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Third,U.S.biotechnology companies face intense competitionfrom China.TheChinesebiotechnologysectorisexpandingitscapacity,and in some cases,Chinesefirms are exceedingthe performance ofU.S.firms.As U.S.firms seekto growandcommercialize,theyfaceformidable Chinese competitors that are rapidly expanding andbringingproductsandservicestomarketat pricesthathavenofloor.Thisunfaircompetition makesitevenharderfortheU.S.firmstoestablish a foothold in this nascent industry.
The overall picture is of an industry that is extremelystrappedforcapital,withhighcostsand slowtimelines.That,inturn,makesAmerican biotechnology companies vulnerable.
The Chinese CommunistParty(CCP)employs astrategythatexpertshavecalled"brute forceeconomics,asetofpoliciesdesigned toincreaseChina'sdominanceinstrategically important sectors, including biotechnology.!15
The CCP uses a range of legal and illegal tactics toacquirethenecessarytechnologiesandgain marketaccess,includingmakinginvestments, undertakingmergers and acquisitions,dumpingproducts atbelow-market rates,coercing
companies and talent, and buying or stealing intellectual property and data.16
In 2017, for example,two Chinese companiestheprivateequityfundAsia-GermanyIndustrial PromotionCapital(AGlCCapital)andthepharmaceuticalcompanyHumanwellHealthcareacquiredRitedoseCorporation,aSouthCarolina biopharmaceuticalmanufacturer.Thesaleprice was $605 million, a staggering figure some 25 per centmore thanwhat alternativebuyersoffered.17 In 2022,theChinesefrmHuafonpurchased DuPont'sbiomaterialsbusiness and Tennessee manufacturingfacility.TheCommitteeonForeign InvestmentintheUnitedStates(CFIUS),which focusesonnationalsecurityconcernsrelated to suchtransactions,reviewedandapprovedthe purchasewithqualifications.Buteventhough measureswereputinplacetolimitthetransferof intellectualpropertyfromDuPontthathaddual-useimplications,the Chinesecompanyended upobtainingtheintellectualpropertyanyway.
Other notable CFIUS-cleared transactions includethesaleofSyngenta(whichhassignificant controloftheglobalseedmarket)toChemChina andthesaleofCompleteGenomics(which hascutting-edgeDNA sequencingtechnology) to theBeijingGenomics Institute(BGl).Many otherquestionabletransactionswerenoteven reviewed.CFIUSis nowwakinguptothenational securitythreatof Chinesecapital intheU.S. biotechnology sector.
Chinese companies are also amassing control and leverageoverlargesegmentsoftheglobalbiotechnologymarket.Theglobalbiopharmaceutical behemoth Wuxi AppTec,forinstance,obtained itsposition through a staggeringnumber of acquisitionsofU.S.andinternationalfirms.These includetheBritishfirmOxfordGeneticsLimited (whichspecializesinmammaliancellengineering),ResearchPointGlobal(acontractresearch organizationbased inTexas),HDBiosciences(a California-based company specializing inpreclinicaldrugdiscovery),andAppTecLaboratory Services (a medical device and biologics testing firm withfacilities inMinnesota,Pennsylvania, and Georgia).18 Wuxi AppTec is so entrenched in Americanbiopharmaceuticalsupplychainsthat Americanfirmsestimatetheywouldneedatleast eightyearstodevelopalternativesourcesforits services.119
BGl is another case in point.BGl is less a true privatecompanythananextensionoftheCCP, havinggained itsmarket advantageinpart throughundisclosed statesubsidies.120Thefirm alsogainedatechnologicaladvantagefromU.S. sequencingcompanies——legally,by acquiring
CompleteGenomics,and illegally,bywillfully infringing on patented technology owned by Illumina.2BGl's combination of state support and Americanintellectualpropertyallows the companytoundercutmarketratesforsequencingtechnologies.22Asof2020,BGlsaiditcould sequenceahumangenomeforjust 100$ ，
In anothermovemadepossiblebysubsidiesfrom Beijing,theCommissionheardfromstakeholders that Chinese firms are offering U.S. biotechnology firms,particularly those strugglingto access affordablemanufacturingplants,freecustom facilities if they move theiroperationstoChina.
In thefaceofChina'saggressiveeffortstodominate thebiotechnologyindustry,theU.S.government must fightback,takingtargetedstepstounleashAmerican innovation,capital,and manufacturingcapacity.he U.S. government will need to shoulder some of the riskofearly-stagefinancingforbiotechnology and encourageprivateinvestmentthroughdemand-side measures.Itshouldusetargetedpublicsupportto seednewprivateinvestmentincriticalgaps,mitigatingtheneedfora moreexpensive approachtoclaw backU.S.capabilitiesin thefuture..
To mobilize the U.S. private sector in support of biotechnology, theUnitedStatesmust:
Simplify regulation for American biotechnology companies.
Streamlineregulatory processes toalleviateunnecessaryburdens and acceleratethe commercialization of innovations.
Attract private capital to support biotechnology.
Enhanceincentives and signal demand forprivateinvestment to bridge funding gaps and support the commercialization of emerging companies.
Scale up and de-risk manufacturing.
Support pre-commercial manufacturingfacilitiesthatenable the scaling up of emerging bioproducts and defray costs for individual firms and investors.
Protectcriticalbiotechnologyinfrastructure.
Safeguardvitalinfrastructure againstexternalthreats.
Fightbackagainstbrute force economics.
Counteractunfaircompetitive practices employed by China, leveling the playingfield for U.S. companies.
By adoptingtheserecommendations,theUnitedStates couldleanintothe strengthof itsprivatesector,neutralizethe advantagestheCCPusesto undermineU.S.nationalsecurity,andserveallAmericansby bringingbeneficial biotechnologies to marketfasterto defend, build,nourish,and heal.
Section 2.1
Simplify Regulation for American Biotechnology Companies
More than15federal offces and programs play some part in U.S. biotechnology regulation, with threeagenciesinleadingroles:theAnimaland PlantHealthInspectionService(APHIS)within the DepartmentofAgriculture(USDA),theFood and DrugAdministration(FDA)withintheDepartment ofHealthandHumanServices(HHS),and the Environmental Protection Agency (EPA).123The result isafragmented regulatorysystem inwhich no singlefederalentityisempoweredtostandardize redundant processes or adjudicate overlapping jurisdictions.
Since the 1980s, the U.S. biotechnology regulatory systemhasoperatedasapatchworkbecause agencieslargelyrelyonstatutoryauthoritiesthat were not intended for biotechnology, resulting inmisalignmentbetweentheirmandatesand technological advancements.24Agencies are constrainedbyoutdatedoroverlybroad interpretationsofstatutorymandates.TheUSDA,for example,tookmajorstepstofast-trackreviews andprovideexemptions,adoptinganewrulefor certaingeneticallyengineered organisms in 2020, butthiscommon-senseregulatoryimprovement wasvacatedbyafederalcourtin2024.25
AMapforaClearRegulatoryPathway
This is an example of a clear pathwayforone product.Not all products willhave the same pathway.
Chapter2
Challenges of the U.S. Biotechnology Regulatory System
Innovatorshaveidentifiedfourkeychallengeswithin the U.S.biotechnologyregulatory system.First,they faceuncertainty about whichagencies areresponsibleforregulating theirproducts.Second,they must navigateoverlappingprocessesacrossmultiple agencies.Third,theyfrequentlyencounterunnecessaryregulatoryburdensforproductsthathave alreadybeendeemedsafe.Fourth,evenwhenthey overcomethesehurdles,theregulatoryagencies' limited capacities result in significant delays.
Because each agency acts independently and there isno coordinated wayto entertheregulatorysystem, innovatorscanstruggletodeterminewhoisresponsibleforregulatingtheirproducts.Itisoftenunclear how regulatory agencieswork togetherto review products,and innovators canface lengthy delays as products are bounced between agencies.Engineered insects,forexample,mayfall undertheFDA'sanimal drugauthority,EPA'spesticideauthority,andAPHIS's plantand animal healthauthority.Developersof gene-drive mosquitoes,which are engineered to reducepathogentransmissionorfertilityintheir offspring,werepassed offfromagencytoagencyfor nearly10 years.26 In contrast, similar mosquitoes that aremodifiedwithout biotechnology areregulated by the EPA and gained approval in just fiveyears.
Even afteridentifying the appropriate starting point, innovatorsmustnavigatea convolutedmazeof overlappingprocessesacrossmultipleagencies. Eachagencyhasitsownrequirements,timelines,and procedures,resultinginduplicativeandasynchronous review.Innovators must contact each regulatory agencyseparately,andeachproductmustfollowa uniquepathtoobtainmultipleapprovalsatdifferent times.Innovatorshavetorepeatthemselves,double back,and changecoursewithlittlepredictability,all ofwhichisremarkablyinefficient.
Theseobstaclespose aparticularchallengefor biotechnology products that are similar to products madewithconventional methodsortoproducts thathavebeenrepeatedlyreviewed.Forexample, non-browning apples andpotatoeshavebothbeen approved inthe United States,but regulatory agencies areunabletotakeprior approvalsinto account to expedite reviews of similar products. As of today, a non-browning avocado,peach,or pearwould likely face the same lengthy approval process, even when the non-browning traits are the same.27
Finally,afternavigatingthisregulatorymaze,innovators must wait their turn in an ever-lengthening queue.Regulatory agenciesface persistent understaffingdespiteagrowingbacklogofapplications. Timelines varyfrom productto product,but some innovationshavebeenheldbyagenciesforadecade ormore.28Ifagenciesdonotshifttheirfocusonto the most novel and complex products,the backlog willonlygrow,and more innovationswill remain uncommercialized.
Focus Review on Novel Products
Biotechnologyis apowerfultoolforproducingsafe andbeneficialproducts.Thepotentialrisksstem notfromthetechnologyitself butfromthenovel products it enables.29 For decades, biotechnology hasbeensafely used toproduce life-savingmedicineslikeinsulin.Butitcanalsobeusedtocreate novelproductsthathavecharacteristicsnotfoundin nature.Somebiotechnologyproductsarethemselves livingorganisms,which live onandreplicatewhen introduced intothe environment.Theseproducts mayhaveeffectsthatrequire acloserlook.
Several othercountriesaresimplifyingorhavealready simplifed regulations for certain biotechnology products.Not surprisingly,innovators areincreasingly seekingapproval inthosecountriesfirstoreven moving theiroperations there.Without efforts to simplify and clarifyU.S.biotechnologyregulation,this offshoringtrend islikelyto continue,and the United Stateswilllose its hard-wonleadershipinbiotechnology development and commercialization.
The recommendations in this section aim to simplify America'sbiotechnologyregulatorysystem.Iftaken together,theywould result in more straightforward and risk-proportionateregulation thatwould encourage innovators to bring biotechnology products tomarketefficiently and transparently,while still protectinghumanhealthandtheenvironment.
"Americanagricultureisvitaltoournationalandeconomic security, yet it faces a host of challenges, from pests and environmental stressorsto the growing threat of cyberattacks on this distributed and diversified sector. Advances in biotechnology and biomanufacturing can enhance our resilience against these threats, but realizing thesebenefitswill require anactiveefforttokeeppace with current challenges,including thePRC'sefforts to close the gap in agricultural innovation."
·CommissionerDawn Meyerriecks
Food Security is National Security
The American agricultural sector encompasses over a third of all U.S. land and almost 3.5 million farmers, ranchers,fishers, and other producers,and faces many potential vulnerabilities.i These vulnerabilities are especially concerninginlightofarapidlyevolvingthreatlandscapewith profoundconsequencesforournationalandeconomic security.vii
Threatstoagriculturecomeinmanyforms.Diseasesand pestscostfarmers anestimated 590$ billionglobally eachyear.viiMoreover,geopolitical conflicts increasingly threatenglobal supply chains: after Russia's 2022 invasion ofUkraine,globalfertilizerpricestripledduetoWestern sanctions onRussianexports.x
Biotechnology and biomanufacturing offerexciting new opportunitiestoprotectAmerican agriculturefrom these threats.Forinstance,advancesinthesebiotechnologies couldimprovethenutritional qualityoffoods,boostplant andanimalresistancetodisease,andreducetheneed forfertilizer.\*Domesticallyproduced bioproducts could supportrobustsupplychainsforeverythingfromfeedstockstochemicals,creating newjobs andgrowing our economy.xi
Realizing the full potential of agricultural biotechnology requires addressing the challenges it faces.Total U.S. spendingon agricultural research hasfallenby a third since peaking in 2002.xi By contrast, China is now the largestglobalfunderofagriculturalresearchanddevelopment (R&D),and China-based companies are acquiring and consolidating global agricultural companies tobolster their technology portfolio.xii For all of these reasons, it is critical that theUnitedStatesleverage the opportunities of biotechnology todaytobuild an agricultural sectorthatis upto the challengesoftomorrow.
2.1aRecommendation
Congress must direct federal regulatory agencies to create simple pathways to market and exempt familiar products from unnecessary regulation.
The U.S. biotechnology regulatory system was intendedtoregulateproductsbasedontheircharacteristicsandrisks,ratherthantheprocessesused to create them.30 Unfortunately,this distinction has erodedovertime,resultinginunnecessary and burdensomeregulation.Thecurrentapproachis notjustunwise;itisalso unsustainable,giventhe growing numberof truly novel biotechnology products entering the development pipeline.The default governmentpolicy should be that if a biotechnology product isgenerally understood tobesafe and can bemade throughconventional means,it shouldbe regulatednodifferentlythanconventionalproducts. If a biotechnology product is similar to previously reviewedproductsthatarewell-understoodby regulators,itshouldbeexemptfromfurtherreview. Regulators should spend their time and energy on understandingtheeffectsoftrulynovelproducts made with biotechnology.
To achieve these goals, the National Biotechnology Coordination Office (NBCO) (see recommendation 1.1a) should be empowered to drive simplified biotechnology product regulation.Congress should direct the NBCO to:
leadandcoordinatebiotechnologyregulation efforts across the interagency through a deputy directorforregulation(thoughregulatory
authorities would remain with existing agencies); work with regulators to resolve overlaps, gaps, and ambiguities;
work with regulators to map clear regulatory pathways,includingtosimplifyandease
regulationforfamiliarproducts andconduct regulatory trials;
build and maintain digital infrastructure; and communicateclearlyandconsistentlyabout biotechnology regulation.
To accomplish thesegoals,the NBCOshould be staffed withfull-timebiotechnology science and regulatorypolicyexperts,aswellasexpertsin human-centered design,software engineering, and science communication. Staffing needs may decreaseovertimeasclearregulatorypathways are successfullyestablished.Additionally,Congress should grant the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget(OMB)the authoritytodetermineandenforce clearregulatorypathwayswhentheregulators cannotreachconsensus.
CreateSimplePathwaysand Exemptions
To create simple pathways to market, regulators shouldidentifybiotechnologyproductsthatcould have arisen naturallyorthroughconventional methods,asthesegenerallyposenoadditional risk,and exemptorexpeditetheirregulatoryreview.31
Currently,regulatoryagencieslackthestatutory authorityto applytheirexpertisetoreduceregulation forwell-understoodproducts.Instead,theyarerequiredtoevaluateeachproductindependently,even when similarproductshave alreadybeenreviewed andfoundtobesafe.
Recentjudicialactions,suchastheSupremeCourt decisioninLoperBrightEnterprisesv.Raimondoand aruling against the USDAintheNorthernDistrict of California,haveraised uncertainty aboutagencies'ability to interpret their authorizing statutes.32 Regulatory agencies may nowface additional legal challengeswhenusingauthoritiesthat arenotexplicitlyintendedforbiotechnology,and it maybeharder for agencies to nimbly address novel products.As a resultofthedecisionreversingUSDA'spolicy,developersof biotechnology products are againsubject topotentiallylengthyandcost-intensivepermitting processes.33
To address these challenges, Congress should authorizeregulatorstoreduceorremoveregulatory hurdlesforfamiliarproductsbasedonaccumulated evidence,enablingagenciestoreallocateresources toward supporting emerging biotechnologies.
