Njengoko unyango oluphucukileyo lusanda luvela phantse inyanga nenyanga, ukudluliselwa kobuchwepheshe okusebenzayo phakathi kwamayeza e-biopharmaceuticals kunye nabavelisi kubaluleke ngakumbi kunangaphambili. UKen Foreman, uMlawuli oyiNtloko weSicwangciso seMveliso kwi-IDBS, uchaza indlela isicwangciso sedijithali esilungileyo esinokukunceda ngayo uphephe iimpazamo eziqhelekileyo zokudluliselwa kobuchwepheshe.
Ulawulo loMjikelo woBomi beBiopharmaceutical (BPLM) lubalulekile ekuziseni amayeza amatsha onyango nasindisa ubomi kwihlabathi liphela. Lugubungela zonke izigaba zophuhliso lwamayeza, kubandakanya ukuchongwa kwamayeza afanelekileyo, iimvavanyo zeklinikhi zokumisela ukusebenza kakuhle, iinkqubo zokwenziwa, kunye nemisebenzi yokuhambisa la mayeza kwizigulana.
Ngayinye kwezi ndlela zokusebenza kwemibhobho ethe nkqo idla ngokubakho kwiindawo ezahlukeneyo zombutho, apho abantu, izixhobo, kunye nezixhobo zedijithali ezenzelwe ezo mfuno. Ukudluliselwa kobuchwepheshe yinkqubo yokuvala izikhewu phakathi kwezi ndawo zahlukeneyo ukuze kudluliselwe ulwazi lophuhliso, imveliso kunye nokuqinisekiswa komgangatho.
Nangona kunjalo, neenkampani ze-biotech ezidumileyo zijongene nemingeni ekuphumezeni ngempumelelo ukudluliselwa kwetekhnoloji. Nangona ezinye iindlela (ezifana nee-antibodies ze-monoclonal kunye neemolekyuli ezincinci) zifanelekile kwiindlela zeqonga, ezinye (ezifana nonyango lweeseli kunye ne-gene) zintsha kakhulu kwishishini, kwaye ubunzima kunye nokuguquguquka kwezi ndlela zonyango zintsha kuyaqhubeka nokongeza kwinkqubo esele ibuthathaka. Ukunyusa uxinzelelo.
Ukudluliselwa kobuchwepheshe yinkqubo enzima ebandakanya abantu abaninzi ababandakanyekayo kwikhonkco lokubonelela, ngamnye esongeza imingeni yakhe kwi-equation. Abaxhasi be-biopharmaceutical banamandla okulawula yonke inkqubo, belungelelanisa ukwakhiwa kwekhonkco lokubonelela neemfuno zabo zokucwangcisa eziqinileyo ukuze bakhawulezise ixesha lokuya kwimarike.
Abo bafumana ubuchwepheshe obulandelayo nabo baneengxaki zabo ezizodwa. Abanye abavelisi bathethe ngokwamkela iimfuno zokudluliselwa kobuchwepheshe ezintsonkothileyo ngaphandle kwemiyalelo ecacileyo necacileyo. Ukungabikho kolwalathiso olucacileyo kunokuchaphazela kakubi umgangatho wemveliso kwaye kudla ngokulimaza ubudlelwane ekuhambeni kwexesha.
Misela uthotho lokubonelela kwangethuba kwinkqubo yokudlulisela ubuchwepheshe xa ukhetha indawo yokuvelisa efanelekileyo. Oku kuquka uhlalutyo loyilo lwesityalo somenzi, uhlalutyo lwabo kunye nolawulo lwenkqubo, kunye nokufumaneka kunye nokufaneleka kwezixhobo.
Xa kukhethwa i-CMO yomntu wesithathu, iinkampani kufuneka zihlole ukulungela kwe-CMO ukusebenzisa amaqonga okwabelana ngedijithali. Abavelisi ababonelela ngedatha eninzi kwiifayile ze-Excel okanye ephepheni banokuphazamisana nemveliso kunye nokubeka esweni, nto leyo ekhokelela ekulibazisekeni kokukhutshwa kwe-lot.
