Njengoko unyango oluntsonkothileyo luvela rhoqo ngenyanga, ugqithiso lwetekhnoloji olusebenzayo phakathi kwe-biopharmaceuticals kunye nabavelisi kubaluleke kakhulu kunangaphambili.UKen Foreman, uMlawuli oMkhulu weSicwangciso seMveliso kwi-IDBS, uchaza indlela isicwangciso esihle sedijithali esinokukunceda ukuba ugweme iimpazamo eziqhelekileyo zokudlulisa iteknoloji.
Ulawulo lwe-Biopharmaceutical Life Cycle Management (BPLM) sisitshixo sokuzisa amayeza amatsha onyango kunye nokusindisa ubomi kwihlabathi.Ibandakanya zonke izigaba zophuhliso lwamachiza, kubandakanywa ukuchongwa kwamayeza, ulingo lwezonyango ukufumanisa ukusebenza kakuhle, iinkqubo zokwenziwa kwemveliso, kunye nemisebenzi yekhonkco lokubonelela ukuhambisa la machiza kwizigulana.
Nganye yale mibhobho emi nkqo isebenza kwiindawo ezahlukeneyo zombutho, nabantu, izixhobo, kunye nezixhobo zedijithali ezilungiselelwe ezo mfuno.Utshintshiselwano ngeteknoloji yinkqubo yokuvala izikhewu phakathi kwala macandelo ahlukeneyo ukuze kudluliselwe ulwazi lophuhliso, imveliso kunye nokuqinisekiswa komgangatho.
Nangona kunjalo, nezona nkampani zisekiweyo zebhayoloji zijongene nemingeni ekuphumezeni ngempumelelo ugqithiso lwetekhnoloji.Ngelixa ezinye iindlela (ezifana ne-monoclonal antibodies kunye neemolekyuli ezincinci) zifanelekile kwiindlela zeqonga, ezinye (ezifana nonyango lweseli kunye nofuzo) zintsha kushishino, kwaye ukuntsonkotha kunye nokuguquguquka kolu nyango lutsha kuyaqhubeka ukongeza kwiselfowuni esele ibuthathaka. inkqubo Ukunyusa uxinzelelo.
Ukutshintshwa kweteknoloji yinkqubo enzima ebandakanya abadlali abaninzi kwikhonkco lokubonelela, ngamnye wongeza imingeni yakhe kwi-equation.Abaxhasi be-Biopharmaceutical banamandla okulawula yonke inkqubo, ukulungelelanisa ukwakhiwa kwekhonkco lokubonelela kunye neemfuno zabo zokucwangcisa eziqinileyo ukukhawuleza ixesha lokuthengisa.
Abamkeli betekhnoloji esezantsi nabo banemingeni yabo eyahlukileyo.Abanye abavelisi bathethe ngokwamkela iimfuno zokudlulisa itekhnoloji entsonkothileyo ngaphandle kwemiyalelo ecacileyo nemfutshane.Ukunqongophala komkhombandlela ocacileyo kunokuchaphazela kakubi umgangatho wemveliso kwaye kaninzi kulimaza intsebenziswano ekuhambeni kwexesha.
Ukuseka ikhonkco lokubonelela kwangoko kwinkqubo yokudluliselwa kweteknoloji xa ukhetha eyona ndawo ifanelekileyo yokuvelisa.Oku kubandakanya uhlalutyo loyilo lweplanti yomenzi, uhlalutyo lwabo kunye nolawulo lwenkqubo, kunye nokufumaneka kunye nokufaneleka kwesixhobo.
Xa ukhetha i-CMO yomntu wesithathu, iinkampani kufuneka kwakhona zivavanye ukulungela kwe-CMO ukusebenzisa amaqonga okwabelana ngedijithali.Abavelisi ababonelela ngedatha eninzi kwiifayile ze-Excel okanye ephepheni banokuphazamisa imveliso kunye nokubeka iliso, okukhokelela ekulibazisekeni kokukhululwa okukhulu.
