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APRIL2025
REPORTSUMMARY
Charting the Future of Biotechnology
An action plan for American security and prosperity
Table of Contents
Message from the Chair and Vice Chair 4
Executive Summary 6
Introduction 18
What Is Biotechnology, and How Will t Shape America's Future? 18
China's Vision for Biotechnology 25
The United States Is Falling Behind in Key Areas 26
China Is Closing the Gap 28
The United States Must Win the Biotechnology Race 32
About the Commission and Report 34
Commission Background 34
Report Methodology 36
Report Scope 36
Next Steps 37
Recommendations 38
Chapter1: PrioritizeBiotechnology at the National Level 42
1.1 Establish a National Biotechnology Coordination Offce 44
1.2 Elevate Biotechnology Across the Executive Branch 46
1.3 Establish the Office of Global Competition Analysis and Include Foresight Capabilities 47
Chapter 2:MobilizethePrivateSectortoGetU.S.ProductstoScale 50
2.1 Simplify Regulation for American Biotechnology Companies 53
2.2 Attract and Scale Private Capital to Support Biotechnology 62
2.3 Scale U.S.Innovations 68
2.4 Protect Critical Biotechnology Infrastructure 74
2.5FightBackAgainstChina'sBruteForceEconomicTactics 76
Chapter3:Maximize theBenefitsofBiotechnologyforDefense 81
3.1 Define Department of Defense Principles for Ethical Use of Biotechnology 83
3.2 Field Biotechnology at Scale across the Force 84
91
Chapter 4:Out-Innovate Our Strategic Competitors 98
4.1 Treat Biological Data as a Strategic Resource 100
4.2 Block China from Obtaining Sensitive U.S.Biological Data 11
4.3 Launch Grand Research Challenges to Unlock Leap-Ahead Capabilities 12
4.4 Protect Against the Harms of Biotechnology 116
Chapter 5: Build the Biotechnology Workforce of the Future 122
5.1 Equip the U.S. Government with Necessary Biotechnology Resources and Expertise 126
5.2 Support Job Creation Across the United States for Americans at AllSkill Levels 131
5.3 Attract and Retain Trusted Foreign Talent 134
Chapter 6: Mobilize the Collective Strengths of Our Allies and Partners 138
6.1PromoteBiotechnology with U.S.Allies andPartners 140
6.2 Protect Biotechnology with US. Allies and Partners 145
Appendices 147
Appendix A: Technical Glossary 147
Appendix B: Acronyms Found in this Report 149
Appendix C: More Details on Biological Data Standards (4.1) 152
Appendix D: More Details on Grand Challenges for Biotechnology (4.3) 153
Appendix E: More Details on Equipping the U.S. Government Workforce (5.1) 157
Appendix F: More Details on Supporting American Job Creation (5.2) 160
Appendix G: More Details for Promoting Biotechnology with U.S. Allies and Partners (6.1) 162
Appendix H:Five-Year RecommendationFundingTable 163
Appendix : Acknowledgments 168
References 175
3
Message from the Chair and Vice Chair
We stand at the edge of a new industrial revolution, one that depends on our ability to engineer biology. Emerging biotechnology,coupled with artificial intelligence, will transform everything from the way wedefendandbuildournationtohowwenourishand provide careforAmericans.
In 2022, Congress charged the National Security CommissiononEmergingBiotechnology(NSCEB) withdevelopingrecommendationstoadvanceU.S. leadershipinbiotechnologyfornationalsecurityand economicresilience.Whatfollowsthisletterisan actionplanthat,ifexecutednow,willunleashprivate sectorjobcreationineverycornerofourcountry, reshoremanufacturing,andfreeusfromsupplychain dependenciesonChina.ItwillensuretheUnited States——not China—endures asthebestplacefor biotechnology discovery,invention,and entrepreneurship.And it will helpkeepouradversariesfrom usingthispowerful technologytogainbattlefield advantage or geopolitical leverage.
In1903,abronzeplaquewasplacedonthepedestal of the Statue of Liberty describing"A mighty woman with a torch,whose flame is the imprisoned lightning? The task before us is to unlock the unparalleled power andpotential ofAmericancreativity and innovation—our nation's imprisoned lightning——to achieve enduringglobaltechnological leadership.
America has led in biotechnology since the 1970s, but thelandscapeisrapidlychanging.Alittleovera yearago,weassertedthattheUnitedStateswasstill ahead,despiteconsiderableeffortsbythePeople's Republic of Chinato surpassus.We nowbelieve the United States is falling behind in key areas of emergingbiotechnology as China surges ahead.
Congresswisely created ourgroup ahead ofbiotechnology's coming inflection point. There is time to act, butnotime towait.
ItisaprivilegetoleadourfellowCommissionersand talentedstaffinthiswork.Weextendourdeepest thanksto all who contributed to thedevelopmentof theserecommendationsandtothosewhowillhelpus achieve this visionforthe American people.
Senator Todd Young Chair
Dr.Michelle Rozo Vice Chair
Outreach Map: Biotechnology is Everywhere
Once clustered onthe coasts, American biotechnologyis becoming a nationalindustry of internationalimportance. To assess emerging biotechnology, we met with thousands of experts and stakeholders across nearly everystate andcontinent.Wpok withfarmer,cientists,entreneur,engineer,general,cholard regulators.evevisitdlabfatorislsspitalsndasesftheseperpectiveshaventribut ourrecommendations.
Outreach 0 Visit
National
Global
Executive Summary
Americans arealreadyfamiliarwith howtheChinese governmentconductseconomicwarfarewithcrucial technologiessuchassemiconductors:cornerthe supplychain,thenchokeittoweakentheUnited States.ButthisisnotthelasttimeBeijingwill run this play,and it isnoteventhemostdangerousversionof it.
Imagine a not-so-distant future whereresearchers inShanghaidevelopabreakthroughdrugthatcan eliminatemalignantcells,effectivelyendingcancer asweknowit.ButwhentensionsoverTaiwanreach a breaking point,the Chinese Communist Party (CCP),the strategic apparatus ofthe Chinese government,hoardsthetreatmentundertheguise of national security,cuttingoffsupplytotheUnited States.Afteryears of access,this lifesavingdrugis immediately in shortage,requiringdoctorstoration it whileAmericanbiotechnologycompaniesscramble toreconstituteproductionintheUnitedStates.The streetsandsocialmediaoverflowwithpeopledemandingthattheUnitedStatesabandonTaiwan.The Administrationfacesanagonizingchoicebetween geopolitical priorities and public health.
Thisscenario is fiction.But something like it could soonbecomerealityasbiotechnologytakescenter stageintheunfoldingstrategiccompetitionbetween theUnitedStatesandPeople'sRepublicofChina (China).
Based on two years of research and consultation with private and public experts, this report comes to a sobering, even frightening, conclusion: China is quickly ascending to biotechnology dominance, having made biotechnology a strategic priority for 20 years. To remain competitive, the United States must take swift action in the next three years. Otherwise, we risk falling behind, a setback from which we may never recover.
Biology hasbeen a well-defined scientificdiscipline formorethan200years.Butthankstobreakthroughs in artificial intelligence (Al), engineering, and automation,biology isbecomingmorethanjust a field of discovery; it is becoming a field of design. Chemistrymadethisleapinthe1880swhenchemical engineeringunlockedrubber,plastic,andsynthetic fibers,materialsthattransformedsociety.Physics followed inthe1940s,whenacademic theoryled to theatomicbomb,semiconductors,andcomputers. Nowforthe first time inrecent history,the United Statesfinds itself competing with a rival overa new formofengineeringthatwillcreatetremendous wealth,but,inthewronghands,couldbeusedto developpowerfulweapons.Countriesthatwinthe innovationracetendtowinactualwars,too.
We are entering the age of biotechnology,a time whenbiologyisthebasisofinnovation.Frommore productiveseedsandtargetedcancertherapies tothepossibilityofgeneticallyenhancedsoldiers, biotechnology'sreachextendsfarbeyondthe laboratory. Every strategic sector—including defense,healthcare,agricuture,energy,andmanu facturing—canbeadvanced bybiotechnology,but alsobreachedbyit,too.Thesearenotjustmattersof scientific achievement;theyarequestionsof national security,economicpower,andglobalinfluence.
Falling further behind would signal a global power shifttowardChinaandcreateanarrayofnewstrategic challengesfortheU.S.government:
WhatwoulditmeanforworldorderifChina developedbiologicalmeansfordramatically extendinghuman lifeorenhancingcognitive capabilities?
Whowill controlthebiological intellectualproperty (IP),from sustainable energyto advanced agriculture,thatmayproveasvitalinthe21st centuryasfossilfuelswereinthe2oth?
Whatwould theimplicationsbeforglobal securityifanadversaryengineeredpathogens and used them againstus?
China's recent success across core biotechnology capabilities,includingAl-driven drug discovery platforms and biomanufacturing, signals that they may sooneclipse us.And ifthathappens,theUnited Statesmayneverbeable tocatch up.Inprevious generations,wemighthavehaddecadestomaintain ourlead,butnow,thewindowto act isjustyears.
Al is accelerating us toward this inflection point. Using toolssuchasAlphaFoldfromGoogle'sDeepMind, scientistshavepredictedhundredsofmillionsof intricate3Dproteinstructures,providingadeeper understandingofbiology.Whatoncetookmonthsor evenyearscannowbedoneinaweekend.WithAl, alongwithgeneeditingtoolslikeCRISPR,scientists willsoonbeabletocreatematerialsfromscratch, preventillnessesatthelevelofgeneticcode,and developmoreresilientcropsandlivestock.
Though the United States'advantage was once thought unassailable, China has emerged as a powerhouse in Al-enabled biotechnology.For example,theCEOofChinesetechnologygiantBaidu alsoestablishedBioMap,a lifesciencesandAlfrm with offices inBeijing,Suzhou,HongKong,andPalo Alto.4BioMapannounced thefirstlifescienceAl foundationmodeltohit100+billionparameters, whichitcallsthelargestofitskind.In2024,BioMap signedanagreementwiththeHongKongInvestment Corporation, a government-owned fund, to launch a bio-computinginnovationacceleratorprogramin HongKongtodevelop thebiotechnologyecosystem there.It and otherbiotechnology companiesuse Altodesignbiologicalproducts.Companieslike thesethenworkwithChina'sleadingbiomanufacturer,WuXiAppTec,toproducethematscaleinits global networkoffacilities.WuXiAppTec,whichhas transferredAmericanIPtotheChinesegovernment, manufacturesessentialingredientsforwidelyused medicationsthattreat leukemia,lymphoma,obesity, and Human Immunodeficiency Virus(HiV).7
China has longbeenproficient at acquiring IP fromabroad—throughbothlegal channels(such asmergers and acquisitions) and illegal channels (such astheft).Now it knows howto put that IP to workthroughstate-backedentities.Amultinational company invents akey drug,a national champion like WuXi AppTec scales it up, and then the CCP can controlaglobal supplychain.Chinahasaccomplished this feat through massiveinvestmentsin itsdomestic biotechnologysector,includinga400-foldincrease in biopharma R&Dspending,overthepast decade.8 NationalchampionslikeWuXiAppTechavebenefited greatlyfromsuchgovernmentsupport.313Nowwith 38,000employeesandalmost$6billioninrevenue in2023,WuXiAppTechasbecometheHuawei equivalent for biotechnology.9 In 2024, an industry tradegroup surveyed U.S.biopharmaceutical companiesandfoundthat79percentofthosecompanies dependonWuXiAppTecandotherChina-based
companiesforatleastsomecomponentoftheir manufacturing.Asprecisionmedicineadvances,itis likelythatsuchdependencewillonlygrow.
This situation isexactlywhat the CCPwants.The Commission'sresearchindicatesthatChinaislikely tofollowthesameplaybookwithbiotechnology as ithaswithotherstrategictechnologies.First,they steal.Then,theyscale.Oncetheyhavecornered themarket,they strangle.
In late 2024, China cut off U.S.access to gallium and germanium,jeopardizing U.S.semiconductor production. According to the U.S. Geological Survey (USGS),acompleterestrictionofthese mineralsby China could slash U.S.GDPby$3.4billion.2But the economicdangeroflosingthebiotechnologycompe tition is muchgreater.
