タンパク質と器具のコンビネーション

非経口投与器具および代替投与器具とタンパク質製剤の統合

1月11日〜12日

この部会は、タンパク質製剤と非経口投与器具および代替投与器具の統合にまつわる最新のトレンドと課題を網羅するもので、ドラッグデリバリーのための非侵襲的な投与経路や代替的な投与経路についての議論も行われることになっています。また、タンパク質デリバリーシステムを形成して、安定性を維持し、有効で安全な標的服用量を守っていくうえでの具体的な検討課題についても論じられる予定です。さらにこの部会では、効果的で安全なデリバリー、規制の遵守、商業上の成功を実現することができるタンパク質と器具のコンビネーションの設計と開発などに関する詳細なケーススタディや討論も予定されています。

非経口投与製品と器具の製品化

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.

患者のニーズに合わせた投薬形態の最適化

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)

ドラッグデリバリーのための非侵襲的な投与経路と代替的な投与経路

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

商業面および規制面の課題の把握

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

プレフィルドシリンジとコンビネーション製品のための処方

Formulation Development of Biologic Products in Prefilled Syringes

Nagarajan “Raja” 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