PTK 2015 Banner 
2015 Peptalk M Banner 

Pipeline Three Icon Pipeline Three Header 

Cambridge Healthtech Institute’s 7th Annual
Optimizing Biologics Formulation Development
Case Studies of Problem Solving for Challenging Formulations,
Novel Biotherapeutics and Packaging/Device Systems

January 19-20, 2015


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 2015, the Seventh Annual congress focuses on the correlation of predictive stability studies with actual clinical results, formulating high-concentration proteins, the interface of drug products with delivery and packaging systems and the management of ever-increasing amounts of analytical data in the formulation function. 

Preliminary Agenda 


KEYNOTE PRESENTATIONS  

NanoCrud: Roles of Nanoparticles in Aggregation Pathways, Adverse Immunogenicity and Quality Assessment of Therapeutic Proteins  

John F. Carpenter, Ph.D., Professor, Pharmaceutical Sciences; Co-Director, Center for Pharmaceutical Biotechnology, University of Colorado Anschutz Medical Center 

Strategies for Establishing a Formulation Function – a MacroGenics Case Study 

Tom Spitznagel, Ph.D., Vice President, Development, MacroGenics, Inc.   


PREDICTIVE ANALYTICAL STUDIES IN FORMULATION DEVELOPMENT 

Estimation of Shelf Life Based on Accelerated Stability Data 

Wei Wang, Ph.D., Scientist, Research and Development, Pfizer   

Correlating Predictive Analytical Studies with Actual Results  

Lisa A. Kueltzo, Ph.D., Staff Scientist, Formulation Development, Vaccine Production Program Laboratory, National Institutes of Health  

Studies on Developability and Predictive Stability Techniques  

Deniz Temel, Ph.D., Postdoctoral Researcher, Technical Development, Biogen Idec  


OVERCOMING FORMULATION CHALLENGES 

Formulation Development for Highly Unstable Proteins  

Ramil Latypov, Ph.D., Principal Scientist, Amgen  

Pharmaceutical Challenges During Late Stage Development of an ADC  

Sreedhara Alavattam, Ph.D., Senior Group Leader, Late Stage Pharmaceutical Development, Genentech – a Member of the Roche Group 

Case Study of a Multi-Antigen/Protein Formulation 

Murali Bilikallahalli, Ph.D., Associate Director, Formulation Sciences, Proteins, Vaccines & Oligos, MedImmune  

Handling the Data Deluge in Formulation Development  

Steven LaBrenz, Ph.D., Scientific Director, Drug Product Development, Janssen R&D  

Antimicrobial Preservatives in Parenteral Formulations – Practical Implications of Peptide/Preservative Interactions 

Petteri Heljo, Ph.D., Postdoctoral Researcher, Early Stage Pharmaceutical Development, F. Hoffmann-La Roche 

Fluorescence and Light Scattering Methodologies in Biopharmaceutical Development  

Malgorzata Tracka, Scientist II, Formulation Sciences, MedImmune 


FORMULATION IMPACTS OF PACKAGING AND DELIVERY SYSTEMS 

PFS Filling of High-Concentration (HC) mAb Formulations – Minimization of Formulation Drying and Nozzle Clogging 

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

Stability of Biopharmaceuticals in Plastic Pre-Filled Syringes in Comparison with Glass Pre-filled Syringes 

Swaroopa Paratkar, Ph.D., Research Investigator, Bristol-Myers Squibb  

Emerging Technologies for the Alternative Delivery of Vaccines and a Preclinical Case Study on Formulation Development of a Sublingual Vaccine  

David Burkhart, Ph.D., Investigator, GlaxoSmithKline Biologicals  

Integrating Drug and Device Development: The Pathway Towards Successful Combination Product Development 

Didier Pertuy, Vice President, Drug-Device Integrated Development, Sanofi