for the treatment of insulin dependent diabetes mellitus ......diabetes mellitus (iddm) jdrf and eli...
TRANSCRIPT
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RequestforPROPOSALS:
GLUCOSERESPONSIVEGLUCOSEMODULATINGTHERAPIES
forthetreatmentofInsulinDependentDiabetesMellitus(IDDM)
JDRFandEliLilly
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¡ JDRFMission
¡ JDRFResearchPriorityPrograms
¡ GlucoseResponsiveGlucoseModula;ngTherapies–whatarewelookingfor?
¡ OverviewofProposalRequest
¡ Q+Aopportunity
PresentaDonOverview
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LESS UNTIL NONE
JDRF’sVisionfortheFuture
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DeliveryofConAnuousTherapeuAcImprovements
Side-Effects
ComplicaAonsPaAentBurden
GlycemicControl
SafetyNormalPhysiology
Restored
Easier,Safer,LessWorry,BeLerLife
Therapies Cure
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JDRFResearchPriorityPrograms
ARTIFICIAL PANCREAS
COMPLICATIONS BETA CELL REPLACEMENT
GLUCOSE CONTROL
RESTORATION PREVENTION
Significant advances are improving how people live with the disease and bringing us closer to a biological cure and universal prevention.
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2008: Preclinicalconceptwithpreliminaryinvitroresultssupported throughIDDPtoSmartCellsInc.(2008)
2009: Developedprototypeinsulinmoleculesanddemonstratedproof-of-principleàGarneredaddi;onalsupport(JDRF,Angels,NIDDK-SDP,etc.)
2010: Demonstratedproof-of-conceptinanimalmodels2010: SmartCellsInc.acquiredbyMerck–SmartInsulinunderdevelopment
JDRFSupportedSmartInsulinProgram
Insulin Conjugate
Glucose
Glucose Binding Protein
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GlucoseResponsiveGlucoseModulaDon
WorkingDefiniDon:
¡ Therapiesthatcanmodulatetheac;vityand/orconcentra;onofafreely-circula;nginsulinanalogorotherinsulinreceptoragonistasafunc;onofchangesinglucoseconcentra;onoverthephysiologicallyrelevantrange.
¡ Systemsinwhichtheac;vityand/orconcentra;onofafreely-circula;ngglucagon,glucagonreceptoragonistorinsulinreceptorantagonistaremadedependentonchangesinglucoseconcentra;on.
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ProjectedOutcomes
Expectedoutcomesfromprojectproposalswoulddemonstratebutnotbelimitedto:¡ Modula;onofac;vity/concentra;onofaglucose-concentra;onmodula;ngagentinresponsetochangesinsoluteconcentra;on.
¡ Dataindica;nganunderstandingofthemechanismbywhichchangesinglucoseconcentra;onsresultinchangesinac;vityand/orconcentra;on.
¡ Theestablishmentofanaly;caltechniquestoassesstheunderlyingmechanismbehindthechangesinac;vityand/orconcentra;on.
¡ Datasuppor;ngapathforwardtowardtheu;lityofglucoseasthetriggerforchangesinac;vity/concentra;onoverthephysiologicallyrelevantconcentra;onrange.
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¡ Selectedinves;gatorsandtheirins;tu;onswillberequiredtosignamodifiedJDRF“ProgramAwardAgreement”whichwills;pulatecondi;onsinaddi;ontoJDRF’sstandardTermsandCondi;ons.Thesemayinclude:• Priorapprovalofpublica;ons/presenta;ons• Protec;onofIntellectualProperty• ThegranttoEliLillyofanon-exclusiveresearch-uselicenseandanop;ontonego;ateanexclusivelicensetoIPgeneratedduringthefundingperiod.
Mechanism:JDRF–EliLillyCo-funding
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¡ FullApplicaDonRelease:TuesdayNovember17,2015
¡ ApplicaDonSubmissionDeadline:ThursdayJanuary14,2016• Applicantsshouldregisterandsubmittheircompletedfullproposalapplica;oninRMS360(hdp://jdrf.smartsimple.us).
¡ ProjectedApplicaDonReviewPeriod:LateJanuary–LateApril• Thereviewprocesswillincorporateexternalexpertswhoreviewasvolunteersonourscien;ficreviewpanelatthediscre;onofJDRFScien;ficStaffandEliLilly.Thereviewerswillassessthescien;ficmeritandvalidityofthesubmidedproposals.Forallofthereviewedapplica;ons,JDRFScien;ficStaffandEliLillywillmakeajointfinaldecisionregardingaproposal’sscien;ficmerit.
