policy levers and strategies - national academies

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Making the Living World Engineerable - Synthe7c Biology, the UK Approach Lionel Clarke, co-chairman UK Synthe6c Biology Leadership Council* NAS, Washington D.C. 16 Nov 2016 *Note: presenta6on represents a personal reflec6on, not an official view of the SBLC Policy Levers and Strategies

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MakingtheLivingWorldEngineerable-  Synthe7cBiology,theUKApproachLionelClarke,co-chairmanUKSynthe6cBiologyLeadershipCouncil*NAS,WashingtonD.C.16Nov2016*Note:presenta6onrepresentsapersonalreflec6on,notanofficialviewoftheSBLC

PolicyLeversandStrategies

Whatisthe(UKSynthe6cBiology)Roadmap?1

Ø  Todevelopemergingpla6ormtechnologywithmul:plepoten:alapplica:onsintoaneffec:vecapabilitydeliveringclearvalue

Ø  NOTaprojectplantoafixedtarget…astraightroad…...morelikeahikingmapinunfamiliarterritory…orperhapsaguidetose6ngupaNa8onalPark–wheretobuildpathsandbridges,wheretopostwarningsignsandsetupsafetybarriers…

Whatisthe(UKSynthe6cBiology)Roadmap?2

Ø  Drivenbyunmetneeds,spanninghealthtosustainableenergyØ  notaprojectplantowardsasetendpoint,yetpurposeful

Ø  Aguidingframework,reflec:ngcommiHeeconsensusØ  alignedbehindacommonvisionandvaluesystemØ  relevantdepartmentsandstakeholdersremainresponsiblefordelivery

Ø  Speedandefficiencyenhancedbyan:cipa:ngfutureapplica:onsØ  S7mula7ngdiscussionsandac7onswellinadvanceofpoten7aldeployment

Ø MechanismforassessingprogressandreshapingasneededØ  follow-updocumentsbuilduponoriginalRoadmapfounda7on,notdisplace

TheUKApproach

Ø  Synthe:cBiologyiden:fiedasapoten:allysignificantscien:ficgrowthareawithacademicstrengthintheUKØ  PublicDialogue2011providedpreliminaryguidanceØ  ….buthowtorealiseitspoten7al?

Ø  ConveneaRoadmapCoordina:onGroupØ  Ledbyanindustrialist,butwithkeystakeholderrepresenta7onØ  BroaderengagementviaworkshopsandSpecialInterestGroupØ  Governmentobservers,butindependentrecommenda7ons

Ø  ConveneaLeadershipCounciltooverseeprogress,updateandre-steerasneededØ  Sub-groupsandOpenMee7ngstoenablemoreinclusionandengagement

Vision:…ofasynthe7cBiologySectorthatis:Ø  economicallyvibrant,diverseandsustainable:

wherebusinessesaresuccessfullydevelopingandintroducingnewproducts,processesandservices–leadingtosignificantrevenuesandemployment

Ø  cuSngedge:leadingscien7ficadvancesandwitharesilientplaVormofunderpinningtechnologies–deliveringclearadvantagesinapplica7ondevelopment

Ø  ofclearpublicbenefit:anexemplarofresponsibleinnova7on,incorpora7ngtheviewsofarangeofstakeholdersandaddressingglobalsocietalandenvironmentalchallengeswithinaneffec7ve,appropriateandresponsiveregulatoryframework

Ø Learnfrompast–GMOsandotherexperiencesØ Technologymustbedevelopedinasociallyresponsible

fashion–‘ResponsibleResearchandInnova7on(RRI)’Ø UKneedstobe,andbeseentobe,leadingthewayin

frameworksandmethodologiesforRRIØ RelevantStakeholders,RegulatorsandPublicsshouldbe

engagedinprocessesfromoutset;SocietyhastobeEnrolledØ GatherpreliminaryviewsviaPublicDialogue(2011)

ValueSystem

fivekeyques6onsthatsynthe6cbiologistsshouldbewillingandabletoanswer:

Ø whatisthepurpose?Ø whydoyouwanttodoit?Ø whatareyougoingtogainfromit?Ø whatelseisitgoingtodo?Ø howdoyouknowyouareright?Addedtowhichweshouldalsobepreparedtoconsider:Ø Whatmaybetheconsequenceofnotdoing?

ResponsibleResearchandInnova7on

2011

July2012Roadmap:BuildingFounda7ons-mul7disciplinarycentres,communityandvaluesystems

Jan2013Synthe7cBiologyPolicy:oneofthe‘EightGreatTechnologies’

Synthe:cBiologyUK:anindependentlycoordinatedresponsetoastrategicchallenge

1+6SBRCs,2DTCs&1IKCestablished:ExtendingUKFounda7onalandTransla7onalCapability

CambridgeUniversityandJohnInnesCentrevImperialCollegeLondon

2009

Synthe6cBiologyDoctoralTrainingCentre

SBRCs:Synthe6cBiologyResearchCentresDTC:DoctoralTrainingCentresIKC:Innova6onandKnowledgeCentre

+Governancesub-group+Sci&Techsub-group+BIASynBioAdvisoryCommifeealsoworkingwithBSI,NPL

UKSynthe:cBiologyLeadershipCouncilCo-Chairmen:Prof.LionelClarkeRt.Hon.DavidWillefs(2012-14)GeorgeFreemanMP(2014-16)

Dstl

Synthe7cBiology–anadvancingfron7er?

