Accelerating biomedical innovation: a case study of the
SPARK program at Stanford University, School of Medicine
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Citation
Kim, Esther S., Paige M.C. Omura, and Andrew W. Lo. “Accelerating
Biomedical Innovation: a Case Study of the SPARK Program at
Stanford University, School of Medicine.” Drug Discovery Today 22,
no. 7 (July 2017): 1064–1068.
As Published
http://dx.doi.org/10.1016/J.DRUDIS.2017.03.015
Publisher
Elsevier BV
Version
Author's final manuscript
Citable link
http://hdl.handle.net/1721.1/120750
Terms of Use
Creative Commons Attribution-NonCommercial-NoDerivs License
Teaser
The
Stanford
SPARK
program
is
an
innovative
academic–industry
partnership
for
translating
academic
biomedical
research.
This
article
highlights
SPARKs
model,
which
can
provide
a
template
for
other
universities
and
institutions
interested
in
de-risking
and
facilitating
the
translation
of
biomedical
research.
Accelerating
biomedical
innovation:
a
case
study
of
the
SPARK
program
at
Stanford
University,
School
of
Medicine
Esther
S.
Kim
1,2,
Paige
M.C.
Omura
1,3and
Andrew
W.
Lo
1,4,5,61MITLaboratoryforFinancialEngineering,SloanSchoolofManagement,Cambridge,MA,USA 2MITTechnologyandPolicyProgram,Cambridge,MA,USA
3MITDepartmentofChemicalEngineering,Cambridge,MA,USA
4MITComputerScienceandArtificialIntelligenceLaboratory,Cambridge,MA,USA 5MITDepartmentofElectricalEngineeringandComputerScience,Cambridge,MA,USA 6AlphaSimplexGroupLLC,Cambridge,MA,USA
Translating
academic
medical
research
into
new
therapies
is
an
important
challenge
for
the
biopharmaceutical
industry
and
investment
communities,
which
have
historically
favored
later-stage
assets
with
lower
risk
and
clearer
commercial
value.
The
Stanford
SPARK
program
is
an
innovative
model
for
addressing
this
challenge.
The
program
was
created
in
2006
to
educate
students
and
faculty
about
bringing
academic
research
from
bench
to
bedside.
Every
year,
the
program
provides
mentorship
and
funding
for
approximately
a
dozen
SPARK
‘scholars,’
with
a
focus
on
impacting
patient
lives,
regardless
of
economic
factors.
By
reviewing
the
detailed
structure,
function
and
operation
of
SPARK
we
hope
to
provide
a
template
for
other
universities
and
institutions
interested
in
de-risking
and
facilitating
the
translation
of
biomedical
research.
Introduction
In this case study we profile the structure and impact of the SPARK Translational Research
Program at Stanford University School of Medicine, a partnership between academics and
individual experts in industry dedicated to overcoming the hurdles of translating academic
discoveriesintodrugsand diagnosticsthataddressunmet clinicalneeds.SPARK’sunderlying
philosophyisthatacademiahasanimportantparttoplayindecreasingthetimeandcostof
developingnewtherapeuticsanddiagnosticsthatbenefitsociety.Bystudyingthisinnovative
partnership,weaimtoprovideatemplateforotheruniversitiesandacademicmedicalcenters
interestedinlaunchingtheirowntranslationalmedicineaccelerators.
Academia—definedheretoincludenonprofituniversitiesandscientificresearchinstitutions
—isamajorstakeholderthatcanplayanimportantpartinprogressingmedicaldevelopment.
Theinteractionsbetweenacademia,thepharmaceuticalindustryandregulatoryauthoritiesare
ofparamountimportanceforensuringthequality,efficacyandsafetyofdrugsinclinicaland
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KEYNO
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REVIEW
Correspondingauthor:Lo,A.W. (alo-admin@mit.edu)
1359-6446/ã2017ElsevierLtd.Allrightsreserved.
commercialuse.Newmodels,suchasthatofSPARK,canfacilitate
partnershipsamongstakeholdersandacceleratethe
commerciali-zationofbiomedicalresearch.
