Kasancewa ƙarƙashin matsin lamba don yin gasa a cikin yanayi mai ƙalubale na tattalin arziki da fasaha, dole ne kamfanonin harhada magunguna da fasahar kere-kere su ci gaba da haɓaka cikin shirye-shiryensu na R&D don ci gaba da wasan.
Sabbin sabbin abubuwa na waje suna zuwa ta nau'i daban-daban kuma sun samo asali a wurare daban-daban - daga dakunan gwaje-gwaje na jami'a, zuwa kamfanoni masu zaman kansu masu tallafi da ƙungiyoyin bincike na kwangila (CROs). Bari mu sake yin bitar wasu abubuwan bincike masu tasiri waɗanda za su yi “zafi” a cikin 2018 da bayan haka, kuma mu taƙaita wasu manyan ƴan wasan da ke tuƙi sabbin abubuwa.
A bara an taƙaita BioPharmaTrendda dama muhimmanci trendsyana shafar masana'antar biopharmaceutical, wato: ci gaban fannoni daban-daban na fasahohin gyaran kwayoyin halitta (musamman, CRISPR/Cas9); girma mai ban sha'awa a cikin yanki na immuno-oncology (Canjin CAR-T); ƙara mayar da hankali kan binciken microbiome; zurfafa sha'awa ga madaidaicin magani; wasu muhimman ci gaba a cikin gano maganin rigakafi; haɓakar farin ciki game da hankali na wucin gadi (AI) don gano / haɓaka magunguna; ci gaba mai rikitarwa amma saurin girma a fannin maganin cannabis; da ci gaba da mayar da hankali kan pharma akan shiga cikin samfuran fitar da kayayyaki na R&D don samun damar sabbin abubuwa da ƙwarewa.
A ƙasa akwai ci gaba na wannan bita tare da ƙarin wuraren bincike da yawa da aka ƙara cikin jerin, da kuma wasu tsawaita sharhi kan abubuwan da aka zayyana a sama - inda suka dace.
1. Amincewar Artificial Intelligence (AI) ta hanyar pharma da Biotech
Tare da duk maganganun da ke kewaye da AI a zamanin yau, yana da wuya a ba kowa mamaki da wannan yanayin a cikin binciken harhada magunguna. Duk da haka, ya kamata a lura cewa kamfanonin AI-kore da gaske sun fara samun karfin gwiwa tare da manyan magunguna da sauran manyan 'yan wasan kimiyyar rayuwa, tare da haɗin gwiwar bincike da yawa da shirye-shiryen haɗin gwiwa -nanshine jerin maɓalli na maɓalli ya zuwa yanzu, kumanantaƙaitaccen bita ne na wasu sanannen ayyuka a cikin sararin "AI don gano magunguna" a cikin watanni da yawa da suka gabata.
Ana bincika yuwuwar kayan aikin tushen AI a duk matakan gano magunguna da haɓakawa - daga ma'adinan bayanan bincike da kuma taimakawa wajen gano maƙasudi da tabbatarwa, don taimakawa tare da sabbin mahaɗan gubar da ƴan takarar magunguna, da tsinkaya kaddarorinsu da kasada. Kuma a ƙarshe, software na tushen AI yanzu yana iya taimakawa wajen tsara tsarin hada sinadarai don samun abubuwan ban sha'awa. Hakanan ana amfani da AI don tsara gwaje-gwaje na farko na asibiti da na asibiti da kuma nazarin bayanan ilimin halittu da na asibiti.
Bayan gano magungunan da aka yi niyya, AI ana amfani da shi a wasu wuraren bincike, alal misali, a cikin shirye-shiryen gano magungunan phenotypic - nazarin bayanai daga manyan hanyoyin tantance abun ciki.
Tare da babban abin da aka fi mayar da hankali kan farawar AI akan ƙananan ƙwayoyin ƙwayoyin cuta, akwai kuma sha'awar amfani da irin waɗannan fasahohin don ganowa da haɓaka ilimin halittu.
2. Fadada sararin samaniya don binciken gano magunguna
Wani muhimmin sashi na kowane ƙaramin shirin gano magungunan ƙwayoyin cuta yana fuskantar bincike - gano waɗancan kwayoyin halittar farkon waɗanda zasu fara tafiya zuwa ga magunguna masu nasara (da wuya su tsira daga wannan tafiya, kodayake) - ta hanyar haɓakawa da yawa, inganci da matakan gwaji.
