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Real-World Evidence Conference

Translating Insights into Real-World Value.


Speakers

  • Brian  Bradbury, PhD, MA

    Brian Bradbury, PhD, 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.

  • Dorothee B Bartels, PhD, MSc

    Dorothee B Bartels, PhD, MSc

    • Head of Global Real World Evidence and Digital Science
    • UCB, Germany

    Dorothee joined UCB from X, Moonshot (Alphabet Inc.), where she was Clinical and Real World Data Strategy Lead. Prior she was 12 years with Boehringer Ingelheim as Corporate Head of Global Epidemiology and then Chief Digital Science Officer in the innovation Lab, Bi X. She maintains appointments as Associate Professor for Public Health and Epidemiology at Hannover Medical School (MHH) and as Adjunct Professor for Epidemiology and Biostatistics at McGill University. She is a fellow of the International Society of Pharmacoepidemiology and founder and immediate past chair of the Special Interest Group Digital Epidemiology.

  • 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.

  • Simon  Dagenais, PhD, MSc

    Simon Dagenais, PhD, MSc

    • Senior Director, Real-World Evidence
    • 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 was the global head of RWE for neurology programs at Vertex Pharmaceuticals and supported the clinical development of genetic therapies for Duchenne muscular dystrophy and other rare diseases. Prior to Vertex, Simon worked in health economics and outcomes research and pharmacovigilance at Pacira Pharmaceuticals.

  • 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 as Vice Chair of Board of Directors of Worcester Polytechnic Institute.

  • 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.

  • Jingyu (Julia)  Luan, PhD

    Jingyu (Julia) Luan, PhD

    • Global Regulatory Affairs Director, BioPharmaceuticals R&D, CVRM
    • AstraZeneca, United States

    Dr. Jingyu (Julia) Luan is a Global Regulatory Affairs Director in AstraZeneca, leading global drug development and regulatory strategies for the treatment of cardiovascular and renal disease. Prior to AstraZeneca, she worked at the 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 a board member and Vice President of Chinese Biopharmaceutical Association and board member of FDA Alumni Association.

  • David  Martin, MD, MPH

    David Martin, MD, MPH

    • Vice President, Clinical Safety and Risk Management
    • Moderna, United States

    David Martin leads clinical safety and risk management including CSRM RWE activities across the 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 RWE 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.

  • Delphine  Saragoussi, MD, MSc

    Delphine Saragoussi, MD, MSc

    • Executive Director, Real-World Evidence
    • Evidera, France

  • 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.

  • Sulabha  Ramchandran, PhD, MS

    Sulabha Ramchandran, PhD, MS

    • Vice President and Head, US and Regions, Value Evidence and Outcomes
    • GlaxoSmithKline, United States

    Sulabha Ramachandran, Ph.D. is currently VP and Head, US and Regions, Value Evidence and Outcomes at GSK. Her accountabilities include scientific leadership and alignment across regions and markets to drive definition and delivery of value through real world and patient focused evidence generation. Sulabha is a health services researcher with 15+ years of experience in the pharmaceutical industry. She has held several prior health outcomes leadership roles, with accountabilities for payer evidence and pricing strategies, building enterprise -wide RWE capabilities, planning and execution of integrated evidence plans and driving excellence in methodology and innovation across health outcomes research.

  • Yun  Lu, PhD, MS

    Yun Lu, PhD, MS

    • Mathematical Statistician, Office of Biostatistics and Epidemiology, CBER
    • FDA, United States

    Dr. Yun Lu is a Mathematical Statistician working for the Food and Drug Administration (FDA)/Center for Biologics Evaluation and Research (CBER)/Office of Biostatistics and Epidemiology (OBE)/Analytics and Benefit-Risk Assessment Team (ABRA). Dr. Lu received her Ph.D. in Biostatistics from Johns Hopkins Bloomberg School of Public Health. Dr. Lu joined FDA/CBER/OBE 10 years ago and she has extensive experiences with vaccine safety and effectiveness studies using real-world data including Medicare Data from the Centers for Medicare and Medicaid Services (CMS). Dr. Lu has been involved in vaccine approvals as a real-world evidence reviewer.

