<<

have beenimplemented. ofthem, suchastheAcademic Some scientists.” ofbothacademic andindustrial the closeworking science is needed to provide Such research this knowledge. needs doesnotexist, thendiscovery andifthatknowledge knowledge, can only move along the translational pathway through the use of Research Council attheUKMedical (MRC), research andindustry “you care solutions. According to Chris Watkins, director oftranslational a genuineinterest intranslatingbasicfindingsinto viablehealth together for with drugdiscovery necessary resources andexpertise within company walls, and, from theacademicside, accessto the thatdoesnotexistside, accessto biologyandto new expertise research division. former generalmanagerof Maruyama, Takeda’s pharmaceutical are essential, notjustnicetopartnerships have,” said Tetsuyuki and the growing realization by companies big pharma that these more withindustry, entrepreneurial academicscientiststo working opment pipeline. haschangedrecently istheopennessof “What ofnoimmediatescience projects benefitto acompany’s devel throughtions ranging arrangements to from basic fee-for-service and vice versa, to ideas to advance new the clinic, with collabora collaboratingwithacademia, There isalongtraditionofindustry innovation with academic Experimenting R&D are becomingsynonymous witheachother” greatin thefuture BDand willbecreative short, BDengagement.In elementofexceptionalheld beliefthatacritical R&Dorganizations tallied up;however, are positive, biomarkers theearly andit’s awidely final scorecard for and what didn’t what worked is years from being are ofexperiments beingdoneacross“lots theecosystem, andthe development (BD). challenging existingnotionsofbusiness with academicpartners, modelsforR&Dinnovationnew through externalizing collaboration and strategic of inwhichcompaniesare shift testing outavariety amajorcultural isexperiencing thesector innovation to fact, thrive. In for innovativement hungry science is helping academic biomedical focus onlater-stage assets, aventure investor andpharma environ previous continuesto years. Andalthoughthebulkofthisactivity andvaluesinmany therapeuticareas werelicensing activity upfrom offerings andofmergers andacquisitionsreached highs, historic and 2015 wasaboomyear for ofinitialpublic biopharma—numbers Gaspar Taroncher-Oldenburg the openinnovation model, setting the stageforcrop ofpartnerships. a fertile with new forms ofcollaboration between andindustry, academia such as is undergoing a periodofgreatAcademic partnering diversification andgrowth, partnerships academic up Opening sortium, founded in 2012 and based at Johns Hopkins University, founded Hopkins in2012and basedatJohns sortium, ontheacademicside. started Consortium, TheDrug Discovery con To academiaandindustry, many closethegapbetween initiatives are, from theindustry ofpartnering drivers ofthistype The principal As atAtlas highlighted recently by BruceBooth,partner Venture, 1 . - - - -

scientists andcenters andprovides worldwide themwith,among of academic drug discovery has established an interactive network the technology transfer organization ofGermany’s Planck Max discovery. The LDC, established in 2008 Planckby Max Innovation, collaborationsfor drug early as anenablerofacademia–industry nies andwithotherfunders, anapproach thathashelpeditto serve to withcompa interact research alsohastheflexibility intheUK, academic missionto support withaprimary a government agency are inGermany anotherdriver. Center (LDC) Discovery The MRC, to namejustafew. UCB’s andGSK’s alliancewithHarvard Fast Discovery Track Challenge, tives include Lilly’s and Phenotypic Target initiatives, Drug Discovery academic researchers initia and disease foundations. industry Other created with to advance preclinical innovation in partnership being to leadingacademiccenters andwhere is auniqueR&D network for ofsites located aseries Therapeutic inproximity Innovation, research—andin preclinical ’s proof-of-concept Centers regional hubsdesigned to applycollaborative andflexiblemodels Centers— Innovation centers &Johnson includetheJohnson have originated inindustry. Examplesinvolvingpartners dedicated membersandthelife scienceindustry. consortium and collaboration between aplatform forother services, partnering per year.Innovations. BioCentury Source: PPPs 200and400new with between beingestablished PPPs have ofthebiotech ecosystem, becomeanintegral part established globallyinthepastfive years. Figure 1: (PPPs) The number ofpublic–private partnerships

