Transcript: Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices 09-29-2016

276 Pages·2016·0.53 MB·English

by  Capital Reporting Company

Capital Reporting Company
Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

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1 FOOD AND DRUG ADMINISTRATION (FDA)
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8 COORDINATED DEVELOPMENT OF ANTIMICROBIAL DRUGS AND
9 ANTIMICROBIAL SUSCEPTIBILITY TEST DEVICES
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11 Thursday, September 29, 2016
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15 Sheraton Silver Spring Hotel
16 8777 Georgia Avenue
17 Silver Spring, MD 20910
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21 Reported by: Dylan Hinds,
22 Capital Reporting Company
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Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

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1 A P P E A R A N C E S
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3 Jane Ambler, PhD
4 Vice President, Clinical Microbiology
5 Wockhardt Pharmaceuticals,
6 Helen Boucher, MD
7 Director, Infectious Diseases Fellowship Program
8 Associate Professor of Medicine
9 Tufts University School of Medicine
10 Samuel Bozzette, MD, PhD
11 Vice President, Medical Affairs-Americas
12 bioMérieux
13 Bill Brasso
14 Senior Staff Scientist
15 BD Diagnostics
16 Darcie (Roe) Carpenter, PhD
17 Director, Clinical Affairs
18 Beckman Coulter (Microscan)
19 Ed Cox, MD, PhD
20 Director, Office of Antimicrobial Products (OAP)
21 Center for Drug Evaluation and Research (CDER)
22 FDA
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Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

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1 A P P E A R A N C E S (Continued)
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3 Ian Critchley, PhD
4 Vice President, Clinical Microbiology
5 Allergan
6 Roger Echols, MD
7 Consultant
8 Shionogi
9 Robert Flamm, PhD
10 JMI Laboratories
11 Steve Gitterman, MD, PhD
12 Deputy Director, Division of Microbiology
13 Devices(DMD)
14 Office of In Vitro Diagnostics and Radiological
15 Health (OIR)
16 Center for Devices and Radiological Health (CDRH)
17 FDA
18 Romney Humphries, PhD
19 Section Chief, Clinical Microbiology
20 Associate Professor, Clinical Pathology
21 David Geffen School of Medicine, UCLA
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Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

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1 A P P E A R A N C E S (Continued)
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3 Amanda Jezek
4 VP, Public Policy and Government Relations
5 Infectious Diseases Society of America
6 Kevin Krause
7 Director and Head of Microbiology
8 Achaogen
9 Olga Lomovskaya, PhD
10 Vice President, Biology
11 The Medicines Company
12 Amy Mathers, MD
13 Associate Professor
14 University of Virginia
15 Sandra McCurdy
16 Field Microbiology Affairs Director
17 Melinta Therapeutics
18 Melissa Miller, PhD
19 Professor of Pathology and Laboratory Medicine
20 Director, Clinical Molecular Microbiology Lab
21 Associate Director, Microbiology-Immunology Lab
22 UNC School of Medicine, UNC Chapel Hill
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Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

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1 A P P E A R A N C E S (Continued)
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3 Mary Motyl, PhD
4 Senior Principal Scientist
5 Merck
6 Sumathi Nambiar, MD, MPH
7 Director, Division of Anti-Infective Products
8 (DAIP)
9 OAP, CDER, FDA
10 Jean Patel, PhD
11 Deputy Director, Office of Antimicrobial
12 Resistance
13 Centers for Disease Control and Prevention (CDC)
14 Charlene Reed, PhD
15 Chief Executive Officer
16 The Foundation to Combat Antimicrobial Resistance
17 John Rex, MD
18 Senior Vice President and Chief Strategy Officer
19 Infection Business Unit
20 AstraZeneca, plc
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Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