Babban abin da ke tattare da binciken bugu shine samun damar zuwa sararin faɗaɗɗen nau'in sinadari kamar kwayoyin halitta don zaɓar 'yan takara daga, musamman, don binciken ilimin halitta mai niyya. Ganin cewa tarin abubuwan da ake da su a hannun kantin magani an gina su a wani bangare bisa ƙananan ƙirar ƙwayoyin cuta waɗanda ke yin niyya da sanannun maƙasudin nazarin halittu, sabbin maƙasudin nazarin halittu suna buƙatar sabbin ƙira da sabbin dabaru, maimakon sake yin amfani da sinadarai iri ɗaya.
Bayan wannan buƙatar, dakunan gwaje-gwaje na ilimi da kamfanoni masu zaman kansu suna ƙirƙira ma'ajin bayanai na mahaɗan sinadarai fiye da abin da ake samu a cikin tarin rukunin kamfanonin harhada magunguna. Misalai sun haɗa da bayanan GDB-17 na ƙwayoyin cuta masu kama da juna waɗanda ke ɗauke da kwayoyin halitta biliyan 166,4 daFDB-17na miliyon 10 masu kama da gutsuttsura mai nauyin atom masu nauyi 17;ZINK- bayanai na kyauta na mahaɗan kasuwanci-samuwa don yin gwajin kama-da-wane, mai ɗauke da kwayoyin halitta miliyan 750, gami da miliyan 230 a cikin tsarin 3D waɗanda ke shirye don docking; da ci gaban da aka samu kwanan nan na sararin samaniyar sinadarai ta hanyar Enamine - 650 miliyan kwayoyin da za'a iya nema ta hanyarREAL Space Navigatorsoftware, kuma337 miliyan kwayoyin bincike(ta kamanni) a EnamineStore.
Wata hanyar da za a bi don samun damar sabon filin sinadarai irin na miyagun ƙwayoyi don buguwar bincike shine ta amfani da fasahar ɗakin karatu ta DNA (DELT). Sakamakon yanayin "raga-da-pool" na haɗin DELT, yana iya yiwuwa a samar da adadi mai yawa na mahadi a cikin farashi- da ingantaccen lokaci (miliyoyin zuwa biliyoyin mahadi).nanrahoto ne mai fa'ida kan tarihin tarihi, dabaru, nasarori, iyakancewa, da makomar fasahar ɗakin karatu na DNA.
3. Nuna RNA tare da ƙananan ƙwayoyin cuta
Wannan yanayin yanayi ne mai zafi a sararin gano magunguna tare da ci gaba da jin daɗi: masana ilimi, farawar fasahar kere kere da kuma kamfanonin harhada magunguna suna ƙara yin aiki game da niyya na RNA, kodayake rashin tabbas yana da girma.
A cikin halitta mai rai.DNAadana bayanai donfurotinkira daRNAyana aiwatar da umarnin da aka sanya a cikin DNA wanda ke haifar da haɗin furotin a cikin ribosomes. Duk da yake yawancin kwayoyi ana ba da umarnin su ne akan sunadaran sunadaran da ke da alhakin cuta, wani lokacin bai isa ya murkushe hanyoyin ƙwayoyin cuta ba. Da alama dabara ce mai wayo don farawa tun da farko a cikin tsari kuma ta yi tasiri ga RNA kafin a haɗe sunadaran, don haka yana da tasiri sosai kan tsarin fassarar genotype zuwa nau'in phenotype maras so (bayyanar cuta).
Matsalar ita ce, RNAs sanannen mummunan hari ne ga ƙananan ƙwayoyin cuta - madaidaiciya, amma suna iya murɗawa, ninke, ko mannewa kanta, ba da rancen ba da sifar sa zuwa aljihunan ɗaurin ƙwayoyi masu dacewa. Bayan haka, da bambanci da sunadaran, sun ƙunshi tubalan ginin nucleotide guda huɗu kawai wanda hakan ya sa dukkansu kamanceceniya da wahala ga zaɓin zaɓi ta ƙananan ƙwayoyin cuta.
