JonathanD.

Moreno
GainofFunctionResearch:
SecondSymposium
March1011,2016

WhatKindofStakeholderamI?

FormerlyKnownasPatient

FiduciaryKnowledge

OutstandingQuestions
Whatisabetterterm thanGoF?
Whataboutnaturalmutations,escape
mutants,etc.?
WouldageneralizedGoF policybetoobroad?
Aresafetyrecordsappropriateforquantifying
risksoflabaccidents?
Areaccidentsadequatelyreportedorreported
atall?

MoreQuestions
Aretherealwaysacceptable,safer
alternatives,eitherforvaccinedevelopment
orbasicresearch?
AreGoF methodsessentialforvaccine
development?
Onceanepidemichasstartedhowvaluableis
basicscience?

Agreement(IThink)
Muchregulationfailstohitthemarkforthisfield
andcouldneedlesslydelayvaccinedevelopment
(e.g.,NovartisandHPAIV)
Someregulationisneeded,bothforbiosafety
andbiosecurity
Biocontainment doesnothaveaperfectrecord
Riskmitigationoftenonlyrequiressome
imagination
Sometimesthereareacceptablealternativesto
GoF,evenifnotthebestoption

MoreAgreement(Maybe)
GoF dataalonecannotpredictemergenceofa
pandemic(genotypestophenotypes),but
perhapsthisisgettingbetter
Prepandemicstrainselectioncouldbe
transformativeinnewvaccinedevelopment;
longtermpotential
Humansarevulnerabletocertainnaturalstrains
thatcouldbetargeted,e.g.,batSARSlike
coronavirusstrains
AnimalmodeldevelopmentforSARSandMERS
shouldbepermitted

ANewRealTimeAssessmentModel?
Triggeringcriteriainvolveintentionaland
foreseeableproblematicelements(NSABB):
Increasedtransmissibility
Virulence
Lackofavailablecountermeasures

PrecedentsforaNewModel
Milestonesrequiredinventurecapitalprojects
andinresearchcontracts
Phasedclinicaltrials/IRBs
Patientbypatientreassessmentininnovative
surgery
Limitsonstudycontinuation/DSMBs

BuildingonaBestPractice
UniversityofWisconsinBiosecurityTaskForce
DURCsubcomm >fullIBC>BiosecurityTask
Force
BTFmembersfrombiosafety,environmental
healthandsafety,communications,health
services,lawenforcement,etc.
MissiontoensurehighestlevelofsafetyforSelect
Agentlabs
Establishandapplyriskmitigationprinciples

RBATs
RiskBenefitAssessmentTeams
Independentandmultidisciplinary
Representperspectivesofscienceandsecurity
communities
Iterativeprocess
Scheduledbasedonmilestonesandperhaps
unannouncedaudits
Assessmentsbasedoncasespecificriskbenefit
parameters
MayhelptoeducateaboutbestpracticesforGoF
Voluntaryormandatory

RBATS
Informativeandconsultativebutnot
dispositive
Posture:Provetousthatyouhave
consideredtherisksandbenefitsatthisstage
ofyourwork.
Movebeyondapaperprocesstoadynamic,
realtimeprocess

Problems
Morebureaucracy
Whopays?
Doesntsolvetherapidresponseproblem