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Program - 5th Annual Biomanufacturing Summit 2013, San Diego

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  • 1. WWW.BIOMANSUMMIT.COMPROGRAMSAN DIEGO,CALIFORNIA,USAResearched and Produced by:
  • 2. Pre-event Workshop Biomanufacturing Summit 201313:00 Delegate Registration13:30 Chairpersons Welcome AddressLaura Parks, President and Business Unit Director, DSM Pharmaceuticals USA13:35 Strategic Planning and Facility Integration DevelopmentKathy McGee, Former SVP, Strategic Operations, Real Estate and Capital Projects, Shire Regenerative Medicine USA• Examining the development of Shire Regenerative Medicines new cGMP manufacturing facility• Capitalizing on the benefits of a flexible manufacturing facility plan• Designing with a long-term strategy in mind to facilitate M&As and adopted products• Innovative concepts for enhancing manufacturing flexibility for approved and future products• Assessing manufacturing strategy, infrastructure needs, ultimate selection and build-out of a multi-product biologics facility14:15 Panel Discussion: Mastering Quality While Increasing Single-use Capacity in Manufacturing FacilitiesGerry Collins, Chairman, PharmaChemical Ireland, Global Platform Leader Large Molecules, Janssen Pharmaceuticals IrelandTimothy Hahn, SVP, Manufacturing and Process Development, Novavax USAAndy Stober, Director, Manufacturing Sciences, Biogen Idec USALee R. Williams, Senior Director, Process and Analytical Development, Emergent BioSolutions USAParrish Galliher, Founder & Chief Technology Officer, Xcellerex, GE Healthcare Life Sciences USAMark Bamforth, President and Chief Executive Officer, Gallus BioPharmaceuticals USA• What conditions dominate the decision to move from stainless steel to single-use systems?• Challenges in realizing the full capability of manufacturing with single-use technologies• Managing the introduction of single-use technologies to improve compatibility across machinery15:05 Quality WorkshopWhy Optimizing the Quality of Your CMOChoice Should Include a Focus on Quality andRegulatory ExperienceCarson Sublett, VP, Operations and Site Director, DSMPharmaceuticals USA• Understanding nuances between agencies leads to successfuloutcomes• Tips on systems and planning to manage successful audits• Case study on a unique PAI audit• Importance of collaboration between sponsor and CMO• Ensuring supply reliabilityManufacturing Excellence WorkshopImplementing a System for Managing PotentCompounds Acceptance at a Biological CMOChristine Vannais, Senior Manager, Safety, Health andEnvironmental Affairs, Fujifilm Diosynth Biotechnologies USA• Illustrating methods used to evaluate all projects entering FujifilmDiosynth Biotechnologies CMO operations• Analyzing the means and methods to manage potent compounds•Considerations for toxicology reviews, facility fit and employeesafety15:50 Networking and Refreshments16:20 Quality WorkshopDeploying New QC Laboratory TechnologiesRobert F. Burgoyne, Director, Americas Field Marketing, WatersCorporation USA• How can new technologies meet evolving regulatoryrequirements and guidelines?•Evaluating key decisions - streamlined batch release tests vs.OOS events preparedness• What role can mass spectrometry play in quality control?• Business drivers that influence decisionsManufacturing Excellence WorkshopAssessing Future Manufacturing Challenges inContinuous OperationJohn Bonham-Carter, VP, Business Development, RefineTechnology USA• Regulation, standardization and science - fact or fiction•Upgrading facilities to handle continuous processing vs. buildingnew facilities - which is the better option?•Successfully integrating continuous upstream and downstreamprocesses• Overcoming operational issues for materials and staff17:05 QualityAddressing the Need for Better ProcessControlsManufacturing ExcellenceCase Study: Genzymes Geel Plant - EffectivelySourcing and Implementing a ManufacturingExecution System
