Preliminary Program for SBE's Accelerating Biopharmaceutical Development Conference

Date and Time

Speakers

Title

Speaker Type

Tuesday, March 10

Session 1: Setting the Conference Context and Drivers
Chair: Bob Adamson (Wyeth)
8:00AM-10:00AM

Rob Garnick (Genentech)

Recent Developments in Biosimilars

Keynote

Janice Reichert (Tufts University)

Development Trends for Biotherapeutics

Keynote

Session 2: Emerging, "Disruptive" Technologies: Disruptive Science and Technology
Chairs: Gordon Moore (Centocor), Brian Kelley (Genentech) and Jim Swartz (Standford)
10:30AM-12:30PM

Stefan Wildt (Merck)

Mab Expression in Picchia using GlycoFi Technology

Annie De Groot (Epivax)

Immunology Models

Bill Warren (Vaxdesign)

Accelerated Vaccine Development

Karen O’Neil (Cyntrix)

Centyrin Alternative Scaffolds:  A new Biotherapeutic Platform for J&J

Session 3: Cutting-Edge Analytical Techniques
Chairs: Rohin Mhatre (BiogenIdec) and Tom Porter (Wyeth)
2:00PM-4:30PM

 Tom Laue (University of New Hampshire)

Advances in Analytical Ultracentrifugation and Analytical Electrophoresis

Kermit K. Murray (Louisiana State University)

Coupling Mmicrofluidic Chips to MALDI Mass Spectrometry

Igor Kaltashov (UMass Amherst)

Mass Spectrometry-Based Strategies to study Protein Architecture, Dynamics, and Binding

 Steve Cohen (Waters Corp.)

Chromatographic Analysis for Biopharmaceuticals: Current Trends and Future Prospects

Judy Chou (Genentech)

High Throughput Analytical Methods for Bioprocess Development

4:30PM-6:30PM

Poster Session

Wednesday, March 11

Session 4: Cell Culture Process Development
Chairs: Timothy Charlebois (Wyeth)  and Rohini Deshpande (Amgen)
8:00AM-10:00AM

Florian Wurm (ETH-Lausanne)

Transient Expression in CHO Cells

Greg Hilller, (Wyeth)

High Yield Expression in CHO Cells 

Luhong He (Lilly)

Quantitative Analysis of Transfected MoAb Genes in Recombinant Single Cells and Its Application in Cell Line Generation

Dennis Kraichley (Centocor)

 Fluorescent Protein G Methylcellulose Screening -- a More Predictive Approach to Isolate High-Producing Candidate Manufacturing Cell Lines?

Session 5: Critical Quality Attributes, Specifications and Comparability
Chairs: Reed Harris (Genentech) and Paul Tsang (Amgen)
10:30AM-12:30PM

Sally Anliker (Lilly)

Control Strategy

Patrick Swann (FDA)

Regulatory Considerations for Evaluating Product Quality

Paul Motchnik (Genentech)

Defining and Assigning CQAs

Izydor Apostol (Amgen)

Analytical Perspective on Product Specification Lifecycle During Biotech Development

Session 6: High Throughput Protein Formulation Development
Chairs: David Volkin (Centocor) and Bruce Kerwin (Amgen)
2:00PM-4:30PM

Juan Alvarez (Johnson and Johnson)

Application of High Throughput Technologies in the Development of Biopharmaceuticals

Russ Middaugh (University of Kansas, Department of Pharmacy)

An Empirical Phase Diagram/High Throughput Screening Approach to the Formulation of Macromolecular Systems

Mark Manning (Legacy Biodesign)

 Efficient and Rationale Development of Liquid Formulations of Biopharmaceuticals

Byeong Chang (Symyx Technologies Inc)  

A Parallel, Microscale, Automated Approach to (Pre)Formulation and Stress Test Studies for Large Molecules

Albert Lee (Genentech)

High Throughput Formulation Screening using Rapid Stress Methods

6:00PM-9:00PM

John Carpenter (University of Colorado)

Protein Aggregation: Causes, Consequences, Control and Challenges

Keynote

4:30PM-6:30PM

Poster Session

Thursday, March 12

Session 7: Emerging, “Disruptive” Technologies:  Disruptive Science and Technology
Chairs: Gordon Moore (Centocor), Brian Kelley (Genentech), and Jim Swartz (Stanford)
8:00AM-10:30AM

Saddetin Ozturk (Centocor)

Facilities Based on Disposable Technology

Brian Hubbard (Amgen)

Future Directions in Purification Technology

Brian Kelley (Genentech)

Industrialization of mAb Processing: What Hath CHO Wrought

Tom Ranshohoff (Bioprocess Consultants)

Challenges of Introduction of New Technologies

30-Minute Discussion

Session 8: Functional Interaction, Integration, and Synergy in Platform Development – from Amino Acid Sequence Identification to Protein Delivery
Chairs: Brendon Hughes (Wyeth) and Patricia Alred (Centocor)
11:00AM-12:30PM

Hubie Scoble (Wyeth)

BioPharma Development Platform Concepts - What's Next?

Victor Fung (Amgen)

Gaining Momentum from Platforms - How Other Functions Took a Good Idea and Made It Better

Pat Alred (Centocor/GPSG)

Applying QbD Principles as a Function of Product Maturity

Session 9: Rapid and Economic Purification Process Development
Chairs: Jorg Thommes (BiogenIdec) and Paul Mensah (Pfizer)
2:00PM-4:30PM

Sam Guhan (Amgen)

Lynn Conley (Biogen Idec)

Using Partition Designs to Reduce Purification Process Characterization Time

Christopher J. Gallo (Wyeth BioPharma)

Development of a Late Phase off-Platform Manufacturing Process within a Platform Development Timeline

Tangir Ahamed (SynCo Bio Partners)

The Use and Misuse of Rules-of-Thumbs for Rapid Development of Ion-Exchange Chromatography Process

Kjell Eriksson, Karol Lacki, Hans J Johansson and Gunter Jagschies (GE Healthcare)

Development and Scale-up of a Downstream Process for a Monoclonal Anti-body. A Case Study

Vendor Session