Resource Taxonomy: News

BURLINGAME, Calif., August 4, 2025 — In a bold move to accelerate regulatory innovation and meet growing global demand, Accumulus Synergy, a nonprofit industry association, today announced the formation of Accumulus Technologies, a new commercial technology company created to scale and evolve the Accumulus platform (“Platform”)—a secure, cloud-based regulatory connectivity solution originally incubated within Accumulus Synergy and launched in 2024.

The spinout includes both the transfer of the Accumulus platform and the team responsible for its development, representing a strategic step toward broader Platform adoption and deeper support for the life sciences – regulatory ecosystem. Accumulus Technologies will lead the ongoing advancement of the Platform to meet growing global demand.

“The Accumulus platform has reached a critical point in its trajectory, and the opportunity to expand its impact and reach has never been greater,” said Francisco Nogueira, CEO of Accumulus Technologies. “By spinning out Accumulus Technologies, we are doubling down on our commitment to serve the entire life sciences regulatory ecosystem—regulators, sponsors, and patients around the world—with greater agility. This is about building the infrastructure the world needs to bring therapies to patients faster, no matter where they live.”

A Proven Platform Ready to Scale

Built to further enhance regulatory exchange, the Accumulus platform provides a shared digital environment where life sciences organizations and regulatory authorities can engage in real time, with simultaneous access to regulatory content and submissions.

With more than 60 countries already having access, the Platform is supporting modern regulatory approaches such as reliance, work sharing, and simultaneous global submissions, helping to shorten approval timelines by up to 90%, while advancing the longer-term goal of a converged, digitally enabled global regulatory ecosystem.

“The broader ecosystem is making significant strides in its own digital transformation—adapting new technologies, embracing innovation, and advancing shared goals of greater efficiency and access,” commented Nogueira. “As part of this global movement, Accumulus Technologies aims to serve as a strategic enabler, providing the infrastructure and tools needed to support collaborative, technology- driven regulatory progress at scale.”

Mission Continuity, Commercial Agility

Accumulus Technologies will continue to pursue the core purpose that guided the Platform’s development: enabling faster, more connected regulatory collaboration to accelerate access to therapies globally. The new company will lead the development, delivery, and advancement of the Platform, with the autonomy to raise capital, forge strategic partnerships, and offer enhanced services such as integration, implementation, and advisory support.

Accumulus Synergy will continue as a nonprofit industry association focused on advancing regulatory policy supporting digital transformation through cross-sector collaboration between industry, policymakers, and technology developers. While the two entities will operate independently, both are aligned in their aim to improve regulatory connectivity and patient access on a global scale.

Led by a Proven Team

Accumulus Technologies will be led by the team from Accumulus Synergy that helped to bring the Platform to life, ensuring continuity, momentum, and deep industry knowledge:

• • Francisco Nogueira, Chief Executive Officer
• • Chanille Juneau, Chief Product and Technology Officer
• • Jack Quigley, Chief Operating Officer
• • Jillian Wein Riley, Chief Legal Officer
• • Kevin Charest, Chief Information Security Officer
• • Dominique Lagrave, Chief Regulatory Officer
• • Nahed Khairallah, Chief People Officer

Nogueira will continue to serve as CEO of both Accumulus Synergy and Accumulus Technologies during a transition period working closely with the regulatory, policy, and advocacy team, after which a new CEO will be appointed to lead the nonprofit association.

A Future-Ready Platform for Global Users

Looking ahead, Accumulus Technologies will continue expanding platform capabilities—including intelligent tools to streamline regulator questions, multilingual support, and broader use cases from discovery through post-approval. The company also sees opportunity in adjacent markets, such as medical devices, biosimilars, and generics, and aims to meet growing global demand with speed and flexibility.

“Every day matters when patients are waiting for life-saving therapies,” Nogueira said. “The long-term vision remains clear: to build a globally connected regulatory ecosystem where innovation moves at the speed of science—and patients, regardless of geography, gain timely access to safe, effective treatments. That’s what we’re building. And we’re just getting started.”

Visit https://AccumulusTechnologies.com for more information on the platform, and https://AccumulusSynergy.org to learn more about the future of Accumulus Synergy.

About Accumulus Synergy

Accumulus Synergy is a global, nonprofit industry association committed to accelerating regulatory innovation to benefit patients worldwide. Through a policy-driven, patient-focused, and globally aligned approach, we advocate for digital transformation that places patients at the center of regulatory progress. By uniting life science organizations, policymakers, and technology leaders, we’re creating a collaborative ecosystem where emerging science and policy evolve together—advancing health equity and expediting access to medicines.

