生物製劑開發最適化

從早期階段到管理處方和生產關係，克服安定性、加工及生產的課題，開發合乎目的之醫藥品

1月9日∼10日

此部會網羅與生物製劑處方有關之最新傾向和課題，聚焦於早期的製劑處方及藉由特性描述（characterization）縮短開發期間、克服安定性的課題等主題。此外，克服早期的製劑處方與特性描述、篩選、凝集的課題，利用有效的分析手法，因應技術移轉的課題，亦預定進行與實驗的設計和高容許量原則的利用有關之主題的詳細個案研究及討論。

開發製劑最適化的策略

Increasing Formulation Knowledge Space Leveraging Automation

Jamie Moore, Ph.D., Associate Director and Senior Scientist, Early Stage Pharmaceutical Development, Genentech

Solidification of Protein Solutions Using Clathrate Hydrates as a Potential Stabilization Tool

Evgenyi Shalaev, Ph.D., Associate Research Fellow, Pharmaceutical Development, Pfizer

Effectively Transitioning Early Phase Formulation Development to External Partners

Kendall Kessler, Head, Business Operations, Senior Principal Scientist, Biotherapeutics Pharmaceutical R&D, Pfizer

Improving Vaccine Development: Empirical Approaches vs. Rational Design

Manmohan Singh, Ph.D., Global Head, Vaccine Formulation Science, Novartis Vaccines

Optimizing Vaccine Formulation Development

Dominique Lemoine, Ph.D., Director, Head of Formulation Development, R&D, GSK Biologicals

安定性問題的掌握與克服

Overcoming Stability Issues and Successfully Completing Technology Transfer

Daniel Adams, Executive Chairman, Protein Sciences; Founder, Biogen

Understanding Underlying Principles of Protein Degradation Pathways and Their Impact on Formulation Design Space

Sharon Gao, Ph.D., Principal Scientist, Protein Sciences, aTyr Pharmaceuticals

Bioavailability and Activity of Low Viscosity, Ultra-High Concentration Nanoparticle Antibody Dispersions

Jennifer Maynard, Ph.D., Assistant Professor, Chemical Engineering, University of Texas at Austin

製劑篩選和最適化

High-Throughput Profiling of Therapeutic Proteins for Developability Assessment

Kapil Gupta, Ph.D., Research Investigator III, Integrated Biologics Profiling, Novartis Pharma

Miniaturized Developability Assessment of High Concentration Antibody Formulations

Sylvia Kiese, Ph.D., Formulation Scientist and Galenical Project Manager, Formulation Research Biologics & Parenterals, F. Hoffmann-La Roche Ltd

High-Throughput Screening Implementation and Accelerated Stability Studies Utilization

Speaker to be Announced

High-Throughput Screening Methods for Formulation Development of Biotherapeutics and Vaccines

Fernando Ausar, Ph.D., Senior Scientist, Bioprocess Research and Development, Sanofi Pasteur

Novel Nanoformulation of Polymyxin B, a Peptide Antibiotic

Israel (Rudi) Rubinstein, M.D., Professor of Medicine, University of Illinois at Chicago