product sterility by supporting environmental monitoring, process simulation, and smoke studies programs and well as facilitating internal Microbiology Communities of Practice focused on bioburden control.  Throughout her career, she has interacted with various regulatory agencies and supported internal audits as a Microbiology SME.
  • Kim R. Sobien, MBA

    PETNET Solutions | A Siemens Company

    Kim Sobien is currently the Principal Sterility Assurance Engineer for PETNET Solutions, a wholly owned subsidiary of Siemens Medical Solutions USA, Inc., which operates the largest network of PET radiopharmacies worldwide.

    Previously she has served as an Associate Director of Regulatory Compliance at Merck, Regulatory Compliance Lead at BD Rx, Inc., and Microbiology Laboratory Manager at Oso BioPharmaceuticals.  Her pharmaceutical industry career encompasses a breadth of experience with injectable pharmaceutical product Quality and Compliance, including pre-filled syringe generics, radiopharmaceuticals, and parenteral pharmaceutical contract manufacturing.

    Kim has a B.S. in Microbiology from the University of Wisconsin – La Crosse and a Master of Business (MBA) degree with an emphasis in Global Management from the University of Phoenix.  She is a member of the Parenteral Drug Association (PDA), past co-chair of the PDA Annual Global Conference on Pharmaceutical Microbiology, a member of the PDA Microbial Data Deviations (MDD) Technical Report writing team, and a Senior Member of the American Society for Quality (ASQ).

  • Ed C. Tidswell, PhD, BSc

    Merck

    Dr. Tidswell is Executive Director within the Sterile and Microbiology QA organization of Merck.  This role has ownership over microbiology issues across sterile and non-sterile sites within the Global Manufacturing Division.  His prior appointments include global R&D, and quality leadership roles supporting and innovating across large volume parenteral, small volume parenteral (small molecules, biologics, vaccines), medical device and bulk active pharmaceutical ingredient manufacturing and testing platforms for the likes of Baxter Healthcare, Eli Lilly and Evans Vaccines.  Dr Tidswell continues to actively publish and is a leading authority on pharmaceutical microbiology, risk, aseptic and sterile manufacture.  From 2013 he has served on the PDA’s Science Advisory Board and is currently a member of the PDA Journal’s Editorial Board.  In June 2010 Dr. Tidswell joined and continues to serve on the USP expert committee on Microbiology & Sterility Assurance.

  • James Agalloco

    James P. Agalloco, BEChE, MSChE, MBA

    Agalloco & Associates Inc.

    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.

  • Jay Bolden

    Jay S. Bolden

    Eli Lilly and Company

    Mr. Jay Bolden is an Senior Consultant Biologist in the Eli Lilly and Company Global Quality Laboratories.  He is an internal endotoxin subject matter expert and leads a team with global QC oversight for developing, validating, transferring and troubleshooting endotoxin, microbiology, QPCR and ELISA methodologies.  Jay holds a B.S. in Biology and an Environmental Studies certificate from Indiana University, and has over 19 years of industry experience in development, process and laboratory microbiology, and microbiology laboratory leadership.

  • Crystal Booth

    Crystal M. Booth, MM

    PSC Biotech

    Crystal M. Booth, M.M., is a Regional Manager a PSC Biotech and has over 20 years of experience in pharmaceutical microbiology, environmental monitoring, and quality assurance.  She obtained her master’s degree in microbiology from North Carolina State University.  Crystal is a seasoned award winning technical writer and author of Method Development and Validation for the Pharmaceutical Microbiologist.  During her career, Crystal has worked in microbiology, consulting, quality assurance, CDMOs, R&D, and quality control laboratories.  Crystal has developed and validated numerous microbial methods and has worked with many different product types. 

  • Reyes Candau-Chacon

    Reyes Candau-Chacon, PhD

    FDA

    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.

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    Hilary A. Chan, MS

    Takeda
  • Andrew Dick

    Andrew Dick, MS

    Johnson & Johnson

    Andrew Dick is a Senior Principal Microbiologist at J&J Consumer.  He has worked for Johnson and Johnson consumer for 14 years and has expertise in contamination prevention, troubleshooting contamination issues, involved in product recalls, conducting microbiological risk assessments at non-sterile and aseptic processing facilities, developing policies for cleaning and sanitization, microbiological test methods and validation protocols, suitability policy, and auditing of laboratories.

