official guide and roadmap to the bioprocess theater booth #1001 cevec is a global solution and...

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12:00pm – 1:15pm ROUNDTABLE - Managing the Contract Relationship Chairperson: Patricia Seymour, Senior Consultant, BioProcess Technology Consultants Panelists: Stephen Taylor, Senior Vice President, Commercial, FUJIFILM DioSynth Justin Skoble, Senior Director, Technical Operations, Aduro Biotech Tom Douville, Director, Biopharmaceutical Development, Kolltan Pharmaceuticals Lily Vakili, Senior Counsel, Faber, Daeufer & Itrato PC CLINICAL/COMMERCIAL MANUFACTURING TRACK 1:30pm – 1:55pm The Expanding DNA and Gene Therapy Market Speaker: Tony Hitchcock., Technical Director, Cobra Biologics 2:00pm – 2:25pm Strategies in Large-Scale Manufacturing: Rapid, Flexible Capacity Expansion with Novel Utilization of Unique Single-Use Facility Design Speaker: Joe Wypych, General Manager, Seattle Facility, CMC Biologics 2:30pm – 2:55pm From Transactional to Strategic Collaboration in Biopharmaceutical Manufacturing Speaker: Uwe Buecheler, Senior Vice President, Biopharmaceuticals, Boehringer Ingelheim 3:00pm – 3:25pm Cell Therapy Commercialization - How Do We Get There? Speaker: David Smith, Vice President, Global Business Development, Lonza 3:30pm – 3:55pm Designing and Implementing a New State-of-the Art Single-Use Facility for Late Stage and Commercial Production Speaker: John Haney, Senior Project Manager, Avid Bioservices Thursday, June 18 BIO BUSINESS ROUNDTABLES 10:30am –12:00pm PBOA EXECUTIVE ROUNDTABLE: CDMO Challenges and Opportunities Moderator: Gil Roth, Founder/President, Pharma & Biopharma Outsourcing Association Panelists: Thomas Thorpe, Chief Executive Officer, Afton Scientific Michael Riley, Vice President and General Manager, Catalent Biologics Victor Vinci, Vice President and Chief Scientific Officer, Cook Pharma Amit Arora, Chief Marketing Officer, Jubilant HollisterStier 1:00pm-2:30pm WOMEN IN BIO ROUNDTABLE: Women Moving Forward and Up: Boldly Taking That Next Step Moderator: Jamie Strachota, Executive Director, Women in Bio Panelists: Educational Kay Wellman, Faculty Member and Coordinator, Johns Hopkins University Biotechnology Enterprise Programs Entrepreneur Deb Bowes, Founder and President, Chevy Chase BioPartners Science/Business/Law Sherri Oslick, Partner, McDonnell Boehnen Hulbert & Berghoff LLP Head Hunter Ashley Bowman, Search Solution Group Official Guide and Roadmap to The BioProcess Theater and Exhibition Zone Booth #3207 Tuesday, June 16 BIOMANUFACTURING STRATEGIES TRACK 12:00pm – 1:15pm ROUNDTABLE - Stretching for the Trifecta: Innovative Strategies for Speeding Development, Lowering Costs, and Enhancing Quality Chairperson: Thomas C. Ransohoff, Vice President, BioProcess Technology Consultants Panelists: Joanne Beck, Senior Vice President, Process Development, Shire Mark Brower, Senior Research Chemical Engineer, Merck Lynne Frick, Director, Continuous Processing, The Americas, Pall Corporation Parrish Galliher, CTO Upstream Xcellerex, GE Healthcare CELL LINE/PROCESS DEVELOPMENT TRACK 1:30pm-1:55pm Using Miniaturization and Automation to Improve Cell Line Development and Selection Speaker: Karen Fallen, Vice President, Business Unit Head, Clinical Development and Licensing, Lonza 2:00pm-2:25pm Media Toolbox - A Rapid and Effective Process Development Strategy to Deliver Reliable, High-Quality Biomanufacturing Processes Speaker: Min Zhang, Principal Scientist and Group Leader, Upstream Process Development, FUJIFILM DioSynth 2:30pm-2:55pm CAP Go Cell Expression System - The New Standard in Authentic Human Glycosylation Speaker: Hartmut Tintrup, Chief Business Officer, Cevec 3:00pm-3:25pm Implementing Clone Generation in Fast-Track Manufacturing of Proteins Speaker: Guillaume Plane, Development and Marketing Manager, EMD Millipore 3:30pm-3:55pm Advances in Research Tools to Accelerate Drug Development Speaker: Raymond Price, Senior Director of Business Development, DiscoverRx Wednesday, June 17 FORMULATION/FILL/FINISH TRACK 10:00am-10:25am Vaccines, Global Health, and the Future of Fighting TB Speaker: Matt Feldman, Senior Manager, Strategic Communications, Aeras 10:30am-10:55am Biopharmaceutical Formulation - A Journey from Expression to Patient Speaker: Greg Adams, Director, Analytical and Formulation Development, FUJIFILM DioSynth 11:00am-11:25am Mitigating the Risk of Filling Biologics with an Advanced Aseptic Process and Glass-Free Vials Speaker: Bill Hartzel, Director of Strategic Execution, Catalent Pharma Solutions 11:30am-11:55am Anatomy of a Lyophilization Process: Considerations for a Successful Tech Transfer Speaker: Anthony Cannon, Head of Drug Product Manufacturing Technology, Samsung Biologics

