ACDM25 Speakers

As an experienced data manager leader Ashley has worked across therapeutic area disciplines within both the pharmaceutical and CRO industries. He has over 14 years experience in Clinical Data Management and started my career in the late phase Data Management department at PAREXEL.

Ashley progressed into a Data Management operational leadership position where he had overall accountability, as an account lead, for the execution of the Data Management strategy on numerous complex Oncology studies.

Ashley joined the Oncology team within the Data Monitoring and Management department at Pfizer in 2018 and am currently a Director, Senior Asset Lead supporting the development of a number of key, pivotal compounds. He is also business lead for Pfizer’s development and implementation of the Smart Data Query (SDQ) tool, an industry first leveraging AI/ML to hyper-accelerate complex data review and reconciliation activities. In addition he supports a number of other innovation projects within Pfizer in the fields of AI/ML and RBDM.

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Norah Cassidy holds the position of GCP and pharmacovigilance inspector with the Irish health products regulator, the Health Products Regulatory Authority (HPRA). She is the Irish representative at the GCP EMA co-ordinated inspector working group. Prior to this she has held positions in pharmaceutical and not for profit organisations as a quality manager, a project lead and a clinical research associate. Norah holds a PhD in molecular biology and a post graduate diploma in medical device regulatory affairs.

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Dominique Delforge is a seasoned professional with over 15 years of experience as a GCP Inspector at FAMHP in Belgium. His role involves inspecting the compliance of clinical trials, including investigators, ethics committees, and sponsors, both nationally and internationally under the EMA. Dominique has successfully led over a hundred inspections, demonstrating his experience in various aspects of GCP, such as Data Management, Statistics, and Clinical Trial Management.

Currently serving as a functional team leader within the GCP division at FAMHP, Dominique actively participates in EMA working groups, contributing to guidance’s and training initiatives. With a significant interest in data science and IT tools, he aims to further develop his expertise and contribute to the advancement of GCP practices within the FAMHP and the broader European regulatory community.

Dominique holds a degree in Business Administration and a graduate degree in Chemistry from the “Université Catholique de Louvain (Belgium)”. Before joining FAMHP, Dominique Delforge gained valuable experience in quality control and assurance in food industry at Nestlé and pharmaceutical product marketing at various pharma companies, where he specialized in oncology and haematology products.

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Sam Parnell is Director of Business Development at eClinical Solutions, where he combines his expertise in clinical trials, technology, and data to drive innovation and collaboration across the biopharma landscape. With extensive experience creating solutions that enhance data management efficiencies and deliver ROI, Sam is known for his strategic mindset and dedication to advancing the life sciences industry.

A recognized voice in the industry, Sam founded and co-hosted the Transformation in Trials podcast, engaging with leaders and innovators across the product lifecycle to explore the key trends and technologies shaping the future of clinical trials. Beyond the podcast, Sam regularly organizes running meet-ups at conferences across Europe, bringing together his passions for fitness, networking and sparking new industry conversations.

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Dr Torsten Stemmler is head of GCP inspections at the Federal Institute for Drugs and Medical Devices (BfArM). He has been involved in GCP inspections since 2017 and has contributed to various European guidelines (e.g. Guideline on computerised systems and electronic data in clinical trials). He has a background in data management and neurobiology (specialising in psychophysics). He is currently working on GCP inspections and artificial intelligence in the EMA eSubgroup.

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Adam is an independent consultant with over 35 years’ pharma experience. He has led Central Monitoring, Medical & Safety Data Review, Clinical Data Management, Business Process Management, Clinical Quality & Learning functions and transformation programs including Risk Based Quality Management and software implementations in several organisations. Adam brings analytical, process-centric and innovative approaches to projects. He is passionate about RBQM and business process maturity and how these can transform the execution of clinical trials. Adam has a B.Sc. in Applied Biology, is a Certified Project Manager and Lean Six Sigma Green Belt.

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Mats Sundgren, PhD, MSc, is a distinguished authority in Health Data Strategy, serving both industry and academia. With an impressive career spanning over 37 years in the pharmaceutical industry, Mats has made significant contributions across various domains, including Discovery, Development, Manufacturing, IT R&D, Patents, Clinical Science, and Data Science & AI. His work places him at the forefront of technological innovation in the field.

In 2022, following an illustrious 12-year tenure as the global integration lead for Electronic Health Records (EHR) services at AstraZeneca, Mats expanded his professional endeavors. He now holds several key roles: Senior Industry Scientific Director and co-founder of the i~HD (European Institute for Innovation through Health Data), Executive Strategic Advisor for IgniteData, and Chairman of the Board of the Research Foundation IMIT (Institute of Managing Innovation and Technology). IMIT includes prominent institutions such as Chalmers University of Technology, Royal Institute of Technology, Lund University of Technology, and Stockholm School of Business. Additionally, he serves as a Board Member of the Center for Health Governance at Gothenburg University. In July 2024, Mats assumed the role of Scientific Adviser for IOMED, a company specializing in AI-powered technology for healthcare data activation.

Mats has an extensive portfolio of work, including over 70 publications, books, and patents in Life Science, Economics, and Social Science. His areas of expertise encompass Health Data Science & AI, Clinical Science, Clinical Trials Management, Business Modelling, Innovation & Creativity Management, and Device Development.

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Louise is a Data Management Process & Innovation Specialist at Novo Nordisk. In her capacity as a QMS specialist, she is dedicated to enhancing quality and processes in Clinical Data Operations & Insights. With more than 17 years of experience in clinical trials, covering areas such as GCP, monitoring, data management, and integration projects, she brings a comprehensive view from her work in hospitals, academia, pharma, a regulatory body, and as part of cross-industry collaboration in TransCelerate. She holds a PhD in clinical trials and a master’s degree in pharmacy. Louise has a strong interest in leveraging data insights to advance clinical research.

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Henrik holds a Master’s degree in Engineering specialized in Applied Mathematics and Statistics, complemented by a Master’s degree in Biostatistics, and recently completed an executive MBA. With over 17 years of experience in the industry, his career spans Nycomed, Takeda, Lundbeck, and presently Novo Nordisk. Throughout the majority of his tenure, he has been deeply involved in Biostatistics, initially as a project responsible statistician and later as the leader of departments comprising statisticians and statistical programmers.

Currently, he spearheads a cross-functional department within Data Science-Clinical Data Operations & Insights, known as Data Management Process & Innovation. In this role, he oversees a broad spectrum of responsibilities, including managing the DM quality management system, orchestrating competency development & learning programs, implementing the DM change management framework, overseeing automation projects, and introducing visualization tools.

Passionate about fostering collaboration, Henrik is dedicated to bridging the gap between data & quality specialists and diverse stakeholders, with a vision to “transform data into knowledge.” His focus remains on driving organizational development and leading change management efforts in support of the digital transformation of data (science) deliverables.

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