Whatwould itmeanfortheUnitedStatesand the worldiftheCCPgainedcontroloffoundationaltechnologiesinkeysectors,fromagriculturetomedicine to energy and defense?
The Commission has everyreasontobelievethat the CCPwill weaponizebiotechnology.China already deploysgenomicsurveillancetoidentify,track,and control UyghurMuslims,partofanextensivesystem oftechnologyenabledgenocide.In2018,anostensiblyrogueChinesescientistproducedgenetically modified babies and thoughbrieflyimprisoned,is alreadybackinthelab.4Now,withitsMilitary-Civil Fusion(MCF) strategy,the CCPaimstousebiotechnology-poweredtroops(itcallsthishuman-machine teaming"intelligentwarfare")tomakethePeople's Liberation Army(PLA) a"world-class military"by 2049.15Dronewarfarewill seemquaint if wearefaced withgeneticallyenhancedPLAsuper-soldierswith fused human and artificial intelligence.
AttheoutsetofWorldWarl,theUnitedStatesdid notyetfully appreciatehowairplaneswouldrapidly changethenatureofwar.Butonceweunderstood thesignificanceof aviationforforceprojection, reconnaissance,logisticalsupport,andbeyond, wedominatedtheskies.Similarly,thefullimpactof thebiotechnologyrevolutionwill notbeclearuntil it arrives.Butone thingiscertain:itiscoming.There will be a ChatGPT moment for biotechnology, and if China gets there first, no matter how fast we run, we will never catch up.
Ourwindowtoactis closing.Weneed atwo-track strategy:makeAmericainnovatefaster,andslow China down.
Onthehomefront,biotechnology holdsimmense potentialforimprovingthelivesofeveryday Americans.Aftertwoyearsofassessingthelandscape,weestimatethatby2030,mostpeopleon theplanetwillhaveconsumed,used,worn,orbeen treated by a product of emergingbiotechnology. By2035,biomanufacturingwillbeusedtoonshore theproductionofcritical chemicals,securingsupplychains andsupportingnewjobs.Bythe2040s, wewillhavehighlyaccuratebiosensorsthatcan monitorpersonalhealth,fitness,andnutrition,and enablepersonalizedtreatmentplanstodramaticallyimprovehealth.By2045,fewerpeoplewilldie fromheartdisease,thankstocelltherapyandthe 3Dprintingoforgansfortransplant.Bythe2050s, wewillbeabletocollectraremineralsfromthe moonandMars,usingroboticmissionstobiomine in space.
An American-led future of biotechnology can bring all ofthishome.Sohowdowerealize thisfuture?
The United States should not try to out-China China;that is a losing strategy.Instead,we must leanintoourinherentstrengths.Ouropeninnovationecosystemattractstoptalentfromacross theglobe,andAmerica'scapitalmarketsremain fourtimes larger than China's.Weunderstand thatinnovationneednotcomeatthecostof safety,security,andresponsibility.Wearehome tomanyoftheworld'sleadingpublicandprivate research institutions,withmorebiotechnology patents,companies,andNobelPrizewinnersthan any other country.!Modernbiotechnology is an Americaninnovation.
This is not about our ability torunfast;it is about us trippingoverourownshoelaces.WhiletheUnited States innovates better than any other country in theworld,wealsomakeitunnecessarilydifficultto commercializeandscaleourbestideas.Weneed a“private-public"partnership for biotechnology, driven by industry incollaboration withgovernment. By couplingsupply-side incentivestodriveR&Dand initial growth with targeted demand-side signals to reduceinvestmentrisks,thefederalgovernmentcar unleashprivatesectorcapitaltodriveaworld-class biotechnology industry.
Slowing China's progress requires ending our own willful blindness to itsbiotechnology ambitions.We mustdefendourbiotechnologyIPanddataagainst Chinese state-sponsored corporate espionage, evenifitmeansrejectinganattractiveinvestment. WemustnottreatChinese state-runcompanies as ordinarycompetitorsinourmarket,evenifitmeans usingmoreexpensivealternatives.Chinadoesnot havearighttoAmericanresearch—period.
The choice is stark: do nothing and accept defeat, or act swiftly and give America a fighting chance.
Executive Summary
The Commission's main recommendation is this: the U.S. government should dedicate a minimum of $15 billion over the next five years to unleash more private capital into our national biotechnology sector.
Any smaller amount risks hamstringing U.S. inovation and product development.The advancement ofU.S. biotechnolgyrequiresabalanced approach,fostering competitionwithout picking winners, while alsoleveling the playing feld byblunting China's non-market actions.While ingenuity thrives onfree enterprise, the pressures of quarterly earnings candiscourage companies frommaking bold technologicalleaps.The government's role s not to createa sluggish bureaucracy, but rathertounlock private capitaland streamline regulation,empowering Americanengineers and entrepreneurstodowhattheydobest:win.
Principles for Action
01
Promote U.S.biotechnologyinnovation.
Throughout our history,the United States hashad anoutsizedimpactontheworldbecauseofour innovationecosystem,frommedicinestotheinternal combustionenginetospace.lfwewanthumanityto benefit from progress in biotechnology,we want our democratic valuestolead the way.
03
Usenational securitytools toprotect ourinnovation and industrial base in biotechnology.
This means preventing the loss of ourtechnological leadership while alsopreventing risky supply chain dependencies.
02
Be thebiotechnologypartnerof choice for the world.
Whilewe haveled inthepast,wehave notdoneso alone.Weneed toworktogetherwithourpartners and allies to deliver on the benefits of biotechnology while alsopreventingmisuse.
04
Work with the international community, includingChinawhereprudent,todevelop best practices and standards for biosafety andbiosecuritytopreventagainstmisuse, whetherdeliberateoraccidental.
Advances in emerging biotechnology pose risks. Updating protocols and strengthening international standardsforbiosafety and biosecurity alongside biotechnologydevelopmentcouldhelppreventor mitigatefuturebiologicalthreatsregardlessoftheir origin.
RecommendationOverview
Afteranextensivestudy,includingmorethan0stakeholderconsultations,aholisticreviwofunclassifd and classifed material site visits acrossthe United States, and meetings withforeign government and technologyleaders,theCommissionhasdevelopeda set oftop-priorityrecommendations that, takentogether wil ensurethatweoutrunandslowdownBeijinginthebiotechnologyrace.
Pillar 1
PrioritizeBiotechnologyattheNational Level
Twentyyears ago,theCCPmadebiotechnologya strategicpriority.The U.S.government's approach has been piecemeal and uncoordinated, and westilllackthehigh-level departmentaland agencyleadershipweneed to execute a national biotechnologystrategy.The UnitedStatesmust remedythisstrategicweaknessby adoptinga moreproactiveposture.
1.1a CongressmustestablishaNational Biotechnology CoordinationOffice(NBCO)withintheExecutiveOfficeofthe President with a director,appointed bythePresident,whowould coordinateinteragencyactionsonbiotechnologycompetitionand regulation.
Pillar 2
MobilizethePrivateSectortoGetU.S.ProductstoScale
While China providesits leading companies with cheap capital through government subsidies and investments, Americas strong private markets remainourcore advantage.We must leverage our capital marketstoadvance nationalbiotechnolgy priorities.Complexregulations, underutizedcapital mited domestic scale-upcapacity and insuffcient protections allprevent ourbiotechnologysectorfromreaching itsfull potentialBy enabling our companies to compete on fair footing,the United States can build a resilient biotechnology ecosystem.
2.1aCongress must direct federal regulatory agencies to create simple pathways to market and exempt familiar products from unnecessary regulation.
2.2a 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.
2.3a Congress must authorize and fund the Department of Energy and the Department of Commerce to develop a network of manufacturing facilities acrossthe country for precommercial bioindustrial product scale-up.
2.4a Congress must direct the Department of Homeland Security to ensure that biotechnology infrastruc. ture and data are covered under"critical infrastructure."
2.5a Congress must require public companies to disclose single points of supply chain vulnerability located inforeign countries of concern.
5bCongress must prohibit companies that work with U.S.national security agencies and the Department of Health and Human Services from using certain Chinese biotechnology suppliers deemedtoposeanationalsecuritythreat.
Pillar 3
Maximize theBenefitsof BiotechnologyforDefense
Whilebiologyrepresents aparadigmshift inwarfare,theDepartment ofDefense DOD)isnot deployingbiotechnology-enabled capabilities,leavingourmilitaryvulnerableWemust developthesetechnologies inline with Americanvaluesbefore the CCP advancesthem withoutethical constraints.
3.1aCongress must direct the Department ofDefense to consult with stakeholders to define principlesfor ethical use of biotechnology for the U.S. military.
3.2a Congress must direct the Department of Defense to work with private companies to build commercial facilities across the country to biomanufacture products that are critical for Department of Defense needs.
3.3a Congress must require outbound investment rulesto ensure that U.S.capital does not support Chines development of certain biotechnologies that could pose a national security risk.
Pillar 4
Out-Innovate Our Strategic Competitors
Harnessing our innovative strength will require prioritization.We must treat biologicaldataas geopolitically important,as China alreadydoes.Wemust ensure that researchershavethetoolstheyneed tocontinue conducting the best research in the United States. And we must emphasize safety, security, and responsibity—so that the norms and standards of innovation align withAmerican values and interests.
Congress must authorize the Department of Energy to create a Web of Biological Data (WOBD), a single point of entry for researchers to access high-quality data.
4.2a Congress must conduct oversight ofexisting policies, and add newones where warranted,toensurethat China cannot obtain bulk and sensitive biological data from the United States.
4.3aCongress must establish Centers forBiotechnology within the existing National Laboratory network to support grand research challenges.
4.4a Congress must direct the executive branch to advance safe,secure, and responsible biotechnology research and innovation.
Pillar 5
Build theBiotechnologyWorkforceoftheFuture
America'sgreatest strengthhasalwaysbeenitspeople,yet theUnitedStatescurrentlylacksabioliterate workforce.Federaldepartments and agencies must ensure that theiremployees are appropriately skilled and trained toadvance and securebiotechnology.Wemust alsostrengthenourdomesticbiotechnologyworkforce andsustainthepipelineoftalent,both athomeand from abroad.
5.1aCongress must direct the Office ofPersonnel Management to provide workforce training in biotechnology across the interagency.
5.1b Congress must ensure that federal agencies have the necessary expertise across national security and emergingbiotechnologyissues.
5.2a Congress must maximize the impact of domestic biomanufacturing workforce training programs.
Pillar 6
Mobilize the CollectiveStrengths ofourAllies and Partners
Our allies and partners are already loking to implement theirown policies to promote and safeguard biotechnology.TheUnitedStatesshouldcoordinatewithlikemindedcountriesonresearch,talent,andcommercializationtoharnessthepowerofbiotechnologytosolve oursharedproblems.
6.1a Congress must include biotechnology in the scope of the Department of State's International Technology Security and Innovation Fund to appropriately fund international biotechnology policy, researchanddevelopment(R&D),andsecuresupplychains.
ExecutiveSummary
Ifthe United States seizes this moment,
The Future of Biotechnology Has Immense Potential
Defend
The United States military produces what it needs,whenitneedsit,whereitisneeded.
The U.S. defense industrial base is deteriorating, whichleavesAmericaandouralliesvulnerableon thebattlefield.Today,ittakesmorethanamonth toproduce thesamenumberofartilleryshellsthat Ukraineusesinjustthreedays.lfwarbrokeoutwith China,theU.S.militarywould runoutofpreferred munitions within days.Biotechnology gives usthe toolstoreshoretheproductionofchemicalsusedin munitions,increasingthe speed and efficiencywith which we can resupply.
Thesame technologywill beused inthefutureby forwardoperators.Withbiotechnology,platoonswill be able to synthesizefood,munitions,and therapeuticsdirectlyonthefrontlinesusingtechnologiesthat couldfitinabackpack,instead ofrelyingonmaterials produced thousands ofmiles away at home. Biotechnologywillsavelivesonthebattlefield and preventtheneedforcostlyordangerousrefuel or resupplymissions.
Build
American manufacturers power our economy with resources produced here at home.
