Meet <strong>the</strong> Speakers BreakfastFountain7:15 am - 8:00 amComplimentary for attendees who purchased<strong>the</strong> 5-Day Week Experience Pass.Pre-registration required.After an intensive week of learning; we inviteyou to come mix and mingle with <strong>the</strong> conferencespeakers over breakfast. Not only does this passgive you unlimited access to <strong>the</strong> entire week – butnow you have exclusive access to interactive Q&Awith some of our speakers.Session KeynotesMariner’s Ballroom8:00 Chairman’s Opening RemarksHoward Levine, Ph.D., President,BioProcess Technology Consultants8:15 Innovations in BiopharmaceuticalProduction – A Manufacturer’sPerspectiveAbhinav Shukla, Ph.D.Vice President, Process Developmentand Manufacturing, KBI Biopharma8:45 Disruptive Technology for Purification ofBiosimilar and Biobetter AntibodiesPete GagnonSenior Research Technology Specialist,Bioprocessing Technology Institute,Singapore9:15 Drug Substance Fragmentation -Managing Changes on a Global Scale andHarmonization of SpecificationsE. Morrey Atkinson, Ph.D.Vice President, Process <strong>Sciences</strong>,Bristol-Myers SquibbFriday, March 1, 2013ADC Developmentand ProductionDriftwood7:30 Coffee8:00 Session Keynotes: Abhinav Shukla, Ph.D., KBI BiopharmaPete Gagnon, Bioprocessing Technology Institute, SingaporeE. Morrey Atkinson, Ph.D., Bristol-Myers Squibb – (see details to <strong>the</strong> left)9:45 Networking Refreshment BreakOvercoming Facility Implications,Production Issues andManufacturing Challenges10:15 Facility Implications - How to DesignFacilities to Handle Larger(Commercial)Batches EffectivelyMary Robinette, Process Lead, Engineering, SAFC10:45 Safety Handling of Antibody-DrugConjugates in R&D and Manufacturing and<strong>the</strong> SafeBridge Certification ProcessJohn Farris, President and Chief Executive Office,SafeBridge Consultants, Inc.11:15 Points to Consider in <strong>the</strong> Development of aControl Strategy for an ADCPaul McCormac, Ph.D., Director, Bio-manufacturing<strong>Sciences</strong> Group, Pfizer Global Supply, Pfizer Inc.11:45 Lunch on Your OwnOvercoming Facility Implications,Production Issues andManufacturing Challenges1:30 A CMOs Perspective on ADC DrugSubstance Manufacturing - Challenges withScale Up, Safety Issues, Critical ProcessParameters and Tech TransfersMichael Bienkowski, Ph.D., Manager,Process Development, SAFC Pharma2:00 UNPUBLISHED DATA Implementing anAutomated Pre-Clinical Filling Line for ADCsat Pilot ScaleJoseph Sexton, Senior Supervisor, Process DevelopmentOperations, Purification and Filling Pilot Plant,Genentech, a member of <strong>the</strong> Roche Group2:30 Considerations for Effective Manufacturingof Antibody Drug ConjugatesJason Brady, Head of Business Development,Conjugates and Cytotoxics,Lonza Custom Manufacturing3:00 Panel Discussion:Best Practices, Regulations and Certificatesfor Handling Highly Potent CompoundsAppropriatelyModerator:John Farris, President and Chief Executive Officer,SafeBridge Consultants, Inc.3:30 Close of BDP WeekDevelopment ofBispecific AntibodiesShorelineStrategies to Improve <strong>the</strong> MoleculeDesign, Solubility, Stability and Half-<strong>Life</strong> as Well as Reduce Toxicity forBispecific AntibodiesUNPUBLISHED DATA Modular Development ofmAb2 Bispecific Antibody Drug Candidatesin OncologyJohn Haurum, Ph.D., M.D., Chief Executive Officer,F-starCASE STUDY • UNPUBLISHED DATA EngineeringAntibody Fc Region for Heterodimericand Monomeric Form of Fc: Applicationsto Bispecific and Monovalent IgG withEnhanced FunctionalitiesGunasekaran (Guna) Kannan, Ph.D., PrincipalScientist, Biologics Optimization, Amgen Inc.CASE STUDY • UNPUBLISHED DATA AzymetricAntibody Design: Impact on Developabilityof Bispecific TherapeuticsSurjit Dixit, Ph.D., Chief Technology Officer,Zymeworks Inc.Development of Generic orPlatform Production Process forBispecific AntibodiesUNPUBLISHED DATA Development of a GenericBispecific Purification PlatformJosefine Persson, Ph.D., Senior Group Leader,Genentech, a member of <strong>the</strong> Roche GroupCASE STUDY • UNPUBLISHED DATA Developmentof a Platform Purification Process forBispecific MoleculesKenneth Kang, Ph.D., Principal Scientist,BioProcess <strong>Sciences</strong>, ImClone Systems, a whollyownedsubsidiary of Eli Lilly and CompanyStructural and FunctionalCharacterization, ClinicalDevelopment and Safety Assessmentsfor Bispecific AntibodiesInnovations in Bispecfic AntibodiesLaurie Iciek, Ph.D., Principal Toxicologist,Translational <strong>Sciences</strong>, MedImmune, Inc.CASE STUDY Bispecific Antibodies -Combining Different Specificities to AchieveSuperior FunctionalityUlrich Brinkmann, Ph.D., Senior Principle Scientist,Roche Pharma Research & Early Development,Germany18 www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/BDPWeek
NEWTHISYEAR<strong>IBC</strong> <strong>Life</strong> <strong>Sciences</strong> Presents State-of-<strong>the</strong>-Art…Flexible FacilitiesInnovative Biopharmaceutical Manufacturing Solutions for Multi-Product Pipelines,Global Markets, On-Demand Scale-Up/Scale-Down and Capacity OptimizationApril 2-4, 2013 • The W Hotel • San Francisco, CAAre Your Facilities and CMO’s Prepared for…• Multi-product/Multi-use Facilities• On-Demand Scale-Up/Scale-Down• Mobile and Modular Concepts• Implementation of Single-Use• Diverse Products: Vaccines, mAbs• Clinical and Commercial Flexibility• Rapid Facility Deployment• Regulatory, Quality & Technical Risks7 Case Studies Illustrate How to Enhance Your Production StrategiesLearn More at: www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/FacilitiesBiopharmaceutical Development & Production Week 19
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