Number of PPPs National-level agencies suchin the as UKthe and MRC the Lead initiatives innovation to withacademic advanceearly-stage Other 100 200 300 400 0 2011 2012

Year 2013

In that time, In 2014 biopharmadealmakers.nature.com |June2016 | 2015

- -

B3 B3

allou/iStock

feature feature B4 tions, so-called investigator-sponsoredtions, so-called are studiesandtrials stillone perception ofinterest.” ofpossibleconflicts Butdespite thesepercep academics(especially physician scientists)becauseofthe support Development. & Early is increasingly difficult to to spend money “It academic relations Pharma Research and collaborations at Roche when thefundsgoto aspecificlab,” López, saidJuanCarlos headof experience, often particularly academiaandindustry between One of themainhurdles isthe “intense scrutiny thatinteractions ( BioCentury PPPs formed per year globally in the past five years, according to ofthebiotech ecosystem, with 200–400newan integral part as anengine for thecreation companies, ofnew have become Such PPPs, whichfoster academicinnovation andalsocanserve players suchasgovernment organizations anddiseasefoundations. (PPPs) and other established bypartnerships academia, industry rations overall, butausefulproxy isthenumberofpublic–private andotherstakeholders. with industry universities andresearch centers by settinguptranslationalpartnerships Institute, capitalizes onbasicresearch comingoutofleadingGerman companies for collaborative R&Dprojects. Source: Pharmagellan. to avoid ofinterest. are any conflicts optimized Many oftheseweb for interfaces compliance, are andinsomecases they theonly pointofaccessfor many pharma andlarge to pharma biotech ensureMost companieshave thatR&Dgrants developed are onlinecollaborationinterfaces awarded andmanaged withtransparency Table 1:Companies offering onlineinvestigator-initiated interfaces studyandtrial (IIS andIIT) Vertex Teva Takeda Shire Roche/Genentech Regeneron Pfizer Novo (Takeda) Millenium Merck KGaA Merck &Johnson Johnson GlaxoSmithKline Gilead Eli Lilly Eisai Squibb Bristol-Myers Ingelheim Boehringer Biogen Bayer AstraZeneca Astellas Abbvie Company Against thisoverall positive backdrop, several challengesremain. isdifficultto accurate determine numbersofacademiccollabo It |June2016 | Fig. 1 biopharmadealmakers.nature.com ) 2 . www.vrtx.com/our-communities/vertex-investigator-initiated-studies https://iss.tevapharm.com/ www.takeda.com/research/iisr/ ist.shiresupport.com/home/ www.sanofi.us/l/us/en/layout.jsp?scat=0E0D4D31-992C-46B3-A65B-7FFD4CDFFC8F www.gene.com/good/grants/scientific-project-support regeneron.envisionpharma.com/vt_regeneron/ iisgrants.regeneron.com/account/ www.pfizer.com/research/rd_partnering/investigator_initiated_research www.novonordiskiss.com/ www.novartis.com/our-work/research-development/clinical-trials www.millennium.com/ourScience/PreclinicalRequestSystem.aspx www.ist.emdserono.com/ engagezone.merck.com/faq.html www.medivation.com/research_development/investigator-sponsored-research www.jsa-investigator.com/home iss.gsk.com/ www.gilead.com/research/investigator-sponsored https://www.genzyme.com/Company/Working-With-Genzyme/Partnering www.lillyinvestigatorresearch.com/Pages/default.aspx www.eisaigrants.com/IIS.aspx www.celgene.com/research-development/clinical-trials/investigator-initiated-trials/ www.bms.com/clinical_trials/investigator_sponsored_research/ initiatedstudiesiis.html us.boehringer-ingelheim.com/our_responsibility/grants-and-funding/investigator_ medicalresearch.biogen.com/Investigator-Initiated-Trials.aspx www.iss.bayer.com/ www.astrazeneca.com/Research/externally-sponsored-research www.astellasinvestigatorsponsoredresearch.com/ www.amgen.com/partners/research.html www.abbvie.com/research-innovation/home.html Webpage