The United States isdangerouslyreliant on other countries, including our adversaries,forour supply ofthecriticalmineralsusedinessentialconsumer products,likelaptopsand cellphones,aswellas defense and weapons systems.The United States andmanyofourpartnersdopossesssubstantial quantitiesof rareearthmetals—butin manycases, theyaremixedwithvastamountsoftoxicwasteand arethereforeconsideredunusable.
Biotechnologywill enableAmericanminersand manufacturers to unlock these deposits.Using custom-designedproteinsthat act likemicroscopic robots,biotechnology allows usto separate high-purityrareearthelementsandothercriticalminerals fromtoxicwastewithunprecedentedselectivity and cost-effectiveness.Biotechnology solutionslike thesewilllowercosts,increasedomesticproduction ofcriticalminerals,andreduceourdependenceon countries like China.
Nourish
Farmersgrowmorefood usingless land, water, fertilizer, and pesticides.
Droughts, wildfires,floods, pests, and diseases cost farmers billions every year. Invasive pests alone cost the United States economymore than 1.2$ trillion overthelast60years.
Using biotechnology,farmers are already growing cropsthatrequirelesswaterandaremoreresistant topests.We are alreadywell on ourwayto developingnitrogen-producingmicrobesthatreduceor eliminatetheneedforexpensivefertilizer.These
adaptationsaregame-changers:U.S.farmerswho investin drought-and pest-resistant cropsearn approximatelythreetimesmorerevenuecompared to conventional crops.
Futurebiotechnologieswillgeneratemorerevenue forAmericanfarmers,makingouragriculture sector stronger and more sustainable,whileincreasing the supplyofaffordableandnutritiousfoodforfamilies across the country.
Heal
Doctorstreat—and beat—disease.
Inthecaseoftoomanydiseases,weonlyknowhow to treat their symptoms,not the underlying issue.For example,thestandardofcareforpatientswithsickle cell anemia(SCA) is toreceive regularblood transfusionstomanage,butnoteliminate,theirdisease. Sicklecelldiseaseaffects100,000Americans, causinglife-threateningdisabilitiesand earlydeath.
GenetherapiesforSCAcanreplace thediseased blood cellswithhealthyones,providingatrue cure. The first gene therapies for SCA were approved in 2023, and in the coming years, similar cures could bedevelopedforawiderangeofdiseasessuchas muscular dystrophy,cysticfibrosis,diabetes,and cancer.
But if the United States fails to act,
The Future of Biotechnology Could Be Catastrophic
Attack
Adversaries exploit human enhancements to outmaneuver and overwhelm the American warfighter.
Militaryforcesareinherentlylimitedbyhuman capabilitiesinphysicality,strategyweaponry,and logistics.Biotechnologycoulderasetheselimitations.
Ouradversariescouldengineer“supersoldiers”with geneticallyenhancedphysical capabilities,suchas greaterintelligence and enduranceand the abilityto makedecisionsquickerandmoreaccurately.Paired withnewtechnologieslikeimplantedbrain-computer interfacesthattapdirectlyintoasoldier'sbrain chemistry,thesesupersoldierscouldattackour military—beforeourleaderscanevenact.
Destroy
Enemies silently attack American infrastructure, disrupting transportation and trade.
It's easy to imagine a future where our enemies stealthilydeploymicrobesengineeredtodegrade wood and concrete to weaken our roads, buildings, and bridges.Picture the Francis Scott Key Bridge collapseinBaltimore,whichcosttheeconomyan estimated15millioneachdayitwasclosedandup to4billion intotal losses—butcarried out silently, sothatourleaderscannotdetectorprevent this catastrophe.
Converging technologies—-biotechnology superchargedbyAl,forexample—couldarmadversaries withthetoolstocreatequietand unstoppablechaos, makingusfight an invisible enemy.
Starve
Grocery shelves are empty, families go hungry, and farmers suffer when adversaries attack our agriculture sector.
Livestockdiseases costfarmers$358.4billion each yeargloballyinlostproduction,drivingupfoodcosts forAmericans.Modifyaplantpathogensothatit specificallytargets cropsgrown intheUnitedStates,and thoseexistingdiseaseswill become superspreaders thatdecimatelivestock,cripplefarmers'livelihoods, skyrocketcostsatthegrocerystore,andmake Americans go hungry.
Harm
Americans get sick and die because they don't have accessto the medicines they need.
The United States is overly and dangerously reliant onforeignsourcesforourmedicinesandtherapeutics.Weimportupto90%ofourmostcommonly used medicine suchas ibuprofen,hydrocortisone, and acetaminophenfrom China.
In a major global conflict, our adversaries could weaponizethisdependencebycuttingoffouraccess tobasicmedicinesortolife-savingtherapeutics suchaschemotherapies,eitherasretributionorasa preemptivemove.TheUnited Stateswouldface the impossiblesituationof defendingoursovereigntyand security,whiletryingtosourcetreatmentsformillions of Americans.
Introduction
What Is Biotechnology, and How Will It Shape America's Future?
TheUnited States islocked ina great-powercompetition with China that will define thecoming century. This contestwill shape thesecurity ofournation,the strengthofoureconomy,andthewell-beingofour people.Unlikethegreat-powerstrugglesofthepast, this one is playing out less through arms races, land grabs,andproxywarfare thanthroughthe questto dominate cutting-edge technology.
Biotechnology,the design and engineering of biological systems,isthe next battlefield ofthisgreat-power competition.Biotechnologystartswiththecelland provides the tools to reprogram it.It allows scientists togroweverythingfrommedicinestocropstomaterials, enabling "biology by design," in the words of one pioneering U.S. company.! In short, biotechnology allows humanstoprogram life itself.
Emerging biotechnology holds exhilarating potential for the United States.Ifa product istoo expensive to make or an industrial process too difficult to carry out,biotechnologyallows ustogrow an alternative. Theapplicationsreach into every sector:biotechnologiesthatalreadyexisttodayhavethepowerto transformAmerica'smilitarycapabilities,endour dangeroussupplychaindependencies,strengthen foodsecurityand agriculturalresilience,and cure life-threatening diseases.And developments inthis sector areadvancing at blistering speed.
BiotechnologyRepresents the Next Transformative Leap for Human Potential
Human developmenthas alwaysbeendrivenforward bytechnological revolutions.Theprehistoric Agricultural Revolutionsawthedomesticationof plants and animalsthatradicallytransformed civilizations.8TheIndustrial Revolution ofthe eighteenth and nineteenthcenturiesbrought aboutmechanizationthatvastlyincreasedeconomicoutput.9And in ourowntime,theInformationAgehasrevolutionized the way we live and work.20
Now,the biotechnology revolution is here. And its transformativepowerisnearlyunlimited.Although biotechnology has not yet reached itsinflection point, itiscoming,fasternowthaneventwoyears agowhen the Commission began its work.
Biological systems areuniquelypowerful because theyhave adaptedtoperform complexchemistry naturally.Butbiology'scomplexitycanalsolimitscientists'abilitytoharness itsfull potential.Forexample,there are 20,000individual genes inthe human genome,whichcontainsthe codethatinstructscells toproduceproteins,mostofwhichperform multiple jobswithinacell.ThesameDNAcodeproduces distinctfunctionsacrosshundredsofcelltypes,each ofwhichfulfllspecializedroles andworkinconcert withone another.Biology isnotyetfullyengineerable becauseofthis complexity.
Enter artificial intelligence (Al). Today, Al is beginning todecipherthepatternsthatgovernthebehavior ofbiological systems.ThankstoAl'stremendous modelingpower,inthefuturewewill nolonger need toknow(orexpendthehumaneffortandtime determining)exactlyhowabiologicalsystemworks inordertoharnessit.Instead,wewillbeableto programcellsasweprogramcomputers,accurately and precisely engineering biology in orderto achieve desired results.
Taketheproblemoffiguringoutwhatshapesproteins fold into,which was a“grand challenge”forbiologyfor morethan5OyearsuntilresearchersfromDeepMind releasedtheAlsystemAlphaFoldin2021.Byhuman calculationsaloneitwouldtakelongerthantheageof theknownuniverse toenumerate all 10{300} possible shapesofasingleprotein.2AlphaFoldcanaccurately predictmostproteinstructurestowithinthewidth ofanatom,afeatthatearnedtheteambehinditthe 2024 Nobel Prize in Chemistry.22
Al is well-suited forbiology; once models canbecome asfluent inDNA andotherbiological molecules as theynowareinhumanlanguage,theresultswillbe profound.Soon,decadesofbiotechnologybreakthroughswillhappen in mereyears.Already,there areglimpsesoftheimprovementsthatAl-enabled biotechnologywillunlock.In2023,forexample, InsilicoMedicine,whoseR&Dfacilitiesarelocatedin HongKong,announced thatit hadproduced thefirst fully Al-generated drug, a treatment foridiopathic pulmonary fibrosis, a deadly lung disease.23
Justaspeopletodaycanfreelyleveragethe powerofcomputers,whichoncerequired specializedcodingskills,soontheywillbe able to engineer biology just as easily.
Already,thecostofsequencingahumangenome hasplummetedfromthehundredsofmillionsof dollars ittook inthe early2000s toless than 1,000$ today.24DNAsynthesizers,whichallowresearchers to print bespoke strands of DNA to make everything fromheat-tolerantcropstovaccines,costjusttens of thousands of dollars.25 As costs come down, morepeoplewillbeabletosolvemoreproblems more cheaply and quickly than ever. Soon emerging biotechnologywillchangenearlyeverysectorofour economyandtoucheveryaspectofourdailylives, withprofound implicationsforeconomiccompetitiveness and national security.
IftheUnitedStatesWinsthe Biotechnology Race, Our NationWill Be Stronger, Safer, Richer, and Healthier
We are in a race to win the biotechnologyfuture. Countries that master the Al-biotechnology convergencewillgaintremendousstrength andprosperity. Theywill alsogettoshapehowthese technologies are used fordecades,if notcenturies,to come.
For the United States, achieving global biotechnology superiority is animperative.If America secures its position as the greatest biotechnology power in the world,wewillseemajorgainsinfivecritical areas: defense, supply chains, agriculture, healthcare, and computing.
Nobel-WorthyBiological Data: AnAlphaFold CaseStudy
The 2024 Nobel Prize in Chemistry is a testament to thepotentialofartificialintelligenceandbiotechnology(AlxBio)innovation.One recipient,the American scientistDavidBaker,used computationalresources todesignnovelproteinswithnewfunctions.Theother tworecipients,theBritishscientist and entrepreneur DemisHassabis and theAmericanscientistJohn Jumper,workedatGoogleDeepMindonAlphaFold, anAl modelthatpredictswithhighaccuracythe three-dimensional shapeofproteins,oneofthe hardestandmostimportantproblemsinbiological research.
Mostmedicinesaredesignedtointeractwiththe specific shape of a protein, like a key in a lock. Many antibiotics,forexample,targetanddeactivateproteinsthatbacterianeedtoliveandkillthebacteriaby bindingto those necessaryproteins.Determiningthe 3D shapes of proteins accurately and rapidly can aid inquicklydesigningnewantibioticsorvaccinesfor emergingdiseases.
ThecomputationaleffortsthatearnedtheseNobel Prizeswouldnotbepossiblewithoutthedecadesof workdonetobuildmeticulousdatasets.Onedatabase,theProteinDataBank(PDB),isfilledwith3D proteinstructures,primarilydeterminedoneata time inlow-throughputlabs,whichhelpedresearchers understandthelogicofproteinstructuresand how thosestructuresrelatetotheirfunctions.vThePDB isanoutstandingtestcaseinAl-readydata,because eachdata submissionhasrigorousmetadata and qualitymeasurerequirements.Theserequirements havemadethedataparticularlyusefultocomputationalresearchers,whocanuseittodeveloppioneeringAl modelslikeAlphaFold.
Biotechnology Innovation of Today
Biotechnology Innovation of Tomorrow
HighPerformance Compute
Defense
Emerging biotechnologies will help America maintain U.S. military superiority.
Advances in biotechnology represent a paradigm shiftinhowconflictscanbefought andwon.The countriesthatseizethemomentwillretainorachieve superpower status.Those thatfailto dosowill not onlyfallbehindbutalsobecomevulnerabletotheuse of biotechnology against them.