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1 A P P E A R A N C E S (Continued)
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3 Daniel Sahm, PhD
4 Chief Scientific Officer, VP Microbiology Global
5 Services
6 IHMA
7 Ribhi Shawar, PhD
8 Branch Chief, General Bacteriology and
9 Antimicrobial Susceptibility Branch
10 DMD, OIR, CDRH, FDA
11 Fred Tenover, PhD
12 Vice President, Scientific Affairs
13 Cepheid
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Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

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1 C O N T E N T S
2 AGENDA ITEM PAGE
3 Introductory Remarks
4 Sumathi Nambiar, MD, MPH 9
5 FDA Perspective on Antimicrobial Susceptibility
6 Test Development
7 Ribhi Shawar, PhD 17
8 Clinical and Laboratory Perspective
9 University of Virginia
10 Amy Mathers, MD 32
11 UCLA
12 Romney Humphries, PhD 42
13 Pharmaceutical Company Experience/Perspective
14 Merck
15 Mary Motyl, PhD 53
16 Achaogen
17 Kevin Krause 72
18 Diagnostic Device Manufacturer Experience/Perspective
19 BD Diagnostic Systems
20 Development of Commercial Products for
21 Antimicrobial Susceptibility Testing
22 Bill Brasso 98
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Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

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1 C O N T E N T S (Continued)
2 AGENDA ITEM PAGE
3 Beckman Coulter
4 Antimicrobial Susceptibility Testing:
5 Challenges to Getting to Market
6 Darcie (Roe) Carpenter, PhD 117
7 Antimicrobial Susceptibility Testing:
8 Suggestions Going Forward
9 Bill Brasso, Darcie Carpenter, PhD 125
10 Clarifying Questions from Audience/Panelists 132
11 Roles and Resources in Coordinated Development
12 UNC School of Medicine
13 Melissa Miller, PhD 149
14 Centers for Disease Control and Prevention
15 Jean Patel, PhD 157
16 Clarifying Questions from Audience/Panelists 164
17 Panel Discussion 214
18 Concluding Remarks
19 Ed Cox, MD, PhD 262
20 Steve Gitterman, MD, PhD 264
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Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

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1 P R O C E E D I N G S
2 INTRODUCTORY REMARKS
3 DR. NAMBIAR: All right. Is this better?
4 Okay. We’ll start again. So, good morning, and
5 welcome to the FDA workshop on coordinated development
6 of antimicrobial drugs and AST devices. My name is
7 Sumathi Nambiar, and I’m from the Division of Anti-
8 Infective Products.
9 So the last several months, we’ve heard from
10 various stakeholders, clinicians, clinical
11 microbiology laboratories, drug and device
12 manufacturers that there are challenges on many fronts
13 to make antimicrobial susceptibility testing available
14 in a timely fashion, following approval of a new
15 antibacterial drug.
16 And so, at today’s meeting, we would like to
17 understand what some of the challenges or bottlenecks
18 are in making antimicrobial susceptibility testing
19 available in a timely manner once a new antibacterial
20 drug is approved.
21 We hope that this meeting will provide an
22 opportunity for a robust discussion on this issue and
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Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

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1 hopefully identify some potential solutions to address
2 the challenges so that appropriate treatments can be
3 made available to patients.
4 Just a couple of slides on the microbiology
5 aspects of antibacterial drugs, really from a drug
6 perspective and Ribhi will talk about it from a CDRH
7 perspective.
8 I think many of you are familiar with this
9 guidance document on microbiology data and it was
10 recently updated as of last month. And this guidance
11 document provides overall information that is needed
12 or the program -- the microbiology program that is
13 needed to support the development of systemic
14 antibacterial drugs.
15 I’ll also touch upon the microbiology
16 section of labeling, and I’m sure most of you are
17 familiar with this, but would serve as a reminder. So
18 subsection 12.4 describes -- which is the microbiology
19 subsection -- describes the relevant microbiology data
20 for the drug. It describes the mechanism of action,
21 mechanisms of resistance, interaction with other
22 antimicrobials, et cetera.
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