- -

arrangements withdifferentarrangements degrees ofopenness. of OI; rather,incarnations there is a continuum of collaborative five years, is ‘open innovation’ (OI). Noonedefinitionfitsallpossible over world thepastdecade, andespeciallyover thepast partnering One conceptthathasbeengainingmomentuminthelife sciences innovation Open solutions found.” drivers are openlydiscussedandaccepted, andmutuallyagreed away [from them]. Truly effective collaborationoccurswhenthese whereas commercial may drivers force scientiststo move industrial problems inresearch,can devote the knotty more time to tackling Watkins. However, headded, thiscanalsobeastrength, “as academics drivers andperspectives, suchas publications andtimescales,” said siderably. have sectors academicandindustrial somedifferent “The ago, thelanguageandincentives onbothsidesstilldiffer con understandeachotherbetter didjustten thanthey years industry standards hightransparency very academia and large and biotech pharma companies, albeit now with points for collaborative entry of theR&D principal studies between A second challenge is that, despite the fact thatacademiaandA secondchallengeisthat,despite thefact 3 ( Table 1 Clinical andpreclinical Scope Clinical andpreclinical Clinical Clinical andpreclinical Clinical andpreclinical Clinical andpreclinical Clinical andpreclinical Clinical andpreclinical Clinical andpreclinical Clinical Clinical Preclinical Clinical andpreclinical Clinical Clinical andpreclinical Clinical Clinical Clinical Clinical andpreclinical Clinical Clinical Clinical Clinical andpreclinical Clinical Clinical Clinical Clinical andpreclinical Clinical Clinical andpreclinical ). - vote of the UK academic of confidence research in the quality able by thecompaniesfree ofcharge. This amounts anenormous “to compounds have now been made avail Sixty-eight opportunities. compoundsto exploreaccess theirdeprioritized novel therapeutic Lilly, Pfizer, Takeda and UCB—to enable UK academic researchers to &Johnson, companies—AstraZeneca, Johnson pharmaceutical GSK, Centre for Lead Discovery. andtheMRC–AstraZeneca Asset Initiative Sharing MRC–Industry including unique two initiatives involving compound the sharing: aleading role ininitiating anumberofOIactivities, hastaken MRC for withashared example, theUK, goal. the rators In inconsortia together fundingagenciestoand private potential bring collabo ofgovernment butalsoleverage thecapacity partners industrial for thebetter. andthepotential foribility information sharing have madealeap outcome ofeachindividual research butoverall project, theaccess­ regulated indifferent ways dependingonthecompany andthe andaccessto the results fromproperty thesecollaborationsare high-throughput screening usingnovel diseasemodels. Intellectual have also opened up their compound for libraries researchers to do drugs—has been amajorfocus. parallelto this, In some companies chemicalprobes and well-characterized ‘shelved’ clinical-stage compounds—including concept, providing accessto proprietary traditional, closedandexclusive collaborations. such asleadcompoundsefficientlyormore efficientlythan orassets cangenerate knowledge of openaccessarrangements collaborations inaprecompetitive environment andunderarange andisfounded onthenotionthatprogramsindustry pursuedas anywhere elseintheworld,” said Watkins. isnoothersuchinitiative ofasimilarscaleandbreadthbase—there openess of these collaborations varies witheachprogram.openess ofthesecollaborationsvaries Source: Pharmagellan. openinnovation (OI) collaborative andlarge R&Dprojects.Many to pharma biotech support companieshave developed onlinecollaborationinterfaces The level of Table 2:Listofpharma andlarge biotech companies offering innovation onlineopen interfaces Merck KGaA &Johnson Johnson GlaxoSmithKline Eli Lilly Bayer AstraZeneca Astellas Amgen Abbvie Company For withseven hasworked theAsset Initiative, theMRC Sharing Many OI collaborations not only by are academic and supported has tested theAmong the OI approaches with which industry academia between and happens atOI the typically interface http://openinnovation.astrazeneca.com/ http://www.astellas.com/jp/a-cube/ https://www.amgenscience.com/ http://www.openinnovation.abbvie.com/ Webpage open_innovation_portal.html /open_innovation_portal/ http://www.emdgroup.com/emd/products/ http://www.jnjinnovation.com/partner-with-us http://www.dpac.gsk.com/ https://openinnovation.lilly.com/dd/ innovation-partnering/ https://pharma.bayer.com/en/ - -