Izixhobo zanamhlanje ezifumanekayo kurhwebo zixhasa utshintshiselwano lwedijithali lweeresiphi, izatifikethi zokuhlalutya, kunye nedatha yebhetshi.Ngezi zixhobo, iinkqubo zolawulo lwenkqubo yolwazi (PIMS) inokuguqula ukudluliselwa kwetheknoloji ukusuka kwimisebenzi engatshintshiyo ukuya kukwabelana ngolwazi oluguquguqukayo, oluqhubekayo nolusebenzisanayo.
Xa kuthelekiswa neenkqubo eziyinkimbinkimbi ezibandakanya amaphepha, iispredishithi kunye neenkqubo ezingafaniyo, ukusetyenziswa kwe-PIMS kubonelela ngenkqubo eqhubekayo yokuphonononga iinkqubo ukusuka kwisicwangciso solawulo ukuya kuthotyelo olupheleleyo lweendlela ezilungileyo kunye nexesha elincinci, iindleko kunye nomngcipheko.
Ukuze uphumelele, isisombululo sokudlulisa iteknoloji ngaphakathi kwintengiso ephilileyo kunye nentsebenziswano yokuthengisa kufuneka ibe ngokubanzi ngaphezu kwezisombululo ezichazwe ngasentla.
Incoko yakutshanje kunye ne-Global COO yoMlawuli oPhambili weNtengiso yeNtengiso ibonise ukuba inombolo enye umqobo wokuqhawula phakathi kwezigaba ze-BPLM kukungabikho kwesisombululo esikhoyo sokuthengisa iteknoloji yokudlulisa iteknoloji ehlanganisa zonke iinxalenye zenkqubo, kungekhona nje ukuphela kwemveliso.indawo.Le mfuno ibaluleka ngakumbi kwiinkqubo zokwandisa i-biopharmaceutical yemveliso enkulu yonyango olutsha.Ngokukodwa, ababoneleli bezinto eziluhlaza kufuneka bakhethwe, iimfuno zexesha ziqwalaselwe, kunye neenkqubo zokuvavanya uhlalutyo ezivunyelweneyo, zonke ezifuna ukuphuhliswa kweenkqubo zokusebenza eziqhelekileyo.
Abanye abathengisi bazisombulule iingxaki ezithile, kodwa eminye imisebenzi ye-BPLM ayinaso izisombululo ngaphandle kwebhokisi.Ngenxa yoko, iinkampani ezininzi zithenga "izisombululo zamanqaku" ezingenziwanga ukuba zidibaniswe kunye nomnye.Izisombululo zesoftware ezinikezelweyo zenza imiqobo eyongezelelweyo yobugcisa, njengokunxibelelana kwii-firewall ezinezisombululo zamafu, imfuneko yokuba amasebe e-IT aqhelane nemigaqo emitsha yobunini, kunye nokudityaniswa nzima kunye nezixhobo ezingaxhunyiwe kwi-intanethi.
Isisombululo kukusebenzisa uhola wedatha odibeneyo owenza lula ulawulo lwedatha, ukunyakaza kunye nokutshintshiselana phakathi kwezixhobo ezahlukeneyo.
Abanye abantu bakholelwa ukuba imilinganiselo yeyona nto iphambili ekucombululeni iingxaki.I-ISA-88 yolawulo lwebhetshi ngumzekelo womgangatho wenkqubo yokuvelisa owamkelwa ziinkampani ezininzi zebiopharmaceutical.Nangona kunjalo, ukuphunyezwa kwangempela komgangatho kunokwahluka kakhulu, okwenza ukudityaniswa kwedijithali kube nzima kunokuba bekucetywa ekuqaleni.
