I te mea e piki haere ana te matatau o ngā maimoatanga tata ki ia marama, he mea nui ake i mua te whakawhiti hangarau whai hua i waenga i ngā rongoā koiora me ngā kaihanga. E whakamārama ana a Ken Foreman, te Kaiwhakahaere Matua o te Rautaki Hua i IDBS, me pēhea te āwhina a te rautaki matihiko pai i a koe ki te karo i ngā hapa whakawhiti hangarau noa.
Ko te Whakahaere Huringa Ora Koiora Rongoā (BPLM) te mea nui ki te kawe mai i ngā rongoā whakaora hou me ngā rongoā whakaora ora ki te ao. Ka kapi i ngā wāhanga katoa o te whanaketanga rongoā, tae atu ki te tautuhi i ngā rongoā e hiahiatia ana, ngā whakamātautau haumanu hei whakatau i te whai huatanga, ngā tukanga hanga, me ngā mahi mekameka tuku hei tuku i ēnei rongoā ki ngā tūroro.
Ko ia o ēnei mahi paipa poutū kei roto i ngā wāhanga rerekē o te whakahaere, me ngā tāngata, ngā taputapu, me ngā taputapu matihiko kua whakaritea mō aua hiahia. Ko te whakawhiti hangarau te tukanga o te hono i ngā āputa i waenga i ēnei wāhanga rerekē hei whakawhiti i ngā mōhiohio whanaketanga, whakaputa me te whakapūmau kounga.
Heoi, ahakoa ngā kamupene hangarau koiora tino rongonui, he uaua ki te whakatinana angitu i te whakawhiti hangarau. Ahakoa he pai ētahi tikanga (pēnei i ngā paturopi monoclonal me ngā ngota iti) mō ngā huarahi tūāpapa, he mea hou tonu ētahi atu (pēnei i te rongoā pūtau me te ira) ki te umanga, ā, ko te uaua me te rerekētanga o ēnei maimoatanga hou kei te tāpiri tonu ki tētahi tukanga ngoikore. Ka piki ake te pēhanga.
He tukanga uaua te whakawhiti hangarau e uru ana ki ngā kaiwhakaari maha i roto i te mekameka tuku, e tāpiri ana ia tangata i ō rātou ake wero ki te whārite. Kei ngā kaitautoko koiora rongoā te mana ki te whakahaere i te kaupapa katoa, me te whakataurite i te hanganga mekameka tuku me ā rātou hiahia whakamahere pakari kia tere ake ai te wā ki te mākete.
He wero motuhake anō hoki ā ngā kaiwhiwhi hangarau o raro. Kua kōrero ētahi kaihanga mō te whakaae ki ngā whakaritenga whakawhiti hangarau uaua me te kore he tohutohu mārama, poto hoki. Ka pā kino te kore o te aronga mārama ki te kounga o te hua, ā, he maha ngā wā ka pā kino ki ngā hononga mahi tahi i te wā roa.
Whakatūria he mekameka tuku i te tīmatanga o te tukanga whakawhiti hangarau ina whiriwhiria te whare hanga tino tika. Kei roto i tēnei ko te tātari i te hoahoa o te whare hanga a te kaihanga, tā rātou ake tātari me te whakahaere tukanga, me te wātea me te tohu o ngā taputapu.
I te wā e whiriwhiri ana i tētahi CMO tuatoru, me arotake anō hoki e ngā kamupene te rite o te CMO ki te whakamahi i ngā tūāpapa tiritiri mamati. Mā ngā kaihanga e whakarato ana i ngā raraunga rota i roto i ngā kōnae Excel, i runga pepa rānei, ka taea te whakararuraru i te whakaputanga me te aroturukitanga, ka hua ake he whakaroa i te tukunga rota.
Ko ngā taputapu hokohoko o ēnei rā e tautoko ana i te whakawhitiwhiti matihiko o ngā tohutao, ngā tiwhikete tātari, me ngā raraunga puranga. Mā ēnei taputapu, ka taea e ngā pūnaha whakahaere mōhiohio tukanga (PIMS) te huri i te whakawhiti hangarau mai i ngā mahi tūmau ki te tiritiri mātauranga hihiri, haere tonu, me te mahi tahi.
Ki te whakatauritea ki ngā tukanga uaua ake e whakamahi ana i te pepa, i ngā ripanga tātai me ngā pūnaha rerekē, mā te whakamahinga o te PIMS ka whakaratohia he tukanga tonu mō te arotake i ngā tukanga mai i te rautaki whakahaere ki te tutuki katoa i ngā mahi pai me te iti ake o te wā, te utu me te mōrearea.
Kia angitu ai, me whānui ake te otinga whakawhiti hangarau i roto i tētahi hononga hokohoko hauora i ngā otinga kua whakaahuatia i runga ake nei.