  • 3. Jim Thomas, VP, Process and Product Development,Amgen USA• Understanding where PAT and QbD integrate•Collecting and analyzing PAT data to enhance bioprocessingquality•Driving biomanufacturing innovation through QbD and PATsciencesBart Haerkens, Project Director, MES, Genzyme, a Sanoficompany Netherlands• Selecting the best MES package and realizing standardizedsystems must be selected to fit• Ensuring targets and timelines are met•Generating an efficient execution plan to meet the needs of thesystem, facility and product•Realizing the importance of Master Batch Records – describingand documenting the production process in a qualified manner•Generating an efficient training programme to ensure theworkforce supports MES integration• Gearing up for the Q4 system validation stages17:50 Panel Discussion: Improving Quality and Communication Up and Down the Supply ChainRayne Waller, VP, Supply Chain Management, Amgen USAKevin McNelly, VP, Supply Chain Operations, MedImmune USABrian McRee, Senior Director, Global Supply Chain, Genentech USAKimberly Matheson, Deputy Director, Clinical Bulk Manufacturing, Sanofi Pasteur CanadaJohn Monetti, VP, North America, World Courier USA• How can the commercial organization engage with manufacturing teams to better manage supply?• Anticipating and mitigating variations in product quality and delivery times• Building a robust two-way flow of information into multi-region transportation collaborations• Ensuring supply and demand is balanced – key supply chain metrics18:35 Chairpersons Closing RemarksLaura Parks, President and Business Unit Director, DSM Pharmaceuticals USA
  • 4. Day One Biomanufacturing Summit 201307:30 Delegate Registration08:15 Chairpersons Welcome AddressLaura Parks, President and Business Unit Director, DSM Pharmaceuticals USA08:20 Global Outlook - Addressing the Challenges of Supply Chain Sourcing and Manufacturing in Emerging MarketsAndrew Skibo, EVP, Operations, MedImmune USA• Understanding the stark contrast between outsourcing for biologics and small molecule drugs• Examining options to safeguard manufacturing processes against deliberate violation of SOPs• Strategies for tech transfer and IP protection in emerging markets• Ensuring quality oversight before investing in CMOs08:55 Developing a World-Class Quality Monitoring SystemRonald C. Branning, former Chief Quality Officer, Genzyme, a Sanofi company USA• Identifying and managing instances of noncompliance with GMPs• Developing a quality system infrastructure to ensure compliance in a fast growing company• Creating comprehensive quality council monitoring and controls and a 10-year remediation plan09:30 One-to-One Business Meetings, Networking and Refreshments11:15 Panel Discussion: Improving Processes for Biomanufacturing OperationsTony DAmore Ph.D., VP, BioProcess R&D North America, Sanofi Pasteur CanadaMayo Pujols, Executive Director, Technical Operations, Merck & Co. USANitya G. Ray, Ph.D., SVP, Manufacturing, Progenics Pharmaceuticals USASusan Dana Jones, Vice President, BioProcess Technology Consultants USAAles Strancar, Chief Executive Officer, BIA Separations Republic of SloveniaKeith L. Carson, Founder and Editor-in-Chief, BioProcessing Journal USA• Screening manufacturing processes and technologies for optimum productivity• Ensuring robustness and quality of manufacturing performance• Integrating cost effective purification technologies to improve process economics11:50 Quality WorkshopA Process Intelligence Platform isRequired to Support ICH Q8, Q9, Q10and Continuous Process VerificationJustin Neway, Chief Science Officer, AegisAnalytical Corporation USA• How to obtain predictive high quality outcomes inyour manufacturing processes•Satisfying FDA validation guidelines with a processintelligence system•Best practices for managing and sharing dataacross departments and geographiesSupply Chain ManagementWorkshopFill and Finish Supply ChainManagement - Combining theConvenience of LocalManufacturing with the Security andAccess of a Global Supply ChainHoward L. Levine, Founder and Chief OperatingOfficer, Biocrescentia USAKevin Orfan, VP, Business Development, HospiraOne 2 One USA• Why to plan your Fill & Finish supply chain strategyearlier than later•How to balance the need for manufacturingresource efficiency today with the need for aneffective and secure global supply chain tomorrow•Practical frameworks to evaluate prospective fill &finish manufacturing partnersManufacturing ExcellenceWorkshopSelecting