University of Utah NSF I-Corps 2016 Application PI!Full!Name!

Position!Faculty!status!Department!

Co6Primary!Investigators:!

Entrepreneurial!Team:!

Other:__________________________________________________________________________________________________!!!!!!

Technology!and/or!Invention!!

Description:!(your!answers!to!questions!below!will!allow!us!to!select!areas!of!training!that!may!required!special!emphasis)!!!

Co6PI(s):! Position! Faculty!Status! Department!

Do!you!have!an!entrepreneurial!team!identified?!If!Yes:!!Provide!name(s)!and!status!of!team!(i.e.6!undergraduate/graduate!student,!resident,!post6doctoral!fellow)!

If!No:!!

Status!of!Intellectual!Property:!!!(Select Highest achieved level)

Describe need technology addresses: (200 char max)

Description:(200 char max)!

ealthcare elated

echnology eadiness e el

(See Appendix)

!!!!!!

Additional!material:!Please!attach!a!digital!copy!of!the!following,!if!available!(check!box!if!included).!� Photo!of!prototype!���

University!TVC!disclosure!Patent!application!cover!page!or!abstract!Other:_________________________________________________________________________________________!

!Program!outcome!expectations (Please&list&the&most&important&outcomes&you&expect&to&achieve&by& !participating&in&this&program) !(200 char max)

Signature! Date!____________________!

Areas*of*assistance*desired: (Se e pp )*siness De elo entsto er Disco ery ar et esearch

ntre re rshieg latory

nding ent re nding

Prototyping/Technology Developmenth r (200 char max)

Appendix(Technology*Readiness*Level Pharmaceutical*Drugs Pharmaceutical*Biologics Medical*Devices

TRL1 Technical,Watch Maintain,scientific,technical,watch Maintain,scientific,technical,watch Maintain,scientific,technical,watchTRL2 Basic,Technology,Research Research,ideas,and,protocols,are,developed Research,ideas,and,protocols,are,developed Research,ideas,and,protocols,are,developed

TRL3 Research,to,Prove,FeasibilityHypothesis,testing,and,initial,proof,of,concept,(PoC),is,demonstrated,in,a,limited,number,of,in#vitro#&#in#vivo,models

Hypothesis,testing,and,initial,proof,of,concept,(PoC),is,demonstrated,in,a,limited,number,of,in#vitro#&#in#vivo,models

Hypothesis,testing,and,initial,proof,of,concept,(PoC),is,demonstrated,in,a,limited,number,of,in#vitro#&#in#vivo,models

TRL4 Technology,DemonstrationPoC,and,safety,of,candidate,drug,formulation,is,demonstrated,in,a,defined,laboratory,or,animal,model

PoC,and,safety,of,candidate,biologic,or,vaccine,construct,is,demonstrated,in,a,defined,laboratory,or,animal,model

PoC,and,safety,of,candidate,device,or,system,is,demonstrated,in,a,defined,laboratory,or,animal,model

TRL5 Technology,Demonstration PreIclinical,studies,,including,GLP,animal,safety,&,toxicity,,sufficient,to,support,IND,application

PreIclinical,studies,,including,GLP,animal,safety,&,toxicity,,sufficient,to,support,IND,application

MDICDRH,review,of,Investigational,Device,Exemption,(IDE),results,is,sufficient,to,begin,investigation

TRL6 Technology,DemonstrationPhase,1,clinical,trials,support,proceeding,to,phase,2,clinical,trials.,Investigational,New,Drug,(IND),application,submitted,to,and,reviewed,by,FDA,(CDER)

Phase,1,clinical,trials,support,proceeding,to,phase,2,clinical,trials.,Investigational,New,Drug,(IND),application,submitted,to,and,reviewed,by,FDA,(CBER)

Class,III,device,safety,is,demonstrated.,510(K),data,demonstrates,substantial,equivalency,to,predicate,device.

TRL7 System/Subsystem,Development Phase,2,clinical,trial,is,completed.,Phase,3,clinical,trial,plan,is,approved,by,FDA,(CDER)

Phase,2,clinical,trial,is,completed.,Phase,3,clinical,trial,plan,is,approved,by,FDA,(CBER)

Final,product,design,is,validated,and,final,prototypes,are,produced,and,tested.

TRL8 System,Test,,Launch,,&,Operations Phase,3,clinical,trial,is,completed.,FDA,(CDER),approves,New,Drug,Application,(NDA)

Phase,3,clinical,trial,is,completed.,FDA,(CBER),approves,Biologic,License,Application,(BLA)

FDA,(CDRH),approves,the,Premarket,Approval,(PMA),for,medical,device,or,applicable,510(K),for,devices

TRL9 Postmarket,surveillance Post,marketing,studies,and,surveillance Post,marketing,studies,and,surveillance Post,marketing,studies,and,surveillance