    Andrew has trained numerous personnel for both internal and external manufacturing networks.  He has also provided contamination control and investigation technique training for originations such as to the Parenteral Drug Association, Personal Care Products Counsel and Pharmaceutical Microbiology Forum. Recently (May 2019), he gave a half day seminar to the FDA CDER, Office of Compliance held at their headquarters.

    Andrew had also worked in the personal products industry, food industry and clinical microbiology. 

    In 2018, Andrew published a book with the PDA, “Contamination Prevention for Nonsterile Pharmaceutical Manufacturing”.   He also co-authored PDA Technical Report #67 “Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices and Cosmetics”.

    Andrew has a M.S. degree in Microbiology from Wagner College, Staten Island NY.  He’s earned an Alumni Fellow award at Wagner College in 2018.  He has a B.S. degree in Medical Technology.

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    Geneviève Dufour

    Health Canada

    Analyst in the Health Canada Microbiology Laboratory since 2011

    Bachelor degree at University of Montreal in Microbiology and Immunology

    Previous jobs were in research and development in molecular biology and genetics, Genome Quebec and CNRC

  • Rob Dunn

    Rob Dunn, PhD

    Biologist and Author, Never Home Alone: From Microbes to Millipedes, Came Crickets, and Honeybees, the Natural History of Where We Live
  • Irving Ford

    Irving Ford, MSc

    Celgene, Biotechnology Company

    Irving Ford is currently the Head of CAR T QC Laboratories at Celgene. Prior to joining Celgene, Irving was a significant contributor for activities supporting the 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 designed, implemented and managed paperless laboratories.

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

    Irving has served as the subject matter expert during numerous contract service provider audits as well as for regulatory inspections/filings. Irving was also involved in a successful consent decree remediation.

    Irving is an active member of PDA and recently served on the planning committee for the 2018 PDA Global Conference on Pharmaceutical Microbiology. Irving is also a co-author/contributor for the PDA’s TR for EM of Low Bioburden Facilities.

    Currently, Irving is working on a task force for creating an ISO Standard for the apheresis collection. Irving is also co-authoring a White Paper for appropriate microbiological controls for ATMPs manufacturing.

  • Richard Friedman

    Rick L. Friedman, MS

    FDA

    Richard L. Friedman is the Deputy Director, Science and Regulatory Policy, Office of Manufacturing and Product Quality, which is part of the compliance office in FDA's Center for Drug Evaluation and Research (CDER).  This position includes oversight of regulatory action recommendations relating to inspections and manufacturing site acceptability, and promoting sound regulatory policy development.  Mr. Friedman has authored several publications on topics including sterile drugs and quality systems.  Mr. Friedman has been a faculty member in Temple University School of Pharmacy’s  QA/RA graduate program since 2003. Prior to joining FDA in 1990, Mr. Friedman worked in the toxicology research division of Parke-Davis. Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989, and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.

  • Dennis Guilfoyle

    Dennis E. Guilfoyle, MS, PhD

    Johnson & Johnson

    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”

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    Fatima Hasanain

    Nordion, A Sotera Health Company

    Fatima Hasanain, MSc, is a Polymer Materials Specialist for Nordion (Canada) Inc., a leading supplier of gamma sterilization technology to the healthcare market. Fatima has a variety of expertise in radiation effects on polymer materials, pharmaceuticals and gamma sterilization. Fatima is the Technical Manager of the Dosimetry lab at Nordion and a member in the ASTM Radiation Processing: Dosimetry and Applications Subcommittee. She is also a member in the American Association of Medical Instrumentation (AAMI), International Organization for Standardization (ISO), and Parenteral Drug Association (PDA). Fatima is also a teaching faculty at PDA teaching about radiation sterilization. Fatima has publications in various peer reviewed journals including the Radiation Physics and Chemistry, PDA Journal of Pharmaceutical Science and Technology, Polymer, and Dyes and Pigments. Fatima holds a Masters degree in Organic and Polymer Chemistry and Bachelor of Science in Biochemistry and Biotechnology both from Carleton University.

  • Ayako Hasegawa

    Ayako Hasegawa, PhD

    Allergan

    Ayako Hasegawa, PhD, is currently leading R&D Pharmaceutical Microbiology department at Allergan as an associate director, focused on implementation of risk based holistic micro control strategy and evaluation of new technology providing best solution for micro challenges including micro QC tests.

    Ayako received both bachelor’s and doctorate degrees from University of California, Los Angeles. During her 11 years at Allergan, she was instrumental in strategic evaluation of alternative sterilization technologies, optimization of sterilization process and aseptic manufacturing process including process simulation, and spearheaded microbiological risk assessment of container closures for preserved and preservative-free, multi-dose products.

