Welcome to Accumulus Synergy

We are developing a global information exchange platform to transform how drug innovators and health regulators interact to bring safe and effective medicines to patients faster and more efficiently.
Check out our White Paper.

Our main goal is to accelerate the availability of safe and effective medicines for patients.

Sponsored by leading biopharmaceutical companies, Accumulus Synergy was formed in 2020 to create innovative solutions that can reduce regulatory review times and transform global data exchange. The non-profit company is creating a first-of-its-kind cloud-based platform intended to support interactions between the biopharmaceutical industry and health authorities worldwide. The single-platform approach aims to improve speed, transparencies and efficiencies in the regulatory process by leveraging advanced technology and tools for data exchange. This will help reduce the cost of innovation and ultimately bring patients safe and effective medicines faster.

Spiraling costs in R&D together with the availability of technology are forcing a much-needed disruption in the approach to regulatory submissions and approvals. Additionally, current methods for data exchange and communication between pharmaceutical companies and global health authorities have also not kept pace with advancements of information technology. A radical transformation is needed from a static transactional exchange between sponsors and regulators to a dynamic approach capable of exploiting the full range of data sources and technology tools. This global collaboration provides a platform which will improve stakeholder interactions, accelerate medicines to patients and exchange real time data globally.

Led by Francisco Nogueira, the Accumulus CEO, and a team of highly experienced pharmaceutical executives, the company in consultation with health authorities worldwide is designing, developing, and deploying, full-scale, cloud-based solutions that could enable collaborative review by regulators. The Accumulus team is currently evaluating use cases with regulators for parallel review and CMC (chemistry, manufacturing and control) stability updates, focused on identifying critical components that may improve the time of new drug applications and approvals.

We’ve assembled a team of global collaborators to help drive the Accumulus Synergy vision.

Amgen logo
Astellas Pharma
bms logo
gsk logo
Johnson and Johnson
Lilly
Pfizer
Roche
Sanofi logo
Takeda

Accumulus Synergy is led by a collection of pharmaceutical veterans with deep industry expertise.

Frank Nogueira

Chief Executive Officer

Frank joined from Genentech, a Roche company, where he as a Vice President focused on applying his 20 years of enterprise, regulatory strategy, asset development and commercialization experience to deliver enterprise value and bring medicines to patients. As a senior leader he served in multiple global head positions, including Business Strategy, Project and Portfolio Management, Regulatory Operations, Medical Writing, Labeling & Established Products, Data Transparency, and Quality & Compliance. Most recently we oversaw the development and delivery of Roche’s Oncology medicines portfolio to China and Lifecycle leader of an Alzheimer’s molecule. Frank 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.

Jeremy Chadwick, Ph.D., MS

Chairman of the Board;
Senior Vice President and Head Global Development Office, R&D Takeda Pharmaceuticals

Jeremy is the Accumulus Synergy chairman of the Board. He joined Takeda from Shire and has more than 30 years of broad international pharmaceutical experience managing multiple functions including regulatory affairs, program management, drug safety, development operations, strategic planning, biostats and DM, and QA. Jeremy earned his Ph.D. and MS in statistics from the University of London, and BS (1st Class) in Mathematics from DeMontfort University, UK.

Eddie Reilly

Vice Chair of the Board;
Chief Regulatory Officer, Head of Global Regulatory Affairs at Sanofi

Eddie is vice Chair of Accumulus Synergy. He is a qualified pharmacist, with a post graduate degree in Pharmaceutical Medicine. After completing his studies, he worked in different areas of pharmacy (hospital, retail) before focusing within the Pharmaceutical Industry. Eddie has more than 20 years’ experience in the Pharmaceutical Industry, predominantly in the area of Regulatory Affairs. Earlier in his career, Eddie also worked as a pharmaceutical assessor with the Irish Medicines Board (now the HPRA) in Dublin, Ireland. Eddie received his pharmacy degree from Trinity College in Dublin.

Karin Van Baelen, PharmD

Board Member;
Head, Global Regulatory Affairs at Janssen, Pharmaceutical Companies of Johnson & Johnson

As the head of Global Regulatory Affairs (GRA) at Janssen, Karin leads an organization of approximately 1,100 highly qualified colleagues who foster relationships with Health Authorities around the world to help Janssen deliver cutting-edge healthcare solutions to patients. In support of Janssen GRA’s commitment of being a future-focused organization, Karin fosters a diverse and inclusive community of regulatory talent and oversees the development of regulatory strategy for products from all Janssen Therapeutic Areas. She joined Johnson & Johnson in 1993 from Upjohn Benelux. Karin earned her Pharmaceutical Sciences degree at the University of Antwerp Belgium.

Helen Fitton, Ph.D.

