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Learn more about Rx-360An International Supply Chain ConsortiumFountain9:00 am Panel Discussion:Preventing Raw Material AdulterationModerator:Martin VanTrieste, Senior Vice President, Quality,AmgenPanelists:Tim Valko, Executive Director, Operations RiskManagement, AmgenDrew Kelner, Ph.D., Executive Director, GlobalAnalytical Sciences, AmgenLucy Cabral, Head, Supplier Quality Managementand Distribution Quality SSF, Genentech, Inc.Robert Arnott, Senior Director, Quality,Baxter Healthcare Corporation12:15 Technology WorkshopShorelineCritical Factors for Optimal ViralFiltration Performance Mónica Cardona, Marketing Manager,Global Air/Vent Product Manager, Pall Life SciencesWin Prizes!The BDP Week Passport ContestDon’t miss out on this fun and interactive experience asyou tour through the BDP Week Exhibit Hall. Stop by theseparticipating exhibitors and get your passport initialedand you could walk away with several prizes along withinnovative ideas. Participants are to turn in their passportat the registration desk by 3:30 pm on Tuesday and againby 3:00 pm on Thursday. Winners will be announcedTuesday at 3:45 pm and again on Thursday at 3:30 pm.The drawing will be held in the back of the exhibit hall nextto the IBC show office. You must be present to win!Prizes for Monday-Tuesday:Swedish Hand Crafted Art Glass donated by Genovis, Booth 225Kindle Fire donated by Patheon, Booth 119Fujifilm Camera donated by Fujifilm Diosynth, Booth 219Kindle Fire donated by Boehringer Ingelheim, Booth 113$200 American Express Gift Card donated by ABL, Booth 226Prizes for Wednesday-Thursday:$150 Visa Gift Card donated by Charles River, Booth 227$150 American Express Gift Card donated by Life Technologies,Booth 312Noise Cancellation Headphone donated by Biotechlogic, Inc.,Booth 211AMX Gift Card donated by Avid Bioservices, Booth 320Fujifilm Camera donated by Fujifilm Diosynth’s, Booth 219Kindle Firedonated by Boehringer Ingelheim, Booth 113Swedish Hand Crafted Art Glass donated by Genovis, Booth 225$200 American Express Gift Card donated by ABL, Booth 226Tuesday, February 26, 2013Process Validation andContinuous VerificationGrand Ballroom Salon G7:30 Coffee8:15 Chairman’s RemarksPeter Calcott, Ph.D., President, Calcott ConsultingImplementing Process Validationand Continuous Verification inthe New Paradigm8:30 Implementing the 2011 ProcessValidation GuidanceVijay Chiruvolu, Director, Corporate Validation,Amgen Inc.9:00How Are Small to Mid-Sized CompaniesIncluding Virtuals Implementing theNew Guidances? (9:15)Peter H. Calcott, Ph.D., President,Calcott Consulting, LLC.Chairman’s Opening RemarksAnders Lund, Ph.D., Principal Scientist, BioanalyticalDevelopment, Genzyme, A Sanofi CompanyFeatured PresentationWhere Is Innovation Still Needed inAnalytical Development?Michael G. Mulkerrin, Ph.D., Vice President,Process Development, OncoMed PharmaceuticalsSequence Variant AnalysisCASE STUDY • UNPUBLISHED DATA AminoAcid Misincorporation – Errors Made byNature and Human During Production ofRecombinant ProteinsLi Tao, Ph.D., Group Leader, Analytical Developmentand Testing, Biologics Manufacture and ProcessDevelopment, Bristol-Myers Squibb Company9:30 CASE STUDY • UNPUBLISHED DATADetection of Low Level Sequence Variants atthe DNA LevelIldana Valisheva, M.S., Senior Research Associate,Protein Analytical Chemistry Department,Genentech, A Member of the Roche Group10:00 Networking Refreshment Break in Exhibit and Poster HallImplementing Process Validationand Continuous Verification in theNew Paradigm (continued)10:45 CASE STUDY A QbD Approach Applied in aDownstream Purification Unit OperationYing Yang, Senior Development Specialist,Purification Process Development, Shire HGT11:15Comparing Small vs. Large Biotech’sApproaches to the FDA’s ProcessValidation Guidance – ResourceLimitations, Cost and Time Challengesand Other Practical ConsiderationsHamid Mollah, Ph.D., Head of Quality Engineeringand Validation, XOMA (US) LLCProcess-Related Impurity AnalysisCASE STUDY • UNPUBLISHED DATA The Use ofOrthogonal Methods for Host Cell ProteinDetection in Pharmaceutical Bulks to AssistProcess DevelopmentJudy Shimoni, Ph.D., Senior Scientist, Departmentof Protein Analytical Chemistry,Genentech, A Member of the Roche GroupUNPUBLISHED DATA Characterization of HostCell Proteins in Biopharmaceuticals Using2D LC-MS/MSPeng Pan, Ph.D., Senior Scientist, TransitionalResearch, Genzyme, A Sanofi Company11:45 CASE STUDY • UNPUBLISHED DATA Some “Ah-Ha”Moments in Host Cell Protein AssaysMartin Vanderlaan, MBA, Ph.D., Director,Analytical Operations, Genentech, A Member ofthe Roche Group12:15Technology Workshop Sponsored by:Analytical TechnologiesGrand Ballroom Salon A12:45 Networking Luncheon in Exhibit and Poster Hall(Shoreline) (see details to the left)8 www.IBCLifeSciences.com/BDPWeek
