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Real World Evidence Conference

How Real World Evidence can be used for regulatory purposes


Speakers

  • Robert  Suruki

    Robert Suruki

    • RWE Strategy Lead, Immunology
    • UCB Pharma, Inc., Belgium

    Robert Suruki, Sc.D., is the RWE Strategy Lead for Immunology at UCB. In this role, Robert is responsible for developing and implementing the global RWE strategic plan for all assets/indications in the immunology therapeutic area to ensure that UCB is leveraging RWE to optimize and successfully execute on the respective strategies across the development pipeline, including clinical development, regulatory affairs, patient safety, medical affairs, market access, and commercial/marketing. Prior to joining UCB, Robert was a member of the respiratory epidemiology team at GSK and was the Global Epidemiology Lead for the mepolizumab (Nucala) program.

  • Bart  Barefoot

    Bart Barefoot

    • Director, Real World Evidence Policy & Advocacy
    • GlaxoSmithKline, United States

    Bart Barefoot, J.D., is Director of Real World Evidence Policy and Advocacy at GlaxoSmithKline. Bart is the global lead for GSK’s external engagement efforts to foster the development of RWE ecosystems and to advance the appropriate adoption of RWE by health care decision-makers. He serves on the executive board of the IMI GetReal Initiative and actively participates in the Duke-Margolis RWE Collaborative. Prior to joining GSK in 2004, Bart practiced health care regulatory law, specializing in health data issues. He is a graduate of Duke University and the University of North Carolina at Chapel Hill.

  • Paul M. Coplan, MBA, FISPE

    Paul M. Coplan, MBA, FISPE

    • Vice President, Medical Device Epidemiology & Real-World Data Analytics
    • Johnson & Johnson, United States

    Paul Coplan, ScD, MBA, is Vice President and Head of Global Medical Device Epidemiology at Johnson and Johnson. He is also adjunct assistant professor in Epidemiology at the University of Pennsylvania Perelman School of Medicine. Paul has been engaged in using RWE in the successful FDA approval of 8 pediatric and 1 adult vaccines and 9 pharmaceutical drugs over the past 24 years in drug, vaccine and biologic development research at Merck, Wyeth, Pfizer, the International Partnership for Microbicides (a non-profit pharmaceutical company), and Purdue Pharma. He has published 72 peer-reviewed journal articles and over 400 conference abstracts/posters and has conducted studies in 15 countries.

  • Jacqueline A. Corrigan-Curay, JD, MD

    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.

  • Nancy A. Dreyer, PhD, MPH, FISPE

    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.

  • Debra  Schaumberg, MPH

    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.

  • Marni  Hall, PhD, MPH

    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.

  • Sheila  Mahoney Jewels, MBA

    Sheila Mahoney Jewels, MBA

    • Independent Workforce Advocate
    • LifeSciHub , United States

    Sheila has over 25 years of experience in reg/clin ops, having operated as an SME on both the sponsor and vendor sides. Her current focus as an independent consultant (IC) is advocating for the independent workforce, and helping sponsors engage with them. Sheila has spent the last two years immersed in the world of HR and Procurement tech in order to transition mature, "Future of Work" technologies from other verticals to life sciences in the form of LifeSciHub. LifeSciHub is an online resource marketplace of SME ICs, the goal is to provide extremely easy, and compliant, access and engagement for the Sponsors who need specifically qualified experts for projects. Think Airbnb or Lyft, for SMEs!

  • Mark  Stewart, PhD

    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.

  • Brian D. Bradbury, PhD, MA

    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.

  • James  Harnett, PharmD, MS

    James Harnett, PharmD, MS

    • Senior Director, Lead, Real World Data and Analytics, Patient and Health Impact
    • Pfizer Inc., United States

    Dr. James Harnett is a Senior Director, Real World Evidence Lead in Pfizer’s Patient & Health Impact organization. Dr. Harnett supported establishing the RWDnA function at Pfizer in 2012 and was previously a Team Lead in Health Economics & Outcomes Research. Dr. Harnett has worked for over 17 years creating and leading research programs across therapeutic franchises in US, Global, and Account focused roles. He founded and oversaw the first payer-manufacturer research partnership with Humana, supported establishing an EHR/NLP partnership with Humedica, spearheaded payer pragmatic clinical trials and serves as a representative for several initiatives on regulatory application of RWE.

