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Cambridge Healthtech Institute’s 12th Annual

Optimizing Biologics Formulation Development
( 優化生物製劑處方開發 )

Exploring the Future of Tools and Techniques for Formulating Novel Biologic Drug Products

1月20日~21日

Part of the Formulation & Stability pipeline

Cambridge Healthtech Institute’s 12th Annual Optimizing Biologics Formulation Development conference is an essential yearly gathering of analytical and formulation scientists from leading industry companies that provides an exchange of scientific developments and emerging technologies in an environment that encourages discussion with colleagues. For 2020, the meeting will address the formulation challenges of emerging modalities, new strategies for predictive analysis at this stage, exciting new analytical methodologies and accelerating and the best practices being employed to overcome formulation challenges.

Preliminary Agenda

KEYNOTE PRESENTATION: How Accelerated Formulation Designs Can Lead to Accelerated Clinical Trials & Approvals

Murali Bilikallahalli, PhD, Vice President and Head of Technical Operations, Acceleron Pharma

FORMULATION FOR EMERGING MODALITIES

Biologics Co-Formulation Product Development – Challenges and Case Studies

Jainik Panchal, PhD, Associate Principal Scientist, Sterile Formulation Sciences, Merck

The Relevance of Size Impurities in mRNA-Loaded Lipid Nanoparticle Formulations

Flaviu Gruia, PhD, Principal Scientist, Drug Product Analytical Development, Moderna Therapeutics

Drug Product Development and Manufacturing Approaches to a Multi-Modality (Biologics, Gene Therapy, Oligonucleotide and Small Molecules) Portfolio

Kapil Gupta, PhD, Director, Protein Pharmaceutical Development, Biogen

Resolving Container Closure Challenges for Cold Storage of Gene Therapy Products

Pooja Sane, PhD, Scientist, BioMarin Pharmaceuticals

PREDICTIVE METHODS FOR FORMULATION DEVELOPMENT

Thermodynamic and Biophysical Evaluation of IgG2 Isoforms for Predicting Long-Term Stability

Radhakrishna Maroju, PhD, Principal Scientist, DPDO, Biologics CMC, Teva Pharmaceuticals

Physics-Based Simulations to Predict Developability of Antibody Therapeutics

Saeed Izadi, PhD, Scientist, Genentech

Computational Predictive Tools

Pavan Ghatty, PhD, Senior Scientist, Amgen

New Approaches to Subvisible Particle Detection and Characterization

Julie Champion, PhD, Associate Professor, Chemical and Biomolecular Engineering, Georgia Tech

Characterizing Interface-Related Protein Stability Issues

Samantha Pace, PhD, Research Investigator, Bristol Myers Squibb

OVERCOMING FORMULATION CHALLENGES

Formulation Strategies for Labile Protein Molecules: A Bi-Specific Antibody Case Study

Xiaofeng Lu, Ph.D., Principal Research Scientist, Pharmaceutical Development, AbbVie, Inc.

Issues to Consider While Developing Novel Formulation Excipients

Krishna M.G. Mallela, PhD, Associate Professor, Pharmaceutical Sciences, University of Colorado

Effect of Temperature and Secondary Packaging on Photostability of Biological Products

Shalini Minocha, PhD, Staff Scientist, Formulation Development, Regeneron

Best Practices for Working with Contract Organizations for Formulation Development

Aniket Badkar, PhD, Director, Biologics Product Development, Allergan



* 活動內容有可能不事先告知作更動及調整。

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2020年會議節目和培訓研討會


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