Specifically,Congressshould amend relevant statutesthatgiveagenciesauthoritytoregulatebiotechnologyproducts,suchasthePlantProtectionAct, theFederalFood,Drug,and CosmeticsAct,and the
ToxicSubstancesControl Act.Amendmentsshould clearlydelineatewhichagenciesareresponsiblefor eachtypeofproduct and authorizetheNBCOand the OlRA to resolve any remaining overlaps, gaps, and ambiguities.
Map Clear RegulatoryPathways that Resolve Regulatory Overlaps, Gaps, and Ambiguities
Congress should instruct the NBCO to guide regulatory agencies in creating interagency agreements that map clear regulatory pathways. The NBCO wouldworkwithagenciestoensurethatsuch agreementsdescribeexpected timelines,data requirements,and decisionpointsforeachproduct type.Eachmapwouldshowhowadevelopercould advancetoeachstep,withclearhandoffsbetween agencies.Agreementswould alsofacilitateinformationsharingacrossagencies,withappropriate safeguardsforconfidentialbusinessinformation. High-qualitymaps thatdelineate all applicable regulatoryprocessesduringresearch and development(R&D)would allowinnovatorsandinvestorsto accuratelyestimatewhatittakestogettomarket.
Conduct Regulatory Trials to Inform Clear RegulatoryPathways
For products that lack a clear regulatory pathway, Congress should authorize theNBCO to workwith regulatorsto create a regulatory“sandbox,"an environmentfeaturingshort-termtrialsofproposedtests sothattheycanevaluatenewregulatorypathways andpotentialimprovementstoexistingpathways.
Sandboxescanhelpfacilitatedialoguebetweendevelopers andregulators,informingthedevelopment ofregulatoryprocessesthatfacilitateinnovation while mitigating risks.134 Governments are increasingly creating regulatory sandboxes for emerging technologies,astheUnitedArabEmirates andSpain have done.35 In 2024, the United Kingdom created the EngineeringBiologySandboxFund tosupport regulator-ledsandboxprojectsthataccelerate regulatoryreforms.136
TheNBCO-led sandboxwould allowinnovatorsto propose new orupdated regulatorypathways.For example,aninnovatorcouldproposeanewtesting methodtoreplacea moreexpensive,oldermethod. Workingtogether,theNBCO,theinnovator,and
regulatorswould develop and conducta short-term trialforthenewmethod,withmetricstodetermine success.Ifthe proposed method meets established guidelinesforsafety and efficacy,theNBCOwould then workwithregulatorstoupdateregulatory pathways accordingly.
TheNBCO could also use theregulatorysandboxto identifywaystoacceleratetheapprovalofcrucial products.TheFDA provides“emergency use authorization"formedicalcountermeasuresandexpedited processesforcertaintherapiesanddevicesthat meetaseriousmedicalneed.37Buttherearefew expeditedprocessesforagricultural orindustrial products,leavinginnovationssuchasdisease-resistantcitrustreeslanguishinginreviewwhileAmerican farmers are forced to expend resources removing diseasedtrees.38
VerifyVoluntaryStandardsfor Biotechnology
Alongsidetheregulatoryprocess,voluntarystandards canboostconfidence in newproducts——for example,helpingfarmersweighthevalueofnew agriculturalinputs,foodmanufacturersevaluatethe benefits of new ingredients,and insurers considerthe risks of introducing new products into existing supply chains.
TheUSDA'sProcessVerifiedProgram(PVP)allows companies,tradegroups,and othersto create custom standardsthroughafee-for-servicemodel, with audits to ensure that the standards are being followed.139 The USDA is already authorized to use auditsforproductsinfoodandagriculture,butisnot currently using this authority for biotechnology.140 Congress should encourage theUSDAto advertise the PVP as an optionfor biotechnology products, therebyhelpinginnovatorstodetermineifthe programcouldprovidevalueforthemand their customers.
Build Digital Infrastructure to Simplify Biotechnology Regulation
Each regulatory agency currently has its own submissionportal,forms,processes,and datarequirements. Eventhoughregulatorshavetakensome steps tocoordinate,biotechnologyproductdevelopers mustsubmit the sameinformation multiple times in differentformats,afrustrationthathasled themto callfora“single door"approachthatwould streamline submissions, data requirements, and timelines.41 Moreover,each regulatory agencykeeps its own repositoriesofregulatorydecisions,insomecases providinglimited or no public information.This lack oftransparencypresents a challengeforinnovators, consumers,andothersseekingtoidentifywhatpaths products have taken throughtheregulatory system and which productshavepreviously been approved.
Congress should authorize theNBCOto build and maintain a single point of entry for biotechnology innovators atbiotech.gov(seerecommendation1.1a).
The NBCO could create easy-to-find repositories of interagency agreements and regulatory decisions, driving toward a“single door"application process for biotechnology products that would minimize the administrativeburdenonbothindustryand government.
Communicate Clearly and Consistently about Biotechnology Regulation
It should be easierforindustry and the public to find useful information aboutbiotechnologyregulations. Researchers and startups need tounderstand regulatoryrequirementssothattheycangatherthe necessarydataandmakesounddecisionsearlyin productdevelopment,andinvestorsneedabetter graspofregulatorypathwaystoassessmarket readiness.Consumersshouldalsohaveeasyaccess toinformation aboutbiotechnologyproductsand the processes used toensure theirsafety.
The NBCO could work across the agencies on:
Regulatory guides
Providing guidance for innovators as they enter and progressthroughtheregulatorysystemforthefirst time(theNBCOwouldbuildonlessonslearnedfrom theFDA'sVeterinary InnovationProgram(VIP),which givesdevelopersofanimaldrugsfeedbackandother assistance during theregulatory process)142
Public outreach
Exploringoutreach methodstoidentify concerns and improvepublic understandingof biotechnology(includingcollaborationwithcommunityleaderssuchas Master Gardeners,who help provide science-based informationtothepublic).143
Developeroutreach
Delivering plain-language information about biotechnologyregulationfor the developer community, including academia and industry.
Regulatory diplomacy
Working toward international alignment of biotechnology product regulations.Thiscould include reviewing applications collaboratively,aligning data requirements,andsharingriskassessments,allof whichcould shortenregulatorytimelinesandreduce burdenforboth developers and regulators.(See Section 6.1for more detail onregulatory diplomacy).
RainbowPapaya: A Regulatory Success Story
The historic story of the Rainbow papaya shows the importanceofboth agricultural biotechnology and streamlined regulation. The papaya ringspot virus devastated the U.S.papaya industry in the1990s. Scientistsdetected thevirusoncommercialpapaya farms in1992,and by1995,Hawaiianfarmers could nolonger grow papayas.xiv
With support from the Department of Agriculture (USDA), Dr. Dennis Gonsalves led a team of scientists atCornell Universityindevelopingavirus-resistant papayausingagenefromthevirusitself,effectively vaccinatingthe
plant.xTheteam crossbred theresistant plants
withcommercial varieties,resultingintheRainbow papaya.xvi
The scientists grew Rainbow papayas on a farm that hadgoneoutofbusinessduetothedestructivevirus, demonstrating that the newpapaya wasresistant andstillhadthefamiliarqualitiesthathadexistedfor generations.xi Next, the Rainbow papaya underwent a thoroughbutexpeditedreviewbytheUSDA,the Environmental ProtectionAgency(EPA),and the Food and Drug Administration(FDA)to ensureit was safeforconsumptionandtheenvironment.In1997, the Rainbow papaya was officially approved and made available forwidespread cultivation.xvi
Biotechnology saved the Hawaiian papaya industry. Lessthantwoyearsaftertheirlivelihoodswere wiped out,farmers returned togrowing papaya and the threat ofthe virus waned.xixThis example shows thatbiotechnologycanpromotefoodsecurityand economicsecurityifregulatoryframeworksbalance safetyreviewswith timely accessforfarmers.Today, U.S. crops and livestock are under constant threat from pests and diseases, including citrus greening, wheatrust,avianinfluenza,andAfricanswinefever. xxBiotechnology can help combat these hazards and ensurecontinuedprosperityofAmericanfarmers.
2.1bRecommendation
Congress should direct federal regulatory agencies to prepare for novel products to come to market.
Even if biotechnology product regulation is simplified and coordinated,theU.S.government's low regulatorycapacitywill continuetodelaythecommercializationofbiotechnologyproductsintheUnited States.Regulatory agencies cannot keep up with the exponential increase in applications for regulatory review.44TheAPHIS,forexample,received and completedanaverageof4.5requestsforreview eachyearbetween1992 and2022.In2023alone,it received 43 requests.45 This increase in applications isexpectedtocontinueandwillquicklyoverwhelm regulatory agencies.
Congress should prepare regulatory agencies forthe productsofthefutureinthreeways.First,itshould ensure thatagencieshavethenecessarycapacity and expertise toreviewtheseproducts.Second, Congress should give regulators access to public-private partnerships through a regulatory foundation. Finally,Congressshouldestablish aregulatory researchprogram thatprovidesthe scientificunderpinning needed to simplify biotechnology regulation.
Bolster Regulatory Agency Capacity
Staffing at regulatory agencies has remained constantevenasapplicationshavemorethandoubled inrecentyears.ExpertssharedwiththeCommission that the Food and Drug Administration (FDA) has only nine employeesworkingonfoodsafetyforplants and microorganisms produced with biotechnology, despitetheimportanceofpre-marketoversight forsuchfoods,andthe Environmental Protection Agency(EPA)hasonlysixstaffreviewingapplications forthecommercialuseofcertainmicroorganisms produced withbiotechnology.Senior scientists are stretchedparticularlythinsincetheymustprovide technicalreviews,meetwithinnovators,develop rules,coordinatewithdomesticandinternational regulators,andtrainjuniorstaff,amongother responsibilities.
Appropriatorsshouldprovide smallfundingincreases for all biotechnology regulatory agencies,with additionaltargetedincreasesfora subsetofthese agencies. After years of flat budgets and growing workloads,a modestboostinregulatory capacity
wouldbenefitAmericanbiotechnologycompanies and unlockmajoreconomicgrowthbyenablingmore productstosafelyenterthemarket.TheNBCOcould work with regulatory agenciesto quantify staffing and expertise needs,particularly asthose needs shiftto address novel products.
Inaddition,theNBCOcouldcoordinateabiotechnologyregulatoryfellowshipprogramforfederalgovernmentemployees.Sucha programwould improve theregulatoryworkforce,helpprovidecontinuing educationforcurrentfederal employees,and encourage cross-functional understanding of biotechnology researchandregulation.Whiletheprimaryparticipants would be current regulators,the program could alsobeopentootherfederalgovernmentemployees, such as lawyers who work in regulatory agencies, policyadvisorsintradeagencies,andprogram offcers in research agencies.Fellowships could include a capstone project on regulatory topics, such asclearregulatorypathways,digitalinfrastructure,or communication strategies.
EstablishaFoundation toEnable Biotechnology Innovation
Regulatory agencies need access to external experts inordertoimproveregulatoryprocesses,scanthe horizonforemergingtechnologies,andengagewith the public,amongotheractivities.Governmentaffliatedfoundationsprovideaflexibleandefficient waytosupplementfederalactivities.Examples includetheReagan-UdallFoundationfortheFDAand theFoundationforEnergySecurityand Innovation (affliated with the Department ofEnergy(DOE) andestablishedbytheCHIPSandScienceActof 2022).A more recent example is the Foundation forStandardsandMetrology,whichwasproposed inCongressin2024andwouldbeaffiliatedwith the National Institute of Standards and Technology (NIST).146 Some government-affliated foundations focusonR&Dandothersmakepolicyrecommendations, but none focus on biotechnology.
To fill the gap,Congress should establish an independent, non-profit foundation to support U.S. biotechnology productregulation.Thisfoundation could work with the NBCO and across biotechnology regulatoryagencies.Industrystakeholdershaveexpressed interest in partnering with regulatory agencies through a foundation,includingbyfinancially supportingit.Toprotect against potential conflicts ofinterest,thefoundationwouldhavestrictaccountability requirements in its authorizing language.
While creating a foundation is no substitute for sufficientlyfundingregulatory agencies,it would significantly increase their capacity by allowing regulatorstofocusonregulation.Afoundationwould bringtogetherexpertsfromacademia,industry,and government to share information about regulatory challenges,andsuggestwaysofsolvingthem.ltcould alsomakerecommendations abouthowregulation might incentivize innovation—for example, proposing simplifiedregulationsforcertainplatformstoencouragecompaniestomodernizetheirmanufacturing practices.
ThefoundationcouldalsohelptheNBCOandfederal agencieswithcommunicationandoutreach.For example,the foundation could offer a regulatory fellowshipforinnovators and othersinvolved in biotechnology product development,includinga short course on biotechnology regulation. Shadowing experiences andotherinteractionsbetweendevelopersandregulatorswouldhelpdevelopersbetter understand regulatory processes and help regulators understand thoseprocessesfromthevantagepoint ofdevelopers.Externalfellowswouldnothandle potentiallysensitivedeveloperdata,andsafeguards wouldaddresspotentialconflictsofinterestand protect confidential business information.Eventually, programscould placefederalemployeesinacademia,industry,ortradegroupsforadditional learning experiences.
meetregulatoryresearchneeds,andBRAGdoes notsupportthemulti-season,multi-locationstudies necessarytoevaluatethepotentialenvironmental impacts of biotechnology products.Furthermore, researcherswhostudybiotechnologyproducts outsideofagriculturemaynotevenbeawareofthe USDA's programs.
Congress should establish a biotechnology regulatory research program at the National Science Foundation(NSF).Tomakecertainthattheresearch istargetedtoregulators'needs,theNSFshould collaborate with theNBCO and regulatory agencies in designing requests for proposals. In implementing this program, the NSF should use a variety of funding mechanisms,includingresearchgrants,cooperative agreements,and temporaryresearch consortia to ensurethatresearchersproducetheinformationthat regulatorsneedtoallowotherstounlockinnovation. IftheNSFprogramisestablished,Congressshould considerrollingBRAG'sresponsibilitiesintoit.
U.S. regulatory agencies need scientific information to justify simplifying regulatory pathways. In 1992, Congressestablished theU.S.Department of Agriculture(USDA)BiotechnologyRiskAssessment ResearchGrants(BRAG)programtofund research that supportsbiotechnologyregulation,butits success has beenlimited.Funded by withholding two percent of the budget of USDA biotechnology researchprojects,theprogramreceivesonly 5-6$ million annually.47This amount isinadequateto
In addition,Congressshould instructtheNSFto contractwiththeNationalAcademiesofScience, Engineering,and Medicine(NASEM)to studythe safetyand benefits of biotechnologytools and products relative to conventional manufacturing methods and otherhuman activities.NASEM has conducted multiple studies related to biotechnology, butnone haveprovided a consensus onthe safety of biotechnology tools.148 Such a study would yield a publicsourceofhigh-qualityinformationneededto updateregulationsforU.S.biotechnologyproducts and identify any gaps in scientific information needed for regulation.
Establish a Federal Biotechnology RegulatoryResearchProgram
After years of flat budgets and growing workloads, a modest boost in regulatory capacity would benefit American biotechnology companies and unlock major economic growth by enabling more products to safely enter the market.
Attract and Scale Private Capital to Support Biotechnology
Precise federalaction cande-risk investment and unlock the private capital necessaryto scale up and commercialize biotechnologyinnovations.
The U.S.government can achieve this goalthrough both"push” and "\*pul' measures, coupling supply-side incentivesto drive R&D,innovation, and initial growth withdemand-side signalstoreduce investment risks, attract private sectorsupport, andensure thelng-termresiliencyof domestic productionThesestepswillbecriticalto creatingarobustcommercial biotechnologysectorintheUnitedStates.
2.2a Recommendation
Congress must establish and fund an Independence Investment Fund, led by a non-governmental manager, that would invest in technology startups that strengthen U.S. national and economic security.
Private capital alone will not carry biotechnologies that are criticaltoU.S.national security alongthe pathfromthelaboratorytothemarket;thetechnical and business risks are simply too high. While governmentfunding should not singlehandedly propela companythroughthatstage,itcanactasapowerful signal toprivate investors about theimportance and viability of a company or technology.
Several U.S.governmenteffortshave attempted to solve theproblemof seeding and attracting capital toward technologies criticaltoU.S.nationalsecurity.