Translational
medicine
background
Thepastfewdecadeshavebroughttremendousbreakthroughsin
the fundamental knowledge necessary for understanding,
pre-venting, diagnosingandtreating manydiseases—breakthroughs
suchashumangenomesequencing,immunotherapiesandgene
therapies.However,theprocessoftranslatingnewdiscoveriesinto
productsseverelylagsbehindthepaceofdiscovery.Thetransition
periodwhenadevelopingtechnologyisseenaspromisingbutis
toonewtovalidateitscommercialpotentialandunabletoattract
the necessary funding for itscontinued development has been
coinedthe‘valleyofdeath’[1].Investorsarereluctanttobearthe
fullcostofenteringthevalleyofdeath,owingtothehighriskand
historicallylowreturnoninvestmentforearly-stageR&D.
Conse-quently, only 12% of active preclinical assets reside in large
pharmaceutical companies [2], and 80–90% of biomedical
re-searchprojectsneverprogresstotrialsinhumans[1].
Translationalmedicineisa growingfield,focusedon
addres-singthisgapbetweenmedicaldiscoveryandcommercialization
[3]. Within the past decade, the National Institutes of Health
(NIH) has made translational research a priority, forming the
National Center forAdvancing TranslationalSciences(NCATS)
and launching the Clinical and Translational Science Award
(CTSA) programin 2006.Additionally, at least three journals
aredevotedtofurtheringthefield:ScienceTranslationalMedicine,
JournalofTranslationalMedicineandNewHorizonsinTranslational
Medicine.
The risk-averse attitude in industry opposes the culture of
academia, where risk-taking is often rewarded by promotion
and recognition. The essentialrole of academic institutions in
commercialdrugdevelopmentcallsforabetterfunding
mecha-nism to reward academic contributions and a more efficient
academic–industry collaboration.Although thisprocess is
com-plicatedbythefactthatacademicandcommercialinterestsarenot
alwaysaligned,anevolvinghybriddrugdiscoverymodelcanbe
useful in mitigating risks and increasing productivity. SPARK
providesonesuchexample(Fig.1).
The
origin
and
mission
of
SPARK
The SPARK program was founded in 2006 by Professor Daria
Mochly-Rosen,whocameupwiththeideawhileservingasSenior
Associate Dean for Research in the Dean’s Office of Stanford
UniversitySchoolofMedicine.Twoyearsbeforeherappointment,
shehadtakenaleaveofabsencefromStanfordtofoundherown
company,KAIPharmaceuticals,whichwassubsequentlyacquired
by Amgenin 2011.From herexperiencewithKAI, Dr
Mochly-Rosen found that bridging the translational research gap was
extremely challenging and not necessarily an intuitive process
foracademics.Recognizingtheneedforeducationandfundingto
helpheracademiccolleaguestranslatetheirresearchinto
thera-pies,DrMochly-RosencreatedSPARKwithcrucialearlybacking
fromtheDean’sOfficeoftheSchoolofMedicine,whichallocated
thefundstolaunchtheprogramandcontinuestoprovide
finan-cialsupport.DrMochly-RosenthenrecruitedDrKevinGrimes,an
academicinternistwithdrugdevelopmentexperience,tojoinher
asco-directoroftheprogram.Nowinitstenthyear,SPARKoffers
training, support and mentorship to academic researchers to
pursuebasicresearchwithpotentialmedicalapplications.SPARK’s
statedgoalis‘tomovefivetotennewdiscoverieseachyearfrom
thelab tothe clinicand/ortocommercialdrug and diagnostic
development’[4].
How
SPARK
operates
TheSPARKprogramiscenteredonitsresearchers.Selectedproject
leaders,calledSPARK‘scholars,’receiveUS$50000annuallyfor
twoyears,in additiontoextensiveeducationalmentoringfrom
SPARKadvisors.Everyyear,SPARKselectsaclassof10–15scholars
that remain in the program for a two-year cycle. Since SPARK
startedacceptingopen applicationsin itsfourthyear, over400
projectshavebeen submittedforconsiderationintheprogram.
