LEADER 02934nam 2200661 a 450 001 9910812068203321 005 20200520144314.0 010 $a0-309-17816-9 010 $a1-282-08355-4 010 $a9786612083556 010 $a0-309-12089-6 035 $a(CKB)1000000000785689 035 $a(OCoLC)726823396 035 $a(CaPaEBR)ebrary10286191 035 $a(SSID)ssj0000114554 035 $a(PQKBManifestationID)11129889 035 $a(PQKBTitleCode)TC0000114554 035 $a(PQKBWorkID)10125386 035 $a(PQKB)11547321 035 $a(MiAaPQ)EBC3378464 035 $a(Au-PeEL)EBL3378464 035 $a(CaPaEBR)ebr10286191 035 $a(CaONFJC)MIL208355 035 $a(OCoLC)923280041 035 $a(EXLCZ)991000000000785689 100 $a20090925d2009 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 00$aBreakthrough business models $edrug development for rare and neglected diseases and individualized therapies : workshop summary /$fTheresa Wizemann, Sally Robinson, and Robert Giffin ; Forum on Health Sciences Policy, Institute of Medicine of the National Academies 205 $a1st ed. 210 $aWashington, D.C. $cNational Academies Press$d2009 215 $a1 online resource (149 p.) 300 $aBibliographic Level Mode of Issuance: Monograph 311 $a0-309-12088-8 320 $aIncludes bibliographical references (p. 104-105). 327 $aIntroduction and overview -- Current model for financing drug development : from concept through approval -- The Food and Drug Administration's Orphan Drug Program -- Diverse funding models -- Strategies for facilitating sharing of research materials and data -- Strategies of navigation intellectual property -- Strategies for facilitating clinical trials -- Summary. 330 $a"The Institute of Medicine's Forum on Drug Discovery, Development, and Translation held a public workshop on June 23, 2008, titled "Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies." The purpose of the workshop was to explore innovative strategies for orphan drug development."--P. 3. 606 $aOrphan drugs$xGovernment policy$zUnited States 606 $aPharmaceutical policy$zUnited States 606 $aDrugs$xDesign$zUnited States 615 0$aOrphan drugs$xGovernment policy 615 0$aPharmaceutical policy 615 0$aDrugs$xDesign 676 $a615/.19 701 $aWizemann$b Theresa M$0890630 701 $aRobinson$b Sally$0620917 701 $aGiffin$b Robert B$01653478 712 02$aInstitute of Medicine (U.S.).$bForum on Drug Discovery, Development, and Translation. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910812068203321 996 $aBreakthrough business models$94039330 997 $aUNINA