Medical Devices

Public Workshop - Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices, September 13, 2017

The Food and Drug Administration (FDA) is announcing a public Workshop entitled "Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices."

The purpose of the workshop is to promote discussion of the scientific and regulatory challenges associated with the efficient development of traditional devices for antimicrobial susceptibility testing (AST) and molecular or novel diagnostic technologies for the detection of antimicrobial resistance markers. Specifically, this workshop will address the new regulatory solutions to some of these challenges created by the 21st Century Cures Act.


Date, Time and Location

This meeting will be held September 13, 2017, beginning at 8:30 a.m. - 5:00 p.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking, security and travel information please refer to Public Meetings at the FDA White Oak Campus.

Webcast

Agenda

Morning Session - Traditional AST Devices

TimeTopicsPresenter(s)
7:30-8:30AMRegistration 
8:30-8:40AMWelcome and Meeting GoalsSteve Gitterman
FDA, CDRH
8:40-9:00AMFDA Perspective on 21st Century Cures LegislationJohn Farley
FDA, CDER
9:00-9:20AMPerspective on Current Reference MethodsRomney Humphries
UCLA
9:20-9:40AMIndustry Perspective on the Challenges of AST Methods and the Role of STMABill Brasso
BD Diagnostic Systems
9:40-10:00AMFDA Perspective and Experience with Review of AST devicesRibhi Shawar
FDA, CDRH
10:00-10:15AMBreak 
10:15-10:30AMIndustry Perspective on the Advantages and Challenges of Novel AST MethodsSteve Metzger
Accelerate Diagnostics
10:30-12:00PMPanel Discussion 
12:00-1:00PMLunch 

Afternoon Session - New Technologies for Detection of Resistance

TimeTopicsPresenter(s)
1:00-1:05PMIntroduction to Afternoon SessionKristian Roth
FDA, CDRH
1:05-1:25PMRecent Industry Experience and Perspective on the Advantages and Challenges of Methods for the Detection of Resistance MarkersMike Dunne
bioMérieux
1:25-1:40PMPublic Health Implications of Antimicrobial Resistance SurveillanceDaniel Sahm
IHMA
1:40-2:00PMClinical and Laboratory  Experience with Interpretation and Reporting Resistance MarkersPatricia Simner
Johns Hopkins Hospital
2:00-2:15PMFDA Perspective on Scientific Review of Novel Technologies for Detection of ResistanceKimberly Anderson
FDA, CDRH
2:15-2:40PMChallenges of the Clinical Use and Interpretation of Genotypic vs. Phenotypic Drug Resistance TestingRobert Bonomo
Cleveland VA MC
Scott Evans
Harvard University
2:40-2:55PMEfforts and Resources for Addressing Antimicrobial ResistanceJean Patel
CDC
2:55-3:15PMPublic CommentsPatricia Conville
FDA, CDRH
3:15-3:30PMBreak 
3:30-5:00PMPanel Discussion 
5:00-5:10PMClosing RemarksUwe Scherf
FDA, CDRH

Workshop Moderators: Ribhi Shawar (Session I), Steve Gitterman (Session II)

Panel Members, Session I (Morning):
John Farley (FDA, CDER) , Melissa Miller (UNC School of Medicine), Barbara Zimmer (Beckman Coulter), Amy Mathers ( Infectious Diseases Society of America), Richard (Tom) Thomson (University of Chicago Pritzker School of Medicine), Bill Brasso (BD Diagnostic Systems), Romney Humphries (UCLA), Jean Patel (CDC), Steve Metzger (Accelerate Diagnostics)

Panel Members, Session II (Afternoon):
Karen Bush (University of Indiana), David Perlin (Rutgers University), Thomas Kirn (Rutgers Robert Wood Johnson Medical School ), Mariana Castanheira (JMI labs), Shawn Lockhart (CDC), Mike Dunne (bioMérieux), Anna Lau (NIH), Susan Sharp (ASM), Patricia Simner (Johns Hopkins Hospital)

Registration to Attend the Workshop

Registration is closed. Seating is full so there will not be on-site registration for this workshop.

Contact Us

For questions regarding workshop content please contact:

Natasha Townsend,
Food and Drug Administration,
Center for Devices and Radiological Health,
10903 New Hampshire Ave., Bldg. 66 rm. 5525, Silver Spring, MD 20993-0002,
Tele: 301-796-5927,
Email: natasha.townsend@fda.hhs.gov.

Speakers' Biographies

Steve Gitterman:
Dr. Gitterman is currently Deputy Director of the Division of Microbiology Devices, Office of In Vitro Diagnostic Diagnostics and Radiological Health at the Food and Drug Administration (FDA). Dr. Gitterman is board-certified in Internal Medicine and Infectious Disease. In addition to his work at FDA, he is an attending physician in Infectious Diseases at the Washington, DC, Veterans Administration Medical Center and Assistant Professor of Medicine at the Uniformed Services University of the Health Sciences.