¡ EarliestResponsetoApplicants:May2016
¡ EarliestAnDcipatedStartDate:June2016
RFATimelines
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¡ FundingrequestsforStrategicResearchAgreements(SRA)willbeconsideredforamaximumof$200,000USDperyear,includingamaximumof10%indirectcosts,forupto2yearsdura;on.
¡ FundingrequestsforInnova;veGrantswillbeconsideredforamaximumof$110,000USDperyear,includingamaximumof10%indirectcosts,for1year.• *Applica;onswhosebudgetand/or;melineexceedstheabovespecifiedguidelines,mustobtainJDRFstaffapprovalpriortosubmikngthefullproposal.
• Projectswouldbefundedas• StrategicResearchAgreements(SRA)(hdp://grantcenter.jdrf.org/grant-center/informa;on-for-applicants/grant-mechanism-descrip;ons/strategic-research-agreements/
• InnovaDveGrants(hdp://grantcenter.jdrf.org/grant-center/informa;on-for-applicants/grant-mechanism-descrip;ons/innova;ve-grants/).
FundingMechanism
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¡ Fullproposalapplica;onsshouldbesubmidedviatheRMS360system(/jdrf.smartsimple.us)usingtheresearchplantemplateprovidedandincludingthefollowinginforma;on:• Background/Ra;onaleandSpecificAimsofoverallproject• Overviewofhypotheses,goals,deliverablesandcollabora;veframeworkasapplicable• Title,leadinves;gatorandadescrip;onandspecificaimsofindividualprojects(ifcollabora;ve/network)• Expecteddeliverablesandimpactoftheproposedstudywithpoten;alnextsteps• IntellectualPropertyorcommercialeffortsassociatedwiththecurrentapplica;on• Totalbudget/budgetbyyearbyproject• BiosketchesforallPrincipalInves;gatorsandKeyPersonnel
FullProposalApplicaDon
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¡ JDRFisusingagrantsmanagementsystemtocollectonlineapplica;onsubmissionscalledRMS360.ThetoRMS360linkisasfollows:hdps://jdrf.smartsimple.us/s_Login.jsp.• Pleasenotethatifyouarenewtothesystem,youmustregisterandlogindetailswillbegenerated.
§ Calldetailsanddeadlinescanbefoundinthe“FundingOpportuni;es”tabofRMS360.
§ Allmaterialsandtemplatespertainingtotheapplica;oncanbefoundonceyou’veini;atedanapplica;oninRMS360.
§ ItisrecommendedtouseGoogleChromeorFirefoxwhenusingRMS360,asthesebrowsersaremostcompa;blewiththesystem.
RMS360
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ChallengesàOpportuniDes
¡ Lackoftechnical/scien;ficpriorartàOp;onswideopen;stagedapproach
¡ Cross-func;onalexper;seneededàCollabora;veteamofdiversebackgrounds
¡ UnknownregulatorypathàInsulinandnon-insulinbasedtherapiesmayprovideguidance
¡ AcuteandlongtermsafetyàEliLillytoofferscien;ficandtechnicalexper;se/know-howandotherresources
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¡ Agroupofhighlytalentedresearchersfromaspectrumofdisciplines,perspec;ves,andresearchmethods
¡ Willingtoshareknowledge,resourcesmethodsanddata
¡ Individualprojectsshouldcontributetoacommon,well-definedresearchprogramgoal
¡ Supportedbyappropriatedatasharingandcollabora;veagreements
¡ Capableofdevelopingandundertakingadecision-makingstructuretoensuregoodcommunica;on,smoothprogressandcollec;veapproachestoovercomeobstacles
WhatisaCollaboraDveTeam?
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¡ Ques;onsoneligibility,suitabilityofproposalsandnetworkstructure:• SanjoyDuda([email protected])
¡ Ques;onsonlogis;cs,deadlinesorsubmissionproblems:• JamiGoodman([email protected])
¡ Fortechnicalsupport,pleasecontactSmartSimpleSupportServicesviaemailsupport@smartsimple.comorphone(866)239-0991.SupporthoursareMondaythroughFridaybetween5:00amand9:00pmUSEasternStandardTime.
WhereshouldquesDonsbedirected?
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TurningTypeOneto
ThankYou