2015 BPD Header

Cambridge Healthtech Institute’s 3rd Annual
Overcoming Formulation Challenges for Biopharmaceutical Development:
Formulation and Process Optimization, Analytics, Device Integration and New Biologics
August 3-4, 2015
Part of CHI's 7th Annual The Bioprocessing Summit

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


The popular third annual Overcoming Formulation Challenges for Biopharmaceutical Development conference will cover latest trends and challenges in biologic formulations development, process optimization, manufacturing, and device and packaging considerations for existing and emerging protein therapeutics. The conference will showcase case studies, especially unpublished and innovative work, on the use of the effective scale up strategies, excipient induced instability, process challenges, fill finish challenges, and predictive tool for rapid formulation and stability screening. We invite you to attend to learn from and network with the leading experts from around the world in the field of biologics formulation development.


Preliminary Agenda 


OVERCOMING FORMULATION CHALLENGES

Transformational Science: Moving From the Challenges of High Concentration mAbs to Meeting the Needs of Highly Potent Bispecifics

Sachin Dubey, Ph.D., Head of Formulation Development, Process Development, Glenmark Pharmaceuticals SA

Overcoming Formulation Challenges for Drug-Device Combination Products

Jamie Tsung, Ph.D., Principal Scientist, Momenta Pharmaceuticals, Inc.

Considerations and Approaches for Late Stage Formulation Development of Biologics

Hardeep Samra, Ph.D., Senior Scientist, Formulation Sciences, MedImmune, Inc.


EXCIPIENTS INTERACTIONS IN PROTEIN FORMULATION

Critical Considerations for Surfactant Stability in Biopharmaceutical Formulations

Sandeep Yadav, Ph.D., Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.

Challenges in Co-Formulating Polysorbates and Preservatives in Multi-Use Biologics Formulations

Shuai Shi, Ph.D., Associate Principal Scientist, Sterile Product and Analytical Development, Merck


QbD, PROCESS CHALLENGES & DRUG PRODUCT QUALITY

QbD in Late Stage Formulation Optimization - A Case Study

Mark Yang, Ph.D., Director, Fill Finish Development, Genzyme - a Sanofi Company

Mixing Monoclonal Antibody Formulations Using Bottom-Mounted Mixers – Impact of Mechanism and Design on Drug Product Quality

Yuh-Fun Maa, Ph.D., Principal Engineer, Pharmaceutical Processing and Technology Development, Genentech, Inc.


PROTEIN AGGREGATION & PARTICLE MEASUREMENTS

Stability Challenges for Protein Therapeutics: Anticipating Aggregation Phenomena at Early Development Stage

Joël Richard, Ph.D., Senior Vice President Peptides, Technical Operations, Ipsen

Strategy for Characterization and Control of Submicron and Subvisible Particles in Biologics

Nataliya Afonina, Ph.D., President and Principle Consultant, AN Biologics Consulting LLC

Addressing the Gaps in Particle Measurements for Biotherapeutic Solutions

Reema Raghavendra, M.S., MBA, Scientist II, Global Protein Sciences, AbbVie, Inc.




For more details on the conference, please contact:
Nandini Kashyap
Conference Director
Phone: 781-972-5406
Email: nkashyap@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