Njengoba ukwelashwa okuyinkimbinkimbi kuvela cishe njalo ngenyanga, ukudluliselwa kobuchwepheshe okuphumelelayo phakathi kwe-biopharmaceuticals nabakhiqizi kubaluleke kakhulu kunanini ngaphambili. UKen Foreman, uMqondisi Omkhulu Wesu Lomkhiqizo kwa-IDBS, uchaza ukuthi isu elihle ledijithali lingakusiza kanjani ukugwema amaphutha avamile okudluliselwa kobuchwepheshe.
Ukuphathwa Komjikelezo Wokuphila Kwe-Biopharmaceutical (BPLM) kuyisihluthulelo sokuletha imithi emisha yokwelapha nesindisa impilo emhlabeni. Ihlanganisa zonke izigaba zokuthuthukiswa kwemithi, okuhlanganisa ukuhlonza abantu abazongenela imithi, izivivinyo zemitholampilo ukuze kutholakale ukusebenza kahle, izinqubo zokukhiqiza, kanye nemisebenzi yochungechunge lokuhlinzeka ukuze kulethwe le mithi ezigulini.
Ngayinye yalezi zindlela zokusebenza kwamapayipi aqondile ivame ukuba khona ezingxenyeni ezahlukene zenhlangano, nabantu, imishini, namathuluzi edijithali aklanyelwe lezo zidingo. Ukudluliselwa kobuchwepheshe kuyinqubo yokuvala izikhala phakathi kwalezi zingxenye ezahlukene ukuze kudluliselwe ulwazi lokuthuthukiswa, ukukhiqiza kanye nokuqinisekiswa kwekhwalithi.
Kodwa-ke, ngisho nezinkampani ze-biotech ezisunguliwe kakhulu zibhekene nezinselele ekusebenziseni ngempumelelo ukudluliselwa kobuchwepheshe. Ngenkathi ezinye izindlela (ezifana nama-antibodies e-monoclonal kanye nama-molecule amancane) zifanelekela izindlela zesikhulumi, ezinye (ezifana nokwelashwa kwamaseli kanye nezakhi zofuzo) zintsha kakhulu embonini, futhi ubunzima kanye nokuguquguquka kwalezi zindlela zokwelapha ezintsha kuyaqhubeka nokwengeza enkambisweni ebuthakathaka kakade. Yandisa ingcindezi.
Ukudluliselwa kobuchwepheshe kuyinqubo eyinkimbinkimbi ehilela abantu abaningi ababambe iqhaza ochungechungeni lokuhlinzeka, ngamunye enezela izinselelo zakhe kulesi sibalo. Abaxhasi be-biopharmaceutical banamandla okuphatha lonke uhlelo, belinganisa ukwakhiwa kochungechunge lokuhlinzeka nezidingo zabo zokuhlela eziqinile ukuze basheshise isikhathi sokuya emakethe.
Abamukeli bezobuchwepheshe abasezansi nabo banezinselele zabo ezihlukile. Abanye abakhiqizi bakhulume ngokwamukela izidingo zokudlulisa ubuchwepheshe eziyinkimbinkimbi ngaphandle kwemiyalelo ecacile neqondile. Ukuntuleka kwesiqondiso esicacile kungathinta kabi ikhwalithi yomkhiqizo futhi kuvame ukulimaza ukubambisana ngokuhamba kwesikhathi.
Misa uchungechunge lokuhlinzeka kusenesikhathi enkambisweni yokudlulisa ubuchwepheshe lapho ukhetha indawo yokukhiqiza efaneleke kakhulu. Lokhu kufaka phakathi ukuhlaziywa komklamo wesitshalo somkhiqizi, ukuhlaziywa kwabo kanye nokulawulwa kwenqubo, kanye nokutholakala kanye nokufaneleka kwemishini.