Existing financing mechanisms include:
a partnership amongtheDepartmentof HealthandHumanService's(HHS)Biomedical AdvancedResearchandDevelopmentAuthority (BARDA)and theGlobal HealthInvestment Corporation(GHIC),a non-profitventure capital entity (GHIC deploysgovernment money to makeventure capital style investments in medical countermeasures for health security);149
In-Q-Tel(IQT),a non-profit strategic investorthat investsonbehalfoftheU.S.nationalsecurity community across a range of technology sectorsincluding space,microelectronics,and biotechnology;150and
theOffceofStrategicCapitalattheDepartment ofDefense(DOD),whichhaspartnered with the SmallBusinessAdministration(SBA)tocreate theSmall BusinessInvestmentCompanyCritical Technology (SBICCT) Initiative.51 Through the SBICCT, fund managers deploy low-cost, government-guaranteedcapitalinalignmentwith DOD's critical technology areas (CTAs), including biotechnology.152
Eachoftheseinvestmentvehiclesservetocommercialize technologies in the United States,but they all serve different purposes and gaps remain. For example,noneoftheseinvestmentvehicleshasin itsmandatetheresponsibilitytosupportand commercialize thetypeoftechnologiesthat would create a competitortoWuXiApptec.Withoutanadditional investment approach,emergingtechnologies that are importantforU.S.national security will fail.
Congress must establish the Independence InvestmentFundattheDepartmentofCommerce (DOC) to support high-priority areas of national securitytechnologythatareleftunaddressedbycurrent initiatives.Thesetechnology areas encompass a broadrange of national security concerns,expanding beyond strictlydefenseandintelligenceapplications. By makinginitialinvestmentsin high-potential areas, thefundcouldsignalmarketopportunitiesandincentivizeprivateinvestorstofollowsuit.Theinvestments wouldleadtoa“crowding-in”effect,unlockingprivate capitaltoscaleupnationalsecuritytechnologyproducts.Roughly3Opercentofthefund'scapitalshould be set aside specifically for emerging biotechnology investments.
Government-Backed,Private-Run
TheDoCwould set overarchingstrategicpriorities for the fund. The fund would be operated by a nongovernmentalinvestmentpartner,withexperienced fundmanagersmakinginvestmentdecisionswithout day-to-day government oversight.The DOC could suggesttechnologystartupsforconsiderationby thefundmanagers,butthefundwould havethefinal sayonthosespecificinvestmentdecisions.Thefund would be established with the support of a strategic advisoryboard,includingventurecapital investors, largeequityinvestors,andadesignatedrepresentativefromtheNationalBiotechnologyCoordination Office (NBCO)(see recommendation 1.1a).
Strategic funding would allow for longer time horizons and accommodate theuncertaintyinherent inscaling innovative technologies,particularly in sectors such asbiotechnologythatfaceextendedcommercializationtimelinesandentrenched marketcompetition.
Maximizing Impact
Thegoalofthefundwouldbetoearnreturnsthrough continuousaccesstoprivatemarketinvestments that enable self-sustainment afterinitial appropriationsfrom Congress.Thereis apossibilitythata second,smallerallocationwillbenecessaryroughly 10 years after establishment ofthe fund, depending on investment returns and howlong thefund needs to become self-sustaining.
Thefund'soperational model isdesignedtomaximize efficiency and impact.By delegatinginvestment decisionsto anexperiencedinvestmentpartner and establishing a strategic advisoryboard,thefund ensuresabalancebetweengovernmentoversight
and privatesectoragility.Additionally,itsstructure would drivetoward long-termself-sustainment, reducingits dependenceon continuousgovernment appropriationswhile attractingsignificantprivate capital.Thesefeatureswould makethefund adaptable andscalable,sothatitisbestpositionedto support a wide array of national securitytechnology investments, particularly in high-risk areas such as biotechnology where existingmodelsfall short.
Partners
Thefundwouldbedirected toinvestinAmerican companiesbutcould possess the authoritytomake limitedinvestmentsincompaniesinallied countries whereappropriate,and overtime,seektopartner withalliedfunds,suchastheNATOInnovationFund and theUKNationalSecurityStrategicInvestment Fund.
Without an additional investment approach, emergingtechnologies that are important for U.S. national security will fail
Chapter2
Financing a Biotech Startup
Whiteboard to Vision 50K-500K Pre-Seed
This initial capital can helpa biotechnologyfounderpursuekeyscientific discoverysteps,suchasconducting preliminary labresearchtoconceptualize a product idea and hiring a foundingteamtoforma company.
PrivateFundingSources Family and friends, crowdfunding, incubators,loans
Analogous GovernmentFunding Sources
Grants(e.g.,SmallBusiness Innovation Research/Small Business Technology Transfer(SBIR/STTR)),loans,cooperativeagreements,someequityinvestments(e.g,In-Q-Tel(IQT),Biomedical Advanced Research andDevelopment Authority-Global HealthInvestment Corporation(BARDA-GHIC))
Vision to Prototype 500K-2M Seed
The first offcial equity investment roundcanallowabiotechnologycompany to purchase lab infrastructure, undertakeproof-of-conceptexperiments,andconductmarketresearch toensurethatithasaviableproduct withaclearpathtomarket.
PrivateFundingSources
Angelinvestments,venturecapital, crowdfunding
AnalogousGovernmentFunding Sources
Grants(e.g, SBIR/STTR), loans, cooperativeagreements,someequity investments(e.g.,IQT,BARDA-GHIC)
Prototype to
Initial Production
2M-10M
SeriesA
Next,a biotechnology company must securefundingtocontinueproduct developmentwithtechnologymaturationinfrastructure,conductpre-clinical trials(ifapplicable),andnavigatethe regulatory process.
PrivateFundingSources Venturecapitalprivateequity
Analogous GovernmentFunding Sources
Grants,loans(e.g.,Departmentof DefenseOfficeofStrategicCapital (DOD OSC)),cooperative agreements, prototype contracts(e.g.,Defense InnovationUnit(DIU))
Initial Production
to Scaled up
Production
10M-30M
SeriesB
30M-200M
SeriesC
Growth capital is typically provided fora biotechnology company with a proventrackrecordofstablegrowth. Thiscapitalcanthenenablethe companytoscaleupitsproductwith technologymaturationandcommercialinfrastructure,conductclinical trials(if applicable),secure regulatory approvals,and pursue product and/or marketexpansion.
PrivateFundingSources Venturecapital,privateequity
AnalogousGovernmentFunding Sources
Grants, loans (e.g,DOD OSC), cooperative agreements,prototype contracts (e.g.,DIU)
Scaled Up Production toSustained Commercial Product Maturity,Acquisition,xit
Biotechnology companies can use maturestagefundingtoestablisha dominantmarketposition,explore internationalmarkets,andconsider options such as mergers,acquisitions, orgoingpublic.
PrivateFundingSources Private equity,hedgefunds,investment banks,initialpublicofferings(IPOs)
Analogous GovernmentFunding Sources Productioncontracts,procurement
2.2bRecommendation
Congress should direct the Department of Energy (DOE) and the Department of Health and Human Services (HHS) to use existing authorities to smooth out unpredictable and inconsistent demand for biotechnology products through advance market commitments (AMCs) and offtake agreements and provide new authorities where necessary.
Biotechnology products that meetexistingU.S. governmentneedsstruggletoattractprivatesector investment andscaleup.Thesedifficultiesarisein partbecause thegovernment isnot clearly signaling consistent demand for biotechnology.
Biotechnology can satisfy the technical needs of variousagencies.ConsidertheDOE'seffortstodevelop nontoxiclubricantsforhydropowerequipment,some ofwhichcould bemanufactured withcost-competitiveandscalablebiomanufacturing.153The problem,however,isthatbiotechnologycompanies donotalwaysknowwhatisneeded,when,andby whichpartofthegovernment.Furthermore,current governmentprocurementmechanismsgenerate inconsistentdemand.Thechallengesarefamiliarto anyonecontractingwiththegovernment:singleyear appropriations,abrupt policy shifts,and crises can all drive volatility in demand. Companies producing antibodydrugs,forexample,encounteredaspike andsuddendropingovernmentdemandduringthe COVID-19 pandemic.154 It is critical to clearly define andsmoothoutdemandforbiotechnologyproducts thatcanfulfillgovernmentneeds.Companiesand investors,especiallythoseinprivateequity,lookfor steadymarketdemandasevidencethattheyshould pursue scale-up.
To signal consistent demand,governments can use advancemarketcommitments(AMCs)andofftake agreements.AMCs are a promise topurchase a productthatdoesnotyetexist,ifadevelopercan makeit atscale.Theyhelp companiesde-riskthe costs of new product development by positioning the U.S.government as the first,but not only,buyer. Offtake agreements arepromisestopurchasean ex istingproductinmultipleordersoveragivenperiod. They help companies demonstrate toprivate investorsthatthereissteadydemandwithingovernment marketsfortheirproducts.55GovernmentAMCs andofftakeagreementsintendnottocreate artificial demandbutrathertoformalizeacommitmentto purchaseproductsthatfulfllexistingneeds and standards.156
Congress should direct theDOE and the HHS to leverage othertransaction authorities(OTAs)—a flexible procurement mechanism authorized by Congress—to establishAMCs for biotechnology products thatmeetexistingtechnical needs,signaling demand topull theseproducts throughdevelopment. TheDOEshould alsoestablishofftake agreements, signalingdemand topull developed biotechnologies through scale-up.
TheDOEandtheHHSshouldeachdefinewhich oftheirexistingtechnical needscanbemetwith biotechnology.The DOE,for example,might need biobased lubricantsforhydropowerequipment,while HHS might want new vaccine platforms forU.S.public health.Once those needs are defined,the DOE and the HHS should determine which biotechnologies would most benefit fromAMCs(such asthose that have notyet scaled up) and which would benefit from offtake agreements.
AMCs and offtake agreements should be meticulouslydesignedinconsultationwithtechnicaland marketexpertsfromboth inside and outsidethe government.EachAMCorofftakeagreement should detail agreed-on prices, specifications, delivery timelines,andframeworksforevaluation.Finally,for Congressionaloversightpurposes,theDOEand the HHS should reportannuallytoCongressontheir AMCs and offtake agreements. This oversight mechanism would ensure that the agreements are meeting theirobjectives and timelines so thatthegovernment is not locked into expensive orunneeded pledges.
2.2cRecommendation
Congress should restore full and immediate expensing of research and development(R&D)expenditures.
Recentchanges to the Internal Revenue Code have reduced theamountof R&Dcoststhatbusinesses can deduct annually.Previously,a company could fullydeductitsdomesticR&Dexpendituresinthe yearinwhichthoseexpenditureswereincurred, butcompaniesmustnowspread thosedeductions across five years.
Forbiotechnologystartups,the amortizationofR&D expensingcanmakeithardertostay afloat.R&D accounts for about a quarterof the overall spending by biotechnology companies.57
Congress should restore full and immediate expensingofdomesticR&DexpendituresunderSection174 oftheInternal RevenueCode.Areturntothisprior treatmentofR&Dexpensingwouldprovidesomefnancial cushion for small businesses as they develop theirtechnologies.158
2.2d Recommendation
Congress should improve the effectiveness and reach of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programsto supportearly-stage innovation.
TheSmallBusinessAdministration's(SBA)Small Business InnovationResearch(SBIR)and Small Business Technology Transfer (STTR) programs are mechanismsfortheU.S.governmenttostrategically investinearly-stagetechnologies,includingbiotechnologies.Poweredbyanetworkoffederalagencies, "America'sseed fund"isintended toprovide non-dilutivefunding——thatis,investment that does not require owners to give up equity—-to help emerging technologiesmove toward commercialization.159 Elevenfederal agenciesparticipateintheprograms, andeachagencywithaR&Dbudgetofover $$100$ millionsets aside3.2percentofitsbudgetforitsown SBIR/STRRprograms,withearlyresearchaward amounts limited to $$306,000andpre-commercialization award amounts limited to1.5 million.60
The SBIR/STTRprograms comprise one ofthe largesthard techseedfundsintheworld.Yetthere isno overarching,coherent strategyfor deploying its over 3$ billionofannualfunding.Eachfederalagency allocatesgrantsinaccordancewith itsrespective
mission without any broader considerations.Forbiotechnology inparticular,funding is fragmented across theDOD,theNSF,theEPA,theDOC,theUSDA,and theDepartmentofHomeland Security(DHS).SBIR/ STTRgrantapplicationscanbe cumbersome.Some early-stagecompaniesfindthesizeofearlyresearch grants(whichrange from $$100,000$ to $$306,000$ depending on the agency)not worth the effortto apply.
Theprogramswouldbebetteriftheymoreeasily reachedcompanieswhosetechnologyhavehigh potentialforcommercialization.Federal SBIR/STTR programadministratorsmayhaveno experience investingintheindustry,and eventhoughfederal agencieshave thelegalauthoritytograntSBIR/ STTRfundstobusinessesownedbyhedgefunds orprivateequityfirms,theyareinappropriately excludingthesebusinessesfromparticipatingintheir SBIRprograms.61Criticshaveaccused theSBIR/ STTR programs of fostering"SBIR mills,"whereby frmsobtainmultipleearly-stageSBIRgrantsfor
Chapter2
An SBIR Success Story
As "America's Seed Fund," the Small Business Innovation Research (SBIR) and Small Business Technology Transfer(STTR) programs aimto stimulate technological innovation,foster smallbusinesses in meeting federal research and development (R&D) needs, encourage participationfrom socially and economicallydisadvantaged individuals in technology innovation, and increase private sector commercialization offederal R&D through early-stage, high-risk funding.xxi
Geno, a San Diego-based biotechnology company that has received SBIR/STTR grants, provides anilluminating example of how suchfunding in early-stage research can translate intotechnological innovation and economic growth in an emerging industry.Founded in 1998,Geno was awarded multiple SBIR/STTR grants in support of various research efforts between 2000 and 2007.xi Since then, Geno has commercialized GENO Bio-BDO,a process technology that harnesses plant sugars to produce the widelyused industrial chemical1,4-butanediol. Geno has grownthe company's porfolioto include plant-based nylon production and has secured partnerships with brands including Lululemon and L'Oreal.xi In August 2024, Geno received 1.51$ million from the Department of Defense's (DOD) Distributed Bioindustrial Manufacturing Program (DBIMP) to plan a multiproduct biorefinery for polymer precursors that have applications in the aviation and automobile markets.xxiv
short-termrevenuewithoutevercommercializing a product.162
Lastly,even ifSBIR/STTRgrants reachhigh-potentialcompanies,theyremainvulnerableto China'sbruteforceeconomictactics.A2021 DOD report found that Chinese state-sponsoredfirmstargetSBiR-fundedcompaniesfor intellectualpropertyacquisitionandtheft.63In 2023, the SBA issued due diligence guidelines tomanagetheriskofintellectualpropertytheft from foreign governments, but they applied only to current recipients and new applicants.164
Giventhelargeannual budget,itiscritical thatpolicymakersensurethattheSBIR/STTR programshavethedirection neededtocatalyze emergingbiotechnologystartups.
Congressshouldensurethatfundingreaches biotechnologycompaniesthathavehigh commercializationpotentialandarecritical toU.S.national securityinterests.To ensure thatgrantsarestrategicallyallocated,Congress should provide direction, resources, and guardrails. Itshouldconveytheimportanceoffundingincritical technology areas alongside an overall increase of the set-aside percentage for the SBIR/STTR programs. Theprogramsshouldbereformedtobetterincorporateindustryexpertiseandcommercialization potential whenreviewing grants.Congress should also considerways of solvingthe problem of companiesthatrepeatedlyconsumeSBIR/STTRresources withouteverreachingcommercialization.TheSBIR/ STTR programs should alsobe streamlined so that theyallocategrantsmorequicklyandefficiently. Lastly,Congressshould expand therecentmeasures that mitigate risks of foreign intellectual property theft and require the reporting of foreign acquisitions of past grant recipients.
