You are on page 1of 3

Colorado Senator Michael Bennet

ColoradoBioScienceAssociationServesasCatalystinAssemblingCEORountableDiscussion forSenatorMichaelBennetandFDACommissionerMargaretHamburg attheAnschutzMedicalCampusinAurora


TheColoradoBioScienceAssociation(CBSA)broughtmorethan35industryCEOstogethertodaytodialoguewith SenatorMichaelBennetandU.S.FDACommissionerMargaretHamburgattheAnschutzMedicalCampusinAurora. AtSenatorBennet'srequest,CBSAdesignedtoday'ssessiontosharethebioscienceindustry'sspecificandunique needsinbringinginnovativedrugsanddevicestomarketundercurrent,oftenconstraining,marketconditions.

Denver,CO,August22,2011,3p.m.EasternTheColoradoBioScienceAssociation(CBSA)workedwithSenatorMichael Bennet'sofficeinassemblingagroupofmorethan35bioscienceindustryCEOsfromitsmembershiptodialoguewith theSenatorandMargaretHamburg,M.D.,CommissioneroftheU.S.FoodandDrugAdministration(FDA)today.Dr. JeffreyShuren,Director,CenterforDevicesandRadiologicalHealth,andDr.VickiSeyfertMargolis,SeniorScience AdvisortotheFDAsChiefScientist,accompaniedCommissionerHamburghere. TheannouncementismadebyHolliRiebel(formerlyBaumunk),CBSAPresident&CEO,whosays"SenatorBennet invitedCommissionerHamburgandhercolleaguestoColoradofortheCEORoundtable.Thesessiontodayisapositive nextsteptoworkCBSAhasalreadycontributedtoSenatorBennet'sColoradoansForAnInnovationEconomy(CFAIE), andspeaksstronglytotheworktheSenatorisdoingonourindustry'sbehalf.Weappreciatetheopportunitytohost CommissionerHamburginourstateforthefirsttimeandshareourindustry'sspecificanduniqueneedsforbringing innovativedrugsanddevicestomarketundercurrent,oftenconstraining,marketconditions." AccordingtoLillyMarks,VPforHealthAffairsandExecutiveViceChancellor,AnschutzMedicalCampus,theRoundtable sessiontookplaceontheAnschutzMedicalCampusinAurorawheretheFDAdelegationalsotouredresearchand clinicaltrialfacilitiesbeforedepartingthecity. Lastweek,Sen.BennetsentalettertoCommissionerHamburgaddressinghisthoughtsforhowtheFDAshouldproceed infosteringinnovation:Atatimewhenournationsdrug,biotechnology,andmedicaldevicestartupcompaniesare strugglingtoaccesscapital,wemuststrivetoprovidethemwithregulatoryclarityandpredictabilityinawaythatissafe forpatientsbutalsomeetstheirexpectationsregardinginnovation,Sen.Bennetwroteintheletter. FurtherinhislettertoCommissionerHamburg,Sen.Bennetaskedhowtheagencyplanstoaddressthefollowingareas asitstrivestomodernizeitsregulatorysystemtoadapttothe21stcentury:

Regulatoryreformandtransparencythatwillsimplifymanufacturingprocesses,ratherthanaddcomplexityto businessoperations Incorporationofmodernscientifictools,standards,andapproachestoadvanceinnovation Recognitionofinnovativeapproachestakenbyotherglobalregulatorysystemstoenhancecertaintyand predictability Incorporationofprivatepublicapproachestoeaseinvestmentininnovation More

Page2 "Patientsinthiscountryaredemandingthatweleadininnovationandtimelyaccesstobreakthroughtherapiesand cures.Atatimewhenournationsdrug,biotechnology,andmedicaldevicestartupcompaniesarestrugglingtoaccess capital,wemuststrivetoprovidethemwithregulatoryclarityandpredictabilityinawaythatissafeforpatientsbut alsomeetstheirexpectationsregardinginnovation.Ibelievewehaveanopportunitytodogoodthingsforpatientsand acriticalsectoroftheU.S.economy.IlookforwardtopartneringwithyoutoensuretheFDAfostersinnovationand promoteseconomicgrowth."Sen.Bennetsaid. DavidPerez,Chairman,BloodManagementBusiness,TerumoCorporation,andPresidentandCEO,CaridianBCTand TerumoTransfusion,agreeswithSen.Bennetthat"accesstocapitalandspeedtomarketofnewinnovationsismore criticalnowthanever."InadditiontotheCBSABoardofDirectors,Mr.PerezalsoservestheAdvancedMedical TechnologyAssociation(AdvaMed)asamemberoftheboardofdirectorsanditsStrategicPlanningCommittee,vice chairoftheTechnologyandRegulatoryAffairsCommittee,andasthechairoftheBloodProductsandTechnology Sector. AccordingtoCBSABoardChairSteveOrndorff,CEOofArielPharmaceuticalsandalsoamemberoftheCFAIE,theFDA recentlyannouncedaStrategicPlanforRegulatoryScience,whichaimstofosterinnovationthroughbetter science."LikeSen.Bennet,ourAssociationapplaudsthoseefforts,butweurgetheFDAtodomoretopromote economicgrowth,Americancompetitivenessandinnovation,"Orndorffsaid. ThefollowingCBSAcompaniesparticipatedintheRoundtableDiscussionwithSenatorBennet,CommissionerHamburg andtheCommissioner'scolleaguesfromWashington:

Pharma/Biotech: Amgen Apopologic ARCABiopharma ArielPharmaceuticals ArrayBioPharma,Inc. ColoradoInstituteforDrug,DeviceandDiagnosticDevelopment ClovisOncology GlobeImmune Inviragen Merck N30Pharma NextgenPharma Tolmar

MedDevice/Diagnostics: AlloSource BaxaCorporation Biodesix CaridianBCT Clarmedix Covidien Gambro LabsInc. Medivance MedtronicNavigation Sharklet SomaLogic ValveXchange More

Page3 AgBio Invitria VentureCapitalGroups: BoulderVentures HighCountryVentures Universities/Associations: AnschutzMedicalCampus ColoradoBioscienceAssociation ColoradoClinicalandTranslationalSciencesInstitute ColoradoCenterforDrugDiscovery(C2D2) FitzimonsRedevelopmentAuthority UniversityofColorado,AMC UniversityofColoradoTechnologyTransferOffice Regulatory: RegleraCorp RegulusPharmaceuticalConsulting AboutColoradoBioScienceAssociation TheCBSAisanotforprofitcorporationprovidingservicesandsupportforColorado'sgrowingbiosciencesindustry. Withmorethan350members,CBSAactivelyworkstopromotethegrowthoftheindustrybyworkingforabetter businessenvironment,growthestate'sbiotechworkforce,fightforpoliciesthatsupportastrongbioscienceindustryin thestateandspeakwithasinglevoiceonbehalfoftheindustry.Formoreinformation,visit http://www.cobioscience.com. ### Contacts: MaeDesaire,DirectorofMarketing,ColoradoBioScienceAssociationhttp://www.cobioscience.com7203825918, mdesaire@cobioscience.com MaggieChamberlinHolben,APR,AbsolutelyPublicRelationshttp://www.absolutelypr.com3039849801, maggie@absolutelypr.com

You might also like