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Page 1: Official Guide and Roadmap to The BioProcess Theater BOOTh #1001 CEvEC is a global solution and service provider for the production of biopharmaceuticals using a unique human cell

12:00pm – 1:15pm ROUNDTABLE - Managing the Contract Relationship Chairperson: PatriciaSeymour,Senior Consultant, BioProcessTechnologyConsultants Panelists: StephenTaylor,Senior Vice President, Commercial,FujiFilmDioSynth justinSkoble,Senior Director, Technical Operations, AduroBiotech TomDouville,Director, Biopharmaceutical Development, KolltanPharmaceuticals lilyVakili,Senior Counsel,Faber,Daeufer&itratoPC

CLiNiCAL/COMMERCiAL MANUfACTURiNg TRACk

1:30pm – 1:55pm The Expanding DNA and gene Therapy Market Speaker: TonyHitchcock.,Technical Director,CobraBiologics

2:00pm – 2:25pm Strategies in Large-Scale Manufacturing: Rapid, flexible Capacity Expansion with Novel Utilization of Unique Single-Use facility Design Speaker: joeWypych,General Manager, Seattle Facility,CmCBiologics

2:30pm – 2:55pm from Transactional to Strategic Collaboration in Biopharmaceutical Manufacturing Speaker: uweBuecheler,Senior Vice President, Biopharmaceuticals, Boehringeringelheim

3:00pm – 3:25pm Cell Therapy Commercialization - How Do We get There? Speaker: DavidSmith,VicePresident,GlobalBusinessDevelopment, lonza

3:30pm – 3:55pm Designing and implementing a New State-of-the Art Single-Use facility for Late Stage and Commercial Production Speaker: johnHaney,Senior Project Manager,AvidBioservices

Thursday, June 18 BiO BUSiNESS ROUNDTABLES

10:30am –12:00pm PBOA ExECUTivE ROUNDTABLE: CDMO Challenges and Opportunities Moderator: GilRoth,Founder/President,Pharma&Biopharma OutsourcingAssociation Panelists: ThomasThorpe,Chief Executive Officer,AftonScientific michaelRiley, Vice President and General Manager, CatalentBiologics VictorVinci,Vice President and Chief Scientific Officer, CookPharma AmitArora,Chief Marketing Officer,jubilantHollisterStier

1:00pm-2:30pm WOMEN iN BiO ROUNDTABLE: Women Moving forward and Up: Boldly Taking That Next Step

Moderator: jamieStrachota,ExecutiveDirector,WomeninBio

Panelists: Educational KayWellman,Faculty Member and Coordinator, johnsHopkinsuniversityBiotechnologyEnterprisePrograms Entrepreneur DebBowes,Founder and President,ChevyChaseBioPartners

Science/Business/Law SherriOslick,Partner, mcDonnellBoehnenHulbert&BerghoffllP

Head Hunter AshleyBowman,SearchSolutionGroup

Official Guide and Roadmap toThe BioProcess Theater and Exhibition Zone

Booth #3207

Tuesday, June 16 BiOMANUfACTURiNg STRATEgiES TRACk

12:00pm – 1:15pm ROUNDTABLE - Stretching for the Trifecta: innovative Strategies for Speeding Development, Lowering Costs, and Enhancing Quality Chairperson: ThomasC.Ransohoff,Vice President, BioProcessTechnologyConsultants Panelists: joanneBeck,Senior Vice President, Process Development,Shire markBrower,Senior Research Chemical Engineer,merck lynneFrick,Director, Continuous Processing, The Americas, PallCorporation ParrishGalliher,CTO UpstreamXcellerex,GEHealthcare

CELL LiNE/PROCESS DEvELOPMENT TRACk

1:30pm-1:55pm Using Miniaturization and Automation to improve Cell Line Development and Selection Speaker: KarenFallen,Vice President, Business Unit Head, Clinical Development and Licensing,lonza

