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Bacteriophage Therapy: Scientific and Regulatory Issues Public Workshop

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Bacteriophage Therapy: Scientific and Regulatory Issues Public Workshop TRANSCRIPT OF PROCEEDINGS IN THE MATTER OF: ) ) BACTERIOPHAGE THERAPY: ) SCIENTIFIC AND REGULATORY ISSUES ) PUBLIC WORKSHOP ) (This transcript has not been edited or corrected, but appears as received from the commercial transcribing service. Accordingly the Food and Drug Administration makes no representation as to its accuracy.) Pages: 1 through 300 Place: Rockville, Maryland Date: July 10, 2017 HERITAGE REPORTING CORPORATION Official Reporters 1220 L Street, N.W., Suite 206 Washington, D.C. 20005-4018 (202) 628-4888 [email protected] 1 BEFORE THE DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S. FOOD AND DRUG ADMINISTRATION IN THE MATTER OF: ) ) BACTERIOPHAGE THERAPY: ) SCIENTIFIC AND REGULATORY ISSUES ) PUBLIC WORKSHOP ) Room 1D-13 NIAID Conference Center 5601 Fishers Lane Rockville Maryland Monday, July 10, 2017 The parties met, pursuant to the notice, at 8:37 a.m. MODERATORS: RANDALL KINCAID, Ph.D. NIAID PAUL CARLSON, Ph.D. Center for Biologics Evaluation and Research, FDA PARTICIPANTS: DORAN FINK, MD, Ph.D. Center for Biologics Evaluation and Research, FDA CARA FIORE, Ph.D. Center for Biologics Evaluation and Research, FDA JÉRÔME GABARD, Ph.D. Pherecydes Pharma JASON GILL, Ph.D. Department of Animal Science, Texas A&M Heritage Reporting Corporation (202) 628-4888 2 PARTICIPANTS: (Cont'd.) ANDRZEJ GÓRSKI, MD, Ph.D. Hirszfeld Institute of Immunology and Experimental Therapy, Polish Academy of Sciences MARION GRUBER, Ph.D. Center for Biologics Evaluation and Research, FDA BETTY KUTTER, Ph.D. Faculty Emeritus, The Evergreen State College SUSAN LEHMAN, Ph.D. AmpliPhi Biosciences PETER MARKS, MD, Ph.D. Center for Biologics Evaluation and Research, FDA DEEPAK NARAYAN, MD Yale University School of Medicine ROBERT T. "CHIP" SCHOOLEY, MD Department of Medicine, University of California, San Diego SCOTT STIBITZ, Ph.D. Center for Biologics Evaluation and Research, FDA JOSEPH TOERNER, MD, MPH Center for Biologics Evaluation and Research, FDA RY YOUNG, Ph.D. Center for Phage Technology, Texas A&M Heritage Reporting Corporation (202) 628-4888 3 C O N T E N T S SESSION 1: PAGE Bacteriophage Therapy Then and Now, 9 Ry Young Bacteriophage Therapy: The Polish Approach, 41 Andrzej Górski Multidrug-resistant Acinetobacter: When the Antibiotics Fail, 61 Chip Schooley Phage Therapy for Resistant Pseudomonas Dacron Graft Infection, 80 Deepak Narayan The Gap Between Phage Therapy Clinical Study and Compassionate Treatments, 93 Jérôme Gabard Panel Discussion 114 SESSION 2: Needs and Challenges of Therapeutic Phage Characterization, 150 Jason Gill Getting from Lab Bench to Clinic: CMC and Practical Considerations for Phage Products, 174 Susan Lehman Regulatory Pathways and CMC Considerations for Bacteriophage Products, 197 Scott Stibitz Clinical Regulatory Considerations for Evaluation and the Use of Bacteriophage Products, 218 Doran Fink Single-species Antibacterial Drug Development: A Perspective from the Division of Anti- Infective Products at CDER, 241 Joseph Toerner Panel Discussion 258 Heritage Reporting Corporation (202) 628-4888 4 1 P R O C E E D I N G S 2 (8:37 a.m.) 3 DR. KINCAID: Good morning, everyone, and 4 thank you for coming. As the agency host for this 5 meeting, I want to welcome you all. Dr. Peter Marks, 6 the Center Director of Biologics at the FDA, will be 7 giving some more in-depth opening remarks, but I just 8 as a representative of NIAID, one of the co-sponsors, 9 I just wanted to welcome you all and thank you for 10 attending. 11 At NIAID in particular, our programmatic 12 efforts are driven by a combination of recognition of 13 unmet medical needs and scientific opportunity. I 14 think we all can recognize that antimicrobial 15 resistance is a present and growing unmet medical need 16 that needs attention, and this meeting and you coming 17 here today, you are bringing us scientific 18 opportunities that we wish to capitalize on and 19 programmatically develop projects to move forward, and 20 so I'm very hopeful for this meeting to give us some 21 ideas and concepts that we, in conjunction with our 22 sister agency at the FDA, can move forward to better 23 prepare the ground for regulatory science that will 24 enable the development in this whole category of 25 countermeasures. Heritage Reporting Corporation (202) 628-4888 5 1 So I wish you a very productive and pleasant 2 and entertaining and educational meeting, and I'll 3 turn it over to Peter. 4 DR. MARKS: Okay. So welcome, everyone. 5 Thank you all for coming to this workshop on 6 bacteriophage therapy that's covering both scientific 7 and regulatory issues. 