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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
[email protected]
(415) 519-6610
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Funded by Amgen, Astellas, Bristol Myers Squibb, GSK, Janssen, Lilly, Pfizer, Roche, Sanofi and Takeda
The companies will support the rollout of a cloud-based platform with the potential to transform the way the biopharma industry communicates and exchanges information with health authorities worldwide
Burlingame, CA, January 22, 2021 — Ten of the world’s leading biopharmaceutical companies today announced the formation of a new non-profit corporation, Accumulus Synergy, Inc., which is intended to support interactions between industry and health authorities worldwide to enable real-time collaboration and data exchange, as well as data submission.
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.
“Current methods for data exchange and communication between pharmaceutical companies and global health authorities have not kept pace with advancements in information technology,” said Francisco Nogueira, interim Chief Executive Officer of Accumulus Synergy and Vice President of Regulatory Affairs at Roche. “In consultation with health authorities, Accumulus Synergy seeks to modernize, integrate, and streamline communication and data exchange between biopharmaceutical companies and global regulators, as well as to facilitate potential regulatory harmonization in priority areas, using the latest in cloud technology. By creating a powerful data-sharing ecosystem, we have the potential to advance delivery of healthcare. Accumulus Synergy looks to create significant value for patients, healthcare providers, health authorities, and biopharma companies globally.”
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. Accumulus Synergy plans to consult with the Japanese Pharmaceutical and Medical Devices Agency, the European Medicines Agency, the U.K. Medicines and Healthcare products Regulatory Agency, and the U.S. Food and Drug Administration, as well as other health authorities worldwide.
“I am very excited to see Accumulus progress after over a year of careful planning,” said Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development and Medical at Pfizer. “This project reflects the importance of collaboration among stakeholders to improve pharmaceutical development, with the potential to enable faster and more efficient exchange of information and data with health authorities.”
“Collaborations focused on science and advanced technologies make us more efficient and ultimately accelerate our ability to improve outcomes for patients – an approach Sanofi has fully embraced,” said John Reed, Executive Vice President, Global Head of Research & Development at Sanofi. “Accumulus’ coordinated efforts to lead data-sharing solutions will reduce the time it takes to make innovative new medicines available to patients, and that’s a goal worthy of support.”
“The Accumulus Synergy vision is transformative. Accumulus Synergy will proactively engage global health authorities in building a cloud platform to enable efficient filing and review of documents and data. Importantly, Accumulus will build upon and complement the collaborative efficiency solutions developed by TransCelerate BioPharma, Inc. This will result in an acceleration of medicine access across geographies and reduce drug lag,” added Paul Stoffels, Chief Scientific Officer, Johnson & Johnson.
“We are pleased to see Accumulus advance its strategic objective to transform communication and data exchange between biopharma companies and health authorities, an effort complementary to the objectives of TransCelerate Biopharma. We look forward to our continued collaboration with Accumulus in areas of common interest,” said Dalvir Gill, Chief Executive Officer, TransCelerate Biopharma.
“Health authorities, physicians, and biopharmaceutical companies all share a common purpose to bring safe, transformative medicines to patients as quickly as possible,” added Andy Plump, M.D., Ph.D., President of Research & Development at Takeda. “Accumulus Synergy is an opportunity to reimagine regulatory and data-sharing pathways globally and better deliver on that purpose.”
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
[email protected]
(415) 519-6610