Pamene njira zamakono zikuchulukirachulukira zikuchulukirachulukira mwezi uliwonse, kusamutsa ukadaulo pakati pa mankhwala a biopharmaceuticals ndi opanga ndikofunikira kwambiri kuposa kale lonse. Ken Foreman, Mtsogoleri Wamkulu wa Njira Yogulitsa ku IDBS, akufotokoza momwe njira yabwino ya digito ingakuthandizireni kupewa zolakwika zomwe zimachitika kawirikawiri zosamutsa ukadaulo.
Kasamalidwe ka Moyo wa Mankhwala Ogwiritsa Ntchito Mankhwala (BPLM) ndiye njira yobweretsera mankhwala atsopano ochiritsa komanso opulumutsa moyo padziko lonse lapansi. Ikufotokoza magawo onse a chitukuko cha mankhwala, kuphatikizapo kuzindikira omwe akufuna kugwiritsa ntchito mankhwala, mayeso azachipatala kuti adziwe momwe angagwiritsire ntchito bwino mankhwalawo, njira zopangira, ndi zochitika zoperekera mankhwala kuti apereke mankhwalawa kwa odwala.
Ntchito iliyonse ya mapaipi oyima nthawi zambiri imapezeka m'malo osiyanasiyana a bungweli, ndipo anthu, zida, ndi zida zama digito zimapangidwa kuti zigwirizane ndi zosowa zimenezo. Kusamutsa ukadaulo ndi njira yolumikizira mipata pakati pa magawo osiyanasiyanawa kuti isamutse chidziwitso cha chitukuko, kupanga, ndi chitsimikizo cha khalidwe.
Komabe, ngakhale makampani odziwika bwino a biotech amakumana ndi zovuta pakukhazikitsa bwino kusamutsa ukadaulo. Ngakhale njira zina (monga ma monoclonal antibodies ndi mamolekyu ang'onoang'ono) ndizoyenera kugwiritsa ntchito njira zolumikizirana, zina (monga chithandizo cha maselo ndi majini) ndi zatsopano m'makampaniwa, ndipo zovuta ndi kusiyanasiyana kwa njira zatsopanozi zikupitilira kuwonjezera njira yofooka kale. Kuonjezera kupanikizika.
Kusamutsa ukadaulo ndi njira yovuta yomwe imakhudza anthu ambiri omwe akuchita nawo ntchito zosiyanasiyana mu unyolo wopereka zinthu, aliyense akuwonjezera mavuto ake pa equation. Othandizira mankhwala a biopharmaceutical ali ndi mphamvu zoyendetsera pulogalamu yonseyi, kulinganiza zomangamanga za unyolo wopereka zinthu ndi zosowa zawo zokonzekera kuti afulumizitse nthawi yopita kumsika.
Anthu omwe amalandira ukadaulo wotsatira ali ndi mavuto awoawo. Opanga ena alankhula za kuvomereza zofunikira zovuta zosamutsa ukadaulo popanda malangizo omveka bwino komanso achidule. Kusowa kwa malangizo omveka bwino kungakhudze kwambiri ubwino wa malonda ndipo nthawi zambiri kumavulaza mgwirizano m'kupita kwa nthawi.
Khazikitsani unyolo wogulira zinthu kumayambiriro kwa njira yosamutsira ukadaulo posankha malo oyenera opangira zinthu. Izi zikuphatikizapo kusanthula kapangidwe ka fakitale ya wopanga, kusanthula kwawo ndi kuwongolera njira, komanso kupezeka ndi kuyenerera kwa zidazo.
Posankha CMO wa chipani chachitatu, makampani ayeneranso kuwunika momwe CMO alili okonzeka kugwiritsa ntchito nsanja zogawana digito. Opanga omwe amapereka zambiri m'mafayilo a Excel kapena papepala amatha kusokoneza kupanga ndi kuyang'anira, zomwe zimapangitsa kuti kutulutsidwa kwa zinthu kuchedwe.
Zipangizo zamakono zomwe zikupezeka m'masitolo zimathandiza kusinthana kwa maphikidwe, ma satifiketi owunikira, ndi deta yamagulu. Ndi zida izi, machitidwe owongolera zidziwitso (PIMS) amatha kusintha kusamutsa ukadaulo kuchokera ku zochitika zosasinthika kupita ku kugawana chidziwitso chosinthasintha, chopitilira komanso chogwirizana.
Poyerekeza ndi njira zovuta kwambiri zokhudzana ndi mapepala, ma spreadsheet ndi machitidwe osiyanasiyana, kugwiritsa ntchito PIMS kumapereka njira yopitilira yowunikira njira kuyambira njira yoyendetsera mpaka kutsatira kwathunthu machitidwe abwino ndi nthawi yochepa, mtengo ndi chiopsezo.
