Thomas (Tom) Brookland has worked in the Pharma industry for the last 15 years, combining interests in regulatory science, health technology and policy research. He joined Hoffmann La Roche in 2008 and in this time has held multiple roles within regulatory product development across molecules and therapeutic areas, in addition to globally and regionally focused policy lead roles in the emerging areas of RWD/RWE, big data, digital health and AI/ML. His current work and passion is focused on strategy and external engagement in the European policy landscape for data, digital and AI, supporting the development of new policy options as the convergence of medical knowledge, technology and data science is revolutionising patient care.

Adrian Cassidy is the Vice President and Head of Global Evidence Generation at Novartis with responsibility to develop novel data and evidence applications across the development lifecycle of innovative medicines. As an epidemiologist, Adrian has over 20 years of industry and public sector experience in real world evidence generation, as well as an established track record of building and leading highly successful evidence generation groups and data/digital/analytics platforms. Adrian is passionate about solving healthcare challenges and transforming clinical practice to deliver outcomes that matter for patients.

Michael is the Chief Operating Officer and Head of Market Access Strategy at PHMR. In this role, he is responsible for ensuring that the research delivered matches the strategic needs of our clients. Michael has extensive experience in the development of health economic models and indirect treatment comparisons, utility measurement and health valuation, strategies for collection and use of real-world data, and the development of dossiers to support HTA submission. He also has substantial experience in working with different stakeholders, including through the use of early scientific advice through HTA agencies, to lead the development of integrated evidence plans and allow for access needs to be incorporated from early in development.

Solène is the Global RWE Policy Lead for UCB in Brussels, Belgium. In this role, she is leading and coordinating the external engagement strategy that aims to advance acceptance of RWE by healthcare decision-makers from early clinical development through to in-market treatment options. Within this role, she is actively involved in different activities such as the IMI EHDEN project. Prior to this, she held various positions in access, pricing and health economics and outcomes research in Global Market Access mostly focusing on neurology solutions for patients.

Regulatory and R&D professional with extensive experience across a network of industry, government, academic and healthcare system partners and stakeholders. Broad range of expertise in all aspects of medicines and device research and development including evidence generation, licensing, manufacturing, market access and on-market support. Specific areas of expertise include clinical trials, biologics, real world evidence, paediatric drug development, medical devices, pharmacovigilance, CMC and regulatory policy and strategy development.

Senior health engineer with 15 years of global drug development experience in children & rare diseases. Cecile joined C-Path as scientific director, prior to C-Path, she was with a medtech company for 2 years and scientific officer in the Paediatric division of Science & Innovation at EMA for 12 years where Cecile has been leading the EMA extrapolation strategy and was an expert for the ICH E11(R)1 guideline.

Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined MSD in 2017 to lead regulatory policy efforts ex-US for innovation that leads to better treatment for patients globally. Since 2020 this scope has expanded, as Ginny now leads the talented and experienced Global Regulatory Policy and Intelligence team for MSD. Her work has regularly focused on policy shocks that challenge innovation and access to novel therapies for patients, including global and industry-wide policy work on BREXIT, COVID-19 and now the R&D impacts of the Inflation Reduction Act.

Claudia Cabrera-Moksnes graduated from Tulane University School of Public Health with a master’s degree in Epidemiology. She completed her doctorate degree at Sahlgrenska Academy at Göteborg University, Department of Primary Health Care and she also holds a Licentiate in Medical Science, from 2005. Claudia has worked in Industry for 17 years across all therapy areas and patient safety, of late she has focused on the build of large global studies related to respiratory disease. In her most recent position, she leads studies in Patient Safety, China RWE development as part of the Global Evidence Hub, as well as leading Clinical Trial Diversity research.

Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic research and regulatory experience, the latter at both the European Medicines Agency (EMA) and MHRA. Previously she was Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust and most recently an Industrial Strategy Challenge Fund Director at UK Research and Innovation.

