Njengoba ukwelashwa okuthuthukayo kuvela cishe nyanga zonke, ukudluliswa kobuchwepheshe obusebenzayo phakathi kwe-biopharmaceuticals nabakhiqizi kubaluleke kakhulu kunangaphambili.UKen Foreman, Umqondisi Omkhulu Wesu Lomkhiqizo kwa-IDBS, uchaza ukuthi isu elihle ledijithali lingakusiza kanjani ugweme amaphutha avamile okudlulisa ubuchwepheshe.
I-Biopharmaceutical Life Cycle Management (BPLM) iwukhiye wokuletha imithi emisha yokwelapha nesindisa impilo emhlabeni.Ihlanganisa zonke izigaba zokuthuthukiswa kwezidakamizwa, okuhlanganisa ukuhlonza abantu abazokhethwa emithini, izivivinyo zomtholampilo ukuze kutholwe ukusebenza kahle, izinqubo zokukhiqiza, kanye nemisebenzi yochungechunge lokunikezela ngale mithi ezigulini.
Ngayinye yale misebenzi yepayipi eqondile ivame ukuba khona ezingxenyeni ezihlukene zenhlangano, nabantu, okokusebenza, namathuluzi edijithali enzelwe lezo zidingo.Ukudluliswa kobuchwepheshe kuyinqubo yokuvala igebe phakathi kwalezi zingxenye ezahlukene ukuze kudluliselwe ukuthuthukiswa, ukukhiqizwa kanye nolwazi lokuqinisekisa ikhwalithi.
Kodwa-ke, ngisho nezinkampani ezisungulwe kakhulu ze-biotech zibhekana nezinselele ekusebenziseni ngempumelelo ukudluliswa kobuchwepheshe.Nakuba ezinye izindlela (njengamasosha omzimba we-monoclonal kanye nama-molecule amancane) zifaneleka ezindleleni zepulatifomu, ezinye (ezifana nokwelashwa kwamangqamuzana nofuzo) zintsha embonini, futhi ubunkimbinkimbi nokuhlukahluka kwalezi zindlela zokwelapha ezintsha kuyaqhubeka kwengeza endleleni evele intekenteke. inqubo Khulisa ingcindezi.
Ukudluliswa kobuchwepheshe kuyinqubo eyinkimbinkimbi ebandakanya abalingisi abaningi kuchungechunge lokuhlinzeka, ngamunye enezela izinselelo zakhe kuzibalo.Abaxhasi be-Biopharmaceutical banamandla okuphatha lonke uhlelo, ukulinganisa ukwakhiwa kochungechunge lokuhlinzeka ngezidingo zabo eziqinile zokuhlela ukusheshisa isikhathi sokumaketha.
Abamukeli bobuchwepheshe be-downstream nabo banezinselelo zabo ezihlukile.Abanye abakhiqizi bakhulume ngokwamukela izidingo zokudlulisa ubuchwepheshe eziyinkimbinkimbi ngaphandle kwemiyalelo ecacile nefushane.Ukungabi nesiqondiso esicacile kungaba nomthelela omubi kwikhwalithi yomkhiqizo futhi kuvame ukulimaza ubudlelwano ngokuhamba kwesikhathi.
Sungula uchungechunge lokunikezela ngaphambi kwenqubo yokudlulisa ubuchwepheshe lapho ukhetha indawo yokukhiqiza efaneleke kakhulu.Lokhu kubandakanya ukuhlaziya ukwakheka kwemishini yomkhiqizi, ukuhlaziya kwabo kanye nokulawulwa kwenqubo, kanye nokutholakala kanye nokufaneleka kwemishini.
Lapho kukhethwa i-CMO yenkampani yangaphandle, izinkampani kufanele futhi zihlole ukulungela kwe-CMO ukusebenzisa izinkundla zokwabelana ngedijithali.Abakhiqizi abahlinzeka ngedatha eningi kumafayela e-Excel noma ephepheni bangaphazamisa ukukhiqizwa nokuqapha, okuholela ekubambezelekeni kokukhishwa okukhulu.
Amathuluzi anamuhla atholakalayo kwezentengiso asekela ukushintshana kwedijithali kwamaresiphi, izitifiketi zokuhlaziya, nedatha yeqoqo.Ngalawa mathuluzi, amasistimu okuphatha ulwazi olucutshungulwayo (i-PIMS) angaguqula ukudluliswa kobuchwepheshe kusuka emisebenzini engaguquki kuya ekwabelaneni kolwazi okuguquguqukayo, okuqhubekayo nokusebenzisanayo.
Uma kuqhathaniswa nezinqubo eziyinkimbinkimbi kakhulu ezihlanganisa amaphepha, amaspredishithi nezinhlelo ezihlukene, ukusetshenziswa kwe-PIMS kunikeza inqubo eqhubekayo yokubuyekeza izinqubo kusukela kumasu okuphatha kuya ekuthotshelweni okuphelele kokwenza okuhle okunesikhathi esincane, izindleko nobungozi.
Ukuze uphumelele, isixazululo sokudlulisa ubuchwepheshe ngaphakathi kobambiswano olunempilo lokumaketha nokumaketha kufanele luphelele kunezixazululo ezichazwe ngenhla.
