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(sduda@jdrf.org)

¡ Ques;onsonlogis;cs,deadlinesorsubmissionproblems:• JamiGoodman(jgoodman@jdrf.org)

¡ Fortechnicalsupport,pleasecontactSmartSimpleSupportServicesviaemailsupport@smartsimple.comorphone(866)239-0991.SupporthoursareMondaythroughFridaybetween5:00amand9:00pmUSEasternStandardTime.

WhereshouldquesDonsbedirected?

TurningTypeOneto

ThankYou