About Accumulus Technologies

Accumulus Technologies is a leading cloud technology provider reimagining how life sciences organizations and national regulatory authorities work together to accelerate the drug development lifecycle, from drug discovery through global availability. Spun out from nonprofit Accumulus Synergy in 2025, our secure, purpose-built, SaaS platform enables real-time collaboration and continuous data streaming – powering faster decisions, global alignment, and accelerated access to therapies for patients worldwide. With a focus on innovation, trust, and impact, Accumulus Technologies is connecting the global regulatory ecosystem through a single, scalable solution.

Media Contact:

Robin Bectel
REQ for Accumulus Technologies
accumulus@req.co

BURLINGAME, Calif., June 4, 2025 (GLOBE NEWSWIRE) — Today, Accumulus Synergy (“Accumulus”) announced a strategic partnership with Veeva Systems (“Veeva”) focused on enabling connectivity to help the life sciences industry more effectively exchange regulated information with national regulatory authorities (NRAs) around the world. The partnership aims to empower customers with the tools needed to meet today’s regulatory interoperability demands while maintaining the flexibility to adapt to the evolving regulatory technology landscape.

“Our partnership with Veeva is an important step forward in enabling our collective customers to maximize the benefit of the two technologies – Accumulus’ single dossier in the cloud and Veeva’s comprehensive Regulatory Information Management (RIM) platform,” said Francisco Nogueira, CEO of Accumulus. “At Accumulus, we have seen tremendous cycle time improvements driven by our platform. Through this partnership, we’re poised to significantly increase organizational efficiency for our customers by providing connectivity between Veeva RIM and the Accumulus platform.”

The partnership is designed to bridge current requirements and emerging needs, supporting near-term connectivity while aligning with global efforts to modernize regulatory technology. It will enable life sciences organizations to seamlessly connect systems across borders and platforms without being locked into legacy approaches.

“Our customers are eager to find innovative solutions to drive efficiencies in NRA interactions and review cycles,” said Marc Gabriel, Vice President, Regulatory at Veeva. “We look forward to working with Accumulus to build connections to advance the industry.”

The Accumulus-Veeva partnership represents a shared vision for an ecosystem where collaboration drives progress and sponsors are empowered with meaningful solutions. Accumulus and Veeva are positioning the industry for sustainable innovation by bridging Veeva RIM and NRAs in the cloud.

About Accumulus SynergyAccumulus Synergy is 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. 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 members include leading global pharmaceutical companies.

Media Contact
E: allison.mari@accumulus.org
P: 540-907-6053

BURLINGAME, Calif., February 5, 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.

Media Contact
E: allison.mari@accumulus.org
P: 540-907-6053

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

BURLINGAME, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) — Accumulus Synergy, Inc. (“Accumulus”), is revolutionizing the scalability of reliance pathways, enabling a recent submission from Sanofi to multiple national regulatory authorities (NRAs) around the globe. As industry leaders are set to leverage the Accumulus platform for upcoming projects, its ability to handle concurrent submissions across multiple jurisdictions is proving to be a game-changer.

“The Accumulus platform introduces unprecedented scalability and is designed to unlock the full potential of reliance pathways and regulatory collaboration as a whole,” said Francisco Nogueira, CEO at Accumulus. “We’re offering a solution that helps shorten cycle times, accelerate review and feedback, and increase equitable patient access on a global scale. We’re not just making reliance pathways viable—we’re making them scalable and operational.”

Sanofi’s adoption of the Accumulus platform marks another move towards fit-for-purpose technology that ensures secure, real-time global regulatory connectivity. Many of the NRAs involved in the Sanofi submission are repeat users of the Accumulus platform, underscoring the Platform’s capacity to meet the needs of industry and regulators alike.

“Sanofi has long been at the forefront of regulatory innovation as a founding member of Accumulus,” said Eddie Reilly, Chief Regulatory Officer, Head of Global Regulatory Affairs at Sanofi. “Today’s regulatory landscape requires innovative solutions that can evolve with the increasing complexity and volume of submissions. With the Accumulus platform’s unique capability to support multiple reliance submissions concurrently, we can now scale up our efforts in ways that were previously unattainable. This scalability allows us to accelerate the delivery of potential new treatments to patients, driving greater efficiency and impact.”

With numerous planned submissions underway for 2024, the Accumulus platform is setting a new standard for managing simultaneous submissions to multiple national regulatory authorities, paving the way for a much anticipated fully digital, single global dossier. 

