Dr. Jaclyn Bosco Global Head of Epidemiology & Scientific Strategy in Real World Evidence at IQVIA, is responsible for driving real-world evidence (RWE) generation for regulators, clinicians, patients and payers using passive and primary data collection through clinicians and person-generated health to support the safety and effectiveness of drugs, biologics, and medical devices from early clinical development through the post-approval phase. She identifies the best approach for capturing data on a global scale as well applies local approaches to address market-specific needs. As a thought leader in real world research, she is invited to speak at international congresses and sits on scientific advisory boards and committees.

Dr. Carrigan has over 20 years of experience in observational studies with a focus on study design and methodology. He is experienced with the use of electronic medical records (EMR), administrative claims data, and registry data. He has worked with observational data in a number of settings and therapeutic areas including oncology, neuroscience, respiratory disease, and vaccine safety. In recent years, he has focused on applying epidemiological methods to real-world oncology data to augment evidence from clinical trials.

Simon is an epidemiologist and health economist with expertise in designing, conducting, and communicating scientific studies related to the clinical and economic value of therapies for neurologic conditions. He is currently the global RWE lead for Internal Medicine at Pfizer. Prior to Pfizer, Simon was the global lead for Neurology in the RWE COE at Vertex Pharmaceuticals and supported programs for acute pain, Duchenne muscular dystrophy, and other neurologic conditions. Prior to Vertex, Simon worked in RWE, health economics and outcomes research, and pharmacovigilance at Pacira Pharmaceuticals.

Alicia Gilsenan, PhD, is Vice President, Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan’s primary area of expertise is pharmacoepidemiology and therapeutic risk management and the structured benefit-risk assessment of medications. Since joining RTI in 1997, she has applied state-of-the-art approaches to the design, conduct, and analysis of both retrospective and prospective epidemiologic studies, most recently focusing on consultation, design, and implementation of postauthorization safety studies in the US and in Europe in area of vaccine and drug safety. She is adjunct professor in Epidemiology at the UNC-Chapel Hill and teaches an intro to Pharmacovigilance course to graduate students biannually.

Hetal Pansuria, Pharm.D., is an experienced regulatory professional and pharmacist with 20 years of experience in the health care industry. In her role as Vice President of Regulatory Affairs, Clinical, Nonclinical, and Ad-Promo at Pacira BioSciences, Hetal oversees the development and execution of regulatory strategies for clinical, nonclinical, and advertising-promotional reviews of drugs, biologics, and medical devices. Hetal works closely with senior leaders and cross-functional teams to develop effective regulatory strategies that optimize the development pathway for products in all stages of development, including early-stage assets & marketed products. She also oversees ad-promo reviews and labeling activities for all products.

Dr. Motiur Rahman is a Senior Epidemiologist and Policy Advisor in Real-World Evidence (RWE) Analytics within the Office of Medical Policy at CDER, FDA. He leads the consult service for reviewing RWD study submissions, leads international regulatory collaborations including ICH initiatives, and supports internal training and process development. He serves as FDA topic lead for the ICH E23 Working Group, contributes to FDA-funded demonstration projects, and is a core member of the RWE Subcommittee. Dr. Rahman joined FDA in 2022 after more than a decade of academic and industry experience conducting observational studies across diverse therapeutic areas.

Lina Titievsky, MPH PhD, is a head of Hepatology Epidemiology in Global Epidemiology at GSK. Prior to joining GSK, Lina's professional journey included working in safety epidemiology across multiple therapeutic at Pfizer, leading a medical research organization at Intercept and RWE team responsible for cell and gene therapies at Vertex. In her current role, she leads a group of epidemiologists responsible for generating RWE in support R&D throughout the products' life cycle, ranging from pre-clinical needs all the way through the regulatory approval. Lina holds a PhD in Epidemiology from Columbia University and is an ISPE Fellow.

Xiang Zhang is the Head of Medical Affairs and HTA Statistics and a co-lead of the Forum for Observational Research Excellence at CSL. He leads a team of statisticians, epidemiologists, and RWE scientists to support RWE generation across drug life cycle including clinical development, regulatory submissions, product launches, and commercialization. This team also provide statistical support for HTA submissions and other peri-launch activities to secure market access for CSL products. He has authored or co-authored over 40 peer-reviewed publications and a book in causal inference in RWD analysis. He is a member of both RWE and HTA scientific working groups under the American Statistical Association.

