Regulatory Authorities Around the World Engage as the Nonprofit Supports a Global Reliance Project
BURLINGAME, CA, February 8, 2024 – Accumulus Synergy, Inc. (“Accumulus”) is proud to announce that it has launched the initial version of its first-in-kind information and data exchange platform.
“Today marks the beginning of a new era for the life sciences – regulatory ecosystem,” commented Frank Nogueira, Accumulus Chief Executive Officer. “This release is the first step toward achieving our mission to dramatically accelerate critical therapies to citizens of the world. We believe that there has never been a better time to use advanced technologies to simplify regulatory interactions in service of patients. At Accumulus, we are bringing forward the much anticipated concept of “a dossier in the cloud” to support real-time information exchange between those that develop medicines and those that review and approve them.”
In a Roche-led Reliance Pilot that follows World Health Organization (WHO) principles of good reliance practices, Regulatory Authorities across six continents are using the Accumulus platform to submit questions and receive sponsor answers on a Post-Approval Change (PAC) submission. Since the Accumulus platform enables the Q&A to happen in a central, secure location that is visible to all participants, there is greater transparency among Regulatory Authorities, with the opportunity to drastically reduce the number of information exchanges between individual organizations.
“We are thrilled to actively participate in this groundbreaking initiative, proudly serving as the pioneer in piloting the Accumulus platform,” expressed Ralf Altenburger, Senior Vice President, Cell and Gene Therapy and Global Head of Pharma Technical Regulatory at Roche. “The prospect of streamlining the regulatory approval process across 48 countries holds immense promise. This advancement could potentially expedite access to cutting-edge medicines by nearly two years, offering a significant advance for patients facing life-threatening conditions such as breast cancer.”
Demonstrating responsible innovation is key to building trust and delivering on Accumulus’s commitment to democratize the platform for the entire life sciences – regulatory ecosystem. “While a Reliance Pilot in the post-approval space is a wonderful initial use case for showing the value of moving from one-on-one interactions to one-to-many interactions, the secure and compliant nature of the Accumulus platform will be broadly applicable across the regulatory lifecycle,” noted Jacques Mascaro, Chair of the Accumulus Board of Directors and Senior Vice President, Global Head of Oncology Regulatory Science, Strategy & Excellence at AstraZeneca. “The launch of the platform moves the Accumulus mission from concept to reality.”
To learn more about platform access and the different ways to engage with Accumulus Synergy, please email [email protected].
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 Amgen, Astellas, AstraZeneca, Bristol Myers Squibb, GSK, Johnson & Johnson, Lilly, Merck, Pfizer, Roche, Sanofi, and Takeda.