{"id":611011,"date":"2024-06-11T06:30:15","date_gmt":"2024-06-11T10:30:15","guid":{"rendered":"https:\/\/platohealth.ai\/veeva-rd-summit-ai-automation-and-collaboration-will-support-trials-of-the-future\/"},"modified":"2024-06-11T08:02:04","modified_gmt":"2024-06-11T12:02:04","slug":"veeva-rd-summit-ai-automation-and-collaboration-will-support-trials-of-the-future","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/veeva-rd-summit-ai-automation-and-collaboration-will-support-trials-of-the-future\/","title":{"rendered":"Veeva R&amp;D Summit: AI, automation and collaboration will support trials of the future","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"<div class=\"article-image\">\n<figure class=\"article-image__container\">\n<p>                                    <img decoding=\"async\" src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/06\/veeva-rd-summit-ai-automation-and-collaboration-will-support-trials-of-the-future.jpg\" alt><figcaption class=\"c-featured-image__description\">The Veeva R&amp;D Summit Europe was held in Madrid on June 4 and 5. Image credit: GlobalData<\/figcaption><\/figure>\n<\/p><\/div>\n<p class=\"drop-cap\">Artificial intelligence (AI), automation and collaboration were all topics at the forefront of discussion at the 10<sup>th<\/sup> Veeva R&amp;D Summit Europe.<\/p>\n<p>The summit, held at the Marriott Madrid Auditorium on June 4-5 was attended by 1,500 industry experts including sponsors, sites, contract research organisations (CROs) and patient advocates.<\/p>\n<p>Among those in attendance, it was clear there is a desire to use AI and automation to help speed up drug development, however there was acknowledgement that it needs to be used appropriately, so it does not end up increasing burden.<\/p>\n<p>There was also a desire for all those involved in drug development to collaborate seamlessly in all areas, including collaboration and conversations with regulators.<\/p>\n<h2 class=\"wp-block-heading\" id=\"h-ai-and-automation-place-in-data-management\">AI and automation place in data management<\/h2>\n<p>During the opening keynote, executives from Veeva spoke about the importance of using AI and automation across various areas of the R&amp;D cycle.<\/p>\n<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/06\/veeva-rd-summit-ai-automation-and-collaboration-will-support-trials-of-the-future-1.jpg\" alt=\"James Reilly, VP, Development Cloud Strategy.\" class=\"wp-image-207487\"><figcaption class=\"wp-element-caption\">James Reilly, VP, Development Cloud Strategy. Image credit: Veeva Systems<\/figcaption><\/figure>\n<p>James Reilly, VP, Development Cloud Strategy discussed how Veeva aims to work with customers\u2019 existing AI technologies by developing an application programming interface (API) which will allow data extraction to feed into warehouses and large language models.<\/p>\n<div class=\"gdm-company-profile-unit__container\" id=\"company_profile_form\">\n<p class=\"gdm-company-profile-unit__sub-heading\">Access the most comprehensive Company Profiles<br \/>\n            on the market, powered by GlobalData. Save hours of research. 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However, we want you to make the most<br \/>\n                        beneficial<br \/>\n                        decision for your business, so we offer a free sample that you can download by<br \/>\n                        submitting the below form\n                    <\/p>\n<p>                    <span class=\"gdm-company-profile-unit__text\">By GlobalData<\/span><\/p>\n<div class=\"reveal-form__wrapper\">\n<p>                                <small><\/small><\/p>\n<p>                            <small><\/small>\n                        <\/p>\n<p>                        <label for=\"consent-box\">Tick here to opt out of curated industry news, reports, and event updates from Clinical Trials Arena.<\/label>\n                        <\/p>\n<p>                            &lt;!&#8211;<\/p>\n<div class=\"form-consent__container\">\n<p>                                <label for=\"consent-box\">I consent to GlobalData UK Limited collecting<br \/>\n                                    my<br \/>\n                                    details provided via this form in accordance with the privacy<br \/>\n                                    policy<\/label>\n                            <\/div>\n<p>&#8211;&gt;<\/p>\n<p>\n                                <button id=\"form-submit-btn\" class=\"form-submit__button button primary solid\"><br \/>\n                                    Submit and<br \/>\n                                    download<\/button>\n                            <\/p>\n<p>                                    <span class=\"inline\">Visit our <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.verdict.co.uk\/privacy-policy\/\">Privacy Policy<\/a> for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.<\/span><\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<p>Avril England, general manager of Vault, <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.globaldata.com\/store\/report\/?cdmsid=1485403&amp;scalar=true&amp;utm_source=Features&amp;utm_medium=22-207472&amp;utm_campaign=company-profile-hyperlink-nonlgp\">Veeva Systems<\/a>, went on to speak about how automation will be integrated into regulation to <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.clinicaltrialsarena.com\/news\/veeva-summit-artificial-intelligence-automation-key-topics\/\">assist sponsors in flagging questions raised by regulators in trial submissions.