“The amountofbiology thatisgenerated by theacademiclabs—the “The ics inorder to investigate difficult targets inanopen environment. a scenario, companies pharma share tool compounds with academ not ofideasbutthescienceneededto solve theproblems. such In vidually. The OIapproach to suchchallengesisthrough crowdsourcing couldaddress indi that nosinglecompany oracademiclaboratory scientific understandingandbenefitpatients. further published inpeer-reviewed to maximize journals theirpotential to More ofOI,research importantly, andinthespirit findingswillbe compound library, antibodiesandotherrelevant technologies. and staff, andGSKwillalsoprovide accessto itsnondevelopment resources,nizations will contribute in-kind including lab space Research inLondon. oftheagreement, Undertheterms bothorga establishedFrancisship withthenewly for Institute Biomedical Crick proponent anearly ofOI,recently enteredGSK, alarge OIpartner wide range of open collaborations can be envisioned. For instance, to bemostlynonrestrictive. by company andtend ofthesecollaborationsvary and otherterms ofresults, for to theirdevelopment. Ownership publish rights port sup companies reward thebestideaswithfinancialand/orin-kind ing withtheresearchers proposing them( sourcing mightbeinterested to ideasthey identifynew indevelop that enable them to use crowddeveloped online OI interfaces ­ medicines.disease anddevelop new moleculesthatwillhelpthemunderstand the identificationofnew this initiative tospecifically allow to researchers support to optimize global R&D center of its new in Cambridge equipment as part equipment. The company hasalsoagreed to purchase additional 1.9 millioncompoundsandassociated high-throughput robotic academic researchers withfree accessto AstraZeneca’s of library • • • • • • • • • • • • • • • • • • innovationOpen program(s) • • • One key opportunity provided by OI is the chance to tackle problems provided problems by OIisthechanceto tackle opportunity One key Ultimately, OIprovides withinwhicha aconceptualframework Beyond these initiatives, some companies biopharma have also The MRC–AstraZeneca Centre for provides Lead UK Discovery • • • • • • • • • • • • • • • • • • • • • Neglected andtropicalNeglected diseaseR&Dcollaborations design Remote compoundsynthesisandlibrary compoundacquisitionforNew compoundlibrary In silico Cloud-based (PartnerYourAntibodies)Antibody R&Dsupport Healthcare technology funding(Grants4Apps) Novel target andMOA funding(Grants4Targets) (Grants4Leads) Small-molecule leadvalidationandoptimizationfunding R&D challenges(grants inareas ofinterest to AZ) candidates) profiling ofnovelMolecular (assay andcharacterization drug (MOA) (target/mechanism ofaction projects) Compound library Pharmacology toolbox (compounds for preclinical research) human trials) Clinical compoundbank(clinical safety dataavailable for institutes andbusinesses) to (restricted Japaneseuniversities, (a-cube) drugdiscovery Joint (AmBER) researchInternal tools andcompoundsfor preclinical research tools andcompoundsforInternal preclinical research [excludes UShealthcare professionals] Library) R&Dcompoundsandderivatives(Mini Deprioritized screeningHigh-throughput (HTS) ofsourced compounds Compound accessfor preclinical research Target validationandleadoptimization and in vitro in silico characterization ofnovel characterization drugcandidates drugdesign Table 2 biopharmadealmakers.nature.com |June2016 | ). In mostinstances, ). In