Izixhobo zanamhlanje ezithengiswayo zixhasa ukutshintshiselana ngedijithali kweeresiphi, izatifikethi zohlalutyo, kunye nedatha yebhetshi. Ngezi zixhobo, iinkqubo zolawulo lolwazi lwenkqubo (i-PIMS) zinokuguqula ukudluliselwa kobuchwepheshe ukusuka kwimisebenzi engaguqukiyo ukuya ekwabelaneni ngolwazi oluguquguqukayo, oluqhubekayo nolusebenzisanayo.
Xa kuthelekiswa neenkqubo ezintsonkothileyo ezibandakanya amaphepha, iispredishithi kunye neenkqubo ezahlukeneyo, ukusetyenziswa kwe-PIMS kubonelela ngenkqubo eqhubekayo yokuphonononga iinkqubo ukusuka kwisicwangciso solawulo ukuya ekuthobeleni ngokupheleleyo iindlela ezilungileyo zokusebenza ngexesha elincinci, iindleko kunye nomngcipheko.
Ukuze siphumelele, isisombululo sokudlulisela ubuchwepheshe ngaphakathi kobudlelwane obusempilweni bokuthengisa nokuthengisa kufuneka sibe sibanzi ngakumbi kunezisombululo ezichazwe apha ngasentla.
Incoko yakutshanje ne-Global COO yoMlawuli oPhambili weNtengiso kwiShishini ityhile ukuba umqobo wokuqala ekuhlukaniseni phakathi kwamanqanaba e-BPLM kukungabikho kwesisombululo sokudlulisela ubuchwepheshe esifumanekayo kurhwebo esigubungela zonke iindawo zenkqubo, kungekuphela nje ukuphelisa imveliso. Le mfuneko iba yinto ebaluleke ngakumbi kwiinkqubo zokwandiswa kwe-biopharmaceutical kwimveliso enkulu yezonyango ezintsha. Ngokukodwa, ababoneleli bezinto eziluhlaza kufuneka bakhethwe, kuqwalaselwe iimfuno zexesha, kwaye kuvunyelwene ngeenkqubo zovavanyo lohlalutyo, zonke ezifuna ukuphuhliswa kweenkqubo zokusebenza ezisemgangathweni.
Abanye abathengisi baye bazisombulula iingxaki ezithile ngokwabo, kodwa eminye imisebenzi ye-BPLM ayinazo izisombululo ezingaqhelekanga. Ngenxa yoko, iinkampani ezininzi zithenga "izisombululo zamanqaku" ezingenzelwanga ukudityaniswa. Izisombululo zesoftware ezizinikeleyo kwindawo ethile zenza imiqobo eyongezelelweyo yobugcisa, njengonxibelelwano phakathi kwee-firewalls kunye nezisombululo zelifu, imfuneko yokuba amasebe e-IT aziqhelanise nemigaqo emitsha yobuqu, kunye nokudibanisa okunzima nezixhobo ezingaxhunyiwe kwi-intanethi.
Isisombululo kukusebenzisa indlela edibeneyo yolwazi eyenza kube lula ukuphathwa kwedatha, ukuhambahamba kunye nokutshintshiselana phakathi kwezixhobo ezahlukeneyo.
Abanye abantu bakholelwa ukuba imigangatho yeyona nto ibalulekileyo ekusombululeni iingxaki. I-ISA-88 yolawulo lwebhetshi ngumzekelo womgangatho wenkqubo yokuvelisa owamkelwe ziinkampani ezininzi ze-biopharmaceutical. Nangona kunjalo, ukuphunyezwa komgangatho ngokwawo kunokwahluka kakhulu, okwenza ukuhlanganiswa kwedijithali kube nzima kunokuba bekucwangcisiwe ekuqaleni.