“Our Platform is redefining how life sciences organizations manage regulatory submissions and interact with stakeholders to accelerate the delivery of life-saving treatments,” added Nogueira. “By bridging the gap between life sciences organizations, regulators, and external partners, the Accumulus platform is leading the way in the digital transformation, ensuring collaboration at scale to meet the growing demands of the global healthcare ecosystem. This is another key step towards the moonshot of a single dossier in the cloud.”

To learn more about Accumulus Synergy, visit accumulus.org.

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 Contact
Allison Mari
allison.mari@accumulus.org
540-907-6053

Following the launch of Accumulus Synergy’s innovative cloud-based information exchange platform, CSL joins the nonprofit industry association 

BURLINGAME, Calif., September 17, 2024 (GLOBE NEWSWIRE) — Accumulus Synergy, Inc. (“Accumulus”), and its Founding Sponsors are proud to welcome CSL as its first member organization. This collaboration marks significant progress in collectively bringing together industry stakeholders to advance the mission of dramatically accelerating critical therapies to citizens of the world. 

“We are honored to welcome CSL to our member community,” commented Frank Nogueira, Accumulus Chief Executive Officer. “A membership with Accumulus is an investment in the ecosystem. We closely engage with national regulatory agencies (NRAs), trade associations, life sciences organizations, and non-governmental organizations (NGOs) within the global regulatory environment to accelerate regulatory exchange and data harmonization. In industries as dynamic and rapidly evolving as pharmaceuticals, science, and technology, being part of a strong, innovative network is essential.”

The Accumulus membership model is designed to help shape regulatory policy and raise awareness of the need for global harmonization of regulatory requirements and data standards. Ultimately, these efforts drive digital transformation to accelerate therapies to patients worldwide. With a shared commitment to advancing these interests, both Accumulus and CSL are well-poised to amplify their collective impact and drive positive change on a global scale. 

“Accumulus Synergy is a catalyst for change. Leading with purpose and vision, Accumulus is not merely innovating but pioneering an industry paradigm shift for regulatory harmonization and digital transformation,” said Emmanuelle Lecomte-Brisset, Global Head of Regulatory Affairs at CSL.

Membership is now open to participants within the regulatory ecosystem, including life sciences organizations, health associations, private/non-profit foundations, and other institutions. Accumulus offers member organizations unparalleled access to valuable resources, thought leadership, networking opportunities, and policy-shaping efforts tailored to industry needs.

“We are excited to see our community expand and our work focus on collectively advancing opportunities for regulatory data convergence, data harmonization, and digital transformation,” said Khushboo Sharma, Accumulus Chief Regulatory Innovation Officer. “With a steadfast dedication to innovation and collaboration, it is a privilege to have CSL join us.”

To learn more about membership and subscription opportunities with Accumulus Synergy, contact us at info@accumulus.org.

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

About CSL

CSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus, and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus, and operational excellence enables us to identify, develop, and deliver innovations so our patients can live life to the fullest. For more information about CSL, visit CSL.com.

Media Contact
Allison Mari
allison.mari@accumulus.org

Nonprofit Industry Association, Accumulus Synergy, is the primary sponsor and funder of a newly published data standard that streamlines data exchange and contributes to a more connected and patient-centered healthcare ecosystem

BURLINGAME, Calif., May 14, 2024 (GLOBE NEWSWIRE) — Accumulus Synergy, Inc. (“Accumulus”), a nonprofit industry association enhancing data exchange for the life sciences-regulatory industry, is proud to share a newly published global standard for the exchange of Pharmaceutical Quality (PQ) data: the Fast Healthcare Interoperability Resources (FHIR®) Implementation Guide for PQ (Industry) data standard.

As the life sciences-regulatory industry continues its digital transformation journey, efficient data exchange remains a critical challenge. PQ content is reused throughout the medicinal product lifecycle accounting for the majority of information exchanged across organizations. In response to this challenge, Accumulus Synergy sponsored the initiative on behalf of industry at large leveraging Health Level Seven International’s (HL7) next-generation standard, FHIR®, to streamline data exchange and collaboration. This harmonized, structured international data standard will expedite the preparation of global regulatory filings and reduce the time to exchange data from hours and days to minutes and, eventually, seconds.

“Our sponsorship of the PQ (Industry) data standard is an example of our active partnership within the regulatory ecosystem to help shape policy and raise awareness to positively impact public health,” commented Frank Nogueira, Accumulus Chief Executive Officer. “As an industry association, we have both an opportunity and a responsibility to help shape data standardization and harmonization, ultimately propelling the industry toward a fully data-driven global dossier in the cloud. Coupled with the recent launch of our collaboration and data exchange platform, we are pushing the boundaries of what is possible.”

