ExportationofGOFPolicytoInternationalStakeholders

CaseStudiesfromRecentEvents
NationalAcademies,March910,2016
MichaelCallahanMD,DTM&H,MSPH1

1.
2.

SeniorScientist,Vaccine&ImmunotherapyCenter(VIC)MassachusettsGeneralHospital;
HASTYteam,RescueMedicine,KCenter forEmergingZoonosis,Chulalongkorn UniversityMedicalCenter,
Bangkok,Thailand

Financialconflicts:HealthAdvisoryBoard,IJETHealthSecurities,Annapolis;
MassachusettsGeneralHospital(fundedbyDTRAandNIAID)
President,UnitedTherapeutics,DivisionofCellularTherapies
Disclaimer
Informationpresentedinthisbriefingarethoseoftheauthoranddonotrepresent
officialpolicyoftheDARPA,theU.S.DepartmentofDefense;MassachusettsGeneral
Hospital,UnitedTherapeuticsCorporationorRescueMedicineHASTYTeam1.

GainofFunctionActivities
Intentional

Beneficent:
Totestprobability ofacquisitionofenhancedvirulence
Totestcountermeasures(MCM)againstenhancedvirulence
TotestMCMsagainstenhancedresistance
Market:
Topreserveprofit bytestingagainstfuture resistantstrains
Toincreasemarketsharewithmorepotentbiologics
Nefarious:
Offensiveordefensivebiomunitions
Industrialsabotage(industrialpoultrywars)

Unintentional
Naturalhardeninginresponsetoconvalescent,vaccinatedorprophylaxed population
Bioerror resultingfromfieldrelease(infectiousvaccines)
UNCLASSIFIED:DISTRIBUTIONUNRESTRICTED

U.S.PolicyforGainofFunctionBiomedicalResearch

InternationalGOFActivities(2007)
FSUexBioweaponeers:
domesticallyfundedto
testMCMsforWestern
marketsandEIDs

B.CereusG9241
anthrax)strainexport
withoutcontrolS

CNSZIKA
WNVmodifiedtotest
neurtotrophism

Monkeypox/Ebola
MARVsamplesnowinover
600labsin~8countries

EconomicAnthrax
NigerianlocalWOIanthrax
vaccinespropagateagent

Bioventure:aggressivedrugand
vaccineR&Dwithuneven
regulatoryinsight(longduration
botox;newcarbapenams
H5N1
Poultryvaccinestestedagainstmost
lethal,drugresistantflu
recombinants

GOFPolicyAlignment:DomesticandForeign
BioVenture:introduceIRBandBWCguidancetoforeignventurecapital;
incentivizemarketentrythroughcompliance
Vaccines:
1. licensesafe,effective,inexpensivevaccinestoforeignmarketsor
2. exportrationalvaccinedesignstoforeignproviders
USGfundedperformers:ensureUSGqualifiedexpertreviewofacademic
claimsforbiosafetyandpathogenresearch(Conakryincident)
IncentivizeHostNationCompliance:usemetricswhichdemonstratelocal
benefit

FurtherReading
Bioindustry Initiative(BII)fortheFormerSovietUnion,U.S.Dept ofState
BioengagementProgram(BEP),U.S.Dept ofState
ProceedingsforBiologicalCooperativeThreatReduction,LakeComo,2008
DefenseThreatReductionAgency,2010AnnualReview,LasVegas
AppendixIII,BiologicalWeaponsConvention
InternationalHealthRegulation2007(October2014WHOmeetingfor
Ebola)
SequenceInPlace:AEngagementStrategyforSovereignHealthSecurity,
2010ASMBiodefense(2012)