Uma ukhetha i-CMO evela eceleni, izinkampani kumele futhi zihlole ukulungela kwe-CMO ukusebenzisa amapulatifomu okwabelana ngedijithali. Abakhiqizi abahlinzeka ngedatha yenqwaba kumafayela e-Excel noma ephepheni bangaphazamisa ukukhiqizwa nokuqapha, okuholela ekubambezelekeni kokukhishwa kwenqwaba.
Amathuluzi anamuhla atholakala kwezentengiselwano asekela ukushintshaniswa kwedijithali kwezindlela zokupheka, izitifiketi zokuhlaziya, kanye nedatha yeqoqo. Ngala mathuluzi, izinhlelo zokuphatha ulwazi lwenqubo (i-PIMS) zingaguqula ukudluliswa kobuchwepheshe kusuka emisebenzini engaguquki kuya ekwabelaneni ngolwazi oluguquguqukayo, oluqhubekayo nolusebenzisanayo.
Uma kuqhathaniswa nezinqubo eziyinkimbinkimbi kakhulu ezihilela iphepha, amaspredishithi nezinhlelo ezihlukene, ukusetshenziswa kwe-PIMS kunikeza inqubo eqhubekayo yokubukeza izinqubo kusukela esu lokuphatha kuya ekuhambisaneni ngokugcwele nemikhuba emihle kakhulu ngesikhathi esincane, izindleko kanye nengozi.
Ukuze kuphumelele, ikhambi lokudlulisa ubuchwepheshe ngaphakathi kobambiswano oluhle lokumaketha nokumaketha kumele libe nenani elikhulu kunezixazululo ezichazwe ngenhla.
Ingxoxo yakamuva ne-COO Yomhlaba Wonke yoMqondisi Ohamba Phambili Wokumaketha Kwemboni iveze ukuthi isithiyo esikhulu ekuhlukaniseni phakathi kwezigaba ze-BPLM ukuntuleka kwesisombululo sokudlulisa ubuchwepheshe esitholakala kwezentengiselwano esihlanganisa zonke izingxenye zenqubo, hhayi nje kuphela indawo yokukhiqiza. Lesi sidingo siba sibaluleke kakhulu ezinhlelweni zokwandisa imithi ye-biopharmaceutical zokukhiqizwa okukhulu kwemithi emisha yokwelapha. Ikakhulukazi, abahlinzeki bezinto zokusetshenziswa kufanele bakhethwe, kucatshangelwe izidingo zesikhathi, futhi kuvunyelwane ngezinqubo zokuhlola zokuhlaziya, konke okudinga ukuthuthukiswa kwezinqubo zokusebenza ezijwayelekile.
Abanye abathengisi baxazulule izinkinga ezithile bodwa, kodwa eminye imisebenzi ye-BPLM ayikabi nazixazululo ezivele zivele. Ngenxa yalokho, izinkampani eziningi zithenga “izixazululo zamaphuzu” ezingaklanyelwe ukuhlanganiswa. Izixazululo zesofthiwe ezinikezelwe endaweni ethile zidala izithiyo ezengeziwe zobuchwepheshe, njengokuxhumana phakathi kwama-firewall nezixazululo zamafu, isidingo sokuthi iminyango ye-IT izivumelanise nezinqubo ezintsha zobunikazi, kanye nokuhlanganiswa okunzima namadivayisi angaxhunyiwe ku-inthanethi.
Isixazululo ukusebenzisa umgwaqo omkhulu wedatha ohlanganisiwe owenza kube lula ukuphathwa kwedatha, ukunyakaza kanye nokushintshana phakathi kwamathuluzi ahlukene.
Abanye abantu bakholelwa ukuthi amazinga ayisihluthulelo sokuxazulula izinkinga. I-ISA-88 yokuphathwa kweqoqo iyisibonelo senqubo yokukhiqiza eyamukelwa izinkampani eziningi ze-biopharmaceutical. Kodwa-ke, ukusetshenziswa kwangempela kwale nqubo kungahluka kakhulu, okwenza ukuhlanganiswa kwedijithali kube nzima kunalokho okwakuhlosiwe ekuqaleni.
