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”.

Carine Odouard is the Global Business Development Director and Head of RWE at Carenity, The Patient Insights’ Company (EvidentIQ Group). Before joining Carenity, Carine spent 15 years working in the Pharma Industry. She began her career in Marketing working for AstraZeneca and Baxter in various therapeutics areas. She then held responsibilities in commercial strategy and market access to finally join Roche as Commercial Head within the Market Access Team focusing her efforts to ensure a better access to innovation for patients. Driven by the desire to make patient-centricity come true she joined Carenity to facilitate real-life patients' studies.

Frank Pétavy is head of Methodology in the EMA Task Force on Data, Analytics and Methods. His team at EMA provides expert advice to sponsors during drug development and in the assessment of marketing authorisation applications across therapeutic areas. Frank also coordinates activities of the group of European statistical assessors, the Biostatistics Working Party, which includes the development of methodology guidelines. Frank has been or is still involved in ICH working groups on estimands, adaptive designs and the clinical electronic structured harmonised protocol. Frank holds a post-graduate diploma in biostatistics. Prior to EMA, he spent 14 years working in clinical development in the pharmaceutical industry in Spain and in the UK.

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.

Theodor studied statistics at the Dortmund University of Technology and at the University of Auckland. He joined the Institute of Biostatistics at Hannover Medical School in 2009 where his main areas of work were consulting, teaching and clinical trials. He also served as a deputy member for the Ethics Committee at Hannover Medical School and completed a PhD in Biostatistics. Theodor works as a Seconded National Expert at the EMA since September 2020.

Rodrigo Palacios is an Executive Director in Regulatory Policy at Roche. He is responsible for advancing global policy on data and technology in the regulatory domain. These topics include Cloud Submissions, Data Standardisation (e.g. IDMP), structured data submissions, eCTD and Regulatory Information Management. Rodrigo represents Roche in EFPIA and PhRMA Regulatory Technology expert groups and acts as PhRMA's deputy topic lead in the ICH M4Q R2 Expert Working Group. He has over 25 years of experience in data and technology strategy, Information Technology management, software development and consulting.

Andrew Raven joined Health Canada in 2004. He holds a Bachelor of Science in Molecular Biology and Genetics and a Master of Science in Mathematics and Statistics both from the University of Guelph. He has previously worked as a biostatistician and senior biostatistician, assessing study design and conduct as well as statistical methodologies and analyses in pre-market prescription drug submissions at the Pharmaceutical Drugs Directorate (PDD) (formerly TPD). He has been manager of the Biostatistics, Epidemiology, and Pharmacometrics Unit of PDD since 2015.

Mathieu Galtier, PhD - Owkin Chief Product Officer. Mathieu graduated from ENS and Mines ParisTech and completed his PhD in Machine Learning applied to Neuroscience at Oxford and Inria. He started his career at Rythm, a neurotech startup, where he directed research and algorithms and led the Morpheo project. He is devoted to deploying AI in a responsible way. He now leads Owkin’s Connect business unit and serves as the Company’s Chief Product Officer.

Lada Leyens has a background in human genetics, health economics and personalised medicine. She has worked at Health Authorities for over 8 years, mainly in the approval of clinical trials and as a GCP inspector at Swissmedic. At EMA she was in the specialised disciplines office working in the centralised procedure and with the PKWP and PGWP. At Roche, Lada was the Regulatory Lead for digital health programs and the Regulatory Shaping Lead on Clinical Trial Innovation. At Takeda, she leads the therapeutic are of GI and Inflammation for the EUCAN region and is vice-chair of EFPIA-CREG. Lada is passionate about leveraging innovative technologies to make drug development more efficient and bringing innovative drugs faster to patients.

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.

Marcia holds a master’s degree in Mathematics and a Ph.D. in Biostatistics. In 2015, she started working at the Institute of Medical Statistics at the RWTH Aachen University Hospital. Her main responsibilities included teaching and consulting on the design and analysis of observational studies. Marcia joined the Data Analytics and Methods Task Force at the European Medicines Agency as Seconded National Expert in August 2020.