Duk da haka,yawan ci gaba na baya-bayan nansuna ba da shawarar cewa a zahiri yana yiwuwa a haɓaka ƙanana masu kama da ƙwayoyi, masu aiki da ilimin halitta waɗanda ke nufi RNA. Bayanan kimiyya na zamani sun haifar da saurin zinare ga RNA -akalla kamfanoni goma sha biyusuna da shirye-shiryen sadaukar da kai gare shi, gami da babban kantin magani (Biogen, Merck, Novartis, da Pfizer), da farawar fasahar kere kere kamar Arrakis Therapeutics tare da$38M Series A zagayea cikin 2017, da Expansion Therapeutics -Jerin $55M A farkon 2018.
4. Sabbin maganin rigakafi
Akwai damuwa mai girma game da haɓakar ƙwayoyin ƙwayoyin cuta masu jurewa - superbugs. Suna da alhakin mutuwar kusan 700,000 a duk duniya a kowace shekara, kuma bisa ga nazarin gwamnatin Burtaniya, wannan adadin zai iya karuwa sosai - har zuwa miliyan 10 nan da 2050. Bacteria suna tasowa kuma suna haɓaka juriya ga maganin rigakafi waɗanda aka saba amfani da su tare da babban nasara, sa'an nan kuma ya zama mai girma. mara amfani da lokaci.
Rubutun maganin rigakafi mara nauyi don magance sauƙaƙan lokuta a cikin marasa lafiya da kuma yin amfani da maganin rigakafi da yawa a cikin kiwon dabbobi yana lalata yanayin ta hanyar haɓaka ƙimar maye gurbin ƙwayoyin cuta, yana mai da su jure wa magunguna tare da saurin ban tsoro.
A gefe guda, gano maganin rigakafi ya kasance yanki mara ban sha'awa ga binciken harhada magunguna, idan aka kwatanta da haɓaka ƙarin magungunan 'mai yiwuwa' na tattalin arziki. Wataƙila shine babban dalilin da ya haifar da bushewar bututun sabbin azuzuwan ƙwayoyin rigakafi, tare da na ƙarshe da aka gabatar fiye da shekaru talatin da suka gabata.
A zamanin yau binciken maganin rigakafi ya zama yanki mai ban sha'awa saboda wasu sauye-sauye masu fa'ida a cikin majalisar dokoki, ƙwaƙƙwaran pharma don zuba kuɗi a cikin shirye-shiryen gano maganin rigakafi, da kuma masu saka hannun jari - cikin farawar fasahar kere kere ta haɓaka magungunan kashe ƙwayoyin cuta. A cikin 2016, ɗayanmu (AB)yayi bitar yanayin gano magungunan kashe kwayoyin cutakuma ya taƙaita wasu daga cikin abubuwan da aka fara a sararin samaniya, ciki har da Macrolide Pharmaceuticals, Iterum Therapeutics, Spero Therapeutics, Cidara Therapeutics, da Entasis Therapeutics.
Musamman ma, ɗayan mafi ban sha'awa na kwanan nan a cikin sararin maganin rigakafi shinegano Teixobactinda kuma kwatankwacinsa a cikin 2015 ta ƙungiyar masana kimiyya karkashin jagorancin Dr. Kim Lewis, Daraktan Cibiyar Ganewar Cutar Kwayoyin cuta a Jami'ar Arewa maso Gabas. Wannan sabon nau'in maganin rigakafi mai ƙarfi an yi imanin zai iya jure haɓakar juriyar ƙwayoyin cuta a kansa. A bara, masu bincike daga Jami'ar Lincoln sun yi nasarar ƙera wani nau'in teixobactin da aka haɗa, wanda ya ba da wani muhimmin ci gaba.
Yanzu masu bincike daga Cibiyar Nazarin Ido ta Singapore sun nuna nau'in nau'in ƙwayar ƙwayar cuta na iya samun nasarar warkar da Staphylococcus aureus keratitis a cikin nau'in linzamin kwamfuta; kafin aikin teixobactin an nuna shi kawai a cikin vitro. Tare da waɗannan sababbin binciken, teixobactin zai buƙaci ƙarin shekaru 6-10 na ci gaba don zama maganin da likitoci za su iya amfani da su.