Reliable and RobustBioprocess Analyzers - Cedex Bio™and Cedex Bio HT™ SystemsSabrina Reinhard, Team Manager, Roche BiotechDevelopment, Clinical Supply Center, FermentationAnalytics, Roche USA• Overcoming the challenges of optimizingfermentation/cell culture•Obtaining higher product yields and reducingproduct waste by avoiding membrane basedtechniques•Increasing precision, accuracy, linearity andsensitivity as compared to membrane-basedtechnology•Measuring diverse analytes such as glucose,lactate, glutamine, glutamate, ammonia, LDH, Naand K12:30 Networking Lunch13:30 QualityManaging Quality on a Global Scale -ICH Q10 - What Does it Mean andHow Can it Help?Jaspreet Gill, VP, Global Quality & Compliance,Baxter Healthcare USA• Identifying the critical needs of quality beforemanufacturing•Best practices for moving quality forward andcoming into compliance with ICH Q10•Strategies for identifying and monitoring CQAs andCPPsSupply Chain ManagementAccelerating Technology Transferand Manufacturing into EmergingMarketsTony DAmore Ph.D., VP, BioProcess R&D NorthAmerica, Sanofi Pasteur Canada• Assessing the opportunities and threats of vaccineproduction in Asia•Analyzing the risk management and technicalcapabilities of CMOs before selecting a contractor•Developing quality processes to help drive downoperational costsManufacturing ExcellenceGenerating Competitive Advantageand Improving Performance throughLean BiomanufacturingGary Harpenau, Senior Director, ExternalManufacturing, Elanco Animal Health - Eli Lillyand Company USA• Developing and applying lean principles to yourbiomanufacturing operations•Securing buy-in and input from both managementand the workforce•Using OpEx programming to drive quality andcompliance performance•Correcting inefficiencies through coordinatinginternal and external manufacturing efforts•Taking the next step - evolving current standardoperating procedures for continuous improvement14:05 Supply Chain Management WorkshopPrinciples of Good Distribution Practices and theInfluences on a Full-service Chemical ManagementManufacturing Excellence WorkshopHydrophobic Cation Exchange Media, Nuvia™ cPrime™for the Purification of Recombinant Proteins
  • 5. ModelJohn Hollenbach, Vice President and General Manager, Doe & Ingalls USA• Contrasting modern distribution models with the future of full-service chemicalmanagement•Ensuring supply chain security through competent chemical managementservices• Building reliable and auditable business processes•Uncovering new ways to do business and find innovative supply chainsolutionsXuemei He, R&D Scientist, Process Chromatography Division, Bio-RadLaboratories USA• Exploring the unique selectivity of mixed-mode chromatography for challengingbiomolecule separations• Interactions between protein molecules and mixed-mode media• Development of chromatographic methods• Case studies on the removal of process and product impurities14:40 One-to-One Business Meetings, Networking and Refreshments16:00 Manufacturing Paradigms for Antibody Drug ConjugatesVaughn B. Himes, Ph.D., EVP, Technical Operations and Process Sciences, Seattle Genetics USA• Building a robust supply chain• Reducing timelines and improving efficiencies• Developing relationships to support emerging technologies16:35 Panel Discussion: Facilities of the FutureJim Miller, VP and Head, Global Biologic Drug Substance Manufacturing, Genentech USARandy J. Maddux, VP and Site Director, GMS Rockville, GlaxoSmithKline USARonald C. Branning, former Chief Quality Officer, Genzyme, a Sanofi company USAMichael Cicio, VP, Operations and Site Management, Lonza Biologics USARick Hancock, President and Chief Executive Officer, Althea Technologies USA• What will facilities look like in the next 5-10 years?• What is the future of biomanufacturing?• Breakthrough technologies poised to revolutionize the industry17:25 Chairpersons Closing RemarksLaura Parks, President and Business Unit Director, DSM Pharmaceuticals USA17:30 Networking Drinks ReceptionSponsored by VWR International
