2015 BPD Header

Cambridge Healthtech Institute’s 2nd Annual
Early Analytical Development for Biotherapeutics
Optimizing the Selection and Performance of Preclinical Analytical Studies
August 5-6, 2015
Part of CHI's 7th Annual The Bioprocessing Summit

August 3-7, 2015 | Westin Copley Place Hotel | Boston, Massachusetts


Preliminary Agenda 

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.

Keynote Presentation: Talk Title to be Announced

Ivan Correia, Ph.D., Senior Principal Research Scientist, Global Protein Sciences, AbbVie Bioresearch Center


MOLECULAR ASSESSMENT AND EARLY STAGE ANALYTICAL STRATEGIES

Early Developability Screen of Therapeutic Antibody Candidates Using Taylor Dispersion Analysis and UV Area Imaging Detection

Alexandra Lavoisier, Scientist, Biologics Center, Novartis, Switzerland, Biologics Center, Novartis, Switzerland

Case Study: Talk Title to be Announced

Haripada Maity, Ph.D., Research Advisor, Formulation Development, CMC Development, Eli Lilly and Company


ASSAY DEVELOPMENT AND TROUBLESHOOTING

Applications of Mass Spectrometry in Early Development

William M. Matousek, Ph.D., Staff Scientist, Regeneron Pharmaceuticals, Inc.

Biophysical Assays for Study of Aggregation and Subvisible Particles

Mario Hubert, Ph.D., Principal Scientist, Bristol-Myers Squibb


EARLY ANALYTICAL DEVELOPMENT FOR NOVEL BIOTHERAPEUTICS AND BIOSIMILARS

Analytical Development for Knob-into-Hole Bispecific Antibodies

Hongbin Liu, Ph.D., Scientist, Genentech

Analytical Development for Cell-Based Therapeutics

Gautam Banik, Ph.D., Vice President, Process Sciences and Manufacturing, Cellerant Therapeutics

Analytical Development for PEGylated Protein Therapeutics

Nathan Brown, Ph.D., Senior Scientist, AbbVie

Biochemical Characterization of BMP-7 for a New Bone Healing Indication

Michael Annunziato, Principal Scientist, Process and Formulation Development, Olympus Biotech

Identification of Quality Attributes in Early Biosimilar Development

Tilen Praper, Department Head, Analytical Development, Sandoz, Slovenia


DEVELOPMENT AND TROUBLESHOOTING OF CELL-BASED POTENCY ASSAYS

Method Development Guidance to Reduce Variability in Complex Cell-Based Potency Assays

Kathleen Shields, Senior Research Scientist, Pfizer


AUTOMATION AND EMERGING TECHNOLOGIES

High Throughput Analytical Tools for Cell Line Development and Cell Culture Process Development Support

Raga Markely, Ph.D., Scientist, Biogen Idec

Accelerating First in Human Purification Process Development through Full Automation of HCP Testing by AlphaLISA

Zheng Ouyang, Automation Specialist, Biologics Process Development, Bristol-Myers Squibb

Application of High Throughput Analytical Methods and Instrumentation

Ling Santora, Ph.D., Senior Scientist, AbbVie




For more details on the conference,
please contact:

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

For exhibit & sponsorship opportunities, please contact: 

Companies A-K:
Elizabeth Lemelin
Business Development Manager
Phone: 781-972-1342
Email: elemelin@healthtech.com 

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