Tun lokacin da aka gano teixobactin a cikin 2015, wani sabon dangin maganin rigakafi da ake kira malacidins sun kasancebayyana a farkon 2018. Wannan binciken har yanzu yana kan matakin farko, kuma bai kusan ci gaba ba kamar sabon bincike kan teixobactin
5. Zane-zane na Phenotypic
Darajar hoto:SciLifeLab
A cikin 2011 marubuta David Swinney da Jason Anthonysun buga sakamakon bincikensugame da yadda aka gano sababbin magunguna tsakanin 1999 da 2008 yana bayyana gaskiyar cewa an gano yawancin ƙananan ƙwayoyin ƙwayoyin cuta na farko ta hanyar yin amfani da gwajin phenotypic fiye da hanyoyin da aka yi niyya (28 da aka yarda da magungunan vs 17, bi da bi) - kuma ya fi daukar hankali idan aka yi la'akari da cewa tsarin da aka yi niyya ne wanda ya kasance babban abin da aka mayar da hankali kan lokacin da aka bayyana.
Wannan bincike mai tasiri ya haifar da sake farfadowa na yanayin gano magunguna tun daga 2011 - duka a cikin masana'antar harhada magunguna da kuma a cikin ilimin kimiyya. Kwanan nan, masana kimiyya a Novartisgudanar da wani bitana halin da ake ciki a halin yanzu na wannan yanayin kuma ya zo ƙarshe cewa, yayin da ƙungiyoyin bincike na harhada magunguna suka ci karo da ƙalubale masu yawa tare da tsarin phenotypic, akwai raguwar adadin allon da aka yi niyya da kuma haɓaka hanyoyin phenotypic a cikin shekaru 5 da suka gabata. Mafi mahimmanci, wannan yanayin zai ci gaba fiye da 2018.
Mahimmanci, bayan kwatanta phenotypic da hanyoyin tushen manufa, akwai bayyananniyar dabi'a zuwa ƙarin hadaddun gwaje-gwajen salula, kamar tafiya daga layin salula mara mutuwa zuwa sel na farko, ƙwayoyin haƙuri, al'adu, da al'adun 3D. Saitin gwajin kuma yana ƙara haɓakawa, yana tafiya da nisa fiye da abubuwan karantawa iri ɗaya zuwa lura da canje-canje a cikin sassan salula, bincike-biyu har ma da hoton tantanin halitta.
6. Gabobi (jiki) -on-a-chip
Microchips da aka yi layi da raye-rayen sel na ɗan adam na iya kawo sauyi ga haɓakar ƙwayoyi, ƙirar cuta da keɓaɓɓen magani. Wadannan microchips, da ake kira 'gabobin-on-chips', suna ba da yuwuwar madadin gwajin dabbobin gargajiya. A ƙarshe, haɗa tsarin gaba ɗaya hanya ce ta samun tsarin "jiki-kan-a-a-a-chip" gabaɗaya don gano muggan ƙwayoyi da gwajin ɗan takarar ƙwayoyi da tabbatarwa.
Wannan yanayin yanzu babban abu ne a cikin gano magunguna da sararin ci gaba kuma mun riga mun rufe matsayin yanzu da mahallin tsarin "gagaru-on-a-chip" a cikin kwanan nan.mini-bita.
Yayin da shakku da yawa ya wanzu wasu shekaru 6-7 da suka wuce, lokacin da masu sha'awar ɗaukar ra'ayi suka bayyana ra'ayoyi kan filin. A yau, duk da haka, masu sukar sun kasance suna ja da baya. Ba wai kawai suna da hukumomin kula da kudade barungumi manufar, amma yanzu yana karuwakarbaa matsayin dandalin bincike na miyagun ƙwayoyi ta hanyar pharma da ilimi. Fiye da dozin biyu tsarin gabobin ana wakilta a cikin na'urorin kan guntu. Kara karantawa game da shinan.
