Brian D. Bradbury is Vice President and Head of the Center for Observational Research (CfOR) at Amgen, Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) to support the development and continuous benefit:risk assessment of Amgen's medicines. Brian also holds an Adjunct Professor of Epidemiology appointment at the University of California, Los Angeles. He received his DSc in Epidemiology from Boston University and a MA in Education and Psychology from Pepperdine University. He has authored/co-authored 80+ peer-reviewed publications in the areas of pharmacoepidemiology, cancer, kidney, cardiovascular and bone disease.

Dr. John Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research, FDA. As an internist and epidemiologist, his responsibilities related to real-world evidence (RWE) include developing internal Agency processes, interacting with external stakeholders, and coordinating demonstration projects as well as guidance development. Dr. Concato joined FDA from Yale School of Medicine and the U.S. Department of Veterans Affairs, where he was a clinician, educator, independent investigator, research center director, and Professor of Medicine. He has a BE degree from The Cooper Union, MD & MS degrees from New York University, and an MPH degree from Yale University.

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.

Marni Hall is Vice President of Regulatory Science and Strategy for IQVIA Real-World Solutions, providing scientific oversight and strategic direction on the expanded use of real world evidence for regulatory and other uses, by applying her expertise in regulatory science, drug safety, and patient-centricity. Following her role as Director of Regulatory Science in CDER’s Office of Surveillance and Epidemiology, she served as Senior Vice President of Research and Development, Informatics, and Policy at PatientsLikeMe. Dr Hall received her training in biochemistry and molecular epidemiology at Columbia University, and currently serves as Vice Chair of Board of Directors of Worcester Polytechnic Institute.

Dr. Brad Jordan is a Head of Regulatory Affairs Policy at Flatiron Health, where his team works to advance the use of Real-World Evidence for regulatory decision-making. Brad was at Amgen for 15 years prior to joining Flatiron, where he led Global Regulatory and R&D Policy for Oncology and for Biosimilars and Biologics.

Nirosha Mahendraratnam Lederer, PhD is Head of US Government Partnerships at Aetion. In this role, she leads partnership opportunities with the US federal government and advises clients on RWE trends. Before joining Aetion, she led the RWE portfolio at the Duke Margolis Center for Health Policy including developing policies and strategies for increasing the usability and acceptance of RWD and RWE for regulatory and payment decision-making. She previously served as SME in Patient-Focused Drug Development at the US FDA Oncology Center of Excellence and worked at Avalere Health. Dr. Lederer served on Capitol Hill with the House Committee on Ways and Means Subcommittee on Health during the passage of the Affordable Care Act.

Dr. Yun Lu is a Mathematical Statistician and real-world evidence (RWE) reviewer working for the Food and Drug Administration (FDA)/Center for Biologics Evaluation and Research (CBER)/Office of Biostatistics and Pharmacovigilance (OBPV). Dr. Lu received her Ph.D. in Biostatistics from Johns Hopkins Bloomberg School of Public Health. Dr. Lu joined FDA/CBER in 2010 and she has extensive experiences with reviewing RWE related submissions and conducting vaccine safety and effectiveness studies using real-world data (RWD) including Medicare claims data from the Centers for Medicare and Medicaid Services (CMS).

Dr. Jingyu (Julia) Luan is a Senior Director of Global Regulatory Affairs in AstraZeneca, leading global drug development and regulatory strategies as well as innovative regulatory initiatives, eg, RWE. Prior to AstraZeneca, she worked at FDA for 13 years and held positions with increasing responsibilities, including Statistical Reviewer, Team Leader, and Acting Deputy Division Director. She had extensive experience in multiple therapeutic areas for both new and generic drugs. In addition, she was a research faculty member at Johns Hopkins University and a statistical consultant at the University of Kentucky. Dr. Luan is President-elect of Chinese Biopharmaceutical Association and Board Member/Committee Co-chair of FDA Alumni Association.

