Pamene chithandizo chamakono chikuchulukirachulukira pafupifupi mwezi uliwonse, kusamutsa kwaukadaulo kwaukadaulo pakati pa biopharmaceuticals ndi opanga ndikofunikira kwambiri kuposa kale.Ken Foreman, Mtsogoleri Wamkulu wa Product Strategy ku IDBS, akufotokoza momwe njira yabwino ya digito ingakuthandizireni kupewa zolakwika zomwe zimagwiritsidwa ntchito potengera ukadaulo.
Biopharmaceutical Life Cycle Management (BPLM) ndiye chinsinsi chobweretsa mankhwala atsopano komanso opulumutsa moyo padziko lapansi.Zimakhudza magawo onse a chitukuko cha mankhwala, kuphatikizapo chizindikiritso cha anthu omwe akufunafuna mankhwala, mayesero a zachipatala kuti adziwe momwe angagwiritsire ntchito bwino, njira zopangira, ndi ntchito zoperekera mankhwala kuti apereke mankhwalawa kwa odwala.
Iliyonse mwamapaipi oyimirirawa amakhalapo m'malo osiyanasiyana a bungwe, ndi anthu, zida, ndi zida za digito zogwirizana ndi zosowazo.Kutengerapo kwaukadaulo ndi njira yotsekera mipata pakati pa magawo osiyanasiyanawa kuti asamutsire chitukuko, kupanga ndi chidziwitso chaukadaulo.
Komabe, ngakhale makampani otsogola kwambiri a biotech amakumana ndi zovuta pakukwaniritsa kusamutsa kwaukadaulo.Ngakhale njira zina (monga ma antibodies a monoclonal ndi mamolekyu ang'onoang'ono) ndi oyenera kutsata njira zamapulatifomu, zina (monga ma cell ndi gene therapy) ndizatsopano kwambiri m'makampani, ndipo zovuta ndi kusiyanasiyana kwamankhwala atsopanowa zikupitilirabe kufooka kale. ndondomeko Kuonjezera kuthamanga.
Kusintha kwaukadaulo ndi njira yovuta yomwe imaphatikizapo ochita masewera angapo pagulu loperekera, aliyense akuwonjezera zovuta zake pa equation.Othandizira a Biopharmaceutical ali ndi mphamvu zowongolera pulogalamu yonseyo, kulinganiza nyumba zogulitsira zinthu ndi kukonzekera kwawo kosasunthika kuyenera kufulumizitsa nthawi yogulitsa.
Olandila ukadaulo wakumunsi amakhalanso ndi zovuta zawo zapadera.Opanga ena alankhula za kuvomereza zovuta zosinthira ukadaulo popanda malangizo omveka bwino komanso achidule.Kupanda malangizo omveka bwino kumatha kusokoneza khalidwe la malonda ndipo nthawi zambiri kumawononga mgwirizano m'kupita kwanthawi.
Khazikitsani njira zogulitsira koyambirira pakusintha kwaukadaulo posankha malo oyenera kupanga.Izi zikuphatikizapo kusanthula kwa mapangidwe a zomera za opanga, kufufuza kwawo ndi kayendetsedwe ka kayendetsedwe kake, ndi kupezeka ndi kuyenerera kwa zipangizo.
Posankha CMO ya chipani chachitatu, makampani ayeneranso kuwunika kukonzeka kwa CMO kugwiritsa ntchito nsanja zogawana digito.Opanga omwe amapereka zambiri m'mafayilo a Excel kapena pamapepala amatha kusokoneza kupanga ndi kuwunika, zomwe zimapangitsa kuti kuchedwetsedwe kutulutsidwa.
Zida zamakono zomwe zilipo pamalonda zimathandizira kusinthana kwa digito kwa maphikidwe, ziphaso zowunikira, ndi data ya batch.Ndi zida izi, njira zoyendetsera zidziwitso (PIMS) zitha kusintha kusamutsa kwaukadaulo kuchokera kuzinthu zosasunthika kupita ku kugawana chidziwitso champhamvu, chopitilira komanso chogwirizana.
Poyerekeza ndi njira zovuta kwambiri zomwe zimaphatikizapo mapepala, ma spreadsheets ndi machitidwe osiyana, kugwiritsa ntchito PIMS kumapereka ndondomeko yopitilirapo yowunikira ndondomeko kuchokera ku ndondomeko yoyendetsera kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe kake
Kuti zitheke, njira yosinthira ukadaulo mkati mwa mgwirizano wabwinobwino wotsatsa ndi malonda uyenera kukhala wokwanira kuposa mayankho omwe tafotokozawa.