Sumathi Nambiar:
Dr. Sumathi Nambiar is Director of the Division of Anti-Infective Products, Office of Antimicrobial Products, since July 2013. Dr. Nambiar joined the Division of Anti-Infective Products in 2002. In her current role, Dr. Nambiar provides regulatory oversight for anti-infective products, including antibacterial, antifungal, and antiparasitic drugs.

Dr. Nambiar is board-certified in pediatrics and pediatric infectious diseases. She completed her pediatric residency at the Inova Fairfax Hospital for Children, VA and her fellowship in pediatric infectious diseases at Children's National Medical Center, Washington DC. She received her MPH from The George Washington University School of Public Health.

Romney Humphries:
Dr. Romney Humphries is a D(ABMM) clinical microbiologist. She served as Section Chief of the Clinical Microbiology Laboratory at UCLA for 6 years, after finishing a clinical CPEP fellowship at UCLA. She is currently the Chief Scientific Officer for Accelerate Diagnostics. Dr. Humphries is a member of the CLSI Antimicrobial Susceptibility Testing Subcommittee. For this group, she chairs several ad hoc working groups, including the Coordinate Development of Antimicrobials and ASTs. Dr. Humphries is a member of the College of American Pathologists Microbiology Resource Committee, the APHL/ASM Antimicrobial Resistance Laboratory Workgroup. Dr. Humphries has authored over 100 peer- reviewed papers on the topics of clinical microbiology, focusing primarily on antimicrobial resistance and the laboratory detection of antimicrobial resistance.

Bill Brasso:

  • Senior Staff Scientist in ID/AST Research & Development at BD Diagnostic Systems, Sparks, MD
  • Employed with BD in Sparks, MD since 1985 (32 yrs)
  • Focus for past 20 years has been with AST development for the Phoenix automated system platform, as well as manual methodologies
  • Received B.S. in Microbiology at University of Maryland, College Park, MD (1985). Received certificate for “Antimicrobial Agents and Chemotherapy” course from Creighton University School of Medicine, June 1997.
  • Advisor to the CLSI AST Subcommittee (Jan. 2015 – present), as well as a voting member for the Methodology Working Group; Co-chairperson for the Broth Microdilution Ad Hoc Working Group (2013 to present), as well as a member of several other CLSI Working Groups.
  • Current member & Past-President (2013 and 2007) of the Susceptibility Test Manufacturers Association (STMA), also acting as liaison to the CLSI AST Subcommittee.
  • Most recent publication, “The Modified Carbapenem Inactivation Method (mCIM) for Phenotypic Detection of Carbapenemase Production among Enterobacteriaceae”, Pierce V., et al, J. Clin. Microbiol. Aug. 2017, 55:2321-2333. (Others available upon request.)
  • Resides in Columbia, MD with wife, Bonnie. Two grown children, Rebecka and Benjamin.

Ribhi Shawar, Ph.D (ABMM)
Branch Chief at the Division of Microbiology, (OIR), (CDRH), FDA
Dr. Ribhi Shawar currently serves as the Branch Chief at the Division of Microbiology in the Office of In vitro Diagnostic and Radiological Health (OIR) at the Center for Devices and Radiological Health (CDRH) at FDA where he specializes in the area of antimicrobial susceptibility testing and detection of resistance. Dr. Shawar has a Ph.D. in Medical Microbiology and an M.Sc. in Medical Parasitology. He is a certified diplomate by the American Board of Medical Microbiology (ABMM) for 25 years. Dr. Shawar is a recognized clinical microbiologist with diverse experience in hospital settings, diagnostic and pharmaceutical microbiology and anti-infective drug development with strong knowledge in regulatory aspects both in antimicrobial drug products and infectious disease diagnostics. Dr. Shawar has authored multiple publications in peer reviewed journals, served or currently serves as advisor to several CLSI Sub-committees and is the recipient of multiple awards including GSK Gold Award. He served for two terms as Chair of the ABMM Standards and Examinations Committee (Parasitology) and as member of the editorial board of the Journal of Clinical Microbiology. Prior to joining FDA, Dr. Shawar served in multiple roles at various institutions including Baylor College of Medicine, VA Medical Center in Houston, PathoGenesis Corporation, Chiron (Novartis) in Seattle, and GlaxoSmithKline in Philadelphia.