<\/a><\/p>\n<p>Veeva has implemented a new feature to its regulatory system, Vault RIM, which allows users to annotate emails from regulators, with the notes then being used to create data records so that the regulator\u2019s concerns can be addressed. England went &nbsp;on to add that AI could also be helpful in this model.<\/p>\n<p>\u201cAI will play a logical role here as well. Could we use an AI tool to help assess what should be highlighted and making it another step easier?\u201d asked England.<\/p>\n<h2 class=\"wp-block-heading\" id=\"h-novo-nordisk-s-ai-plans\">Novo Nordisk\u2019s AI plans<\/h2>\n<p>In a panel discussion, <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.globaldata.com\/store\/report\/?cdmsid=1633801&amp;scalar=true&amp;utm_source=Features&amp;utm_medium=22-207472&amp;utm_campaign=company-profile-hyperlink-nonlgp\">Novo Nordisk<\/a> vice-president Ibrahim Kamstrup-Akkaoui spoke about how the company hopes that <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.clinicaltrialsarena.com\/news\/novo-nordisk-ambitious-plan-reduce-live-one-day\/\">AI will help in reducing trial set-up from final protocol approval (FPA) to go live to just one day.<\/a><\/p>\n<p>Kamstrup-Akkaoui said that the company is currently working on a four-week average, with hopes to drop this average to two weeks in the next year, and down to just one day in 2026.<\/p>\n<p>A push to just one day will take a lot of work, however Kamstrup-Akkaoui said that the company is utilising its DataNow team and AI systems as well as continue to harness its close relationship with CROs and partners to speed the process up.<\/p>\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"771\" src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/06\/veeva-rd-summit-ai-automation-and-collaboration-will-support-trials-of-the-future-2.jpg\" alt class=\"wp-image-207488\"><figcaption class=\"wp-element-caption\">A panel including Novo Nordisk vice-president Ibrahim Kamstrup-Akkaoui (L) at Veeva Systems R&amp;D Summit Europe. Image credit: GlobalData<\/figcaption><\/figure>\n<p>Also from Novo Nordisk, senior vice president Thomas Senderovitz spoke about how big pharma needs to have more involvement with <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.clinicaltrialsarena.com\/news\/veeva-summit-ai-regulation-pharma-needs-day\/\">agencies as they set AI regulation<\/a>.<\/p>\n<p>\u201cThe challenge is that you have different regulatory systems that do not always have the same view,\u201d Senderovitz explained.<\/p>\n<p>The <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.clinicaltrialsarena.com\/news\/scope-fda-fireside-chat-ai-drug-development\/\">US Food and Drug Administration (FDA)<\/a> is currently putting together draft guidance around the use of AI. Although the newest <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.clinicaltrialsarena.com\/news\/controlling-pharma-machine-ema-ai\/\">European Medical Agency<\/a> (EMA) Clinical Trials Regulation (CTR) documents do not include any mention of AI, it is something which the regulator is open to speaking with sponsors about.<\/p>\n<h2 class=\"wp-block-heading\" id=\"h-ai-to-investigate-alternative-indications\">AI to investigate alternative indications<\/h2>\n<p>Senderovitz also touched on how the company plans to use AI to increase what indications it will investigate for its lead candidate semaglutide.<\/p>\n<p>The company plans to use AI to look through additional data collected in completed and ongoing trials to highlight benefit in other indications.<\/p>\n<p>There have been <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.clinicaltrialsarena.com\/features\/glp1ra-beyond-obesity-diabetes-where-is-the-limit\/\">ongoing trials investigating glucagon like peptide 1 receptor agonists (GLP-1RAs) in indications<\/a> beyond type 2 diabetes, where Novo Nordisk\u2019s drug is approved as Ozempic, and obesity where the drug is approved as Wegovy.<\/p>\n<p>Trials have shown efficacy of the candidate in cardiovascular indications, even in patients without type 2 diabetes or obesity.<\/p>\n<figure class=\"wp-block-image size-large is-resized\"><img decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/06\/veeva-rd-summit-ai-automation-and-collaboration-will-support-trials-of-the-future-3.jpg\" alt class=\"wp-image-207490\"><figcaption class=\"wp-element-caption\">The Veeva R&amp;D Summit Europe was opened by Chris Moore, President of Veeva Europe. Image credit: Veeva Systems<\/figcaption><\/figure>\n<p>Other trials are investigating these candidates in central nervous system, genito urinary system, muscoskeletal disorders and nutritional disorders, and others.<\/p>\n<p>Despite there being a big push in the opening keynote to the utilisation of AI in R&amp;D, Young said that he does not believe that AI will be utilised in all areas.<\/p>\n<h2 class=\"wp-block-heading\" id=\"h-ai-must-be-a-solution-not-a-burden\">AI must be a solution, not a burden<\/h2>\n<p>When asked about whether AI would be used by Veeva to transfer data from a patient\u2019s electronic health records (EHR) to electronic data capture (EDC), Richard Young, vice president or Strategy Vault CDMS, at Veeva, said he was apprehensive about its usage here, adding it could actually add more burden to already over-stretched sites.