The Food and Drug Administration (FDA) is announcing a public workshop regarding antibacterial drug development for patients with unmet need and developing antibacterial drugs that target a single species. FDA is interested in discussing the scientific challenges pertaining to such development programs, including enrollment challenges, clinical trial designs and trial population. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. government agencies, public health organizations, academic experts, and industry on various aspects of drug development for new antibacterial drugs for patients with unmet need and new antibacterial drugs that target a single species. The input from this public workshop will also help in developing topics for future discussion.
|Date||July 18 and 19, 2016|
July 18th: 8:30 a.m. to 5:00 p.m.
July 19th: 8:30 a.m. to 4:00 p.m.
|Location||The public workshop will be held at FDA's White Oak campus, 10903 New Hampshire Ave., Building 31 Great Room, Silver Spring, MD 20993. For information regarding the FDA campus map, directions to FDA and security procedures, please visit the FDA website at: Public Meetings at the FDA White Oak Campus|
|Registration||Registration is free for the public workshop. Interested parties are encouraged to register early. Seating will be available on a first-come, first-served basis . To register electronically, e-mail registration information (including name, title, firm name, address, telephone, and fax number) to: UnmetNeed2016@fda.hhs.gov. Persons without access to the Internet can call 301-796-1300 to register. Persons needing a sign language interpreter or other special accommodations should notify Ms. Jessica Barnes or Ms. Lori Benner (see Contact Persons) at least 7 days in advance.|
Day 1Web Recordings:
Speaker Presentations Day1
- Dudley,M. Planning and Executing a Carbapenem/ Beta-lactamase Inhibitor Program Focused on Treatment of KPC-Producing CRE (PDF - 1.5MB)
- Friedland, I. Developing Antibacterial Drugs for Patients with Unmet Need: Experience and Recommendations (PDF - 403KB)
- Nambiar, S. Trial Considerations for Unmet Need (PDF - 193KB)
- Rubin, D. Evaluating antibacterial drugs in unmet need settings (PDF - 681KB)
Larsen, J. BARDA’S MARKET RESEARCH FOR A CLINICAL TRIAL NETWORK FOR ANTIBIOTICS(PDF - 563KB) Viele, K. InnovativeTrial Designs(PDF - 369KB) Rex, J. Developing antibacterial drugs for unmet need and so that we stay ahead of the epidemic: Points to consider for developers(PDF - 362KB) Ambrose, P. Pharmacometric Considerations in Unmet Need Programs(PDF - 2.6MB) Cavaleri, M. Regulatory pathways and approaches to unmet needs(PDF - 139KB) Cox, Public Workshop— Facilitating Antibacterial Drug Development for Patients With Unmet Need(PDF - 154KB)
- Grey, I.Facilitating Antibacterial Drug Development...[short version] (PDF - 10.1MB)
Grey, I. Facilitating Drug Development.[Long version](PDF - 17.3MB)
Speaker Presentations Day 2
Overview Unmet Need Drug X-1 handout(PDF - 214KB) Boucher, H Facilitating Antibacterial Drug Development for Patients with Unmet Needs and Developing Drugs that Target a Single Species: Perspective from Academia(PDF - 213KB) Cavaleri, M. Antibacterial drug targeting single species(PDF - 143KB) Nambiar, S. Case Study: FDA Perspective(PDF - 296KB) Kim, P. Drug X-1: Hypothetical case of an antibacterial targeting a single bacterial species(PDF - 170KB) Tomayko, J. Challenges of developing narrow-spectrum and adjunctive therapies(PDF - 266KB) Cox, Public Workshop Developing Antibacterial Drugs That Target a Single Species(PDF - 62KB) Rex, Drug X-1 P3 Clinical Program(PDF - 210KB) Handout - During the Meeting(PDF - 209KB) Cox, E. Facilitating Antimicrobial Drug Development...(long version)(PDF - 16.8MB) Cox, E. Facilitating Antibacterial Drug Development...[short version](PDF - 14.2MB)