Chapter2
For U.S.biotechnology innovators,the biggest roadblocktocommercializationisprovingthattheir products and processes can scale,thus showing investorsapathtofinancialreturn.Thebreadthof products that biotechnology can make translates into abroadrangeofinfrastructureneeded tomake them, includingfacilities,equipment,andmanufacturing processes.The United Statesfacestwo mainchallenges to securing this infrastructure.
First,the United States lacks biomanufacturing capacity.165 Researchers are generating new products faster than manufacturing capacity is increasing. Buildingnewfacilitiesis expensive and time-consuming.Precommercialfacilitiescancost $$100–200$ million—whilefacilitiesforcommercialscalecantake two tofiveyearstobuild and prepare andcostupto $$2$ billion.166
As a result, American companies, particularly early-stage ones, mainlyuseoverseasmanufacturing capacity to scale processes for commercialization during the initial stage of bringing a product to market, and a number of foreign governments are investing billions to create even more biomanufacturing infrastructure.67
Second,biomanufacturingtechnologiesofthefuture haveyettomatureintoroutinecommercialapplications. Today's biomanufacturing facilities are generallyoptimizedforonetypeofproduct and areusually not compatiblewithotherproducts.68Afacility
designedtomakevaccines,forexample,cannoteasily pivottomaking chemicalswithout a majorretrofit. Building more ofthisbespoke,traditional capacity will not translate intomaking a widerrange ofproducts underoneroof.
Manufacturinginnovations that are under development,such asgreater automationand continuous manufacturing(aprocessbywhichinputs are continuouslyfedintoasystem,asopposedtomade inbatches),couldchangetheparadigmforbiomanufacturing.These innovationscould lead to smaller, lessexpensivefacilities that usemodular equipment andcleanroomstomanufactureproductsatlower cost while usinglessenergy.Despite early signs of promise,both the bioindustrial and biopharmaceuticalsectorshavebeenslowtodevelopandadopt thesetechnologies,primarilybecauseofconcerns that they might pose regulatory risk and not recoup theircapital investments.
Tocreatethebiomanufacturinginfrastructureofthe future in the United States, Congress should invest in thescienceofbiomanufacturingscale-up,undertake biomanufacturinggrand challenges(seeSection 4.3b and Appendix D for more detail), create data-sharing platforms and artificial intelligence/machine learning (Al/ML)tools to accelerate biomanufacturing design (see 4.1aand 4.3c),and support domesticprecommercialfacilitiesthat integrate expanding state-ofthe-artinfrastructuretohelpinnovatorsmaturetheir technologies.Inaddition,thereareothergovernment entitiesresponsibleforsupportingcommercial-scale manufacturingcapacity,suchastheDOE'sLoan ProgramsOfficeandtheAdministrationforStrategic Preparedness and Response (ASPR) BioMap Consortium.
Takentogether,theseactionswould advance Americanleadershipandbolsterlocaleconomies,all while minimizing long-term federal spending.
Biomanufacturing 101: An Introduction to Fermentation
Like traditionalmanufacturing,biomanufacturing allowstheUnitedStatestouse whatithastomake what it needs. The most widespread formof bimanufacturing calledfermentation,usesiving microorganismsto transforminputs int products.These products include everything frombeertommunotherapiestofuel Asimplied processisoutlinedbelw.
Step1
Infrastructure
Biomanufacturers first select two key ingredients:afeedstock,which acts as the “food" to be transformed, and the chassis organism, which"eats"the feedstock to produce the product. Critical enablers, such as water, energy, and natural chemicals, are also essential inputs.
WhatareFeedstocks?
Feedstocks are bulk raw materials used as an input for an industrial process.For biomanufacturingtoday,acommonfeedstockissugarderivedfrombiomasssourceslikecornand sugarcane.Lesscommonbiomass sourcesinclude corn stalks and husks,forestdebrisand waste gasfrom steel mills.Advancements inthe conversiontechnologiesthat turnbiomass sourcesintofeedstockscouldmakemanysourceseasiertouse.
WhatareChassis?
Much like how a chassis ina car is a standard structural frame that canbeused with different engine sizes,seats,and colors, a chassis inbiomanufacturing is a biologicalframe that allows forcustomization.lnbiomanufacturing,scientistscustomizechassiswithspecificgenetic sequencesto produce desired products.Most chassis used inbiomanufacturing today are microorganisms,suchasyeast,thathave suffcientgeneticinformationandmoleculartools available.esearchers are studyingmanyothercelltypes,suchasalgae and plant cells,as potential novel chassis toproducefuture products.
Process Design
Biomanufacturers can now design the entire process. They determine how much of each input is needed toyield the desired amount and form of the product, whetherthefeedstocks need processing tobe more“edible"forthe chassis, and what packaging is needed to distribute the final product.
Infrastructure
Biomanufacturing needs arange of specific equipment and facilities,from glass beakersto giant bioreactortanks.As biotechnologiesmaturefromlabscalediscoveriestocommercial products,innovatorsmust changetheirequipment andfacilitiestomatcheachdevelopment stage.
Step2
Fermentation
The chassis"eats" and transforms the feedstock into the desired product through fermentation inbioreactors.ioreactors,software,and sensorshelptocreate a controlled environment (settingtherighttemperature,humidity,andoxygenlevels,forexample)tomaketheprocess asefficientandeffectiveaspossible.
Step3
Downstream Processing
Fermentation results ina mixture that includes both the target product and waste products. Manufacturers need to isolate the target product through purification and recovery methods that remove waste.
Step4
Final Steps
Manufacturers package and transfer the end product to consumers who willuse it as-is or as aningredientforotherproducts.
Chapter2
Infrastructure Across Stages to Scale Biomanufacturing
Laboratory& Bench Technology Maturation
Initial discover and prototyping phaseforbioproduction.
Iterativeprocess of maturing technologyandprocessestoreach quantityandcostforthemarket.
Commercial
Commercialproductionwhere optimizedprocessesconsistently meetmarketdemand.
2.3aRecommendation
Congress must authorize and fund the Department of Energy (DOE) and the Department of Commerce (DoC) to develop a network of manufacturing facilities across the country for precommercial bioindustrial product scale-up.
TheUnited States hasmanyfavorable conditionsfor scalingindustrial biotechnology, including its abundantfeedstocks,reliableutilities,extensivetransportationinfrastructure,and proximitytoconsumers. But even so, companies tend to do their scale-up abroad.169
Congressmust authorize theDOCand theDOEto createfacilitiesthatcompaniesandresearchers canusetoprovethattheirlabinventionsworkat pilotand demonstrationscalebeforemovingtofull commercial scaleproduction.This effortshould include expanding existing DOE facilities and building newfacilities.(SeeSection3.2forrecommendations to addressbiomanufacturingfortheDepartmentof Defense (DOD).)
Congressshouldrequire theDOEandtheDOC,in collaboration with theNBCO(see recommendation 1.1a),tolay out a strategy to create a network of new precommercialfacilitiesacrossthecountryforscaling upbioindustrial products.This networkshould integratenext-generationtechniques(seeSection 4.3c) and data-sharing platforms (see Section 4.1a).
These precommercial facilities should be designed as userfacilities.Theiroperatingmodels and capabilities should alignwith the needsoftheircustomers, whethertheybefrom industry orfrom othergovernment entities such as a National Lab. Charging fees forcertainuserswould also ensurefinancial viability throughcost-sharingwiththeprivatesector,prevent operationaldependenceonasinglecompany's success,andprovideregularfeedbackregardingthe effectivenessofthesescale-upfacilities.Ifthefacilitiesarenotmeetingtheirneeds,companieswould notpayforaccess andthefacilitywould beforcedto adjust.Thissetupwouldensurethegovernmentdoes notfinancelarge-scalebiomanufacturingfacilities that no one uses.
As a promising example, policymakers should look to the BioBased Europe Pilot Plant(BBEPP)in Ghent, Belgium,auserfacilitythatwascapitalizedwith
contributionsfromtheEuropeanUnionandthelocal governmentbutwhoseoperations arefundedprincipally by user fees!70 Its non-profit model ensures that thefacility'sfinancialhealthisnotdirectlytiedtothe successorfailureoftheindividualcompaniesthat useit.
Withinsixmonths,theDOCand theDOEshould jointlysubmitaplantoCongressoutliningconcrete steps to finance and construct these facilities. They should coordinatetheirstepswithotheragencies thatfinancescale-upfacilities andshould describe how the plans address a gap not flled by other agencies.Thedepartmentsshouldincludespecificssuch as theprocessforsiteselection,designspecifications,andconstructiontimelinesaswellasspecifics abouthow,once thesites areselected,thedepartmentswouldengagewithcommunitystakeholders, local industry,andnearbyacademicinstitutions.
Congress should evaluate the departments' plans to ensure thattheproposedfacilities aredistributed across the country, make the most of existing infrastructure, and are located near skilled workers, feedstocks,andfeedstockprocessingfacilities.
Congressshould conductregular oversightofthe progressthedepartmentsaremakingonconstructingthefacilitiesand,oncebuilt,collectmetricsabout their operation, usage, and financial health. Congress shouldrequiretheexecutivebranchtomeetambitious timelines and quality metrics before continuing toappropriatefundsforthiseffort.Additional facilitiesshouldnotbebuiltunlessthereisdemand for them.
DepartmentofCommerceFacilities
The specific focuses of each facility may vary based onlocalresources,expertise,andneeds,butthe DOC should considerthefollowing infrastructure and capabilitiesforallfacilities:
awiderangeofproducts,includingdedicated CurrentGood ManufacturingPractice(CGMP) compliantequipmenttoscale-upfood-and agricultural-related products and processes;171 a variety of fermentation methods, including gas, solid state,and continuous fermentation; infrastructure tosupport a variety of nonfermentationbiomanufacturing,suchascell-free systems;
biomassprocessingequipmentthatsupports biological conversion and other conversion
methods;
numerous downstreamprocessingcapabilities, including product recovery and purification
equipment;
fermentation capacity that ranges from pre-pilot tointermediate,including atleast a75,000-liter tank,with additional capacityasfeasible;and datainfrastructurethatintegrateswithaWebof BiologicalData(WOBD)(seerecommendation 4.1a).
NewDepartmentofEnergyFacilities
Underthis strategy,theDOE should propose new facilitiesthatwouldeach:
upgradestoequipmentandanexpansionof fermentation capacity;
cutting-edge infrastructure driven by industry needs, including automated bioreactors,gas fermentation equipment, processing equipment foremergingfeedstocks,andequipmentfor
bioprocessingcriticalmaterialssuchasrare earth elements;
applicationandtooldevelopment,equipment and algorithm testing, and process improvement; and
apilotprogramtoestablishdigitalinfrastructure for collecting biomanufacturing and
bioprocessing data.
Increase Support for Existing Department of Energy Facilities
TheDOE's current userfacilitiesinclude the AdvancedBiofuels andBioproductsProcess Development Unit(ABPDU) at LawrenceBerkeley National Laboratoryand theIntegratedBiorefinery ResearchFacility(IBRF)attheNationalRenewable Energy Laboratory(NREL).These not-for-profit facilities offerstrategicpartnerships,jointresearch projects,technologylicensing,andavarietyofother avenuesforacademicstopartnerwithNational Laboratory groups, allin an effort to de-risk the scale-upofbiotechnologyproductsandprocesses withintheDOEmandate.
TheABPDUhassuccessfullyworkedwithnumerous companiestohelpmature a variety of biotechnology products.172 But it also has long wait times and is constrained by its currentfunding and equipment, preventingitfrommeetingthesubstantialneedsof industry andgovernment.TheIBRF,whichboasts a largerbiomanufacturingfermentationcapacityand hasbeenusedextensivelyformanycross-sector collaborations,faces the same constraints.73
Congress should increase support forexisting DOE facilities,whichwould allowthemtoincreasethe numberand speed oftheircollaborationswithprivate industry and academia,upgrade theirequipment, workonnovel bioprocessingtechnologies,and drive next-generation advancements inbiomanufacturing thatcouldbespurredbygrandresearchchallenges for biotechnology (see Section 4.3).
ExpansionofexistingABPDUandIBRFfacilities should include:
upgradestoequipmentandanexpansionof fermentation capacity;
cutting-edge infrastructure driven by industry needs, including automated bioreactors,gas fermentationequipment,processing equipment for emerging feedstocks, and equipment for
bioprocessing critical materials such as rare earth elements;
applicationandtool development,equipment and algorithmtesting,andprocessimprovement; and
apilotprogramtoestablishdigitalinfrastructure for collecting biomanufacturing and
bioprocessing data.
Creatingnewfacilitieswithasimilarpartnership structure, along with expanding and capitalizing on existingABPDUandNRELfacilities,wouldallow theDoEtoexpanditsprecommercialdevelopment infrastructureacrossthecountryandsupportmore companiesatallstagesofcommercialization.
"Biomanufacturing is rapidly becoming a core pillar of the American economy. By investing in the full development pipeline for emerging biotechnologies—-from technology maturationinfrastructuretoAlresearchforproductionat scale—theseproposalsadvance ourposition as aglobal leader while building a strong and innovative American biotechnology sector."
·CommissionerEricSchmidt
2.3bRecommendation
Congress should direct the Department of Commerce (DOC) to create a public-private biopharmaceutical manufacturing center of excellence focused on developingandscalingnewwaystomakemedicines.
Biopharmaceuticalmanufacturingrequiresflexible andaffordabledevelopmentinfrastructureto ensure thatinnovativeproductscanrapidlymove fromthelabtocommercial-scaleproduction.Itis importantthatsuchinfrastructurecomplieswith regulatoryrequirementsandiscommerciallyrelevant sincewhenabiopharmaceutical companytakesa productthroughFDAreview,regulatorsevaluate how the product is made.Methods that incorporate CGMP,Quality byDesign(QbD),and Chemistry, Manufacturing,and Controls(CMC)guidance are particularly vital for ensuring efficient and effective manufacturing and subsequent regulatory approval.174
Once a company chooses a manufacturing method thatisapprovedbyregulators,theincentivetoiterate onthatmanufacturingmethoddecreases,sincea changecouldrequireadditionalregulatoryscrutiny. As a result, companies may not pursue manufacturinginnovations,evenonesthatarefasterormore cost efficient.75 The biopharmaceutical sector needs manufacturinginnovations,givenhowexpensiveand difficultbiopharmaceuticalsaretoproduce.Thesectorneedstoadvancetheirmanufacturingprocesses andcatalyzefull-scaleproductionintheUnited Statesespeciallytosolvefuturetechnicalchallenges. Once completed, such a center would bring togethercompanies,academics,andgovernment scientiststoadvanceinnovativebiopharmaceutical manufacturing.
Congress should appropriate 120$ million to the DOC tocreateabiopharmaceutical manufacturingcenter ofexcellence thatwould:
innovateandadvancethescienceof biopharmaceutical manufacturing,especially for products important to U.S.national security, healthsecurity,and economicsecurity(suchas genetherapiesandantibodies);
supportGMP,QbD,CMC,and similarguidance to ensure effective and efficient manufacturing andimproveregulatoryunderstandingof innovative manufacturingmethods; and
focusonworkforcetraininganddevelopment byworkingwitheducational andcommunity partnerstobolsterbiotechnologytalent.
TheDOCshouldcompetitivelybidthecontractto run thefacility.Forexample,theNational Institute forInnovationinManufacturingBiopharmaceuticals (NIIMBL),aDOCManufacturingUSAInstitute,isone organizationfocused onadvancingbiopharmaceutical manufacturingthatcouldbeinvolvedwith the center.
Protect Critical Biotechnology Infrastructure
2.4aRecommendation
Congress must direct the Department of Homeland Security (DHS) to ensure that biotechnology infrastructure and data are covered under "critical infrastructure."
The Cybersecurity and Infrastructure Security Agency(CISA),within theDHS,is the operational lead for federal cybersecurity policy and operations and thenationalcoordinatorforcriticalinfrastructure security and resilience.76Its activities are guided byalistof16CriticalInfrastructureSectorsthat PresidentialPolicyDirective(PPD)21established in 2013.177
CISA is responsible for engaging with stakeholders intheseCritical InfrastructureSectors,includingfor thepurposeofrevisingtheNational Infrastructure ProtectionPlan (NIPP).78 Biotechnology infrastructurecuts acrossanumberofthesedesignated Critical InfrastructureSectors,includingthehealth, agricultural,and industrialsectors.
