Real World Evidence Conference
Brian D. Bradbury, PhD, MA
- Vice President, Center for Observational Research
- Amgen, Inc., United States
Brian D. Bradbury is Executive Director in the Center for Observational Research (CfOR) at Amgen, Inc, and an Adjunct Assistant Professor of Epidemiology at UCLA. He leads a team of epidemiologists, biostatisticians, data scientists and programmers who use real-world data (RWD) to generate evidence to support decision-making. His team is responsible for Amgen’s RWD platform, and for conducting epidemiologic research to characterize target patient populations, help design clinical studies, conduct post-marketing commitment studies, and execute comparative effectiveness and safety research. He received his DSc in Epidemiology from Boston University and has authored/co-authored 70+ publications in the area of pharmacoepidemiology.
Nancy A. Dreyer, PhD, MPH, FISPE
- Chief Scientific Officer and Senior Vice President
- IQVIA, United States
Nancy Dreyer is Chief Scientific Officer and SVP at IQVIA. She crafts real-world evidence for regulators, clinicians, patients and payers through pragmatic trials and non-interventional studies. An Adjunct Professor of Epidemiology at the U. of N Carolina School of Global Public Health, she also serves on the Clinical Trials Methods Advisory Panel for PCORI. She was named twice to PharmaVOICE’s list of 100 most influential and inspiring individuals in life sciences, and received DIA’s 2019 Global Inspire Award for Author of the Year for “Advancing a framework for regulatory use of real world evidence: When real is reliable.” Her work has been used by global regulators, with recent reference in the new RWE Chinese guidelines for using RWE.
Marni Hall, PhD, MPH
- Vice President, Clinical Evidence
- IQVIA, United States
Marni Hall is Vice President of Clinical Evidence for IQVIA Real-World & Analytic 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 on the Board of Worcester Polytechnic Institute.
Debra Schaumberg, MPH
- Vice President, Scientific Affairs Real World Evidence
- Evidera, United States
Debra Schaumberg is Vice President of Scientific Affairs and Real-World Evidence at Evidera | PPD. An internationally recognized expert in epidemiology, she brings >25 years of experience designing and leading research investigations spanning the spectrum of RCT through all aspects of RWE generation and integration, including designing and leading early to late phase clinical trials, pragmatic and virtual trials, case-control studies, and large cohort studies.
Mark Stewart, PhD
- Vice President, Science Policy
- Friends of Cancer Research, United States
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.
Jacqueline A. Corrigan-Curay, JD, MD
- Director, Office of Medical Policy, CDER
- FDA, United States
Jacqueline Corrigan-Curay, J.D., M.D., serves as Director of the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research, FDA. OMP is comprised of the Office of Prescription Drug Promotion (OPDP) and the Office of Medical Policy Initiatives (OMPI). Dr. Corrigan-Curay leads the development, coordination, and implementation of medical policy programs and strategic initiatives, including policy development on real world evidence, drug labeling, prescription drug promotion, clinical trial oversight and innovative trial design. She works collaboratively with other CDER program areas, FDA centers, and stakeholders on enhancing policies to improve drug development and regulatory review processes.
Mark J Cziraky, PharmD
- Vice President of Research
- Anthem HealthCore, United States
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, PhD
- Vice President of Business Development
- 23andMe, United States
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, MSc
- Co-Founder and CEO
- Hexoskin, Canada
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.
- Co-Founder & President
- Evidation Heath, Inc., United States
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.
Sally Okun, MHS, RN
- Vice President Policy and Ethics
- PatientsLikeMe, United States
Sally Okun is Vice President for Policy and Ethics at PatientsLikeMe. Since joining the company in 2008 she has overseen numerous aspects of the site’s early development related to health data integrity, medical ontology, drug safety platform and more recently leading the company’s Ethics and Compliance Advisory Board. Sally ensures that patient voice and insight are integrated into diverse health policy initiatives at the national and global level, and is the company’s liaison with external organizations, government and regulatory agencies. She has overseen the company’s Research Collaboration Agreement with the FDA and is a member of numerous advisory groups.
Frank W. Rockhold, PhD, MSc
- Professor of Biostatistics
- Duke Clinical Research Institute, Duke University Medical Center, United States
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, PhD, MPH
- Associate Group Director, Personalized Healthcare Data Science
- Genentech, United States
Khaled Sarsour joined Genentech in 2012 where he currently leads a team of scientists in the Personalized Health Care Data Science group delivering real world evidence and insights across the phases of drug development in immunology and infectious diseases programs. Before joining Genentech, Khaled spent 5 years at Eli Lilly and company in the global patient outcomes and real world evidence group. Khaled has coauthored more than 32 peer-reviewed publications and many more conference abstracts in a range of therapeutic areas investigating the safety and real world effectiveness of treatments. He holds a doctorate in epidemiology from the school of public health at the University of California, Berkeley.
George Savage, MD
- Co-founder and Chief Medical Officer
- Proteus Digital Health, United States
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 P. Stein, MD
- Director, Office of New Drugs, CDER
- FDA, United States
Peter Stein, M.D., 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.
Sebastian Schneeweiss, DrSc, MD, MS, FISPE
- Professor of Medicine and Epidemiology
- Harvard Medical School and Brigham & Women's Hospital, United States
Sebastian Schneeweiss, MD, ScD, is a Professor of Medicine and Epidemiology at Harvard Medical School and Chief of the Division of Pharmacoepidemiology, Department of Medicine, Brigham and Women’s Hospital. His research focuses on the comparative effectiveness and safety of biopharmaceuticals. He has developed analytic methods to improve the scientific validity of epidemiologic analyses using complex longitudinal healthcare databases for newly marketed medical products. The overarching theme of his research is applying advanced real-world data analytics for regulatory decision making transparently and in rapid cycles. His work is funded by NIH, PCORI, Arnold Foundation, IMI, and FDA where he is also a voting consultant.
David T Gilbertson, PhD
- Chronic Disease Research Group, United States
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.
Anuraag Kansal, PhD
- Senior Research Leader and Director
- Evidera, United States
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, PhD
- Senior Vice President, Real World and Late Phase
- Syneos Health, United States
David Thompson, PhD is a health economist with 25+ years of experience in HEOR consulting and real-world research design. He currently holds the position of Senior Vice President for Real-World & Late Phase Research at Syneos Health, where he provides RWE design solutions to study sponsors. Dr. Thompson also serves as Editor-in-Chief for ISPOR's publication, Value & Outcomes Spotlight, and is a steering committee member for the Clinical Trials Transformation Inititative (CTTI), an organization jointly founded by FDA and Duke University. He also serves on the advisory committee of the Duke-Margolis RWE Collaborative
- Professor, Department of Epidemiology, Gillings School of Global Public Health
- University of North Carolina, Chapel Hill, United States
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.