Ingxoxo yakamuva ne-Global COO yoMqondisi Wezokumaketha Kwemboni Ehamba Phambili iveze ukuthi isithiyo sokuqala sokuhlukanisa phakathi kwezigaba ze-BPLM ukungabi khona kwesixazululo esitholakalayo sokuthengisa ubuchwepheshe esihlanganisa zonke izingxenye zenqubo, hhayi nje ukuqeda ukukhiqiza.indawo.Lesi sidingo siba sibaluleke nakakhulu ezinhlelweni zokunwetshwa kwe-biopharmaceutical zokukhiqizwa okukhulu kwemithi yokwelapha emisha.Ikakhulukazi, abahlinzeki bempahla eluhlaza badinga ukukhethwa, izidingo zesikhathi zicatshangelwe, futhi kuvunyelwene nezinqubo zokuhlola ukuhlaziya, konke okudinga ukuthuthukiswa kwezinqubo zokusebenza ezijwayelekile.
Abanye abathengisi baxazulule izinkinga ezithile ngokwabo, kodwa eminye imisebenzi ye-BPLM ayikabi nazo izixazululo ngaphandle kwebhokisi.Ngenxa yalokho, izinkampani eziningi zithenga "izixazululo zamaphuzu" ezingaklanyelwe ukuhlanganiswa nomunye nomunye.Izixazululo zesofthiwe ezinikezelwe endaweni zenza izithiyo ezengeziwe zobuchwepheshe, njengokuxhumana kuzo zonke izindonga zomlilo ezinezixazululo zamafu, isidingo sokuthi iminyango ye-IT ivumelane nezinqubo zobunikazi ezintsha, nokuhlanganiswa okunzima namadivayisi angaxhunyiwe ku-inthanethi.
Isixazululo ukusebenzisa umgwaqo omkhulu wedatha odidiyelwe owenza ukuphathwa kwedatha kube lula, ukunyakaza nokushintshisana phakathi kwamathuluzi ahlukene.
Abanye abantu bakholelwa ukuthi izindinganiso ziyisihluthulelo sokuxazulula izinkinga.I-ISA-88 yokuphathwa kwenqwaba iyisibonelo sezinga lenqubo yokukhiqiza elamukelwa izinkampani eziningi ze-biopharmaceutical.Kodwa-ke, ukuqaliswa kwangempela kwezinga kungahluka kakhulu, okwenza ukuhlanganiswa kwedijithali kube nzima kunalokho okwakuhlosiwe ekuqaleni.
Isibonelo yikhono lokwabelana kalula ngolwazi mayelana nezindlela zokupheka.Namuhla, lokhu kusakwenziwa ngezinqubomgomo zokulawula ukwabelana kwedokhumenti ye-Word ende.Izinkampani eziningi zifaka zonke izingxenye ze-S88, kodwa ifomethi yangempela yefayela lokugcina incike kumxhasi wezidakamizwa.Lokhu kubangela ukuthi i-CMO ifanise wonke amasu okulawula nenqubo yokukhiqiza yawo wonke amaklayenti amasha abawathathayo.
Njengoba abathengisi abaningi ngokwengeziwe basebenzisa amathuluzi athobela i-S88, izinguquko nokuthuthukiswa kwale ndlela kungase kwenzeke ngokuhlanganiswa, ukutholwa kanye nokubambisana.
Ezinye izindaba ezimbili ezibalulekile ukuntuleka kwamagama ajwayelekile enqubo kanye nokungabi bikho obala ekushintshisaneni kwedatha.
Kule minyaka eyishumi edlule, izinkampani eziningi ezithaka imithi zenze izinhlelo zangaphakathi “zokuvumelanisa” ukuze zimise ukusebenzisa kwabasebenzi bazo amagama avamile ezinqubo nezinhlelo.Kodwa-ke, ukukhula kwemvelo kungenza umehluko njengoba amafekthri amasha asungulwa emhlabeni wonke, athuthukisa izinqubo zawo zangaphakathi, ikakhulukazi lapho enza imikhiqizo emisha.
Ngenxa yalokho, kunokukhathazeka okukhulayo mayelana nokuntula ukubona kusengaphambili ekwabelaneni ngedatha ukuze kuthuthukiswe izinqubo zebhizinisi nezokukhiqiza.Lokhu kugoqa kungenzeka kushube njengoba izinkampani ezinkulu ze-biopharmaceutical ziqhubeka nokusuka ekukhuleni kwezinto eziphilayo ziye ekuthengeni.Izinkampani eziningi ezinkulu zemithi zizuze le nkinga njengefa ngemva kokuthola izinkampani ezincane, ngakho uma zilinda isikhathi eside ukuthi ukuhwebelana kwedatha kucutshungulwe, kuzophazamisa kakhulu.