The SPARK scholars are required to attend interactive weekly
Wednesdaymeetingsthatincludelecturesfromindustryexperts
and project updates that occur on alternate weeks. Although
fundingislimitedtotheselectedscholars,everyuniversity
mem-beriswelcometoattendtheWednesdaymeetingsandengagein
educationalsessions.Currently,100individuals,including
scho-lars,Stanfordcommunitymembersand SPARKadvisornetwork
members,attendregularly.
REVIEWS DrugDiscoveryTodayVolume00,Number00May2017 DRUDIS-2007;NoofPages5
Pleasecitethisarticleinpressas:D.O.C.Kim,D.O.C.Acceleratingbiomedicalinnovation:acasestudyoftheSPARKprogramatStanfordUniversity,SchoolofMedicine,DrugDiscov Target
identification and validation
Screening, hit identification
Lead identification
Lead
optimization Preclinical
Clinical trials
(Phases I & II) Phase III
Academia
Biotech
Big Pharma
Drug
IDEA
S P A R K
At Stanford
Drug Discovery Today
FIGURE1
SPARKfillsthegapbetweenacademicdiscoveryandindustry.
2 www.drugdiscoverytoday.com Reviews KEYNO TE REVIEW
Throughoutascholar’sSPARKtenure,fundingisdistributedas
projectmilestonesaremet.Oncea milestoneisachieved,
addi-tionalfundscanberequestedforthenextstageofdevelopment.
Any unused funds revert back to the general pool of funds,
managedcentrallybySPARK.AccesstoStanford’sinfrastructure,
facilitiesandresourceshelpstomaximizeuseoftheUS$50000.
OnekeytoSPARK’ssuccessisitsabilitytotapintothemedical
school’sresources,providingacademicresearcherswithaccessto
clinicianstobetterunderstandthe clinicalimplicationsoftheir
research.
AkeyelementoftheSPARKtrainingisteachinginvestigators
to think using a translational approach.The scholars learn to
identifytheunmetclinicalneedofthepatientandtounderstand
the problem in tandem with product development. In other
words, theyare trainedto ‘keep the end in mind’throughout
theprocess.SPARKusesprojectmanagementtoolssuchastarget
product profiles andproject timelinesto help teams planand
identifykeymilestones,necessaryendpointsandcrucialdecision
points.
Management
The SPARK program, currently led by Drs Mochly-Rosen and
Grimes,operateswithamanagementteamoffiveindividualsthat
oversees communications with project teams, runs its weekly
meetings,overseesSPARK funds and otherwise manages
opera-tions.AlthoughthemajorityofthefundsforSPARKcomesfrom
the Dean’s Office, the program operates independently within
StanfordUniversityandismanagedsolelybytheSPARKteam.
The
advisors
OneofthemostimportantkeystoSPARK’ssuccessistheadvisor
network,thankstoitsstrength,expertiseandengagement.
Advi-sorsvolunteertheirtimetoworkwithSPARKprojects,attendthe
weeklymeetingsandparticipateinevaluatingpotentialprojects.
Theyhavenoownershiporrightstoanyinventionsorintellectual
property from the program. As of 2016, SPARK had over 100
advisorswithsignificantentrepreneurialorindustryexpertisein
drug development, generally in a specific therapeuticarea. On
occasion,advisorsareorganizedintoworkinggroups,focusedon
areassuchasmedicinalchemistry,biologics,financingand
ven-turecapital,businessdevelopmentandclinicaltrialdesign.
Toalleviateconcernsaboutthedisclosureofscholars’research
and assetsat the Wednesday meetings,SPARK mandates
confi-dentialityagreementsforallattendeesandhasworkedtocreatea
cultureoftrustandsharingwithintheprogram.Advisorsremain
engagedbecauseoftheirinterestinthecoresciencebehindthe
projects and the opportunity to remain part of such a strong
networkofindustryexperts.Mentoringisanopportunityforthese
advisorstohaveanadditionalimpactondrugdevelopmentina
low-riskenvironmentandcontinuetousetheexpertiseandskills
gainedfromtheir industryexperience. Further, workingwitha
mission-drivenprogramdedicatedtotranslationalmedicineoffers
anopportunitytohelpbringimpactfulproductstomarket,which
mightnothavebeentheprimaryfocusoftheadvisors’former
for-profitindustryemployers.Theadvisors’commitmentto
further-ingscientific knowledgewithout financialcompensation
main-tainstheintegrityoftheprocessand themissionofthe SPARK
program.
