生物制剂开发最适化

从早期阶段到管理处方和生产关系，克服安定性、加工及生产的课题，开发合乎目的之医药品

1月9日～10日

此部会网罗与生物制剂处方有关之最新倾向和课题，聚焦于早期的制剂处方及藉由特性描述（characterization）缩短开发期间、克服安定性的课题等主题。此外，克服早期的制剂处方与特性描述、筛选、凝集的课题，利用有效的分析手法，因应技术移转的课题，亦预定进行与实验的设计和高容许量原则的利用有关之主题的详细个案研究及讨论。

开发制剂最适化的策略

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

安定性问题的掌握与克服

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

制剂筛选和最适化

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