In the1900s,theUnitedStateswasthefirsttotake flightbutfellbehindinthemilitarydevelopmentof airpower going into World War I.26 Nevertheless, once itrecognizedthatairplanescouldbecomecentralto military doctrine,fromforce projectionto reconnaissancetologistical support,the U.S.military prioritized airpowerintimetoreapitsenormousadvantagesin WorldWar ll.
Just as aviationfundamentally changed the nature of military operations, so too can biotechnology.
For example,biotechnology could revolutionize logisticsbylinking strategic objectives withtactical flexibility.Whereplanesshortenedresupplytimes and extended operational reach,synthetic biology couldenableon-demandproductionofessential resources such as fuel,food,and medicine,reducing relianceonvulnerable supplychains.Imagine a battlefieldwhereshelf-stablesyntheticbloodremoves theneedtorefrigerate andtransportmultipleblood types.Suchadvancements could simplifylogistics, allowwarfighterstosafelyextendtheiroperational range,andenhancebattlefieldsurvivability.
Biotechnology is also the best defense against bioweapons.The United States does not and will nothave anoffensivebioweaponsprogram.Other countriesdo.27 Thebestdeterrentistomaster biotechnologysothattheUnitedStatescanprevent, detect,and respond toanybiologicalevent.
Fielding biotechnologyfordefense requires a mindset shift.Instead of viewing thistechnology as acollectionofseparatetools,weneedtoseeitasa comprehensiveframeworkthattransformsthemilitary's approachtologistics,surveillance,operations, and,ultimately,deterrence.
Supply Chains
Biotechnologies can rebuild global supply chains for the critical components powering our economy.
Bytheendofthedecade,accordingtooneestimate, biomanufacturingwill be used extensivelyinmore than a third oftraditional manufacturing industries, representingnearly 30$ trillioninglobal value.28 Plastics,cement,metals,andtextilescouldsomeday allbegrownratherthanproduced.Inadditiontoproviding new and safe domestic methods of production, biomanufacturing also offers good, high-skilled jobs.
One area with especially promising biotechnology applications is theminingand processingof rare earthelements,whichareessential componentsof everythingfromcarstocomputerstocellphones.29 Today,Chinaproduces about60percentofthese minerals andprocesses asmuch as90percentof them.30Someofthesemineralssitunused inthe UnitedStatesbecausethey aretoohard toseparate out from mining waste.31 Companies are now using biotechnology to create enzymes that can specificallytargetandextractmineralsfrom depositsthat arecurrentlyimpossibletoseparate.2Atscale,this newmethodofsourcingcritical mineralscould help meetdemandfromsemiconductorandadvanced weaponsmanufacturers,whileinsulatingour economyfromtheCCP'sexploitationofthiscritical industry.
Agriculture
Biotechnology can revolutionize agricultural production in America.
Biotechnology is already the norm in much of American agriculture.Over 90 percent ofU.S. soybeans,corn,andcottonareenhancedusing biotechnologytohelpfarmersreducetheneedfor land, water, and chemical inputs.3 We are already startingtoseethebenefitsofbiotechnologyfor
agriculture,withcattlethatcanstaycoolerandcontinuetoproducemilkinhotconditionsandcustom soil microorganisms thatcanpull nitrogenfrom the airandreducefertilizerneeds.34Thesetechnologies willbeagame-changerforAmerica'sfarmers,while givingconsumers acrossthecountry accesstoless expensiveandmorenutritiousfood.
Healthcare
Biotechnology can transform healthcare in America.
Biomanufacturingwillenablebetterandlessinvasive treatmentsthatextendand improvelives.In2023, theFood andDrugAdministration(FDA)approved thefirstCRISPR-basedgenetherapiesforsickle cell disease, a life-threatening condition afflicting some100,000Americans.35Similargenetherapies couldprovidetargetedandeffectivetreatmentsfor manyotherdiseases.Accordingtooneestimate,45 percentofthetotalglobal burdenofdiseasecouldbe treatedwithexistingbiotechnologies.36
Biomanufacturingcould alsoreduceU.S.dependence on foreign supply chains for pharmaceuticals. Starting inthe1990s,American producers began offshoring drug manufacturing made through the traditional chemicalprocessbecauseitinvolvestoxic chemicals.7But as many ashalf ofthe drugs on the
FDA's listofessential medicines couldbeproduced usingbiomanufacturinginstead.
Biotechnology can also protect Americans from publichealththreatssuchastoxicwaste.?8American researchersaredevelopingbiomanufacturedmaterialsthatcanbreakdownchemicalcompoundsknown as per-and polyfluoroalkyl substances(PFAS), persistent toxic substances that are used in many consumergoods andoftenendupinthewatersupply.39 PFAS is found in drinking water for an estimated 95 million Americans, including a number of military personnelandtheirfamilies.0TheDepartment ofDefensehasdeterminedthat722militarysites acrossthecountrymaybecontaminatedwithPFAS.41 Biotechnologyoffersasolution,suchasspongesthat promote natural microbial growth that can soak up andbreakdownPFAS.42
Computing
Biotechnology can change the future of computing power.
There are limitations to silicon-based computers.As theworld continuestogeneratemassivevolumesof data, one major concern is the diffculty of building enoughphysical storage.Football field-sized data centers are croppingup across the country,taking upvast amountsoflandandstrainingtheelectrical grid.43Biotechnologyhas the potential to reimagine data storage and computingpowerby replacing silicon-based parts withDNA.DNA canhold an unbelievable amount of information.The entire Library of Congress holds approximately 24petabytesof data, a quantity that could fit in a poppy seed-sized amount of DNA.44
Biology also holds thepotential to tackle computationalproblemsthatarechallengingfortraditional computers,andreplace,modify,orcreatethe semiconductorsthataresocriticaltothefieldof computing.314
China's Vision for Biotechnology
China hasmade nosecretof itsgoalforbiotechnology:touseittoachieveglobaleconomic andmilitary supremacy.
For decades, the CCP has pursued Military-Civil Fusion (MCF), an aggressive strategy that, among otherthings,governshowitwill usebiotechnology.By 2049,theCCP aims touseMCFto turn thePeople's Liberation Army(PLA) intoa world-class military that can rival or defeat our own.48 Biotechnology is a critical componentofthisstrategy,and China is strivingtodevelop and integratebiotechnologyinto litswarfightingcapabilitiesbeforeanyoneelse.49
In 2020, Chinese President Xi Jinping instructed the CCPto“incorporatebiosecurityintothenational securitysystem.50AlthoughPresidentXimade this statementtopushforlegislationonbiosecurity,the CCPandPLA have taken thismessage toheart.The CCP has launched an aggressive, whole-of-nation effort to develop the most cutting-edge biotechnologiesand usethemtoadvanceitsmilitaryand economicobjectives.51
China is investing heavily in gene editing, bionic robots,human-machine teaming,and biomanufacturing,and itistargetingthesetechnologiesfor militaryapplications.Toaccelerateitsprogress,ithas collapsedthebarriersbetweenciviliananddefense research.Asaresult,ostensiblyprivateChinese companiessuchasBGl,oneoftheworld'slargest genomeresearchorganizations,effectivelyserveto implementtheCCP'stechnologypolicies.52While supersoldiersmaysound likesciencefictiontoday, inrealitytheCCPhaslongcalledfor"populationimprovement,”and hasbacked researchintotopics like the genetic basis of intelligence.5 Experts interpret this as willingness to pursue eugenics.54
Indeed,some Chinese scientists arealready turning togeneeditingtoachievepopulationimprovement. In 2018,aChinesebiophysicistcreatedtheworld'sfirst geneticallymodified babies,shockingtheinternationalscientificcommunity,whichhadcalledfora pauseonthistypeofgeneticmodificationresearch.55 Thegeneticmodificationswere intended toproduce humansthatweremoreresistanttoinfections.56One caneasilyimagineafuturewhereembryosareedited forintelligenceandotherdesiredtraits.
The defense implications of such innovations are alarming.lf China wins the military biotechnology race,itsforceswillgain advantagesthatourswill lack.
The consequences for human rights are just as troubling,giventheCCP'slaxattitudetowardeugenics and obsession with surveillance.Beijing could wield biotechnologytocontrol itspopulation,intimidate ethnic minorities,and perpetrategenocide.In Xinjiang,Chinese authoritieshavealreadycollected genomicdataonmillionsofpeopletoidentifythose whoareethnicallyUyghur,contributingtogenocide against thisgroup.57It iseasytoimagine theCCP collectingtheDNAofoutspokendissidents inthe diaspora toidentify andpunish theirfamiliesback in China.
China has alsorepeatedlyfailedto honorinternationalcommitments—includingwithholdingcritical informationandsamplesduringtheearlystagesof COVID-19——and engaged in nontransparent,nonreciprocal,and coercivebehaviorsthatundermine meaningful engagement on biotechnology.
The United States is Falling Behind in Key Areas
Formostofthetwentiethcentury,theUnitedStates dominatedthefieldofbiotechnology.American researchinstitutions and scientistsunlockedcutting-edge innovationsthatweretheenvy oftheworld.
In the1940s,theU.S.DepartmentofAgriculture, workingwiththeprivatesector,discoveredhowto producenewstrainsofpenicillinand beganmass producingthedrug,saving untold millions of lives.58 In the1970s,Americanbiochemistswerethefirstto learn how to“cut" DNA fragments from one source andjointhemwithanother.Theyfounded theworld's first biotechnology company, Genentech, which producedthefirstsyntheticinsulinandhassincecreated dozensofothermedicinestotreateverythingfrom cancertomultiplesclerosis.59Inthe1990s,theUnited StatesledtheHumanGenomeProject,amassive internationaleffortthatidentifiedandsequencedthe full human genome for the first time.60
TheUnited States owes these successes toits tremendousunderlyingstrengths.We arehometo manyoftheworld'spremierbiotechnologyexperts and leadingpublicandprivateresearchinstitutions. Ouropeninnovationecosystemattractstoptalent from across the globe.Both our government and our privatesectoremphasizefundingfoundational research and development(R&D),ratherthanfunding onlyfullyrealizedproducts.Wehavemorebiotechnologypatents,companies,andNobelPrizewinners thananyothercountry.Modernbiotechnologyisan American innovation.
Unfortunately,manyofthesestrengthshavebegun toatrophy.Above all,biotechnology companies are strugglingintoday'smarketenvironment.Atthe beginningofthebiotechnologyboomintheearly 2000s, abundant private capital poured into fledgling companiesthatwerepushingtheboundariesfar beyond traditional biopharmaceutical applications. Butwhenthemarketrecentlycontracted and lending becamemoreexpensive,manybiotechnologycompanies were hit hard.62 Investors fled to saferinvestments,returningtobiopharmaceuticalswithdefined return profiles and moving away from cutting-edge biotechnology applications in medicine,agriculture, industrial manufacturing,energy, and defense.
TheUnitedStatesLacksaFederal Strategy
To win the biotechnology race, we need to start by gettingourown housein order.Currently,the U.S. governmenthasnocohesive,intentional biotechnology strategy,while China is gainingground thanks to itsaggressiveandcarefullycoordinatedstate-led initiatives.63Support forbiotechnology investment isbipartisanandwidelychampionedacrossthe United States.But our policymaking is fragmented. Coordinationbetweentheexecutive andlegislative branchesofgovernmentandwithintheexecutive branch is poor. And the federal government's regulatorysystem iscomplexandoutdatedduetoa patchworkoflaws and authorities.
OurFederal FundingHasStagnated
In the1960s,federal R&Dspendingreached nearly 2percentofGDP.Today,it has declined tojustO.6 percent.64 The problem is not just how little funding thereisbutalsowhatgetsfunded.Withfewerfederal dollars available and funding agencies less tolerant offailure,researchersandtheirinstitutionstendto pursue less risky,moreincremental research.Fartoo little federal funding goes toward innovative,disruptiveprojectswhosebreakthroughswill shapethe future of biotechnology.
