Resource Taxonomy: News

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
paul.laland@accumulus.org
415.519.6610

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
paul.laland@accumulus.org
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
Paul.Laland@accumulus.com
(415) 519-6610