Accumulus Synergy

🚀 In partnership with CEPI (Coalition for Epidemic Preparedness Innovations), we’re proud to announce the launch of a new regulatory preparedness pilot! 🌍This initiative brings together 19 national regulatory authorities (NRAs) and other organizations to collaboratively review technical best practices documentation developed by a global group of vaccine experts from industry and academia. ☁️Leveraging the Accumulus cloud-based technology platform, the pilot will demonstrate how transparent, parallel reviews can dramatically improve collaboration in scientific advice-like procedures. This approach will aim to align developers and regulators ahead of potential emergencies and build critical shared understanding that can be applied during public health crises, ultimately leading to more efficient regulatory reviews and expedited access to vital vaccines. 🧪Participating experts from NRAs and organizations include Australia, AVAREF, Brazil, Canada, Egypt, El Salvador, European Vaccine Hub, Ghana, India, Indonesia, Japan, Malaysia, Senegal, South Africa, United Kingdom, United States, Singapore, South Korea, and Zimbabwe. Stay tuned for the outcomes and lessons learned from this innovative pilot!

It was an honor to present on "Digital Transformation in Regulatory Tools and Dossier Submission" during #RAPSEuroConvergence 2025. The conversation around regulatory modernization is accelerating—and it’s inspiring to see so many changemakers leaning into what’s next. Thank you to all who joined the session and to the #RAPS team for creating space for these important conversations. #AccumulusSynergy #RegulatoryTransformation #LifeSciencesInnovation #RAPS2025

👏 Thank you to everyone who joined our webinar last week! With record-breaking attendance, it's clear that the future is now. And, a special thank you to Michael Abernathy for being our featured guest and for candidly sharing the #Amgen experience. 🌐 Earlier this year, Amgen used the Accumulus platform to submit industry’s first digitally generated #dossier to nearly two dozen countries—simultaneously. Powered by the Platform's one-click solution, Amgen is on track to reduce global approval timelines from 4+ years to under 1 year—with a stretch goal of under 6 months. 📣 Hear Mike speak to this ambitious goal—and the estimated $10M+ cost benefit for just a single change. ➡️ The time is now to accelerate critical therapies to citizens of the world. Stay tuned as we share webinar highlights, key takeaways, and more in the coming days! 💻 Ready to get started? Visit https://lnkd.in/ermMiSEi for more information. #RegulatoryInnovation #DigitalTransformation #LifeSciences #GlobalSubmissions #HealthTech #AccumulusPlatform #Accumulus

Join our Director, Regulatory Innovation Strategy & Policy, Ashley Jones-Mitchell at #RAPSEuro Convergence! You can find her on Thursday, May 15th during the "Digital Transformation in Regulatory Tools and Dossier Submission" session where she will be talking all things dossier evolution. If you are interested in learning more about the opportunity to move from #dossier submissions to data submissions, make sure to add this session to your plans! #RAPS #accumulus #accumulussynergy #datasubmissions #regulatoryinnovation

📅 Last week, #Accumulus had a unique opportunity to participate in a Congressional Fly-In, in DC, organized by the #AllianceforaStrongerFDA. Participants in the Fly-In included leaders from life sciences organizations, food industries, trade associations, and patient advocacy groups. Among other important topics, members of our team highlighted: ▪️ The critical importance of modern, innovative #ITinfrastructure in improving #regulatoryefficiency  ▪️ The value of secure data-sharing, both within the #FDA and across agencies like #NIH To learn more about the Alliance for a Stronger FDA, visit: https://lnkd.in/gatr-8xQ

Don't miss out. Join Francisco Nogueira, Michael Abernathy, and Dominique Lagrave on Wednesday, May 7th at 10 AM ET for The Accumulus Platform Advantage: How Leading Pharmaceutical Companies Are Unlocking Millions in Value! There is still time to register: https://lnkd.in/e4fx3NGj

📰 Accumulus Synergy Featured in “The Future of Regulatory Filings: Digitalization”: https://lnkd.in/ei2X62_Y 🔦 We’re proud to be highlighted in the latest AAPS Open publication, which explores the need for digital transformation in regulatory processes across the biopharmaceutical industry. While drug development has evolved rapidly, regulatory submissions still rely heavily on manual, document-driven workflows—resulting in delays and inefficiencies. The article outlines key enablers of transformation: ➡️ Structured Content and Data Management (SCDM): Organizes data into reusable components to reduce errors and streamline submissions ➡️ Artificial Intelligence (AI): Improves regulatory forecasting and decision-making through advanced data analysis ➡️ Cloud-Based Platforms: Enable real-time collaboration between sponsors and regulators, accelerating review cycles ➡️ Standardized Data Formats: Support global harmonization via PQ/CMC, ISO IDMP, and HL7 FHIR 🌐 At Accumulus, we are proud to be a leading cloud technology provider reimagining how life sciences organizations and national regulatory authorities work together to accelerate cycle times from drug discovery through global availability. With a focus on innovation, trust, and impact, we are leading the future of digital transformation - connecting the global regulatory ecosystem through a single, scalable solution. #DigitalTransformation #RegulatoryInnovation #CloudTech #LifeSciences #AccumulusSynergy #StructuredData

