Sezvo mishonga yakaoma ichiramba ichikura mwedzi wega wega, kutapurirana tekinoroji kunobudirira pakati pemishonga yemishonga inorapa zvipembenene nevagadziri kwave kukosha kupfuura kare. Ken Foreman, Mukuru weZvigadzirwa zveChigadzirwa kuIDBS, anotsanangura kuti nzira yakanaka yedhijitari inogona kukubatsira sei kudzivirira zvikanganiso zvinowanzoitwa pakutapurirana tekinoroji.
Kutarisira Kutenderera Kwehupenyu Hwemishonga (BPLM) ndiyo kiyi yekuunza mishonga mitsva yekurapa uye inoponesa hupenyu pasi rose. Inosanganisira matanho ese ekugadzirwa kwemishonga, kusanganisira kuzivikanwa kwemishonga inokwanisa kushandiswa, miedzo yekiriniki yekuona kushanda kwayo, maitiro ekugadzira, uye mabasa ekutengesa mishonga iyi kuvarwere.
Kushanda kwepaipi imwe neimwe yematanho aya ekuisa mapaipi emagetsi kunowanzo kuwanikwa munzvimbo dzakasiyana dzesangano, nevanhu, zvishandiso, uye maturusi edhijitari akagadzirirwa zvinodiwa izvozvo. Kutamisa tekinoroji inzira yekubatanidza mikaha iri pakati pezvikamu izvi zvakasiyana kuti utumidze ruzivo rwekusimudzira, kugadzira, uye vimbiso yemhando yepamusoro.
Zvisinei, kunyange makambani e biotech agara aripo anotarisana nematambudziko mukubudirira kwekushandisa tekinoroji. Kunyange zvazvo dzimwe nzira (dzakadai se monoclonal antibodies nemamorekuru madiki) dzakakodzera nzira dzepuratifomu, dzimwe (dzakadai se cell and gene therapy) dzichangobva kushandiswa muindasitiri, uye kuomarara uye kusiyana kwemishonga iyi mitsva kunoramba kuchiwedzera kune nzira yatove isina kusimba Kuwedzera kumanikidzwa.
Kuendesa tekinoroji inzira yakaoma inosanganisira vanhu vakawanda vari muchikamu chekutengesa, mumwe nemumwe achiwedzera matambudziko ake. Vatsigiri vemishonga yemishonga vane simba rekutarisira chirongwa chose, vachienzanisa kuvaka kwechikamu chekutengesa nezvinodiwa zvavo zvekuronga zvakasimba kuti vafambise nguva yekuenda kumusika.
Vagamuchiri vetekinoroji vari pasi pekambani vanewo matambudziko avo akasiyana. Vamwe vagadziri vakataura nezvekubvuma zvinodiwa zvakaoma zvekutumira tekinoroji vasina mirairo yakajeka uye yakapfupika. Kushaikwa kwenhungamiro yakajeka kunogona kukanganisa kunaka kwechigadzirwa uye kazhinji kunokanganisa kudyidzana kwenguva refu.
Gadzirai nzira yekugovera zvinhu pakutanga kwekutamisa tekinoroji pakusarudza nzvimbo yakakodzera yekugadzira zvinhu. Izvi zvinosanganisira kuongorora dhizaini yefekitori yemugadziri, kuongorora kwavo pachavo nekudzora mashandiro, uye kuwanikwa uye kufanirwa kwemidziyo.
Pakusarudza CMO wechitatu, makambani anofanirwawo kuongorora kugadzirira kweCMO kushandisa mapuratifomu ekugovana madhijitari. Vagadziri vanopa data rehuwandu mumafaira eExcel kana papepa vanogona kukanganisa kugadzirwa nekutarisa, zvichikonzera kunonoka kwekuburitswa kwehuwandu.
Zvishandiso zviripo nhasi zvinotsigira kuchinjana kwemaresipi, zvitupa zvekuongorora, uye data remabheti. Nezvishandiso izvi, masisitimu ekutarisira ruzivo rwemaitiro (PIMS) anogona kushandura kutamiswa kwetekinoroji kubva kumabasa asingachinji kuenda kukugovana ruzivo runoshanduka, rwunoenderera mberi uye runoshanda pamwe chete.
Zvichienzaniswa nemaitiro akaomarara anosanganisira mapepa, maspredishiti uye masisitimu akasiyana, kushandiswa kwePIMS kunopa maitiro anoenderera mberi ekuongorora maitiro kubva pahurongwa hwekutarisira kusvika pakutevedzera zvizere maitiro akanakisa pasina nguva shoma, mutengo uye njodzi.
