\nModerna Therapeutics pioneered mRNA technology to develop vaccines and therapies that scale quickly, reduce \nWhile Moderna\u2019s work on Spikevax is critical, it is only one of the company\u2019s global initiatives. Moderna is \nTo facilitate these ambitious plans, Saxena and her team are automating manual processes and integrating \nTo increase overall agility, Saxena\u2019s team decided to streamline change control management, a costly and \nFor example, impact assessments, which measure the effect of changes on various product characteristics in \nModerna previously deployed ³Ô¹Ï±¬ÁÏ Registrations and ³Ô¹Ï±¬ÁÏ QMS, and because both applications use a common \nOn a fundamental level, the connection also gives both quality and regulatory departments a much better \nBy deploying the ³Ô¹Ï±¬ÁÏ Quality to RIM Connection, the regulatory team automatically sends country assessments \nHaving relevant quality and regulatory data and documentation in one place also reduced the risk of \nUsers can also access historical data to see what decisions were made so they can build on that information \nIn the future, Saxena plans to explore additional benefits that the connection could bring. For example, having 1<\/sup> Bancel,S.<\/a>, remarks made in ³Ô¹Ï±¬ÁÏ Quality to RIM Connection streamlines previously time-consuming and manual processes across regulatory and quality.<\/p>\n","protected":false},"featured_media":62676,"parent":0,"template":"","product-link-list":[1395,1428],"class_list":["post-65983","customer-stories","type-customer-stories","status-publish","has-post-thumbnail","hentry","product-link-list-veeva-commercial-cloud","product-link-list-veeva-medical-solutions"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/65983"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/customer-stories"}],"version-history":[{"count":3,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/65983\/revisions"}],"predecessor-version":[{"id":83938,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/65983\/revisions\/83938"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/62676"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=65983"}],"wp:term":[{"taxonomy":"product-link-list","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/product-link-list?post=65983"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nrisk, and adapt to different targets. So far, its efforts have paid off, as shown by the record-setting development
\ntimelines seen with Spikevax, its mRNA vaccine for COVID-19.1<\/sup>\n<\/p>\n
\ninvesting in overall R&D agility and nurturing its growing pipeline, which currently consists of 40 developmental
\nvaccines and therapies for rare and infectious diseases and oncology. Clear and consistent guidance from
\nsenior management and a mantra of \u201cscale and collaborate\u201d have helped them prioritize the projects that will
\nbring the most value, says Juhi Saxena, Moderna\u2019s associate director of regulatory and clinical platforms, who
\njoined the company during the COVID-19 pandemic.\n<\/p>\n
\nbusiness groups to improve collaboration. \u201cWe\u2019re a platform company and we believe in digitization and
\nintegration,\u201d she comments.\n<\/p>\nAutomating change control<\/h2>\n
\ntime-consuming process that involves regulatory and quality departments. Most companies still use manual,
\ndisconnected, and redundant change control processes that put companies at risk of noncompliance and can
\ndelay the launch of new therapies.\n<\/p>\n
\ndifferent locations, are cumbersome when approached with traditional tools and methods. At most companies,
\nthe assessment is first done in RIM but must be replicated in QMS. Tracking data and communications across
\nteams is difficult because data is typically stored on different spreadsheets in different countries, so there is
\nvery little transparency and a lot of manual effort.\n<\/p>\n
\ndata framework, Saxena\u2019s team had a unique opportunity to leverage the ³Ô¹Ï±¬ÁÏ Quality to RIM Connection. This
\nmade change control management more efficient by eliminating redundant manual processes and making data
\neasier to find and share. Both regulatory and quality can now initiate processes and transfer data to each other
\nin real time, empowering quality teams to make decisions sooner and based on the right information.\n<\/p>\n
\nunderstanding of each other\u2019s strategies, constraints, and operations. Previously, workflows involving the two
\nteams required several rounds of back-and-forth communication. Now, the process is well defined and
\nconsistent, and users must follow specific steps within a certain amount of time, Saxena explains.\n<\/p>\nThe benefits of connection<\/h2>\n
\nto the quality department. \u201cNow, the data points and relevant information don\u2019t have to be requested, or sit in
\nsomeone\u2019s inbox for two days,\u201d Saxena says. This has significantly reduced the time required to assess regional
\nimpacts of manufacturing or other changes and send that information on to the supply chain and quality
\ndepartments so that they can perform lot distribution.\n<\/p>\n
\nnoncompliance, Saxena explains. \u201cWe have a proper audit trail in place, and if we need to, we can always go back
\nand see which action was performed when and by whom. Beyond its compliance benefits, the connection
\nfacilitates the development of better processes for strategy and CMC within the regulatory department, and for
\nsupply and distribution within the quality department,\u201d she adds.\n<\/p>\n
\nwhen they encounter a change for the same drug product or one from the same product family.\n<\/p>\n
\naccess to historical data could lend itself to developing predictive models that would improve future regulatory
\nand quality decisions based on what has worked well in the past. For now, the ³Ô¹Ï±¬ÁÏ Quality to RIM Connection
\nhelps reduce manual and redundant tasks, allowing Moderna\u2019s teams to focus on patients and adapt to changing
\nwork processes as the company and its pipeline of therapies and vaccines continue to grow2<\/sup>.\n<\/p>\n
\n
\n\u201cCOVID-19 Vaccine Development and Its Enduring Impact on Life Sciences Innovation, Speed,
\nClinical Trial Advancement, and Collaboration,<\/a>\u201d Galien Foundation Forum, October 29, 2020
\n2<\/sup> Byrne J., \u201cModerna to expand commercial network across six additional countries in Europe\u201d, Biopharma-Reporter,
\nFebruary 17, 2022.
\n<\/footnotes><\/p>\n","protected":false},"excerpt":{"rendered":"