Summary:

The Food and Drug Administration is holding a public workshop entitled “Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis."  The purpose of the public workshop is to discuss the clinical trial design challenges and future considerations for inhaled antibacterial products to treat cystic fibrosis (CF) and non-CF bronchiectasis. 

Date and Time: 

The public workshop will be held on Wednesday June 27, 2018 from 8:30 a.m. to 4:30 p.m. (Eastern Time)  

Location

The will be held at FDA's White Oak campus, 10903 New Hampshire Ave., Building 31 Great Room, Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.  

Registration:

To register, please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone to [email protected] by June 11, 2018. Registrants will receive email confirmation when they have been accepted. Persons without access to the Internet can call 301-796-1300 to register. Onsite registration on the day of the meeting will be provided based on space availability.  

Requests for Oral Presentations:

During online registration you may indicate if you wish to present during a public comment session or participate in a specific session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by June 19, 2018. All requests to make oral presentations must be received by the close of registration on June 15, 2018. If selected for presentation, any presentation materials must be emailed to [email protected] no later than June 21, 2018. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. 

Contact:

If further information is needed, please contact Lori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6221, Silver Spring, MD 20993-0002, 301-796-1300.   

Streaming Webcast:

This public workshop will also be webcast at the following site: https://collaboration.fda.gov/inhaledantibacterials/ If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview.  

Meeting Materials:

The agenda, speaker slides and other meeting material will be posted here a few days prior to the workshop. Please note that only printed copies of the agenda, affiliations and disclosures will be provided during the meeting. Please print/bring your own slides, as these will not be provided on the day of the meeting as printed copies. 

Agenda

FDA Public Workshop Development of Inhaled Antibacterial Treatments for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis June 27, 2018 (PDF - 144KB) 

Affliations and Disclosure:

Speakers and Panelists (PDF - 47KB)

Presentations:

• Cross-Cutting Device and Human Factors Challenges and Considerations.  Nguyen, Quynh, MS, FDA and Lakhani, Deepika, PhD, FDA.
  • Perspective on The Role of Human Factors in Inhalational Products Design and Development, (PDF - 558KB) Nguyen, QuynhNhu MS, FDA
  • Regulatory Perspectives for Device Development for Inhalation Combination Products(PDF - 1008KB) Lakhani, D. PhD., FDA
• Overview and Issues: Developing Inhalational Products for the Treatment of Chronic MRSA Infection in Cystic Fibrosis. (PDF - 99KB)  Mishra, Shimant, MD, FDA
• Inhaled Antimicrobial Therapy for CF: A  Regulatory Evolution.  (PDF - KB) Mishra, Shimant, MD, FDA
• Inhaled Antibiotics in Cystic Fibrosis: Current State and Future Considerations (PDF - 1521KB).  David Nichols, MD
• Prevention of Exacerbations/ Management of CF Patients Chronically Infected with Pseudomonas aeruginosa.  (PDF - 568KB) Allende, Maria, MD, FDA
• Non-Cystic Fibrosis Bronchiectasis: Historical Perspective of Product Development. (PDF - 140KB) Smith, Thomas, MD, FDA
• Care of the Bronchiectasis Patient: Current State. (PDF - 1,278KB)  Tino, Greg, MD
• Case Study on Developing an Inhalational Therapy for Non-Cystic Fibrosis Bronchiectasis
  • Part 1 Patient Selection and Trial Duration.  (PDF - 138KB) Kim, Peter, MD, FDA
  • Part II Endpoint Consideration. (PDF - 140KB) CDR Tracy, LaRee, PhD, FDA
• Heterogeneous Nature of non-Bronchiectasis Aetiology. (PDF - 581KB) Kitlowski,

 

Webcast Recordings:

A recording(s) of the workshop will be posted here shortly after the completion of the workshop.

Part 1: https://collaboration.fda.gov/p3g2ilndpee/
Part 2: https://collaboration.fda.gov/p8lt8vm504x/
Part 3: https://collaboration.fda.gov/p8qf4zzawya/
Part 4: https://collaboration.fda.gov/p9j4rvvzfn1/

Transcripts: 

Development of Inhaled Antibacterial Treatments for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis (PDF - 1267KB) 

 

 

 

 

 

 

 

FDA Public Workshop Development of Inhaled Antibacterial Treatments for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis June 27, 2018