Meeting November 19, 2019 Page 1 1 FOOD AND DRUG ADMINISTRATION 2 ________________________________ 3 FDA-IDSA-NIH-Pew Public Workshop 4 Enhancing the Clinical Trial Enterprise for 5 Antibacterial Drug Development in the United States 6 ________________________________ 7 8 DATE: Day 1: November 18, 2019 9 TIME: 8:30 a.m. 10 LOCATION: FDA White Oak Campus 11 10903 New Hampshire Avenue 12 Building 31 Great Room 13 Silver Spring, MD 20993 14 REPORTED BY: Michael Farkas, Notary Public 15 JOB No.: 3472551 16 17 18 19 20 21 22 23 www.CapitalReportingCompany.com 202-857-3376 Meeting November 19, 2019 Page 2 1 PARTICIPANTS: 2 3 JOHN FARLEY 4 AARON DANE 5 ROGER LEWIS 6 DAVID MELNICK 7 RIENK PYPSTRA 8 CHIBUZOR UCHEA 9 VANCE FOWLER 10 CYNTHIA SEARS 11 SARA COSGROVE 12 REBECCA REINDEL 13 LINDSEY BADEN 14 WES KIM 15 JOHN REX 16 HELEN BOUCHER 17 SUMATHI NAMBIAR 18 ERIN DUFFY 19 AMANDA JEZEK 20 KEVIN OUTTERSON 21 JANE KNISELY 22 DENNIS DIXON 23 www.CapitalReportingCompany.com 202-857-3376 Meeting November 19, 2019 Page 3 1 MARK ALBRECHT 2 AMY LEITMAN 3 NICK KARTSONIS 4 RYAN CIRZ 5 SUE CAMMARATA 6 MANOS PERROS 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 www.CapitalReportingCompany.com 202-857-3376 Meeting November 19, 2019 Page 4 1 P R O C E E D I N G S 2 JOHN FARLEY: So good morning, 3 everybody. I'm John Farley. I'm the Acting Director 4 of what is now called the Office of Infectious 5 Diseases at the Center for Drugs here at FDA. We want 6 to welcome you to this workshop. 7 Next slide, please. 8 So I thought we might go ahead and 9 start the morning by focusing on why we're all here. 10 This is -- should look familiar to those of you who 11 have taken a look at the recent CDC AMR threats 12 report. We've had some progress from stewardship 13 efforts, but the serious public health challenge 14 continues with 2.8 million antibiotic resistant 15 infections each year and 35,000 deaths. 16 How about this? Okay. I will lean 17 forward. 18 So I want to begin the day by just 19 thanking Ed Cox for his leadership here at the agency. 20 As most of you are aware, he left government service 21 after nearly two decades, and really a steady hand and 22 focus on science and the data on his part played a key 23 www.CapitalReportingCompany.com 202-857-3376 Meeting November 19, 2019 Page 5 1 role in the progress over the last decade, making safe 2 and effective new antibacterial drugs available for 3 patients in the setting of AMR. 4 I also want to take a moment to thank 5 everybody who is sitting in this room for your 6 steadfast commitment, your innovation, your positive 7 dialogue, and your collaboration in the midst of what 8 has been a decade of scientific and economic 9 challenges. 10 So we at the agency really appreciate 11 your commitment. Cindy -- I was telling Cindy Sears 12 earlier, I come from the world of perinatal HIV where 13 I felt like we built a strong collaborative 14 partnership over time and there were major 15 accomplishments. And I feel like the dynamic is the 16 same here, and it's really an honor for those of us in 17 the agency to be part of that. 18 I thought we'd begin today by just 19 doing some brief introductions, and your disclosures 20 are already listed in the program, so you don't have 21 to provide any voluntary disclosures as you introduce 22 yourself. But maybe we'll start with Aaron and move 23 www.CapitalReportingCompany.com 202-857-3376 Meeting November 19, 2019 Page 6 1 around the table from there. 2 AARON DANE: I'm Aaron Dane. I'm a 3 statistical consultant who's been working in the area 4 of infectious diseases for about 20 years. 5 ROGER LEWIS: Good morning. I'm Roger 6 Lewis. I'm the Chair of Emergency Medicine at Harbor- 7 UCLA Medical Center and the Senior Medical Scientist 8 at Berry Consultants where I focus on adaptive and 9 innovative clinical trial design. 10 DAVID MELNICK: I'm David Melnick, the 11 Chief Medical Officer at Spero Therapeutics, a small 12 biotech based in Cambridge, Massachusetts. We have 13 three active programs in the antibacterial space. 14 RIENK PYPSTRA: Hi, I'm Rienk Pypstra. 15 I'm head of development for the hospital business unit 16 in Pfizer; hospital business unit includes all the 17 antibiotics. I have also some years of experience 18 with developing antibiotics. 