Indeed, PPD-21 designates as critical a number of sectorsrelevanttobiotechnology:chemicals,critical manufacturing, the defense industrial base, energy, foodandagriculture,andhealthcareandpublic health.79 But these areas are neither specific to biotechnologynoraretheyreflectiveofthefullbreadth ofthebiotechnology sector.8oCurrently,thefederal governmentdoesnotadequatelyprotecteither physical biotechnologyinfrastructureorsensitive biologicaldata,despitetheirmajorramificationsfor the economy, public health, and national security.181
Adversaries and malicious actors will increasingly target the biotech nology sector's infrastructure and data.182
Already,theyhavecarriedoutnumerousattempted andsuccessfulcyberattacksoncriticalinfrastructure in biotechnology,including against hospitals and agriculturalfacilities.83
Biologicaldata,whicharecriticaltodiscoveryand frequently contain sensitive personal information, facespecificvulnerabilities.Somefederalgovernmentefforts underwayaimtoprotectsensitive types ofbiologicaldata,includingtheNationalInstituteof Standardsand Technology(NiST)frameworkfor genomiccybersecurityand theNational Instituteof Health's(NIH) GenomicData Sharingpolicy.84But thesepiecemealeffortsdonotholisticallyaddress the changing landscape of genomic and biometric cybersecurity.
The DHS has existing authorities to help the privatesectorprotectitsmostvaluableandnational security-relevant physical and digital assets,but its sector-based approachmeansthere arecurrently noclearly-designated,biotechnology-specificcritical infrastructureprotections.TheDHS needstotreat biological data, along with the entire biotechnology sector,as criticalinfrastructureforcybersecurity purposes.85
To this end,Congress must direct theDHS to ensure thatthebiotechnologysectoriscoveredbythelist of Critical InfrastructureSectorsandrequireClSAto integrate theprotectionofgenomic andothersensitive biometric data into itsnational strategy.Together, these actions should ensure that biotechnology infrastructure and data is covered under"critical infrastructure”and dulyprotected as such.
Given the urgent need to address this gap, once this recommendationispassedintolaw,theDHSshould submit a work plan within 45 days. Since somebiotechnology-specificinfrastructureis already covered, this work plan should ensure that biotechnology is covered undertheexistingsectors,ratherthan adding it as a new one.
TheDHSshould considerincludingintheworkplan:
apreliminarylistofbiotechnologyinfrastructure stakeholders, such as the Bioeconomy
Information Sharing and Analysis Center
(BIO-ISAC);
anoutreachplantoensurethatstakeholders are aware that they are covered under existing Critical InfrastructureSectors(and whichones); an action plan to ensure that biotechnology stakeholders arerepresented at their
appropriate consortia and Coordinating
Councils;and
anactionplantoupdatetheNational
InfrastructureProtectionPlan(NIPP)by2026, withinputfromthebiotechnologysector.
Following the submission of this plan, DHS would execute it and submit a final report to Congress based onitsfindings.Thisentireprocessshould take less than a year.
Additionally,Congress should amend the Cybersecurity and Infrastructure Security Agency Act of 2018 to:
categorizegeneticdatasystemsthatinvolve genomicsequencesandothersensitive biometricdataascriticalinfrastructure;
requireCISAandbiotechnologysector stakeholders,includingthegovernmentagencies responsibleforbiosecurity(seeSection4.4a),to togetherdevelopsecurityprotocolsforgenetic data, including joint exercises and data sharing;
increase the staff at CISA asnecessary to implement security policies and protocols related to the new responsibilities regarding genomic andothersensitivebiometric data;
implementtrainingforfederalpersonnelon protectinggeneticand othersensitivebiometric data,addressing unique security challenges and ethicalconsiderations;
incorporate genetic and biometric data security intothenational cybersecuritystrategy,thereby ensuringanongoingfocusonand adaptationto newthreats;and
collaboratewithentitiesworkingonbiosecurity (see Section 4.4a)to ensure that security concerns are synchronized (forexample, coordinatingwhenthesedata connectwith systems that convert them into physical genetic sequences).
NolaterthantwoyearsaftertheNiPPisupdated, CongressshoulddirecttheDHStoconducta follow-upevaluation.Ifthereareadditionalcritical biotechnology areas that do not fit underthe current sectors,thatfindingshouldbeexplicitlystated inthe DHS's report to Congress.
Section 2.5
Fight Back Against China's Brute Force Economic Tactics
China devotes billionsof dollars in state subsidiesto propup companies that would not withstand normal market forces.Its goal is not onlyto support Chinese biotechnology companies but also to court fledgling foreign frms that are struggling to commercialize theirinovations.The CCPis even willing to subsidize national champions beyond the pointof market viability,just toundercut companiesbased intheUnited States and allied countries.
China is taking advantage ofthebarriers to commercialization intheUnited States soit can enterand, in some cases,dominatemarkets.TheUS.overnmentmust thereforebothremovethosebarriersand preventChina from using adversarial capital and non-market practicestoundermine U.S.companies and gain controlof strategicmarkets.
2.5a Recommendation
Congress must require public companies to disclose single points of supply chain vulnerability located inforeign countries of concern
For companies seeking to maximize profits and minimize costs,relying on single-source suppliers haslongbeen an attractive strategy.Thisapproach oftenleadsto short-term savingsbyconcentrating orderswitha limitednumberofvendors,resultingin loweroperationalandlogisticscosts.Manyofthese single-sourcesuppliersareheadquarteredorhave manufacturingfacilitiesinChina.86These dependen ciescancauseproblemsfora companyintimesof global instabilityandconflict.
To de-riskfuture investments,theU.S.government mustrequirecompaniestoreporttheirsupplychain vulnerabilities.Greatertransparencyintopotential supplychainvulnerabilitieswill helpinvestorsbetter assessriskandincentivizediversification,ifneeded.
Congressshould directtheU.S.Securities and ExchangeCommission(SEC)torequirepublicly heldsecuritiesandcompaniesofacertainsizetofile annualreportswiththeSECdisclosingtheexistence ofsingle-sourcesupplierslocatedinforeigncountries ofconcern.Thisrequirementwould applyonly to publiclyheldsecuritiesandcompaniesinvolvedinthe production oftechnologies criticaltoU.S.economic and national security,including biotechnology.
TheWide Range of Biotechnology Critical Enablers
While theAlboomhas dramaticallyincreased demand forresourcesdirectly linkedtoAl, suchastraining data andcom putingpower,thebomhasaloput majorstrainsonothercmmonresourcessuchasland,water adelectricitymilarl biotechnologyreliesonawide rangeofcriticalenablers withcomplexsupplychains.Asthe sector grows, these critical enablers maybecome chokepoints orbottlenecksthat could jeopardize orstuntthe entire biotechnology industry.
2.5bRecommendation
Congress must prohibit companies that work with U.S. national security agencies and the Department of Health and Human Services (HHS) from using certain Chinese biotechnology suppliers deemed to pose a national security threat.
U.S. companies rely too much on firms located in China for the production and supply of critical biotechnologies.Thisreliancepresentstwovulnerabili ties.First,sensitivebusiness and biological data may be collected and shared with the Chinesegovernmenttosupport itsmilitarybiotechnology ambitions. Second,theChineseCommunistParty(CCP)could instructitsstatechampionbiotechnologycompanies to severtieswith theirAmerican customers,leaving the U.S. biotechnology industry without suppliers of keyproducts and services.
CongressmustpasslegislationthatprohibitscompaniesthatworkwiththeDOD,theDOE,theintelligence community (IC),and the HHS fromusing Chinese biotechnologysuppliersthataredeemedtoposea national securitythreat.
These agencies are likely to have the most biotechnology-related transactionswiththegreatest national security impact. Chinese biotechnology companiesthatshouldbecoveredbythisprohibition includethoseonthe"Chinesemilitarycompanies" listmaintainedbytheDODunderSection1260Hof the2021NationalDefenseAuthorizationAct(NDAA), thoseontheDoC'sEntityList,andanyothercompanyof"nationalsecurityconcern,"asdesignatedby thePresident(with authoritydelegabletoacabinet secretary).
Companieswould have anappropriate amountof timetowinddownlong-termcontractsandmoveto lessriskyalternativesuppliers,suchasthosebased in theUnited States and allied countries.
2.5cRecommendation
Congress should reform the Committee on Foreign Investment in the United States (CFIUS) to better and more nimbly screen the highest-impact, highest-risk types of investment in critical technology sectors in the United States.
CFIUS is an interagency committee that reviews the nationalsecurityimplicationsofforeigninvestmentsin U.S.companies or operations.Its jurisdiction includes thereviewofmergers,acquisitions,andtakeoversthat result inforeigncontrolofaU.S.business,alongwith non-controllinginvestmentsinU.S.businessesrelated tocriticaltechnologies,criticalinfrastructure,sensitive personal data,andcertainrealestatetransactions.
Adversarial investments area criticalvectorof vulnerabilityin theU.S.biotechnology industry.Before the2018 ForeignInvestmentRiskReviewModernizationAct (FIRRMA)expandedCFIUS'spurview,thecommittee failed torecognizethestrategicimportance ofbiotechnology and allowed Chinese companiestoacquire strategictechnologiesandcapabilitiesthroughforeign direct investments.
AfterFIRRMA,CFIUShas triedtoprioritize strategic sectorssuchasbiotechnology.Butinpractice,itsmandate andresources areinsufficienttoprotectagainst adversarial investment inemergingtechnologies.
The Commission's analysis of past biotechnology-relatedCFIUScasesand thewayFIRRMAhasbeen applied haverevealedfourkeyvulnerabilitiesincurrent authorities.
First,current definitions for“critical technology constrainthescopeofCFIUS'sreview.Thesedefinitions rely on static lists,such as the DOD's U.S.Munitions List,theDOC's Commerce Control List(CCL),and the DOC'sSection1758listofemergingandfoundational technologies.87CFIUSreliesontheDOC'sSection1758 list, but this list is updated infrequently.
Second,CFIuSdoesnotcurrentlyhavejurisdictionover greenfieldinvestments,"—wherebyacompanycreates acompletelynewbusinessoperationinaforeigncountryviatheestablishmentofnewphysicalfacilities-and hasjurisdictiononly overjointventuresthatresult in control of an existingU.S.business.Yet both types of transactionsposesecurityrisks.In2022,CFIUScleared theChinese companyFufengGroup'spurchase of 370acresofagricultural landinNorthDakota,near theGrandForksAirForceBase,becauseitdeemed
the transactiontobeoutsideof itsjurisdiction.88Joint ventures,fortheir part, pose risks of intellectual property theft and technology transfer,evenwhen a foreign companyhas a non-controlling interest.
Third, CFIUS is not mandated by lawto analyze the controlofstrategicsupplychainsandmarketsinthe courseofitsreviewprocess.Underthecurrentstatute, CFIUS maytake into account“"the cumulative control of,orpatternofrecenttransactionsinvolvinganyone typeofcriticaltechnologybyaforeigngovernment orforeignperson”when consideringnational security risks,butit isnotexplicitlyrequiredtodoso.89Thus,the CFIUS review process can sometimes failto prevent foreignadversariesfrom“slicing and dicing”market controlofcriticaltechnologysectorsthroughmultiple transactions.
Andfinally,CFIuShasblanketreviewforcovered transactionsinvolvingalliedcountries,inadditionto countriesofconcern.Althoughthereareexemptions forcertainforeignstatesfrom CFIUSjurisdiction of nonpassiveminorityinvestmentsandrealestate transactions(alsoknownastheExceptedForeignState andExceptedRealEstateForeignStateslists),the CFIUSreviewprocessdoesnotdifferentiatebetween foreignadversariesand allieswhen assessingtransactionsrelatedtocriticaltechnologies.Asaresult,CFIuS's finite time andresourcesarespread acrosscases withdifferinglevelsofsecurityriskwhenreviewingfor certain covered transactions.90
The2022CFIUSExecutiveOrderonEvolvingNational SecurityRisksand CFIUS enforcementguidelines(EO 14083) attempted to address some of these issues in investment screeningforemergingtechnologies, includingbiotechnology.9AFebruary2025National SecurityPresidential Memorandumsignaledfurther executiveinterestfromtheTrumpAdministration toimproveCFIUSreviewandoutboundinvestment screeningforstrategictechnologies,suchasbiotechnology.192However,there are limitstowhatcanbe accomplishedsolelythroughexecutivebranchactior without legislative changes.93
Congress should reform CFIuS to better and more nimbly screenthehighest-impact,highest-risktypesof investmentintocriticaltechnologysectorsintheUnited States.To ensure this,Congress should amend the FIRRMAto:
Expand definitions of"critical technology”for CFIUS review.Thelegal definition of“critical technology"shouldbeexpandedinorderto give CFIUSgreaterflexibility when screening investmentsbyforeignadversariesincritical technologyareas.Congressshoulddirectthe Secretary oftheTreasurytoreviewcasesinvolving technologiesof"nationalsecurityconcern,andto enumerateanysuchtechnologiesthatmeetthis definitionthat arenotcoveredbyexistinglists of critical technologies.
Reform CFIUS review tono longerbe"countryagnostic"forcertaincoveredtransactions. CongressshoulddirecttheDepartmentof Treasury (Treasury)to generate an“excepted foreignstate”listofallied countriesthat haveinvestmentsecuritypracticesthatare harmonizedwiththoseoftheUnited States andwhosetransactionswouldgothrough
an expedited reviewprocess.The Secretary of the Treasury wouldbe given the authority toscrutinizeinvestmentsoriginatinginthese countriesonlywhenthereisevidenceof undisclosedinterestsorcontrolofafirmby athirdcountryorwhentheSecretaryofthe Treasury(whoseauthorityinthiscasewould benon-delegable)determinesthatthereisa significantnationalsecurityriskintheproposed transaction.
Expand CFIUS'sjurisdiction toinclude noncontrollingjointventures andgreenfield investmentswhenacountryofconcernisinvolved.
MandatethatCFIuSanalyzethecontrolofstrategic supplychainsandmarketsaspartofitsreview process.
Lastly,to effectively carry out its legislative mandate, Congress should provide Treasury with the resources itneedstomodernizethedigitalsystemsthatunderpinCFIUS'sanalysisandexpand itsanalysts'access toup-to-datebusinessandotherdata.
2.5d Recommendation
Congress should direct the International Trade Commission (ITC) to investigate Chinese dumping or oversupply of biotechnology products and services.
China's top-down strategies, subsidies, and anticompetitivepracticesoftendistortglobalmarkets.Without normalpricefloors orthe economicpressure to maintainproductioninproportiontodemand,Chinese firmshavebeenabletofloodglobalmarketswithcheap goods and acquire control of critical industries.
There is emerging evidence that China is distorting biotechnology marketsinparticular.BeijingGenomics Institute(BGl) and MGl Techhavefinanced theirgrowth inanatypicalmannerthatindicatesundisclosedstate involvementandsubsidization,underminingtheirforeign competitors in thegenomic sequencing market.94 China'sabilitytomanufacture activepharmaceutical ingredients(APls)at disproportionately lowprices led Indiatoimposeaunilateralanti-dumpingdutyon certainAPlsfromChinain2022toprotectitsdomestic manufacturing industry.95
If the ITC receives a petition or a Congressional directive,ithastheauthorityandresourcestoinvestigate thematerialimpactofforeignsubsidiesandmarket dumping on U.S.industry.Theresults ofthat investigation would inform executive branch action on any remedy(such as atariff ora countervailing duty)that mightleveltheplayingfield.Congressshould direct theITCtospeedilyinvestigateChinesesubsidization andproductionovercapacityinbiotechnologythat couldeconomicallyharmtheUnitedStates.IftheITC's investigationconfirmsChinesedumpingandoversupplyin thebiotechnology industry,then theDoC's InternationalTradeAdministration(ITA)canusethis informationtoinformsubsequentexecutivebranch action.Forexample,foranti-dumpingcases,theITAcar issueadditionaldutiesonimporteditemstooffsetthe below-costpricing.Similarly,forcountervailingduties (CVD)cases,the ITAcan issue duties equivalenttothe subsidyamountsontheimporteditems.