Theadministrativerequirementsoffederalfunding——lengthy paperwork,evidence of previous success,andthelike—alsomeanthatitiseasierfor establishedresearchersand well-resourced institutionstocapturethesedollarsthantheirlessexperiencedorsmallercounterparts.Researchersshould be ableto spendless time writing grant proposals andfillingoutpaperworkfordwindlingpotsoffederal funds and more time innovating.
We Fail to SufficientlyCommercialize Innovations
While theUnitedStates haslong excelled at advancingourfundamentalunderstandingofscience,it hasfocused lessonconvertingideas intoproducts, particularly those with strategic promise.Moreover, poorinfrastructure,alackoflong-termcapitalinvestment,andconfusingmarketsignals allservetoshrink America'sshare oftheglobal biotechnology market. China, by contrast, picks national champions and aggressivelyadvantagesthemthroughCCPpolicies toensure thattheyseize asmuchglobal market share as possible.65
Inaddition,Americanbiotechnologycompanieshave tonavigate a thicketofslow,unpredictable,and complexregulationstobringproductstomarketwhile regulatoryagenciesfacerepeatedlegal challengesto theirenforcementofoutdatedrules.Untilwefixboth thesecommercializationproblems,ourinnovation edgewillcontinuetoerode.
Our Innovation Edge Is Eroding
Thefutureof biotechnologyisinextricablylinked withthatofAl,and themoreresearchersuseAl topowerbiotechnologydiscoveries,the more essential high-qualitybiological datawill become. ButtheUnitedStateshasfailedtoamass alarge repositoryofbiologicaldatathatcouldbeleveraged by researchers, thereby forgoing a game-changing strategic resource.
Federal funds also do not adequately support researchinfrastructure,suchaslabspace,equipment,andcomputingpower,whichresearchersand innovators need to generate the high-quality biological datathatleadtodiscoveries.66
ThecombinationoflessfederalfundingforbiotechnologyresearchandinsufficientdatatodriveAlpowereddiscoveryputsAmerica'sinnovationedge at risk,compared to countries such asChina that are willingtoinvest heavilyinbiotechnologyresearch and data.
America Is No Longer the Premier Destination for Top Talent
As impressive as it has been over the years, the Americaneducation and trainingsystemisnotproducingenough skilledworkerstomeetthe demands of the biotechnology industry,particularly outside of themajorhubsofBostonandSanFrancisco.67While weremaina leaderin attractinginternationaltalent, China is quickly catching up. We desperately need amoreaggressivestrategytoattract,develop,and retainthebestmindsinthefield.
We Fail to Harness the Strengths of Our Allies and Partners
As withmany other aspects oftechnological dominance,theUnitedStatescannotwinthebiotechnologyracealone.Wemustworkwithothercountries tosolvehardproblemsandbuildaninternational ecosystemthatfillsthegaps inourowncapabilities. Forexample,in2012AmericanandFrenchscientists workedtogethertounderstandandcharacterizethe CRISPR-Cas9 genetic scissor tool, which led to its adaptationintotherevolutionaryCRISPRtechnologiesavailabletoday.68
Many U.S. allies and partners offer unique capabilities.CompaniesinDenmarkaredrivingadvances inbiomanufactured chemicals,includingforusein healthcare.69 Germany is doing the same for biomass forenergy.7TheUnitedKingdomisleadingefforts in computational biology research.7 South Korea is establishingitselfasahubforbiopharmaceutical manufacturing.72Japanisadvancingregenerative medicineandbiomanufacturing.And Indiaisprioritizingcost-effectivebiomanufacturing,particularlyof vaccines.74We must do more totake advantage of our partners'unparalleledstrengths,whichcould include enteringintoreciprocaldata-sharingagreements or poolingdemandforbiotechnologyproducts.
Currently, the U.S. government has nocohesive,intentionalbiotechnology strategy, while China is gaining ground thanks to its aggressive andcarefullycoordinatedstate-led initiatives.
China Is Closing the Gap
President Xihas made it clear that emerging technologies such as biotechnology willshape the future. And he has moved quickly to seize the advantage. China has long relied on aggressive industrial policies to get ahead in the sectorsit considers vital. This track record gives it a clear playbookforhowto win the biotechnologyrace and then translate that victory into military and economic power.75
China Emphasizes Biotechnology as a "Strategic Emerging Industry"
For nearly two decades, China has made biotechnologyapriority.76Asearlyas2007,theCCPannounced plansto"setuphigh-techindustrial basesforbiotechnology,"and in 2011, it designated biotechnology asa“strategic emergingindustry,”unleashinga comprehensivepackage offinancing,subsidies,and diplomatic support for the Chinese biotechnology sector.77
In2014,PresidentXideclaredtotheChinese AcademyofSciencesthathiscountrycouldnotbecomea"technologicalvassalofothercountries"and insistedthatitpursueapathofindependentscientific innovation.8InanApril2020speech,heelaborated on thisvision:
"We must place greater emphasis on basic research inheredity,genetics,virology,pidemiologyand immunology,accelerateR&Dandtechnological innovationofrelateddrugsandvaccines,andattach greaterimportancetoapplicationsofinformation anddatatechnologiesinthesefields."79
Laterthatyear,Chinaenactedabiosecuritylaw,further enshrining biotechnology, genomics, and other life-sciencesresearch underCCPandstate control, includingunderthePLA.80
China Provides Massive State Support for Hand-picked Winners
The CCPlavishes its chosen domesticfirms with subsidiesandpreferentialregulatorytreatmentthat advantagethemattheexpenseofforeigncompetitors.Itcomplements thisstrategybyhelpingChinese firms acquire U.S.companies that are developing promisingtechnologies.In2012,forexample, BGl bought the U.S.-based sequencing company Complete Genomics, bringing American technology underCCPcontrol.315Today,BGlisaworldleaderin sequencing,thanksinnosmallparttothesupport thattheCCPhasgivenit toundercutthecompetition withbelow-marketprices.
The Chinese government has made tremendous investmentsinits domesticbiotechnologyindustry, plowing money into developing talent and building researchinfrastructure,unliketheUnitedStates, whichhasnostrategicvisionorcoordinationfor federal biotechnologyfunding.81
In agriculture, the Chinese government uses its regulatorysystemtodelayapprovalforAmericandevelopedseeds andrequirelarger-than-normal samplesofseeds.ThisallowsChinatodevelopits ownversionsofAmericanseedvarietiesinafraction ofthetimeitwouldotherwisetake.82
China now boasts over 100 biotechnology research parksand17industrialclusterswhereresearchers canconductbiologicalresearchanduseAlinbiodiscovery.83ThesesitesofferChineseresearchers everythingtheyneedtoscaleupinnovations,from thelaboratoriestotesttheirideastotheinfrastructuretobringtheirproductstomarket.84China'srapid investment into these sitescould allow the country tosurge more students intoitsbiotechnology workforce,creatingafeedbackloopthatwould expand its biotechnology industryfasterthan we areableto growours.
China Deploys Predatory Capital and Acquires Intellectual Property (IP)
China regularly exploits America's open market by funding acquisitions of U.S. biotechnology startups solely for the purpose of acquiring their IP. A telling exampleisChinesepharmaceutical company WuXiAppTec,whichhaspurchased anumberof U.S.firms, granting it access to the best technology intheworld.85ThankstoacquiredAmerican IP, it nowdominatesthebiomanufacturingofpharmaceuticals and has earned a reputation among biotechnologycompaniesasacriticalfirmthatcan solvethehardestmanufacturingproblemsinas little asa week.BecauseofWuXiAppTec'sedge,the Americanbiopharmaceuticalindustryisnowutterly reliant on it.In 2024,an industry group surveyed U.S. biopharmaceuticalcompaniesandfoundthat79 percentofthosecompaniesdependonitandother Chinese-based contractors for manufacturing.86 WuXiAppTec'ssuccesswasbuiltonthebackofU.S. technology.7Butnow it is theUnitedStates that is vulnerable.In that sense,WuXiAppTec is the new Huawei.88
China Prioritizes Data Control and Security
Chinaunderstands theimportance ofgenetic data, and itsinvestmentsingeneticsequencingservices havegiven it vast amountsofgenomic information. National championssuchasBGl collectdataon behalfof(and arefunctionallyindistinguishable from)theChinesestate,grantingtheCCPaccess tomassivetrovesofdatathatpowerdevelopments inbiotechnology.89TheCCP's2020biosecuritylaw establishedanationalbiosecurityinformationbank withwhich companiesmustshare alltheir"biosecuritydata andmaterials.Ifinterpretedbroadly,thelaw wouldrequiresharingdataforall"humangenetics resources"(human tissue,DNA samples,and so on), including all clinical trial data.90
China is Working to Win the CompetitionforTalent
Fewer Chinese students are choosing to pursue highereducationabroadnowthaninprevious years. The number of Chinese students studying abroadincreasedyear-by-yearfrom2013to2019; however,thatnumberhassteadilydeclinedsince theCOVID-19pandemic.9Morethan80percentof ChinesePhDswho dostudy abroadreturnhome after,where theycan end upworkinginChinesefirms ordirectlyfortheCCP.92Inthisregard,20yearsof Chinese investment in its domestic biotechnology industryarepayingoff.Indeed,Americans and Europeans withbiotechnologyexpertise are also studyingandworkinginChina,drawnbythevast governmentresourcesavailabletoresearchersand students.93
China's Strategy is Working
Aspartof itsstrategy,theCCPseekstodominate theglobalbiotechnologyindustrysothatother countries,includingtheUnitedStates,aredependent onthechannelsitcontrols.Chinaisalreadydeeply embeddedintheUnitedStates'criticalbiotechnology supply chains,including those for life-saving medicines and agriculture.Every yearfrom2014 to 2022,the United States sourced up to 28percent oftotalactivepharmaceuticalingredientimports from China.94 Chinese state-owned Syngenta is now theworld'slargestseedandagriculturalchemicals conglomerate,with$27billionofannualsales and unprecedentedglobal influence.95 These dependenciesmakeushighlyvulnerabletoChinesepressure.
$300 billion
increase in market value of Chinese biotechnology firms
From2016to2021,the market value of Chinese biotechnology firms grew 100-fold,to $300 billion.96 These companies' combined marketcapitalization is second onlyto that of U.S. companies,and Chinese firms are ontrack tocatch up quickly.
increaseinnumberof Chinesebiotechnologydeals
The share of clinical trials launched byChineseheadquarteredbiopharmaceutical companiesrosefrom justthreepercentin2013to28 percent in2023.97And theglobal shareofChina'spharmaceutical outputincreasedfromjustover fivepercentin2002tonearly25 percent in 2019.98 The number of dealsChinesebiotechnology companies strucktolicense their ownIPtoothersmorethandoubledfrom15in2019to33in2023 mostly in oncological therapeutics.9 In 2023,the FDA approved threenewdrugsbiomanufactured in China.100
In 2019, China applied for 22 percent of all international patents, surpassing the United states and the EU.
InrecentearsChinaasbecomethelargestfunderfagricultural&Dintheworldupassingtheitd States andthe EU In209,forthefrst time inhistory,China applid formore internationalpatents than th United States. Many of these Chinese applications were for agricultural patents that use CRISPR.02
China's advances in R&D are payingoutacrossthebiotechnology landscape,mostnotably in syntheticbiology.In 2010, researchersintheUnited States published45percentofthe world'smosthighlycitedpapers on syntheticbiology,with Chinese researchersaccountingforjust 13 percent.By 2023,that ratio hadflipped:Chineseresearchers published60percentofthe most-cited papers while U.S. researchaccountedforjust 7 percent.03
"We must place greater emphasis on basic research in heredity, genetics, virology, epidemiology and immunology, accelerate R&D and technological innovation of related drugs and vaccines, and attach greater importance to applications of information and data technologies in these felds."
-President Xi
The United States Must Win the Biotechnology Race
China is using every tool at its disposal to replace the United States as the global leader in biotechnology. The CCP's strategy is to make its firms less dependentontheworld,and theworld moredependenton them. And it is succeeding.
In thefaceofthisonslaught,nosingle actionwillbe enough;there is no silverbullet that will singlehandedly delayChina'sprogressbya decadeorsecure U.S. dominance for a generation.Rather, the U.S. governmentmustaggressivelydeployall thetools at its disposal to preserve American biotechnology leadership.