  • Sudip  Parikh, PhD

    Sudip Parikh, PhD

    • Senior Vice President and Managing Director, DIA Americas
    • DIA, United States

    Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute

  • Todd  Phillips, PharmD, RAC

    Todd Phillips, PharmD, RAC

    • Director, Global Regulatory Affairs
    • Cardinal Health, United States

    Todd Phillips, PharmD, RAC, is Director of Global Regulatory Affairs for Cardinal Health Regulatory Sciences. Dr. Phillips provides strategic development and regulatory consulting services to a variety of drug and biological product manufacturers. He has more than 15 years of experience in regulatory affairs, drug development, clinical project management and product marketing. Dr. Phillips’ experience was gained at FDA and in various positions within the pharmaceutical industry, CRO and regulatory consulting environments.

  • Alex  Mutebi, PhD, MSc

    Alex Mutebi, PhD, MSc

    • Director, Real World Evidence
    • Vertex Pharmaceuticals, United States

  • Simon  Dagenais, PhD, MSc

    Simon Dagenais, PhD, MSc

    • Director, Global Center of Excellence, Real World Evidence
    • Vertex Pharmaceuticals, United States

    Highly-effective Senior Director with strong clinical background, graduate training in clinical epidemiology, health economics and outcomes research, and over 15 years of experience designing, conducting, and communicating research projects and analyses to health care providers, administrators, policy makers, researchers, and other stakeholders. Extensive hands-on experience with study design, data analysis, and execution in the pharmaceutical, managed care, academic, and nonprofit sectors, as demonstrated by numerous scientific publications and presentations related to evidence-based medicine, systematic reviews, and health economics and outcomes research in several therapeutic areas, including acute pain and chronic pain.

  • Cort  Hayflinger

    Cort Hayflinger

    • President
    • Hayflinger Analytical Services, LLC, United States

    Cort Hayflinger has been working with real world health care data for nearly 20 years in a variety of settings, including pharmaceutical companies, academia, and the federal government. Trained as a biostatistician and SAS programmer, Cort has extensive hands-on experience with developing and executing analyses of large health care databases. He is the President of Hayflinger Analytical Services, which offers consulting services related to real world data, SAS programming, and statistical analyses to a variety of clients in the life sciences industries. Cort often works closely with researchers in health economics and outcomes research, pharmacovigilance, real world evidence, and related functions at pharmaceutical companies.

  • Daniel  Caños, PhD, MPH

    Daniel Caños, PhD, MPH

    • Deputy Director, CDRH
    • FDA, United States

    Daniel Caños, PhD, MPH is the Acting Director for CDRH/OPEQ’s Office of Clinical Evidence and Analysis (OCEA). Prior to this, Daniel was the Deputy Office Director in OCEA, having spent the previous three years at the Centers for Medicare and Medicaid Services (CMS), where he was the Director of the Evidence Development Division in the Coverage and Analysis Group (CAG). Prior to his work at CMS, Daniel was Associate Director in the Division of Epidemiology in OSB, CDRH, originally joining FDA in 2008. Daniel holds a Bachelor’s degree in Psychology from the University of Cincinnati, a Master’s of Public Health from the George Washington University, and a PhD in Epidemiology from the University of North Carolina at Chapel Hill.

  • David  Martin, MD, MPH

    David Martin, MD, MPH

    • Vice President, Pharmacovigilance
    • Moderna, United States

    David Martin leads pharmacovigilance globally across the entire pipeline 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 which assessed benefits and risks for vaccines and other products regulated by the Center for Biologics. Subsequently, he led the Real World Evidence Staff in the Office of Medical Policy and reviewed all submissions containing real world evidence intended to demonstrate the effectiveness of drugs or biologics regulated by the Center for Drug Evaluation and Research. He is also the originator of the open-source FDA MyStudies mobile application.

  • Tengbin  Xiong

    Tengbin Xiong

    • Head of RWE Solutions and HEOR
    • Happy Life Technology, United States

    Tengbin Xiong mainly responsible for HEOR ,clinical research design and providing researchers with the best data resources and analytical methods in health technology assessment combined with real world evidence generated in medical big data research in HLT. Prior to joining HLT, Dr. Xiong worked as a Senior Consultant in HEOR and RWE Research at IQVIA Asia Pacific and China. Dr. Xiong has also been responsible for managing and supervising clinical trials at the University of Cambridge and related HEOR and results research consultancies. He has published many SCI international journal articles and international academic conference reports. Dr. Xiong graduated from University of Birmingham, UK with a PhD. of Public Health and Epidemiology.