<\/p>\n<p>\u201cSites are overburdened. We need to help our sites be genuinely better and faster. If we introduce AI within middlewares, it cannot just be to reduce costs and fees,\u201d explained Young. \u201cIt has to be an investment and it has to solve a problem.\u201d<\/p>\n<p>Young went on to say that his primary concern with using AI to extrapolate data from EHRs is whether that data has been entered correctly correct to begin with as once it is transferred, it will not be possible to edit that data.<\/p>\n<p>By having a human make that transfer, although it is more time consuming, it ensures that the data is accurate and does not add additional work for sites in having to ensure all the data transferred is accurate, Young added.<\/p>\n<p>There are however companies developing <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.clinicaltrialsarena.com\/news\/ai-rwd-avoid-replication-clinical-trials\/\">this kind of software<\/a> who argue that it does indeed make it easier for site staff, however it does require some human interaction to ensure accuracy.<\/p>\n<h2 class=\"wp-block-heading\" id=\"h-summit-closes-with-touching-tale\">Summit closes with touching tale<\/h2>\n<p>The summit ended with an emotional closing keynote from Terry Pirovolakis, CEO of Elpida Therapeutics talking about his journey to finding a treatment for his son Michael <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.clinicaltrialsarena.com\/news\/elpida-gene-therapy-phaseiii-trial-spg50\/\">who was diagnosed with Spastic Paraplegia Type 50 (SPG50).<\/a><\/p>\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"551\" src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/06\/veeva-rd-summit-ai-automation-and-collaboration-will-support-trials-of-the-future-4.jpg\" alt class=\"wp-image-207491\"><figcaption class=\"wp-element-caption\">Terry Pirovolakis, CEO of Elpida Therapeutics talking about his journey to finding a treatment for his son Michael. Image credit: Veeva Systems<\/figcaption><\/figure>\n<p>Pirovolakis and his wife were told that nothing could be done for Michael, however this answer was not good enough for the family.<\/p>\n<p>Pirovolakis went on to find researchers and fund the development of a gene therapy before setting up Elpida to move the candidate through the trial process.<\/p>\n<p>The company is conducting a Phase I\/II trial, with Michael being the first patient dosed. The company has plans to initiate a Phase III trial of its candidate, Melpida, in August 2024.<\/p>\n<p>Pirovolakis also spoke about how the company has purchased a number of dropped gene therapies for ultra rare diseases from sponsors and biotechs and will be looking to&nbsp;develop these.<\/p>\n<p>In a space where funding is low, Pirovolakis explained that the company will be selling a number of the <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.pharmaceutical-technology.com\/features\/inside-the-world-of-priority-review-vouchers-where-time-is-money-part-i\/\">priority review vouchers (PRVs<\/a>)&nbsp;for these candidates to big pharma companies and use the funds gained from these vouchers to help finance further development and clinical trials of the candidates.<\/p>\n<p><!-- Newsletter banner start --><\/p>\n<p>&lt;!&#8211;  &#8211;&gt;<\/p>\n<div class=\"grid-container\">\n<section class=\"gdm-newsletter-banner__container\">\n<div class=\"gdm-newsletter-banner__wrapper-container gdm-newsletter-banner__wrapper-container--article\">\n<div class=\"gdm-newsletter-banner-info__wrapper\">\n<div class=\"gdm-newsletter-banner-logo__container\">\n                    <img decoding=\"async\" src=\"https:\/\/www.clinicaltrialsarena.com\/wp-content\/themes\/goodlife-wp-B2B\/assets\/images\/newsletter-new.svg\" alt=\"Email newsletter icon\">\n                <\/div>\n<div class=\"gdm-newsletter-banner-info__container\">\n<h3 class=\"gdm-newsletter-banner__heading wp-noreslt\">Sign up for our daily news round-up!<\/h3>\n<p class=\"gdm-newsletter-banner__sub-heading\">Give your business an edge with our leading industry insights.<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<\/div>\n<p><!-- Newsletter banner end --><\/p>\n<footer class=\"article-footer\">\n                                <!-- article-actions start --><\/p>\n<p><!-- .gdm-article-actions -->                                <!-- article-actions end --><br \/>\n                            <\/footer>\n<ul class=\"plato-post-bottom-links\">\n<li class=\"plato-post-bottom-link-amplifi\">SEO Powered Content &amp; PR Distribution. <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.amplifipr.com\">Get Amplified Today.<\/a><\/li>\n<li class=\"plato-post-bottom-link-platodata-network\">PlatoData.Network Vertical Generative Ai. 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The summit, held at the Marriott Madrid Auditorium on June 4-5 was attended by 1,500 industry experts [&hellip;]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":611027,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[49],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/611011"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=611011"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/611011\/revisions"}],"predecessor-version":[{"id":611026,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/611011\/revisions\/611026"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/611027"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=611011"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=611011"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=611011"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}