Chinahasrunitsplaybookbeforewithothertechnologies,and we havelessonsto drawonforhowto counterit.Considersemiconductors.Chipswere originally an American invention,and China had laggedfarbehind.Inrecentyears,however,Chinabe gantoclosethegap,whiletheUnitedStatesitselfall but lost the ability to produce leading-edge chips.04
In 2022, Congress passed the CHIPS and Science Act,whichseekstostimulatetheproductionof semiconductorsonU.S.andalliedsoil,andthe CommerceDepartmentenactedexportcontrolsto prevent advanced semiconductortechnologyfrom gettingintoChina's hands.05As aresult,theUnited Stateshasagainbecomeaglobalhubforadvanced chipmanufacturing.106China's climbupthe chip-manufacturingvalue chain has slowed;it hascontinued to struggletoproduce advanced chipsatscale,inpart hindering its progress in Al and other dual-use and military applications.107
Wecan stillsecure ourposition astheworld's biotechnologyleaderifweactnow.Ifwefailtomeet the moment,however,U.S.economic and military leadershipwill beweakenedforgenerations.
HowtoWin the Biotechnology Race
To make upfortwo decadesof complacency,we must launch a whole-of-government strategy to promote the U.S.biotechnology industry.We must mobilizeourprivatesectorsothatAmericanproducts dominatetheglobalbiotechnologymarket.Wemust attractprivatecapital throughsuchmechanisms asanIndependenceInvestmentFundand advance purchasecommitmentsfromthefederalgovernmenttosmoothoutdemand.Weneedtocreate public-privatepartnershipssothatcompaniescan getthesupport(suchasguidanceonnavigatingthe governmentcontractingandregulatoryprocesses) andfinancialbackstoptheyneedtotestinnovations earlyandscalewhatworks.We alsoneedtoinvest in ourtalentpipeline,makeiteasiertocollectanduse standardizedbiologicaldata,andboostfundingfor R&D.
Wemustdo all ofthisinamannerthat alignswith Americanvaluesandprioritizessafety,security,and responsibility. Our values are one of our key enduring advantages;they are what unites uswith our allies anddifferentiatesusfromouradversaries.Sacrificing ourvaluesforshort-termgainswould only serveto imperil U.S.leadership in thelong-term.
The government canbe a force multiplierthat reinvigorates theUnited States'historicstrengths and helpsensurethatthecountryfinishesthebiotechnologyraceinfirstplace.Theselong-termmeasuresto promotedomestictechnologiesandcompanieswill ensurethatwecanoutrunChinainthiscontestand avoid needingtomake aCHIPSAct-sized investment to catch up.08
Our strategy must not just promote American technology,but protect it,too.The U.S.government hasanarrayoftoolsatitsdisposaltopreventtransactions that would harm the United States. Applying themtobiotechnologyshouldpreventthetransferof sensitivebiologicaldatathatcouldbeusedagainst theUnitedStates.Thegovernmentshould reform the Committee onForeignInvestment intheUnited States (CFIUS) so it can better block predatory Chinese investments in the U.S. biotechnology industry.Itshould imposerestrictionsonoutbound investment to prevent U.S.investments from supporting Chinese biotechnology companies that pose nationalsecurityrisks.ltshouldenactnewexport controls on specific types of biotechnology equipment that would threaten our national security if they fell intothehandsofthePLA.And itshouldrequire firms whose supply chains rely on China to publicly disclose their dependencies and prohibit U.S.governmentcontractors andgranteesfromprocuringgoods fromChinesebiotechnologyfirmsthatcouldcreate such dependencies.
The U.S.government cannot adopt a one-size-fits-all approachtothebiotechnologysector.Indevisingexportcontrols,forinstance,theAdministrationshould remainflexible.It shouldbewillingtodeploy them inareaswheretheycouldhaveastrategicbenefit, includingonacountry-widebasis,butalsobewilling toamend themiftheyriskultimatelysettingback U.S.biotechnology leadership.Biotechnology supply chains areparticularly diffuse,with important technologiesdispersed acrosstheworld,a characteristic that requires export controls tobesurgical and nimble to be effective.o9 When it comes to reducing investment and supply chain risks,by contrast,the Administrationshould pursuewider-rangingprotectionmeasures,sincetheseposefewerdownsiderisks to domestic industry.
Biotechnologyisalessconsolidated industrythan others,suchasthesemiconductorsector,andtechnological breakthroughsregularlyoccuratstartups and small firms.But small biotechnology companies oftenfacea tough choice:doingbusiness with China orgoingoutof business.Thatiswhyprotection must gohand in hand with promotion.A comprehensive strategyshould notjustrestricttransactionswith China thatcould posenational securityrisksbutalso openupnewmarketopportunitieswithintheUnited States and allied and partner nations.
Nosinglesteponitsownwill ensurethattheUnited StatescanoutrunandslowdownChinainbiotechnology.Buttogether,ourrecommendationsofferthe bestchanceofsuccess.Thereisstilltime,butthe window is rapidly closing.
The inflection point for biotechnology has not yet arrived. Ultimate leadership of the sector is still up for grabs. With chips and advanced telecommunicationswewere caught flat-footed. But with biotechnology, fortunately, we can act early and decisively.
Introduction
About the Commission and Report
Commission Background
In2021,recognizingthenationalsecurityimplicationsofemergingbiotechnology,Congress cametogetheronabipartisanbasistocreate the National Security Commission on Emerging Biotechnology(NSCEB).Establishedaspartof theannualdefenseauthorizationbill(FY22NDAA) the Commissionwasgivena clear and urgent mandate:toconductacomprehensivereview ofemergingbiotechnology'simpactonnational securityandprovidepracticalrecommendations topreserve American dominance in this field.
TheNSCEBis anindependentcommission currentlycomprisedof11commissionersappointedbyabipartisangroupofMembersofthe HouseandSenate.WeincludefourMembers of Congress——twofrom each chamber,and two from each party——and seven prominent industry leaders,academicexperts,and formergovernmentofficialsfrom thedefenseandintelligence communities.
Our workis short-term in nature. Our directive is toproviderecommendations and supporttheir implementation,afterwhich point——specifically, eighteenmonthsafterthereport'spublication, as required by statute—thisCommissionwill dissolve.
NSCEB Commissioners
Senator Todd Young Chair
Dr.Michelle RozoVice Chair
Senator AlexPadilla
Congresswoman StephanieBice
Congressman RoKhanna
Dr.Angela Belcher
Dr.Eric Schmidt
Dr.AlexanderTitus
Dr.Dov Zakheim
Report Methodology
Our final report is the product oftwo years of intensive study.Itsfindingsand recommendationsreflect inputfromhundredsofexperts andgovernmentofficials both in the United States and abroad, covering everyfacetofbiotechnology and nationalsecurity.In total,wemetandinterviewedmorethan1,800people fromover30countriesonsixcontinents.Thisreport has alsoundergone aformal reviewprocessby all Commissioners and reflects the unanimous consensusofourCommission.
While this report has been submitted to the CongressionaldefensecommitteesandthePresident, wehavealsomadeitfullyavailabletotheAmerican public. This is intentional: to win the biotechnology race,we mustmobilizenotonlypolicymakersbut alsotheprivatesectorandgeneralpublicinsupport of atargeted and aggressivenational biotechnology strategy.
Report Scope
This report lays out a set of practical recommendations that,if adopted,will both advance our progress and slowthatof ourstrategic adversaries—particularly China—-in the race for biotechnology supremacy.
The Commission conductedresearchfrom April 2023to February 2025 to inform this report. Our research isongoing,and we anticipate expandingon theserecommendations inthe comingmonths as thetechnologyadvancesand thepolicylandscape evolves.
Withinourscopeofemergingbiotechnology,wehave focused primarily on thedesign and engineeringof biological systems, devices, and parts. Other biotechnology applications that build toward far-future capabilities,suchasbrain-computerinterfaces,are not the primary focus ofthis report.
We define national security broadly, reflecting today's complexgeopolitical realities.Weunderstand nationalsecuritytoencompasstraditionaldefense issuesaswellasthebroaderconsiderationsof economicresilienceandcompetitiveness,health security,foodsecurity,andenergyindependence and security.
This report provides recommendations only within the scope of biotechnology.Manyrelated fields,such as biodefense,food security,and energy security,do notexclusivelyimplicatebiotechnology.Inthe case ofbiodefense,forexample,biothreatsexistwithout biotechnology, and remain lethal and prevalent to this day.
Organizations suchas the Bipartisan Commission onBiodefenseaimtoaddressthefullrangeof biothreats.Wedonotseektoduplicatethiswork. Instead,wepresentrecommendationspertainingto biodefense in the context of emerging biotechnology,specificallyboththe challenges and potential solutionsthistechnologyraises.Forexample,our recommendations——includingproposalsfora DepartmentofEnergy-ledWebofBiologicalData (WOBD), pilot-scale precommercial manufacturing facilities, and grand research challenges—will,if enacted,enableU.S.researcherstoproducemedicinesthatserve asadefense againstbiothreats.But biotechnologyisonlypartofthe solution.Thework oftheBipartisanCommissiononBiodefenseand theinauguralDepartmentofDefenseBiodefense Posture Review coverimportant areas outside the scope ofthisreport.
Similarly, while we address biotechnology applicationsacrossmanyindustries,wedonotcoverthe full span of any specific industry sector. Emerging biotechnology will play an increasingly critical role in agriculture,pharmaceuticals,andotherkeyindustries,butitwillnotprovidethesolesolutiontothe challengestheseindustriesface.Biotechnology,for example,will superchargeeffortstohelptheUnited Statesdomesticallyproducetheactivepharmaceutical ingredients(APls) needed for essential medicines, but it alone cannot solvethemajorvulnerabilities in ourhealth supply chains.The United States will need toidentifywaystoonshoretoday'sgenericdrugmanufacturing,includingthroughpolicyandlegislation.
Weseparatelyissued aclassifiedannextothisreport thatprovidesadditionaldetailsonhowpolicymakers should prioritizebiotechnologyforU.S.national security. The annexis available uponrequest to those withtheappropriateclearanceand avalidatedneed toknow.
However,thereisfarmorethatpolicymakerscould dobeyondtherecommendationspresented inthese reportstoaddressthisexpansiveandcriticalsetof nationalandeconomicsecurityissues.
Next Steps
Overthenext18months,thisCommissionwillwork withSenators,MembersofCongress,Congressional staff,and theAdministrationto support theintroductionandpassageoftherecommendedlegislation outlinedinthisreport.Duringthistime,wealsointend to continue work on select areas to further develop targeted recommendations.Weaimtoprovide,for example,more specific recommendations onregulatoryactionstailoredtoeachofthethreeindividual regulatory agencies.
Themissionahead isclear.Westand on thecuspof massive developments in emerging biotechnology. If we act now,theUnitedStates cansecure itsposition asthebiotechnologyleaderintheworldfordecades to come.We lookforward toworkingwithour partnersingovernment and industry tobring about this future.
If we act now, the United States can secure its position as the biotechnology leader in the world for decades to come.
Recommendations
Pillar1
Prioritize Biotechnology at the National Level
1.1a Congress must establish a National Biotechnology Coordination Office (NBCO) in the Executive Office of the President with a director, appointed by the President, who would coordinate interagency actions on biotechnology competition and regulation.
1.2a Congress should direct each relevant agency to designate a senior officialto lead biotechnology policy.
1.3a Congress should establishthe Office of Global Competition Analysis to develop timely data and technol. ogyforecastingto inform policymakers'decisions.
Pillar 2
Mobilize the PrivateSectorto Get U.S.Products toScale
2.1a Congress must direct federal regulatory agencies to create simple pathways to market and exempt
familiar products from unnecessary regulation. Congress should direct federal regulatory agencies to prepare for novel products to come to market.
2.2a 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.
2.2b Congress should direct the Department of Energy and the Department of Health and Human Servicesto 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.
2.2c Congress should restore fuland immediate expensing of research and development (R&D) expenditures.
2.2d Congress should improve the effectiveness and reach ofthe Small Business Inovation Research (SBIR) and Small Business Technology Transfer (STTR) programs to support early-stage innovation.