  • 6. Day Two Biomanufacturing Summit 201308:15 Delegate Registration08:45 Chairpersons Welcome AddressLaura Parks, President and Business Unit Director, DSM Pharmaceuticals USA08:55 Panel Discussion: Understanding the Challenges Facing U.S. Competiveness and Innovation in BioIndustriesJoerg Heidrich, SVP, Global Head, Product Supply - Biotech and Berkley Site Head, Bayer HealthCare USAPaul Marshall, SVP, Operations and Quality, Amylin Pharmaceuticals USACharles Laranjeira, SVP, Technical Operations, Cubist Pharmaceuticals USATonia Becker, Group Publisher, Pharmaceutical Manufacturing, PharmaQbD.com USA• What is the next vanguard to refill drug pipelines?• In-house vs. outsourcing – which manufacturing model is working?• How is the increasing complexity of our supply networks changing our quality oversight approach?• How much quality oversight do we have and need over our suppliers and their suppliers?• Identifying where to focus attention during manufacturing to keep-up with market pressures and demand09:45 Quality WorkshopReal-Time vs. "Risk-Time" -Variability and its Impact onDebottlenecking, ProcessOptimization and Schedulingin BiotechRick Johnston, Founder and Principal,Bioproduction Group USA• Understanding the need for real-time dataand modeling to mitigate variability•Case studies on the impact of variabilityon debottlenecking and schedulingprojects in large-scale facilities•Reducing risk and increasing reliability inmanufacturing facilities using model-driven approaches to processoptimizationCell Culture WorkshopCombining the ProvenPerformance of Single-useBioreactors with State-of-the-art Controllers for ImprovedCell Culture OperationsWilliam Whitford, Senior MarketManager, Cell Culture, Thermo ScientificCell Culture and BioProcessing, ThermoFisher Scientific USA• Case Study – Looking at the combinationof HyCell CHO media used in the SUB TK(Turnkey Single-Use Bioreactor)•Achieving more precise control over theprocess that benefit both cell growth andproductivities•Integrating high-yield chemically definedmedia for cell culture using CHO cellsManufacturing ExcellenceWorkshopAccelerating BioprocessOptimization through the useof Next Generation GenomicsTechnologiesLen van Zyl, Ph.D., Chief ExecutiveOfficer and Chief Scientific Officer,ArrayXpress USA• Applying Next Generation Genomicstechnologies to achieve results•Radically improving bioprocessesperformance through state-of-the-arttechnologies•Strategies for increasing efficiency,cutting costs and streamlining processes•Maintaining high levels of quality control indownstream processing10:20 Morning Refreshments11:05 QualityImproving BiomanufacturingOperations and Plant Designthrough Single-use SystemsBerthold Bodeker, Chief Scientist, Head,Cell Culture and Pilot Plants, BayerPharma AG Germany• What does the next generationfermentation plant look like?•Addressing the limitations and risks ofsingle-use technologies•Considering technologies to go fromcampaign mode to parallel products in aballroom concept•Supporting manufacturing flexibilityacross single-use systems•Enabling quicker constructions andestablishment of regional productionfacilitiesSupply Chain ManagementSharing the Burden ofManaging Supply ChainCosts, Risk and VolumeVolatility - the Role of theManufacturing Group toEnsure-to-End Supply to theCustomer is ExceptionalPaul Clayton, VP, Supply Chain, Logisticsand IT, GlaxoSmithKline USA• Can manufacturers and their customerstruly align objectives for costmanagement, risk management andgrowth?•How can manufacturing groups supportother efforts to cultivate a partnershipculture where that culture is desired?•Ensuring people and operational stylessustain a true partnership•Structuring continuous improvementprograms into supply chain operations tofacilitate a win-win situation betweenclients and suppliersManufacturing ExcellenceDebottleneckingDevelopment Pipelines toOptimize Processes andMaximize ManufacturingEfficiencyNitya G. Ray, Ph.D., SVP, Manufacturing,Progenics Pharmaceuticals USA• Critical considerations for ADCmanufacturing•Challenges and opportunities in ADCdevelopment•How do you optimize the manufacturingprocess for better control of theconjugated species?•Innovative technologies for the nextgeneration ADC product development11:40 QualityCase Study: Harmonizing the Scientific andTechnical Principles of ICH Q11Manufacturing ExcellenceCase Study: Rapid Establishment of Biologicsat Gilead Sciences