8 The workshop's co-sponsored by the Center 9 for Biologics Evaluation and Research at the Food and 10 Drug Administration, in collaboration with the 11 National Institute of Allergy and Infectious Diseases 12 at the National Institutes of Health, and before I go 13 much further I'd like to take a moment to thank those 14 at both institutions for all of their work and their 15 efforts putting together what should be a very 16 engaging and informative program over the next two 17 days. 18 I also want to take the opportunity to thank 19 all of those who will be presenting and serving on 20 panel discussions for making the time to travel here 21 and to do so, all of those who have braved Metro to 22 make it here, thank you, even those coming from 23 locally. 24 Antibiotic development got underway 25 seriously in the 1940s and reached its heyday in the Heritage Reporting Corporation (202) 628-4888 6 1 1950s and 1960s. Although initially it was the source 2 of miraculous cures for a variety of infections that 3 were previously difficult or impossible to treat, it 4 was not long before the problem of resistance to 5 antibiotics that had been developed occurred. 6 Over the past two decades, such antibiotic 7 resistance has really escalated to crisis-level 8 proportions, and we now have the development of 9 Methicillin-resistant Staphylococcus aureus that's 10 present in many communities at high levels, 11 vancomycin-resistant enterococci, and a variety of 12 gram-negative organisms, such as Klebsiella and 13 Pseudomonas species, that are resistant to multiple 14 different antibiotics. In fact, some are remarkably 15 resistant. 16 Ironically, though it was discovered a bit 17 over a century ago before the modern antibiotic era, 18 bacteriophage may turn out to be important 19 therapeutics in combatting antibiotic-resistant 20 infections. 21 First discovered by the English 22 microbiologist Twort in 1915 and then characterized 23 further by the French-Canadian scientist Félix 24 d'Herelle, it was not until decades later the details 25 of the lytic mode of action of phage were understood. Heritage Reporting Corporation (202) 628-4888 7 1 Such limitations in mechanistic understanding, 2 combined with the ready availability of antibiotics 3 following the Second World War, led to the development 4 of phage therapy for the treatment of human infections 5 in the United States and Western Europe to really slow 6 down and to be shelved for a number of decades. The 7 work on phage therapy continued in some Eastern 8 European countries, including Poland and Russia. 9 Over the past decade, however, the 10 investigation of potential phage therapy has seen a 11 renaissance globally as certain infections have proven 12 to be quite resistant to our existing complement of 13 antibiotics and the discovery of novel antibiotics to 14 combat such resistance have become increasingly 15 challenging from a practical perspective. 16 On the other hand, phage therapy appears to 17 be non-toxic in humans and in animals, and phage have 18 the benefit that their bacterial specificity allows 19 sparing of the remainder of the beneficial microbiota. 20 In addition, there's the potential to either select or 21 engineer phage to target bacteria that develop 22 resistance to these agents. 23 Over the next two days there will be talks 24 and discussions covering the scientific, 25 manufacturing, clinical, and regulatory issues Heritage Reporting Corporation (202) 628-4888 8 1 surrounding the use of phage therapy. Though 2 challenges clearly remain in the development of phage 3 therapy for the prevention or treatment of infections 4 in humans, their potential clinical utility seems 5 quite promising in a time when other options seem much 6 less so, and that's particularly in certain 7 circumstances, and thus -- let's see -- the adage 8 "What's old is new again" seems quite appropriate when 9 describing the situation with phage, or said more 10 modernly, "Old is the new new," and we look forward to 11 a very informative and productive workshop over the 12 next days. 13 Thank you very much, and we really 14 appreciate your coming today. 15 (Applause.) 16 DR. KINCAID: Good morning, everyone. My 17 name is Randall Kincaid, and I'll be serving as 18 moderator in the first session today. Just so that 19 you're aware of it, we have an additional room, a 20 companion room which is connected by VTC, and it is 21 possible that if questions arise from those in that 22 room, we will be entertaining sort of alternate 23 questions if that comes up. 24 Before we begin, I was asked to make a 25 couple brief statements. First of all, that each Heritage Reporting Corporation (202) 628-4888 9 1 speaker outside of the government was asked to submit 2 documentation outlining their financial interests. 3 This is an important matter, and these records are all 4 in place. And secondly, that the proceedings of the 5 workshop are being recorded for purposes of 6 transcription and these will be made available at the 7 end of our sessions.
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