David Martin leads Global RWE for Moderna. Previously he completed 20 years of active duty service split between the United States Air Force and Public Health Service. At the FDA he led the Division of Epidemiology in the Center for Biologics. Subsequently, he established the Real World Evidence group in the Office of Medical Policy to drive the agency's scientific, guidance, and submission review responses to the RWE provisions of the 21st Century Cures Act. He initiated key RWE pathfinding efforts with external stakeholders including RCT Duplicate and the open-source FDA MyStudies mobile application. He holds an MD and MPH from Johns Hopkins and is board certified in occupational & environmental medicine as well as clinical informatics.

Executive Director in the RWE group at Evidera, PPD, part of Thermo Fisher Scientific, in Paris, France. Dr. Saragoussi is a physician specialized in Public Health and epidemiologist. In the pharmaceutical industry during 12 years and then as a consultant for the past 5 years, she has developed and implemented various RWE plans to support market access. Her research methods expertise covers the collection of primary data as well as the use of electronic databases. It includes natural history studies, burden of illness evaluations, treatment patterns descriptions, PRO validations, real-world effectiveness studies. Dr. Saragoussi is also well versed in the generation of RWE to meet regulatory needs.

Mark Stewart is vice president of science policy at Friends of Cancer Research (Friends), an advocacy organization based in Washington, DC that drives collaboration among partners of every healthcare sector and creates and implements policies ensuring patients receive the best treatments in the fastest and safest way possible. Mark leads the development and implementation of the organization's research and policy agenda as well as overseeing the conduct of research projects to inform ongoing policy discussions. He regularly participates in policy discussions and meetings throughout the year to help catalyze meaningful change for oncology healthcare and patients.

Dr. Fried is Professor of Medicine and Director of Hepatology at the University of North Carolina at Chapel Hill. Dr. Fried trained at the State University of New York at Syracuse and the National Institutes of Health. He is co-author of 200+ publications in the liver disease field and is currently co-chair of the NIH Hepatitis B Research Network. He is co-principal investigator of the HCV-TARGET network which was recently awarded the FDA Excellence in Regulatory Science Award for contributions to optimizing management for hepatitis C. TARGET PharmaSolutions, co-founded by Dr. Fried, develops real-world evidence communities based on the TARGET platform.

Anna is a Director and RWE Scientist in the RWE Center of Excellence at Pfizer, where she designs RWE strategy and works with teams across the drug development lifecycle to generate RWE in support of organizational decision making and regulatory engagement. Anna has more than 15 years’ experience utilizing real-world and clinical data to conduct healthcare research. Her prior work includes leading study teams in the design and implementation of outcomes research studies in the payer space, and on behalf of pharmaceutical and medical device companies in support of regulatory submission and post-marketing commitment. Over the course of her career, Anna has published extensively, and won the AMCP Award for Research Excellence.

Jonathan is a Director and RWE Scientist in the RWE Center of Excellence at Pfizer, where he designs and executes on RWE strategy and works with teams across the drug development lifecycle. Jonathan has more than 10 years’ experience utilizing real-world and clinical data to conduct and communicate healthcare research. His prior work includes working in medical affairs where he also led RWE education initiatives for Pfizer colleagues. Jonathan holds a PhD from McGill University in Pharmacoepidemiology where he is also currently an instructor in the department of Medicine.

Dr. Jaclyn Bosco Global Head of Epidemiology in Real World Solutions 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.

TARRY AHUJA, PhD is currently the Director of the new Post-Market Drug Evaluation Program at CADTH, the leading HTA agency for Canada. Prior to this he was a senior medical real-world evidence scientist for Eli Lilly for Europe and Canada. He has worked for over 10 years in the hospital setting in the area of sleep disorders and he has over 10 years of clinical research in the areas of otolaryngology, Alzheimer’s, stroke and ischemia with the National Research Council of Canada. He holds a PhD in Neuroscience with a specialty in electrophysiology and pharmacology, and has been a lecturer at Carleton University teaching “Biological Foundations of Addictions” and “Health Psychology” for over 15 years.

Mr. Harvey has over 20 years of experience in epidemiology and biostatistics. He has worked for academic institutions, government entities (NIH/NIAID), and now industry. In his role at Janssen, he provides thought leadership on generating RWE for regulatory decision-making and is motivated by the innovative approach of linking clinical trial data to real-world data. In prior roles, Ray provided onsite subject matter expertise for large multicentered, multinational infectious disease clinical trials and epidemiological studies focused on HIV and TB while working and living in Kampala, Uganda. This was a pivot period as it coincided with the initial phase roll out of The President's Emergency Plan for AIDS Relief (PEPFAR).