Kuti zinthu ziyende bwino, njira yosinthira ukadaulo mkati mwa mgwirizano wabwino wamalonda ndi malonda iyenera kukhala yokwanira kuposa njira zomwe zafotokozedwa pamwambapa.
Posachedwapa, kukambirana ndi Global COO wa Mtsogoleri Wotsogola wa Zamalonda pa Zamalonda kunavumbulutsa kuti cholepheretsa chachikulu pakuchepetsa magawo a BPLM ndi kusowa kwa njira yotumizira ukadaulo yomwe imapezeka m'masitolo yomwe imakhudza mbali zonse za ndondomekoyi, osati kungomaliza kupanga. Kufunika kumeneku kumakhala kofunikira kwambiri m'mapulogalamu okulitsa mankhwala a biopharmaceutical popanga mankhwala atsopano ambiri. Makamaka, ogulitsa zinthu zopangira ayenera kusankhidwa, nthawi yofunikira kuganiziridwa, ndi njira zoyesera zowunikira zomwe zavomerezedwa, zonse zomwe zimafuna kuti pakhale njira zoyendetsera ntchito.
Ogulitsa ena athetsa mavuto ena okha, koma ntchito zina za BPLM sizili ndi mayankho omveka bwino. Chifukwa chake, makampani ambiri amagula "mayankho a mfundo" omwe sanapangidwe kuti azigwirizana. Mayankho odzipereka a mapulogalamu apakhomo amapanga zopinga zina zaukadaulo, monga kulumikizana kudzera m'ma firewall ndi mayankho amtambo, kufunikira kwa madipatimenti a IT kuti azolowere ma protocol atsopano, komanso kuphatikizana kovuta ndi zida zakunja.
Yankho lake ndikugwiritsa ntchito njira yolumikizirana yolumikizirana deta yomwe imapangitsa kuti kasamalidwe ka deta, kayendetsedwe kake, ndi kusinthana kwa deta kukhale kosavuta.
Anthu ena amakhulupirira kuti miyezo ndiyo njira yothetsera mavuto. ISA-88 ya kayendetsedwe ka gulu ndi chitsanzo cha muyezo wa njira zopangira womwe umavomerezedwa ndi makampani ambiri opanga mankhwala. Komabe, kukhazikitsa kwenikweni kwa muyezo kumatha kusiyana kwambiri, zomwe zimapangitsa kuti kuphatikiza kwa digito kukhale kovuta kuposa momwe kunafunidwira poyamba.
Chitsanzo ndi kuthekera kogawana mosavuta zambiri zokhudza maphikidwe. Masiku ano, izi zikuchitikabe kudzera mu ndondomeko zazitali zowongolera kugawana zikalata za Word. Makampani ambiri amaphatikizapo zigawo zonse za S88, koma mawonekedwe enieni a fayilo yomaliza amadalira wothandizira mankhwala. Izi zimapangitsa kuti CMO igwirizane ndi njira zonse zowongolera ndi njira zopangira kasitomala aliyense watsopano amene akutenga.
Pamene ogulitsa ambiri akugwiritsa ntchito zida zotsatizana ndi S88, kusintha ndi kusintha kwa njira imeneyi kungabwere chifukwa cha kuphatikizana, kugula ndi mgwirizano.
Nkhani zina ziwiri zofunika ndi kusowa kwa mawu ofanana pa ndondomekoyi komanso kusowa kwa kuwonekera poyera pakusinthana deta.
M'zaka khumi zapitazi, makampani ambiri opanga mankhwala achita mapulogalamu amkati "ogwirizanitsa" kuti agwirizane ndi momwe antchito awo amagwiritsira ntchito mawu ofanana pa njira ndi machitidwe. Komabe, kukula kwachilengedwe kungapangitse kusiyana pamene mafakitale atsopano akukhazikitsidwa padziko lonse lapansi, ndikupanga njira zawo zamkati, makamaka popanga zinthu zatsopano.
Chifukwa cha zimenezi, pali nkhawa yaikulu yokhudza kusowa kwa chidziwitso pa kugawana deta kuti akonze njira zamabizinesi ndi zopangira. Vutoli likhoza kukulirakulira pamene makampani akuluakulu a biopharmaceutical akupitiliza kusintha kuchoka pakukula kwa organic kupita ku kugula. Makampani ambiri akuluakulu opanga mankhwala alandira vutoli atagula makampani ang'onoang'ono, kotero akamadikira nthawi yayitali kuti deta isinthidwe, zimakhala zovuta kwambiri.
