BURLINGAME, Calif., Feb. 05, 2025 (GLOBE NEWSWIRE) -- In an industry-defining moment, Accumulus Synergy (“Accumulus”) has powered Amgen’s groundbreaking regulatory submission: the first-ever, digitally generated Chemistry, Manufacturing, and Controls (CMC) Post Approval Change (PAC) dossier, delivered to the Reference Country and nearly two dozen participating Reliance countries, simultaneously. This transformative achievement aims to redefine the regulatory landscape by accelerating global approvals while setting a new benchmark for transparency and efficiency.
Leveraging the Accumulus platform, the digitally generated dossier created by Amgen using its proprietary AI and novel Structured Content and Data Management (SCDM) software is being reviewed by the Reliance Reference Country and all participating regulators at the same time. This means that every jurisdiction involved has real-time access to all regulatory information, from submission details to ongoing questions, answers, and updates, as it becomes available. This transparency not only has the potential to accelerate review timelines but also to pave the way for a fully digital regulatory ecosystem.
“For the first time ever, sponsors are able to submit a single, digital, global dossier to multiple regulators around the world with just a click of a button,” said Francisco Nogueira, CEO of Accumulus. “The Accumulus platform isn’t just a technological advancement, it’s a reimagining of regulatory processes which could ultimately lead to patients receiving the treatments they need sooner.”
With this submission, Accumulus and Amgen have taken a crucial first step in redefining the Reliance concept. Unlike conventional Reliance projects where regulators must wait for the Reference Country’s completed review to gain access to critical data, Amgen is utilizing the Accumulus platform to democratize information in real-time to all participating regulators, equipping all stakeholders with the same information at the same time.
Leveraging the Accumulus platform’s cutting-edge digital innovation and the transformative power of Reliance pathways, Accumulus and Amgen are working to minimize CMC variances caused by lengthy registration timelines and diverging regulatory requirements, addressing one of the most persistent challenges in global regulatory filings. This approach aims to realize more efficient review and approval timelines, the return of facility capacity to sponsors, and accelerated access of medicines to patients globally.
“As a company dedicated to innovation, this is a proud moment for Amgen. Simultaneous regulatory submissions through the cloud could lead to faster reviews, approvals, and accelerated access to medicines for patients who need new treatment solutions,” said Mark Taisey, Senior Vice President Global Regulatory Affairs, Amgen. “Using Amgen’s proprietary AI and SCDM software, we are looking forward to the next step in the industry’s digital evolution. By moving to cloud-based digital dossiers, we’re unlocking the true potential of digital transformation in regulatory collaboration. Democratized access to information ensures that every country, regardless of its role in the Reliance process, has the tools and data needed to drive faster decisions.”
“As Accumulus continues to lead the charge in global regulatory transformation, it remains committed to creating a faster, more transparent, and collaborative future,” added Nogueira. “We’re not just talking about the future of regulatory submissions; we’re actively creating it. Our Platform is reshaping how information is shared, how regulators and industry collaborate, and how approval timelines are accelerated, all with an unwavering commitment to the highest standards of compliance and security.”
About Accumulus Synergy
Accumulus Synergy is a global, nonprofit industry association developing a transformative data exchange platform that aims to enable enhanced collaboration and efficiency between life sciences organizations and global Regulatory Authorities while also affording users the ability to extract dynamic, data-driven insights. Accumulus is working with key stakeholders in the life sciences – regulatory ecosystem to build and sustain a platform that aims to meet regulatory, cybersecurity, and privacy requirements spanning clinical, safety, chemistry, and manufacturing and regulatory exchanges and submissions. Accumulus Synergy Sponsors include leading global pharmaceutical companies.
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E: allison.mari@accumulus.org
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