Program Information - IBC Life Sciences

Strategy Discussion Forums
(Rotunda)
1:45 Manufacturing: What will Take us
to the Next Level of Efficiency
and Economics
Sponsored by
Moderator:
Peter Latham, President, Latham BioPharm Group
Panelists:
Shishir Gadam, Ph.D., Director, Manufacturing
Science and Technology, Genentech, Inc.
Dave Lescinski, Vice President, Chromatography,
Pall Life Sciences
Alison Moore, Ph.D., Vice President, Corporate
Manufacturing, Amgen Inc.
Thomas C. Ransohoff,
Vice President and Senior Consultant,
BioProcess Technology Consultants, Inc.
Dr. Jens H. Vogel, Global CMC Development
Team Leader and Head, Isolation and Purification,
Bayer Healthcare
Willard Waterfield, Ph.D., Senior Director,
Manufacturing Sciences & Technology,
Andover and Pearl River, Pfizer GMS
Tuesday, September 21, 2010 (continued)
Formulation Strategies for Protein Therapeutics (Room 555A/556)
1:10 Chairperson’s Remarks
Haripada Maity, Ph.D., Senior Scientific Manager, Formulation Development,
ImClone Systems, A Wholly-Owned Subsidiary of Eli Lilly & Co.
Development of Formulation and Drug Product Design Space
Keynote Presentation
1:15 Holistic QbD: The Integration of Formulation, Process Development
and Process Validation
Sherry Martin Moe, Ph.D., Director, Late Stage Pharmaceutical and Processing Development,
Genentech, Inc.
2:00 CASE STUDY Lyophilization Process Validation based on Quality by Design
Bingquan (Stuart) Wang, Ph.D., Senior Scientist, Pharmaceutics, Genzyme Corporation
Keynote Presentation
2:30 Particles, Particles Everywhere: Causes, Consequences and Control of
Aggregates and Subvisible Particles in Therapeutic Protein Formulations
John F. Carpenter, Ph.D., Professor, Department of Pharmaceutical Sciences, University of Colorado
3:15 Networking Refreshment Break
Comparability and Characterization Exercises during Formulation Development
3:45 CASE STUDY Comparability Assessments with Protein Therapeutic and Vaccine Dosage
Forms: Challenges and Opportunities
David Volkin, Ph.D., Distinguished Professor, Pharmaceutical Chemistry, University of Kansas
4:15 Characterization of Site Specific Degradation Pathways of Antibody-Maytansinoid
Conjugates (AMC)
Alex Lazar, Ph.D., Mass Spectrometry Group Leader, Analytical and Pharmaceutical Sciences Department,
ImmunoGen, Inc.
4:45 CASE STUDY Evaluating the Impact of a Container Closure Change on the Stability
of a Protein Therapeutic
Angela W. Blake-Haskins, Ph.D., Senior Scientist II, Drug Product Sciences Department, Human Genome Sciences, Inc.
5:15 Session Ends
5:30 Opening Night Reception in the Exhibit and Poster Hall Sponsored by
Recovery & Purification
(Room 552)
8:00 Chairperson’s Remarks
Gary J. Welch, Director, Process Science,
Abbott Bioresearch Center
Advances in Process Monitoring
and Control in Downstream
Processing
8:15 Evaluation of Raman Spectroscopy
for Purification Operations
Natraj Ram, Ph.D., Senior Group Leader,
Purification, Technical Operations,
Abbott Bioresearch Center
8:45 On-line HPLC as a PAT for
Controlling Product Collection
from Process Scale
Chromatography Columns
Rick E. Cooley, Market Development Manager,
Process Analytics, Dionex Corporation
9:15 Using Multivariate Batch
Process Monitoring and Soft
Sensors for Advanced Process
Control in Commercial Scale
Purification Operations
Thomas Mistretta, M.S., Senior Engineer, Process
Development, Amgen Inc.
9:45 Networking Refreshment Break
in Exhibit and Poster Hall
Sponsored by
Wednesday, September 22, 2010
7:00 Registration and Coffee
Rapid Vaccine Development
and Production (Room 555B)
8:10 Chairperson’s Remarks
Ulrich Valley, Head, Technology Development,
Novartis Vaccines & Diagnostics, Inc., Germany
Keynote Presentation
8:30 Global Vaccine Production
Challenges: Emerging
Immunotherapeutics,
Manufacturing Flexibility
and Reducing COGS
Pierre Fournier, Ph.D., Associate Vice President,
Manufacturing Technology International,
Sanofi Pasteur, France
Lessons Learned from the
2009 Flu Season to Guide
Rapid Vaccine Development and
Manufacturing Scale Up
9:15 CASE STUDY Cell Culture Based
Pandemic Flu Production
Ulrich Valley, Head, Technology Development,
Novartis Vaccines & Diagnostics, Inc., Germany
9:45 Networking Refreshment Break
in Exhibit and Poster Hall
Sponsored by
Formulation Strategies for Protein
Therapeutics (Room 555A/556)
8:10 Chairperson’s Remarks
Angela W. Blake-Haskins, Ph.D., Senior Scientist II,
Drug Product Sciences Department, Human Genome
Sciences, Inc.
Keynote Presentation
8:15 Modeling Protein Degradation
Processes and the Development
of Rational Approaches
to Stabilization
Bernhardt Trout, Ph.D., Professor, Chemical
Engineering, Massachusetts Institute of Technology
Implementing Analytical
Methodsand Control Steps for
Subvisible Particles
Keynote Presentation
9:00 NIST Perspective on Standards
and GMP Processes for Subvisible
Particles in Protein Therapeutics
Dean Ripple, Ph.D., Group Leader, Process Measurements
Division, Process Sensing Group, National Institute of
Standards and Technology
9:45 Networking Refreshment Break
in Exhibit and Poster Hall
Sponsored by
10:30 Does SE-HPLC Tell the Whole Story
Use of Orthogonal Methods to Detect
Aggregates and Subvisible Particles
Brian K. Meyer, Ph.D., Research Fellow,
Merck Research Laboratories
BioProcess International Conference & Exhibition 11