UK top 100 technology influencer in 2019, operational strategy collaborator, blockchain advocate, eCOA and patient engagement thought leader with over 19 years in the NHS on commission by the DOH and in Industry (Hoffman La-Roche, Amgen, ALMAC, ICON and Biogen). An R&D transformation change champion. DIA Patient Engagement Voluntary Community Leadership team. Experience across various therapeutic areas and broad range of Phase I, II, III and IV trials including Neurology, IBD, Rare Disease and Gene Therapy. Hybrid virtual trials leader.

Niels Buch Leander is leading Regulatory Affairs and Safety at NNIT, responsible for NNIT's delivery and business development within Regulatory Affairs and Safety. He is revenue responsible for 100+ consultants and people management responsible for 40+ RA and Safety business consultants across Switzerland, Germany, Denmark, Polen and UK. Regulatory Affairs reports to NNIT's Board of Directors as one of NNIT’s 10 strategic “Winning Solutions”.

Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA initiatives. Additionally, she is responsible for the regional patient engagement and learning design initiatives, being the liason for the Middle East and SEE regions. Previously, she was Public Health Promotion Projects Manager at the Portuguese Pharmaceutical Society. Sara is a Master of Pharmacy since 2015 and a Soft skills Trainer since 2012, having delivered over 300h of Training internationally primarily focused on creating impactful interactions.

Background and experience in the clinical field and afterward in research and devel-opment of pharmaceuticals in the Biotech and Pharmaceutical Industry for 17 years with a long list of publications in high-impact journals. 4 years as Director of Division responsible for Medical Evaluation and Biostatistics – both Human and Veterinary Medical Evaluation, Danish Medicines Agency. As of 1st of January 2021 Director of Division responsible for Medical Strategy and Innovation, Danish Medicines Agency. Co-Chair of the joint HMA/EMA Big Data Steering Group. Member of the Board of Directors, Copenhagen Centre for Regulatory Science, University of Copenhagen Member of the Scientific Advisory Board, EHDEN, European Health Data Evidence Net

Susant Mallick comes up with 23+yrs of Pharma and IT background on building disruptive solutions/products in Clinical and Regulatory space. He is technology evangelist on cutting edge technology like (Artificial Intelligence, Machine Learning, IoT, Cloud etc) and an industry leading speakers across geographies. He has been working with various customers and partners in pharma and healthcare to drive digital transformation in clinical and regulatory landscape. He was instrumental in implementing/building many Regulatory solutions using advanced technology. Innovation and Digital Transformation in Healthcare and Life Sciences are two key focus areas.

Ian Rentsch has over 25 years’ experience in Multinational Corporate Affairs, Outsourcing Management & Clinical Research Development working in large multinational companies including large biopharma and Contract Research Organizations Globally and in Emerging Markets. Most recent roles include General Executive Management, Leadership of regional clinical teams, Business Operations and Strategic Business Development in the Contract Research Industry & Clinical Technology.

Anja Schiel has studied Biology at the Johannes Gutenberg-University, Mainz, Germany. She received her PhD from the Free University in Amsterdam in 2006 and worked several years as Post-Doc before starting at the Norwegian Medicines Agency (NoMA) in 2012. At NoMA she is working as special adviser/Statistician/Methodologist both on regulatory (EMA) and HTA projects. She has been Chair of EMA’s Biostatistics Working Party 2017 - 2019 and just finished her 3-year term as Chair of the Scientific Advice Working Party (SAWP) at EMA. She continues currently as alternate member of the SAWP and is Member of the new Methodology Working Party (MWP) recently established at EMA. She also leads the international HTA team at NoMA.

Gregory Daniel, PhD, MPH, is the Global Head of Public Policy at Eli Lilly & Company in Washington, D.C. Greg is also on the board of directors for the Innovation in Value Initiative (IVI), adjunct associate professor at the UNC Eshelman School of Pharmacy, and Visiting Expert at the Duke-NUS Centre of Regulatory Excellence, Duke-National University of Singapore Medical School. Formerly, he was deputy center director at the Duke-Margolis Center for Health Policy as well as fellow and managing director in the Center for Health Policy at the Brookings Institution. Greg received his PhD in pharmaceutical economics, policy, and outcomes from the University of Arizona, and an MPH, MS, and BS in Pharmacy from The Ohio State University.