Synthe7cBiologystemsfromconfluenceofmodernsmartdata-intensivetechnologieswithadvancingbiologicalunderstandingatthegene7clevel

Ø ‘AnaloguetoDigitalRevolu:oninBiology’Asaresultofgreaterautoma7onandtheapplica7onofengineeringprinciplesofcharacterisa7on,standardisa7onandmodularisa7ontobiologicalsystems,predictabilityanddevelopmentspeedscanbeincreasedandcostsreduced

DomainofSynthe7

cBiology

‘Analogue’

‘Digital’

Design

BuildTest

Produce

Analyse

Registriesofstandardizedparts

EngineeringPrinciplesofcharacterisa7on,standardisa7on,modularisa7on

1953:DiscoveryofstructureofDNACrickandWatson

1990-2003HumanGenomeProject

1984:DNAfingerprin7ng

1970’s:gene7cengineeringdeveloped

HighThroughputAnalysistechniquesdeveloped

CostsofReadingandWri7ngDNAreduced

Costsofdatahandlingandanalysisreduced

Rapid,accurategene-edi7ngtoolsdeveloped(e.g.CRISPR)

SpeedandPredictabilityincreased

Biodesign

Design-to-outcomeprocessesaccelerated

Synthetic Biology: a timely response !linking technological potential to market needs !

Ref:UKSynthe6cBiologyRoadmapJuly2012

GlobalChallengesandNeedsIncreasingeffec7venewsolu7onsbecomingtechnologicallypossibleandcommerciallyviable

‘RapidbutnotHasty’valuesystem,regulatorydevelopment,governanceandsocialengagementembeddedinRoadmapandStrategicPlan

Synthe:cBiology

Design

BuildTest

Produce

Analyse

Biodesign

RapidTechnologicalDevelopmentDNAsequencing,synthesisandautomatedhigh-throughputanalysisincreasingspeedandpredictabilityDNAdesignandgeneassemblybecomingmuchcheaperandmorewidelyaccessible,facilita7ngroutestoinnova7vebio-basedsolu7ons

Commercial considerations provide !a further set of checks and constraints !

Ø Whatistheneed?Ø Howeffec7vearecurrentsolu7ons?Ø Howcouldanimprovedsolu7onhelp?Ø Howcouldsynthe7cbiologycontributetowardsgenera7ngthissolu7on?

Ø Howwillsuitabilityandacceptabilitybechecked?

hfps://connect.innovateuk.org/web/synthe7c-biology-special-interest-group/2016-uk-synbio-strategic-plan

UKSynBioStrategicPlan2016LaunchEvent:24Feb2016

July2012Roadmap:BuildingFounda7ons-mul7disciplinarycentres,communityandvaluesystems

Jan2013Synthe7cBiologyPolicy:oneofthe‘EightGreatTechnologies’

Feb2016StrategicPlan2016:commercialisingapplica7ons

Synthe:cBiologyUK:anindependentlycoordinatedresponsetoastrategicchallenge

Synthe7cBiology–2016UKStrategicPlanmappingoutroutestoindustrialisa7onandcommercialisa7onfrominnova7veresearchbase

SupplyingthePipelinewith

Op7ons

Transla7ngInves7ng

Commercialising

DevelopingEconomicandSocialValue

EXPERTWORKFORCE

SUPPORTIVEBUSINESS

ENVIRONMENT

INDUSTRIALISATIONANDCOMMERCIALISATION

EFFECTIVETOOLKITS

EFFICIENTENTERPRISE

Standards&Metrology

DesignTools

Leading-edgeAccessible

infrastructure

NetworkedandPartnered

Value-driven

Transla:onandDeliveryFocus

Skilled

Entrepreneurialmindset

StructuredTraining

Confidencetoinvest

Effec:veGovernance

Responsiblestewardship

HEALTHYRESEARCHBASE–INNOVATIVEOPTIONS

QuickWinsGrandChallengesandAspira:ons

SBLC

Agility

Responsiveness

Coordina:on

UKSynthe7cBiology–Interna7onalPartnerships

•  UKhassetouttobeamongsttheworldleadersinsynthe:cbiology.Coordinatedinvestmentsandini:a:veshelpingtoachieveandbenefitfromthis.–  over£300minvestedinR&Dtodate,plusprivateinvestments.SecondonlytotheUS.–  seekingtoleverageinvestmentstodatetoretainini7a7veandafractfurtherinvestments

•  Informa:on-basedpla6ormlendsitselftogeographicallydistributedopera:ons–  opportuni7esarisingindevelopingaswellasdevelopedmarkets–  UK-basedcommercialapplica7onsfordevelopingmarketsincludearsenicsensorforcleanwater,

controlofmosquito-bornediseasessuchasZika,bespokedrugsandvaccineproduc7on

•  Interna:onalpartnershipsanimportantfeatureofrecentdevelopmentofthefield–  shapedthroughworkshopsandjointresearchprogrammeswithUS,Europe,Chinaandothers–  seekroleas‘partnerofchoice’–valuableinestablishingstandards,regula7ons,accesstomarkets–  interna7onaltrainingandresearchpartnershipsincludeLEAP,synberc,iGEMandERA-SynBio

Thank You