Kusowa kwa mawu ofanana potchula magawo kungayambitse mavuto kuyambira chisokonezo chosavuta pakati pa mainjiniya a njira zomwe akukambirana za njira zomwe zimagwiritsidwa ntchito mpaka kusiyana kwakukulu pakati pa deta yowongolera njira zomwe zimaperekedwa ndi malo awiri osiyana omwe amagwiritsa ntchito magawo osiyanasiyana poyerekeza mtundu. Izi zingayambitse zisankho zolakwika zotulutsa ma batch komanso ngakhale "Fomu 483" ya FDA, yomwe yalembedwa kuti iwonetsetse kuti deta ndi yolondola.
Kugawana deta ya digito kuyeneranso kuganiziridwa mwapadera kumayambiriro kwa njira yotumizira ukadaulo, makamaka pamene mgwirizano watsopano wakhazikitsidwa. Monga tanenera kale, kutenga nawo mbali kwa mnzanu watsopano mu kusinthana kwa digito kungafunike kusintha chikhalidwe m'njira yonse yoperekera, chifukwa ogwirizana nawo angafunike zida zatsopano ndi maphunziro, komanso makonzedwe oyenera a pangano, kuti atsimikizire kuti mbali zonse ziwiri zikutsatira malamulo.
Vuto lalikulu lomwe Big Pharma imakumana nalo ndilakuti ogulitsa amawapatsa mwayi wopeza makina awo ngati pakufunika kutero. Komabe, nthawi zambiri amaiwala kuti ogulitsa awa amasunganso deta ya makasitomala ena m'ma database awo. Mwachitsanzo, Laboratory Information Management System (LIMS) imasunga zotsatira za mayeso owunikira zinthu zonse zopangidwa ndi ma CMO. Chifukwa chake, wopanga sadzapereka mwayi wopeza LIMS kwa kasitomala aliyense payekha kuti ateteze chinsinsi cha makasitomala ena.
Pali njira zingapo zothetsera vutoli, koma nthawi yowonjezera imafunika kuti pakhale ndikuyesa zida zatsopano ndi njira zomwe zimaperekedwa ndi ogulitsa kapena omwe adapangidwa mkati. M'magawo onse awiri, ndikofunikira kwambiri kugwiritsa ntchito dipatimenti ya IT kuyambira pachiyambi, chifukwa chitetezo cha deta ndichofunika kwambiri, ndipo ma firewall angafunike ma netiweki ovuta kuti asinthane deta.
Kawirikawiri, makampani opanga mankhwala a biopharmaceutical akamayesa kukhwima kwawo pa digito pankhani ya mwayi wosamutsa ukadaulo wa BPLM, ayenera kuzindikira zovuta zazikulu zomwe zimapangitsa kuti ndalama ziwonjezeke komanso/kapena kuchedwa kukonzekera kupanga.
Ayenera kujambula zida zomwe ali nazo kale ndikuwona ngati zidazo zili zokwanira kukwaniritsa zolinga zawo zamabizinesi. Ngati sichoncho, ayenera kufufuza zida zomwe makampaniwa amapereka ndikuyang'ana ogwirizana nawo omwe angathandize kutseka kusiyana kumeneku.
Pamene njira zosinthira ukadaulo wopanga zinthu zikupitilizabe kusintha, kusintha kwa digito kwa BPLM kudzatsegula njira yopezera chisamaliro chapamwamba komanso chachangu kwa odwala.
Ken Forman ali ndi zaka zoposa 28 zaukadaulo komanso ukadaulo mu IT, ntchito, ndi kasamalidwe ka zinthu ndi mapulojekiti omwe amayang'ana kwambiri mapulogalamu ndi malo opangira mankhwala. Ken Forman ali ndi zaka zoposa 28 zaukadaulo komanso ukadaulo mu IT, ntchito, ndi kasamalidwe ka zinthu ndi mapulojekiti omwe amayang'ana kwambiri mapulogalamu ndi malo opangira mankhwala.Ken Foreman ali ndi zaka zoposa 28 zokumana nazo komanso ukadaulo mu IT, ntchito, kayendetsedwe ka zinthu ndi mapulojekiti omwe amayang'ana kwambiri mapulogalamu ndi mankhwala.Ken Foreman ali ndi zaka zoposa 28 zokumana nazo komanso ukatswiri mu IT, ntchito, kayendetsedwe ka zinthu ndi mapulojekiti omwe amayang'ana kwambiri mapulogalamu ndi mankhwala. Asanalowe nawo Skyland Analytics, Ken anali Mtsogoleri wa NAM Program Management ku Biovia Dassault Systemes ndipo anali ndi maudindo osiyanasiyana a director ku Aegis Analytical. Kale, anali Chief Information Officer ku Rally Software Development, Chief Commercial Officer ku Fischer Imaging, komanso Chief Information Officer ku Allos Therapeutics and Genomica.
Alendo oposa 150,000 pamwezi amagwiritsa ntchito izi kuti atsatire bizinesi ya biotech ndi zatsopano. Ndikukhulupirira kuti mudzasangalala kuwerenga nkhani zathu!