  • Christopher  Ceppi

    Christopher Ceppi

    • Chief Product Officer
    • Science 37, United States

    Christopher Ceppi is an executive and technologist with over 20 years of experience building and leading teams dedicated to innovation. He is a recognized thought leader in how best to apply technology to advance the conduct of clinical research in ways that benefit both patients and scientists. As Chief Product Officer at Science 37, Christopher leads the technology organization at Science 37. He oversees the software engineering, product management, and data teams responsible for the design and development of the groundbreaking NORA platform.

  • Michael  Fried, MD

    Michael Fried, MD

    • Co-Founder & Chief Medical Officer
    • TARGET PharmaSolutions, United States

    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.

  • Michelle  Longmire, MD

    Michelle Longmire, MD

    • Co-Founder and Chief Executive Officer
    • Medable Inc., United States

    Michelle Longmire MD, is Co-founder and Chief Executive Officer of Medable. Dr. Longmire is a Stanford-trained physician-entrepreneur dedicated to transforming healthcare through innovation. Dr. Longmire has a background in epigenetics, novel diagnostics, and imaging. Dr. Longmire founded Medable in 2014 to enable healthcare technology to be as seamless, integrated, and adaptive as the human body.

  • Eileen  Mack Thorley, MPH

    Eileen Mack Thorley, MPH

    • Senior Research Scientist
    • PatientsLikeMe, United States

    Eileen Thorley, MPH is a Sr. Research Scientist at PatientsLikeMe. She received her undergraduate from the University of Notre Dame and graduate degree (MPH) from Boston University School of Public Health with a focus in epidemiology and maternal and child health. Ms. Thorley has over 10 years research and analytic experience in observational studies, patient-generated health data (PGHD), survey design, statistical analysis, and outcomes research.

  • Sharon-Lise  Normand, PhD

    Sharon-Lise Normand, PhD

    • Professor of Health Care Policy (Biostatistics)
    • Harvard Medical School, United States

    Sharon-Lise Normand, Ph.D., is S. James Adelstein Professor of Health Care Policy (Biostatistics) in the Department of Health Care Policy at Harvard Medical School and Professor in the Department of Biostatistics at Harvard School of Public Health. Her research focuses on the development of statistical methods for health services and outcomes research, including the evaluation of medical devices, causal inference, provider profiling, evidence synthesis, item response theory, and latent variables analyses. Her application areas include cardiovascular disease, severe mental illness, medical device safety and effectiveness, and medical technology diffusion.

  • Jeremy A Rassen, DrSc, MS

    Jeremy A Rassen, DrSc, MS

    • President and Chief Science Officer
    • Aetion, United States

    Jeremy A. Rassen, ScD is a pharmacoepidemiologist with 25 years of academic and industry experience. He is co-founder, president, and chief science officer at Aetion, a health care technology company that delivers real-world evidence for life sciences companies, payers, and regulatory agencies. Prior to founding Aetion, Dr. Rassen was Assistant Professor of Medicine at Harvard Medical School, where he focused on methods to improve the quality and validity of real-world data studies. He also worked in Silicon Valley in a variety of tech companies. Dr. Rassen received his bachelor’s degree in Computer Science from Harvard College and his master’s and doctorate degrees in Epidemiology from the Harvard T.H. Chan School of Public Health.

  • Andrew  Raven, MSc

    Andrew Raven, MSc

    • Manager for Biostatistics and Epidemiology Unit, HPFB
    • Health Canada, Canada

    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 worked as a biostatistician, senior biostatistician, and manager in the Biostatistics and Epidemiology Unit within the Therapeutic Products Directorate. He has been manager of the Biostatistics and Epidemiology Unit for 3 years.

  • Gigi  Hirsch, MD

    Gigi Hirsch, MD

    • Executive Director
    • Massachusetts Institute of Technology (MIT) Center for Biomedical Innovation, United States

    Dr. Hirsch is the Executive Director of the MIT Center for Biomedical Innovation (CBI) where she leads NEWDIGS, a “think and do tank” that is re-engineering pharmaceutical innovation to deliver more clinical value to patients faster, in ways that work for all stakeholders. NEWDIGS’ flagship project on “Adaptive Biomedical Innovation” (ABI) helped inspire the successful EU-wide Adaptive Pathways pilot program led by the European Medicines Agency (2014-2016).

