OSLO, Norway and BURLINGAME, Calif., Dec. 10, 2024 (GLOBE NEWSWIRE) -- Accumulus Synergy’s innovative cloud-based data-sharing platform could accelerate access to vaccines and other health technologies by enabling multi-country regulatory submissions and expediting regulatory review and approval, potentially helping to end future emerging infectious disease outbreaks swiftly and more equitably.
Supported by $19.1 million in funding from CEPI, the regulatory collaboration platform developed by global non-profit Accumulus Synergy, could enhance access to medical countermeasures by bolstering information equity. The platform seeks to enable regulatory authorities—responsible for approving new health products—to simultaneously review standardised, pertinent data on vaccine safety, efficacy and quality, allowing them to approve a health product based on that shared assessment—a process known as ‘reliance.’
In pursuit of improving regulatory readiness and expediting vaccine authorisation during public health emergencies, CEPI is building a global regulatory preparedness framework that leverages Accumulus’ platform for real-time collaboration and providing information equity that has been historically absent in many countries.
The COVID-19 pandemic highlighted the need for regulatory reform as access to essential health technologies in many cases was often delayed due to challenges within the existing regulatory system, including duplication of efforts, limited capacity and inequitable access to data required to approve medicines in Global South countries. All of these are underscored by the limited sharing of assessment reports between regulatory authorities.
“The CEPI-Accumulus partnership provides a unique solution to the challenges of pandemic preparedness by enabling seamless collaboration between regulatory authorities, industry stakeholders, and global health organisations across the world,” said Adam Hacker, Director and Global Head of Regulatory Affairs and Quality at CEPI. “The platform will be instrumental in managing disparate regulatory systems by streamlining and expediting access to crucial information needed to rapidly approve potentially lifesaving vaccines, helping us to stay ahead in the fight against pandemics.”
“Our partnership with CEPI is about more than just readiness; it's about creating a cohesive, global response network that leaves no one behind,” added Frank Nogueira, CEO of Accumulus. “Together, we are creating a new paradigm for emergency preparedness—one that prioritises speed, accuracy, and global coordination. With CEPI’s financial support, we will continue advancing our platform to ensure critical therapies reach those who need them faster than ever before.”
The CEPI-Accumulus partnership further enables the Accumulus platform to be available at little to no cost for regulatory authorities in Global South countries and increases access for developers in those countries and certain CEPI awardees, particularly in the case of a Public Health Emergency of International Concern. By equipping regulatory bodies in resource-limited settings with this cloud technology, this collaboration ensures that every nation, regardless of economic status, can contribute to and benefit from a unified global health response.
The project will start with a pilot of the platform with seven regulatory authorities to explore best practices to support vaccine developers in public health emergencies. The hope is that by bolstering regulatory preparedness now, when the next public health emergency strikes, the Accumulus platform will harness learnings from the preparedness phase to expedite approval and access to medical countermeasures during an emergency. This level of preparedness will support CEPI’s 100 Days Mission, a goal—embraced by leaders of the G7 and G20—to deliver pandemic-beating vaccines in as little as 100 Days.
About CEPI
CEPI was launched in 2017 as an innovative partnership between public, private, philanthropic and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic disease threats and enable equitable access to them. CEPI has supported the development of more than 50 vaccine candidates or platform technologies against multiple known high-risk pathogens and is also advancing the development of rapid response platforms for vaccines against a future Disease X. Central to CEPI’s pandemic-beating five-year plan for 2022-2026 is the ‘100 Days Mission’ to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days.
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.
Media contacts
CEPI
E: press@cepi.net
P: +44 7387 055214
Accumulus Synergy
Email: allison.mari@accumulus.org
Tel: 540-907-6053
source: Accumulus Synergy
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