Biomanufacturing Critical Products
Acetaminophen (pain reliever, brand name Tylenol)
Traditional Manufacturing
Biomanufacturing
The United States sources 70% of its acetaminophenfromChina, leavingAmericavulnerabletoChinesesupplierdisruptions,during theCOVID-19pandemicxxvi
ResearchersattheGreatLakesBioenergyResearchCenterhave patented a method to convert lignin, a complex molecule derived fromplantssourceddirectlyintheUnitedStates,intoacetaminophen.Thisprocessnotonlypresentsanalternativeproduction process for products like Tylenol but also serves as a secondary sourceofrevenuefroma bioproductionprocess,improvingthe economicviability.xvi
D
Sunscreens, Anti-Aging Creams, and Facial Cleansers
Traditional Manufacturing
Biomanufacturing
Squalene,usedinmanysunscreens,anti-agingcreams,andfacial cleansers,isanaturallyproducedcompoundthathydratesand detoxifiestheskin.Butmostsqualenecomesfromtheliversof sharks found throughout the Northeast and Central Atlantic,Asia, and the SouthwestPacific Ocean.xvii An estimated 2.7 million sharkshavebeenharvestedeachyeartomeetthesqualene demandforthecosmeticindustryalone,increasingtheriskof shark extinction and creating an unstable supply.
Biomanufacturersareusingengineeredyeast,sugarcane,and precisionfermentationtoproduceanalternativeversionfor squalene,called“squalane,”atcommercialscalewithoutthe needforsharks.xxix
Not only is squalanemore stable and effective thansqualene,xx but domestic production of squalane willalso makeU.S.supply chainsmoreresilientwithoutharmingsharkpopulations.
Rubber Tires
Traditional Manufacturing
Biomanufacturing
U.S.dependence on foreign sources of rubber dates back to WorldWarll,whentheUnitedStateswascutofffrom 95% ofthe global rubbersupplyin1942.Today,theUnitedStatescontinues tosourceitsrubberfromabroad,primarilyfromAsia.Thisleaves the United Statesvulnerabletovolatile supply chain disruptions andpricespikes,suchaswhenadroughtinThailandcaused global natural rubberpricestoreachrecord highsxxxi
Severalorganizationsareusinggeneticmodificationand selectiveplantbreedingtoturnrubber-containingplants,like dandelions,intocommerciallyviablealternativesourcesof rubber.xxi
Forexample,aresearchpartnershipbetween theU.S. Department ofAgriculture (USDA), Bridgestone,and the University of Arizona is working toincrease rubber production ina shrubcalledguayule.xxii Theteams aimtoincrease domestic production of natural rubberusing biotechnology,while reducingpollutionandwastecomparedtotraditionalrubber manufacturing.
Naloxone (opioid overdose medication, brand name Narcan)
Traditional Manufacturing
Biomanufacturing
Thebaine,aprecursortonaloxone,issourceddirectlyfrom poppyplants,whichtakeyearstogrow.Onceharvested,manufacturersusechemicalprocessingtoconvertthethebaineinto naloxone.xxiv But only a few countries, including India,Turkey, and Australia,canlegallygrowpoppyplants.x
Onecompanycommerciallyproducesthebainethroughprecisionfermentation,removingtheneedforpoppyplantsentirely. Thisprocessusesgeneticallyengineeredyeastthatcanproduce thebaine, reducing the production time from years to weeks. xxvi This fermentation process could be one way to increase U.S. domesticsupplyofthiscriticalprecursor,reducetheoverall productiontimeline,andreducerelianceonothernations.
Military Uniforms
TraditionalManufacturing
TheU.S.militaryreliesontextilesthataredurable and adaptable to differentenvironmentsforuniforms andequipment.Thereis constant demand foruniforms and equipment that are stronger, moreresilient,and canperforminaustereenvironments.
Biomanufacturing
Supported by the Department of Defense (DOD),one company iscreatingsynthetictextilesderivedfromproteinsthatmimic thoseoriginallyfoundinsquidtentacles.Thesenewtextilesare strongerandmoredurablethantraditionalsyntheticfibersand presentanalternativemethodforthemilitarytosourcetheir uniforms.xxxvii
To-Go Food Containers
TraditionalManufacturing
Traditional single-useplasticpackaging,such asto-gofood containers,accountsforapproximatelyonethirdofplastic waste.Almostall manufacturersusesignificantinputstoproduce single-use packaging.xxvi
Biomanufacturing
By combiningagriculturalfeedstockswithacompoundtypically found in mushroom roots called mycelium, one biotechnology companyisessentiallygrowingsingle-usepackaging.The packagingisthermallyinsulative,waterresistant,shelfstable,and compostable,presentingalesswastefuloption.xxix
Laundry Detergent
Traditional Manufacturing
Existing laundry detergents contain a mixture of enzymes, sourcedfromlivingorganisms,andsurfactants,chemicals responsibleforthecleaningactionthatareprimarilysynthesizedthroughchemicalprocesses,aswellasavarietyofother chemicals.x
Biomanufacturing
Biotechnologycompaniesareproducingbetterenzymesthrough protein engineering andmicrobial fermentation.x\*i Forexample, cold-tolerantenzymesallowconsumerstoswitchfromhotto coldwaterwashingwithoutaffectingcleaningability,whichcan reduce energy use by as much as 90% and save the average American household roughly 150$ per year.xli
BabyFormula
TraditionalManufacturing
In 2022,the temporary closure of a major baby formula manufacturingfacility,combined with already-stretched supply chains, roiled thecountry as parents scrambled to get their hands on babyformulafortheirchildren.At thepeakofthe shortage, more than 40% of formula products were out of stock across the country,andoneinfourparentsreportedhavingtotravelmore than 20milestopurchaseformula.xii
Biomanufacturing
Several U.S.biotechnology companies areworkingtofillthese critical supplygaps.Usingprecisionfermentation,companies are usingmodifiedyeastandalgaetobiomanufacturethecomplex nutrientsandproteinstypicallyfoundinhumanbreastmilkfor useinbabyformula.xiHavingnewwaystoproducebabyformula will notonlyensurethatinfantsreceivemorenutrientsbut also giveparentsmorepeaceof mind intermsofensuringamore dependable supply.
Cell Phones and Laptops
TraditionalManufacturing
Criticalminerals suchasgermanium,antimony,andgallium areusedinawiderangeofproducts,fromthecellphonesin everyone'spocketstosemiconductorsused inhighperformance computers.ButtheUnitedStatesisalmostentirelyrelianton Chinaformanyofthesecriticalminerals,includingoverhalfof its annual consumptionfor31of 35 critical minerals.xHowever, China is taking aggressive actions to restrict these shipments to theUnited States.xvi
Biomanufacturing
Biominingcouldincreaseextractionofcriticalmineralsherein theUnitedStatestosupportdomesticproduction,includingfor 14 ofthe 35 critical minerals that currentlylack a domestic productionsource.Geneticallyengineeredmicrobesandplantscan helpextractcritical mineralsfrombothdepositsandrecycled materialsthatalreadyexistintheUnitedStates.
Chapter2
Chapter 3
Maximize the Benefits of Biotechnology for Defense
Biology represents the next paradigm shift in how warscanbefoughtandwon.Atthedawnofthe twentiethcentury,theUnitedStatesfellbehindin airpowerdespitebeingthebirthplaceofaviation because it failed to see how airplanes changed the nature of war.Once the U.S.military started recognizingairplanesascentraltoallmilitary doctrine,itreorganized itselftounlockthetechnology'spotential.Forthemilitary,biologycould proveequallytransformative.
Just asthe inventionofflightforeverchanged force projection, surveillance, and logistics, so couldbiotechnologyredefinewhatispossible inmilitaryoperations.
Biology's ability to grow and adapt could revolutionizelogistics.Justas aviation shortened resupplytimesandexpandedforces'operational reach,emergingbiotechnologycouldenablethe on-demandproductionofessential resources suchasfuel,food,andmedicine,reducingthe military'srelianceonvulnerablesupplychains. Suchadvancescouldsimplifylogistics,extendthe operationalrangeofforwardunits,andenhance battlefieldsurvivability.
Biotechnology's impactonsurveillance could besimilarlytransformative.Biologicalsensors could detectpathogensorchemical threatsin realtime,creatingadynamicandresilientsystem
Chapter3
forbattlefield awareness.Asaresult,warfighters wouldbeabletomakefaster,moreinformed decisionsincomplexenvironments.
Biotechnology also promises new advantages in stealthandmobility.Dynamicbiologicalcamouflage,forinstance,couldshieldwarfightersfrom thermaldetection,whilewearablebiosensors couldadjustmissionparametersbasedonreal-timephysiological data.196
Takentogether,these advances demand a fundamental rethinking of how biology supports sustained,agilemilitaryoperations,revolutionizingwhat it means to defend theUnited States, including building for, nourishing, and healing forcesinthefield.Likeaviationbeforeit,biotechnologyrequiresamindsetshift——fromviewing thetechnology asa collectionofseparatetoolsto understandingitasa comprehensiveframework thatshouldtransformthemilitary'sapproachto logistics,surveillance,and operations.
Several Department of Defense (DoD) entities are already working to advance biotechnology. Thisincludestheimportantworkcarried out by theDOD'sOfficeofStrategicCapital(whichworks toattractandscaleinvestmentinbiotechnologies),theDefenseAdvanced ResearchProjects Agency's(DARPA)Biological TechnologyOffice (whichsimulatesthewarfighter'sbiological systems,optimizescombatcasualtycare,and
improves logistics through distributed manufacturing), and the DOD's Tri-Service Biotechnology fora Resilient Supply Chain(T-BRSC)(which is scalingbiomanufacturedproductssothatthe DODwill have alternativesupply chainsforcritical products).197
The Commission identified several key steps that theUnitedStatesmusttaketobuildonthiswork andrealizethefullmilitarypotentialofbiotechnologytogivethenationvitallead timeagainst itsadversaries.TheseincludedefiningDOD principlesforethical use ofbiotechnology,fielding biotechnology at scale across the U.S. military, andpreventingadversaries,especiallyChina, fromusingordevelopingU.S.biotechnology in waysthatthreaten theUnited States and its allies.
Examples of Biotechnology Research in the Army, Navy, and AirForce
AirForce
The AirForce Research Laboratory is studying the gut microbiometolookforindicatorsof stress or fatigue.This information canbeusedtodevelopprobiotics to decreasewarfighterstress and increase alertness.xivi
Chapter3
Army
TheArmy Research Office is developing genetically engineeredbacteria thatglowwhen exposedtochemicalsassociated withlandmines,enablingsafe and remotedetectionofburied explosives.xilii
Navy
The Naval Research Laboratory iscreatingentirelynewtypes of batteries made from biology. Thesebio-batterieshavethe potentialtobemoreportableand lessof afire hazard than traditional lithium-ionbatteries.xlix
Define Department of Defense Principles for Ethical Use of Biotechnology
Maintaining a military advantage with cutting-edge technology is imperative to deterring adversaries and protecting US.national security.But the DOD must accomplishthat task while maintainingastrong commitment toAmerica's values.
3.1aRecommendation
Congress must direct the Department of Defense (DoD) to consult with stakeholders to define principles for ethical use of biotechnology for the U.S. military.
A markoftheU.S.military'sprofessionalism is its commitmenttoAmericanvalues.TheDoDtakes correctiveactioninresponsetopublicoversightofits development and use ofemerging technology.When emergingAlcapabilitiesbegantoenterbattlefield applications in 2018,forexample,the first Trump AdministrationreleasedaDoDstrategythatlaidthe groundworkforthelawful and ethical applicationof this emergingtechnology,culminatingintheDefense InnovationBoard's(DiB)publicationoffiveethical principles forthe department.98 These principles are a sourceofAmericanstrength,promotingtrust, providingguidance,and encouragingaccountability.
Emerging biotechnology has reached an analogous pointinitsdevelopment.TheUnited Statesdoes not and will nevermaintain anoffensivebiological weaponscapability,inlinewithcommitmentsto theUNBiological WeaponsConvention.99Butthis critical red linenolonger sufficientlycaptures the widevarietyofwaysinwhichthistechnologycould beusedtocauseharm,includingbynon-stateactors andU.S.adversaries.
Bymoreclearly definingitsprinciplesforthe developmentand deploymentofbiotechnology,theDOD wouldbettersupportcriticalinnovationswithinthese boundarieswhileallowingtheUnitedStatestolead by example through strengthened norms surrounding this evolving technology.
Defining principles for ethical use of biotechnology will require the DOD to consult with a wide range of stakeholders,spanning industry,academia,civil society,andlocalcommunities.
Aspartofthis effort,theDODshould consider:
biotechnologiesforwarfighterperformance optimization,includingpoliciesoninformed consent,reversibility,andheritabletreatments; and
biotechnologiesthatcould affectthe
environment.
Section 3.2
Field Biotechnology at Scale across the Force
The Department of Defense (DOD) must deploy and incorporate biotechnology into next-generation warfighting capabilities before the United States'adversaries do.Winning thisrace wil require de-risking the domestic production of defense-related biotechnology products, effcientlyconnecting those outputs tocustomers within the U.S.government,and trainingtherelevantworkforce.
3.2aRecommendation
Congress must direct the Department of Defense (DOD) to work with private companies to build commercial facilities across the country to biomanufacture products thatare critical forDoDneeds.
Theprivatesectorwill notbuildcommercial-scale biomanufacturinginfrastructurefordefense-related productswithoutdirectionfromtheDoD.Toaddress thisconcern,theDODlaunched theDistributed BioindustrialManufacturingProgram(DBIMP)in 2024, which supports private industry and develops commercial scalefacilities that fortifydefense supply chains.200
DBIMP targets high-risk components of the military supplychainthatcouldbealternativelyproduced throughbiomanufacturing,suchasrocketpropellant, jetfuel,chemicalsusedforcoatingsonships,and textiles for military uniforms.201 During the program's frstphase,theDOD awarded planninggrants totaling over $$60$ millionto34companies.Located across thecountry—includinginCalifornia,Nebraska, Ohio,Pennsylvania,Tennessee,andUtah—these companies are developingbusiness and technical plansfortheirbioindustrial manufacturingfacilities.202 Importantly,throughtheseawards,DBIMPhas integrated novel companiesintothenation'sdefense industrial base.Inthesecondphase,theDODintends to award upto $$100$ million per company.203
DBIMP is currently funded through appropriations to Defense Production Act (DPA)Purchases,and biomanufacturingisbutoneofmanyusesofthese funds.204The FY25President's Budget requested 125$ millionforthe“biomanufacturingofcritical chemicals,”butasofDecember2024,neither
the House northe Senate appropriations bills included a line item in the DPA for DBIMP.205 Without Congressional action,theDODcould divertDPA fundsto otherpriorities,a movethatwould hollow out of the DBIMP program before it canfund full-scale biomanufacturingfacilities.
Without adequate and reliable funding,DBIMPwill not be able to continue de-risking projects through early-stagedemonstrationsnorwillitbeabletofund sufficientinfrastructureprojects.As a result,theDOD may alsolosevaluablepartnerships.Greaterrisk and longer project timelines mayfurther discourage small companieswithinnovativetechnologiesfromparticipating in these programs inthefuture.
Congressmustsupportthe commercialization of nationalsecurityrelated biotechnologiesbyappropriating at least 762$ million overthe next five years tofund DBIMP.For DBIMP to succeed in the long run, the DoDmust alsobe clear about its requirements and timelines,its communicationwithindustry partners,anditsplansforaligningindustryoutputswith the needsof defensepurchasers.Sustained funding is critical if this program is to continue supporting andde-riskingsomeofthenation'smostinnovative companies,firmsthatarefieldingmission-critical productsandprocessesattheintersectionof national security and emerging biotechnology.
3.2bRecommendation
Congress should continue oversight of and support for BioMADE's efforts to create a network of facilities that precommercial bioindustrial companies across the country can use to meet Department of Defense (DoD) needs.
