PULMONARY-ALLERGY
DRUGS ADVISORY COMMITTEE MEETING
NDA 50-799, Pulminiq™
(cyclosporine), inhalation solution, Chiron, proposed for the increase in
survival and for the prevention of chronic rejection in patients receiving allogenic
lung transplants, in combination with standard immunosuppressive therapy.
FDA Introductory Remarks Renata Albrecht,
M.D.
[HTML] [PPT] Director, Division of Special
Pathogen
and Immunologic
Drug
Products, FDA
Sponsor Presentation Chiron
Corporation
Introduction Michael
Scaife, Ph.D.
[HTML] [PPT] Chiron
Corporation
Senior
VP Regulatory Affairs,
Compliance
and Quality
Clinical Pharmacology Jeffrey A. Golden, M.D.
[HTML] [PPT]
Pulmonary
and Critical Care Medicine
Efficacy Sarah
Noonberg, M.D., Ph.D.
[HTML] [PPT] Chiron
Corporation
Associate
Director, General Medicines
Therapeutic
Unit
Safety and Benefit Risk Robert
W. Helms, Ph.D.
Professor
Emeritus, Biostatistics
Fellow,
American Statistical Association
[HTML] [PPT] Stephen Dilly, M.D., Ph.D.
Chiron
Corporation
Chief
Medical Officer
Conclusion Michael
Scaife, Ph.D.
Chiron
Corporation
Senior
VP Regulatory Affairs,
Compliance and Quality
Chiron Corporation Supporting Slides
FDA
Presentation
Overview of Clinical Trial Arturo
Hernandez, M.D.
Efficacy and Safety Evaluation Medical
Officer,
Discussion of Analysis Division
of Special Pathogen and
[HTML] [PPT] Immunologic Drug Products, FDA
Marc Cavaillé-Coll, M.D.,
Ph.D.
Medical Team
Leader,
Division of Special Pathogens
and Immunologic Drug Products, FDA
[HTML] [PPT] Jyoti
Zalkikar, Ph.D.
Lead
Statistical Reviewer,
Division of Special Pathogen and
Immunologic
Drug Products, FDA
Questions to the Committee