Dr. Rachele Hendricks-Sturrup is the Research Director of Real-World Evidence (RWE) at the Duke-Margolis Institute for Health Policy in Washington, DC, strategically leading and managing the Institute's RWE Collaborative and RWE policy research portfolio and education. As an engagement expert, biomedical researcher, bioethicist, and policy practitioner, her work centers on addressing implementation, regulatory, and ethical, legal, and social implications (ELSI) at the intersection of health policy and innovation. She presently partners with Duke University faculty, scholars, students, and external practicing experts to advance the Institute's biomedical innovation work.

Nancy Dreyer brings her experience as Chief Scientific Officer at IQVIA Real World Solutions and SVP roles at IQVIA, Quintiles, Outcome Sciences Inc and UnitedHealth Group to independent consultancy. Her work focuses on advancing the use of real-world evidence for safety, effectiveness and natural history research, using diverse forms of data including patient-generated health data, electronic medical records, medical and pharmacy claims, data linkage and data integration. She is a Fellow of International Society of Pharmacoepidemiology (ISPE) and of DIA, and is a Science and Policy Advisor to DIA, Adjunct Professor of Epidemiology at the Univ of North Carolina at Chapel Hill and a member of ISPOR's RWE Leadership Team.

Dr. Eva Oakkar is an epidemiologist with more than 10 years of real world research experience, both in academia and industry. She is responsible for developing novel study methodologies to build comprehensive patient records for research, linking primary and secondary real world data (RWD). In prior roles, Dr. Oakkar focused on designing innovative studies leveraging real world evidence (RWE) in clinical development, developing regulatory strategies for use of RWD and methods and providing scientific leadership for observational research on the natural history of disease, comparative safety/effectiveness and cost of medical treatment.

Sebastian Schneeweiss, M.D., Sc.D., is a Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology, Department of Medicine, Mass General Brigham in Boston. His research focuses on understanding the effectiveness and safety of biopharmaceuticals in clinical practice. He has developed and applied analytic methods to improve the accuracy of estimating causal treatment effects of medical products using complex digital healthcare databases published in >600 articles. He is working closely with the US FDA and EMA to promote robust evidence generation with non-randomized data that supports regulatory decision-making. He is a Fellow of the American College of Epidemiology, of Clinical Pharmacology, and ISPE

Renske ten Ham is an assistant professor at UMC Utrecht, specializing in health economics and health technology assessment of Regenerative Medicines. Her experience includes research at UCSF, Dutch Medicines Evaluation Board, and the Dutch National Health Care Institute (ZIN). She is a recipient of the Greiner Award, University of York Centre for Health Economics Fellowship, and NWO VENI. At UMC Utrecht, she leads the Health Economics Regenerative Medicines group and serves on ZIN’s Scientific Advisory Board. Her research focusses on payment models, development cost, (early) economic evaluations and methods development.

John D. Diaz-Decaro, PhD, MS is a pharmacoepidemiologist and real-world evidence strategist with expertise in real-world evidence, observational study design, and AI-enabled evidence generation. He served as Senior Director and Lead Epidemiologist at ModernaTX, directing a global RWE portfolio across infectious disease and autoimmune programs. He is the founder of Black Swan Causal Labs and chairs the ISPE Digital Technology & AI Special Interest Group. He holds prior adjunct faculty appointments at UCLA and California State University, Dominguez Hills.

Zachariah W Peterson, MPH, BS is a Manager of Biostatistical Programming in the Center for Observational Research at Amgen, Inc. Zach leads a regulatory RWE programming team focused on incorporating regulatory data standards to RWD to support the utilization of RWE in regulatory setting including new drug applications and label expansions. He received his MPH in Epidemiology from the University of Arizona College of Public Health and his BS in Molecular and Cellular Biology from the University of Arizona College of Science.

