Cambridge Healthtech Institute’s 9th Annual

Characterization of Biotherapeutics

Exploring the Analytical Challenges of Today’s Complex Biologics

April 8-9, 2019


As new product formats progress through development and into the regulatory process, the role of analytical characterization is taking on new meaning. Very new modalities present challenges to both analytical scientists and regulatory agencies alike, and this steep learning curve requires a near-constant cycle of adaptation and innovation. The agencies are requiring sponsors to provide ever more complex data across a wide range of analytical methods, and instrumentation suppliers are striving to support this new era with unique product features, software and feature combinations. The PEGS “Characterization of Biotherapeutics” conference explores the progression of analytical development for an exciting range of emerging modalities and offer a case study forum for those working in the field to share ideas, experiences and solutions that support the preclinical and clinical development of new biotherapeutics.

Preliminary Agenda


Characterization Challenges for Exosomes

Damian Houde, PhD, Associate Director, Codiak BioSciences

Characterization of Novel Complex and Antibody Formats

Markus Haberger, PhD, Group Leader, Development Characterization Analytics, Roche Pharmaceuticals, Germany

Expanding Role of Mass Spectrometry in Development of Biotherapeutics

Dhaval Nanavati, PhD, Senior Scientist, AbbVie


The Regulatory Path for Breakthrough Designations and Orphan Drugs

Hardeep S. Samra, PhD, Senior Director, Head, Regulatory Operations, Orphan Drug Unit, IQVIA

CMC Analytical Strategies Designed for Regulatory Dialog Intended for Early Phase IND Filings

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


The Risk Versus Reward Tradeoff in Planning the Extent and Timing of Analytical Studies

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

Presentation to be Announced


FDA Guidance on CMC Information Required in Gene Therapy IND Filings

Michelle Joubert, PhD, Staff Scientist, Analytical Development, Sanofi

Lentiviral Vectors and Characterizing their Potency for Cell Therapy

Marc-André Robert, PhD, Scientist, BioMarin Pharmaceuticals

Application of Analytical Ultracentrifugation: From Protein Therapeutics to Gene Therapy

Qin Zou, PhD, Group Leader, Analytical Research and Development, Pfizer, Inc.

Presentation to be Announced

Eric S. Alonzo, PhD, Scientist, Process and Analytical Development, bluebird bio

Challenges in the Characterization of CAR-Ts: Leveraging Mass Spectrometry During CAR-T Process Development

Ken Prentice, PhD, Senior Scientist, Juno Therapeutics

Characterization Challenges for CAR-Ts; Potency Assays, Release Panel, In-Process Analytics

Kuldip Sra, PhD, Director, QC, Kite Pharma, Inc.


Domain Characterization of Protein Therapeutics In Vivo by Multiplexed NanoLC-HRMS Approaches

Jessy Fan, PhD, Scientist, Amgen

The Roadmap of Bispecific Recombinant Protein Drug Development

Zhimei Du, PhD, Director, Bioprocess, Merck & Company, Inc.


Characterization of Antibody Drug Conjugates

Speaker to be Announced, AbbVie Bioresearch Center

Characterization of Small Molecule Impurities

Jane Zhao, PhD, Senior Scientist, Immunogen

ProteinMentor Developability Assessment: Case Studies for Therapeutic Proteins

Belinda Pastrana, PhD, Chief Executive Officer, Protein Dynamic Solutions

ProteinSimple Presentation to be Announced


* The program is subject to change without notice, due to unforeseen reason.

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