단백질과 기기의 콤비네이션

비경구 투여기기 및 대체 투여기기와 단백질 제제의 통합

1월 11일∼12일

이 부회는 단백질 제제와 비경구 투여기기 및 대체 투여기기의 통합에 관련된 최신 동향과 과제를 다루며, 약물전달을 위한 비침습적인 투여 경로 및 대체적인 투여 경로에 대해서도 논의합니다. 또한 단백질 전달 시스템을 형성하고 안정성을 유지하며, 유효하고 안전한 표적 복용량을 지키기 위한 구체적인 검토 과제에 대해도 논의할 예정입니다. 이 부회에서는 효과적이며 안전한 전달, 규제 준수, 상업적 성공을 실현할 수 있는 단백질과 기기의 콤비네이션 설계와 개발 등에 관한 상세한 사례연구 및 토론도 예정되어 있습니다.

비경구 투여제품과 기기의 제품화

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.

환자의 요구에 맞춘 투약 형태의 최적화

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)

약물전달을 위한 비침습적 투여 경로와 대체적 투여 경로

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

상업면 및 규제면의 과제 파악

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

프리필드 시린지(PRE-FILLED SYRINGES)와 콤비네이션 제품을 위한 처방

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