Workshop on Science and Technology in North American Rapid Vaccine Manufacturing

Draft Agenda (as of Jan. 16, 2007)

January 23, 2006, NSF, Arlington, VA (Room 110, Stafford I)

• 08:00-08:30 Continental Breakfast
• 08:30-08:40 Welcome and Overview
  • Michael Reischman, Deputy Assistant Director, NSF/ENG
  • Duane Shelton, President, WTEC
• 08:40-09:00 WTEC International Assessment of Vaccine Manufacturing
  • Joe Bielitzki, University of Central Florida
  • Presentation (pdf format)

I. Can Current Vaccine Manufacturing Strategy Meet Future Vaccine Needs?

• 09:00-9:30  Regulation of Vaccines:  Challenges and Opportunities
  • Erik Henchal, U.S. Food and Drug Administration
  • Presentation (pdf format)
• 09:30-10:00 Rotavirus Vaccines - A Case Study
  • Dr. John Boslego, PATH
  • Presentation (pdf format)
• 10:00-10:10 Commentary/Moderator: Terry Leighton, Children’s Hosp. Oakland Res. Institute
•   Paper (pdf format)
• 10:10-10:25 Break

II. Can Vaccine Manufacture be Agile, Modular and Responsive?

• 10:25-10:55 Large-Scale Vaccine Manufacture
  • Dr. Shou-Bai Chao, Wyeth Laboratories
  • Presentation (pdf format)
• 10:55-11:25 Single-Use Bioreactors; Rapid Process Development and Scale-Up
  • Dr. Vijay Singh, WAVE Biotech LLC
  • Presentation (pdf format)
• 11:25-11:55 What Limits the Rate of Vaccine Development and Scale-Up?
  • Dr. Alan Shaw, VaxInnate
  • Presentation (pdf format)
• 11:55-12:05 Commentary/Moderator: Dr. Mary Ritchey, Ritchey Associates, Inc.
  • Pre-meeting write-up: Can Vaccine Manufacture be Agile, Modular and Responsive? (pdf format).
  • Paper (pdf format)
• 12:05-13:10Lunch

III. Incorporating Innovation in Bioprocessing

• 13:10-13:40 The Front-End of Vaccine Manufacturing: Getting Good Candidates from the Get-Go
  
  • Dr. Bill Warren, Vax Design
  • Presentation (ppt format)
• 13:40-14:10 Measuring and Optimizing Process Performance
  
  • Dr. Govind Rao, UMBC
  • Presentation (pdf format)
• 14:10-14:40 Miniaturizing Development and Manufacture of Biologics
  • Dr. Klavs Jensen, MIT
  • Presentation (pdf format)
• 14:40-14:55 Commentary/Moderator: Joe Bielitzki
•   Paper (pdf format)
• 14:55-15:10 Break

IV. The Changing Face of Vaccine Development

• 15:10-15:40 Concepts Regarding Adenovirus based Vaccine Systems
  • Dr. Andrea Amalfitano, Michigan State University
  • Presentation (pdf format)
• 15:40-16:10 Total Synthesis and Assembly of a Virus Like Particle
  
  • Prof. Jim Swartz , Stanford University
  • Presentation (pdf format)
• 16:10-16:20 Commentary/Moderator: Steve Drew, Science Partners LLC
  • Pre-meeting write-up: The Changing Face of Vaccine Development – The Systems Approach to Vaccine Manufacture (doc format).
  • Paper (pdf format)
• 16:20-16:45 Discussion and Wrap-Up
  • Joe Bielitzki