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生物製剤開発の最適化 早い段階から処方と生産の関係を管理し、安定性、加工、生産にまつわる課題を克服して、合目的的な医薬品の開発へとつなげるために1月9日〜10日
この部会は、生物製剤の処方にまつわる最新のトレンドと課題を網羅するもので、早期の製剤処方とキャラクタリゼーションによる開発期間の短縮、安定性にまつわる課題の克服といったテーマに焦点を絞り込みます。また、早期の製剤処方とキャラクタリゼーション、スクリーニング、凝集にまつわる課題の克服、有効な解析手法の活用、技術移転にまつわる課題への対応、実験的設計とハイスループット原則の利用といったテーマ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。 製剤開発最適化のための戦略 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
安定性の問題の把握と克服 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
製剤スクリーニングと最適化 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 |