Umzekelo kukukwazi ukwabelana ngolwazi ngokulula malunga neeresiphi. Namhlanje, oku kusenziwa ngemigaqo-nkqubo ende yokulawula ukwabelana ngamaxwebhu eWord. Uninzi lweenkampani lubandakanya zonke izinto ze-S88, kodwa ifomathi yokwenyani yefayile yokugqibela ixhomekeke kumxhasi weziyobisi. Oku kubangela ukuba i-CMO ifanele ihambelane nazo zonke iindlela zokulawula nenkqubo yokuvelisa umthengi omtsha abamthathayo.
Njengoko abathengisi abaninzi besebenzisa izixhobo ezihambelana ne-S88, utshintsho kunye nophuculo kule ndlela lunokwenzeka ngokudityaniswa, ukuthengwa kunye nobudlelwane.
Eminye imiba emibini ebalulekileyo kukungabikho kwamagama aqhelekileyo kule nkqubo kunye nokungabikho kokucaca ekutshintshiselaneni ngedatha.
Kwiminyaka elishumi edlulileyo, iinkampani ezininzi zamayeza ziye zaqhuba iinkqubo zangaphakathi "zokuvumelanisa" ukuze zilungelelanise ukusetyenziswa kwabasebenzi bazo kwamagama aqhelekileyo kwiinkqubo nakwiinkqubo. Nangona kunjalo, ukukhula kwezinto eziphilayo kunokwenza umahluko njengoko iifektri ezintsha zisekwa kwihlabathi liphela, ziphuhlisa iinkqubo zazo zangaphakathi, ingakumbi xa kusenziwa iimveliso ezintsha.
Ngenxa yoko, kukho inkxalabo ekhulayo malunga nokungaqondi kakuhle ekwabelaneni ngedatha ukuphucula iinkqubo zoshishino kunye nemveliso. Le ngxaki isenokukhula njengoko iinkampani ezinkulu ze-biopharmaceutical ziqhubeka nokutshintsha ukusuka ekukhuleni kwezinto eziphilayo ukuya ekuthengweni. Iinkampani ezininzi ezinkulu zamayeza zizuze le ngxaki emva kokufumana iinkampani ezincinci, ngoko ke okukhona zilinde ixesha elide ukuba kusetyenzwe ngokutshintshiselana kwedatha, kokukhona kuya kuphazamisa ngakumbi.
Ukungabikho kwamagama aqhelekileyo okubiza iiparameter kunokukhokelela kwiingxaki eziqala ekudidekeni okulula phakathi kweenjineli zeenkqubo ezixoxa ngeenkqubo ukuya kumahluko amakhulu phakathi kwedatha yolawulo lwenkqubo enikezelwa ziiwebhusayithi ezimbini ezahlukeneyo ezisebenzisa iiparameter ezahlukeneyo ukuthelekisa umgangatho. Oku kunokukhokelela kwizigqibo ezingalunganga zokukhululwa kwebhetshi kwane "Fomu 483" ye-FDA, ebhalwe ukuqinisekisa ukuthembeka kwedatha.
Ukwabelana ngedatha yedijithali kufuneka kunikwe ingqwalasela ekhethekileyo kwizigaba zokuqala zenkqubo yokudluliselwa kobuchwepheshe, ingakumbi xa kusekwe ubudlelwane obutsha. Njengoko bekutshiwo ngaphambili, ukubandakanyeka kweqabane elitsha kutshintshiselwano lwedijithali kunokufuna utshintsho lwenkcubeko kulo lonke uthotho lokubonelela, njengoko amaqabane anokufuna izixhobo ezintsha noqeqesho, kunye namalungiselelo afanelekileyo esivumelwano, ukuqinisekisa ukuthotyelwa okuqhubekayo ngamaqela omabini.