Kuti ibudirire, mhinduro yekuchinjana tekinoroji mukati mekubatana kwakanaka kwekushambadzira nekushambadzira inofanira kunge yakazara kupfuura mhinduro dzatsanangurwa pamusoro apa.
Hurukuro yakaitwa munguva pfupi yapfuura neGlobal COO yeMutungamiriri weKushambadzira weIndasitiri Yakaratidza kuti chipingamupinyi chikuru pakupatsanurwa kwezvikamu zveBPLM kushaikwa kwemhinduro yekuchinjana tekinoroji inowanikwa mukutengeserana inofukidza zvikamu zvese zvemaitiro, kwete kungopedzisa kugadzirwa. Kudiwa uku kunova kwakakosha zvakanyanya muzvirongwa zvekuwedzera mishonga yemishonga yekurapa yakakura. Kunyanya, vatengesi vezvinhu zvekugadzira vanofanirwa kusarudzwa, zvinodiwa nenguva zvinofungwa, uye maitiro ekuongorora anobvumirana, zvese zvinoda kugadzirwa kwemaitiro ekushanda akajairwa.
Vamwe vatengesi vakagadzirisa mamwe matambudziko vega, asi mamwe mabasa eBPLM achiri asina mhinduro dzakajairika. Nekuda kweizvozvo, makambani mazhinji anotenga "mhinduro dzepoinzi" dzisina kugadzirwa kuti dzibatanidzwe. Mhinduro dzesoftware dzakatsaurirwa panzvimbo dzinogadzira zvimwe zvipingamupinyi zvehunyanzvi, zvakaita sekutaurirana pakati pemafirewall nemhinduro dzegore, kudiwa kwemadhipatimendi eIT kuti ajairane nemaitiro matsva emakambani, uye kubatanidzwa kwakaoma nemidziyo isina internet.
Mhinduro ndeyekushandisa nzira yakabatana yedata inoita kuti nyore kushandisa, kufambisa uye kuchinjana data pakati pezvishandiso zvakasiyana.
Vamwe vanhu vanotenda kuti mitemo ndiyo kiyi yekugadzirisa matambudziko. ISA-88 yekutarisira mabheti muenzaniso wemitemo yekugadzira inotorwa nemakambani mazhinji emishonga. Zvisinei, kushandiswa chaiko kwemitemo kunogona kusiyana zvikuru, zvichiita kuti kubatanidzwa kwedhijitari kuve kwakaoma kupfuura zvaitarisirwa pakutanga.
Muenzaniso wekugona kugovera ruzivo nezvemaresipi zviri nyore. Nhasi, izvi zvichiri kuitwa kuburikidza nehurongwa hwekudzora kugovana magwaro eWord. Makambani mazhinji anosanganisira zvikamu zvese zveS88, asi chimiro chaicho chefaira rekupedzisira chinoenderana neanopa mushonga. Izvi zvinoita kuti CMO ifanire kuenzanisa nzira dzese dzekudzora nemaitiro ekugadzira mutengi mutsva wese waanotanga.
Sezvo vatengesi vakawanda vachishandisa maturusi anoenderana neS88, shanduko nekuvandudzwa kwenzira iyi zvinogona kuuya kuburikidza nekubatanidzwa, kutenga uye kubatana.
Dzimwe nyaya mbiri dzakakosha kushaya mazwi akafanana ekuita izvi uye kusajeka kwekujeka mukutsinhana data.
Mumakore gumi apfuura, makambani mazhinji emishonga akaita zvirongwa zvemukati zve "kuwirirana" kuti vashandi vavo vashandise mazwi akafanana pakuita zvinhu nemasisitimu. Zvisinei, kukura kwezvinhu zvakasikwa kunogona kuita mutsauko sezvo mafekitori matsva achitangwa pasi rese, achigadzira maitiro avo emukati, kunyanya pakugadzira zvigadzirwa zvitsva.
Nekuda kweizvozvo, kune kushushikana kuri kukura pamusoro pekushaikwa kweruzivo rwekufanoona mukugovana data kuti kunatsiridze maitiro ebhizinesi nekugadzira. Dambudziko iri rinogona kuwedzera sezvo makambani makuru emishonga yemishonga ari kuramba achichinja kubva pakukura kwemakemikari kuenda pakutenga. Makambani mazhinji makuru emishonga akagara nhaka dambudziko iri mushure mekutenga makambani madiki, saka kana vakamirira kwenguva yakareba kuti data rigadziriswe, ndipo pachava nekukanganisa kukuru.