  • Todd  Johnson, MD, MBA

    Todd Johnson, MD, MBA

    • Senior Vice President, Clinical Research and Head, Digital Research Network
    • Optum, United States

    Todd Johnson, MD, MBA joined Optum in 2017. He is SVP of the Clinical Research Group, which combines Optum Analytics’ clinical research-focused businesses in Patient Reported Outcomes, and Genomics. Dr. Johnson has 20 years of experience founding and managing businesses that combine technology and big data to accelerate drug discovery and development. Past positions include: CEO of CytoVas, a precision medicine company; Founder/ CEO at Noble.MD; VP of Global Marketing for Abbott Labs/AbbVie and SVP and GM at MDS. Dr. Johnson holds a BA from the University of Pennsylvania, an Associate Bachelor of Arts from Oxford, an MD from the Perelman School of Medicine at the University of Pennsylvania, and an MBA from Wharton.

  • Xavier  Kurz, MD, PhD, MSc

    Xavier Kurz, MD, PhD, MSc

    • Head of Data Analytics workstream
    • European Medicines Agency, Netherlands

    Xavier Kurz graduated in 1982 as a Medical Doctor at the University of Liege, Belgium. He specialised in Tropical Medicine and worked for several years in public health projects in Africa and Asia. He obtained a MSc (1991) and a PhD (1997) in Epidemiology and Biostatistics at McGill University, Montreal, Canada. He then joined the Department of Pharmacology of the University of Liege and the Belgian Centre for Pharmacovigilance (Ministry of Health) as scientific expert. He joined the European Medicines Agency (EMA) on 1st September 2005. He is currently leading the Data Analytics team within the Data Analysis and Methods Task Force.

  • Donna  Messner, PhD

    Donna Messner, PhD

    • President and CEO
    • Center for Medical Technology Policy (CMTP), United States

    Donna Messner, PhD is President and CEO of the Center for Medical Technology Policy. She leads the Green Park Collaborative, a multi-stakeholder forum for clinical evidence that is patient-centered, stakeholder-informed, relevant to care and coverage decision-making, and regulator-aligned. She created and leads a GPC program to develop condition-specific core outcome sets with methods to prioritize patient-important outcomes. Current/recent projects include COS for hemophilia, non-alcoholic steatohepatitis, sickle cell disease, asthma, uterine fibroids, and others.

  • Pamela  Tenaerts, MD, MBA

    Pamela Tenaerts, MD, MBA

    • Executive Director
    • Clinical Trials Transformation Initiative (CTTI), United States

    Dr. Tenaerts is the Executive Director at the Clinical Trials Transformation Initiative (CTTI) where she works closely with the Executive Committee to develop and implement strategies to accomplish CTTI’s mission. She provides senior level oversight of the day-to-day operations of CTTI and orchestrates efforts to effectively engage all interested stakeholders to improve the conduct of clinical trials. She is on the Board of Directors for the Society of Clinical Trials and a member of the Advisory Council North America, DIA; Scientific Advisory board DiMe; and MIT’s Collaborative Initiatives Clinical Trials Process Expert Advisory Board.

  • Srihari  Gopal, MD

    Srihari Gopal, MD

    • Senior Director
    • Jansen Research & Development LLC, United States

    Srihari Gopal (Sri) began his pharmaceutical career in 2001 and currently leads Janssen’s R&D efforts in schizophrenia. Dr Gopal received a master’s degree from Duke University in 2003. Prior to Duke, Srihari completed residency training at the Baylor College of Medicine and received his MD degree from Rutgers University in 1995. Prior to Janssen, Sri worked at Forest Laboratories on mood and dementia programs. A prolific writer, he has authored more than 150 peer reviewed publications, posters, abstracts and books. Dr Gopal’s work has published in journals such as American Journal of Psychiatry, JAMA Psychiatry and Nature.

  • Jean  Rommes, PhD, MS

    Jean Rommes, PhD, MS

    • Patient Advocate
    • United States

    I am a COPD patient (diagnosed in 2000) and am active as a patient advocate. My primary interests are providing education regarding COPD to health care professionals, patients, and the general public, encouraging and participating in research and affecting public policy regarding lung health in general.

  • Norman  Stockbridge, MD, PhD

    Norman Stockbridge, MD, PhD

    • Director, Division of Cardiovascular and Renal Products, OND, CDER
    • FDA, United States

    Norman Stockbridge, MD, PhD has been in FDA/CDER's Division of Cardiovascular and Renal Products since 1991 and has been its Director since 2004.

  • Mark J Cziraky, PharmD

    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.

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