Ingxaki ephambili ejongene neBig Pharma kukuba abathengisi baya kubanika ukufikelela kwiinkqubo zabo xa kufuneka. Nangona kunjalo, bahlala belibala ukuba aba bathengisi bagcina idatha yabanye abathengi kwiidathabheyisi zabo. Umzekelo, iLaboratory Information Management System (LIMS) igcina iziphumo zovavanyo lohlalutyo lwazo zonke iimveliso ezenziwe zii-CMO. Ke ngoko, umenzi akayi kunika nawuphi na umthengi ngamnye ukufikelela kwi-LIMS ukuze akhusele ubumfihlo babanye abathengi.
Kukho iindlela ezininzi zokusombulula le ngxaki, kodwa ixesha elongezelelweyo liyafuneka ukuphuhlisa nokuvavanya izixhobo ezintsha kunye neenkqubo ezibonelelwa ngabathengisi okanye eziphuhliswe ngaphakathi. Kuzo zombini iimeko, kubaluleke kakhulu ukubandakanya isebe le-IT kwasekuqaleni, njengoko ukhuseleko lwedatha lubaluleke kakhulu, kwaye ii-firewall zinokufuna iinethiwekhi ezintsonkothileyo ukuze kutshintshiselwane ngedatha.
Ngokubanzi, xa iinkampani ze-biopharmaceutical zivavanya ukuvuthwa kwazo kwedijithali ngokubhekiselele kumathuba okudluliselwa kobuchwepheshe be-BPLM, kufuneka zichonge imiqobo ephambili ekhokelela ekugqithiseni iindleko kunye/okanye ukulibaziseka ekulungiseleleni imveliso.
Kufuneka babhale phantsi izixhobo abanazo baze bagqibe ukuba ezo zixhobo zanele na ukufezekisa iinjongo zabo zoshishino. Ukuba akunjalo, kufuneka bahlole izixhobo ezinikezelwa lishishini baze bakhangele amaqabane anokunceda ukuvala umsantsa.
Njengoko izisombululo zokudlulisela ubuchwepheshe bokuvelisa ziqhubeka nokukhula, utshintsho lwedijithali lwe-BPLM luya kuvula indlela yokhathalelo lwezigulane olusemgangathweni ophezulu nolukhawulezileyo.
UKen Forman unamava angaphezu kweminyaka engama-28 kwi-IT, imisebenzi, kunye nolawulo lweemveliso kunye neeprojekthi ezigxile kwisoftware nakwicandelo lezonyango. UKen Forman unamava angaphezu kweminyaka engama-28 kwi-IT, imisebenzi, kunye nolawulo lweemveliso kunye neeprojekthi ezigxile kwisoftware nakwicandelo lezonyango.UKen Foreman unamava angaphezu kweminyaka engama-28 kwi-IT, imisebenzi kunye nolawulo lwemveliso kunye neeprojekthi ezigxile kwisoftware kunye namayeza.UKen Foreman unamava angaphezu kweminyaka engama-28 kwi-IT, imisebenzi kunye nolawulo lweemveliso kunye neeprojekthi ezigxile kwisoftware kunye namayeza. Ngaphambi kokuba ajoyine iSkyland Analytics, uKen wayenguMlawuli woLawulo lweeNkqubo zeNAM kwiBiovia Dassault Systemes kwaye wayephethe izikhundla ezahlukeneyo zomlawuli kwi-Aegis Analytical. Ngaphambili, wayeyiNtloko yoLwazi kwiRally Software Development, iNtloko yoRhwebo kwiFischer Imaging, kunye neNtloko yoLwazi kwi-Allos Therapeutics and Genomica.
Iindwendwe ezingaphezu kwe-150,000 ngenyanga ziyisebenzisa ukulandela ishishini le-biotech kunye nokuvelisa izinto ezintsha. Ndiyathemba ukuba uyonwabela ukufunda amabali ethu!