2.3a Congress must authorize and fund the Department of Energy and the Department of Commerce to develop a network of manufacturing facilities across the country for precommercial bioindustrial product scale-up.
2.3b Congress should direct the Department of Commerce to create a public-private biopharmaceutical manufacturing center of excellence focused on developing and scaling new ways to make medicines.
2.4a Congress must direct the Department of Homeland Security to ensure that biotechnology infrastructure and data arecoveredunder“critical infrastructure."
2.5a Congress must require public companies to disclose single points of supply chain vulnerability located inforeign countriesofconcern.
2.5b Congress must prohibit companies that work with U.S. national security agencies and the Department of Health and Human Services from using certain Chinese biotechnology suppliers deemed to pose a national securitythreat.
2.5c Congresshould reform the Committe on Foreign Investment in the United States (CFIUS) to better and more nimbly screenthe highest-impact,highest-risktypesof investment incriticaltechnology sectors in the United States.
2.5d Congress should direct the International Trade Commission toinvestigate Chinese dumping or oversupply of biotechnology products and services.
Pillar 3
Maximize the Benefits ofBiotechnology for Defense
3.1a Congress must direct the Department of Defense to consult with stakeholders to define principles for ethical use of biotechnology for the U.s. military.
3.2a Congress must direct the Department of Defense to work with private companies to build commercial facilities acrossthe country to biomanufacture products that are critical for Department of Defense needs.
3.2bCongresshould continue oversight of and support for BioMADE's eforts to create anetwork offacilities that precommercial bioindustrial companies across the country can use to meet Department of Defense needs.
3.2c Congress should require changes to military specifcations(MIL-SPECs) to enable biotechnology companiestomoreeasilyselltheirproductstotheDepartmentofDefense.
3.2d Congress should require the Department of Defense to enterinto advance market commitments(AMCs) and offtake agreements for biotechnology products that are needed for defense.
2eCongress should require the Department of Defense and other agencies involved in national securityto train their workforces to be ready for biotechnology.
3.3a 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.
3.3b Congress should direct the Department of Commerce to consider country-wide export controls blocking the sale of specifc, highly sophisticated U.S.biotechnologyitems to China that would pose a substantial risk to national security if used for military end-uses.
3.3c Congress should require the Department of Defense to incorporate military-relevant applications of emerging biotechnology into wargaming exercises.
3.3d Congress should resource the inteligence community to prioritize understanding adversaries' development of biotechnology and its diverse applications.
Pillar 4
Out-Innovate Our Strategic Competitors
4.1aCongress must authorize the Department of Energyto create a Web ofBiological Data (WOBD),a single point ofentry for researchers to access high-quality data.
4.1b Congress should authorize the NationalInstitute ofStandards and Technologyto create standards that researchers must meet to ensure that U.S.biological data is ready for use in Al models.
4.1c Congress should authorize and fund the Department of Interior to create a Sequencing Public Lands Initiative to collct new data from U.S.public lands that researchers can use to drive innovation.
1dCongress should authorize the National Science Foundation to establisha networkof"cloud labs,” giving researchers state-of-the-arttools to make data generation easier.
4.2a Congress must conduct oversight of existing policies, and add new authorities as warranted,to ensure that China cannot obtain bulk and sensitive biologicaldata from the United States.
4.3aCongress must establish Centers for Biotechnology within the existing National Laboratory network to support grand research challenges.
4.3bCongress should initiate a grand research challenge focused onmaking biotechnology predictably engineerable.
.3c Congress should initiate a grand research challenge focused on making biomanufacturing scale-up predictable,rapid,and cost-competitive.
4.4aCongress must direct the executive branchto advance safe, secure, and responsible biotechnology research and innovation.
Pillar5
Build theBiotechnologyWorkforce oftheFuture
5.1a Congress must direct the Office of Personnel Management to provide workforce training in biotechnology across the interagency.
5.1b Congress must ensure that federal agencies have the necessary expertise across national security and emergingbiotechnology issues.
5.1c Congress should receive accurate,timely, and nonpartisan scientific and technical counsel.
5.2a Congress must maximize the impact of biomanufacturing workforce training programs.
2b Congress should expand educational efforts in biotechnology for American students.
5.3a Congress should authorize new green cardsforbiotechnology talent,especiall fromallied and partner countries.
5.3bCongress should optimize the veting process forforeign nationals to preventillit technology transfer.
Pillar6
Mobilize the CollectiveStrengths of Our Allies andPartners
6.1aCongress must include biotechnologyinthe scope of the Department of State's International Technology Security and InnovationFund to appropriatelyfund internationalbiotechnology policy, research and development(R&D),and secure supply chains.
6.1b Congress should direct the Department ofState and other agencies to promote the US. biotechnology industry in foreign markets, including through commercial diplomacy. Congress should expand regulatory diplomacy for biotechnology.
1d Congress should require the Department of State to form reciprocal biological data-sharing agreements with other countries.
6.1e Congress should direct the Department of State and the Department of Defense to encourage North Atlantic Treaty Organization (NATO) countries to aggregate demand and pool purchasing power for biotechnology products.
6.2a Congress should direct the Department of State, along with the National Institute of Standards and Technology,to support the development of international norms and standards, including defining shared values and interests in biotechnology.
6.2bCongress should require the Department ofState to create a strategyfor harmonizing multilteral export controls.
Chapter1
Prioritize Biotechnology at the National Level
Throughout much of its history, the United States hashadanoutsizedimpactontheworldthanks toitsroleasanengineofinnovation.Fromautomobiles to medicine tonuclearenergy tospace, researchersintheUnitedStateshavebeenatthe forefront.
But in biotechnology,America is at riskof losing itsedge.TheU.S.governmenthasnotprioritized biotechnologyasastrategicsectorlikeithas semiconductorsandartificialintelligence.
Instead,Americahas takena piecemeal and uncoordinatedapproachtobiotechnologypolicy andprograms.Thisdecentralizedapproachto biotechnologyresearchanddevelopment(R&D) hasitsstrengths,butitalsocomeswithinherent weaknesses.Federal scientists andprogram managerspursueawiderrangeofbiotechnology researchprojectsthatadvancethemissionof theirspecificdepartmentoragency,butbecause theirefforts aredisaggregated,theresult isa confusinglandscapeofbiotechnologyresearch that inhibits potential interagency collaborations.
Moreover,thelack of effective coordination has resultedinajumbleofstrategies,investments, andcommitteesscatteredacrossthefederal government.Biotechnology research,regulation, manufacturing,workforcedevelopment,program management,andpolicymakingaretreatedas discreteissuesratherthanconsideredtogether, as they should be.Thisfragmented system is diff cultforbiotechnologyinnovatorsandpolicymakerstonavigate,utterlyopaquetothepublic,and detrimentaltocollaborationacrossthefederal government,academia,and private industry.
Thispiecemeal approachisastrategicweakness.
For now,the United States enjoys theglobal lead inbiotechnology,butitcannotremaincomplacent.Tosecureitsstatus,thecountrymust abandon its reactive approach to biotechnology andadoptaproactiveone.Anewpresidential administration in 2025, coupled with a growing senseofurgency amongpolicymakers about technologicalcompetitionwithChina,gives theU.S.governmenttheopportunitytoadopta concerted strategy.Thatstrategy shouldbegin with openly and urgently making biotechnology a national priority.
The relationships among industry, academia, and government are critical to leadership in biotechnology. And in the United States, government is the weak link.
Section 1.1
Establish a National Biotechnology Coordination Offce 08 Q ￥S
Federaldepartments andagencies performa wide range of activitiesthat advance biotechnology, suchas conducting research and regulating biotechnology products.While valuable, these eforts are fragmented and lack a common understanding of how the federal government should advance biotechnology to meet national goals. There is anurgent need for lasting coordination that would connect federal agencies,provide a long-term strategy,and de-duplicate redundant investments.
1.1aRecommendation
Congress must establish a National Biotechnology Coordination Office (NBCO) in the Executive Offce of the President (EOP) with a director, appointed by the President, who would coordinate interagency actions on biotechnology competition and regulation.
The U.S.government has previously tried to coordinatebiotechnologyefforts across agencies,butthese effortshavegenerallynotkeptpacewithscientific discovery occurring outside of government.o Additionally,noneoftheseeffortsdesignatedasenior official to oversee and advocate for biotechnology effortsinthefederalgovernment.
To coordinate interagency actions and unify the American effort to retain its lead in biotechnology, Congress must establish a National Biotechnology CoordinationOffice(NBCO)in theEOP.TheNBCO wouldoverseeinteragencyactivitiesrelatedtopromoting, protecting,and regulating biotechnology.The NBCO would be headed by a director, appointed by thePresident,to serve as theprincipaladvisoronbiotechnology.Thedirectorwould manageasmall staff thatwouldberesponsiblefortheoperationsofthe NBCOand an interagency committee.The director should bejointly appointed as a principal assistant director within the Office of Management and Budget (OMB)tooverseebiotechnology-related budgets acrossthefederaldepartmentsandagencies.
TheDirectorofthe NBCOwould primarily be responsible for:
creatingand maintaininga national
biotechnology strategy;
assessingthenational securityimplicationsof emergingbiotechnologies,includinganymajor needs or gaps;
providinglong-termstrategicguidanceon
biotechnologyR&D;
streamliningregulationofbiotechnologyproductsincoordinationwithregulatoryagencies (see recommendation 2.1a);
enablingpublic-privatepartnershipswithacademia andindustrythroughaneconomicdevelopment consortium;
identifying biotechnology workforce and training gaps acrossthefederal government(see recommendation5.1a);and
creatingand maintainingafederal websitefor thebiotechnologycommunity(biotech.gov)that wouldofferinformationaboutbiotechnologyfor the public,open opportunities for researchers, guidanceonbiotechnologyregulationsfor
developers, and more.
TheNBCO,asapartfitsresponsibilities,would submitanannualreporttorelevantCongressional committeeswithinformationonfederalefforts relatedtobiotechnology,a summaryoffederal biotechnology spending,and the NBCO's plans for thefollowingyear.Congresscould authorizethe establishmentofthedirectorandtheNBCObyeither amendingexistinglegislation orpassing a newbill The EOP should house the NBCO, and Congress should authorize and appropriatefunds to the NationalScienceFoundation(NSF)forits administration.There is precedent forthis model,which would provide consistent staffing and resources overtime.1
National Biotechnology Initiative
Awhole-of-nationinitiativetoadvancebiotechnologyforfood,health,economic,and nationalsecurities.
TheUnited StatesGovernmenthasnumerousbiotechnologyeffortsscatteredthroughoutthefederal departments and agencies,but there areno effortsto holistically address coordination.
Becauseofalackofcoordination,thereisno effective waytosee theprogress of America'sfull biotechnology landscape, coordinate and maximize researchinvestments,andidentifyassociated national securityimplications.
To solve thisproblem,we recommend establishing and funding the National Biotechnology Coordination Office (NBCO).
A NationalBiotechnologyInitiative,led bythe National BiotechnologyCoordinationOffice,will helpensure thattheUnitedStatesGovernment,in collaborationwithpartners inindustry and academia, ispreparedtoleadthebioindustiralrevolution.
National BiotechnologyCoordination Office
Interagency Coordination
Support interagency activitiesrelatedto biotechnology.
Chapter1
National Security
Assess national securityimplicationsof biotechnology.
Research& Development
Streamlinebiotechnologyregulations.
Regulation
Promoteresearch and developmentfor biotechnology across the interagency.
Section 1.2
Elevate Biotechnology Across the Executive Branch
1.2aRecommendation
Congress should direct each relevant agency to designate a senior official to lead biotechnology policy.
The National Biotechnology Coordination Office (NBCO)would coordinatebiotechnology efforts acrossthegovernmentandprovidestrategicleadershipfromtheWhiteHouse.Ultimately,thedepartments and agenciesthemselves areresponsiblefor the day-to-day implementation of biotechnology policiesandprograms.Butfewhavedesignated seniorleadersatahighenoughleveltoguidebiotech nologyactivitieswithintheiragency andrepresent theiragency'sviewpointsto theWhiteHouse.
