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.

Nancy Dreyer is Chief Scientific Advisor to Picnic Health and Adjunct Professor of Epidemiology at the University of North Carolina. Recently retired from full-time employment as Chief Scientific Officer at IQVIA Real World Solutions, she maintains an active career consulting, publishing and teaching for the International Society of Pharmacoepidemiology (ISPE). She is a Fellow of DIA and a member of DIA's Scientific and Policy Advisory Council, a Fellow of the International Society for Pharmacoepidemiology and a member of the ISPOR RWE leadership team. She has helped advance global use of real-world evidence by medicinal product regulators, with her work cited in guidelines in the US, Europe, and China.

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.

Debra Schaumberg is Vice President, Epidemiology and Head, Strategic & Scientific Affairs at Evidera, a business unit of PPD. An internationally recognized expert in epidemiology and ophthalmology, she brings >25 years of experience in clinical research, designing and leading research investigations spanning the spectrum of RCT through all aspects of RWE generation and integration, including early to late phase clinical trials, pragmatic trials, case-control studies, and large cohort studies. Dr. Schaumberg’s responsibilities cross all areas of the PPD portfolio of service offerings and client solutions. She and her team work collaboratively with clients to provide solutions that advance strategic and scientific aspects of projects.

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.

Jacqueline Corrigan-Curay, JD, MD, serves as Principal Deputy Center Director in the Center for Drug Evaluation and Research, FDA. Dr. Corrigan-Curay provides executive leadership on strategic initiatives that advance CDER's mission to deliver safe, effective and high-quality medications including serving on executive governance committees and overseeing policy development on real world evidence, prescription drug promotion, clinical trial oversight and innovative trial design.

Mark J. Cziraky, PharmD, CLS, is a healthcare executive and entrepreneur with more than 25 years of experience in leading, designing and conducting research studies to improve quality, safety and affordability in healthcare, including randomized clinical trials and retrospective and prospective observational research designs. As the co-founder and Vice President of Research at HealthCore, Dr. Cziraky is currently responsible for the operational oversight of the Life Sciences Research business, and serves as key architect in creating unique, multi-stakeholder research collaborations within the healthcare industry. Dr. Cziraky has Fellowship status in the American Heart Association and the National Lipid Association.

Emily Drabant Conley, Ph.D. joined 23andMe in 2010 and serves as Vice President of Business Development. She is responsible for building strategic partnerships with pharmaceutical and biotech companies, forging research collaborations, and overseeing project execution across a range of therapeutic areas. Prior to 23andMe, Dr. Conley spent 10 years conducting research that combined genetics and neuroimaging to understand neuropsychiatric disease. She was a Research Fellow at the National Institute of Mental Health and is co-author on more than 30 academic publications.

Pierre-Alexandre Fournier is co-founder and CEO of Hexoskin, a Montreal-based company focused on clinical-grade wearable sensors and AI software for health and clinical research. Hexoskin was founded in 2006 and launched in 2013 the first iPhone compatible smart clothing for health monitoring, which won several international awards. At the end of 2018 Hexoskin will equip the International Space Station with a remote health monitoring system for astronauts. His work includes wearable health sensors design for real-world evidence, clinical trials, chronic diseases, and machine learning for health analysis. Pierre-Alexandre is also an advocate for patient empowerment and healthcare innovation through design.

Christine is the Co-founder and President of Evidation Health. Previously, Christine was the Co-founder and Chief Operating Officer of Sense Networks, developers of the first machine learning platform for mobile phone activity data (exited to YP.com). She has also held roles at 3iGroup (Paris), Microsoft XBOX and co-founded Chicago-based Channel IQ, a product analytics platform. Christine has a BA from the University of Washington and an MBA from HEC Paris.

Prior to joining CTTI, Ms. Okun led a consultancy firm that specialized in projects related to patient and public involvement in research, care, policy, and socially accountable ethics. From 2013 to 2019, she served as vice president of the online patient research network PatientsLikeMe (PLM) where she was responsible for the company’s patient advocacy initiatives, contributed to health policy discussions at the national and global level, and was PLM’s liaison with government and regulatory agencies, including the U.S. Food and Drug Administration (FDA), Center for Medicare and Medicaid Services (CMS), and the European Medicines Agency (EMA).

