8:30 a.m. - 8:45 a.m.: Welcome/Introduction - Linda Lambert
Morning Session
Moderator: Arnold Monto
8:45 a.m. - 9:15 a.m.: Vaccine Experiences/Lessons Learned from the Past - Robert Couch
9:15 a.m. - 9:45 a.m.: Recent Vaccine Experience with Novel Antigen - Karl Nicholson
9:45 a.m. - 10:15 a.m.: Potential Pandemic Viruses: Priority for Vaccine Evaluations - Robert Webster; Introductory remarks by Klaus Stöhr
10:15 a.m. - 10:45 a.m.: Break
10:45 a.m. - 11:15 a.m.: Manufacturing Risk Assessment Update and European Regulatory Update - John Wood; Introductory remarks by Klaus Stöhr
11:15 a.m. – 11:45 a.m.: Regulatory Issues - Karen Midthun
Noon– 1:00 p.m.: Lunch
Afternoon Session - Workshop Discussions: Establishing Needs and Variables for Clinical Evaluation
I. Preclinical Tools and Issues
1:00 p.m.: Overview of the Issues and Options for Discussion - Nancy Cox
Moderators: Roland Levandowski, Linda Lambert
Points for Discussion
Availability of Pandemic Reference Strains
Substrates for Production
Availability of Reagents
Safety Considerations
Other Regulatory Issues
Break
II. Clinical Trials: Interpandemic and Pandemic
Overview of the Issues and Options for Discussion, John Treanor
Moderators: Karl Nicholson, John Treanor
Points for Discussion
Viruses/Vaccines to be Evaluated
Vaccine Preparations to be Evaluated
Dose Range and Schedule
Ages for Evaluation
Immunological Assessments
Adjuvants
Tuesday, September 23
8:30 a.m. – Noon: Draft Plan for Clinical Trials
Presentation and discussions of key points raised from Monday, Linda Lambert, Robert Couch
