蛋白质和器具的组合

非口服药器具及替代给药器具与蛋白质制剂的集成

1月11日～12日

此部会网罗集成蛋白质制剂和非口服给药器具及替代给药器具之最新倾向和课题，亦讨论药物投递之非侵袭给药路径和替代给药路径。此外，亦预定讨论有关形成蛋白质传递系统（Delivery System）、维持安定性、遵守有效且安全标的服用量之具体的讨论课题。再则，此部会亦预定举行有关能实现有效安全的传递、遵守法规、商业上的成功之蛋白质和器具组合设计与开发等详细的个案研究和讨论。

非口服给药产品和器具的产品化

Challenges of Commercializing Devices at a Pharmaceutical Company

Donna French, Ph.D., Senior Director, Device Development, Genentech (tentative)

Engineered Drug Delivery for Protein Injection Devices

Amy Heintz, Ph.D., Principal Research Scientist, Advanced Materials Applications, Battelle

Understanding Packaging Systems for Parenteral Administration of Biopharmaceuticals and Biological Products

Speaker to be Announced, West Pharmaceutical Services, Inc.

使配合患者需求的投药形态最适化

Developing Dosage Form Based on Expressed and Latent User Needs

Charlie Hitscherich, Ph.D., Senior Director, Biologics Drug Delivery, Biogen Idec

Improving Biotherapeutic Convenience and Compliance through Delivery and Alternative Delivery Technologies

Speaker to be Announced

Case Study: Treating Hemophilia, Self-Administration with IV Injections

Jonas Fransson, Director, Swedish Orphan Biovitrum (Sobi)

药物投递之非侵袭给药路径和替代给药路径

Peptide Delivery by Inhalation: Simplified

Andrea Leone-Bay, Ph.D., Vice President, Pharmaceutical Research & Development, MannKind Corporation

Case Study: Non-Invasive CNS Delivery for Biologics

Hanne Bentz, Ph.D., Senior Research Fellow, Janssen Pharmaceutical R&D

Needle-Free Delivery of Viscous Biomolecule Formulations

Brooks Boyd, Ph.D., Senior Director, Product Development, Zogenix, Inc.

High Concentration Formulation Development at Integrity Bio, Inc.

Byeong S. Chang, Ph. D., President, Integrity Bio

掌握商业面及法规面的课题

Overcoming Regulatory Hurdles in Drug/Device Development: Current State of Regulation Development for Quality Systems for Combination Products

Michael Gross, Ph.D., RAC, Senior Consultant, Biologics Consulting Group

Approaches to Product, Process and Submission Quality: How Does the FDA Actually Evaluate You and Your Product?

Von Nakayama, Industry Advisor, Retired FDA Reviewer

注射针筒装(prefilled syringe)和组合（combination）产品的处方

Formulation Development of Biologic Products in Prefilled Syringes

Nagarajan 乬Raja乭 Thyagarajapuram, Ph.D., Senior Research Scientist, Pharmaceutical Formulations, Eli Lilly & Co.

New Results on Protein-Silicone Oil Interactions

Devendra (Davy) Kalonia, Ph.D., Professor of Pharmaceutics, Department of Pharmaceutical Sciences, University of Connecticut

Characterization of a New Non-Silicone Lubrication Technology for Parenteral Container
Closure Systems

Fangdong Yin, Ph.D., Manufacturing Science and Technology, Parenteral Commercialization Technology Center, Research Advisor, Eli Lilly

Case Study of Sustained Release of High-Concentration Biologics (protein, mAbs): Paradigm Shift from a Ferrari to a Corolla

Robin Hwang, Ph.D., Independent Consultant

Special Bridging Presentation between Protein-Device & Lyophilization:

Challenges in Development and Tech Transfer of Lyophilization Processes in Dual Chamber Syringes

Brian Wilbur, Ph.D., Process Development Engineer, Biotherapeutics Pharmaceutical R&D, Pfizer