------

B5 B5

feature feature B6 a more realistic valuationofthescienceemanatingfrom academia and capabilities and recognition of expertise of the complementarity by increasing hasentered eramarked anew Academic partnering forward Partnering a papersaying thetarget may bevalidated,” addedEdwards. our target thatprovides adefinitive validationversus thepublication of a company to invest, let’s say, $20Mto develop aprogram surrounding resources onadrugdevelopment program—it isthiscommitmentof tionally asatarget for whichacompany decidesto invest itsinternal over five years. the next industry We define a validated target opera CEO. “Our aspiration isto deliver five novel and validated targets to and anunderstandableroadmap for industry,” saidAledEdwards, SGC’s the way acompany would doit,thussettingcleargoalsfor thescience “At SGCwe have much ourscientificgoalsinmilestones, structured very programs. to initiate their own internal and proprietary the consortium companies can at any point use any insights of the new gathered by agreements thatprecisely delineatepartnering mechanismsby which it’s insightisimportant, almostalways proprietary.”drug discovery I thinkitwillhave alimited role R&D]toolbox—if inthe[external a tion focuses etc. onlyonprecompetitive … spaceswithconsortia, patentable innovations are central,”etary saidBooth. openinnova “If [return oninvestment],a highROI meansthat propri whichinturn frameworks. “Drug R&Drequires tons ofcapital, resulting inaneedfor remains oneofthebiggestchallengesto thetrueopennessofOI are patentable andby whomhasbeenand within anOIpartnership ing theground ofthediscoveries generated rulesfor whatportions establish process. fact, the scienceatpointsalongdiscovery In potential to emerging derive and secure intellectual from property Research Foundation–FAPESP). andSãoPaulo ofEconomic andInnovation Development Ministry Initiative, Ontario Canada, Medicines Innovative Genome Innovation, agencies (Canada Foundation for for Eshelman Institute Innovation, Takeda), together roster withaninternational ofpublicfunding Janssen,Merck &Co., Pharma AG, PfizerIngelheim, and Novartis (AbbVie, Bayeramong itsfundingpartners Pharma AG, Boehringer restrictions. property Today, companies theSGChaseightbiopharma being placed in the public domain without intellectual consortium chemical tools to enabledrugdiscovery, withalloutputsfrom the duce 3Dstructures ofbiomedicallyrelevant proteins anddevelop Canadian funders as a not-for-profit PPP with the mission to pro successfully donethisintheepigeneticsspace,” saidLópez. has by pharma, inpart anoperationsupported Consortium], Genomics of companies efforts interested in those targets. The SGC [Structural crowdsourcing facilitates the internal drug discovery part—greatly The SGC has addressed the intellectual property challenge through challengethrough The SGChasaddressed property theintellectual isthe in any ofpharma OIpartnership to theparticipation Key the The SGCwasestablishedin2003by GSK, and |June2016 | biopharmadealmakers.nature.com - - - - - together innew collaborative Maruyama Maruyama are theseefforts donehalfway—for“If example, part business and their relationshipseveryday with each other,” offered andacademia think about their change inthe way bothindustry drugdiscovery.on early bilities aboundfor thosewillingto seekcreative ways to collaborate R&D,rapidly growing on external possi­ new reliance of the industry quickandunrealistic financialreturns. Given the that de-emphasizes consultant inPhiladelphia, based Pennsylvania, USA. Taroncher-OldenburgGaspar isanindependentbiopharmaanalystand 3. 2. 1. medicines.”new nies thatembracethemandaccelerate theprogress ofinnovative R&Dapproachesmany willtransform oftheseexternal thecompa mentation ishappening around thisconvergence, andI’m confident collaborativein new models. Lots ofBDandorganizational experi companies,biopharma young biotechs, andacademiatogether VCs will bedefinedby aconverging larger R&Decosystem thatbrings thatBooth remarked future“the of innovation in the life sciences not reap thefullrewards oftheirpartnerships,” headded. will dothey tight,butuntilthey neededtothought they holdvery scientistsand academics to letgoofwhatthey for bothindustry risky feelsyour willnotsucceed. mostvaluableassets—they very It sothatyou inareas don’tnering oflow priority have to give away models biotechs, VCs andacademia biopharma companies, young ecosystem that bringslarger defined by aconverging R&D “ Getting the most from academic partnerships themostfromGetting academicpartnerships “requires agenuine And nicely summarizing the potential of academic partnering, thepotential ofacademicpartnering, And nicelysummarizing orations Pharmagellan David, F. &Robey, S.EnablingR&Dcollaborations academiaandpharma. between M.&Romeo,Zipkin, M. com/2015/06/external-innovation-force-multiplier-for-rd/ B.Booth, innovation: External force multiplier for R&D. (2015). T

in thelife sciences willbe he future ofinnovation

http://www.pharmagellan.com/blog/pharma-academia-collab Bruce Booth, partner at Atlas partner Bruce Booth, Venture BioCentury InnovationsBioCentury

1 , 1–6 (2016). Life Sci VC Life Sci (2015).

http://lifescivc.

- - - -