January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 
January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 

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Cambridge Healthtech Institute’s 8th Annual
Optimizing Biologics Formulation Development
Formulation Strategies for Different Stages of Development, New Product Formats,
Device/Delivery Systems and Emerging Analytical Methods

January 18-19, 2016

Each year, the PepTalk Optimizing Biologics Formulation Development meeting brings together an international audience of analytical and formulation scientists from leading industry companies to hear solutions to the most significant challenges in their field. For 2016, the conference focuses on formulation strategies in early and pre-commercial development, the challenges of new molecule and product formats, emerging technologies to support the speed and quality of formulation development, formulation issues for device and packaging systems and problem solving for the challenges in the day-to-day work of protein formulators.

Preliminary Agenda 


KEYNOTE PRESENTATIONS

Formulation Strategies in an Era of Accelerating Timelines and Novel Biotherapeutic Modalities

Ping Y. Yeh, Ph.D., Executive Director, Drug Product Formulation Technologies, Process Development, Amgen, Inc.

Probing the Interface of Protein Stability Analysis, Formulation Development and Biosimilarity Assessments

David B. Volkin, Takeru and Aya Higuchi Distinguished Professor of Pharmaceutical Chemistry, The University of Kansas School of Pharmacy


ANALYTICAL METHODS AND TECHNOLOGIES
FOR FORMULATION DEVELOPMENT

Structure-Based Formulation Effects on Endotoxin Quantification

Tarik Khan, Ph.D., Postdoctoral Fellow, Late-Stage Pharmaceutical and Processing Development, F. Hoffmann-La Roche Ltd.

Biophysical Characterization of Peptide and Protein Formulations

Per-Olof Wahlund, Ph.D., Senior Scientist, Biophysics Screening & Characterization, Novo Nordisk

Analytical Techniques and Assays for Understanding Colloidal and Conformational Stability

Manish Burman, Senior Scientist, Biopharm Innovation, Biopharm Research & Development, GlaxoSmithKline

Luncheon Presentation to be Announced

Russell Burge, Ph.D., Applications Scientist, Freeslate, Inc.


FORMULATION SOLUTIONS FOR NOVEL BIOTHERAPEUTICS

Characterization of Stability and Small Molecule Related Species in Antibody-Drug Conjugates

Colin Medley, Ph.D., Scientist, Genentech, Inc.

Factors Impacting the Stability of Multi-Domain Fusion Proteins

Roberto DePaz, Ph.D., Senior Scientist, Biopharmaceutical Development, MedImmune

Formulation Challenges of Highly Potent Bispecific Antibody Formats

Sachin Dubey, Ph.D., Director, Formulation and Process Development, Glenmark Pharmaceuticals

Challenges in the Development of a Formulation for Monoclonal Antibody Mixtures in the Treatment of Botulism

Susan Babuka, Senior Formulation Scientist, XOMA Corp.


STRATEGIES FOR THE STAGES OF FORMULATION DEVELOPMENT

Bioanalytical Tools for Developability Evaluation

Valentyn Antochshuk, Ph.D., Principal Scientist, Bioprocess Development, Merck

Considerations and Approaches for Late-Stage Formulation Characterization of Biologics

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


DELIVERY AND DEVICES

Formulation Considerations for Developing a High-Concentration Biologics Product in Multiple Presentations

Kapil Gupta, Ph.D., Principal Scientist and Group Leader, Protein Drug Product and Device Development, Biogen

Integrating Design Controls in Formulation Development for Combination Products

Ling Lu, Senior Principal Scientist, Pfizer

Fujifilm DiosynthPresentation to be Announced






For questions about the meeting, please contact:

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

For partnering & sponsorship information, please contact: 

Companies A-K
Jason Gerardi
Manager, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5452
Fax: 781-972-5470
Email: jgerardi@healthtech.com 

Companies L-Z
Carol Dinerstein
Director, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5471
Fax: 781-972-5470
Email: dinerstein@healthtech.com