  • 7. Karen Walker, Global Head, Biologics and BPO Quality,Novartis Pharma AG Switzerland• Moving from a traditional approach to an enhanced approach forprocess development•How this progression aids in product life-cycle management andthe development of a robust control strategy•Applying the concept of design space to your operations and itsrelationship to change management•Successfully submitting information from manufacturing processdevelopment in the CTD formatAshraf Amanullah, Senior Director, Biologics Development,Gilead Sciences USA• Building a biologics portfolio from the ground-up to advanceGilead’s product pipeline•Addressing the challenges and benefits of operating in a smallgroup with end-to-end CMC responsibilities•Strategies for tech transfer from process development to clinicaldrug substance and drug product fill/finish operations•Case studies on antibody production and managing complexrelationships with external providers12:15 ThemedLuncheonLed byComplianceInsightHaunting Words -Avoiding Mistakesthat DestroyCredibilityTroy Fugate, VicePresident,ComplianceInsight USAJulie Waltz Gerlach,Compliance Specialist,Clinical DivisionDirector, ComplianceInsight USAThemedLuncheonLed by NoscoStepping into theFuture of DigitalPackagingRussell Haraf,President,Nosco USAR. Craig Curran,Director, StrategicPlanning andAlliances,Nosco USAThemedLuncheonLed by CharterMedicalChallenges andSolutions toFrozen Storageand TransportDominic Clarke,Ph.D., ProductManager, CellularTherapy & CryogenicStorage, CharterMedical USAThemedLuncheonLed by RefineTechnologiesOpportunities andChallenges inIntegratedContinuousBioProcessingJohn Bonham-Carter, VP, BusinessDevelopment, RefineTechnology USAThemedLuncheonLed by DSMPharmaceuticalsKey Criteria forSelecting andWorking with aCompliantFinished DrugCMOWarren Horton, VP,Quality Assurance,DSMPharmaceuticals USA12:16 Themed LuncheonLed by CatalentFlexible Facilities ofthe Future: SellingStainless for Single-usein our Plant ExpansionMichael E. Jenkins, GeneralManager, Catalent Biologics,CatalentThemed LuncheonLed by Doe & IngallsDeveloping a Full-Service ChemicalManagement Model tomeet cGMP ProductionRequirementsJohn Hollenbach, VicePresident and GeneralManager, Doe & Ingalls USAThemed LuncheonLed by RocheRoche Custom BiotechCedex Bio™ andCedex Bio HT™Systems - Q&A SessionSabrina Reinhard, TeamManager, Roche BiotechDevelopment, Clinical SupplyCenter, FermentationAnalytics, Roche USAThemed Luncheon13:30 Panel Discussion: Learning from the Manufacturing Complexities of Animal HealthBernd Eichenmueller, VP, Operations, Boehringer Ingelheim Vetmedica USAGary Harpenau, Senior Director, External Manufacturing, Elanco Animal Health - Eli Lilly and Company USASteve Berger, Executive Director, Industrial Strategic Projects, North America, Merial, a Sanofi company USALaura Parks, President and Business Unit Director, DSM Pharmaceuticals USA• What are the differences in scales and processes for manufacturing human versus vet vaccines?• Examining the multi-regional challenges of animal health manufacturing and what we’re doing• Profiting from smaller batches and niche markets• Reducing costs and gaining higher titer yields14:10 Setting Modern Quality Standards and Processes for the Biomanufacturing IndustryClaus Weisemann, Ph.D., SVP, Corporate Quality and Compliance, Alexion Pharmaceuticals USA• Developing standards that marry the needs regulators with professional societies and private bodies• Establishing standards that support the most cost effective and transparent routes for biomanufacturing• Taking a risk-based and scientific approach to developing quality and manufacturing controls• Shaping the future of biomanufacturing – striving for continuous quality assurance and real-time data release14:45 Managing Manufacturing ComplexityR. Andrew Ramelmeier, VP, Manufacturing and Facilities, BioMarin USA• Ensuring business growth through smart planning, capital efficiency and talent development• Case studies in managing trade offs and successful management execution• Building quality into operations• Using good science as a foundation• Taking prudent risks and properly managing the product lifecycle
