蛋白質和器具的組合

非口服藥器具及替代給藥器具與蛋白質製劑的整合

1月11日∼12日

此部會網羅整合蛋白質製劑和非口服給藥器具及替代給藥器具之最新傾向和課題，亦討論藥物投遞之非侵襲給藥路徑和替代給藥路徑。此外，亦預定討論有關形成蛋白質傳遞系統（Delivery System）、維持安定性、遵守有效且安全標的服用量之具體的討論課題。再則，此部會亦預定舉行有關能實現有效安全的傳遞、遵守法規、商業上的成功之蛋白質和器具組合設計與開發等詳細的個案研究和討論。

非口服給藥產品和器具的產品化

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藥形態最適化

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)

藥物投遞之非侵襲給藥路徑和替代給藥路徑

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

掌握商業面及法規面的課題

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

注射針筒裝(prefilled syringe)和組合（combination）產品的處方

Formulation Development of Biologic Products in Prefilled Syringes

Nagarajan �gRaja�h 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