Funding
TheSPARKprogramisfundedprimarilythroughtheDean’sOffice
within the School of Medicine, with additional support from
nonprofitorganizationsandtheNIH.SPARKreceivesnorevenue
from itsprojects. Since 2006,US$7.1million hasbeen spent,
coveringstaffsalaries,scholars’researchexpensesandother
pro-gramexpenses.Additionalfundingfortheprogramcomesfrom
theChildren’sHealthResearchInstituteandgoestowardresearch
projectswithapediatricfocus.Itisakeyelementoftheprogramto
operateonfundsthatarenottiedtocommercialincentives.The
programhasalwaysturneddownfundsfromfor-profitcompanies
becauseofdifferencesinincentives.Whereasfor-profitcompanies
areoften drivenby profitability,SPARKis primarilyfocusedon
addressing unmet medical needs. Accepting funding from
for-profit companies suchas big pharma could dilute the mission
andcreaterealorperceivedconflictsofinterest.
Project
selection
AsignificantfactorcontributingtotheSPARKprogram’s
accom-plishmentsistherigorousprojectselectionprocess,conductedby
ahandpickedcommitteeeachautumn.Thecommitteetypically
consistsofthe SPARKmanagementteam,two-to-threeStanford
facultymembersandadozenSPARKadvisors.Thethreeprimary
criteriaforsuccessfulapplicationsarethattheprojectaddressesan
unmetclinicalneed,usesanovelapproachandhasthepotential
fortheSPARKprogramtoimproveitslicensingand/orclinicaltrial
prospectsoverthetwo-yearcycle.Notably,commercialpotential
isnotafactorintheselectionprocess(SeeSupplementarymaterial
onlineforfurtherdetailsontheprojectselectionprocess).
Program
results
and
benefits
TheSPARKprogramhasauniqueandrigoroussuccessmetric.A
project is deemed successful only if it enters a clinical trial, is
licensedortransferredtoanexistingbiopharmaceuticalcompany,
orleadstothefoundingofanewstartup.Inthe10yearssince
SPARKwasfounded,74projectshavegraduatedfromtheprogram.
Of these, 24 were licensed to startup companies, eight were
licensed to existing companies, four have been transferred to
industrywithoutlicensesand31areinclinicaltrials(tenwithout
licenses).Together,thisamountstoasuccessrateof62%(Fig.2)
(SeeSupplementarymaterialonlineforananalysisofthe
unsuc-cessfulor‘‘failed”SPARKprojects).
Additionally, although the SPARK project selection process
focusesonunmetmedicalneeds,theSPARKprogram generates
significant follow-on grants and funding to support further
re-searchforStanford.Thusfar,SPARKhasgeneratednearlyUS$38.7
million in additional grant funding, 4.95-times the amount
providedbytheDean’sofficeoverthesameperiod(Fig.3).Because
follow-on grants weregenerally received in the second yearof
SPARKparticipation,thismultiplewascalculatedusingadiscount
rateof5%andafundingintervaloftwoyears.
Keys
to
success
ThekeystoSPARK’ssuccessincludethestrengthofitsstructure
andmanagement,collaborativeculture,focusonitsmissionand,
inparticular,itsnetworkofadvisors.Thecombinationof
Stanford-affiliatedresearchersandindustryadvisorsleadsto adistinctive
and necessarydiversityofinterestsand experiences.Other
pro-www.drugdiscoverytoday.com 3
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gramscomprisingjustacademicscouldhaveanarrowed
perspec-tive,whereasprogramsthathaveasingleorfewadvisorslosethe
checksandbalancesprovidedbyalargernetwork.SPARKadvisors
receivenofinancialcompensation;theyremaininvolvedwiththe
programbecausetheyseevalueinSPARK’smodelandmission.