Accumulus remains committed to supporting the expansion and adoption of the PQ (Industry) standard as a means of advancing the regulatory ecosystem, and encourages organizations to unite around this structured, standardized approach for information exchange.

“This is a landmark milestone for the biopharmaceutical industry and a critical step forward in our digital transformation journey,” said Rita Algorri, Amgen Senior Manager, Global Regulatory Affairs and Sponsor member of the Accumulus Quality/Chemistry, Manufacturing and Controls Task Force. “Pharmaceutical Quality (Industry), as the first PQ data standard, sets the foundation for the future of data exchange across industry.”

Facilitating generative AI, content reuse, and real-time data exchange, the newly published standard promises to have a profound effect on innovation and creativity. Commenting on the achievement, Michael Abernathy, Amgen Executive Director, Global Regulatory Affairs and Sponsor member of the Accumulus Quality/Chemistry, Manufacturing and Controls Task Force said, “Our industry now has access to a common PQ taxonomy, enabling us to leverage 21st Century digital technologies with the ambition to achieve real-time data exchange within a global cloud-based ecosystem. This is a gamechanger for the biopharmaceutical industry and for patients around the globe.”

To learn more about the FHIR® Implementation Guide and explore collaboration opportunities, please visit Pharmaceutical Quality (Industry). For more information about the creation of this standard, visit PQ (Industry) Data Standard White Paper or email info@accumulus.org.

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 12 leading global pharmaceutical companies.

Media contact:
Allison Mari
allison.mari@accumulus.org
540.907.6053

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 info@accumulus.org.

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.

Media contact:
Jack Quigley
jack.quigley@accumulus.org
445.237.9277

A dozen global pharmaceutical companies have joined effort to accelerate critical therapies to citizens of the world 

BURLINGAME, CA, September 20, 2022 – Accumulus Synergy, a non-profit organization working to develop an information and data exchange platform aimed at transforming how life science innovators and health authorities worldwide interact, today announced Merck, known as MSD outside the United States and Canada, has joined Accumulus Synergy as a sponsor company. 

 “As Accumulus Synergy continues the global journey to drive transformation towards a digital world, I am extremely pleased to have Merck join our mission. Together, we will leverage cloud technology to improve information exchange with and among health authorities in an effort to reduce drug lag for patients around the world,” said Frank Nogueira, Accumulus Synergy CEO. 

“Merck is a pioneer in developing novel medicines and vaccines and providing access to them around the world. As such, we believe Accumulus Synergy platform is an important industry initiative that creates a way for companies to collaborate with health regulators more efficiently,” said Darrel Hicks, Vice President, Global Regulatory Affairs Innovation, Quality and Strategic Operations, who has also been appointed as a Board Member of Accumulus Synergy. 

Accumulus Synergy is developing a powerful and secure cloud-based tool to enhance collaboration, data, and content sharing across all regions of the globe. By leveraging technology to modernize the regulatory lifecycle, this tool will enable a dynamic approach that shifts the focus from documents to data which will create significant value for patients, healthcare providers, health authorities, and biopharma companies globally. Accumulus Synergy will implement the highest safeguards and encryptions to ensure that data is appropriately protected in the company’s ecosystem, in compliance with countries’ privacy laws. 

“Our goal is to break new ground in health equity by dramatically accelerating critical therapies to citizens of the world. Accumulus has an excellent and growing team in place, a Board that is today further strengthened by the addition of Merck, and we continue to hire additional staff to meet our platform development objectives. Our non-profit status provides us the ability to work closely with health authorities around the world to support their own data modernization efforts,” commented Jeremy Chadwick, Ph.D., MS, Accumulus Synergy Chairman of the Board and Senior Vice President and Head of Global Development Office, R&D, Takeda Pharmaceuticals. 

About Accumulus Synergy 

Accumulus Synergy, Inc. is a non-profit organization formed in 2020 to create a cloud-based platform to transform data sharing between the biopharma industry and global health authorities. The common-platform approach aims to improve efficiencies in the regulatory process by leveraging advanced technology, including data science and AI, as well as tools for secure data exchange to improve patient safety, help reduce the cost of innovation, and ultimately bring patients safe and effective medicines faster. It will work with partner companies, key stakeholders, and global health authorities to build and sustain a platform that meets 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. For more information, please visit accumulusv2.wpenginepowered.com. 