Kukambitsirana kwaposachedwa ndi Global COO wa Leading Industry Marketing Director adawulula kuti chotchinga choyamba cholepheretsa kuphatikizika pakati pa magawo a BPLM ndi kusowa kwa njira yosinthira ukadaulo yomwe ikupezeka pamalonda yomwe imakhudza mbali zonse za ntchitoyi, osati kungomaliza kupanga.chochitika.Chofunikirachi chimakhala chofunikira kwambiri pamapulogalamu akukulitsa kwa biopharmaceutical pakupanga kwakukulu kwamankhwala atsopano.Makamaka, ogulitsa zinthu zopangira ayenera kusankhidwa, zofunikira za nthawi zomwe zimaganiziridwa, komanso njira zoyeserera zovomerezeka, zonse zomwe zimafunikira kukhazikitsidwa kwa njira zoyendetsera ntchito.
Mavenda ena athana ndi mavuto paokha, koma ntchito zina za BPLM zilibe mayankho m'bokosi.Chotsatira chake, makampani ambiri amagula "njira zothetsera mfundo" zomwe sizinapangidwe kuti zigwirizane.Mayankho odzipatulira apulogalamu amapangitsa zovuta zina zaukadaulo, monga kulumikizana ndi ma firewall okhala ndi mayankho amtambo, kufunikira kwa madipatimenti a IT kuti agwirizane ndi ma protocol atsopano, ndikuphatikizana movutikira ndi zida zakunja.
Njira yothetsera vutoli ndikugwiritsa ntchito msewu waukulu wa data womwe umathandizira kasamalidwe ka data, kuyenda ndi kusinthana pakati pa zida zosiyanasiyana.
Anthu ena amakhulupirira kuti miyezo ndiyo mfungulo yothetsera mavuto.ISA-88 ya kasamalidwe ka batch ndi chitsanzo cha njira yopangira zinthu zotengedwa ndi makampani ambiri a biopharmaceutical.Komabe, kukhazikitsidwa kwenikweni kwa muyezo kumatha kusiyanasiyana, kupangitsa kuphatikizana kwa digito kukhala kovuta kuposa momwe amafunira poyamba.
Chitsanzo ndikutha kugawana mosavuta zambiri za maphikidwe.Masiku ano, izi zikuchitikabe kudzera mu ndondomeko zazitali zogawana zolemba za Mawu.Makampani ambiri amaphatikiza zigawo zonse za S88, koma mawonekedwe enieni a fayilo yomaliza amadalira wothandizira mankhwala.Izi zimapangitsa kuti CMO igwirizane ndi njira zonse zowongolera ndi kupanga kwa kasitomala aliyense watsopano yemwe amatenga.
Pamene ogulitsa akuchulukirachulukira akugwiritsa ntchito zida zogwirizana ndi S88, zosintha ndikusintha kwa njirayi zitha kubwera kudzera pakuphatikizana, kupeza ndi mgwirizano.
Zina ziwiri zofunika kwambiri ndi kusowa kwa mawu omwe amagwiritsidwa ntchito pa ndondomekoyi komanso kusowa poyera pakusinthanitsa deta.
M'zaka khumi zapitazi, makampani ambiri opanga mankhwala apanga mapulogalamu amkati "ogwirizana" kuti akhazikitse antchito awo kugwiritsa ntchito mawu omwe amagwiritsidwa ntchito potsata njira ndi machitidwe.Komabe, kukula kwachilengedwe kungapangitse kusiyana pamene mafakitale atsopano akukhazikitsidwa padziko lonse lapansi, akupanga njira zawo zamkati, makamaka popanga zinthu zatsopano.
Zotsatira zake, pali nkhawa yomwe ikukulirakulira chifukwa chosowa kuyang'anitsitsa pakugawana deta kuti apititse patsogolo bizinesi ndi kupanga.Vutoli likuyenera kuchulukirachulukira pomwe makampani akuluakulu a biopharmaceutical akupitiliza kuchoka pakukula kwachilengedwe kupita kukupeza.Makampani ambiri akuluakulu opanga mankhwala adatengera vutoli atapeza makampani ang'onoang'ono, kotero akamadikirira kuti kusinthanitsa kwa data kuchitidwe, kusokoneza kwambiri.
Kupanda mawu odziwika bwino pakutchula magawo kungayambitse mavuto kuyambira chisokonezo chosavuta pakati pa akatswiri opanga njira zokambilana za njira mpaka kusagwirizana kwakukulu pakati pa data yoyang'anira ndondomeko yoperekedwa ndi malo awiri osiyana omwe amagwiritsa ntchito magawo osiyanasiyana kuti afanizire khalidwe.Izi zitha kubweretsa zisankho zolakwika zotulutsa komanso ngakhale a FDA "Fomu 483", yomwe idalembedwa kuti iwonetsetse kukhulupirika kwa data.
