Cambridge Healthtech Institute’s 5th Annual Analytical Forum

Accelerating Analytical Development

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

August 15-16, 2018


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.


Preliminary Agenda


OPTIMIZING THE SPEED AND EFFICIENCY OF ANALYTICAL DEVELOPMENT

KEYNOTE PRESENTATION: Balancing Speed and Resource Considerations in the Selection of Fit for Purpose Assays at Each Stage of Development

Jennifer F. Nemeth, PhD, SCPM, Director, Biophysics, Structural Characterization, Biologics Discovery Sciences, Janssen Research & Development

An Efficient Analytical Development Strategy Enabling Expedited Development of Therapeutic Products

Xiaoyang Zheng, PhD, Principal Scientist, Biopharmaceutics Development, Sanofi US

Feasibility and Challenges in Machine Learning Approaches to Predicting Biophysical Properties from Sequence and Structure

Tileli Amimeur, Data Scientist, Molecular Design, Just Biotherapeutics

Best Practices for Comparability Analysis Following Method Changes, Method Bridging

Christina Vessely, PhD, Senior Consultant, Analytical and Formulation Development, Biologics Consulting

Regulatory Considerations in Determining Analytical Strategy for Phase 1 Programs

Vaneet K. Sharma, PhD, Analytical Scientist, Vaccine Development & Manufacturing, International AIDS Vaccine Initiative (IAVI)


EMERGING METHODS AND INSTRUMENTS TO SUPPORT ACCELERATED DEVELOPMENT

Capillary Electrophoresis Sodium Hexadecyl Sulfate (CE-SHS): A Novel Approach to Characterizing the Purity of a Therapeutic Protein

Jeff Beckman, PhD, Research Scientist, Bristol-Myers Squibb

Novel IR Microfluidic Device for Secondary Structure Assessment of an Ab and Its ADC

Karan Shah, Principal Development Associate, Analytical CMC & Formulation, ImmunoGen, Inc.

Online Peptide Immuno-Affinity Enrichment (PIE) LC-MS Application in Biodistribution Studies of Protein Therapeutics

Jessy Fan, PhD, Scientist, Amgen

New Developments in Reducing Sample Size Requirements for Common Assays

Joshua Laber, PhD, Postdoctoral Fellow, AbbVie


SOFTWARE AND DATA MANAGEMENT CHALLENGES

Electronic Lab Environment: Software and Data Challenges

Richa Sarin, Scientist, Technical Development, Biogen

Accelerating Insights through Aggregation of Formulation Data and Metadata from an Integrated Process Development Electronic Database

Shabnam Molloy, Senior Associate Scientist, Amgen


ANALYTICAL DEVELOPMENT CHALLENGES OF NEW MODALITIES

Correlation of Analytical Methods for Next-Generation Biologics from Molecular Assessment to Clinical Development

Alejandro Carpy, PhD, Laboratory Head Biochemistry, Roche, Germany

Analytical Development and Challenges for Bispecific Antibodies

Xiaoyu Yang, PhD, Principal Scientist, Merck

Analytical Platforms in an Era of Novelty and New Modalities

Daniel McDonald, PhD, Researcher, Genentech




For more details on the conference, please contact:

Kent Simmons
Senior Conference Director
Phone: 207-869-9199
Email: ksimmons@healthtech.com


For exhibit & sponsorship opportunities, please contact:

Companies A-K

Sherry Johnson
Business Development Manager
Phone: 781-972-1359
Email: sjohnson@healthtech.com

Companies L-Z

Carolyn Benton
Business Development Manager
Phone: 781-972-5412
Email: cbenton@healthtech.com

For media partnership opportunities, please contact:

Kaushik Chaudhuri
Director of Product Marketing
Phone: 781-972-5419
Email: kchaudhuri@healthtech.com


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Premier Sponsors:

Millipore Sigma
Unchained Labs