Rob Kalesnik-Orszulak is a Senior Director of Global Regulatory Strategy at Bristol Myers Squibb. As Team Lead for genitourinary (GU) tumors, Rob has built a high performing team of global regulatory leads each working on a number of global filings in renal, bladder, and prostate cancer. As the Regulatory Innovation Lead for Real World Evidence (RWE) and Data Science, Rob is also responsible for establishing the regulatory department's expertise, capabilities, and strategy around RWE across all therapeutic areas at BMS. Rob has over 8 years of experience leading regulatory strategy across the drug development lifecycle, from first-in-human trials to mature products, with a focus in oncology.

David Moeny is a pharmacist and pharmacoepidemiologist with experience in clinical pharmacy practice, public health, drug utilization, regulatory pharmacoepidemiology, and international collaborations. At FDA, he has worked in both drug utilization and epidemiology teams and as the director for the Division of Epidemiology-II, participating in numerous evaluations of drug safety issues in Sentinel and other systems. He is currently serving as the Acting Deputy Director for the Office of Pharmacovigilance and Epidemiology in the Office of Surveillance and Epidemiology at the Food and Drug Administration, and is serving as the Rapporteur for the International Council of Harmonization M14 Guideline.

Physician/Epidemiologist for Real World Evidence Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research at the FDA. My main duties include leading demonstration projects intended to support the agency’s evaluation of real world evidence, evaluating real world evidence use cases, and contributing to medical policy development mandated by the 21st Century Cures Act. Key focus areas include FDA-Catalyst and PCORI pragmatic trials as well as replication of clinical trial results with non-interventional study designs.

Jillian Rockland leads Flatiron Health’s Regulatory Strategy team, which supports Flatiron Health’s life science partners in using RWD/E for regulatory decision-making. Previously, she oversaw Flatiron RWE product and operations, managing the scoping, creation and delivery of research-question specific real-world datasets to partners for regulatory use. Prior to joining Flatiron, Jillian managed clinical research teams in executing industry-sponsored, multi-site clinical trials and then led strategy and development for several healthcare technology products. Jillian received her undergraduate degree in Neuroscience from Northeastern University and her MPH in Epidemiology and Biostatistics from Columbia University.

Dr. Vereshchagina is the Vice President, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA represents the country’s leading innovative biopharmaceutical research companies, which are devoted to researching and developing medicines that enable patients to live longer, healthier, and more productive lives. She leads the Regulatory Advocacy team with the focus on the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), as well as other regulatory policy and advocacy issues. Dr. Vereshchagina was the lead PhRMA negotiator for both PDUFA VII and BsUFA III.

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.

Laura Esserman, MD, MBA is director of the UCSF Breast Care Center. She is recognized as a thought leader in cancer screening and over-diagnosis, as well as innovative clinical trial design. She led the creation of the University of California-wide Athena Breast Health Network, a learning system designed to integrate clinical care and research as it follows 150,000 women from screening through treatment and outcomes, and the PCORI-funded WISDOM Study, which tests a personalized approach to breast cancer screening in 100,000 women. She is also a leader of the innovative I-SPY TRIAL model, designed to accelerate the identification and approval of effective new agents for women with high risk breast cancers.

Dr. Wei Hua is currently Acting Deputy Director of Division of Epidemiology-I in the Office of Surveillance and Epidemiology, CDER, FDA. She received her medical degree from China and PhD from the Johns Hopkins School of Public Health. Her areas of expertise include infectious disease epidemiology and pharmacoepidemiology with experience in both experimental and observational studies using primary and secondary data in the U.S. and through multi-site international collaborations. Over the past ten years, Dr. Hua has held multiple roles in the FDA centers for biologics and drugs leading and overseeing epidemiological research and review in the regulatory setting.