Challenges
and
future
plans
Financing
OnemajorchallengeforSPARKistoprocuresustainablefunding
fortheprogram.Currently,theprogramreliesheavilyon
institu-tionalfunds,mainlyfromthemedicalschool’sDean’sOffice,as
well as grants from nonprofit and government agencies. The
programtakesnoequitystakeinprojects,andreceivesnoroyalties
fromitsprojects’revenuesorlicensedeals,becauseprofitingfrom
the projects’ commercialsuccesswould notalignwith SPARK’s
core educationaland socialmission. Asitcurrently stands, the
program needs US$2–2.5 million a year in funding. Ironically,
accordingtotheDean’sOffice,manydonorsfindthistoosmallof
an investment.Goingforward,waysthat SPARKmightfinance
itselfincludealong-termendowmentoranannualallocationin
Stanford’sbudget.
ToexpandSPARK’simpact,theprogram’sfounderswouldlike
to support projects further into the development cycle. Some
projects need more funding to reach a value inflection point;
forexample,anantibodytherapeuticcannotmoveforward
with-outhumanizationoftheantibody—anendeavorthatcostsmuch
morethanthetypicalSPARKinvestmentofUS$50000–100000.
However,expandingtheprogramwillrequiresignificantlymore
fundingthantheprogramcurrentlydeploys.
Institutional
support
AnotherkeyconsiderationisthatSPARK’slongevityreliesonthe
continuedpartnershipandsupportfromtheStanfordUniversity
SchoolofMedicine.ProgramssuchasSPARKneedinstitutional
buy-in,especiallyinthealignmentofthebroaderuniversitywith
their key values. For sucha partnership to thrive, institutions
cannotexpectsubstantialrevenuesorrewards—although
univer-sitiesdobenefitfromincreasedsuccessincommercializing
intel-lectualproperty. Institutionsmustrecognize the significanceof
thelesstangiblebenefits,suchasthecreationofastrong
institu-tionalmemoryandinfrastructure.Forexample,Stanford
Univer-sitybenefitsfromthesuccessesandengagementofformerscholars
whofindindustrypositionswiththehelpofSPARKandcontinue
toremaininvolvedinSPARK.
Measuring
success
Drug development and the translationof researchis a lengthy
endeavor,hencethe long-termimpactofSPARKisstillunclear.
AlthoughSPARK’scurrentsuccessmetricmatchesthe
contempo-rarylandscape,inmovingforwardSPARKwillneedtopinpointthe
rightmetricsandimplementthenecessaryprocessestotrackthe
directimpactof itsprojects.Similarly, SPARKwould benefitby
measuringtheimpactoftheindirectbenefitsoftheprogramtothe
university, such as increased education and job placement in
industry.
REVIEWS DrugDiscoveryTodayVolume00,Number00May2017 DRUDIS-2007;NoofPages5
Pleasecitethisarticleinpressas:D.O.C.Kim,D.O.C.Acceleratingbiomedicalinnovation:acasestudyoftheSPARKprogramatStanfordUniversity,SchoolofMedicine,DrugDiscov
28%
20%
14%
38%
74 Graduated projects
Commercial & in clinic (21) Commercial, not in clinic (15) In clinic, not commercial (10) Other (failed POC/unlicensed yet) (28)
62% Success
Drug Discovery Today
FIGURE2
DistributionofgraduatedSPARKprojectoutcomes.
Total SPARK project investment 7100000
Total additional funding generated 35200000
US$7.1 US$35.2 0 5 10 15 20 25 30 35 40
Total SPARK project investment
Total additional funding generated
Millions (US$)
SPARK follow-on grant funding
Drug Discovery Today
FIGURE3
SPARKhasgeneratedsignificantfollow-ongrantsfrom2007to2015.
4 www.drugdiscoverytoday.com Reviews KEYNO TE REVIEW
Replicating
the
program
Inthe recentdecadesince itslaunch, theprogram has learned
manythingsaboutthechallengesofdrugdevelopment,someof
themuniquetoacademia.Projectsaregenerallysuccessfulwhen
physician-scientistscanidentifyastrongmedicalneed,andwhen
theyarebasedonstrongscience.Furthermore,aclearor
identifi-ablepathwaytopatientsiscrucialfordevelopment.