Kushaikwa kwemashoko akafanana ekupa mazita ezvipimo kunogona kukonzera matambudziko kubva pakuvhiringidzika kuri nyore pakati pemainjiniya ekugadzirisa maitiro kusvika pakusiyana kwakakomba pakati pedata rekutonga maitiro rinopihwa nemasaiti maviri akasiyana anoshandisa maparameter akasiyana kuenzanisa mhando. Izvi zvinogona kutungamira kusarudzo dzisina kururama dzekuburitsa ma "batch release" uye kunyange "Fomu 483" reFDA, iro rakanyorwa kuti rive nechokwadi chekuti data rakavimbika.
Kugovana data redhijitari kunofanirawo kutariswa zvakanyanya pakutanga kwekutamiswa kwetekinoroji, kunyanya kana paine kubatana kutsva. Sezvambotaurwa, kubatanidzwa kwemumwe mubatsiri mutsva mukutsinhana kwedhijitari kunogona kuda shanduko yetsika mukati meketani yese yekugovera, sezvo vadyidzani vangada maturusi matsva nekudzidziswa, pamwe nekurongwa kwakakodzera kwechibvumirano, kuve nechokwadi chekuti mapato ese ari maviri anoramba achitevedzera mitemo.
Dambudziko guru rinosangana neBig Pharma nderekuti vatengesi vanovapa mukana wekushandisa masisitimu avo sezvinodiwa. Zvisinei, vanowanzo kanganwa kuti vatengesi ava vanochengetawo data revamwe vatengi mumadhatabhesi avo. Semuenzaniso, Laboratory Information Management System (LIMS) inochengetedza mhinduro dzebvunzo dzekuongorora zvigadzirwa zvese zvakagadzirwa nemaCMO. Saka, mugadziri haazobvumidze chero mutengi wega wega kuwana LIMS kuitira kuchengetedza kuvanzika kwevamwe vatengi.
Kune nzira dzakawanda dzekugadzirisa dambudziko iri, asi nguva yakawedzerwa inodiwa kugadzira nekuyedza maturusi matsva nemaitiro anopiwa nevatengesi kana vakagadzirwa mukati. Muzviitiko zvese izvi, zvakakosha kubatanidza dhipatimendi reIT kubva pakutanga, sezvo kuchengetedzeka kwedata kuri kwakakosha, uye firewalls dzinogona kuda network dzakaoma kuti vachinjane data.
Kazhinji, makambani emishonga yekurapa (biopharmaceuticals) paanoongorora kukura kwawo kwedhijitari maererano nemikana yekutumira tekinoroji yeBPLM, anofanira kuona zvipingamupinyi zvikuru zvinotungamira mukudhura kwakanyanya uye/kana kunonoka kwekugadzirira kugadzirwa.
Vanofanira kuronga maturusi avanawo voona kana maturusi iwayo akakwana kuzadzisa zvinangwa zvebhizinesi ravo. Kana zvisina kudaro, vanofanira kuongorora maturusi anopiwa neindasitiri uye kutsvaga vadyidzani vanogona kubatsira kuvhara musiyano uripo.
Sezvo mhinduro dzekuchinjana tekinoroji yekugadzira dzichiri kuramba dzichichinja, shanduko yedhijitari yeBPLM ichagadzira nzira yekutarisira varwere vemhando yepamusoro uye nekukurumidza.
Ken Forman ane ruzivo rwemakore anopfuura makumi maviri nemasere muIT, mashandiro, uye manejimendi yezvigadzirwa nemapurojekiti akatarisana nenzvimbo yesoftware nemishonga. Ken Forman ane ruzivo rwemakore anopfuura makumi maviri nemasere muIT, mashandiro, uye manejimendi yezvigadzirwa nemapurojekiti akatarisana nenzvimbo yesoftware nemishonga.Ken Foreman ane ruzivo rwemakore anopfuura makumi maviri nemasere muIT, mashandiro, manejimendi yezvigadzirwa nezvirongwa zvinotarisa pasoftware nemishonga.Ken Foreman ane ruzivo rwemakore anopfuura makumi maviri nemasere muIT, mashandiro, manejimendi yezvigadzirwa nemapurojekiti akatarisana nesoftware nemishonga. Asati ajoina Skyland Analytics, Ken aive Director weNAM Program Management kuBiovia Dassault Systemes uye akabata zvinzvimbo zvakasiyana-siyana zve director kuAegis Analytical. Kare, aive Chief Information Officer kuRally Software Development, Chief Commercial Officer kuFischer Imaging, uye Chief Information Officer kuAllos Therapeutics and Genomica.
Vashanyi vanopfuura 150,000 pamwedzi vanoshandisa iyi nzira yekutevera bhizinesi re biotech nekuvandudzwa kwezvinhu zvitsva. Ndinovimba muchafarira kuverenga nyaya dzedu!