  • Stephen  Doogan

    Stephen Doogan

    • Chief Product Officer
    • Real Life Sciences, Inc., United States

    Stephen is a founding member of Real Life Sciences, Inc. (RLS), a software as a service company that automates the extraction, integration and analysis of unstructured patient data for life sciences organizations. Stephen brings over a decade of experience in natural language processing and machine learning, including product development and analytics roles in pharmacovigilance, outcomes research and clinical data management. Since 2015, Stephen has overseen the development of RLS' lead product ARARA, which supports EU Policy 0070 and 0043 disclosure requirements through automated redaction and anonymization of clinical study documents.

  • Richard  Gliklich, MD

    Richard Gliklich, MD

    • Chief Executive Officer
    • OM1, United States

    Dr. Richard Gliklich is the CEO of OM1, Inc., a real-world data, outcomes and technology company focused on using data and AI to accelerate medical research and personalize medicine, especially in chronic conditions. OM1 develops extensive data networks of participating practices, centers and other partners in immunology, rheumatology, dermatology, cardiometabolic, respiratory, and CNS/behavioral health disorders. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles. A graduate of Yale University and Harvard Medical School and a former Charles A. Dana Scholar at the University of Pennsylvania, Dr. Gliklich is also a surgeon, and the Leffenfeld Professor at Harvard Medical School.

  • Victoria  Hodgkinson, PhD

    Victoria Hodgkinson, PhD

    • Scientific Director
    • Canadian Neuromuscular Disease Registry, University of Calgary, Canada

  • Matthew  Stannard

    Matthew Stannard

    • Life Sciences Advisor
    • InterSystems, United States

    Matthew is a drug and device development professional with more than twenty years of multinational experience spanning the many facets of discovery, development and patient access. He began his career in the laboratory, moving to patient-focused clinical development, and then leadership roles in Business Development & Licensing. Matthew’s most recent venture was a game-changing digital health technology startup where he led business and corporate development, forging industry collaborations to help patients with unmet medical needs secure access to otherwise inaccessible treatment options. Matthew is an Entrepreneur-in-Residence at Yale University, Angel Investor and Screening Committee Member for the Angel Investor Forum of Connecticut.

  • Scott  Swain

    Scott Swain

    • Director of Real-World Evidence and Regulatory Sciences
    • Cardinal Health, Inc., United States

  • Kathleen  Aller

    Kathleen Aller

    • Director of Market Strategy, Healthcare
    • InterSystems, United States

  • Nardin  Farid

    Nardin Farid

    • United States

  • Bruce  Feinberg

    Bruce Feinberg

    • Vice President of Clinical Affairs and Chief Medical Officer
    • Cardinal Health, Inc., United States

  • Alex  MacLeod

    Alex MacLeod

    • Manager, HealthShare Commercial Initiatives
    • InterSystems, United States

    Alex MacLeod joined InterSystems in January 2001 while working towards her Masters’ Degree in Information Systems. Based at the company’s headquarters Alex is a dual citizen of Germany and the US. During her career with InterSystems, Alex has worked in roles within Implementation, Support, and Sales, with a wide range of clients in both the government and private sectors in a number of international markets including Germany, UK and the US. Alex’s exposure to multiple markets and the various aspects of InterSystems’ product and service offerings has enabled her to develop a deep understanding of how InterSystems technology can maximize customer success.

  • Kristi  Savill

    Kristi Savill

    • Director/Principal Scients, Real-World Evident & Insights
    • Cardinal Health Specialty Solutions, United States

  • Qi  Li, MD

    Qi Li, MD

    • Physician Executive
    • InterSystems, United States

    Qi Li, M.D. is in charge of product innovation for the InterSystems HealthShare health informatics platform. In this role, Dr. Li shapes the global product direction to meet provider organizations’ needs around high performance, patient safety, quality improvement, and cost control. Dr. Li will also lead strategic initiatives in areas such as genomics and national healthcare informatics solutions for developing countries. Dr. Li previously held product leadership roles at Harris Healthcare, Partners HealthCare, and several healthcare IT companies. He earned combined M.D. and M.B.A. degrees from Tufts University School of Medicine and a bachelor’s degree from University of Southern Maine.

  • Gillis  Carrigan, PhD, MS

    Gillis Carrigan, PhD, MS

    • Director, Center for Observational Research
    • Amgen, United States

    Dr. Carrigan has over 20 years of experience in observational studies with a focus on study design and methodology. He is experienced with the use of electronic medical records (EMR), administrative claims data, and registry data. He has worked with observational data in a number of settings and therapeutic areas including oncology, neuroscience, respiratory disease, and vaccine safety. In recent years, he has focused on applying epidemiological methods to real-world oncology data to augment evidence from clinical trials.