Kugawana deta ya digito kumafunikanso kupatsidwa chisamaliro chapadera kumayambiriro kwa njira yotumizira teknoloji, makamaka pamene maubwenzi atsopano akhazikitsidwa.Monga tanenera kale, kutenga nawo mbali kwa bwenzi latsopano pakusinthana kwa digito kungafunike kusintha kwa chikhalidwe panthawi yonse yogulitsira, monga ogwira nawo ntchito angafunike zida zatsopano ndi maphunziro, komanso makonzedwe oyenera a mgwirizano, kuti atsimikizire kutsatiridwa kwa onse awiri.
Vuto lalikulu lomwe Big Pharma likukumana nalo ndikuti ogulitsa aziwapatsa mwayi wogwiritsa ntchito machitidwe awo momwe angafunikire.Komabe, nthawi zambiri amaiwala kuti ogulitsawa amasunganso deta yamakasitomala ena muzosunga zawo.Mwachitsanzo, Laboratory Information Management System (LIMS) imakhala ndi zotsatira zowunikira pazogulitsa zonse zopangidwa ndi ma CMO.Chifukwa chake, wopanga sapereka mwayi kwa LIMS kwa kasitomala aliyense kuti ateteze zinsinsi za makasitomala ena.
Pali njira zingapo zothetsera vutoli, koma nthawi yowonjezera imafunika kuti mupange ndikuyesa zida zatsopano ndi njira zoperekedwa ndi ogulitsa kapena kupangidwa m'nyumba.Pazochitika zonsezi, ndikofunikira kwambiri kuphatikizira dipatimenti ya IT kuyambira pachiyambi, popeza chitetezo cha data ndichofunika kwambiri, ndipo ma firewall angafunike ma network ovuta kusinthanitsa deta.
Nthawi zambiri, makampani opanga mankhwala a biopharmaceutical akawunika kukula kwawo kwa digito malinga ndi mwayi wosinthira ukadaulo wa BPLM, ayenera kuzindikira zopinga zazikulu zomwe zimadzetsa kuchulukira kwamitengo komanso/kapena kuchedwetsa kukonzekera kupanga.
Ayenera kupanga mapu zida zomwe ali nazo kale ndikuwunika ngati zidazo ndi zokwanira kukwaniritsa zolinga zawo zamabizinesi.Ngati sichoncho, ayenera kufufuza zida zomwe makampaniwa angapereke ndikuyang'ana abwenzi omwe angathandize kutseka kusiyana.
Pamene njira zosinthira ukadaulo wopanga zikupitilirabe kusinthika, kusintha kwa digito kwa BPLM kudzatsegula njira ya chisamaliro chapamwamba komanso chisamaliro cha odwala mwachangu.
Ken Forman ali ndi zaka zopitilira 28 komanso ukadaulo mu IT, magwiridwe antchito, ndi kasamalidwe kazinthu & ntchito zomwe zimayang'ana kwambiri pamapulogalamu ndi malo azamankhwala. Ken Forman ali ndi zaka zopitilira 28 komanso ukadaulo mu IT, magwiridwe antchito, ndi kasamalidwe kazinthu & ntchito zomwe zimayang'ana kwambiri pamapulogalamu ndi malo azamankhwala.Ken Foreman ali ndi zaka zopitilira 28 komanso ukadaulo mu IT, magwiridwe antchito ndi zogulitsa ndi kasamalidwe ka projekiti amayang'ana kwambiri pa mapulogalamu ndi mankhwala.Ken Foreman ali ndi zaka zopitilira 28 komanso ukadaulo mu IT, magwiridwe antchito ndi zogulitsa ndi kasamalidwe ka projekiti amayang'ana kwambiri pa mapulogalamu ndi mankhwala.Asanalowe nawo ku Skyland Analytics, Ken anali Mtsogoleri wa NAM Program Management ku Biovia Dassault Systemes ndipo adagwira maudindo osiyanasiyana a Aegis Analytical.M'mbuyomu, anali Chief Information Officer ku Rally Software Development, Chief Commercial Officer ku Fischer Imaging, ndi Chief Information Officer ku Allos Therapeutics ndi Genomica.
Alendo opitilira 150,000 pamwezi amawagwiritsa ntchito kutsatira bizinesi yaukadaulo waukadaulo komanso zatsopano.Ndikukhulupirira kuti mumakonda kuwerenga nkhani zathu!