SPARKhasmadesignificantprogressinbridgingthevalleyof
death, but its scope is currently limited to Stanford. Although
somemightarguethatSPARKisuniquelypositionedtosucceed
giventhestrengthofStanfordUniversity’sresourcesanditsSilicon
Valley location, the SPARK founders envision SPARK-like
pro-gramsatuniversitiesacrosstheUSAandabroadplayingalarger
role in systemically affecting early-stage translational efforts.
SPARK-like programshave alreadybeen startedin the USAand
in24universitiesineightcountriesabroad[5].Thesereplication
effortsrelyonaninstitution’sabilitytoobtainbackingfromthe
localacademic and biopharmacommunities,to createa strong
advisornetwork,tocollaboratewithtechnologylicensingoffices
andtomaintainastrongbiomedicalresearchprogram.
Concluding
remarks
SPARKhasachievedremarkablesuccessintranslatingbiomedical
discoveriesthusfar.However,forSPARKtobeanattractivemodel
forotherinstitutions,theprogramwillneedtofurtherarticulate
successmetricsandcollectdatafrompastandcurrentscholarsto
inform futuredecisions. Similarly, anunderstanding ofproject
failures can provide valuable information for future projects.
BecausemanybenefitsfromSPARKcannotbeeasilyquantified,
suchaseducationalandprofessionalenrichment,onechallenge
SPARKfacesismeaningfullycapturingtheimpactoftheprogram,
includingtotalgrantsreceived,prestigeoftheprogram,impacton
universityrecruitingandthefuturesuccessesofgraduatedSPARK
scholars.
Finally, stakeholders across the board, including the Dean’s
Officeofthe StanfordUniversitySchoolofMedicine,agreethat
SPARKhasthepotentialtoinitiateacriticalconversationamong
numerous stakeholders about the need for systemic changein
translationalmedicine.Suchaconversationwouldnotonly
re-ducethebarrierstodrugdevelopmentandincreasetheefficiency
oftheentirebiopharmaindustrybutcouldgetmorelife-saving
therapiesintothehandsofdoctorsandpatientssooner.
Conflicts
of
interest
E.K.andP.O.declarethattheyhavenocompetinginterests.A.W.
L. reports personal investments in BridgeBio Capital (also an
adviser), ImmuneXcite, KEW, MPM Capital, Novalere, Royalty
Pharma and Visionscope, and is a director of Roivant Sciences
andtheMITWhiteheadInstituteforBiomedicalResearch.
Acknowledgments
WethankDariaMochly-RosenandKevinGrimesforagreeingto
participateinthiscasestudyandprovidingaccesstotheSPARK
programstaff,scholars,advisors,supportersanddata.Wethank
KristinaBender,RobertBooth,LeonChen,MarciaCohen,Nina
Kjellson,KatharineKu,JoshLichtman,SteveSchow,Merhdad
ShamlooandEddaSpiekerkoetterforparticipatingininterviews
forthisarticle(seeSupplementarymaterialonlineforinterviewee
biographies).WethankEmilyEgeler,NancyFederspielandthe
SPARKprogramstafffortheirhospitalityandhelpfacilitating
interviewsandprovidinginformationforourresearch.Wealso
thankKailashSwarnaforhisthoughtfulcommentsthroughout
thedevelopmentofthecaseandJaynaCummingsforeditorial
comments.Theviewsandopinionsexpressedinthisarticleare
thoseoftheauthorsonlyanddonotnecessarilyrepresentthe
viewsandopinionsofanyinstitutionoragency,anyoftheir
affiliatesoremployees,oranyoftheindividualsacknowledged
above.
ResearchsupportfromtheMITLaboratoryforFinancial
Engi-neeringisgratefullyacknowledged.Allauthorscontributed
equally.A.W.L.firstconceivedtheideaofwritingacasestudyof
theStanfordSPARKprogramandheldseveralmeetingswithkey
programleadersinpreparationforthestudy.Interviewswere
arrangedandconductedbyE.K.andP.O.inconsultationwithA.
W.L.Allauthorscontributedtothepreparationofthemanuscript.
Appendix
A.
Supplementary
data
Supplementarydataassociatedwiththisarticlecanbefound,in
theonlineversion,athttp://dx.doi.org/10.1016/j.drudis.2017.03.
015.
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