Cambridge Healthtech Institute’s 5th Annual
Early Analytical Development for Biotherapeutics
Optimizing Preclinical Analytical Development for Emerging Biotherapeutics
Part of CHI's Ninth Annual The Bioprocessing Summit

August 23-24, 2017 | Westin Copley Place | Boston, MA


The analytical steps conducted in preclinical development following the handoff of a lead candidate are vital on many levels in determining the fate of that program. This complex effort shapes the optimization of the new product, requires the use of expensive and scarce resources and supports the voluminous regulatory filing that is the early IND application. It is imperative that companies reach this important milestone as quickly and efficiently as possible, while positioning the organization to move rapidly into the GMP production needed for early phase clinical trials. Early Analytical Development for Biotherapeutics will present best practice case studies of how industry companies have approached the most important analytical studies occurring during this stage, focusing on the development and optimization of key assays, the application of automation and the challenges of analytical development for novel modalities.

Preliminary Agenda


Keynote Presentation:
Early Analytical Profiling to Facilitate Biologics Development

Tao He, Ph.D., Associate Research Fellow, BioMedicine Design, Pfizer, Inc.



METHODS AND INSTRUMENTS

How to Develop a Multiple Quality Attributes Method in Three Days

Zhi Chen, Ph.D., Senior Scientist, Molecular and Analytical Development, Global Manufacturing & Supply, Bristol-Myers Squibb

Multidimensional Chromatography Characterization of Drug Load Variants in a Thiol Linked Antibody-Drug Conjugate

Catherine Eakin, Ph.D., Principal Scientist, Seattle Genetics

Implementation of Multiple-Attribute Monitoring (MAM) and Multivariate Analysis

Darryl Davis, Ph.D., Associate Director, Biophysical Research and Analytical Development, Janssen

High Throughput Biophysical Analysis

Ozan Kumru, Ph.D., Research Assistant Professor, Macromolecule and Vaccine Stabilization Center, University of Kansas


EMERGING MODALITIES

Early Analytical Support for Novel Site-Specific ADC Development by Mass Spectrometry

Lintao Wang, Ph.D., Principal Scientist, ImmunoGen

Characterization of Novel General Amyloid Interaction Motif (GAIM)-Immunoglobulin (Ig) Fusions

Ming Proschitsky, Ph.D., Senior Scientist, Research, Proclara Biosciences

Phase Appropriate Analytical Characterization of Recombinant Protein-Based Vaccines

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


OPTIMIZING THE SPEED AND EFFICIENCY OF EARLY ANALYTICAL DEVELOPMENT

Early Developability Evaluation of IgG-Based Novel Biologics Formats

Dana Filoti, Ph.D., Senior Scientist, Drug Product Development Preformulation, AbbVie

High Throughput Analytical Platforms for Early Biopharmaceutical Development

Vladimir Razinkov, Ph.D., Principal Scientist, Amgen

Development and Adaptation of Platformed Analytical Approaches

Marina Kirkitadze, Ph.D., Deputy Director, Head of Biophysics and Conformation Unit, Analytical R&D Biochemistry, Sanofi Pasteur

Best Practices for Optimizing the Speed and Efficiency of Early Analytical Development

Adriana Kita, Ph.D., Development Scientist, Protein Characterization, Alexion Pharmaceuticals




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

For media partnership opportunities, please contact:
Kaushik Chaudhuri
Director of Product Marketing
Phone: 781-972-5419
Email: kchaudhuri@healthtech.com

For exhibit & sponsorship opportunities, please contact:

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

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

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Event at a Glance
Event at a Glance


Celebrating 25 Years


 

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