Dr. Lin was a clinical pharmacist by training and Ph.D in Pharmacoepidemiology. Before joining Amgen, he had his postdoctoral training in Harvard Medical School in the U.S. He is currently a director in Center for Observational Research, Amgen and leading global real-world evidence generation for bone and nephrology therapeutic areas. He also serves as an adjunct assistant professor in National Cheng Kung University in Taiwan. Dr. Lin’s research interests include real-world drug utilization research and comparative effectiveness/safety research. In recent years, he’s been leading several large real-world study to support regulatory decision-makings, including post-marketing safety study and drug effectiveness for label expansion.

Daniel C. Malone, PhD, FAMCP, is a Professor at the University of Utah College of Pharmacy. Dr. Malone has conducted and published over 220 articles in peer reviewed literature on health economics and outcomes research, including cost-effectiveness analyses, burden-of-illness studies, patient reported outcomes studies, and numerous evaluations of healthcare interventions in real-world environments. He was President of the ISPOR from 2015 to 2016. Dr. Malone is a Fellow of the Academy of Managed Care Pharmacy and the American Foundation for Pharmaceutical Education. His awards include Excellence in Pharmacy Award , Professional Achievement Award from the University of Colorado (awarded twice), and two Distinguished service awards from ISPOR.

Motiur Rahman is a Senior Epidemiologist at Real-World Evidence (RWE) Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA). His responsibilities include developing guidance, improving internal Agency processes, stakeholder engagement, collaborating on Agency-funded demonstration projects, and providing consultancy on RWE study submissions. He joined FDA in 2022 after a 10+ years of working experience in academia and industry in conducting observational studies across a wide range of therapeutic areas. Dr. Rahman is a Pharmacist by training and holds a PhD in Pharmacoepidemiology and Master’s in Statistics.

Wendy Turenne is a healthcare analytics specialist with 20 years of experience building bridges between data, analytics, and business strategy. As SVP, of RWD & Delivery Operations, Wendy leads client engagement, data strategy and integration, and operational performance for Aetion. Previous to joining Aetion, Wendy partnered with biopharma companies of all sizes on RWE and HEOR collaborations with Cardinal Health and DaVita. Prior to that, she held analytics and leadership positions across multiple settings: government, population health, hospital, payer, and provider organizations. She holds a BS from the University of Virginia and an MS in Biostatistics from the University of North Carolina, Chapel Hill.

Catherine is a senior pharmacoepidemiologist in the RWE Workstream, Data Analytics & Methods Task Force, at EMA. She previously held various pharma positions, generating and evaluating RWE across all phases of medicine development, including vaccines. She also worked as an epidemiologist at the Centre for Public Health Research and the Malaghan Institute for Medical Research in Wellington, New Zealand, and the WHO International Agency for Research on Cancer in Lyon, France. Her work at EMA focuses on international guidance on RWE, and on public health emergency preparedness as Steering Group member of the EU Vaccine Monitoring Platform. She is co-chair of the ENCePP Steering Group and represents EMA in various RWE-related ICH initiatives.

Dr. Critchlow leads R&D Data Strategy, focusing on synergizing cross-functional capabilities in multi-omics, clinical trial and real world data (RWD) to increase the probability of success in bringing innovative medicines to patients. She previously led Amgen’s Center for Observational Research, providing strategic leadership in use of RWD to inform decision-making by multiple internal and external stakeholders. Prior to joining Amgen in 2004, Dr. Critchlow was on the Epidemiology faculty at the University of Washington. Dr. Critchlow earned her bachelor’s degree from Stanford University, and her MS in Biostatistics and PhD in Epidemiology from the University of Washington.

Nicholaas Honig is a Senior Regulatory Counsel at Aetion. In this role he advises clients on regulatory approaches involving Real-World Evidence and analyzes FDA approval decisions to understand RWE precedent. Prior to joining Aetion, Nicholaas worked at Pfizer in the company's Chief Business Office. He also has practical experience with FDA's Office of Chief Counsel and the Massachusetts General Assembly's Joint Committee on Healthcare Financing. Nicholaas is representing the RWE Alliance at this panel. The RWE Alliance is a coalition of real-world data and analytics organizations with a common interest in harnessing the power of real-world evidence to inform regulatory decision making to improve patients’ lives.