Umzekelo kukukwazi ukwabelana ngokulula ngolwazi malunga neeresiphi.Namhlanje, oku kusasenziwa ngemigaqo-nkqubo yolawulo lokwabelana ngoxwebhu olude.Uninzi lweenkampani zibandakanya onke amacandelo e-S88, kodwa eyona fomathi yefayile yokugqibela ixhomekeke kumxhasi wamachiza.Oku kubangela ukuba i-CMO ifanise zonke izicwangciso zolawulo kwinkqubo yokwenziwa komthengi ngamnye omtsha abayithathayo.
Njengoko besanda abathengisi bephumeza izixhobo ezithobelayo ze-S88, utshintsho kunye nokuphuculwa kwale ndlela kunokuza ngokudityaniswa, ukufunyanwa kunye nentsebenziswano.
Eminye imiba emibini ebalulekileyo kukunqongophala kwesigama esiqhelekileyo senkqubo kunye nokungabikho kwezinto elubala kutshintshiselwano lwedatha.
Kule minyaka ilishumi idlulileyo, iinkampani ezininzi ezixuba amayeza zenze iinkqubo zangaphakathi “zokulungelelanisa” ukumisela umgangatho wokusetyenziswa kwabasebenzi bazo kwesigama esiqhelekileyo kwiinkqubo neenkqubo.Nangona kunjalo, ukukhula kwe-organic kunokwenza umahluko njengoko iifektri ezintsha zisetwa kwihlabathi liphela, ziphuhlisa ezazo iinkqubo zangaphakathi, ngakumbi xa kusenziwa iimveliso ezintsha.
Ngenxa yoko, kukho inkxalabo ekhulayo malunga nokungabikho kokubona kwangaphambili ekwabelaneni ngedatha ukuphucula amashishini kunye neenkqubo zokuvelisa.Lo mqobo unokuba namandla njengoko iinkampani ezinkulu ze-biopharmaceutical ziqhubeka nokusuka ekukhuleni kwezinto eziphilayo ukuya ekuthengeni.Iinkampani ezininzi ezinkulu zamachiza zifumene le ngxaki emva kokufumana iinkampani ezincinci, ngoko ke ukuba zilinde ixesha elide ukuba utshintshiselwano lwedatha luqhutywe, luya kuphazamiseka ngakumbi.
Ukunqongophala kwesigama esiqhelekileyo sokubiza iiparamitha kunokukhokelela kwiingxaki ezisuka kwisiphithiphithi esilula phakathi kweenjineli zenkqubo ezixoxa ngeenkqubo ukuya kwiiyantlukwano ezinzulu phakathi kwedatha yolawulo lwenkqubo ebonelelwa ziziza ezimbini ezahlukeneyo ezisebenzisa iiparitha ezahlukeneyo ukuthelekisa umgangatho.Oku kunokukhokelela kwizigqibo zokukhutshwa kwebhetshi ezingachanekanga kunye ne-FDA's "iFomu 483", ebhaliweyo ukuqinisekisa ukuthembeka kwedatha.
Ukwabelana ngedatha yedijithali kwakhona kufuneka kunikwe ingqwalasela ekhethekileyo kwiinqanaba zokuqala zenkqubo yokudlulisa iteknoloji, ngakumbi xa kusekwa intsebenziswano entsha.Njengoko kukhankanyiwe ngaphambili, ukubandakanyeka kweqabane elitsha kutshintshiselwano lwedijithali kunokufuna utshintsho lwenkcubeko kulo lonke ikhonkco lokubonelela, njengoko amaqabane anokufuna izixhobo ezintsha kunye noqeqesho, kunye namalungiselelo afanelekileyo ekhontrakthi, ukuqinisekisa ukuthotyelwa okuqhubekayo ngamaqela omabini.