Isibonelo yikhono lokwabelana kalula ngolwazi mayelana nezindlela zokupheka. Namuhla, lokhu kusenziwa ngezinqubomgomo zokulawula ukwabelana ngamadokhumenti e-Word ezinde. Izinkampani eziningi zifaka zonke izingxenye ze-S88, kodwa ifomethi yangempela yefayela lokugcina incike kumxhasi wezidakamizwa. Lokhu kuholela ekutheni i-CMO ifanele ukufanisa wonke amasu okulawula nenqubo yokukhiqiza yawo wonke amakhasimende amasha abawasebenzisayo.
Njengoba abathengisi abaningi ngokwengeziwe besebenzisa amathuluzi ahambisana ne-S88, izinguquko kanye nokuthuthukiswa kwale ndlela kungenzeka ukuthi kuza ngokuhlanganiswa, ukuthengwa kanye nokubambisana.
Ezinye izinkinga ezimbili ezibalulekile ukuntuleka kwamagama ajwayelekile enqubo kanye nokuntuleka kokucaca ekushintshaneni kwedatha.
Eminyakeni eyishumi edlule, izinkampani eziningi zemithi ziye zaqalisa izinhlelo zangaphakathi "zokuvumelanisa" ukuze zenze kube sezingeni elifanayo ukusetshenziswa kwabasebenzi bazo kwamagama ajwayelekile ezinqubo nezinhlelo. Kodwa-ke, ukukhula kwemvelo kungenza umehluko njengoba kumiswa amafektri amasha emhlabeni wonke, ethuthukisa izinqubo zawo zangaphakathi, ikakhulukazi lapho kwenziwa imikhiqizo emisha.
Ngenxa yalokho, kunokukhathazeka okukhulayo mayelana nokuntuleka kokubona kusengaphambili ekwabelaneni ngedatha ukuze kuthuthukiswe izinqubo zebhizinisi nezokukhiqiza. Lokhu kuphazamiseka kungenzeka kukhule njengoba izinkampani ezinkulu ze-biopharmaceutical ziqhubeka nokushintsha kusuka ekukhuleni kwezinto eziphilayo kuya ekuthengeni. Izinkampani eziningi ezinkulu zemithi zizuze le nkinga ngemva kokuthola izinkampani ezincane, ngakho-ke uma zilinda isikhathi eside ukuthi kucutshungulwe ukushintshaniswa kwedatha, kulapho kuzophazamisa khona kakhulu.
Ukuntuleka kwamagama ajwayelekile okuqamba amapharamitha kungaholela ezinkingeni ezisukela ekudidekeni okulula phakathi konjiniyela bezinqubo abaxoxa ngezinqubo kuya ekungavumelanini okukhulu phakathi kwedatha yokulawula izinqubo enikezwa amasayithi amabili ahlukene asebenzisa amapharamitha ahlukene ukuqhathanisa ikhwalithi. Lokhu kungaholela ezinqumweni zokukhishwa kweqembu ezingalungile ngisho ne-“Form 483” ye-FDA, ebhalwe ukuqinisekisa ubuqotho bedatha.
Ukwabelana ngedatha yedijithali nakho kudinga ukunakwa okukhethekile ezigabeni zokuqala zenqubo yokudlulisa ubuchwepheshe, ikakhulukazi lapho kwakhiwa ubudlelwano obusha. Njengoba kushiwo ngaphambili, ukubandakanyeka komlingani omusha ekushintshaneni kwedijithali kungadinga ushintsho lwesiko kulo lonke uchungechunge lokuhlinzeka, njengoba ozakwethu bengadinga amathuluzi amasha nokuqeqeshwa, kanye namalungiselelo afanele enkontileka, ukuqinisekisa ukulandelwa okuqhubekayo yizinhlangothi zombili.