2:00pm-2:25pm Media Toolbox - A Rapid and Effective Process Development Strategy to Deliver Reliable, High-Quality Biomanufacturing Processes Speaker: minZhang, Principal Scientist and Group Leader, Upstream Process Development,FujiFilmDioSynth

2:30pm-2:55pm CAP go Cell Expression System - The New Standard in Authentic Human glycosylation Speaker: HartmutTintrup,Chief Business Officer,Cevec

3:00pm-3:25pm implementing Clone generation in fast-Track Manufacturing of Proteins Speaker: GuillaumePlane, Development and Marketing Manager, EmDmillipore

3:30pm-3:55pm Advances in Research Tools to Accelerate Drug Development Speaker: RaymondPrice,Senior Director of Business Development, DiscoverRx

Wednesday, June 17 fORMULATiON/fiLL/fiNiSH TRACk

10:00am-10:25am vaccines, global Health, and the future of fighting TB Speaker: mattFeldman,Senior Manager, Strategic Communications,Aeras

10:30am-10:55am Biopharmaceutical formulation - A Journey from Expression to Patient Speaker: GregAdams,Director, Analytical and Formulation Development, FujiFilmDioSynth

11:00am-11:25am Mitigating the Risk of filling Biologics with an Advanced Aseptic Process and glass-free vials Speaker: BillHartzel,Director of Strategic Execution, CatalentPharmaSolutions

11:30am-11:55am Anatomy of a Lyophilization Process: Considerations for a Successful Tech Transfer Speaker: AnthonyCannon, Head of Drug Product Manufacturing Technology,SamsungBiologics

Page 2: Official Guide and Roadmap to The BioProcess Theater BOOTh #1001 CEvEC is a global solution and service provider for the production of biopharmaceuticals using a unique human cell

www.cevec.com

BOOTh #1001

CEvECisaglobalsolutionandserviceproviderfortheproductionofbiopharmaceuticalsusingauniquehumancellexpressionsystem.CEVEC’sCAP gO expressionplatformcomprisesaportfolioofglyco-optimizedhumansuspensioncelllineswhichallowfortailor-madeglycosylationofrecombinantproteins.Thecellsarehighlyefficientfortheproductionofabroadrangeofotherwisedifficulttoexpressglycoproteinsandprovideauthentichumanpost-translationalmodifications.usingitsproprietarytechnology,CEVEChasrecentlyformedajointventurepartnershipwithmid-sizeCmOsbothinEuropeandnewlyalsointheuStooffercGmPproductionservicesinCAPcells.

www.avidbio.com

www.bioxcellence.com

BOOTh #3627

AsaleadingbiopharmaceuticalcontractmanufacturerBoehringer ingelheim BioxcellenceTMofferstailor-madecontractdevelopmentandmanufacturingservicestothebiopharmaceuticalindustry,providingtheentireproductiontechnologychainfromDNAtofillandfinishunderoneroofatitsfacilitiesinBiberach(Germany),Vienna(Austria),Fremont(uSA)andShanghai(China).

www.aeras-cmo.com

BOOTh #301

Aeras Contract Manufacturing,locatedinRockville,maryland,helpsorganizationswiththechallengingandcomplexprocessoftranslatingvaccines(includingsubunitantigenandviralvaccines)andotherbiopharmaceuticals(includingrecombinantproteinsandmonoclonalantibodies)fromtheresearchlabthroughPhasei/iiclinicaldevelopment.inourBSl2facility,weprovideend-to-endsupportfromprocessdevelopmentthroughcGmPmanufacturingandfill/finishofclinicaltrialmaterials.

www.bptc.com

BPTCistherecognizedworldwideleaderinbiologicsCmCconsulting,providingafullrangeoftechnical,regulatory,andstrategicconsultingservicestocompaniesworkingondevelopment,manufacturing,andcommercializationofbiopharmaceuticalproducts.BPTCworkswithclientstofindsolutionstothechallengesofproducingbiopharmaceuticalsupplyfromclone to commercial®.

BOOTh #533

www.catalent.com/biologics

Roadmap to Premier Biopharmaceutical Suppliers

BOOTh #3230

Accelerating the Development of vaccines and Biologics Avid’sexperienceinmammaliancellculturedevelopmentandcGmP

productionofclinicalandcommercial-scalemonoclonalantibodies,recombinantproteinsandenzymesprovidesyourprogramwithapartnertoadvanceyourmoleculeefficientlythroughearlystagedevelopmentandintoafinishedcommercialproduct.AvidisexpandingitsOrangeCountyCalifornia-basedfacility.Designedforlate-stageclinicalandcommercialproduction,thisnewstate-of-the-artfacilitymorethandoublesAvid’scurrentmanufacturingcapacityandfeaturesmultiplesingle-usebioreactors,modularcleanroomsandthelatestinsingle-usetechnology.