  • John  Concato, MD, MPH, MS

    John Concato, MD, MPH, MS

    • Associate Director for Real-World Evidence Analytics, OMP, CDER
    • FDA, United States

    Dr. Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). After conducting clinical research studies for more than 25 years as an independent investigator and research center director at Yale University & the Department of Veterans Affairs, he now develops, coordinates, and implements medical policy programs and strategic initiatives, with a focus on real-world evidence (RWE). His RWE-related efforts include consulting on submissions, helping to engage external stakeholders, and overseeing demonstration projects as well as guidance development in support of the agency’s evaluation of RWE.

  • Jeff  Elton, PhD, MBA

    Jeff Elton, PhD, MBA

    • Chief Executive Officer
    • ConcertAI, United States

    Jeff Elton is CEO of ConcertAI, a leader in Real-World Evidence and AI technology solutions for life sciences and healthcare. ConcertAI’s mission is to accelerate insights and outcomes for patients through leading real-world data, AI technology and scientific expertise. Previously, Jeff served as Managing Director of Accenture’s Predictive Health Intelligence practice. He was also COO and SVP of Strategy for Novartis and a senior partner in McKinsey’s Medical Products and Pharmaceuticals division. Jeff has also been a founding board member and senior advisor to several early-stage biotechnology companies. Jeff holds a Ph.D. in Business Economics and Marketing and an MBA in Finance and Statistics from the University of Chicago.

  • Charles  Lee, MBA, MS

    Charles Lee, MBA, MS

    • Executive Regulatory Science Director
    • AstraZeneca, United States

    Charles is currently Executive Regulatory Science Director at Astrazeneca. He oversee Global Regulatory strategy and implementation 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 at 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

  • Carrie  Nielson, PhD, MPH

    Carrie Nielson, PhD, MPH

    • Observational Research Senior Manager
    • Amgen, United States

    Carrie focuses on design and analytic methods for RWD in the Center for Observational Research at Amgen. Her experience includes descriptive and comparative effectiveness studies to support new indications, label expansion applications, and post-marketing drug utilization and comparative safety studies. In the Center for Observational Research, she guides innovative study designs and analytic methods to combat confounding, time-related biases, and misclassification of exposures and outcomes.

  • Oriol  Solà-Morales, MD, PhD, MS

    Oriol Solà-Morales, MD, PhD, MS

    • Cheif Executive Officer
    • Fundacio HITT, Spain

    In 2011 I founded HITT, a biotech consultancy specialised in Market Access and Technology Transfer. In 2019 we created the HiTT Foundation to strive for a sustainable healthcare. I have held managing positions in healthcare planning and hospital management, and have been CAHTA’s (Regional HTA) Director from 2007 to 2011. I have served as Innovation Director in Sagessa, a University Hospital trust. I’ve been involved in venture capital and start-ups. I have been a policy advisor to 2 Ministers of Health and member of the Regional Research Advisory Council. I am an assistant professor in Health Economics at Universitat Ramon Llull -IQS, and teach in several courses nationally and internationally and a Research Fellow at the OHE (office for

  • Jon  Campbell, PhD

    Jon Campbell, PhD

    • Senior Vice President for Health Economics
    • Institute for Clinical and Economic Review (ICER) , United States

    Jon (Jonathan D.) Campbell is Senior Vice President for Health Economics at the Institute for Clinical and Economic Review (ICER). Jon joined ICER’s senior management team as a leader in value assessment methods and application; he oversees the growth of ICER’s health economics efforts and leads the continued innovation of ICER’s value assessment methodology. Additionally, Jon continues to build bridges within the global health economics community through engagement with ICER’s Health Economic Council and through leadership and participation in health technology assessment societies and agencies. Further, Jon seeks creative value assessment solutions for ICER’s diverse stakeholders by prioritizing improved outcomes for patients.

  • Richard  Forshee, PhD

    Richard Forshee, PhD

    • Associate Director for Analytics and Benefit-Risk Assessment, CBER
    • FDA, United States

    Richard Forshee is the Acting Deputy Office Director for the Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration. He works on a wide range of issues related to the risks and benefits of blood and blood products, vaccines, and human cell and tissue products. Before joining the FDA, he was the Director of the Center for Food, Nutrition, and Agriculture Policy at the University of Maryland, College Park.

