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HOW BUILDING ADIGITAL BIOTECHIS MISSION-CRITICALTO MODERNAINTRODUCTIONWe are living in a unique time in which the world is changingfaster than ever. This largely is due to an influx and infusionof digital technologies that are reinventing and reimaginingbusinesses across nearly every sector, and dramaticallyshifting societal and economic interactions. While the lifescience industry has, to some extent, adopted variousdigital technologies, it has not had a significant digitaltransformation in how it does business.Most life science companies were in existence before thedigital age, so they have the daunting task of integratingdigital solutions with complex business and organizationalstructures and with legacy technology. In addition, thenature of those companies’ R&D and manufacturing isquite heterogeneous. The companies comprise a medley ofscientific and drug technology platforms across and evenwithin therapeutic areas, hindering opportunities to digitallytransform the business.For younger emerging biotech companies ‘growing up’ inthe digital age, incorporating digital technologies may not beas arduous a task. However, becoming fully digital is both anexpensive and deliberate prospect. With corporate and R&Dprojects vying for resources, heavy investments in digitalinitiatives may fall low on the priority list. Moreover, mostemerging companies are advancing just a handful of drugsin their pipeline and typically doing so in a sequential fashion.So, the need to integrate multiple R&D and/or commercialprograms is not a paramount or even a relevant concern.AT MODERNA, BUILDING A DIGITAL BIOTECH IS AFOUNDATIONAL COMPONENT OF WHO WE AREAND A KEY ENABLER OF WHAT WE ARE TRYING TOACCOMPLISH.The “why” for Moderna starts with our mission: Deliver onthe promise of messenger RNA, or mRNA, science to createa new generation of innovative medicines for patients.Our mRNA medicines are derived from our core mRNAplatform technology and, hence, all fundamentally work thesame way to elicit a similar end result; they direct cells in thebody to make proteins to prevent or fight disease.Our strategy at Moderna is focused on advancing mRNAmedicines across many therapeutic areas and diseasessimultaneously using mRNA as a medicine. Broadlyexploring the potential of our mRNA technology to addressmany diseases simultaneously requires a digital modelthat deeply transforms how we design and manufacturemedicines.This model elicits a cycle of continuous data generation,analysis and learnings, which in turn, inform and acceleratefuture R&D efforts. We are seeing this on two levels:The first is within modalities. For example, withinthe prophylactic vaccines modality, there is researchunderway at Moderna, Merck, NIH and other collaborators.Scientists take learnings and data readouts from preclinicalexperiments, GLP toxicology studies and clinical results tomake ongoing and future efforts move faster, with higherquality and less risk.The second is between and among modalities. ScientistsCopyright, Moderna, Inc. 20201

across the ecosystem have access to real-time data andinformation; learnings in one therapeutic area often arereapplied to another therapeutic area.We rely on digitization to ensure seamless integration acrossthe ecosystem, the ability to share and access data and thecapability to scale and satisfy an ever-increasing demand forresearch mRNA for preclinical and GLP toxicology studies,as well as GMP mRNA to supply an expanding number ofclinical studies.Enabling a 20-year innovation cycleWe believe we are at the beginning of a 20-year mRNAinnovation cycle that most technologies go through beforetheir performance has been optimized. We hope to findearly successes and advance ongoing improvements tothe technology that will permit an ever-greater number ofopportunities as we invest in the platform.Achieving success involves several factors, including learningthe fastest and scaling rapidly, all while maintaining thehighest quality. The only way to ensure this will happen isthrough digitization. Since Moderna’s inception, we haveinvested over 100 million on our digital technologies,robotics/automation, analytics, data science and AI.Given our growth, we expect we will invest more than 100million in digital over the next 5 years.Benefits of DigitizationQUALITY: Reducehuman errors by enablingautomation, repeatabilityand seamless integrationwherever possible.SPEED: Provide largequantities of mRNA acrossthe ecosystem in a rapidtimeframe to permit theacceleration of rationalmRNA drug design and togather, analyze and sharedata in real time to informdecision making.Digitization Building Blocks1) Cloud enablement is a must-have component of ourdigital infrastructure. Our science is rich in complex datasets, and our scientists need computational power, agility tooperate, cost effectiveness and efficiencies in organizing andprocessing data without being hindered by the limitations oftraditional computing technology.2) Integration includes looking for every opportunityto bring our processes and data together in a consistentmanner, avoiding ‘silos of information’ and