Khaled is a drug development scientist with deep and broad expertise in evidence generation and healthcare data science. Throughout his career Khaled built and led teams of multidisciplinary data scientists including epidemiologists, biostatisticians, and AI/ML experts that delivered evidence and insights across therapeutic areas and phases of development. Currently, at Astellas Pharma, Khaled is the global head of evidence generation and advanced analytics where he leads Exploratory Statistical Science, Medical Affairs Statistical Science, and Real-World Data Science to enhance & accelerate data-driven decisions across the value chain. Prior to Astellas, Khaled held leadership roles at Eli Lilly, Johnson & Johnson and Roche-Genentech.

Nicole Mirea Turner, PhD, is a Data Scientist at Plinth Analytics, where she designs and develops software that helps epidemiologists and HEOR scientists work with real-world data, from feasibility dashboards to data-quality monitoring and automated reporting. Trained as a linguist and cognitive scientist, she knows a dataset means little until you understand how and why it was produced. That background also helps her guard against human error and misreadings that erode good science. She does this by building reproducibility and provenance into every tool, so researchers do the right thing by default and their evidence stands up to scrutiny. She's happiest spotting the problem everyone else works around, then solving it.

Daniele Bertolini is a Principal Machine Learning Scientist at Unlearn.AI, where he develops machine learning methods to improve clinical trials. His work focuses on disease progression modeling and statistical approaches for integrating machine learning into clinical trial design, conduct, and analysis. Before joining Unlearn.AI, he worked on natural language processing and machine learning applications in computational physics. He holds a PhD in Theoretical Physics from the Massachusetts Institute of Technology.

Dr. Marie Bradley is a Senior Advisor for RWE in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER). Her responsibilities related to real-world evidence (RWE) include serving as lead for the Advancing Real-World Evidence Program, the Real-World Evidence Subcommittee, and a portfolio of RWE demonstration projects. She also evaluates complex real-world evidence related study protocols submitted to FDA. Recently, she has been helping to drive Agency level RWE initiatives and is co-chair of FDA-RWE-ACCELERATE. Dr Bradley is an established advocate, speaker, and panelist across national and international platforms on RWE related topics and participates extensively in external engagement

Dr. Masanao Sasaki is a biostatistics reviewer at the Pharmaceuticals and Medical Devices Agency (PMDA). He has research experience in academia and has worked in biostatistics, data science, and regulatory science. Dr. Sasaki holds a PhD in Mathematical Medical Science from the Institute of Science Tokyo.

As an entrepreneur and scientist, Mayur has concentrated on advancing medicine with high-noise, big data analysis. Before founding Droice, he played key roles in several startups, including co-founding a biotechnology firm in the diabetes space. He earned his BTech at IIT Kanpur and his MS and PhD at Columbia University, focusing on the computational physics of disease.

Sneha Kishnani is Head of RWE Innovation & Implementation at IQVIA, where she leads the evaluation and deployment of innovative methodologies, AI-enabled solutions, and emerging technologies to advance real-world evidence generation. With more than 19 years of experience across the drug development lifecycle, including over 12 years in RWE, she specializes in translating innovation into scalable solutions that enhance the speed, quality, and impact of evidence generation.

Dr. Verpillat is the Head of the Real-World Evidence (RWE) Workstream at the European Medicines Agency (EMA). He has worked before during 20 years in the pharmaceutical industry where he had global positions in several international companies, always dealing with RWD and non-interventional studies (NIS) in order to bring RWE into research, access and life-cycle product management. He has published over 90 articles in Medline referenced journals. He is/has been involved in many organisations such as ENCePP, ICH (M14 topic leader & E23 rapporteur), European pharma association (efpia) and ISPE (Chair of "Government, Regulators and Public Health Organisations" Council.

Dr. Wang is an Associate Professor at Brigham and Women’s Hospital, Harvard Medical School. She co-led the 1st and 2nd joint task forces between ISPE and ISPOR, co-directs the REPEAT Initiative, a non-profit program with projects aimed at improving the transparency, reproducibility, and robustness of evidence from healthcare databases, and co-directs RCT-DUPLICATE, a series of projects designed to inform FDA guidance on when and how to use real-world data analyses to inform regulatory decision-making.

Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory experience, including roles at both the European Medicines Agency and at the MHRA. Her previous positions include Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust and an Industrial Strategy Challenge Fund Director at UK Research and Innovation.