  • Rebecca Jordan

    Rebecca D. Jordan

    Celgene

    Rebecca Jordan is a Microbiology Specialist at Celgene's West Coast CAR-T manufacturing facility, where she focuses on the multifaceted discipline of contamination control. She has over 10 years’ experience in industry as a QC Microbiologist, where she has supported both large and small manufacturing firms, commercial facility start-up, development through licensure of parenteral drugs, facility and utilities monitoring, APS, CAPA, and quality risk management to name a few. She has also successfully navigated global regulatory audits, developed and implemented aseptic training programs, established EM trend and disinfectant efficacy programs, and consulted on new facility design projects for CAR-T therapy manufacturing. She is a keen investigator whose curiosity and dedication has led to a diverse and rewarding career. She holds a B.S. in Biology from Fitchburg State University.

  • Timothy Kedzior

    Timothy P. Kedzior, MED

    Novartis Pharmaceuticals Corporation

    Timothy Kedzior is Masters Degree educated in Instructional Technologies, with an emphasis on Interactive Technologies, from Wayne State University, Detroit, Michigan.  Thirty-plus years training development, delivery and analysis, in the pharmaceuticals, medical device, nuclear power, automotive, utility, and private sectors.  Certified as a Nuclear Instructor, Internal Auditor, Root Cause Analyst, with experience in Human Performance.

    Currently the Instructional Design Lead with Novartis Pharmaceusticals, working on the CAR-T019 product Kymriah.

  • Anthony Lorenzo

    Anthony F. Lorenzo

    FDA

    Mr. Lorenzo has been with the FDA since March 2010 in the Office of Compliance and Biologics Quality (OCBQ), Division of' Manufacturing and Product Quality (DMPQ), Manufacturing Branch 2 (MRB 2), Center for Biologics Evaluation and Research (CBER). Prior to joining the Agency, he had 20 years of experience in CGMP manufacturing; designing, building, commissioning, and validating biologic manufacturing facilities; and scaling up pilot scale to large scale manufacturing. Today, Mr. Lorenzo is the Team Lead responsible for planning, coordinating, and evaluating the overall review and approval process for BLAs and supplements in the branch.

  • John Metcalfe

    John W. Metcalfe, PhD

    FDA

    Dr. John Metcalfe holds a BA in biology from Merrimack College in Andover, MA, and a PhD in microbiology from the University of Rhode Island.  John spent 14 years teaching college microbiology courses prior to beginning a career in CDER in 2003.  At FDA, John works as a microbiologist where he performs a review of both sterile and non-sterile drug products providing an assessment of microbiological quality.  He is an FDA Liaison to the USP Expert Committee on Pharmacy Compounding, and is a published author in the area of drug product microbiological quality.

  • 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. 

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    Hien T. Nguyen, MS

    Biogen
  • Manshi Patel

    Manshi V. Patel

    Merck & Co., Inc.

    Manshi Patel is the Associate Director of Global sterile and Validation-microbial control COE at Merck in West Point supporting all sterile microbial sites in managing microbial risks by providing expertise in new and existing microbial contamination control solutions aligning with regulatory expectations.  She is a Microbiologist graduated from India with extensive experience in microbiology, sterility assurance and contamination control. 

    She started her career at Quest Diagnostics as clinical microbiologist after which she moved to J&J into Quality where she led the startup of micro lab including implementation and validation of all microbial testing supporting the pilot plant (pre-commercial production system) and bulk products.

    With her expanding experience she took up an opportunity as a quality site microbiologist with oversight of sterility assurance of aseptic operations.  Her contribution included maintenance of the sites maturity level and drive continuous improvement representing Quality as part of manufacturing lean excellence to identify areas to standardize and develop ways to simplify in alignment with GMP regulations.  Additionally, her major contribution was the reduction of excursions (66%) sample site reduction that drove Operation Excellence improvements in compliance.

  • Stacey Ramsey

    Stacey N. Ramsey, MS, SM(NRCM)

    Alcami Corporation

    Stacey Ramsey is a career pharmaceutical microbiologist, specializing in sterile drug product development and testing. Originally from Wichita, Kansas, Stacey received her Bachelor of Science degree from Wichita State University in Biological Sciences, and a Master of Science degree from Friends University. Upon completing her education, she served in QC and development laboratories at Hospira in McPherson, KS, where she developed a broad understanding of manufacturing processes, environmental monitoring and controls, and drug product testing. After spending a decade in contract manufacturing, Stacey relocated to Wilmington, NC where she now serves as a Senior Scientist for contract laboratory, Alcami Corporation. In this role, Stacey specializes in streamlining and improving processes, with an emphasis on innovation and new ideas.