Frank is a full-time Professor of Biostatistics and Bioinformatics at Duke University Medical Center and Managing Partner of HunterRockhold, Inc., which provides strategic consulting to Industry and Government. His career includes senior positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer. He has held faculty appointments at six different universities, served as Chairman of CDISC, and is past president of the Society for Clinical Trials. Frank holds a BA in Statistics and an ScM and PhD in Biostatistics. Frank is a Fellow of the American Statistical Association, The Royal Statistical Society, and the Society for Clinical Trials and is widely published across a wide variety of research topics.

Khaled Sarsour joined Genentech in 2012 where he currently is the global head of RWE hematology leading a team of multidisciplinary scientists delivering RWE and insights across the phases of drug development. Before joining Genentech, Khaled spent 5 years at Eli Lilly and company in the global RWE group. Khaled has coauthored more than 39 peer-reviewed publications and many more conference abstracts in a range of therapeutic areas investigating the safety and real world effectiveness of treatments and informing R&D decisions. He holds a doctorate in epidemiology from the school of public health at the University of California, Berkeley.

George Savage is Chief Medical Officer and Co-founder of Proteus Digital Health, where he focuses on developing the evidence needed to spur adoption of Proteus’s ingestible sensor platform. He serves on the board of the California Life Sciences Association and in 2016 was elected a Fellow of the American Institute for Medical and Biological Engineering. George holds a B.S. in Biomedical Engineering from Boston University, an M.D. from Tufts University School of Medicine, and an M.B.A. from Stanford University Graduate School of Business. George has a 29-year track record of starting and developing technology-based healthcare companies in Silicon Valley.

Peter Stein, MD, is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products. OND provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters. A nationally-recognized leader in pharmaceutical research and development, Dr. Stein joined CDER in 2016 as the OND Deputy Director. Before coming to FDA, he served as Vice President for late stage development, diabetes, and endocrinology at Merck Research Laboratories.

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.

David Gilbertson is the Co-Director of the Chronic Disease Research Group (CDRG) at Hennepin Healthcare Research Institute, and Associate Professor of Medicine at the University of Minnesota. At CDRG, he leads a group of biostatisticians, epidemiologists, data scientists and clinicians using large administrative data sets such as Medicare, to perform surveillance, comparative effectiveness research, and pharmacovigilance studies, related to chronic diseases. His recent interests include advanced methods for confounding control, and improving methods of comorbidity and severity of disease assessment in administrative data sets.

Dr. Kansal leads development of economic analyses, disease simulations, and clinical trial simulations in a wide variety of disease areas, including neurologic, cardiovascular and autoimmune diseases. He led development of the Alzheimer’s Disease ACE simulator, a validated disease simulator for cost-effectiveness, budget impact, and clinical trial simulation. With expertise in a range of modeling techniques, including state-transition (e.g., Markov), discrete event simulation (DES), and dynamic transmission modeling, his recent work has been published in Alzheimer’s and Dementia (TRCI), Heart, and Pharmacoeconomics and has been presented at major economic and clinical conferences.

David Thompson, Ph.D. is Senior Vice President, Real World Research for Syneos Health. Dave is a health economist by training with 25+ years of experience conducting real-world research and consulting for clients in the biopharmaceutical sector. He is Editor-in-Chief of ISPOR’s publication, Value & Outcomes Spotlight, a position he has held since 2008, and serves on the advisory board of the Duke-Margolis Real-World Evidence Consortium.

M. Alan Brookhart is a Professor of Epidemiology at UNC Chapel Hill. His research is focused primarily on the development and application of statistical and epidemiologic methods for studies of prescription medications, vaccines, and other exposures using large clinical and healthcare utilization databases. In this area, he has made contributions to the development of quasi-experimental approaches that can be used to estimate causal effects in the presence of unmeasured or poorly recorded confounding variables. He has also been involved with the development of propensity score and marginal structural model methodology and has also developed new epidemiologic approaches for studying patterns of use medications and healthcare services.