manualintervention. This flow of data between systems,internally and/or externally, enables the automation of ourbusiness processes and the real-time synchronizationof our operations. Many companies struggle due tolegacy systems, siloed data and processes and inherentinefficiencies. To that end, as we grow, we have beenorganizing and managing our data around systems ofrecords. These data are then shared and synchronized,enabling real-time data correlations and other learnings.3) Internet of Things is based on smart, interconnecteddevices producing information about their environmentsand operations. This immense new source of data frominstruments and environments provides real-time guidanceCopyright, Moderna, Inc. 2020SCALABILITY:Accommodate an everincreasing number ofmRNA R&D programswithin and acrossmodalities.COST: Create aninfrastructure that can beleveraged across all R&Dprograms to maximizeefficiencies.to our scientist and engineers and helps us in supplychain and manufacturing with compliance and traceability,including tracking material, controlling inventory andoptimizing instrument usage.4) Automation is radically transforming businesses anddriving a new technology-driven revolution worldwide. Withthe help of robotics, we reach an unprecedented levelof automation that increases our operations’ accuracy,repeatability and throughput, and reduces human errors,dramatically improving our quality and compliance.5) Analytics are necessary to harness the power of ourdata. Using the latest tools and analytical methods, wehave designed an environment that enables us to undertakeany kind of analysis. Having rich and complex data readilyavailable enhances our capability to generate scientific andbusiness insights to make informed decisions.6) Artificial Intelligence (AI) is enabling keybreakthroughs in analytics and predictive modeling thathelps accelerate our learning cycle drastically, providing uswith critical insights into research and production data thatwere otherwise inaccessible and unachievable.2

OUR DIGITIZATION STRATEGYOUR BUSINESS STRATEGY is to advance a broad arrayof mRNA medicines for many diseases simultaneouslyto deliver on the promise of mRNA science for patientsas quickly as possible. Central to this strategy is theenablement of parallel progress and shared learning, byvirtue of a digital infrastructure, built from the groundup, that exploits the inherent replicability of mRNA and itssoftware-like features. As a result, scientists at Moderna andour collaborators are progressing dozens of mRNA R&Dprograms concurrently.Our digital team works closely with their businesscounterparts, defining a digital way of operating that reducesunnecessary process complexity, uses AI to augment ouranalytics, and incorporating automation. We designedsystems from the ground up to use cloud services and tointegrate seamlessly. We organize and manage our dataaround systems of records with related data sets, that arethen shared and synchronized to enable real-time utilization.needs of our technical and scientific efforts – our ResearchEngine and our Early Development Engine.Our Research Engine is designed to move many mRNAresearch programs simultaneously from concept todevelopment candidate nomination. Our Early DevelopmentEngine then advances development candidates throughclinical studies to human proof-of-concept. Each has uniquerequirements as well as the need for continuity between thetwo engines, we utilize both internally developed softwareand algorithms and standard off-the-shelf solutions. Internalsoftware and algorithms support the high need for specificityand differentiation in research as well as the frequentchanges that require short delivery cycles. Off-the-shelfsolutions, including innovative emerging technologies, arethen integrated to ensure seamless business processes.We have two core “engines”, highly adapted to the uniqueRESEARCH ENGINE DIGITIZATIONOUR SCIENTIFIC DIGITAL ENVIRONMENT prioritizes two goals, the rational design ofmRNA medicines and the acceleration of programs through research.Research ning and Ordering mRNAOur scientists turn ideas into mRNA designs using a suiteof tools called the Drug Design Studio (DDS). DDS containsa sequence design app that allows scientists to build novelmRNA sequences using a library of existing sequencecomponents or ones they import. Embedded AI algorithmsconvert amino acid sequences into nucleotide sequencesand optimize a sequence for production.Our existing algorithms use heuristics learned from yearsof accumulated knowledge around the interactions ofmRNA sequence with both production yields and proteinCopyright, Moderna, Inc. 2020expression. Our next generation mRNA and protein designalgorithms use neural networks to incorporate largepublic datasets with our proprietary data to find emergentrelationships to improve our mRNA performance.Once designed, mRNA is sent to our Preclinical Productionteam using the DDS Ordering app, which configures theideal properties for both mRNA and formulations. DDSOrdering automatically performs several AI sequence qualitychecks and optimizations before sending the order toPreclinical Production.3