Steve Metzger:
Steve Metzger has served as the Head of New Products at Accelerate Diagnostics since November 2016. Previously from September 2012, Mr. Metzger served as Head of Discovery responsible for the development and system integration of the Accelerate's Pheno™ BC kit on the Pheno™ platform system. This cleared technology was the first fully automated solution permitted by the FDA for quantitative antibiotic susceptibility testing directly from patient positive blood culture samples. The Pheno™ BC kit is indicated for susceptibility testing of specific pathogenic bacteria commonly associated with bacteremia, the leading cause of sepsis.

Prior to September 2012, Mr. Metzger was Research and Development Manager at the company since December 2007, and as Senior Scientist from 2001 to 2007. Previously, he was responsible for Protein and DNA Sequencing Core Lab at Heska Corporation, Fort Collins, CO, and coordinated the integration of assay methods, software, and optical microscopy instrumentation for the force amplified biosensor program at the Naval Research Laboratory, Washington, D.C. Mr. Metzger is an ACS accredited chemist with a B.A. in Chemistry from The Colorado College.

Michael Dunne
Wm. Michael Dunne, Jr., Ph.D. is currently a senior research fellow for bioMérieux, Inc., based in Durham, NC. Prior to joining bioMérieux, he was medical director of the diagnostic microbiology laboratory at Barnes-Jewish Hospital and Professor of Pathology and Immunology, Molecular Microbiology, Pediatrics, and Medicine at Washington University School of Medicine in St. Louis from 2000-2011 where he remains on the faculty as an adjunct professor. During that time, he established an internationally-recognized training program in medical and public health microbiology which is still active today under the direction of former fellow, Dr. Carey-Ann Burnham. He had previously served as medical director of microbiology laboratories at Henry Ford Health System (Detroit, MI), Texas Children's Hospital (Baylor College of Medicine, Houston, TX) and Children's Hospital of Wisconsin (Medical College of Wisconsin, Milwaukee, WI, where he received his Ph.D. in 1982).

He is a Diplomate in the American Board of Medical Microbiology, and a Fellow of the American Academy of Microbiology, the Infectious Diseases Society of America, the Canadian College of Microbiology and the Pediatric Infectious Diseases Society. He served as a senior editor for the Journal of Clinical Microbiology for ten years and remains on the editorial board. He is also an Adjunct Professor of Pediatrics at the Duke University School of Medicine. He has authored more than 170 peer-reviewed publications, 10 chapters, and is co-editor of a soon-to-be-released text on blood cultures. 

Daniel F. Sahm, PhD, D(ABMM), FAAM
VP Global Microbiology Services & Chief Scientific Officer; IHMA, Inc.
Over 30 years of academic and industry experience focused on antimicrobial sciences and support of anti-infective research and product development. His experience spans the technical, clinical, regulatory, and business aspects required for all phases of product development. He has provided extensive expertise and managed a wide array of laboratory services that to support both small and large biopharmaceutical companies' development of a wide variety of anti-infective products and strategies.

Received his Ph.D. in Microbiology and Immunology from Oklahoma University Health Sciences Center and was a Postdoctoral Resident in Medical and Public Health Laboratory Microbiology at the US Centers for Disease Control and Prevention. Subsequently he held faculty and microbiology laboratory director positions at the University of Chicago and Washington University Medical Centers. More recently he served as the Chief Scientific Officer for Eurofins Global Central Laboratory, and currently he is the Vice President of Global Microbiology Services and Chief Scientific Officer for IHMA, Inc. Over his career he has presented and published over 500 scientific communications, books and book chapters and has provided extensive editorial and societal services for the American Society for Microbiology.

Patricia (Trish) Simner, PhD, D(ABMM)
Trish Simner, PhD, D(ABMM), is an Assistant Professor of Pathology at the Johns Hopkins University and the Director of the Medical Bacteriology and Parasitology Laboratories at the Johns Hopkins Medical Institutions. She completed her PhD at the University of Manitoba in Manitoba, Canada and a two year Clinical Microbiology Fellowship at the Mayo Clinic in Rochester, MN. Her research has focused on understanding the epidemiology and molecular mechanisms of resistance of Gram-negative bacteria, in particular those harboring β-lactamase enzymes. With the increasing prevalence of carbapenemase-producing organism (CPO), her focus has evolved to studying novel diagnostic methods for the detection of these clinically important pathogens and understanding their mechanisms of resistance and spread in the hospital setting. For a young researcher, she is well published with greater than 50 peer-reviewed manuscripts and 9 book chapters.
Dr. Simner is currently the principal investigator for a National Institute of Health (NIH) grant which seeks to understand the molecular mechanisms of antibiotic resistance and spread amongst all CPO in a region of the US endemic for CPO. In addition, she is involved in many interdisciplinary collaborative research projects, including a Centers for Disease Control and Prevention (CDC) Epicenter grant and a NIH R01 subaward with the University of Michigan. She is also interested in novel diagnostic tools for infectious diseases and is actively involved in validating metagenomic next-generation sequencing as a diagnostic tool.

