BURLINGAME, CA, May 12, 2022 – Accumulus Synergy, a nonprofit organization working to develop an information and data exchange platform aimed at transforming how drug innovators and health authorities worldwide interact, today announced AstraZeneca (LSE/STO/Nasdaq: AZN) has joined Accumulus Synergy as a sponsor company. 

“There is tremendous industry excitement about our organization’s vision and our path towards making it a reality. The data and information exchange paradigm, between those who develop medicines and those who review and approve them, is at an inflection point – broad adoption is critical,” said Frank Nogueira, Accumulus Synergy CEO. “I am very pleased that AstraZeneca, a global company with a proven track record of innovation, strong global footprint, and out of the box thinking has united with our deeply committed founding companies.”

“Accumulus Synergy has embarked on an ambitious goal and a critical mission to transform the procedures that underpin the regulatory submission process – and this is strongly aligned with AstraZeneca’s goal to accelerate the discovery, development and delivery of innovative medicines for patients. We are excited to collaborate with Accumulus Synergy to improve efficiencies and pioneer new processes for facilitating the review of critical medicines,” said Jacques Mascaro, Ph.D., MBA, Senior Vice President, Head of Oncology Regulatory Science, Strategy, and Excellence, AstraZeneca, 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 and data and content sharing across all regions of the globe. By leveraging technology to modernize the drug submission process, this tool will aim to 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. 

“Since its inception, I am extremely proud with the progress that Accumulus Synergy has made. With the addition of AstraZeneca to our sponsoring companies and our continuing partnership with global regulatory authorities, we will be in an excellent position to create an information superhighway that enables real-time, efficient insight generation and global convergence toward an innovative and modernized submission 

process,” 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

Funded by leading biopharma companies, the nonprofit 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. For more information, please visit accumulusv2.wpenginepowered.com.

Media contact:
Paul Laland
[email protected]
415.519.6610

LEADERSHIP TEAM MEMBERS

BURLINGAME, CA, April 4, 2022 – Accumulus Synergy, a nonprofit corporation 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 three executive members of the company’s leadership team.

“As we are making excellent progress on priority programs and executing on our strategic plan, we are putting in place a highly experienced management team.  Looking ahead, we will be hiring additional key staff to deliver on near-term and long-term  product roadmap and objectives in consultation with health authorities, sponsors, and other stakeholders,” said Frank Nogueira, CEO of Accumulus Synergy. “Jillian Wein Riley, Dominique Lagrave, and Jack Quigley are proven professionals in their fields and will be critical to our vision of safe and effective medicines reaching patients faster and more efficiently.”

Jillian Wein Riley joins Accumulus Synergy as General Counsel and Head of Legal Affairs from the University of Pittsburgh Medical Center (UPMC) where she most recently served as Associate Counsel. At UPMC, a $24 billion world-renowned health care provider and insurer, Jillian advised on various academic medicine functions with a focus on FDA-regulated issues, products, and industries. She will be responsible for further developing Accumulus Synergy’s legal capability in support of the company’s platform development efforts. This will include all elements of legal and regulatory      compliance and risk mitigation along with coordinating strategic partnerships. 

Prior to her role at UPMC, Jillian served in various legal functions, including as a Law Clerk to the Honorable Cathy Bissoon in the United States District Court for the Western District of Pennsylvania, an attorney in GlaxoSmithKline’s Consumer Healthcare Division, Reed Smith LLP, and the U.S. Food and Drug Administration’s Office of the Chief Counsel. 

Jillian received a Bachelor of Arts degree from Barnard College at Columbia University, a Master’s in Public Health from the University of Pittsburgh Graduate School of Public Health and a Juris Doctor from the University of Pittsburgh School of Law.      

Dominique Lagrave joins Accumulus Synergy as Vice President of Regulatory Innovation and brings more than two decades of global regulatory operations leadership experience. In his new role, Dominique will be responsible for the business development, release, adoption, and democratization of the Accumulus Synergy platform in accordance with the company’s vision and mission. 

Most recently, Dominique was the Head of Global Regulatory Operations at Amgen and was leading the company’s key regulatory technology programs. Besides his work at Amgen, he has been actively involved in developing the Accumulus Synergy technology platform for the past 18 months. Prior to Amgen, Dominique served as a key member of the global regulatory teams at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. 

Dominique is a Board Member of IRISS Forum since 2021 and holds a Pharm D and a master’s degree in International Regulatory Affairs from the University of Paris.

Jack Quigley joins Accumulus Synergy as Head of Business Operations. In this role, Jack will be responsible for corporate strategy, change management, communications, quality, and the cross-functional integration of high priority activities.

Prior to joining Accumulus Synergy, Jack spent several years as a Strategy and Operations consultant in Deloitte’s Life Sciences and Health Care practice, with a particular emphasis on solving challenges in the R&D and Regulatory spaces. At Deloitte, he led teams across a variety of disciplines, including process improvement, supply chain transformation, systems implementation, operating model redesign, and M&A diligence and integration, earning a reputation as a trusted strategic adviser to his clients. 

Jack holds three degrees from Northwestern University: an MBA from the Kellogg School of Management, a master’s degree in Public Policy, and a Bachelor of Arts in Political Science.

About Accumulus Synergy

Funded by leading biopharma companies, the nonprofit 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. For more information, please visit www.accumulus.org.

Media contact:
Allison Mari
[email protected]
540.907.6053

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

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