The Bioindustrial Manufacturing and Development Ecosystem(BioMADE),the DOD's Manufacturing InnovationInstituteforbioindustrial manufacturing,is apublic-privatepartnershipwithnearly300members across37states,includingindustryleaders, academic institutions,andgovernment officials. BioMADE'smissionistoenabledomesticbioindustrialmanufacturingscale-upandcommercialization, developanddeploytechnologiestoenhanceU.S. bioindustrial competitiveness,de-risk infrastructure investments, and expand the U.S.biomanufacturing workforce.206
BioMADE provides a promising model for supporting biotechnology companies that makeupAmerica's defenseindustrial base.Its status asa public-private partnershipfacilitatescollaborationandinformation sharing amongindustry,academia, and government. Theprogram alsoworkswithlocal communitiestoeducate and trainthenextgenerationof biomanufacturers.207
To support these objectives, Congress appropriatedatotalof 400$ millioninfiscalyears82023 and2024forBioMADEtodevelopanetworkof open-access,precommercialbioindustrialfacilities across the country.208 In response to Congressional appropriations,BioMADEannouncedseveralefforts to establish these facilities.209 As of December 2024, however,an issue of statutory interpretation ispreventingBioMADEfrombuildingitsfirstfacility in Minnesota.210 Congress—-through oversight and,if necessary,statutorylanguage—shouldensurethat BioMADE has the authority tospend funds on construction and thatitisusingthosefundstoconstruct facilitiesconsistentwithSection215oftheFY23 National Defense AuthorizationAct(NDAA).211
Congress should workwiththeDoDto ensure that BioMADE is using previously appropriated funds effectivelyandquicklytoestablishfacilitiesasapart ofthenetworkofprecommercialfacilities.Itshould also ensure that the DOD, the Department of Energy (DOE),and the DepartmentofCommerce(DOC) haveclearmechanismsforcollaborationsothat they canleverageinfrastructureacross agencies.lf theseobjectivesaremet,Congressshouldconsider additionalappropriationsinthefuture.
To thatend,CongressshouldrequiretheDODto submitannualreportsthatinclude(ataminimum):
theaveragetimethatittakesBioMADEto executecontracts,fromthetime theorganization closessolicitationsforagrantorcontracttothe timethatthedecisionand associatedfundingare received;
a listofcurrentBioMADEawardees;
all BioMADEgrant amounts,grant purposes, executiontimelines,andbudgetsovertime;and anassessmentofanystatutoryorpolicyhurdles to using Congressionally appropriated funds.
Congressional oversight forthis initiative should include:
siteselectiondecisions,riteria,rocesses,and timelines(criteriashould includediscussionsof operationalmodelsandcompletiontimelines, andapprovalshouldbepeer-reviewed);
grantaward decisions,criteria,processes, timelines,and communicationprocessesfor members(thisselectionprocess should alsobe peer-reviewedfortechnicalfeasibilitybyexternal experts);
membershipinBioMADE,whatmembership provides, and how membership affects usage or paymentforuse oftheinfrastructurenetwork;
thetimeittakesto add newmemberstothe network;and
theestablishmentof mechanismsforinteragency participation,especiallyregardingDOENational Laboratories and current precommercial infrastructure.
3.2cRecommendation
Congress should require changes to military specifications (MIL-SPECs) to enable biotechnology companies to more easily sell their products to the Department of Defense (DOD).
Companies selling biotechnology products may not be abletoselltotheDOD,astheproductsdonot meet military specifications(MIL-SPECs),which serveasacommonlanguagethatensuremilitary productsproducedbydifferentstakeholdersare functionallythe same.22MIL-SPECs arenotintended tofavoronemanufacturingprocessovertheother, butinpractice,manyofthespecificationscanbemet onlywithtraditionalmanufacturing.Asaresult,biotechnologyproductsmaybeunintentionallyexcluded from consideration,and theDODrisksmissingouton criticaltechnologies.
Tomaintainitsedge,theUnitedStatesshould makeit easierfortheDODto:
purchase biotechnology-derived products; adoptbiotechnology-derivedproducts;and maintainitstechnologicaladvantagewhile helping the DODfulfll its mission.
The Secretary of Defense—in consultation with the militaryservices,theUndersecretaryofDefensefor Researchand Engineering,theUndersecretary of DefenseforAcquisitionandSustainment——should releasepublicguidanceonhownongovernment entitiescanprovethemeritofbiotechnologiesand materialsinmeetingMIL-SPECrequirements.
Toensurethatthisguidanceislinked toanefficient andimpartialprocess,Congressshouldalsotask theGovernmentAccountabilityOffice(GAO)with conductingacomprehensiveanalysisofintentional orunintentionalpreconceptions againstbiotechnolOgy and biomaterialsintheMIL-SPECprocess.
Lastly, standards have the greatest utility when they are adopted and applied by many stakeholders. To that end,the DOD should partner with U.S.allies toexplorebroaderinternationalharmonizationof military specifications.
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3.2d Recommendation
Congress should require the Department of Defense (DOD) to enter into advance market commitments (AMCs) and offtake agreements for biotechnology products thatareneeded fordefense.
TheDoDhas not signaled clear and consistent demandforbiotechnologyproductswithdefense applications that meet its existing needs, hindering thescale-upoftheseproducts.Instead,current DODprocurementsresult influctuating demand for emerging technologies such as biotechnology.213 If companies and investors continue todoubt that there will be an end-use market in the DOD, they will notscalebiotechnologyproductsneededfor defense.
Advancemarketcommitments(AMCs)andofftake agreementswould send astrongDoDdemand signalforbiotechnologyproducts,overcomingthe uncertaintyinyear-to-yeardemand thatresults fromdifferencesintheDoD's annual appropriations. There are a number of biotechnology products that could meettheDOD'sneeds.Forexample,theDOD couldusebiobasedconcretetobuildrunwaysor landingpadsorbioremediationtechnologiestobreak down PFAS in water or soil on military instillations.214 Already,theDODhasidentifiedalistofcritical chemicalsthatmayrequiredomesticproductiondue to vulnerabilities in the supply chain,many of which could bebiomanufactured domestically.215
Congressshould directtheDOD touse itsother transaction authorities(OTAs)toestablishAMCsfor biotechnology products that would be produced at scaleintheUnitedStates,meettheDOD'stechnical needs,and arecompetitive oncost,schedule,and performance.CongressshouldalsodirecttheDoD to establishapilotprogramto awardofftake agreements to biotechnology companies.
The DOD has not signaled clear and consistentdemandforbiobased products with defense applications thatmeetexistingDODneeds,hinder ingthescale-upoftheseproducts.
ForAMCs,theUndersecretaryofDefensefor AcquisitionandSustainmentshould:
firstdefinewhichDoDtechnical needscan
bemetwithbiotechnologies such asbiobased concrete,bioremediationproducts,andbiobased chemicals;
designAMCstoinclude agreed-onproduct
prices,specifcations,deliverytimelines,and criteria for evaluation;
designAMCs inconsultationwithtechnical and marketexpertsfrominsideandoutsidetheDOD; exercise OTAs to establish and implement AMCs; reporttoCongressannuallyontheprogressand success of AMCs; and
uselessonslearnedtodevelopandreportto
Congress a strategy for how AMCs and other innovativefinancialtoolscouldbeusedtoprocure biotechnology products that meet U.S.national security needs.
Forofftakeagreements,theUndersecretaryof Defense for Acquisition and Sustainment should:
exercise OTAs to create a pilot Biotechnology Purchase IncentiveProgram to award prizes in the form of offtake agreements to biotechnology companiesforproducts thatmeet theDoD's technical needs,laying out agreed-onprices, specifications,deliverytimelines,and criteria of evaluation; and
report annuallytoCongressontheprogress and successoftheprogramforoversightpurposes and foritspossible extension.
3.2eRecommendation
Congress should require the Department of Defense (DOD) and other agencies involved in national security to train their workforces to be ready for biotechnology.
New technologies and concepts in biotechnology are constantlyemerging,and biotechnologyisincreasingly converging with other emerging technologies, includingAlandquantum.TheDODandintelligence community(IC)workforcemustmaintainanup-todateunderstandingofcriticalandemergingtechnologiestoeffectivelyexecutenationalsecuritypolicy. Tomaximizeeffectiveness,theseeffortsshould reachintothemilitaryservicesandincludetheJoint Staffand combatant commands.
Keeping the government's biotechnology training up-to-dateis especially critical given thefastpace of advances. (For more recommendations on equipping the U.S.government with necessary biotechnology resources and expertise,seeSection5.1.) Currently, however,there arelimitedopportunitiesforfederal employeesworkingon national securityto upskill in biotechnology.
The DOD,theIC,and other agencieswith national securitymandates should upskill theirworkforces inbiotechnology and biosecuritythroughtailored training.Suchtrainingwould helptheU.S.governmentmaintain improved threat awareness andgive employees the up-to-dateknowledge theyneed to make informed decisions about funding and using biotechnology.
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Specifically,Congressshouldrequirethat:
relevantpartsoftheDODandtheICdefinecore competenciesfortheirbiotechnologyandbiodefensepersonnel,includingoutliningrequirements forrefreshertrainingonthelatest advancesin biotechnologyscience,laboratorywork,equipment,and software(theserequirementsshould be informed by corecompetenciesdefined by relevantagencies,suchastheU.S.Department ofAgriculture(USDA)andtheDepartmentof HealthandHumanServices(HHS)(seeSection 5.1b);
theDoDdevelopworkforceeducationand trainingonbiotechnologyforboth uniformed and civilian personnel whose duties involve analyzing, preparingfor,orrespondingtobiological threats;
theOfficeoftheDirectorof National lIntelligence (ODNl)provideeducationalcoursesatthe National Intelligence University (Niu) or other venuestoensurethatintelligenceprofessionals coveringbiotechnologyhaveafunctional understandingof howthefield is advancing;and
theDepartmentofHomeland Security(DHS)— includingCustoms and BorderProtection(CBP), Homeland Security Investigations(HSl),and the Transportation SecurityAdministration(TSA)- as well astheFederal BureauofInvestigation (FBI), develop workforce education and training onbiotechnologyissues,particularlyforpersonnelwhomightencounterinboundandoutbound biologicalsamplesorwhofocusonissuesrelated to illicit technology transfer.
NASEM Report on Research and Development in Biotechnology for Defense Innovation
In additiontotheextensiveoutreachthatthe Commission conducted with external stakeholders,theCommissioncontractedwiththeNational AcademiesofSciences,Engineering,and Medicine (NASEM)to assesstherisks and rewardsofbiotechnology research and development(R&D),with particularfocus on its convergencewith artificial intelligence(Al)andautomation.
Through a seriesof workshops and afinal report, this work emphasized the promise of biotechnology convergingwith othertechnology areas,including recentbreakthroughs and futureinnovations.The NASEMreportlaysouta strategicvisionforoptimizingresearch and innovationatthe intersectionofAl, automation,andbiotechnologyby connecting and coordinatingkeyelementsofthesetechnologies, including robotics,data, compute,and algorithms.
Manyoftheir conclusions and recommendationsare reflected intherecommendations throughout the Commission's own report,showingimportant alignmentofprioritiesbetweenstakeholdersindifferent sectors.
In their main recommendation, NASEM calls for thecreationoftheBiotechnologyCoupledwith Artificial Intelligence and Transformative Automation for LaboratoryYieldingStrategicTechnologies (BioCATALYST)network.Led bytheDepartment of Defense(DoD)andtheOfficeoftheDirectorof National Intelligence(ODNl),thisnetworkwould leverage academicinstitutions,industry,andgovernmenttouseemergingtechnologiestoaddressnationalsecuritychallenges.Thisnetworkwouldinvolve generatingAl-readydatasets,establishingpilottest bedsfortechnologydemonstration,identifyingtechnology transition partners in industry,establishing a researchprogramonethicalandsocietalquestions, and creatinga programforrobust riskassessments.
TheNASEMandCommissionreportssharethe common thread of recognizingthe great potential of biotechnologyfor national security and theimportanceoftakingactionnowtoturnthispotentialinto reality.TheNASEM's report is available here.
Section 3.3
Prevent Adversaries, Especially China. from Using or Developing U.S. Biotechnology for Purposes that Undermine U.S. and Allied National Security
In 1969,the United States took the important step of unilaterallybanningbiological weapons(orbioweapons),stoppingtheoffensivedevelopmentof these capabilities and, shortly thereafter, destroying its bioweapons stockpile.216The UnitedStates subsequentlyled the negotiationsthatresulted in theworldwidebanonthisentireclassofweapons undertheUNBiological Weapons Convention(BWC), signed in 1972.217
Unfortunately,the evidence shows that some parties to that treaty are actively pursuing bioweapons, despitetheircommitmentnotto.TheDepartmentof State(DOS)haspublicly assessed thatbothRussia and NorthKoreamaintainoffensive biological weapons programs that violate the BWO.218 The departmenthasalsoassessed thattheChineseCommunist Party(CCP)—whosestrategyofMilitary-CivilFusion (MCF) blurs the line between commercial and military applications of many technologies—is conducting dual-useresearchactivitiesthatmayalsoviolatethe BWO.219
While non-state actorshavefewerresources and operational capabilities thangovernments,their potentialtoexploitbiologytocauseharmremains deeplyconcerning,underscoringtheneedforthe United States to develop defensive technologies.220
To protect against adversaries'misuse of biotechnology,theUnitedStatesmustbe abletodetectand characterizethewidestpossiblearrayofbiological threats and do so early.Only then can the U.S.governmentrespondeffectivelytoabiologicalincident, whetherthatmeansdevelopingvaccinesagainst thepathogenorshiftingthemanufacturingofother countermeasures into highgear.To attain this ability, theDODshould deployadetectioncapabilitythatis scalable and pathogen-agnostic,coordinating this effort acrossgovernment agencies.
Tocomplementtheseefforts,theU.S.government mustuseall the technologyprotectiontoolsit has toblocktransactionsthatcouldharmU.S.national security,includingthroughforeigndirectinvestments (see recommendation2.5c).Atthe sametime,it must recognize thatthereisnoone-size-fits-allapproach.
Regulatingatthefrontieroftechnologyisdifficult, particularly in biotechnology,given the nascent natureofmanyofitssubfields.TheAdministration mustlegislateoutbound investmentrulestoensure thatU.S.capitaldoesnotcontributetoChinese biotechnologydevelopmentsthatcouldpose a national securityrisk.Itmustalso adoptaflexible approachtobiotechnology exportcontrols and be willingtodeploytheminareaswheretheycouldhave a strategic effect,includingonacountry-widebasis, but also closely scrutinize their efficacy.
To protect against adversaries' misuse of biotechnology, the United States must be able to detect and characterize the widest possible array of biological threats——and do so early.
3.3aRecommendation
Congress must require outbound investment rules that ensure U.S. capital does not support Chinese development of certain biotechnologies that could pose a national security risk.
The U.S. government currently lacks a clear understandingofU.S.investmentsintheChinese biotechnology sector and thus is ina poorposition to makeinformedpolicy decisionsinthis area.Experts sharedwiththeCommissionthatapproximately20 percent of transactions involvingU.S.investment in China donotreportfinancial values.Thisisamissed opportunitytolimit flows of Americancapital into Chinese biotechnology companies in areas that pose strategicrisks.Moreover,recipientsofU.S.capital alsoreapintangiblebenefitssuchasaccesstotalent networks,management support,markets, and additional financing,bolsteringtheir abilitytooutcompete U.S.firms.
InCongress,variousbillshavesoughttoestablish outboundinvestmentnotifications.Ifpassed,the Outbound Investment Transparency Act of 2023 wouldrequireU.S.investorstonotifytheDepartment of Treasury (Treasury) of certain outbound U.S.investments in "covered sectors" (i.e., semiconductors, Al,quantum,hypersonics,satellite communications, andnetworkedlaserscanningsystemswithdual-use applications)to“countries of concern."22 Another bill, the Preventing Adversaries from Developing Critical CapabilitiesAct,wouldrequirethePresident toidentifycategoriesoftechnologiesandproducts in"covered sectors"that may pose a threatto the national security oftheUnited States.222
Theexecutivebranchhasalsotriedtoaddressthis problem.InAugust2023,theBidenAdministration issuedExecutiveOrder14105on"AddressingUnited States Investments in Certain National Security TechnologiesandProductsinCountriesofConcern, whichdirectstheTreasurytoestablish a program
to prohibit or require notification of certain types of outbound investmentsforthree categoriesof nationalsecuritytechnologies:semiconductorsand microelectronics,quantum informationtechnologies, and artificial intelligence.223
None of these efforts have included biotechnology, however.Congressshouldlegislateoutboundinvestmentsrules,includingthemandatorynotificationof outbound U.S.investmentsinrelevantcategoriesof biotechnologies andproductstocountriesofconcern,and include biotechnology as a covered sector for mandatory notification.These requirements would ensure that U.S.capital does not support Chinesebiotechnologydevelopmentinareasthat pose significant national security risks, including thosethatwouldcreateorexacerbatesupplychain dependencies.