Ingxaki enkulu ejongene ne-Big Pharma kukuba abathengisi baya kubanika ukufikelela kwiinkqubo zabo njengoko kufuneka.Nangona kunjalo, bahlala belibala ukuba aba bathengisi bagcina idatha yabanye abathengi kwiinkcukacha zabo.Umzekelo, iNkqubo yoLawulo lweeNkcukacha zeLabhoratri (i-LIMS) igcina iziphumo zovavanyo lohlalutyo kuzo zonke iimveliso eziveliswe zii-CMO.Ke ngoko, umenzi akayi kunikezela ukufikelela kwi-LIMS kuye nawuphi na umthengi ngamnye ukuze akhusele ubumfihlo babanye abathengi.
Kukho iindlela ezininzi zokusombulula le ngxaki, kodwa ixesha elongezelelweyo liyafuneka ukuphuhlisa nokuvavanya izixhobo ezitsha kunye neenkqubo ezinikezelwa ngabathengisi okanye ziphuhliswe ngaphakathi kwindlu.Kuzo zombini iimeko, kubaluleke kakhulu ukubandakanya isebe le-IT kwasekuqaleni, njengoko ukhuseleko lwedatha lubaluleke kakhulu, kwaye i-firewall inokufuna uthungelwano olunzima ukutshintshiselana ngedatha.
Ngokubanzi, xa iinkampani ze-biopharmaceutical zivavanya ukukhula kwazo kwedijithali ngokwamathuba okudluliselwa kobuchwephesha beBPLM, kufuneka zichonge imiqobo ephambili ekhokelela ekugqithiseni kweendleko kunye/okanye ukulibaziseka kokulungela imveliso.
Kufuneka benze imephu yezixhobo esele benazo kwaye baqinisekise ukuba ezo zixhobo zanele na ukufezekisa iinjongo zabo zoshishino.Ukuba akunjalo, kufuneka baphonononge izixhobo ezinikezelwa ngushishino kwaye bajonge amaqabane anokunceda ukuvala umsantsa.
Njengoko izisombululo zotshintshiselwano lwetekhnoloji yokuvelisa ziqhubeka nokuvela, inguqu yedijithali yeBPLM iya kuvula indlela yomgangatho ophezulu kunye nokhathalelo lwezigulane olukhawulezayo.
UKen Forman uneminyaka engaphezulu kwe-28 yamava kunye nobuchule kwi-IT, imisebenzi, kunye nolawulo lwemveliso kunye nolawulo lweprojekthi olugxile kwisoftware nakwindawo yokuthengisa amayeza. UKen Forman uneminyaka engaphezulu kwe-28 yamava kunye nobuchule kwi-IT, imisebenzi, kunye nolawulo lwemveliso kunye nolawulo lweprojekthi olugxile kwisoftware nakwindawo yokuthengisa amayeza.UKen Foreman uneminyaka engaphezulu kwe-28 yamava kunye nobuchule kwi-IT, imisebenzi kunye nemveliso kunye nolawulo lweprojekthi olugxile kwisoftware kunye namayeza.UKen Foreman uneminyaka engaphezulu kwe-28 yamava kunye nobuchule kwi-IT, imisebenzi kunye nemveliso kunye nolawulo lweprojekthi olugxile kwisoftware kunye namayeza.Ngaphambi kokujoyina i-Skyland Analytics, uKen wayenguMlawuli woLawulo lweNkqubo ye-NAM kwi-Biovia Dassault Systemes kwaye wabamba izikhundla ezahlukeneyo zomlawuli kwi-Aegis Analytical.Ngaphambili, wayeyiGosa eliyiNtloko leNgcaciso kwi-Rally Software Development, iGosa eliyiNtloko lezoRhwebo kwi-Fischer Imaging, kunye neGosa eliyiNtloko leNgcaciso kwi-Allos Therapeutics kunye neGenomica.
Ngaphezulu kwe-150,000 yeendwendwe zenyanga eziyisebenzisayo ukulandela ishishini lebhayoloji kunye nokusungula izinto ezintsha.Ndiyathemba ukuba uyakonwabela ukufunda amabali ethu!