7. Bioprinting
Yankin bioprinting kyallen takarda da gabobin ɗan adam yana haɓaka cikin sauri kuma shine, babu shakka, makomar magani. An kafa shi a farkon 2016,Celllinkyana ɗaya daga cikin kamfanoni na farko a duniya don ba da 3D bioink mai bugawa - wani ruwa wanda ke ba da damar rayuwa da haɓakar ƙwayoyin ɗan adam. Yanzu kamfanin na bioprints sassan jiki - hanci da kunnuwa, galibi don gwada magunguna da kayan kwalliya. Hakanan yana buga cubes yana ba masu bincike damar "wasa" tare da sel daga sassan jikin mutum kamar hanta.
Kwanan nan Cellink ya yi haɗin gwiwa tare da CTI Biotech, wani kamfani na medtech na Faransa wanda ya ƙware wajen samar da kyallen ƙwayar cuta, don haɓaka fannin binciken kansa da gano magunguna.
Matashin fara fasahar kere-kere zai taimaka da gaske CTI zuwa 3D buga kwafin ciwace-ciwacen daji, ta hanyar hada kwayar halittar Cellink tare da samfurin kwayoyin cutar kansar mara lafiya. Wannan zai taimaka wa masu bincike wajen gano sabbin jiyya a kan takamaiman nau'in ciwon daji.
Wani farawar fasahar kere-kere da ke haɓaka fasahar bugu na 3D don buga kayan halitta - wani kamfani na jami'ar Oxford, OxSyBio, wandakawai ya samu £10ma cikin Series A kudi.
Duk da yake 3D bioprinting fasaha ce mai matuƙar amfani, tana nan tsaye kuma marar rai saboda tana la'akari da yanayin farkon abin da aka buga kawai. Hanyar da ta fi dacewa ita ce haɗa "lokaci" a matsayin girma na huɗu a cikin abubuwan da aka buga (wanda ake kira "4D bioprinting"), yana ba su damar canza siffofi ko ayyukansu tare da lokacin da aka sanya wani abin motsa jiki na waje.nanbita ce mai fa'ida akan 4D bioprinting.
hangen nesa na rufewa
Ko da ba tare da zurfin nutsewa cikin kowane manyan abubuwan da aka bayyana ba, ya kamata ya bayyana cewa AI za ta ci gaba da ɗaukar wani ɓangare na aikin. Duk waɗannan sabbin wuraren haɓakar biopharma sun zama babban cibiyar bayanai. Wannan yanayin a cikin kansa yana ƙaddamar da wani babban matsayi ga AI, lura kuma, a matsayin postscript ga wannan batun, cewa AI ya ƙunshi kayan aikin nazari da yawa da na ƙididdiga waɗanda ke ci gaba da juyin halitta. Aikace-aikacen AI a cikin gano magunguna da haɓaka matakin farko galibi an yi niyya ne don gano ɓoyayyun alamu da abubuwan da ke haɗa dalilai da tasirin in ba haka ba ba za a iya ganewa ko fahimta ba.
Don haka, ɓangaren kayan aikin AI waɗanda aka yi amfani da su a cikin binciken harhada magunguna sun faɗi yadda ya kamata a ƙarƙashin moniker na "hankalin na'ura" ko "ilimin injin". Waɗannan duka ana iya kulawa da su ta hanyar jagorar ɗan adam, kamar a cikin masu rarrabawa da hanyoyin koyo na ƙididdiga, ko rashin kulawa a cikin ayyukansu na ciki kamar yadda ake aiwatar da nau'ikan hanyoyin sadarwa na wucin gadi. Harshe da sarrafa natsuwa da hanyoyin yuwuwa don rashin tabbas (ko mai ban tsoro) suma suna taka rawar gani.
Fahimtar yadda za a iya haɗa waɗannan ayyuka daban-daban a cikin faffadan horo na "AI" aiki ne mai ban tsoro wanda duk masu sha'awar ya kamata su yi. Daya daga cikin mafi kyawun wurare don neman bayani da bayani shineData Science Centralportal kuma musamman ma rubutun blog na Vincent Granville, wanda akai-akaibayyana bambance-bambancetsakanin AI, jinginar injin, zurfin koyo, da ƙididdiga. Kasance mai yin magana game da abubuwan da ke tattare da AI gaba ɗaya wani abu ne mai mahimmanci na kiyayewa ko gaba da kowane yanayin biopharma.
Lokacin aikawa: Mayu-29-2018