Tuesday, February 26, 2013Contract Manufacturing andTechnology TransferBiopharmaceutical Raw Materials Viral Safety for BiologicalsDriftwood Fountain Shoreline7:30 Coffee8:15 Chairman’s Opening RemarksVincent Turula, Ph.D., M.B.A., Director, External Affairs,BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.Chairwoman’s Opening RemarksPaula Shadle, Ph.D., Principal Consultant,Shadle ConsultingChairman’s RemarksShengjiang Liu, Ph.D., Head and Principal Scientist,Pathogen Safety, Global Biologics Development,Bayer Healthcare PharmaceuticalsScale Up, Technology Transfer andContract ManufacturingEnsuring Supply Chain Transparencyand Supplier QualityRisk-Mitigation forVirus Contamination8:30 Featured PresentationImproving the Collaboration with ContractingManufacturing Organizations: Role ofQuality AssuranceAmer Alghabban, MSc., Director, Global HeadQuality Assurance, Audit Management,Merck Serono, Switzerland9:00 CASE STUDY In-licensing Outsourced ProductsRachel Alford, Ph.D., Associate Director,Purification Development, Alexion Pharmaceuticals9:30 CASE STUDY Getting From Make Versus BuyDecision to Technology TransferHank Stern, MBA, Associate Director, ContractManufacturing, Genentech, Inc., a member of theRoche GroupRaw Material Reliability: Supply, Complianceand Risk Evaluation FactorsJennifer Garner, Senior Engineer, VaccineTechnology Integration, Raw Materials, MerckRx-360 Consortium ModeratedPanel DiscussionPreventing RawMaterial AdulterationModerator: Martin VanTrieste,Senior Vice President, Quality, AmgenPanelists:Tim Valko, Executive Director, Operations RiskManagement, AmgenDrew Kelner, Ph.D., Executive Director, GlobalAnalytical Sciences, AmgenLucy Cabral, Head, Supplier Quality Managementand Distribution Quality SSF, Genentech, Inc.Robert Arnott, Senior Director, Quality,Baxter Healthcare Corporation10:00 Networking Refreshment Break in Exhibit and Poster HallAdventitious Agent ContaminationPrevention for Mammalian Cell CultureProcesses – Are We There Yet?!Robert D. Kiss, Ph.D., Director,Late Stage Cell Culture, Genentech,A Member of the Roche GroupPhysical Inactivation of SmallNon-enveloped VirusesRaymond Nims, Ph.D., Senior Consultant,RMC Pharmaceutical SolutionsThe MIT/Industry Initiative on PreventingAdventitious Agent Contamination inBiomanufacturingMichael E. Wiebe, Ph.D., President,Quantum Consulting, LLCScale Up, Technology Transfer andContract Manufacturing (continued)10:45 Large Scale Protein Purification using HPLCMargit Holzer, Ph.D., R&D Director, NovasepEnsuring Supply Chain Transparencyand Supplier Quality (continued)Managing Suppliers of Critical Raw MaterialsPaula Shadle, Ph.D., Principal Consultant,Shadle ConsultingProgress in Better Understandingof Virus FiltrationHigh Titer and Highly Purified Virus StocksPreparations in Virus Clearance StudiesHorst Ruppach, Ph.D., Global Manager of ViralClearance and Global Coordinator Virology,Charles River Biopharmaceutical Services, Germany11:15 CASE STUDY Challenges Associated with theTransfer and Manufacture of AntibodyDrug ConjugatesManish Jain, MS, Associate Director of TechnologyTransfer, Manufacturing Sciences, Immunogen, Inc.11:45 Considerations for Effective Manufacturing ofAntibody Drug ConjugatesThomas Rohrer, M.S., Senior Director, ADC andBiochemical Technologics, Lonza, Inc.Risk Assessing New Suppliers – A RecombinantProtein Manufacturer’s PerspectiveLada Laenen, Ph.D., Managing Principal Scientist;Head of Cell Culture and Microbiology, GenzymeCorporation, BelgiumYeast Extracts vs. Protein Hydrolysates:What You Should Know to Mitigate ProcessVariability and Enhance Culture PerformanceChristopher Wilcox, Ph.D., R&D Director, Pharma,Nutrition and Functional Ingredients, KerryThe Smart Way to Optimize VirusFiltration StepsAnika Meyer, Product Manager, Viral Clearance,Sartorius Stedim Biotech GmbH, GermanyMitigating the Artifacts of Virus FilterValidation that Compromise the Scale-DownModelAshley Slocum, Biomanufacturing Engineer,EMD Millipore12:15Technology Workshop Sponsored by:(Shoreline) (see details to the left)12:45 Networking Luncheon in Exhibit and Poster HallBiopharmaceutical Development & Production Week 9
Page 3: Week-at-a-GlanceMonday, February 25
Page 10 and 11: Please join us for theBDP WeekBeach
Page 12: Plenary KeynotesMariner’s Ballroo
Page 15 and 16: Thursday, February 28, 2013Antibody
Page 17 and 18: Thursday, February 28, 2013Antibody
Page 19: NEWTHISYEARIBC Life Sciences Presen
Page 22 and 23: Exhibit HallWednesday, 10:20 am - 6
Page 24 and 25: Register Today and Gain Access to T
Page 26 and 27: Notes______________________________

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