Your Partner from Concept to Commercial

Boehringer ingelheim BioxcellenceTM makes outsourcing easy

BOOTh #3301

Catalentisyourstrategicpartnerforbiologicdrugdevelopmentsuccess.Wecreatesmart,tailoredsolutionswithournovelSMARTag™ADCTechnology,oursuperiorgPEx®celllineexpressionsystem,clinicalbiomanufacturingcapabilitiesandintegrateddevelopment,analyticalandclinicalsupplyservicestohelpyougetbetterproductstoclinicfaster.Withourbroadrangeofexpertserviceswedrivefaster,moreefficientdevelopmenttimelinestohelpyoutakemoremoleculestomarketandcreatemoreeffectiveproducts.

Catalent - Smart Biologics. integrated Solutions. Better Treatments.

fully integrated Strategic, Technical and Regulatory Solutions

Tailor-Made glycosylation of Recombinant Proteins

Page 3: Official Guide and Roadmap to The BioProcess Theater BOOTh #1001 CEvEC is a global solution and service provider for the production of biopharmaceuticals using a unique human cell

www.lonza.com

www.cobrabio.com

BOOTh #726

Cobra providesacomprehensivebiologicsandpharmaceuticalsserviceoffering,withmulti-functionalandexperiencedprojectteamsnurturingcustomers’productsfrompre-clinicaltocommercialmanufacturewithinthreeGmPapprovedfacilities.WehaveaproventrackrecordinthecontractmanufactureofDNA,microbialandmammalianProteins,VirusesandAPiproducts,providingaone-stop-shopaswellasstand-aloneservicesfromcelllinedevelopmentthroughtothefillandfinishofpre-filledsyringesandinjectablevials.

www.emdmillipore.com

BOOTh #2915

www.cmcbiologics.com

BOOTh #2727

www.bioprocessintl.com

BOOTh #3207

www.samsungbiologics.com

BOOTh #3607

Samsung BioLogicsisafullserviceproviderofQualitydrivencGmPcontractmanufacturingfortheglobalbiopharmaceuticalindustry.Ourfacilitiesareflexiblydesignedforcosteffectiveproductionofbothmonoclonalandrecombinantdrugsubstanceanddrugproduct.Ourintegratedservicesincludeprocessdevelopment,analyticalservices(methoddevelopment,comparability,iPC,lotrelease&stability)aswellasfill&finish,labelingandpackaginginonelocation.Ourqualitysystemsaredesignedforworldwideregulatorycompliance.

Drug Substance and Drug Product Contract Manufacturing

EMD MilliporeisthelifeSciencedivisionofMerck kgaA ofGermanyprovidingbiopharmaceuticalservicesfrompreclinicalthroughcommercialproduction.Provantage™servicesproduceclinicalmaterialforPhi-iitrialsandofferprocessdevelopment,processoptimization,techtransfer,validationandequipmentqualificationservices,improvingproductivity,reducingriskandloweringcosts.

EMD Millipore Biopharmaceutical Services from Preclinical through Commercial Production

Contract Manufacturing Excellence

CMC Biologicsprovidesfullyintegratedbiopharmaceuticalprocessdevelopmentandmanufacturingservices.WithfacilitiesintheuSAandEurope,theCompanyspecializesinthescale-upandcGmPmanufactureofprotein-basedtherapeuticsforpre-clinical,clinicalandin-marketAPiproduction.CmCBiologics’widerangeofcustomsolutionsincludecelllinedevelopmentusingitsCHEf1®expressiontechnologyplatform,processdevelopmentandanalytical,formulationandcharacterizationservices.CmCBiologicsoffersmanufactureofmammaliancellcultureandmicrobialfermentation.

Your Process Development and Manufacturing Partner of Choice

Lonzaisaleadingpartnertothelifesciencesindustry.Forover30years,lonzahasbeenhelpingemergingandlargebiotechcompaniesimproveandadvancetheirinnovativeproducts.Whetherforpreclinical,clinicalorcommercialsupply,lonza’sflexibledevelopmentservices,industry-leadingmanufacturingprocesses,andbroadtechnologyplatformsenableyourproductstoreachtheirfullpotential,faster.lonzaisaglobalcompanywithmorethan40majormanufacturingandR&Dfacilitiesandapproximately9,800employeesworldwide.

