Accelerating BioPharmaceutical Development Technical Program

March 19

2-5pm

5-8pm

March 20

7-8am

8-10am

Session 1 :  Setting the Conference Context and Drivers

Chair:  Geoff Slaff, Amgen

• Roger Perlmutter, VP of Research and Development, Amgen
• Helen Winkle, Director of the Office of Pharmaceutical Science at the FDA's Center for Drug Evaluation and Research.

10-10:30am

10:30am -12:30pm

Session 2:  Rapid Cell Line Development and Improved Expression System Development.  A dvances 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.

Co-chairs:  Timothy Charlebois (Wyeth) and John Joly (Genentech)

• Amy Shen, Genentech - Stable antibody production cell line development with an improved selection process and accelerated timeline.
• Mark Leonard, Wyeth - High-performing cell line development within a rapid and integrated platform process context.
• Pranhitha Reddy, Amgen - Applying Quality-by-Design into Cell Line Development
• Lin Zhang, Pfizer - Development of a Fully-integrated Automated System for High Throughput Screening and Selection of Single Cells Expressing Monoclonal Antibodies

12:30-2pm

2-4:30pm

Session 3:   High Throughput Bulk Process Development.   Applications of high throughput methodologies, including robotics, for medium optimization and purification process development.

Co-chairs:   Brian Kelley (Wyeth) and Jorg Thommes (BiogenIdec)

• Colette Ranucci, Merck - Development of a Multi-well Plate System for High Throughput Process Development
• Parviz Shamlou, Lilly - A Quality Risk Management Base for Miniaturization of Bioprocesses for  Accelerating Biopharmaceutical Development
• Nigel Titchener-Hooker, U. College London - The Use of Ultra-scale-down Approaches to Enable Rapid Investigation and Characterization of the Initial Downstream Process for Antibody Fragment Production in e. Coli
• Jon Coffman (Wyeth) - High Throughput Purification Development
• Ajoy Velayudhan (J&J/Centocor R&D) - High-throughput and Automated Screening Methods to Facilitate Purificaiton Process Development of Antibodies.

4:30-7:30pm

March 21

7-8am

8-10:30am

Co-Chairs:  Wei-Shou Hu (University of Minnesota) and Duncan Low (Amgen) 

• Jim Swartz (Stanford University) - Cell-free Protein Synthesis
• A.S. De Groot (EpiVax) - Epitope-Driven De-immunization of Protein Therapeutics
• Richard Tran (U. College London) - Evaluation of New Manufacturing Paradigms for Downstream Processing
• David Wood (Princeton) - Self-Associating Self-Cleaving Tags for Protein Purification

10-10:30am

10:30am -12:30pm

Session 5:  Technology Transfer:  Case Studies and Business Practices.  Transfer of processes and assays into pilot plants and final manufacturing facilities.

Co-Chairs:  Dave Reifsnyder (Genentech) and Colette Ranucci (Merck)

• Hassan Madani (Amgen) - Embrel Transfer
• Ray Arnold (Genentech) - Avastin Transfer to Multiple Sites
• Ellen McCormick (Pfizer) - Cp-675.206:  Manufacturing Strategy toward BLA/MAA

• Xiaomi Tong (Emergent BioSolutions) - Technology Transfer:  from Research to Manufacturing for Biodefense Vaccine Products

12:30-2pm

Lunch (vendor and poster review)

2-4:30pm

Session 6:  High Throughput Analytical and Formulation Development.  Applications of high-throughput methodologies, including robotics, for analytical and formulation development.

Co-chairs:  Rick Remmele (Amgen) and Peter DePhillips (Merck)

• Bing He (Amgen) - Automating Formulation Development
• Chris Roberts (University of Delaware) - Designing Stability studies for rapid formulation screening:  guidance from fundamentals of physical protein stability
• Peter DePhillips (Merck) - High throughput analytical development and lot release
• James Broering (Ga. Tech.) -  Predicting Salt Effects on Protein Kinetic Stability:  Implications for Accelerated testing and Formulation of Protein-Based Pharmaceuticals
• Mark Manning (Legacy BioDesign) - Optimizing the Solution Behavior of Biopharmaceuticals:  Rapid Determination of Osmotic Second Virial Coefficients by Self-Interaction Chromatography

4:30-6:30pm

6:30-10pm

Plenary Talk and Conference Banquet 

• Anthony Lubiniecki (Centocor R&D) "Where is the Industry Likely to be Going, and How Much Acceleration is Too Much "

March 22

7-8am

8-10:30am

Co-chairs:  Reed Harris (Genentech) and Paul Tsang (Amgen)

• Thomas Porter (Wyeth) - Assignment and control of desired molecular forms
• Drew Kelner (Amgen) - Application of Quality by Design principles to biopharmaceutical development
• Patrick Swann (FDA) - Pre-Licensure Comparability Considerations
• Dieter Schmalzing (Genentech) - Specification settings for biotechnology products

10-10:30am

10:30am -12:30pm

Co-chairs:  David Robinson (Merck) and Eugene Schaeffer (Bristol-Myers Squibb)

• Brian Kelley (Wyeth) - History of manufacturing capacity management at Wyeth
• Eugene Schaeffer (Bristol-Myers Squibb) - BMS decision-making about manufacturing capacity at Syracuse, Mass and Celltrion 
• Michael Kowolenko (BiogenIdec) - Manufacturing Capacity Planning at BiogenIdec
• Sunil Chhatre (U College London) - Monte-Carlo Based Simulation Software for Evaluating Production Strategies in Commercial-Scale Pharmaceutical Operations

12:30-2pm

Lunch (vendor and poster review)

2-4:30pm

Session 9:  Development Organization and Metrics.  Organizing for efficient discovery, development, and commercialization.  Quantifying improvements in development speed and efficiency.

Co-chairs:  Maureen Halligan (Amgen) and David Chang (Genentech)

• Sue Steven (Genentech) - BioPharmaceutical Development:  Think Like a Scientist, Behave Like a Business
• Suzanne Jones (Amgen) - Using Portfolio Planning, resource Modeling and Metrics Tools to Increase Speed to Development
• Mary DiBiase (BiogenIdec) - Development Speed and Efficiency:  Matrix, Measure, and Manage
• Hubert Scoble (Wyeth) - From Clone to Clinic:  the Art and the Science of an Optimum Development Strategy

4:30-4:45pm

Conference Closing Comments:  Geoff Slaff (Amgen) and Chuck Goochee, J&J/GBSC