  • Helen Saccone

    Helen Y. Saccone, PharmD, MSEL

    FDA

    CAPTAIN Helen Saccone serves as a Senior Advisor within CDER’s Office of Strategic Programs.   CAPT Saccone was part of the inaugural team that initiated the US-EU Mutual Reliance Initiative in 2014, that led the negotiations and implementation of the US-EU Mutual Recognition Agreement for the FDA.

    CAPT Saccone joined FDA in 2008 as a Program Management Officer within CDER’s Office of Compliance, then served as the Associate Director of Global Policy within FDA’s Office of Commissioner.  Prior to joining FDA, she worked as a pharmacy inspector for the DC Department of Health and a Senior Manager of Education at the American Pharmacists Association.

    CDR Saccone received her Doctorate of Pharmacy from Rutgers University and was commissioned into the US Public Health Service in 2009.

  • Anil Sawant

    Anil Sawant, MSc, PhD

    Merck & Co., Inc.

    Dr. Sawant has over 25 years of experience in Quality Operations, GXP Compliance Operations, Auditing, and Ethics & Research Integrity functions.  He has extensive experience working on small molecules, biologics, and vaccines, various dosage forms from injectable to topical, and medical devices and combination products. Prior to joining Merck, Dr. Sawant was Vice President, Enterprise Regulatory Compliance, Johnson & Johnson.  Prior to J&J, he served as the Vice President, Compliance & Research Integrity for Wyeth Pharmaceuticals (now Pfizer). Dr. Sawant holds a B.Sc. Honors and a M.Sc. Honors in Microbiology from Panjab University, India and a Ph.D. in Microbial and Biochemical Sciences from Georgia State University, Atlanta, GA. He has published numerous papers in peer reviewed microbiology and medical journals on glycoproteins, fermentation, medical device development, and GLP and GCP studies. Dr. Sawant has been the lead for four PDA Technical Report and Co-Chairs the PDA Task Force on Data Integrity. Dr. Sawant currently serves on the/PDA Board of Directors, Board of Directors Mind Your Brain Foundation and has served on Board of Directors of Georgia State University Alumni Association.  He is recipient of the Georgia State University Distinguished Alumni Achievement Award and the PDA Distinguished Service Award.

  • Steffanie Strathdee

    Steffanie Strathdee, PhD

    UC San Diego
    Dr. Strathdee is an infectious disease epidemiologist, Associate Dean of Global Health Sciences and Harold Simon Professor of Medicine at the University of California San Diego where she co-directs the Center for Innovative Phage Applications and Therapeutics.  Strathdee recently co-authored a memoir entitled The Perfect Predator: A Scientist’s Race to Save Her Husband from a Deadly Superbug.  In 2018, she was named by TIME magazine as one of the 50 Most Influential People in Health Care for her work that revitalized phage therapy in the West.
  • Kenneth Tai

    Kenneth P. Tai, PhD

    Genentech

    My name is Kenneth Tai and I am currently a quality control scientist at Genentech.  I received my Ph.D. in 2012 studying the structure and function of antimicrobial peptides in innate immunity.  During that time I solved the 3D structure of an antimicrobial peptide using NMR, elucidated multiple conserved regions necessary for its functional activity, and published 9 journal articles.   After graduating, I took a position as a technical applications scientist at ThermoFisher, supporting PCR, real-time PCR, SNP genotyping, relative quantification, gene expression, siRNA, microRNAs, and all Applied Biosystems themocyclers (including real-time).  I led cross-functional projects and troubleshooting between, sales, manufacturing, regulatory, and quality.  I became the global single point of contact (SPOC) for all real-time PCR reagents.  I started my career in quality control at Genentech and served several roles: Senior QC Associate, QC Associate Scientist, and currently, a QC Scientist. I have worked on method development, transfer, and validation for real-time PCR assays for adventitious agents testing. I am currently working to bring Next Generation Sequencing (NGS) as a method to replace multiple adventitious agents testing and to work towards a real-time release of product to provide medicines as quickly as possible to our patients. 

  • Sarah Wallace

    Sarah L. Wallace, PhD

    NASA Johnson Space Center
    Microbiologist, NASA