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: [email protected]
P: +44 7387 055214

Accumulus Synergy

Email: [email protected]
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 www.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
[email protected]
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 [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 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
[email protected]
540-907-6053

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 [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 12 leading global pharmaceutical companies.

Media contact:
Allison Mari
[email protected]
540.907.6053

About Accumulus Synergy

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.

Media contact:
Jack Quigley
[email protected]
445.237.9277

Accumulus Synergy (“Accumulus”), a nonprofit trade association working to address the global need for digital transformation within the life sciences – health authority ecosystem, today announced the appointment of two new executive members of the trade association’s leadership team.

“We are excited to welcome our new leaders, who bring a wealth of experience and expertise, to complement our strategic priority of supporting the life sciences – health authority ecosystem and accelerating the availability of critical therapies to patients around the globe,” said Frank Nogueira, CEO of Accumulus. “Kaarin Gordon joins Accumulus as Chief Growth Officer, and Bill Gibson – formerly our Vice President of Product and interim Chief Technology Officer (CTO) for Accumulus- now serves officially in the CTO capacity.”

Kaarin Gordon joins Accumulus Synergy from TransPerfect, where she served as Vice President of Technology Solutions for Life Sciences. Gordon brings more than 25 years of experience working with life sciences organizations and delivering new and innovative solutions. In her new role at Accumulus Synergy, Gordon is responsible for the democratization of the Accumulus Platform. She is currently leading the strategy for subscription and membership models, in preparation for production-ready offerings in Gordon holds a BA from the University of Michigan and a MBA from Columbia Business School.

Bill Gibson, former Vice President of Product and interim CTO for Accumulus Synergy, now serves officially as the CTO for Accumulus. With three decades of product management and software development leadership experience, Gibson is dedicated to transforming how life sciences organizations and health authorities interact to bring safe and effective medicines to patients faster and more efficiently. Gibson is responsible for driving innovation at Accumulus and is leading the development of the Accumulus Platform to enable enhanced collaboration, work sharing, and data and information exchange between life sciences organizations and health authorities worldwide. Gibson holds a bachelor’s degree in Mathematical Science from the University of North Carolina at Chapel Hill.

About Accumulus Synergy

Accumulus Synergy is a nonprofit trade association working on behalf of industry to address the global need for digital transformation. To help solve for this need, Accumulus is developing a transformative data exchange platform to enable enhanced collaboration and efficiency between life sciences organizations and health authorities worldwide. The Accumulus Platform 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. Accumulus is working with key stakeholders in the life sciences – health authority 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. For more information, please visit www.accumulus.org.

Media contact:
Allison Mari
[email protected]
540.907.6053

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: 

BURLINGAME, CA, August 15, 2022 – Accumulus Synergy, a non-profit organization
working to develop an information and data exchange platform aimed at transforming
how drug innovators and health authorities worldwide interact, today announced the
appointment of Khushboo Sharma as its Chief Regulatory Innovation Officer and a
member of the company’s Executive Leadership Team (ELT).

“We are extremely excited that Khushboo is joining Accumulus Synergy as she
brings a wealth of experience from her tenure at the US Food and Drug Administration
(FDA) and Biotechnology Innovation Organization (BIO), strong engagement with Health
Authorities around the world, along with proven leadership in working with sponsor
organizations of all sizes,” said Frank Nogueira, CEO of Accumulus Synergy.
Khushboo Sharma joins Accumulus Synergy from BIO where she most recently
served as Chief of Staff and Senior Vice President. At BIO, she oversaw the Science and
Regulatory team that largely focused on major regulatory policy initiatives spanning
from preclinical though post-market activities. Through her work at BIO, Khushboo was
at the forefront of identifying challenges and offering concrete solutions and
suggestions to help build the appropriate regulatory framework.
Khushboo joined BIO in 2021 after spending 11 years in various roles at the FDA,
including Deputy Director of Operations in the Office of New Drugs (OND). She oversaw
business, regulatory, and programmatic operations, supported regulatory review for the
New Drugs Regulatory Program through the New Drugs Modernization effort, and
served as an FDA negotiator during the latest Prescription Drugs User Fee Act (PDUFA)
negotiations. Khushboo was named as one of InVivo’s Rising 30 Leaders in 2021 in
Healthcare and Science.

Prior to joining the FDA, Khushboo worked as a scientist for four years at Janssen
Pharmaceuticals, where she managed oncology and therapeutic monoclonal antibody
drug products, supporting development in Phase I/II and Phase III clinical studies. She
earned an undergraduate degree in Biotechnology and Microbiology and her master’s
degree in Business Administration in Healthcare and Biotechnology Industry
Management, both from Pennsylvania State University.

About Accumulus Synergy
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 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, Pfizer, Roche, Sanofi, and Takeda. For more
information, please visit accumulusv2.wpenginepowered.com.

Media contact:
Paul Laland
[email protected]
415.519.6610

Accumulus Synergy (“Accumulus”), a nonprofit trade association working to address the global need for digital transformation within the life sciences – regulatory ecosystem, today announced the appointment of Jacques Mascaro as the new Chair of the Board of Directors (the “Board”).

Jacques Mascaro, Ph.D., MBA, Senior Vice President, Global Head of Oncology Regulatory Science, Strategy & Excellence at AstraZeneca, brings a wealth of experience and leadership expertise to the role. Dr. Mascaro has more than 30 years of global life sciences experience covering Research and Development functions and other responsibilities including innovation, digital transformation, diversity and sustainability. He is also a member of many groups including ESMO, ASCO, DIA, RAPS and the NY Academy of Sciences. This makes him well-positioned to help advance the Accumulus mission of accelerating critical therapies to patients around the globe. In his new role as Chair of the Board, Dr. Mascaro will work closely with the other Directors and members of the Accumulus Executive Leadership Team to ensure the continued success of the organization.

“As the industry pushes the boundaries of science, it is essential to recognize that the interactions and information exchange between regulators and the regulated have remained relatively unchanged,” commented Francisco Nogueira, Accumulus CEO. “Accumulus’s mission to accelerate the availability of therapies to patients is imperative and requires a paradigm shift from a document-centric mindset to a data-driven approach. Collaboration lies at the heart of this transformation, and as an ecosystem we must remain steadfast in our advocacy to reduce drug lag for patients around the world. I look forward to working with Jacques in this new capacity, along with the entire Board, to democratize the Accumulus Platform and achieve digital transformation.”

Dr. Mascaro said, “I am honored to take on the role of Chair of the Board for Accumulus. In the year since joining the Board, I have been continuously impressed by Accumulus’ vision and commitment to making a difference in the life sciences industry through regulatory innovation, and through partnering with all stakeholders globally. While I have seen a great deal of evolution in how we work over the past 30 years, the advancements in technology, security, and learnings from the COVID-19 pandemic provide us a new opportunity to transform how we bring innovative medicines to patients around the world.”

This appointment follows the resignation of founding Chair, Jeremy Chadwick, Ph.D., from Takeda Pharmaceuticals. Accumulus would like to extend its heartfelt appreciation to Dr.Chadwick for his exemplary service.

About Accumulus Synergy

Accumulus Synergy is a nonprofit trade association working on behalf of industry to address the global need for digital transformation. To help solve for this need, Accumulus is developing a transformative data exchange platform to enable enhanced collaboration and efficiency between life sciences organizations and health authorities worldwide. The Accumulus Platform 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. 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.

For more information, please visit accumulusv2.wpenginepowered.com.

Media contact:
Allison Mari
[email protected]
540.907.6053