SUMMARY AGENDA

08:00 Breakfast & Registration

09:00 Chairman’s Opening Remarks

• Stephen Barat Executive Director, Toxicology, Preclinical Pharmacology , and Bioanalytical Strategy, Actavis

Building the Right Team

09:10 The Building Blocks of PFS: What we Know and Needs to be Discovered

• Paolo Mangiagalli Senior Director, Head PFS/ Primary Container Platform, Sanofi

09:40 Challenges of Developing Prefilled Syringes for a Small/Mid-sized Organization

• Sachin Dubey Head of Formulation Development, Glenmark Pharmaceuticals

10:10 Morning Refreshments & Speed Networking

Device & Syringe Materials

11:10 The Value of Polymer Syringes and Needle Technology for Sensitive or Viscous Biologics

• Kevin Constable Director, Technology Development, Terumo

11:40 Regulatory CMC and Design Control Considerations for Pre-filled Syringes – Industry Perspective

• Suzette Roan Associate Director, Regulatory Affairs CMC Combination Products, Biogen Idec

12:10 Modern Syringe Manufacturing – designed by Nipro Pharmapackaging

• Bruno Reuter Director Technology, Nipro Pharmapackaging

12:40 Lunch & Networking

PFS & Device Innovation

14:10 Your Turn-Key Custom PFS Partner

• Shem Fischer Medical Manager, Contract Manufacturing, Oratech

14:20 A Novel Class of Device Technologies: Wearable Bolus Injectors for Large Volume Subcutaneous Delivery

• Diane Doughty Scientist, Drug Delivery & Devices, MedImmune

14:50 User-Centered Design: The Human Factors Perspective

• Tiffany McIntire Human Factors Engineer, Eli Lilly

15:20 Panel: Ensuring Continued Innovation in the Field

• Tiffany McIntire Human Factors Engineer, Eli Lilly
• Diane Doughty Scientist, Drug Delivery & Devices, MedImmune

15:50 Afternoon Refreshments & Networking

Roundtable Discussions

16:20 Roundtable Discussions

• Paolo Mangiagalli Senior Director, Head PFS/ Primary Container Platform, Sanofi
• Suzette Roan Associate Director, Regulatory Affairs CMC Combination Products, Biogen Idec
• Chris Muenzer Drug Delivery Device Engineer, Roche
• Kevin Constable Director, Technology Development, Terumo

17:25 Chairman’s Closing Remarks

• Stephen Barat Executive Director, Toxicology, Preclinical Pharmacology , and Bioanalytical Strategy, Actavis

17:30 Poster Session & Networking Reception