Dr. Schneeweiss's research focuses on assessing the effectiveness and safety of biopharmaceuticals in clinical practice. He has developed analytic methods to improve the accuracy of estimating causal treatment effects of new drugs using complex digital healthcare databases. His work is published in >500 articles and is used for regulatory and coverage decision making around the globe. He is funded by NIH, PCORI, IMI, and FDA where he is also a voting consultant. He is Principal Investigator of the FDA Sentinel Innovation Center and co-leads the RCT-DUPLICATE initiative to understand when and how real-world evidence studies can reach causal conclusions.

Babak Boroojerdi, MD, PhD, MBA is a neurologist and a movement disorders specialist who has been involved in the field of Parkinson’s Disease (PD) and movement disorders through his academic and industry career in the last 25+ years in Germany, US and UK. Babak has conducted numerous studies in the field of PD with a special interest in wearable technologies. He has been a member of the Critical Path Parkinson for several years and has been serving as industry co-director of the Modeling & Simulation team in the last years. He is currently representing UCB at a new IMI project (IDEA-FAST).

Dr. Garry is an epidemiologist with over 15 years of pharmacoepidemiology and academic research experience. She holds a doctorate in epidemiology with a concentration in pharmacoepidemiology from UNC Chapel Hill and an MPH from Tufts University School of Medicine with a dual concentration in biostatistics and epidemiology. She has been with Aetion for over 7 years, providing scientific oversight and support of both client- and Aetion-driven research activities, primarily related to use of RWE for decision-making, including the RCT-DUPLICATE collaboration with Brigham and Women’s Hospital and the FDA.

With a professional and academic bacground within the pharmaceutical industry Niels Grønning possesses extensive knowledge within the area of IT & Life Sciences. His area of expertise is predominantly found within regulatory affairs, IT (strategy, architecture & compliance) and more recently the implementation and impact assessment of ISO IDMP.

Yusuf Henriques is the Founder & Chief Executive Officer (CEO) of IndyGeneUS AI. (pronounced indigenous) IndyGeneUS is a genomics company creating the world’s largest block-chain encrypted repository of indigenous and diasporic African clinical data for disease prevention and detection, drug discovery and development, clinical disease management, and precision health equity. As CEO, he leads strategic direction and partnerships as well as investor relations. Prior to IndyGeneUS, Henriques founded TruGenomix Health Inc., an emerging precision genomics behavioral health company harnessing the power of genomics to improve risk prediction and diagnosis of Post-Traumatic Stress Disorder (PTSD).

Dr. Ibald-Mulli is a trained Epidemiologist and holds a Doctorate degree in Environmental Epidemiology as well as Master’s Degrees in Public Health , Nutrition and Business Administration. Dr Ibald-Mulli has been working in the biopharmaceutical industry for the past 18 years in various roles including clinical development, post marketing research, business operations and most recently in real world evidence generation. Angela recently joined Bayer as Integrated Evidence Generation lead for the Thrombosis franchise having previously held a similar position within Sanofi. Prior to embarking on a career in the pharmaceutical Industry Angela worked as a research scientist at the LMU Institute of Epidemiology in Munich.

Julian is the father of Sergio, a young boy fourteen years old who has Dravet Syndrome Founder the European Dravet Syndrome Federation and Dravet Syndrome Foundation in Spain Dravet Syndrome is an epileptic encephalopathy having long lasting seizures refractory to treatment as severe developmental delay as main symptoms. Julian is software engineer by training, and he works for Microsoft as full time employee on Artificial Intelligence projects. Julian is also founder of Foundation 29, a NPO doing research on AI to improve life of patients: Julian is also member of the Orphan Drug Committee at European Medicines Agency and member of different NPO boards.

Global Director for Public, Private Partnerships at Novo Nordisk, Global Medical Affaris. Former Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been leading EU framework programme workpackages, IMI and TransCelerate Biopharma workstreams in the past. Currently active in development of FHIR for clinical research and use of AI/ML in life science.

Amr is a pharmacist by training, having completed his PharmD degree in Egypt before moving to the Netherlands to pursue his Master’s studies at Utrecht University in the field of pharmaceutical policy. Recently, Amr completed his PhD degree at Utrecht University whereby his thesis focused on the use of Real-World Evidence (RWE) in HTA practice. Amr worked as a pharmacoeconomic assessor and policy advisor at the Dutch National Health Care Institute (ZIN) and was involved in a number of international projects related to RWE generation and use in decision-making, including: IMI-GetReal I/II, IMI-ROADMAP, EUnetHTA JA3 and NEWDIGS. Currenly Amr works as a market access manager at Janssen Pharmaceuticals in the Netherlands.