19 CHIBUZOR UCHEA: Good morning, 20 everybody. My name is Chibuzor Uchea. I'm a science 21 officer in the Drug Resistant Infections Program at 22 the Wellcome Trust. We are working on a range of 23 www.CapitalReportingCompany.com 202-857-3376 Meeting November 19, 2019 Page 7 1 different interventions in the AMR space to lead the 2 program about combatting antimicrobial resistance in a 3 range of different areas. And I'll be speaking later 4 on in tomorrow's session on the use of clinical trial 5 networks. 6 VANCE FOWLER: Good morning. I'm Vance 7 Fowler. I'm the Contact Principal Investigator for 8 the Antibacterial Resistance Leadership Group and the 9 Chair of the Infectious Disease Society Antimicrobial 10 Resistance Committee. 11 CYNTHIA SEARS: Good morning. I'm 12 Cindy Sears. I'm past President of IDSA and Professor 13 of Medicine at Johns Hopkins, and I'm an infectious 14 diseases physician. 15 SARA COSGROVE: Good morning. My name 16 is Sara Cosgrove. I'm a Professor of Medicine at 17 Johns Hopkins also and also in the Division of 18 Infectious Diseases, and I am the Medical Director of 19 our Department of Antimicrobial Stewardship. 20 REBECCA REINDEL: I'm Rebecca Reindel. 21 I'm a pediatric infectious disease physician by 22 training. I'm a Medical Officer in the Office of 23 www.CapitalReportingCompany.com 202-857-3376 Meeting November 19, 2019 Page 8 1 Vaccines in CBER. 2 LINDSEY BADEN: Lindsey Baden. I'm a 3 Physician Investigator at Brigham & Women's Dana 4 Farber, and an Editor with the "New England Journal of 5 Medicine" focusing on infectious diseases. 6 WES KIM: Good morning, Wes Kim with 7 Pew Charitable Trusts. I'm the Senior Officer of our 8 innovation workstream our Antibiotic Resistance 9 Project. 10 JOHN REX: I'm John Rex. I'm an 11 internist trained in infectious diseases. I am 12 currently the Chief Medical Officer of a company, a 13 private company that has an antifungal in phase two, 14 so not specifically a topic for this for today. And 15 also, I work for Wellcome Trust as their advisor for 16 their investment strategy and drug resistant 17 infections. 18 HELEN BOUCHER: Good morning. I'm 19 Helen Boucher from Tufts Medical Center in Boston, 20 where I practice infectious diseases and I'm the 21 Treasurer of IDSA. 22 SUMANTHI NAMBIAR: Good morning. I'm 23 www.CapitalReportingCompany.com 202-857-3376 Meeting November 19, 2019 Page 9 1 Sumanthi Nambiar, Director Division of Anti- 2 Infectives. 3 ERIN DUFFY: Good morning. My name is 4 Erin Duffy. I'm the Chief of R&D of CARB-X. We're 5 going to talk about CARB-X later today. But briefly, 6 we're a global partnership that funds and accelerates 7 innovation and antibiotic drug discovery. 8 AMANDA JEZEK: Hi, I'm Amanda Jezek 9 with IDSA. I'm our Senior Vice President for Public 10 Policy and Government Relations. 11 KEVIN OUTTERSON: Kevin Outterson. I 12 might be the only lawyer around the table. I'm a law 13 professor at Boston University, and I'm the Principal 14 Investigator of CARB-X. 15 JANE KNISELY: Good morning, Jane 16 Knisely. I am with the National Institutes of Health, 17 National Institute of Allergy & Infectious Diseases. 18 DENNIS DIXON: Good morning, everybody. 19 I'm Dennis Kixon, also from National Institute of 20 Allergy & Infectious Diseases at NIH. I'm Chief of 21 the Bacteriology and Mycology Branch. We manage all 22 of the escape pathogens. And I've had a chance to 23 www.CapitalReportingCompany.com 202-857-3376 Meeting November 19, 2019 Page 10 1 observe these challenging areas for nearly three 2 decades at NIH as we've developed various mechanisms 3 to shore up our defenses and had prior experience in 4 academia, political lab, and briefly in industry. 5 MARK ALBRECHT: Good morning, everyone. 6 My name is Mark Albrecht. I am the Chief of the 7 Antibacterials Branch at BARDA. 8 AMY LEITMAN: Good morning. My name is 9 Amy Leitman. I'm the Director of Policy and Research 10 at a patient advocacy group called NTM Info and 11 Research. We advocate on behalf of patients with 12 pulmonary nontuberculous micro bacterial disease, 13 bronchiectasis and other gram-negative pathogens. 14 NICK KARTSONIS: Good morning. My name 15 is Nick Kartsonis. I'm an infectious disease 16 physician, and I currently provide oversight for 17 infectious disease and vaccines at Merck Research Labs 18 at Merck & Co., Inc. 19 RYAN CIRZ: And good morning. My name 20 is Ryan Cirz. I'm currently an independent 21 consultant.