To ensure that each agency has an appropriate champion ofbiotechnology,Congressshould direct relevantdepartmentsand agenciestodesignate a seniorleaderatthe assistantsecretarylevelorequivalenttooverseeandsteerbiotechnology-relatedwork in theirdepartments and agencies.The seniorleader should alsoserve as thedepartment'sprimary liaisonto the director oftheNBCO.
The Commissionidentified several opportunitiesto elevatebiotechnology acrossthefederal government, includingattheDepartmentofDefense(DOD),the Department of Energy (DOE), and the Department of Agriculture (USDA).
Section 1.3
Establish the Office of Global Competition Analysis and Include Foresight Capabilities
TosafeguardU.adershipincriticaltechnologies,theUnitedStatesneedstoassessclassifedpubliand commercialinformationtofullyunderstandwherethenationstandsinrelationtostrategiccompetitors suchas China.Only thenwould the United Statesbe abletomake informed policydecisions about howto strengthenits technology competitiveness.
1.3aRecommendation
Congress should establish the Office of Global Competition Analysis to develop timely data and technology forecasting to inform policymakers' decisions.
Currently,thereisnosinglefederal agencythatuses data-backedanalysestoevaluatetheentireglobal and domesticlandscapeofcriticaltechnologiessuch as biotechnology, artificial intelligence,and quantum computing.Yetthese technologies arevitalto U.S. economic prosperity and national security.
To fix this problem, in 2023, a bipartisan group of Senators introduced the Global Technology LeadershipAct(GTLA)(S.1873),whichwouldestablishthe Officeof Global CompetitionAnalysis (OGCA).2 While this bill has not been signed into law,itprovidesanimportantframeworkforhow theUnitedStatescanundertakeacompetitive analysistounderstanditsowncurrenttechnological vulnerabilities.
In additionto adoptingtheprovisionscovered by the GTLA,thegovernmentwould bewell served by activelyworkingtounderstandwhatthefutureof emergingtechnologiesmighthold.TheUnitedStates tendstoplaycatch-upaftercriticaltechnologies have alreadybecome mainstream.Rarely does the governmentproactivelyidentifyemergingtechnologiessothatitcanimplementpoliciestoensurethe UnitedStatestakesthelead indevelopingthem.
Policymakers already draw on"foresight capabilities" to explore potential scenarios inthefuture,so they canmakemoreinformedpolicydecisionsinthe
present.3 The Food and Drug Administration (FDA), forexample,regularlyconvenesexpertstobetter understand emerging medical devices and biologics (medications derived from living organisms or their cellular components).4TheFDA then usesthe informationgathered toprepareitsregulators and thereby accelerate the timeline for innovations togo to market.
The government's lack of a centralized foresight office,however,meansthatforesightpractitioners mustsetupsuchcapabilitiesfromscratch.Each agencyhastoinvestinsimilarresources and activities,wastingtimeandeffort.
Finally,thefederalgovernmentfailstosufficiently leverageitsvastnetworkofscientistsand technical expertsacrossvariousdepartmentsandagencies. Theirexpertisecould offertheUnitedStates a distinct advantage in foresight, especially foremerging technologies.
Toaddressthese shortcomings,Congress should establishtheOGCA,aSproposedintheGTLA,with an amendmenttoincludestrategicforesight aspart of its responsibilities.Doing so would position the United States to take a more informed,future-orientedapproachtotechnologicaldevelopment.
TheOGCA would havetwoprimary duties.First, itwouldconductcontinual short-andlong-term assessmentsoftheUnitedStates'global competitivenessintechnologyandinnovation.Todothis,the officewouldassesstheUnitedStates'researchand commercializationcapabilities,itspoliciestoward industry,and itsforeigndependencies,andthencomparetheseassetsand liabilitiestothoseofAmerica's strategic competitors.Toinformitsanalyses,the officewouldcollectrelevantinformationanddata fromfederal departmentsand agencies as well as obtaininformationfrom companies that maynot be publiclyavailable.
Second,the officewould hosta“strategicforesight library."Similartohowcommunitylibrariesprovide books, databases,journal subscriptions,and researchexpertise,butdonotconducttheresearch themselves,astrategicforesightlibrarywouldhelp federal departmentsand agenciesconductforesight studiesrelevanttotheirspecificmissions.
This library would:
acquire and maintainresources(such asproprietary datasetsand academicjournals)for departments and agenciesinterested in conductingforesight studies;
maintain a repository of past foresight exercisestocollect and sharebestpracticesand references;
conductoutreachtopromote awareness andadoptionofforesightamongfederal departments and agencies,including through a public-facingwebsite;and
establishacrowdsourcedforecastingplatform thatwouldtapintothecollectiveknowledgeof thousandsofscientistsandresearchersacross the federal government who are actively working on critical and emergingtechnologies.
Driving Biotechnology on Capitol Hil
TheUnitedStatesisonthecuspof a new industrial revolution, driven by biology, that will transform manufacturing,energy,agriculture,healthcare,and more.
This moment represents an inflection point for humanity's relationshipwith thenatural world,and by extensionhow we defend,build,nourish,and heal ourcountry.
The National Security Commission on Emerging Biotechnology was created to explore how emerging biotechnologiescanaffectournationalsecurityand recommendpathsforwardtoCongress.Gettingthis mandate right—ensuring that we producegood policy that resonatesnotonlywithCongressbutalsobuildsabright futureforthecountry—isanaudacioustask.Thecatalyzingforce forthis mission is the four members of Congress whoserveasCommissioners.
Chapter1
Our Congressional Commissioners have unique experiencesofservicetotheCommission.Theyalsohave uniqueassessmentsofAmericanstrengthinscienceand technology, what the stakes are in leading in biotechnology, andwhatisin storeforthe United Statesif Americagets this right.
The Wisdom in this Design
This bipartisan and bicameral advisory body,one that is time-limited and calibrated for highimpact,has a uniqueadvantage.Unlikemanypriorcommissions, this Commission includes two Senators and two Representativesfrom different parts of the country andacrossthepoliticalspectrum,alongsideother Commissioners.
“1 knew the Commission and its findings would have a lastingimpactonthelivesofAmericans,andIwantedto bepartofthatwork,SenatorToddYoung(R-IN) saidofhis appointment.SenatorYoungchairs the Commission and leans on his years of bipartisan work to lead the group.
Senator AlexPadila (D-CA) was likewise eagerto accept theappointment."Iwasexcitedtobeselectedtoserveon the Commissionto helppositiontheUnited States at the forefrontofshapingbiotechnologicaladvancements,"he said."The next generation ofemerging biotechnologies willplayamajorroleinsafeguardingournationalsecurity interests and inenabling sustainable solutionstoglobal challenges."
Prioritizing American Biotechnology
Our Congressional Commissioners are eagerto bring biotechnologyto theforefront of Congress and share the beliefthattheUnitedStatesisprimedtomeetthismoment and tolead the world in biotechnology.
"ThroughthisCommission,we are seekingtoplace newfoundemphasisonthisdomainsothatwecanadequately protect Americans and ourinterests,”said Representative StephanieBice(R-OK-05).Sucha critical missionrequires sharpbipartisanthinkingandbroadbicameralsupport.
Startingwith theFundamentals
Representative Ro Khanna (D-CA-17) sees better access toSTEMeducation as avital pieceofthenationalsecurity puzzle,saying“STEMeducation,and biologyeducation specifically,isessentialforAmerica'sfuture.Asbiotechnologycreatesopportunityandhighlightsnewrisks,a readyandcapableU.S.populationwillbecriticaltoensure safety and security.
"A bioliterate public willensure American leadership in the developmentandfieldingofcriticalnewcapabilitiesand enableustostayaheadofglobalthreats,"SenatorYoung added.Innovatingattheleadingedgeiswhatwillkeepthe United States ahead of its adversaries.
Putting Biotechnology toWorkforthe United States
PrioritizingAmerican leadership in biotechnology is also asavvyeconomicstrategy."Weneedtoprioritizeanew economicpatriotismthatrevitalizesAmericanproduction and lifts up the working class by embracing emerging biotechnologies,”said Representative Khanna.
"I worked hard to be a bridge in the legislative negotiations withmyRepublicancolleagues,”headded,highlightinghis collaborationwithSenatorYoungtohelppass the CHIPS and Science Act of 2022."That was a fantastic bipartisan moment,andnowtheCommissionisyetanotheropportunitytolookatagreatervisionforbuildingAmerica'sfuture.
"lt unlocked investmentsaround the countrytohelpaddress a national security vulnerability,"SenatorYoung said.
TheCongressional Commissionersseethisworkasvitalto get ahead of similar supply chain vulnerabilities in biotechnology,beforeanotherinvestmentatthescaleofCHIPS and Science is necessary.
"Americans want a modern national security strategy and moreinvestmentsathome,”maintainedRepresentative Khanna.
"That's where this report from the Commission comes in," SenatorPadilla said."Biotechnology is a strategic domain essential fortacklingourmost pressing challenges and being prepared forwhat the future will bring."
"We must bebetterpreparedtofacefuture threats,”" RepresentativeBice added."And wemust workdiligently toprotecttheAmericanhomeland."
Congress can and must take steps to strengthen and preparetheAmericanbiotechnologyenterprisetomeet any challenge.
ThisreportfromtheCommissionmaybetheculmination ofoverayearandahalfofwork,buttheworkcontinues beyond itspublication.HowCongressrespondsatthis criticalmomentwilldefinehowtheUnitedStatesout-innovatesstrategiccompetitors,leveragesthebenefitsof biotechnologyforournationaldefense,safeguardsour national security,and makesAmerica theleadingpartner forbiotechnology worldwide.
Chapter 2
Mobilize the Private Sector to Get U.S. Products to Scale
The United States'world-leading capital markets have long supported early-stage biotechnology companies,fuelingdiscoveryafterdiscovery.The Americanventurecapitalinvestmentecosystem isnearlythreetimesthesizeofthenextbiggest: China's.
But the U.S. emerging biotechnology industry facesmajorheadwinds.Afteraperiodofsignificantinvestment,investorslearned thehardway that"hard tech"industries like biotechnology areverydifferentfromindustrieslikesoftware, wheremarginsarenearlyinfinite andscalingis assimpleasbuyingmorecomputersandhiring morepeople.Hardtechlikebiotechnologyand semiconductorsrequirederiskingbothdesign andtechnology,followedbyacapital-intensive processofscalingupmanufacturingcapabilities. Many biotechnology products must then go through regulatory approvals,adding another step intheprocess.Finally,customersmustbuythe productinordertogeneraterevenueanddeliver returnstoinvestors.Forabiotechnologyproduct, movingfrom labtomarketislong andexpensive.
In the currenteconomic landscape,capital has becomescarcerandinvestorshavebecome moreriskaverse.Investorshavebecomemore cautious,inpartbecauseinterestrateshavegone up and in part because many promisingbiotechnologycompanieshavefailedtoproduceattractive returns. As a result, many biotechnology companiesthatlookedpromisingasrecentlyas the early 2020s are struggling to secure funding for subsequent investment rounds. Biotechnology companybankruptcieshita10-yearpeakin2023, leadingtonumerouscompanyclosures,layoffs, and restructurings.
Absentgovernment action,the commercial market will notproduce a biotechnologysectorthat alignswithbroaderU.S.national securityneeds. Threeproblemsstand out.
First, there is often a gap in funding as a company seeksthenecessaryinfrastructuretoscaleup. Venturecapitalistsarewillingtofundbiotechnologydevelopmentandprivateequityiswillingto fund expansiononce there is aprovenproduct, butbetween those two stages capital isharder to come by.In thatgap,novel technologies with strategicornationalsecurityimportance are at risk.
Second, emerging biotechnologies lack confident earlycustomers.Foranemergingtechnology,the first customer not onlytakes the risk of integrating anewproductorserviceintoitssupplychainsbut alsotheriskthataproductorservicewillnotbe delivered on time. Many buyers of biotechnology productsareothercompanieswithinalargely business-to-business(B2B)market,meaningthat biotechnology is often used to produce ingredientsandcomponentsforotherdownstream products.Thus,themarketisextremelysensitive todelaysindeliveryandbuyersarereluctantto commit to meeting their needs with biotechnology products.This reluctance,in turn,makes investors hesitant to bet on emerging biotechnology companies.