90% acceleration. Multi-million dollar cost benefit. One-click solution for an instant and simultaneous #dossier submission to multiple regulators around the world. These are just some of the benefits that leading pharmaceutical companies are realizing when using the #Accumulusplatform to power their submissions, and we want to invite you to hear more! Join Accumulus CEO, Francisco Nogueira, for an exclusive webinar, "The Accumulus Platform Advantage: How Leading Pharmaceutical Companies Are Unlocking Millions in Value," featuring Michael Abernathy from #Amgen.   During this live event: -We’ll take you behind the scenes of a groundbreaking milestone: the successful submission of industry’s first digitally generated dossier—delivered simultaneously to nearly two dozen countries using the Accumulus platform -Offer practical insights and real-world outcomes that you won’t want to miss -Give you the opportunity for question and answers   This webinar is for you if: -You’re looking for ways to realize more efficient review and approval timelines to expedite access of medicines to patients globally -You want to accelerate global submissions to meet every patient, every time -You're curious to hear about the real results of submitting a single, digital, #globaldossier to multiple regulators around the world with just a click of a button   Secure your seat today: https://lnkd.in/e4fx3NGj (Note - Results will vary by customer and submission. Information is representative of in-progress and completed projects.) #regulatoryinnovation #globalhealth #regulatorycollaboration #reliance #harmonization

Earlier this month, #Accumulus hosted a workshop centered on the role of regulatory collaboration and data exchange in accelerating access to therapies for individuals living with rare diseases. A big thank you to our participants and co-hosts, Lina AlJuburi and E. Cartier Esham, Ph.D.! This session brought together a diverse group of participants committed to improving the way critical data and insights flow in drug development. Together, we: 🔍 Identified persistent challenges in data and information exchange, including data privacy and security concerns, lack of standardization and harmonization, and the need for stronger cross-stakeholder coordination. 💬 Shared perspectives on how smarter, more collaborative data sharing can directly benefit rare disease communities by speeding up treatment discovery and fostering stronger research networks. 🌱 Imagined a future of rare disease drug development that is more connected and efficient, with greater alignment between clinical trial sponsors, regulators, and other healthcare stakeholders. As we continue the conversation, Accumulus plans to expand the dialogue to include the voices of other groups such as contract research organizations (#CROs) and #patientcommunities. Stay tuned for future discussions and opportunities to get involved!  #RareDisease #LifeSciences #DataSharing #HealthcareInnovation #ClinicalResearch #PatientCentricity  

🌐 90% acceleration. Multi-million dollar cost benefit. One-click solution for an instant and simultaneous #dossier submission to multiple regulators around the world. These are just some of the benefits* that leading pharmaceutical companies are realizing when using the #Accumulus platform to power their submissions, and we want to invite you to hear more! ➡️ Secure your seat today: https://lnkd.in/e4fx3NGj 📅 Join Accumulus CEO, Francisco Nogueira, for an exclusive webinar, "The Accumulus Platform Advantage: How Leading Pharmaceutical Companies Are Unlocking Millions in Value", featuring Michael Abernathy from #Amgen.   🖥️ During this live event: - We’ll take you behind the scenes of a groundbreaking milestone: the successful submission of industry’s first digitally generated dossier—delivered simultaneously to nearly two dozen countries using the Accumulus platform - Offer practical insights and real-world outcomes that you won’t want to miss - Give you the opportunity for question and answers   ✅ This webinar is for you if: - You’re looking for ways to realize more efficient review and approval timelines to expedite access of medicines to patients globally - You want to accelerate global submissions to meet every patient, every time - You're curious to hear about the real results of submitting a single, digital, global dossier to multiple regulators around the world with just a click of a button   ➡️ Secure your seat today: https://lnkd.in/e4fx3NGj (*Results will vary by customer and submission. Information is representative of in-progress and completed projects.) #accumulussynergy #regulatoryinnovation #webinar