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Hyatt Regency Cambridge

Nov 14, 2019 7:30 AM - Nov 15, 2019 12:30 PM

575 Memorial Drive, Cambridge, MA 02139

Real World Evidence Conference

How Real World Evidence can be used for regulatory purposes


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, JD

Bart Barefoot, JD

Head, Europe Regulatory Policy, GSK, United Kingdom

Bart Barefoot, JD, is Senior Director of European Regulatory Policy at GlaxoSmithKline. He formerly served as GSK's global head of RWE policy development and engagement, where he led the company's efforts to advance the appropriate use of RWE in health care decision-making. He served as co-lead of the IMI GetReal Initiative and played an instrumental role in the establishment of the GetReal Institute. Prior to joining GSK in 2004, Bart practiced health care regulatory law. He is a graduate of Duke University and the University of North Carolina at Chapel Hill.

Paul M. Coplan, DrSc, MBA, MSc, FISPE

Paul M. Coplan, DrSc, MBA, MSc, FISPE

VP, Medical Device Epidemiology & Real-World Data Analytics, Johnson & Johnson, United States

Paul Coplan, ScD, MBA, is Vice President and Head of Medical Device Epidemiology at Johnson and Johnson and adjunct assistant professor in Epidemiology at University of Pennsylvania Perelman School of Medicine. Paul has been engaged in using RWE for 25 years in device, drug, vaccine and biologic development at Johnson & Johnson, Merck, Wyeth, Pfizer, Purdue and the International Partnership for Microbicides, with FDA/EMA approval of 3 medical devices, 9 vaccines and 9 pharmaceuticals . He has published 90+ journal articles, 500+ conference presentations and conducted studies in 15 countries. He has a Doctor of Science in Epidemiology from Harvard, MBA from Wharton Business School, and MS from Univ of Massachusetts.

Jacqueline A. Corrigan-Curay, JD, MD

Jacqueline A. Corrigan-Curay, JD, MD

Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), FDA, United States

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.

Nancy A Dreyer, PhD, MPH, FISPE

Nancy A Dreyer, PhD, MPH, FISPE

Founder, Dreyer Strategies LLC, United States

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.

Debra  Schaumberg, DrSc, MPH

Debra Schaumberg, DrSc, MPH

Vice President and Global Head, Startegic Development Consulting Chair, Evidera | PPD, United States

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.

Marni  Hall, PhD, MPH

Marni Hall, PhD, MPH

Vice President and General Manager, Global Regulatory Science and Strategy , IQVIA, United States

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.

Sheila  Mahoney Jewels, MBA

Sheila Mahoney Jewels, MBA

Drug Development Multi-Functionalist, LifeSciHub , United States

Life sciences R&D Ecosystem Expert, Independent Small Business and Workforce Advocate, Software Platform Developer and Investor. Focus areas include: Regulatory and Clinical Operations, Strategic Patient Engagement, CMC, Real World Evidence, Pharmacovigilance, and Biometrics, Medical Affairs, Market Research, Medical Writing, Data Management, Discovery, Toxicology, Pharmacometrics and Pharmacology, and all of the technology that enables these functional areas, others. Actively creating crypto for organizations in the form of LifeSciHub, a nascent Decentralized Autonomous Organization. Exactly how crypto has upended traditional currency in incredible ways, DAO is a new way that groups can create value outside of hierarchical structure.

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 and patients.

Brian  Bradbury, DrSc, MA

Brian Bradbury, DrSc, MA

Vice President, Center for Observational Research, Amgen, United States

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.

James  Harnett, PharmD, MS

James Harnett, PharmD, MS

Executive Director, Health Economics and Outcomes Research, Regeneron Pharmaceuticals, Inc. , United States

Dr. James Harnett is the Executive Director for HEOR for Oncology/Hematology at Regeneron. Prior to this, Dr. Harnett worked at Pfizer for over 20 years, most recently as the Lead in Global Medical Epidemiology for Oncology and Vaccines helping to establish external control arms and generate epidemiological data for COVID-19 vaccine and antiviral programs. Dr. Harnett supported establishing the RWDnA function at Pfizer in 2012, which facilitated Pfizer's first regulatory RWE submission and label expansion for Ibrance and a more recent publication on regulatory use of RWE in the autoimmune space. As a prior Team Lead in HEOR, he established the first long-term research payer partnership with Humana and advanced the first payer rPCT.

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

Real-World Evidence Lead, Internal Medicine, Pfizer Inc, United States

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.

Cort  Hayflinger, MS

Cort Hayflinger, MS

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, Global Head RWE, Moderna, United States

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.

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 Manager, Science 37, United States

Michael  Fried, MD

Michael Fried, MD

Co-Founder & Chief Medical Officer, Target RWE, 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

CEO & Co-Founder, Medable, United States

As the co-founder and Chief Executive Officer of Medable, Dr. Michelle Longmire is mission-driven to accelerate the development of new therapies for disease. A Stanford-trained physician-scientist, Dr. Longmire witnessed firsthand the critical barriers to drug development – including the time and costs associated with clinical trial participation. She founded Medable to pioneer a new category of clinical trial technologies that remove traditional roadblocks to participation and radically accelerate the research process. Medable is now the industry leader in decentralized and direct-to-patient research, with the ability to serve patients in over 120 languages, 60 countries, and across all therapeutic areas.

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

Co-Founder and President, 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, Epidemiology, and Pharmacometrics 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 previously worked as a biostatistician and senior biostatistician, assessing study design and conduct as well as statistical methodologies and analyses in pre-market prescription drug submissions at the Therapeutic Products Directorate (TPD). He has been manager of the Biostatistics, Epidemiology, and Pharmacometrics Unit of TPD since 2015.

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

Chief Scientific Officer, Medable, United States

Dr. Pamela Tenaerts, currently serving as Medable's Chief Scientific Officer, is a respected advocate for clinical trial innovation. At Duke University, she previously led the Clinical Trials Transformation Initiative, improving efficiency and the quality of trials. With over three decades in conducting and researching clinical trials, her focus on patient engagement and evidence-based approaches has been notable. A board member at MedStar Research Institute, and an active member of the Drug Forum of the National Academies of Science, she holds an MD from the Catholic University of Leuven and an MBA from the University of South Florida.

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 Cardiology and Nephrology, 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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