Media contact: 

Paul Laland 

paul.laland@accumulus.org 

415.519.6610 

Accumulus is the first non-profit corporation designed to establish a relationship between technology, policy and collaboration between drug developers, NGOs, academic institutions and government agencies

Burlingame, CA, May 13, 2021 — Accumulus Synergy, a non-profit corporation intended to support interactions between industry and health authorities worldwide to enable real-time collaboration and data exchange, today announced the appointment of Francisco (Frank) Nogueira as the new chief executive officer (CEO). Mr. Nogueira was previously a vice president of Regulatory Affairs at Roche and served as interim CEO at Accumulus since the fall of 2020.

Accumulus Synergy was formed on July 13, 2020, to develop a cloud-based platform to facilitate data and information sharing with the potential to transform the way the biopharmaceutical industry interacts with health authorities. The common-platform approach to data sharing aims to make the regulatory process more efficient by leveraging advanced technology and tools for data exchange to benefit patients, help reduce the cost of innovation and ultimately bring patients new safe and effective medicines faster.

“One of the learnings from the Covid-19 pandemic is that the biopharma world, including industry, academia and government, can move extremely rapidly in the face of an unprecedented crisis. To go from first sequencing of a new virus to multiple neutralizing antibodies and vaccines in under a year is truly remarkable. At Accumulus Synergy, the vision is to dramatically accelerate the delivery of critical therapies to the citizens of the world by reimagining the interaction and information exchange between stakeholders in the healthcare ecosystem to streamline the regulatory lifecycle. These changes won’t happen overnight, but I am confident that Accumulus Synergy will be have culture that is entrepreneurial, agile and fosters innovation. We will strive to be a magnet for top talent and diverse thinkers based on our social remit, ground-breaking technology and opportunity to make an impact for patients,” said Mr. Nogueira.

“After an extensive search, the Board of Directors has concluded that Mr. Nogueira is the ideal candidate to lead the exciting vision of Accumulus Synergy. In his role as Interim CEO, Mr. Nogueira has demonstrated outstanding leadership and made excellent progress on key company goals. The Board will provide Mr. Nogueira with their full support in building a powerful organization that meets both the short-term goals and long-term aspirations,” said Jeremy Chadwick, Ph.D., chairman of the Board of Directors at Accumulus Synergy and a senior vice president and head of Global Development Office at Takeda Pharmaceuticals.

The initial members of Accumulus Synergy include Amgen, Astellas, Bristol Myers Squibb, GSK, the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), Lilly, Pfizer, Roche, Sanofi, and Takeda, which have provided funding to support the platform and initial applications.

About Francisco Nogueira
Having spent more than 20 years at Genentech and Roche, Mr. Nogueira was most recently vice president and Lifecycle Leader in Alzheimer’s Disease where he was responsible for leading cross-functional team responsible for development and commercialization of a high priority (JEWEL) compound to treat Alzheimer’s disease. Prior to that he was vice president, Product Development, which included leadership of 400+ FTEs in the Regulatory organization made up of medical writing, operations & labeling for Roches’ molecule portfolio along with oversight of marketed products, with revenues exceeding 9 Billion Swiss Francs.

Since 2011, Mr. Nogueira also served multiple Global Head positions, including Business and Strategy, Project and Portfolio Management, Regulatory Operations. As a global leader at Genentech, he was responsible for Data Transparency, Quality and Compliance, Organizational Development, Regulatory operations, Project & Portfolio Management with a senior leadership team. responsible for corporate level transparency of studies, learning and development, communications and change management, and strategic planning of Roche’s portfolio and resource management.

Prior to joining Roche in 1999, he held the position of assistant treasurer at Deutsche Bank (formerly known as Bankers Trust Co. Mr. Nogueira received an Executive Master of Business Administration from Rutgers University, Newark, New Jersey, and a Bachelor of Arts in Earth Science from Kean University, Union, New Jersey.

About Accumulus Synergy, Inc. 
Funded by ten leading biopharma companies, the non-profit Accumulus Synergy, Inc. was formed in 2020 to create a cloud-based platform, to transform data sharing between the biopharma industry and global health authorities. The common-platform approach aims to improve efficiencies in the regulatory process by leveraging advanced technology, including data science and AI, as well as tools for data exchange to improve patient safety, help reduce the cost of innovation, and ultimately bring patients safe and effective medicines faster. It will work with partner companies, key stakeholders, and global health authorities to build and sustain a platform that meets regulatory, cybersecurity, and privacy requirements spanning clinical, safety, chemistry and manufacturing, and regulatory exchanges and submissions.

Media Contact: 
Paul Laland
Paul.Laland@accumulus.org
(415) 519-6610