You can submit a short abstract to us online here 

Meeting Focus: 

The underlying technology for making antibodies, therapeutic proteins and vaccines is increasingly mature.  A current focus for pharma/biotech. companies is how to deliver cost effective, robust, well characterized processes, methods, and products efficiently and quickly.  This conference will focus on recent developments (particularly new, "disruptive" technologies) that will be keys to these increases in speed and efficiency.

Co-Chairs:

Scientific Advisory Board:

• Wolfgang Berthold, VP, Biogen-Idec
• Barry Buckland, VP, Merck
• Brian Kelley, Senior Director, Genentech
• Anthony Lubinecki, VP, Centocor
• Jim Swartz, Professor, Stanford University
• Jim Thomas, VP, Amgen

Topics for the Eight Sessions:

1.  Setting the Conference Context and Drivers

Session Chair:  Bob Adamson (Wyeth)           
Keynote speakers:

• Rob Garnick, Genentech
• John Carpenter, University of Colorado
• Janice Reichert, Tufts University

2.  Rapid Cell Line Development and Improved Expression System Development

The session will highlight advances in expression systems and cell line development that address key drivers in the field:  the need for rapid entry of new product candidates into the clinic and for highly efficient processes that maximize facility utilization and minimize costs of protein manufacture.  This session also includes approaches for streamlining upstream process development.

• Timothy Charlebois (Wyeth) 
• Rohini Deshpande (Amgen)   

3. Rapid and Economic Purification Process Development

This session addresses approaches to optimize the speed, efficiency, and cost of purification process development and manufacturing.     

• Jorg Thommes (BiogenIdec)   
• Paul Mensah (Pfizer) 

4.      Cutting-Edge Analytical Techniques

This session covers applications of the latest analytical technology to support product development, including high-throughput and robotic techniques, mass spectrometry, and separations technology.       

• Rohin Mhatre (BiogenIdec)         
• Tom Porter (Wyeth)

5.   High Throughput Protein Formulation Development

This session includes presentations on both potential applications as well as case studies of high throughput methodologies for formulation development of biopharmaceutical drugs, including quality by design strategies, robotics, rapid analyses and data processing and visualization methods.         

• David Volkin (Centocor)
• Bruce Kerwin (Amgen)

6.  Emerging, “Disruptive” Technologies

This session will review the promise and pitfalls of exploratory process and production technologies, through consideration of technical risks, scale-up potential, impact on process economics and implications for facility design. Advances in protein engineering, novel expression systems, unique molecular platforms and process technologies as well as other topics that could dramatically impact biopharmaceutical development over the next 10 years will be covered.

• Gordon Moore (Centocor)
• Brian Kelley (Genentech)
• Jim Swartz (Stanford)

7.  "Critical Quality Attributes, Specifications and Comparability.  

Phase-Appropriate Process Development Strategies and Regulatory Expectations     

• Reed Harris (Genentech)  
• Paul Tsang (Amgen)       

8.  Functional Interaction, Integration, and Synergy in Platform Development – from Amino Acid Sequence Identification to Protein Delivery

Where can we have the most impact in the Development paridigm?   What are the leverage points?  What are the points of greatest potential synergy between functional areas?
How do we triangulate the issues of speed, cost and product quality during development?
How do the decisions we make prelicensure impact out ability to improve the process post-licensure?          

• Brendon Hughes (Wyeth)     
• Patricia Alred (Centocor)     

You can submit an abstract here.