I roto i tētahi kōrerorero tata nei me te Tumu Whakahaere Matua o te Ao o tētahi Kaiwhakahaere Hokohoko Ahumahi Matua, i whakakitea ko te arai matua ki te wetewete i waenga i ngā wāhanga BPLM ko te kore o tētahi otinga whakawhiti hangarau e wātea ana i te arumoni e kapi ana i ngā wāhanga katoa o te tukanga, ehara i te mea ko te mutunga o te whakaputanga anake. Ka nui ake te hiranga o tēnei hiahia i roto i ngā kaupapa whakawhānui koiora-rongoā mō te whakaputanga nui o ngā rongoā hou. Ina koa, me whiriwhiri ngā kaiwhakarato rauemi mata, me whai whakaaro ki ngā whakaritenga wā, me te whakaae ki ngā tikanga whakamātautau tātari, e hiahia ana kia whakawhanakehia ngā tikanga whakahaere paerewa katoa.
Kua whakatauhia e ētahi kaihoko ētahi raruraru mā rātou anō, engari kāore anō kia puta he otinga hou mō ētahi mahi BPLM. Nō reira, he maha ngā kamupene e hoko ana i ngā "otinga tohu" kāore i hangaia kia whakauruhia tetahi ki tetahi. Ko ngā otinga pūmanawa motuhake kei te papaanga ka hanga he arai hangarau tāpiri, pērā i te whakawhitiwhiti kōrero puta noa i ngā pareārai ahi me ngā otinga kapua, te hiahia o ngā tari IT ki te urutau ki ngā kawa motuhake hou, me te whakaurunga uaua ki ngā taputapu tuimotu.
Ko te otinga he whakamahi i tētahi huarahi raraunga whakauru e whakamāmā ana i te whakahaere raraunga, te nekehanga me te whakawhiti i waenga i ngā taputapu rerekē.
E whakapono ana ētahi ko ngā paerewa te huarahi ki te whakaoti rapanga. Ko te ISA-88 mō te whakahaere puranga he tauira o te paerewa tukanga hangahanga i whakamahia e te maha o ngā kamupene rongoā koiora. Heoi, ka rerekē te whakatinanatanga tuturu o te paerewa, ka uaua ake te whakauru mamati i te mea i whakaarohia i te tīmatanga.
Hei tauira, ko te kaha ki te tohatoha ngāwari i ngā mōhiohio mō ngā tohutao. I ēnei rā, kei te mahia tonutia tēnei mā roto i ngā kaupapa here roa mō te whakahaere tiritiri tuhinga Word. Kei roto i te nuinga o ngā kamupene ngā wāhanga katoa o te S88, engari ko te hōputu tuturu o te kōnae whakamutunga kei te kaitautoko rongoā. Ko te mutunga iho, me taurite e te CMO ngā rautaki whakahaere katoa ki te tukanga hanga o ia kiritaki hou e tangohia ana e rātou.
I te mea ka piki haere te maha o ngā kaihoko e whakamahi ana i ngā taputapu e tutuki ana i ngā whakaritenga S88, tera pea ka puta ngā huringa me ngā whakapainga ki tēnei huarahi mā roto i ngā hanumi, ngā hoko me ngā mahi tahi.
Ko ētahi atu take nui e rua ko te kore o ngā kupu whānui mō te tukanga me te kore o te māramatanga i roto i te whakawhitiwhiti raraunga.
I roto i te tekau tau kua pahure ake nei, he maha ngā kamupene rongoā kua whakahaere i ngā kaupapa "whakaōrite" ā-roto hei whakataurite i te whakamahinga a ā rātou kaimahi i ngā kupu noa mō ngā tikanga me ngā pūnaha. Heoi anō, ka taea e te tipu rauropi te hanga rerekētanga i te mea ka whakatūria ngā wheketere hou puta noa i te ao, ka whakawhanake i ā rātou ake tikanga ā-roto, inā koa i te wā e hanga ana i ngā hua hou.
Nā reira, kei te piki haere te āwangawanga mō te kore o te tirohanga matatau ki te tiritiri raraunga hei whakapai ake i ngā tukanga pakihi me te hanga. Tērā pea ka kaha ake tēnei arai i te mea kei te neke tonu ngā kamupene rongoā koiora nui mai i te tipu rauropi ki te hoko. He maha ngā kamupene rongoā nui kua riro mai i a rātou tēnei raruraru i muri i te hokonga mai i ngā kamupene iti ake, nō reira, ki te roa ake tā rātou tatari kia tukatukahia ngā whakawhitiwhiti raraunga, ka nui ake te raruraru.
Ko te korenga o ngā kupu noa mō ngā tawhā whakaingoa ka arahi pea ki ngā raruraru mai i te whakapoauau noa i waenga i ngā kaihangarau tukanga e matapaki ana i ngā tikanga tae atu ki ngā rerekētanga nui ake i waenga i ngā raraunga whakahaere tukanga e whakaratohia ana e ngā pae rerekē e rua e whakamahi ana i ngā tawhā rerekē hei whakataurite i te kounga. Ka arahi pea tēnei ki ngā whakataunga tuku puranga hē, tae atu ki te "Puka 483" a te FDA, i tuhia hei whakarite i te pono o ngā raraunga.
