Cambridge Healthtech Institute’s 6th Annual

Accelerating Analytical Development
( 加快分析法的開發 )

Optimizing the Speed and Efficiency of Key Analytical Steps in Biotherapeutic Development


Research for this meeting revealed that industry analytical groups are facing increased pressure to deliver key analytical studies used in candidate selection, process development, clinical development and regulatory submissions faster than ever before – and at lower costs. Accelerating Analytical Development offers a best practices forum in which industry scientists and managers can exchange ideas on strategies, new technologies and the integration of analytical methods in support of these goals.  The conference will address the most important roles of the analytical function at every stage of development and provide insights on how different organizations are addressing these challenges.

Proposed presentations should offer case studies of strategies, best practices and novel solutions applied in accelerating and optimizing analytical support of biotherapeutic development programs.

Preliminary Agenda

Keynote Presentation: Accelerating Analytical Development: Thoughts on Driving Force and Strategy

Li Zang, PhD, Director, Protein Analytics, AbbVie


Accelerating Antibody Drug Development from Discovery to IND

Jianwen Feng, PhD, Senior Principal Scientist, Head of Protein Analytics, Jounce Therapeutics

Implementation of a Multi-Attribute Method for Product Control of an Fc Fusion Protein

Le Zhang, PhD, Senior Scientist, Amgen

Analytical Method Performance Monitoring – An Integral Part of the Analytical Method Lifecycle

Dan (Cassie) Liu, PhD, Statistician, Bristol-Myers Squibb

Fast pCQA Assessment of Next-Generation TCBs

Alejandro Carpy, PhD, Senior Scientist, Large Molecule Research, Roche Diagnostics GmbH, Germany

Presentation to be Announced


Automated Sample Preparation Workflow for Novel Biotherapeutics Characterization

Yunan Wang, PhD, Scientist, Amgen

New Applications of Physical Methods in Biotherapeutic R&D

Muthuraman (Muthu) Meiyappan, Head of Analytical Research, Discovery Therapeutics, Shire Pharmaceuticals

Presentation to be Announced

Mark McCoy, PhD, Principal Scientist, Merck

Implementation and Challenges of Integrating a New Platform into Analytical and Formulation Workflows

Prasad Oruganti, PhD, Scientific Leader, GlaxoSmithKline


Analytical Workflows for Early and Late Stage mAb Development

Tyler Carlage, PhD, Senior Scientist, Analytical Development, Biogen

Characterization of Novel Antibody-Based Biotherapeutics by Liquid Chromatography Coupled with Mass Spectrometry

Tasneem Bahrainwala, PhD, Group Leader, Analytical Sciences Mass Spectrometry, MacroGenics, Inc.

Enabling Routine and Reproducible Biotherapeutic Analysis When Data Integrity Matters

John Gebler, PhD, Director, Waters Corporation


Potency Assays for Cell and Gene Therapies

Win-Den Cheung, PhD, Associate Director, Analytical Development, Regenxbio

Revolution Over Evolution: Emerging Technologies Require Alternative Analytical Methods and not Adaptation of Traditional

Elena Smith, PhD, Deputy Director, Quality Control, Sanofi Pasteur

Contrasting Analytical Method Development for High and Low Concentration Biopharmaceuticals

Sachin Dubey, PhD, Head, Formulation and Analytical Development, Glenmark Pharmaceuticals SA, Switzerland

* 活動內容有可能不事先告知作更動及調整。