Dr Jonsson Funk is an Associate Professor of Epidemiology and Director of the Center for Pharmacoepidemiology at UNC. Her research focuses on improving methods for the study of drug safety and effectiveness using real world data including understanding the impact of measurement error in studies using claims and EHR data, methods for generalizing treatment effects from clinical trials to real world populations, and evaluating treatment effect heterogeneity. As principal investigator for the DETECTe Demonstration Project, she led a team that evaluated the performance of approaches to assessing and addressing the threat of unmeasured confounding. Dr Jonsson Funk has 120 peer-reviewed publications spanning multiple therapeutic areas.

Nicole Kellier-Steele is a Senior Director in the Global Patient Safety group at Eli Lilly and Company. Nicole has expertise in epidemiological methods and has worked in the Lilly Global Patient Safety group for over 12 years. Nicole received her PhD from Florida International University and her MPH in Epidemiology from George Washington University. Her experience includes design, analysis, execution of non-interventional studies across multiple therapeutic areas. Nicole supports cross-functional teams and provides epidemiological expertise to for regulatory strategies and obligations for compounds in development, new product launches and marketed products.

Following the completion of his residency and fellowship (RWJ Clinical Scholars Program), Kraig Kinchen joined the outcomes research group at Eli Lilly and Company. After serving in both technical and supervisory roles focused on RWE, he spent ten years as a clinical research physician and senior medical director in a variety of therapeutic areas in clinical development. He returned to outcomes research in 2019 to lead Lilly's Center of Expertise in Global Patient Outcomes and Real World Evidence. Currently, he is the Associate Vice President for Value, Evidence, and Outcomes in the Diabetes Business Unit. Kraig received his undergraduate degree from Tulane, his MSc from Oxford and his MD from Harvard Medical School.

Sarah Sheehan is a Program Lead for the Digital Medicine Society (DiMe) where their work focuses on the use of digital health tools to enable high-quality clinical evidence generation. Previously, Sarah was an Assistant Research Director at the Duke Margolis Center for Health Policy leading biomedical innovation and regulatory science programming. At Duke, they oversaw a portfolio of work related to clinical trial modernization and improved evidence generation, with core efforts on the integration of clinical research and routine care using digital health tools and real-world data, the engagement of community health systems in research, and approaches to achieving representative clinical trial enrollment.

Curran Sidhu, MBS is a Senior Consultant with the Value Access Consulting team at Evidera, a PPD business, and is based in California. He has over five years’ consulting experience in the global market access space. His therapy area experience includes diabetes, neurology, rare diseases, and oncology and encompasses medical devices as well as gene and cellular therapies. Additionally, he has published thought leadership pieces evaluating US payer perception of digital health technology coverage and management, and the impact of ICER on US payer decision making. Curran graduated from Keck Graduate Institute with a Master of Business and Science and from Georgia Institute of Technology with a Bachelor of Science in Biomedical Engineering.

Rachele Hendricks-Sturrup, DHSc, joins Duke-Margolis as the Research Director leading the Center’s Real-World Evidence (RWE) portfolio, including managing its RWE Collaborative. She is a scientist/researcher, health policy and industry professional, journalist, and academician within the fields of health policy, business, and health innovation.

Charles is currently Executive Regulatory Science Director at Astrazeneca. He oversees Global Regulatory science and strategy for therapeutic products in the renal, cardiovascular, diabetes, and NASH disease areas. Prior to this role, Charles was a Product Development Team Leader over a 10 year period at Astrazeneca and Roche where he led cross-functional project teams for programs in the early development phase (Ph0 to Ph2b). Previous to that, Charles spent 10 years in Global Regulatory affairs where he held leadership roles on programs across several therapeutic areas in different stages of development. Charles holds BS in Biology from The Johns Hopkins University, MS from University of Virginia, MBA from Columbia Business School

Peter Mol is the Dutch member of the Committee for Human Medicinal Products. He was a previous member (vice chair) of EMA’s Scientific Advice Working Party. He is co-chair of the EMA Cross-Committee Task force on Registries. He is also a professor of drug regulatory science at the University Medical Center Groningen. His research interest is in the area of regulatory science; from new tools to optimize regulatory decision-making (especially impact of personalised medicine and real world evidence), to improve knowledge transfer and with a specific interest in safety communication.