A global Leader in Life Sciences

BOOTh #3215

The Premier Scientific Publication to the Biopharmaceutical industryTheKeytoeffectiveproductmarketingistoensureyourexpertiseandsolutionsarewellpositionedwithinandsurroundedbyscientificinformationyourcustomersaremostinterestedin.ThisiswhereBioProcess Internationalexcels.Thisisourexpertise.PartnerwithBPitocreateacustomprogramthatperfectlydeliversyoursolutionstothedecisionmakersthatneeditmost.

Page 4: Official Guide and Roadmap to The BioProcess Theater BOOTh #1001 CEvEC is a global solution and service provider for the production of biopharmaceuticals using a unique human cell

BioProcess Zone ExhibitorsCompany Name Booth Number

AAiPharma/Cambridgemajorlaboratories.....................3506Althea..............................................................................................3501AmoytopBiotech........................................................................3220APT....................................................................................................3204AragenBioscience,inc...............................................................3415AsepticTechnologies.................................................................3020Barringtonjameslimited........................................................3504BiOKOREA(KHiDi).......................................................................2909BioProcess International ...........................................3300BloodCentersofAmerica.........................................................3105BostonmountainBiotech.........................................................3509CarbosynthllC............................................................................3117Catalent Pharma Solutions .......................................3301CharlesRiverlaboratories.......................................................3511Cobra Biologics ............................................................ 726CRB....................................................................................................3216CRCPress-Taylor&FrancisGroupllC................................3208CytovanceBiologicsinc............................................................2919Dibaindustriesinc......................................................................3017DVBiologics...................................................................................3013EMD Millipore ............................................................2915EmergentBioSolutionsinc.......................................................3119EmersonProcessmanagement..............................................3405ExcelseBio......................................................................................3606FormexllC....................................................................................3111FUJIFILM Diosynth Biotechnologies ........................3317GoodwinBiotechnology,inc...................................................3109indianaHealthindustryForum..............................................3401KemwellBiopharma...................................................................3408KoreaDrugDevelopmentFund.............................................2901lampireBiologicallaboratories,inc....................................3507loeb&loebllP..........................................................................3608Lonza ..........................................................................3215masyBioServices.........................................................................3100medixScientific&ClinicalResearch.....................................3114meissnerFiltrationProducts....................................................3201NittoDenkoTechnicalCorporation......................................3104NOFCORPORATiON....................................................................3016Oncobiologics,inc.......................................................................3003Patheon...........................................................................................3613PendoTECH....................................................................................3015PhageConsultants......................................................................3610PiramalHealthcare......................................................................3309PuritanProducts,inc..................................................................3102PYRAmiDlaboratories,inc......................................................3601REDBAGSOluTiONS.................................................................3612

Company Name Booth Number

Samsung Biologics ....................................................3607SandozGmbH...............................................................................3409SelexisSA........................................................................................3311SharpPackagingServices.........................................................3203Spectrumlabs.com.....................................................................3200That’sNicellC..............................................................................3001TherapureBiomanufacturing.................................................3500ThomasA.littleConsulting....................................................3510ToxikonCorporation...................................................................3101VGXi..................................................................................................3212Wenderoth.....................................................................................3108WHEATON.......................................................................................3103WorthingtonBiochemical........................................................3009

Contract Services ExhibitorsCompany Name Booth NumberAdvantarlabs.................................................................................631AlfaWassermannSeparationTechnologies.......................5021AlliancePharma...........................................................................5025AmRi...................................................................................................727Avid Bioservices, Inc. ................................................... 533BachemAmericas,inc..................................................................539BioTechnique................................................................................5118BRiBiopharmaceuticalResearchinc......................................840CaseWesternReserveuniversitySchoolofmedicineinnovations.........................................541Coldstreamlaboratories............................................................730CookPharmica...............................................................................734GCT...................................................................................................5019Germfreelaboratories................................................................640GlaxoSmithKlineBiopharmaceuticals....................................349HiQScreen........................................................................................739instituteofindustrialOrganicChemistryBranchPszczyna......................................................................735jubilantHollisterStier...................................................................637KBiBiopharma,inc........................................................................743labSupport.....................................................................................834lSNEContractmanufacturing..................................................741lyophilizationTechnology,inc.................................................737mtibio................................................................................................844multiling..........................................................................................838NEuROSERViCE..............................................................................738OhioClinicalTrialsCollaborative(OCTC)..............................543OnPointCRO...................................................................................644ParagonBioservices,inc..............................................................527PolyPeptideGroup........................................................................635WorldwideClinicalTrials.............................................................842WuXiAppTec,inc...........................................................................643

Companies shown in bold are BPi Theater presenters.