3D Tissue Models
Protien-Device Combinations
Hotel Del Coronado
1500 Orange Ave
Coronado, California

Schedule of Presentations:

Wednesday, January 12, 2011
07:00:00 Conference Registration
07:30:00 Breakfast Presentation |or Morning Coffee
08:15:00 Chairperson’s Opening Remarks
08:20:00 The Impact of Container System on the Optimum Freeze-Drying Process: Contrasting Freeze-Drying in Syringes with Freeze Drying in Vials Michael J. Pikal, Sajal Patel
09:00:00 Freeze-Drying In Syringes: Double-Chamber Cartridges Case Study
09:25:00 Commercialization Of Parenteral Products
09:30:00 Meeting the Challenges in the Commercialization of Parenteral Products and Devices Kurt Van Scoik, Fangdong Yin
10:00:00 Coffee Break, Exhibit and Poster Viewing
10:45:00 Challenges of Commercializing Devices at a Pharmaceutical Company Donna French
11:15:00 Interactive Panel: Strategies and Common Challenges: When Do You Bring the Parenteral Device into Development and How Do You Better Integrate Formulation and Device Project Teams? Danny Chou, Alex Zuyev, Beth Hill, Carl Charlie Hitscherich, John . Patton, Fangdong Yin
12:15:00 Close of Morning Session
12:30:00 Luncheon Presentation | or Lunch on Your Own
13:55:00 Interaction of Protein Formulations with Injection Devices
14:00:00 Chairperson’s Remarks
14:05:00 Two Aspects of Container-Closure Interactions with Protein Therapeutics: Interactions of Proteins and Silicone Oils, and Immunogenic Responses to Microparticulate Contaminants Theodore W. Randolph
14:35:00 Integrating the Examination of Critical Formulation Parameters with the Examination of Critical Syringe Parameters when Developing Protein Formulations in Pre-Filled Syringes Willow DiLuzio
15:05:00 Meeting in the Middle: Finding Technical Success in the Development of Protein Formulation and Injection Device Combination Products Beth Hill
15:35:00 Sponsored Presentation (Opportunity Available)
15:50:00 Networking Refreshment Break
16:30:00 Case Study: Development of Protein Therapeutics in Pre-Filled Syringes: Challenges and Strategies Parag Kolhe
17:00:00 Challenges of Formulation and Combination Product Development for a High Concentration MAb Therapeutic Tom Scherer
17:30:00 Reception in the Exhibit Hall
18:30:00 Close of Day
Thursday, January 13, 2011
07:30:00 Breakfast Presentation |or Morning Coffee
08:10:00 Understanding Commercial and Regulatory Challenges
08:15:00 Chairperson’s Opening Remarks
08:20:00 Obstacles to Commercialization of an Innovative Protein-Device Product: Inhaled Insulin John Patton
08:50:00 The Ten Mistakes to Avoid When Filing INDs and CTAs for Protein Device Combination Products Lorna Speid
09:15:00 Alternative / Innovative Devices & Methods For Parenteral Drug Delivery
09:20:00 Improving Biotherapeutic Convenience and Compliance through Delivery and Alternative Delivery Technologies Joel Richard
09:50:00 Sponsored Presentation
10:05:00 Coffee Break, Exhibit and Poster Viewing
10:30:00 Poster Awards in the Exhibit Hall
10:45:00 Injection Devices for Controlled Release Systems Bill Lambert
11:15:00 Pharmaceutical Studies Supporting Protein Administration via Intrathecal Delivery Device Zahra Shahrokh
11:45:00 Challenges and Opportunity of Large-Volume Protein Injection: Razors and Blades Robin Hwang, Tzung Yang
12:15:00 Close of Morning Session
12:30:00 Luncheon Presentations | or Lunch on Your Own
13:30:00 End of Conference
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