Ukushoda kwamagama ajwayelekile okuqamba amapharamitha kungaholela ezinkingeni ezisukela ekudidekeni okulula phakathi konjiniyela bezinqubo abaxoxa ngezinqubo kuya ekuhlukeni okukhulu kakhulu phakathi kwedatha yokulawula inqubo ehlinzekwa amasayithi amabili ahlukene asebenzisa imingcele ehlukene ukuqhathanisa ikhwalithi.Lokhu kungaholela ezinqumweni zokukhishwa kwenqwaba ezingalungile ngisho “neFomu 483” le-FDA, elibhalelwe ukuqinisekisa ubuqotho bedatha.
Ukwabelana ngedatha yedijithali nakho kudinga ukunakwa okukhethekile ezigabeni zokuqala zenqubo yokudluliswa kobuchwepheshe, ikakhulukazi uma ubudlelwano obusha busungulwa.Njengoba kushiwo ngaphambili, ukubandakanyeka kozakwethu omusha ekuhwebeni kwedijithali kungase kudinge ushintsho lwesiko kulo lonke uchungechunge lokuhlinzeka, njengoba ozakwethu bangadinga amathuluzi amasha nokuqeqeshwa, kanye nezinhlelo zenkontileka ezifanele, ukuze kuqinisekiswe ukuhambisana okuqhubekayo kwazo zombili izinhlangothi.
Inkinga enkulu i-Big Pharma ebhekene nayo ukuthi abathengisi bazobanika ukufinyelela kumasistimu abo njengoba kudingeka.Kodwa-ke, bavame ukukhohlwa ukuthi laba bathengisi babuye bagcine idatha yamanye amakhasimende kuzinqolobane zabo.Isibonelo, i-Laboratory Information Management System (LIMS) igcina imiphumela yokuhlola yokuhlaziya yayo yonke imikhiqizo ekhiqizwa ama-CMO.Ngakho-ke, umenzi ngeke anikeze ukufinyelela ku-LIMS kunoma yiliphi ikhasimende ukuze kuvikelwe ubumfihlo bamanye amakhasimende.
Kunezindlela eziningana zokuxazulula le nkinga, kodwa isikhathi esengeziwe siyadingeka ukuze kuthuthukiswe futhi kuhlolwe amathuluzi amasha nezinqubo ezihlinzekwa abathengisi noma ezithuthukiswe ngaphakathi endlini.Kuzo zombili izimo, kubaluleke kakhulu ukubandakanya umnyango we-IT kusukela ekuqaleni, njengoba ukuphepha kwedatha kubaluleke kakhulu, futhi ama-firewall angase adinge amanethiwekhi ayinkimbinkimbi ukushintshanisa idatha.
Ngokuvamile, lapho izinkampani ze-biopharmaceutical zihlola ukukhula kwazo kwedijithali ngokwamathuba okudlulisa ubuchwepheshe be-BPLM, kufanele zihlonze izithiyo ezibalulekile eziholela ekwenyukeni kwezindleko kanye/noma ukubambezeleka kokulungela ukukhiqiza.
Kufanele benze imephu yamathuluzi asebevele benawo futhi banqume ukuthi lawo mathuluzi anele yini ukufeza izinhloso zabo zebhizinisi.Uma kungenjalo, badinga ukuhlola amathuluzi imboni okufanele iwanikeze futhi babheke ozakwethu abangasiza ukuvala igebe.
Njengoba izixazululo zokudlulisa ubuchwepheshe bokukhiqiza ziqhubeka nokuvela, ukuguqulwa kwedijithali kwe-BPLM kuzovula indlela yekhwalithi ephezulu kanye nokunakekelwa kwesiguli okusheshayo.
U-Ken Forman uneminyaka engaphezu kwengama-28 yesipiliyoni nobungcweti ku-IT, ukusebenza, kanye nokuphathwa komkhiqizo namaphrojekthi okugxile ku-software nasendaweni yezemithi. U-Ken Forman uneminyaka engaphezu kwengama-28 yesipiliyoni nobungcweti ku-IT, ukusebenza, kanye nokuphathwa komkhiqizo namaphrojekthi okugxile ku-software nasendaweni yezemithi.U-Ken Foreman uneminyaka engaphezu kwengu-28 yesipiliyoni nobungcweti ku-IT, ukusebenza kanye nokuphathwa komkhiqizo kanye nephrojekthi okugxile kuma-software nemithi.U-Ken Foreman uneminyaka engaphezu kwengu-28 yesipiliyoni nobungcweti ku-IT, ukusebenza kanye nokuphathwa komkhiqizo kanye nephrojekthi okugxile kuma-software nemithi.Ngaphambi kokujoyina i-Skyland Analytics, u-Ken wayenguMqondisi Wokuphathwa Kohlelo lwe-NAM e-Biovia Dassault Systemes futhi wabamba izikhundla ezihlukahlukene zomqondisi e-Aegis Analytical.Ngaphambilini, ubeyiSikhulu Esiphezulu Solwazi kwa-Rally Software Development, Isikhulu Esiphezulu Sezohwebo kwa-Fischer Imaging, kanye neSikhulu Esiphezulu Solwazi kwa-Allos Therapeutics and Genomica.
Ngaphezulu kwe-150,000 izivakashi zanyanga zonke ziyisebenzisela ukulandela ibhizinisi le-biotech nokusungula.Ngithemba ukuthi uzokujabulela ukufunda izindaba zethu!