Oneyearafterenactment,theSecretaryofthe Treasury should provide a report to Congress that includes information collected from the mandatory notificationrequirementtoinformpotentialfuture measurestoscreenand/orprohibitfutureoutbound biotechnology investments.
3.3bRecommendation
Congress should direct the Department of Commerce (DoC) to consider country-wide export controls blocking the sale of specific, highly sophisticated U.S. biotechnology items to China that would pose a substantial risk to national securityifusedformilitaryend-uses.
Exportcontrolsareanimportanttoolforrestrictingthe misuseoftechnologies.Controlsonbiotechnology-related itemshavelargelybeenharmonizedinternationally throughtheAustraliaGroup,anassociationof42 like-minded countriesfocused onmonitoringtheglobal flow of goods and technologies related to chemical and biological weapons.
These controls workbest when goods and technologies flowthroughavulnerablechokepointandwhenthere isawindowoftimewhereinrestrictingthatchokepoint providesastrategicadvantagetotheUnitedStatesand itsalliesandpartners.Thesecontrolsalsoworkbest whenthereisasmall,well-definedgroupofcountriesand companiesthatcandevelopatechnologyandwhenthey allagreenottoprovidethatcapabilitytocountriesthat cannot developit.Butthe currentexportcontrol system reliesheavilyoncase-by-caseandactor-by-actor assessmentsthatfocusonend uses and end usersof concern.This approach makesit extremely challenging topreventtheflowofsensitiveitemsbecausestate and non-state actorscanobfuscatetheintended end use or divertgoodstoend usersofconcern.224Exportcontrols are an essential part of the U.S.technology protection strategy,buttheycanbe,andarebeing,circumvented.
The United States took a significant step in rethinking exportcontrolsinthecurrentgeopoliticalenvironment with its October 2022limits onthesale ofcertainsemiconductortechnologytoChina.Manyofthesecontrols wereenactedonacountry-widebasis,meaningitdidnot matterwhichparticularentitywithinChinawasrequesting the items.In light of the CCP's MCF strategy,the BidenAdministrationupdated thesecontrolsinOctober 2023 to also apply to any China-headquartered entity, no matterwhereintheworlditisoperating.Thesebroadly appliedbuttightlyscopedcontrolsweredesignedto provide a window of time to slow China from militarizing semiconductortechnology.Andbecausechipproduction reliesonaccesstoextremelyspecializedequipmentproducedonlybyasmall numberofalliedcountries-itis very difficult forChinatoindigenize.Because ofthis,the United States can stillrespond.
Biotechnology is very different.Muchof itsvalueresides in thingsthat are noteasilycontainedbyexport controls, such ashuman capital,biological data, intellectual property,andindustrialprocesses.Aspectsthatarecontrollable,likespecificequipment,willikelynotgivetheUnited States asmuchtime respond asinthe case of semiconductors.Atthesametime,theDoCneedstodevelop agileexport controlstomitigate thethreatofadversaries usingemergingbiotechnologytodoharm.Therefore, the DoC will need tobe not just more aggressive in employingexportcontrolsforemergingtechnologieslike biotechnologybut also nimblerinremovingcontrolsthat are nolongereffective.Goingforward,theDoC should considercountry-wideexportcontrolsthatblockthesale of specific,highlysophisticatedU.S.biotechnologyitems to China.
Tobeeffective,suchcontrolsshouldbe:
specific in the items it governs;
abletogive theUnited States andkeypartnersthe windowstheyneedtosecureadvantages;and
coordinatedwithpromotionmeasures,suchas
enabling domestic firms totap into the proposed IndependenceInvestmentFund(see section2.2a),to ensurethatdomesticcompanies,particularlysmall andmediumenterprises,canmaintainviabilitywhile controls are in place.
Makingcountry-wideexportcontrolsmoreagilewill require a newtypeof relationshipbetweenthegovernmentandindustry,especiallywithsmallerenterprises. It willrequirethe private sectortoworkproactively and ingoodfaithwiththegovernmentandshareinformation abouttheleadingedgeoftechnologyinordertoassist withcraftingmeaningfulcontrols.Itwillalsorequirethat the government ensure that the controls are in place only aslong asthey arestrategicallyhelpful.
Additionally,giventheglobal natureofthebiotechnologyindustry,alliesandpartnerswill needtoconsider the threatof China'sdiversion andmisuseofdual-use biotechnologyequipment.They will need to implement controlsinpartnershipwith theUnited States,thereby collectivelycontrolling equipment of concern on a country-wide basis.
3.3cRecommendation
Congress should require the Department of Defense (DOD) to incorporate mili tary-relevant applications of emerging biotechnology into wargaming exercises.
Biotechnologicaladvancementshavethepowerto fundamentallyalterthewayfuturewarsarefought and won,leavingtheUnitedStatesvulnerableto strategicsurpriseasadversaries'useofbiotechnology rapidly evolves.To ensure that theU.S.military remainsreadyforalleventualities,theDoDshould ensurethatwargamingexercisesincorporate the effectsofemergingbiotechnologies.
U.S.Joint Staff wargaming efforts, such as the annual Globally Integrated Wargames,focus ontesting multi-domainoperationsandexplorehowdifferent militaryforcescanbesynchronizedtocounter emerging threats.225 Incorporating biotechnology into suchwargames,theJointStaff and combatantcommandscouldsimulatescenarioswhere,forexample, biotechnology-enabledenhancementsimproved warfighter performance.Doing so would help the U.S. militarybetteranticipateboththestrategicchallenges and opportunities posed byadvancements
in biotechnology and ensure that it is considered alongsideothercriticalandemergingtechnologies suchascyber and Al whenshapingmilitarydoctrine and operations.
Byincorporatingbiotechnologyintowargames,the military andDoDcivilianscouldbetterunderstand howthelatestbiotechnologicaladvancesmightinfluencetactics,logistics,and force structures,aswellas howtocounteractbio-basedthreats.Thisproactive approachwouldhelptheU.S.militarystay ahead of adversaries in anerawhenbiological innovations could play a central roleinstrategicoperations, ensuring a moreresilient and adaptiveforce.
Theseeffortsshouldbeundertakenincoordination with theOffice of Global Competition Analysis (OGCA) (see recommendation1.3a)to couple wargamingexerciseswithoutsideanalysisandother available foresight tools.
3.3dRecommendation
Congress should resource the intelligence community (IC) to prioritize understanding adversaries' development of biotechnology and its diverse applications.
Ensuring that the United States'threat awareness keepsupwithbiotechnologicaladvancements startswithequippingagencies at thefront linesof evaluatingthesedevelopmentswiththerighttools and resources. In practice, that means making certainthatCongressionaloversightcommittees are informed onthe IC'sevolvingneeds.Congress should require theCentral IntelligenceAgency(ClA), theDefenseIntelligenceAgency(DlA),theFBl,the National Security Agency (NSA), and the ODNI to periodicallybriefrelevantCongressionalcommittees abouttheresourcestheyneedtoanalyzepotential threatsfrombiotechnology.Thisbriefwouldinclude a discussion ofthe tradeoffsthatmay occurif resources aredivertedfromcompetingprioritiesto addressthreatsrelatedtobiotechnology.Already, Congress has undertaken some efforts on this front, including passinga provisioninthe2025NDAA requiring theIC to developa strategyfor countering the waysforeign adversaries use biotechnology.226 The Commission encourages the IC to develop and implementthisstrategy expediently.
Biotechnology Tech Hubs: Driving Economic Growth Across the Country
Technology hubs are a proven way to drive local economic development and forge partnerships acrossgovernment, industry,andeducationalorganizations.Forexample, theNorthCarolinaBiotechnologyCenterhascatalyzed investmentfor40years,growingalocalindustrythat directly employs75,000 people.Building on this model,the DepartmentofCommerce(DoC)launchedtheRegional Technology and Innovation Hubs(Tech Hubs) program in 2023,authorizedbytheCHIPSandScienceAct.Tech Hubs invest inAmericancommunities,funding programs thattargetcriticaltechnologyareas.Theyaimtoscale Americantechnology and discoveries locally,build globally competitivemanufacturing centers,and createwell-paying jobs.
The Tech Hubs program is a recognition that local communitiesbestunderstand whattheyneed togrow. That is why Tech Hubs are public-private partnerships, bringingtogether academia, state and localgovernments, andprivateindustrytomosteffectivelyusefederalfunding to discover,mature,and commercializegroundbreaking technologies.
The 31Tech Hubs,representing communities across America,willead a newera oftechnological innovation. 11 tech hubs focus on biotechnology,such as converting corn into chemicals, advancing biologics in medicine, and developing artificial intelligence(Al) applications for biotechnology.
In2024,theD0C announced over $$500$ million in grants for Tech Hubs.Each Tech Hub provides funding ranging from $$20–55$ million for regional consortia to spend on infrastructure,workforce,and commercializationefforts. This initial fundingjumpstarts regional growth while promotinganorganizationthatreducestheneedfor continuous federal funding.
If the United States is going to capture the opportunities that biotechnologyand biomanufacturing present,Tech Hubs across the country willead the way.The future of biotechnologyislocal,buttheimpactwillbeglobal.
Biotechnology Tech Hubs: Driving Economic Growth Across the Country (continued)
Advanced Pharma ManufacturingTech Hub(VA)
ReGen Valley Tech Hub (NH) \*
iFab Tech Hub(IL)\*
Kansas CityInclusiveBiologics and
Biomanufacturing Tech Hub (MO and KS)
Heartland BioWorks (IN) \*
PRBioTechHub(PuertoRico)
WisconsinBiohealthTechHub(Wl)\* BaltimoreTechHub(MD) Birmingham Biotechnology Hub (AL) GreaterPhiladelphiaRegionPrecisionMedicine Tech Hub (PA,DE,MD, and NJ) Minnesota MedTech 3.0 (MN and WI)
Tech Hub Highlights
Alabama
Birmingham Biotechnology Hub
Mission
Investment
Impact
Enhance drug discovery,vaccine development,anddiagnosticswith artificialintelligence-drivenbiotechnology.lmprovetheefficacyof biotechnologyproducts by increasingthediversityofgeneticdataand clinical trials.
Eligible forfuture funding.Proposals includea lifesciencesincubator, venturepartnerships,secure biobankdatasharing,andAlabama's first Innovation District.
Proposed planswould advance precisionmedicinetechnologies, with initiatives to create jobs and boost the regional economy.
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linois
llinois Fermentation and Agriculture Biomanufacturing Tech Hub (iFAB)
Mission
Investment
Impact
Biomanufacturing&Precision Fermentation-Turncornfeedstocks intovaluableproductslikechemicals,materials,proteins,andfood ingredients using existing agricultural infrastructure.
51$ million to upgrade and expand existinginfrastructure,attract partners, and develop the critical workforce.
Overthenextfiveyears,estimatedto create thousands of new jobs.
Indiana
Heartland BioWorks
Mission
Investment
Impact
Strengtheningdomesticbiotech manufacturing by developing and commercializinghealth-related bioproducts.
51$ millionforworkforce development,andforearly-stageinnovators, amongotherinvestments.
Createthousandsofnewjobsand 2.6$ billioninadditional annual economic output. Part of the funding willbereinvestedintheregion,with workforcedevelopmentinitiativesto supportstartups.
NewHampshire
TheReGenValleyTechHub
Mission
Investment
Impact
Developcost-effectiveregenerative therapiesthataddresschronic diseases and organfailure.Because thisTechHubisledbytheAdvanced RegenerativeManufacturingInstitute (ARMI), a Department of Defense (DOD) Manufacturing Innovation Institute,therewillbeacloserlink between private sector and DOD forneedsinregenerativetherapies tobeclearlycommunicatedtothe community.
44$ million to advance biofabrication infrastructure,raiseawarenessof regenerative therapies,and trainthe criticalworkforce.
Projectedtocreatethousandsof jobs,increaseregionaleconomic productionby 5% by2032,and reducehealthcare costs with theuse ofregenerative therapies.
Out-lnnovate Our Strategic Competitors
Toensurethatthebestresearchintheworld continuestohappenintheUnitedStates,the nationneedstoreinvigorateitshistoricstrengths in innovation.America'stechnologysectorhasa rich history of ambitious research ideas turning intopathbreaking discoveries.TheU.S.-led HumanGenomeProject,forexample,wasfueled byambitiouspublicinvestmentandledtoentirely newmarkets,startingacascadeofinnovationthat continues to shape biotechnology today.227
Thefollowingsectionsincluderecommendations toguaranteethattheUnitedStatesoutpacesits strategiccompetitorswhileensuringsafety,security, and responsibility inbiotechnology innovation bothathomeand abroad.Thischapterexplains whyandhowtheUnitedStatesmusttreatbiologi cal data as a strategic resource, solve challenging researchproblemsbeforeitscompetitors,and protect against the misuse of biotechnology.
While the United States currently leads in biotechnology research and development (R&D), that lead is slipping. The United States is not meeting the moment for biotechnology because it lacks a mechanism for prioritizing high-quality data collection, sufficient support for innovative research ideas, and adequate instrumentation, facilities, and capabilities.
Section 4.1
Treat Biological Data as a Strategic Resource
Biological data lie at theheartofemergingbiotechnologiesand aredefinedbytheNational Instituteof Standardsand Technology(NiST)as"theinformation,includingassociateddescriptors,derivedfrom the structure,function,orprocessofabiological system(s)that is eithermeasured,collected,or aggregated for analysis."228
Biologicaldataincludeawidevarietyofhumandata as well as datafrom animals,plants,fungi,bacteria, andvirusesthatcomprisetherichbiological landscapeoftheUnitedStates.Thesebiologicaldata enablescientiststodiscover,design,and optimize everythingfromindividualcomponentsofcellstothe behavior of whole groups of organisms to the inputs and outputs of biomanufacturingprocesses.
Biological data are especially important for unlocking Al's potential. Just as large language model (LLM) chatbotssuchasChatGPTaretrainedonvast amounts of text from the internet,biological design tools and scientific language models are trained on trovesofbiologicaldatafromresearchefforts.
IftheUnitedStatesistocement itsgloballead inbiotechnology, it must domoreto develophigh-quality data.The country has failed to provide high-quality data in a usable way, address gaps in data holdings, investinautomatedbiologicaldatacollection,or build theinfrastructureneeded toensurethatthe UnitedStatesfullyleveragesitswealthofbiological data.Thefederalgovernmenthasevenfailed to maximizethescientificdiscoveriesandinnovations alreadyheld initsexistingcollections of biological
specimens.U.S.natural history collections alone houseanestimated800millionto1billionbiological specimens,ripeforopportunitiestocollectdifferent typesofbiologicaldata,includinggenomicdata,but the samples are mostly untouched byresearchers.229
China's approach to biological data involves accessingandexploitingpubliclyavailabledatafromaround theworld,includingfrom theUnitedStates,while harvesting its own domestic datasets and closing them offto the rest ofthe world.230 This approach gives China an asymmetric advantage in exploiting biological data and highlights itslack of data-sharing reciprocity.Many Chinese Communist Party (CCP) policiesexplicitlystatethatthegovernmentintends toprioritizethecollectionanduseofbiological data, as do statements from China's medical Al industry.231 Accordingly,the U.S. government must ensure that China cannot obtain bulk and sensitive biological data from theUnited States.
U.S. natural history collections alone house an estimated 800 million to 1 billion specimens, ripe for research and discovery but mostly untouched by researchers.