Inkinga enkulu iBig Pharma ebhekene nayo ukuthi abathengisi bazobanika ukufinyelela ezinhlelweni zabo uma kudingeka. Kodwa-ke, bavame ukukhohlwa ukuthi laba bathengisi bagcina nedatha yabanye amakhasimende ezizindeni zabo zedatha. Isibonelo, i-Laboratory Information Management System (LIMS) igcina imiphumela yokuhlolwa kokuhlaziya yayo yonke imikhiqizo eyenziwe ama-CMO. Ngakho-ke, umenzi ngeke anikeze noma yiliphi ikhasimende ukufinyelela ku-LIMS ukuze avikele ubumfihlo bamanye amakhasimende.
Kunezindlela eziningana zokuxazulula le nkinga, kodwa kudingeka isikhathi esengeziwe ukuthuthukisa nokuhlola amathuluzi nezinqubo ezintsha ezinikezwa abathengisi noma ezithuthukiswe ngaphakathi. Kuzo zombili izimo, kubaluleke kakhulu ukubandakanya umnyango we-IT kusukela ekuqaleni, njengoba ukuphepha kwedatha kubaluleke kakhulu, futhi ama-firewall angadinga amanethiwekhi ayinkimbinkimbi ukushintshanisa idatha.
Ngokuvamile, lapho izinkampani ze-biopharmaceutical zihlola ukuvuthwa kwazo kwedijithali maqondana namathuba okudluliselwa kobuchwepheshe be-BPLM, kufanele zithole izithiyo ezibalulekile eziholela ekukhuphukeni kwezindleko kanye/noma ukubambezeleka kokulungela ukukhiqizwa.
Kumelwe babhale amathuluzi asevele enawo futhi banqume ukuthi lawo mathuluzi anele yini ukufeza imigomo yebhizinisi labo. Uma kungenjalo, kudingeka bahlole amathuluzi imboni enawo futhi bafune abalingani abangasiza ekuvaleni igebe.
Njengoba izixazululo zokudlulisa ubuchwepheshe bokukhiqiza ziqhubeka nokukhula, ukuguqulwa kwedijithali kwe-BPLM kuzovula indlela yokunakekelwa kweziguli okuseqophelweni eliphezulu nokusheshayo.
UKen Forman uneminyaka engaphezu kwengu-28 yesipiliyoni kanye nobuchwepheshe ku-IT, ukusebenza, kanye nokuphathwa komkhiqizo kanye namaphrojekthi okugxile kusofthiwe kanye nesikhala semithi. UKen Forman uneminyaka engaphezu kwengu-28 yesipiliyoni kanye nobuchwepheshe ku-IT, ukusebenza, kanye nokuphathwa komkhiqizo kanye namaphrojekthi okugxile kusofthiwe kanye nesikhala semithi.UKen Foreman uneminyaka engaphezu kwengu-28 yesipiliyoni kanye nobuchwepheshe ku-IT, ukusebenza kanye nokuphathwa komkhiqizo kanye namaphrojekthi agxile kwisofthiwe kanye nemithi.UKen Foreman uneminyaka engaphezu kwengu-28 yesipiliyoni kanye nobuchwepheshe ku-IT, ukusebenza kanye nokuphathwa komkhiqizo kanye namaphrojekthi okugxile kwisofthiwe kanye nemithi. Ngaphambi kokujoyina i-Skyland Analytics, uKen wayenguMqondisi we-NAM Program Management e-Biovia Dassault Systemes futhi wayephethe izikhundla ezahlukene zomqondisi e-Aegis Analytical. Ngaphambili, wayeyi-Chief Information Officer e-Rally Software Development, i-Chief Commercial Officer e-Fischer Imaging, kanye ne-Chief Information Officer e-Allos Therapeutics and Genomica.
Izivakashi ezingaphezu kuka-150,000 ngenyanga ziyisebenzisa ukulandela ibhizinisi le-biotech kanye nokusungula izinto ezintsha. Ngiyethemba ukuthi uzokujabulela ukufunda izindaba zethu!