Board Member;
Senior Vice President Regulatory Affairs at GSK

Helen is responsible for all regulatory strategy and delivery for the GSK vaccines and pharmaceutical development portfolio and for the extensive suite of established licenses worldwide. Her role provides regulatory leadership for R&D, Global Regions (USA, Europe, Japan, China, International) and manufacturing. Helen has over 25 years’ experience and has driven multiple change programs, including implementation of new systems to secure new and innovative approaches and ways of working company wide. Prior to her current role, Helen held positions of increasing responsibility in Regulatory Affairs including VP, Regional Regulatory Affairs and VP Chemistry, Manufacturing and Controls and Nonclinical Regulatory and VP Regulatory Operations. She holds a Ph.D. in Synthetic Organic Chemistry from the University of Newcastle Upon Tyne, UK.

Susanne Gronen

Board Member;
Senior Vice President and Head of Data Science at Astellas Pharma

Susanne leads the Data Science organization in Development for Astellas. Her responsibilities include Biostatistics, Statistical Programming, Data Management and Medical Writing for Clinical Development and Medical Affairs. Over the last few years, Susanne has fully globalized her organization and under her leadership, the department has built a Central Monitoring & Data Surveillance team in support of the overall risk-based monitoring effort. Susanne has spent most of her career in data science functions. Prior to joining Astellas, she worked at a global CRO as a statistician. Susanne holds an MSc in Statistics from the University of Dortmund, Germany.

Pandu Kulkarni, Ph.D.

Board Member;
Chief Analytics Officer, R&D and Vice President, Statistics, Data & Analytics at Eli Lilly and Company

Pandu leads an organization of more than 600 people. His organization is comprised of project statisticians, analytics and data experts, project managers, working in the full pharmaceutical research cycle, from discovery to commercialization for all therapeutic areas. He joined Eli Lilly in 2000 and has held numerous leadership positions including technical and management positions within and outside of Statistics. Pandu obtained his Ph.D. in Statistics at the LaTrobe University, Melbourne, Australia.

Aditi Kumar

Board Member;
Senior Vice President of Product Development Informatics at Roche

A strategic Informatics leader with over 25+ years of industry experience, Aditi serves as the Vice President and Head of Product Development Informatics at Roche. In her role, Aditi serves as the principal technology advisor to the Chief Medical Officer and Head of Global Product Development, setting the vision, direction, management, and execution of Roche's global Product Development Informatics strategy. Prior to joining Roche, Aditi served as the Executive Director for Research and Development Informatics at Amgen, leading information services strategy for its Global Clinical Development, Center for Observational Research, Global Regulatory Affairs, and Global Patient Safety & Labeling. Aditi earned her Bachelor’s degrees in Computer Science from the University of Minnesota, Twin Cities and English Literature from the University of Delhi, India. She is also a graduate of the Executive Management Program at UCLA’s Anderson School of Business.

Michael Robbins, M.S., M.B.A.

Board Member;
Sr. Director and Head, IT for Global Regulatory Sciences at BMS

Michael joined BMS from Celgene and has more than 25 years of diverse business, technology, and consulting experience across the life sciences ecosystem from early research through commercialization. Michael is known for building and leading high performing teams in the delivery of strategy and transformational change programs across the pharma value chain. In addition to a B.A. in computational and synthetic organic chemistry from Binghamton University, Michael holds a M.S. in computer science from NJIT, and an M.B.A in technology entrepreneurship from NJIT.

Jerry Stewart, JD, MS, RPh

Board Member;
Vice President, Head of Global Regulatory Policy & Intelligence at Pfizer

Jerry is responsible for leading the Global Regulatory Policy and Global Intelligence team. Core to his role is to work with trade associations and industry organizations to help shape the future regulatory environment. Jerry drives the creation and implementation of Pfizer’s long-term strategic advocacy plan, ensuring alignment to Pfizer’s development portfolio and stakeholder awareness. He provides leadership and support for Pfizer’s engagement with FDA, EMA, PMDA and NMPA, and key international regulatory organizations such as ICH and WHO. Originally a pharmacist with a degree from Northeastern University, Mr. Stewart has a Master’s degree from Temple University School of Pharmacy and obtained his JD from the Widener University School of Law.

Mark Taisey

Board Member;
Senior Vice President, Global Regulatory Affairs and Strategy at Amgen

Mark is currently responsible for the Amgen’s interactions with health authorities around the world. Having worked in Regulatory Affairs for more than 30 years, he joined Amgen as vice president, Global Regulatory Affairs. Prior to working at Amgen, he was president, Global Regulatory Affairs, at Eisai, where he had regulatory responsibility for Eisai’s pipeline and portfolio of marketed products across all functions and regions. In addition to his corporate roles, Mark has served as an industry representative for the Biotechnology Innovation Organization during the Prescription Drug User Fee Act (PDUFA) V negotiations, and for the Pharmaceutical Research and Manufacturers of America during the PDUFA VI and VII negotiations. Mark holds a degree in Chemistry from the University of Rochester.

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