Dr. Simner is a member of the Subcommittee on Antimicrobial Susceptibility Testing for the Clinical and Laboratory Standards Institute and a member of the American Board of Medical Microbiology exam validation committee for the American College of Microbiology. She is also an Editorial Board Member for the Journal of Clinical Microbiology.

Kimberly Anderson
Dr. Anderson is a Biologist with the Division of Microbiology Devices at FDA reviewing 510(k)s and pre-submissions for diagnostic medical devices. Prior to working at FDA, she earned her PhD in Biochemistry from Tulane University and completed post-doctoral fellowships at Children's Memorial Research Center in Chicago, IL and Loyola University Medical Center in Maywood, IL. Dr. Anderson also served as an FDA Commissioner's Fellow in the Office of Regulatory Affairs where she investigated various molecular typing methods used to characterize bacterial pathogens.

Robert Bonomo, MD
Chief of Medical Service and Director of Geriatric Research, Education, and Clinical Center
Louis Stokes Cleveland VA Medical Center
Vice Chair for Veteran Affairs, Department of Medicine
University Hospitals Cleveland Medical Center
Director, CWRU-Cleveland VAMC Center for Antimicrobial Resistance and Epidemiology
Professor of Medicine, Pharmacology, Molecular Biology and Microbiology, Biochemistry, and Proteomics and Bioinformatics
Case Western Reserve University School of Medicine
Robert.bonomo@med.va.gov, 216.791.3800 x 4788

Dr. Bonomo is Professor of Medicine, Pharmacology, Molecular Biology and Microbiology, Biochemistry, and Proteomics and Bioinformatics at Case Western Reserve University School of Medicine. He also serves as Chief of the Medical Service at the Louis Stokes Cleveland VA Medical Center, Director of the Cleveland Geriatric Research and Education Clinical Care Center, Vice Chair for Veterans Affairs in the University Hospitals Case Medical Center Department of Medicine and Director, CWRU-Cleveland VAMC Center for Antimicrobial Resistance and Epidemiology (Case VA CARES). His research interests include the mechanistic basis of resistance to ß-lactam antibiotics and ß-lactamase inhibitors, the molecular epidemiology of multidrug resistant Gram-negative bacteria, infections in the elderly, and the implementation of molecular diagnostics in clinical care of patients with infectious disease. He is an elected member of the American Academy of Microbiology, the Association of American Physicians, and has been appointed to PCORI as a representative of the Infectious Diseases Society of America. He is also Co-Director of the Laboratory Center of the NIH Sponsored Antibacterial Resistance Leadership Group (ARLG).

Scott Evans
Dr. Scott Evans, Harvard University is the Director of the Statistical and Data Management Center (SDMC) for the Antibacterial Resistance Leadership Group (ARLG). His interests include the design, monitoring, analyses, and reporting of and education in clinical trials and diagnostic studies. He is the author of more than 100 peer-reviewed publications and three textbooks on clinical trials.

Dr. Evans is a member of the Board of Directors for the American Statistical Association and the Society for Clinical Trials, and a former Director for Mu Sigma Rho (the National Honorary Society for Statistics). He is a member of an FDA Advisory Committee, the Steering Committee of the Clinical Trials Transformation Initiative (CTTI), and numerous DMCs. He is the Chair of the Trial of Year Committee for the Society for Clinical Trials and Chair of Q-SPIs DMC Benefit:risk Working Group. He is the Editor-in-Chief of CHANCE and Statistical Communications in Infectious Diseases (SCID).

Dr. Evans is a Visiting Professor at the Department of Medical Statistics at Osaka University in Japan. He's received the prestigious Mosteller Statistician of the Year Award, the Robert Zackin Distinguished Collaborative Statistician Award, and is a Fellow of the American Statistical Association (ASA).

Jean Patel, PhD, D(ABMM)
Science Team Lead, Antibiotic Resistance Coordination and Strategy Unit, National Center for Emerging Zoonotic and Infectious Diseases
Jean Patel is a clinical microbiologist with specific expertise in the laboratory detection of antimicrobial resistance. She has experience leading the CDC Antimicrobial Resistance Laboratory and prior to CDC worked as the Assistant Director of the Clinical Microbiology Laboratory of the Hospital of the University of Pennsylvania. Dr. Patel has served as chair and vice chair of the Clinical and Laboratory Standards Institute Subcommittee for Antimicrobial Susceptibility Testing and works with WHO to develop technical guidance for detecting resistance and strengthening global surveillance of antimicrobial resistance. At CDC she leads implementation of the Antibiotic Resistance Laboratory Network (ARLN) and the Antibiotic Resistance Isolate Bank.

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