Baris Erdogan is the Chief Executive Officer of Clinerion. He studied computer engineering and holds M.Sc. and Ph.D. in educational technology. He practiced data mining techniques in various sectors including healthcare. He lectures on the topics of software development, database management, medical informatics, and project management. His expertise and experience include the management of innovative Medical Informatics projects and implementation of end-to-end Healthcare IT enterprise information systems, both in the public and private sectors.

Tadeusz Lewandowski joined the pharmaceutical industry in 2001, as a statistical programmer in CRO, building clinical trial reporting capabilities. In 2008 joined Roche to work as a Lead programmer on an oncology molecule project, and in 2016 formed and led a group of statistical programming data analytics - working on AA, ML projects, and software development for clinical trials reporting tools. In 2019 co-initiated the NEST project at Roche as a business lead, and in 2021, started a chapter of Pan-pharma code collaboration lead. In 2022 Tadeusz joined Jonson&Jonson/Jansen as a Data Engineering Head.

Sean Manion, PhD is a neuroscientist with two decades of federal brain research and leadership experience. He is the Chief Scientific Officer of ConsenSys Health, a start-up focused on the application of emerging technology (blockchain, decentralized machine learning, and privacy-preserving encryption) in healthcare and life sciences. He completed his doctoral and post-doctoral work as a civilian at Uniformed Services University of the Health Sciences looking at pre-clinical models of post-traumatic stress disorder (1999-2009). He continued work with the Military Health System as Deputy Chief of Staff and later Research Activities Chief for the Defense and Veterans Brain Injury Center (2009-2017).

General Manager of Medicines and Biological Products at ANVISA, Brazil. Responsible for the management of drug and biological product registration submission evaluation teams, authorization to conduct clinical trials in Brazil, and certification of bioequivalence centers. I have been working at ANVISA, Brazil since 2003 mostly with bioequivalence / biowaiver studies and clinical trial evaluations. I'm a pharmacist with specialization in public health, I also holds a Master of Toxicology.

Prior to Acoer, Jim was the Vice President of Technology for Certara and was the Chief Software Architect at the US Centers for Disease Control (CDC). Jim led a number of modernizations of CDC’s public health systems, through implementation of interoperable software, data as a service, blockchain and open source software. Jim has more than twenty years of experience in the technology industry, with over a decade as a founder and CEO of Armedia. With Jim’s expertise, Armedia grew from inception to over 100 employees, and a 5-time Inc. 5000 awardee. Jim is on the board of many technology organizations and the Architecture Lead for PhUSE Blockchain Working Group. He has an MBA from the University of Connecticut.

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.

Álmath is Head of Europe Regulatory Policy at AbbVie. Álmath dually qualified as a pharmacist and a barrister-at-law with a PhD from Trinity College Dublin and postgraduate qualifications in statistics and pharmaceutical medicine. Álmath has extensive experience in regulation and policy having held management and assessment roles at the Irish HPRA (2007-2019) and at EMA's PRAC (Vice Chair 2012-2018). Álmath was called to the Bar of Ireland in 2018 and practiced in Commercial Law prior to joining AbbVie in 2020. At EFPIA, Álmath chairs the Integrated Evidence Generation Working Group. She has prior experience in various global initiatives including at ICH. She is a member of the DIA Regional Advisory Council.

Dr. Rose is a Physician, Entrepreneur, and Blockchain Specialist, who strives to use cutting-edge technology to simplify secure user experiences that increase patient engagement and drive better health outcomes. He has more than 9 years working on Translational Medicine and Phase I/II clinical research projects. Since authoring one of the first 75 whitepapers on creating U.S. hospital interoperability through blockchain technology for the ONC/NIST 2016 inaugural workshop, he has spoken at various conferences on the subject matter. Dr. Rose has been mentioned in Forbes, CoinDesk, The Parallax, and participates on several committees to help create standards for blockchain's technology in healthcare and clinical research.