for the treatment of Insulin Dependent Diabetes Mellitus ......Diabetes Mellitus (IDDM) JDRF and Eli...
Transcript of for the treatment of Insulin Dependent Diabetes Mellitus ......Diabetes Mellitus (IDDM) JDRF and Eli...
RequestforPROPOSALS:
GLUCOSERESPONSIVEGLUCOSEMODULATINGTHERAPIES
forthetreatmentofInsulinDependentDiabetesMellitus(IDDM)
JDRFandEliLilly
¡ JDRFMission
¡ JDRFResearchPriorityPrograms
¡ GlucoseResponsiveGlucoseModula;ngTherapies–whatarewelookingfor?
¡ OverviewofProposalRequest
¡ Q+Aopportunity
PresentaDonOverview
LESS UNTIL NONE
JDRF’sVisionfortheFuture
DeliveryofConAnuousTherapeuAcImprovements
Side-Effects
ComplicaAonsPaAentBurden
GlycemicControl
SafetyNormalPhysiology
Restored
Easier,Safer,LessWorry,BeLerLife
Therapies Cure
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.
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
GlucoseResponsiveGlucoseModulaDon
WorkingDefiniDon:
¡ Therapiesthatcanmodulatetheac;vityand/orconcentra;onofafreely-circula;nginsulinanalogorotherinsulinreceptoragonistasafunc;onofchangesinglucoseconcentra;onoverthephysiologicallyrelevantrange.
¡ Systemsinwhichtheac;vityand/orconcentra;onofafreely-circula;ngglucagon,glucagonreceptoragonistorinsulinreceptorantagonistaremadedependentonchangesinglucoseconcentra;on.
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.
¡ 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
¡ 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
¡ 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
¡ 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
¡ 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
ChallengesàOpportuniDes
¡ Lackoftechnical/scien;ficpriorartàOp;onswideopen;stagedapproach
¡ Cross-func;onalexper;seneededàCollabora;veteamofdiversebackgrounds
¡ UnknownregulatorypathàInsulinandnon-insulinbasedtherapiesmayprovideguidance
¡ AcuteandlongtermsafetyàEliLillytoofferscien;ficandtechnicalexper;se/know-howandotherresources
¡ Agroupofhighlytalentedresearchersfromaspectrumofdisciplines,perspec;ves,andresearchmethods
¡ Willingtoshareknowledge,resourcesmethodsanddata
¡ Individualprojectsshouldcontributetoacommon,well-definedresearchprogramgoal
¡ Supportedbyappropriatedatasharingandcollabora;veagreements
¡ Capableofdevelopingandundertakingadecision-makingstructuretoensuregoodcommunica;on,smoothprogressandcollec;veapproachestoovercomeobstacles
WhatisaCollaboraDveTeam?
¡ Ques;onsoneligibility,suitabilityofproposalsandnetworkstructure:• SanjoyDuda([email protected])
¡ Ques;onsonlogis;cs,deadlinesorsubmissionproblems:• JamiGoodman([email protected])
¡ Fortechnicalsupport,pleasecontactSmartSimpleSupportServicesviaemailsupport@smartsimple.comorphone(866)239-0991.SupporthoursareMondaythroughFridaybetween5:00amand9:00pmUSEasternStandardTime.
WhereshouldquesDonsbedirected?
TurningTypeOneto
ThankYou