Me aro nui hoki ki te tohatoha raraunga matihiko i ngā wāhanga tōmua o te tukanga whakawhiti hangarau, inā koa ka whakatūria he hononga hou. E ai ki te kōrero i mua ake nei, ko te whai wāhi atu o tētahi hoa hou ki tētahi whakawhitiwhiti matihiko me whakarerekē pea i te ahurea puta noa i te mekameka tuku, nā te mea me whai taputapu hou, whakangungu hou hoki ngā hoa mahi, me ngā whakaritenga kirimana e tika ana, kia mau tonu ai te tutuki i ngā whakaritenga a ngā taha e rua.
Ko te raruraru matua e pā ana ki a Big Pharma ko te tuku urunga atu a ngā kaihoko ki ā rātou pūnaha ina hiahiatia. Heoi, he maha ngā wā ka wareware rātou kei te rongoa hoki ēnei kaihoko i ngā raraunga a ētahi atu kiritaki ki roto i ā rātou pātengi raraunga. Hei tauira, kei te pupuri te Pūnaha Whakahaere Mōhiohio Taiwhanga (LIMS) i ngā hua whakamātautau tātari mō ngā hua katoa i hangaia e ngā CMO. Nō reira, kāore te kaihanga e tuku urunga atu ki te LIMS ki tētahi kiritaki takitahi hei tiaki i te tūmataitinga o ētahi atu kiritaki.
He maha ngā huarahi hei whakaoti i tēnei raruraru, engari me nui ake te wā hei whakawhanake me te whakamātautau i ngā taputapu me ngā tikanga hou e whakaratohia ana e ngā kaihoko, e whakawhanakehia ana rānei i roto i te whare. I ngā āhuatanga e rua, he mea tino nui te whakauru i te tari hangarau mōhiohio mai i te tīmatanga, nā te mea he mea nui te haumarutanga raraunga, ā, me whakamahi pea ngā pareā ahi i ngā whatunga uaua hei whakawhiti raraunga.
I te nuinga o te wā, ina aromatawaihia e ngā kamupene rongoā koiora tō rātou pakeketanga matihiko e pā ana ki ngā whai wāhitanga whakawhiti hangarau BPLM, me tautuhi e rātou ngā arai matua e arahi ana ki te nui rawa o ngā utu me/te whakaroa rānei i te rite o te whakaputa.
Me mahere e rātou ngā taputapu kei a rātou, me te whakatau mēnā he rawaka aua taputapu hei whakatutuki i ā rātou whāinga pakihi. Ki te kore, me tūhura e rātou ngā taputapu e tukuna ana e te umanga, me te rapu hoa mahi hei āwhina i te whakakī i te āputa.
I te whanaketanga tonu o ngā otinga whakawhiti hangarau hangahanga, ka whakatakoto te panonitanga mamati a BPLM i te ara mō te kounga teitei ake me te tere ake o te tiaki tūroro.
Neke atu i te 28 tau o ngā wheako me ngā tohungatanga o Ken Forman i roto i te hangarau mōhiohio, ngā mahi whakahaere, me te whakahaere hua me te kaupapa e arotahi ana ki te ao pūmanawa me te rongoā. Neke atu i te 28 tau o ngā wheako me ngā tohungatanga o Ken Forman i roto i te hangarau mōhiohio, ngā mahi whakahaere, me te whakahaere hua me te kaupapa e arotahi ana ki te ao pūmanawa me te rongoā.Neke atu i te 28 tau te wheako me te tohungatanga o Ken Foreman ki te hangarau mōhiohio, ngā mahi whakahaere me te whakahaere hua me te kaupapa e arotahi ana ki te pūmanawa me te rongoā.Neke atu i te 28 tau o te wheako me te tohungatanga o Ken Foreman ki te hangarau mōhiohio, ngā mahi whakahaere me te whakahaere hua me te kaupapa e aro ana ki te pūmanawa me te rongoā. I mua i tana urunga atu ki Skyland Analytics, ko Ken te Kaiwhakahaere o te Whakahaere Kaupapa NAM i Biovia Dassault Systemes, ā, i puritia e ia ngā tūranga kaiwhakahaere maha i Aegis Analytical. I mua, ko ia te Āpiha Matua Mōhiohio i Rally Software Development, te Āpiha Matua Tauhokohoko i Fischer Imaging, me te Āpiha Matua Mōhiohio i Allos Therapeutics me Genomica.
Neke atu i te 150,000 ngā manuhiri e whakamahi ana i ia marama hei whai i te pakihi hangarau koiora me te auahatanga. Ko te tumanako ka pai ki a koe te pānui i ā mātou kōrero!