  • 8. 15:20 Panel Discussion: Standardizing Biopharmaceutical Production Facilities for Global DeploymentClaus Weisemann, Ph.D., SVP, Corporate Quality and Compliance, Alexion Pharmaceuticals USARoberto Darienzo, VP, Manufacturing, Ferring Pharmaceuticals USABruce Johnson, Director, Site Operations, Dendreon USAUlf Danielsson, Chief Operating Officer, Pharmadule Morimatsu AB SwedenTonia Becker, Group Publisher, Pharmaceutical Manufacturing, PharmaQbD.com USA• Ensuring regulatory compliance in emerging markets through facilities design• Streamlining delivery by utilizing single-use components• Creating facilities for clinical products that can be expanded for commercial manufacturing• Optimizing the microbial profile using disposable technologies16:00 Chairpersons Closing RemarksLaura Parks, President and Business Unit Director, DSM Pharmaceuticals USA
  • 9. DELEGATE REGISTRATION FORMMKTBooking Code• BOOK ONLINE at www.biomansummit.com• Call the booking hotline on 1 416 214 1144• Fill out this form and email it to pauline.duhart@wtgevents.comTO REGISTERCOMPANY DETAILSDELEGATE DETAILSCompany Name: Address: Tel: Fax: Name: Job Title: Email: Direct Tel: Cell: Name: Job Title: Email: Direct Tel: Cell: No. of Delegates Amount $PAYMENT DETAILSCREDIT CARD Visa Master Card AmexCard NumberIssue Date / Expiry Date / Security CodePrint Name Signature FOR ALL INQUIRIES CONTACT:Pauline Duhart, Marketing Manager atpauline.duhart@wtgevents.comFor more information call the booking hotline: 1 416 214 1144Please tick one of these boxes to confirmhow you are paying. Checks should bemade payable to‘World Trade Group(North America) Inc.’. Banking details will beprovided on your invoice.BANK TRANSFERACH PAYMENTCHECKFEE: $2,495 USDJan. 28th-30th, 2013VENUE DETAILSSheraton San Diego Hotel & Marina1380 Harbor Island Drive, San Diego, California, USA 92101Tel: 619 610 8932 Web: www.sheraton.sandiego.comYOUR DELEGATEPACKAGE INCLUDES:• Meeting opportunities• Conference sessions• Breakfasts, lunches and refreshments• Networking drinks reception• Themed lucheon discussionsHotel accommodation is not included in the registration fee.Visit www.biomansummit.com for details.PRE-ARRANGED ONE-TO-ONE MEETINGSWorld Trade Group reserves the right to refuse a delegateparticipation in the one-to-one meeting session if entry criteria isnot met. Contact us for more details.There’s no substitute for being there, but if you cannot attend,purchase the On-Demand package which allows you to relive all thesessions at the summit.This entitles you to:- An easy to navigate password protected website.- Access to presentations and accompanying video and audio for up to 12 months after the event.- Share with colleaguesPlease send me my login for the On-Demand package at$500 (Payment must be received before login details are granted)TERMS AND CONDITIONSParticipation at event: The organizer will prepare a schedule ofmeetings and individual delegates will attend the business meetingappointments as detailed on the final itinerary presented to them atthe venue.Cancellation policy: Delegate bookings are transferable but cannotbe cancelled. World Trade Group reserves the right to reject delegateapplications. On-Demand bookings cannot be cancelled.Miscellaneous: Organizer reserves the right to cancel event or changedates and/or the venue upon written notice to delegates withoutliability to delegate company or individual delegates.These terms andconditions are binding upon the parties signing this agreement. Wedo not rent or sell our customer e-mail lists.We may share informationwith other professional organizations (including our event sponsors/exhibitors) to promote similar products and services. In particular,we will share information between different companies in the WorldTrade Group. This agreement is governed by the laws of the Provinceof Ontario and the laws of Canada applicable therein.Payment terms: upon receipt of invoice. An 10% service charge willbe levied to cover onsite event administration costs.If you do not wish your details be passed on to other organizations,please check this box:Personal data is collected in accordance with the Personal InformationProtection and Electronic Documents Act (PIPEDA) andThe ElectronicCommunications Privacy Act (ECPA).