Cambridge Healthtech Institute’s 6th Annual

Accelerating Analytical Development

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

August 14-15, 2019


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

BEST PRACTICES FOR ACCELERATING ANALYTICAL DEVELOPMENT

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 Release and Stability Testing of a 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


EMERGING ANALYTICAL AND AUTOMATION TECHNOLOGIES

Automated Sample Preparation Workflow for Novel Biotherapeutics Characterization

Yunan Wang, PhD, Scientist, Amgen

Biophysical Screening Methods for Candidate Selection

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

Solution NMR Assessments of Therapeutic Peptide and Protein Behavior

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

LESSONS LEARNED FROM ANALYTICAL WORKFLOWS

Representative Small-Scale Purification Workflows Supporting mAb Process Development

Peter Bryngelson, 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

ANALYTICAL DEVELOPMENT FOR NOVEL MODALITIES

Potency Assays for AAV 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




For more details on the conference, please contact:
Kent Simmons
Senior Conference Director
Cambridge Healthtech Institute
Phone: 207-869-9199
Email: ksimmons@healthtech.com

For partnering and sponsorship information, please contact:

Companies A-K
Sherry Johnson
Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-1359  
Email: sjohnson@cambridgeinnovationinstitute.com

Companies L-Z
Carolyn Benton
Cambridge Healthtech Institute
Phone: 781-972-5412
Email: cbenton@healthtech.com


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