  • 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.

  • Nirosha  Lederer, PhD, MS

    Nirosha Lederer, PhD, MS

    • Director, Real-World Evidence Strategy
    • Aetion, United States

    Dr. Lederer oversaw the real world evidence portfolio at the Duke-Margolis Center for Health Policy. Immediately prior, she was a Subject Matter Expert in the Oncology Center of Excellence at FDA. Dr. Lederer has over a decade of pharmaceutical policy and health economics and outcomes research experiences including providing evidence-generation advisory services at Avalere Health, working in commercial and medical roles at Genentech and Bristol-Myers Squibb, respectively, and serving on Capitol Hill during the passage of the Affordable Care Act.

  • Rebecca  Lipsitz, PhD

    Rebecca Lipsitz, PhD

    • Senior Director, TA Regulatory Intelligence and Portfolio Policy, Late R&I RA
    • AstraZeneca, United States

    Rebecca Lipsitz is a Senior Director, Late R&I where she leads regulatory intelligence and policy for the Immunology, Respiratory, and Infection portfolio. Prior to AstraZeneca, she advised and developed policy on a broad range of FDA-related regulatory issues at Janssen. Her portfolio areas included Immunology, Infectious Disease, Vaccines, Precision Medicine, Combination Products, and Real World Evidence. Prior to joining Janssen in June of 2016, she spent her career in the Federal government working on public health emergency preparedness.

  • William  Marks, MD, MS

    William Marks, MD, MS

    • Head of Clinical Science & Head of Neurology
    • Verily Life Sciences, United States

    William J. Marks, Jr., MD, MS-HCM is Head of Clinical Science and Head of Neurology at Verily Life Sciences, formerly Google Life Sciences. At Verily, Dr. Marks is responsible for the team of physicians, other clinicians, and scientists who provide clinical and scientific expertise across the company. For neurology, he leads efforts to advance the understanding of neurological disorders to ultimately improve patient outcomes.. Before joining Verily in 2016, he was Professor of Neurology at UCSF. He is now Adjunct Clinical Professor of Neurology & Neurological Sciences at Stanford University School of Medicine.

  • Donna  Rivera, PharmD, MSc

    Donna Rivera, PharmD, MSc

    • Associate Director for Pharmacoepidemiology, RWD and RWE, OCE
    • FDA, United States

    Donna R. Rivera, PharmD., MSc., is the Associate Director of Pharmacoepidemiology in the Oncology Center of Excellence at the US Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the use of Real World Data (RWD) and RWE for regulatory purposes as well as management of the RWD research portfolio strategy and development of related regulatory policy to support the OCE mission. Dr. Rivera has interests in the use of RWD to increase knowledge of unrepresented populations and advance health equity, observational study designs and RWD methodological approaches, and appropriate uses of RWD for drug development to increase access of effective therapies to patients.

  • Sebastian  Schneeweiss, DrSc, MD

    Sebastian Schneeweiss, DrSc, MD

    • Professor, Medicine and Epidemiology; Chief of the Div of Pharmacoepidemiology
    • Harvard Medical School and Brigham and Women's Hospital, United States

    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.

  • LaRee  Tracy, PhD, MA

    LaRee Tracy, PhD, MA

    • Director, Statistical Science, Medical & Real World Data Analytics
    • Otsuka Pharmaceutical Development and Commercialization, United States

    Dr. LaRee Tracy is a Director of Statistical Science in a medical and real-world data analytics group at Otsuka PDC. Dr. Tracy has over 26 years' experience in research and development, including over 17 years at the US FDA/CDER where she worked as a mathematical statistician in the Office of New Drugs. Her research focus in on the design and analyses of clinical trials and observational studies designed for regulatory purposes. She is experienced in multiple therapeutic areas and is trained in both statistics and epidemiology. Recently, Dr. Tracy joined Otsuka to lead a statistical team dedicated on research and implementation of methods around the use of real world data and machine learning in product development.

  • Alison  Cave, PhD

    Alison Cave, PhD

    • Chief Safety Officer
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

    Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic research and regulatory experience, the latter at both the European Medicines Agency (EMA) and MHRA. Previously she was Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust and most recently an Industrial Strategy Challenge Fund Director at UK Research and Innovation.

  • Cathy W Critchlow, PhD, MSc

    Cathy W Critchlow, PhD, MSc

    • Vice President, R&D Data Strategy
    • Amgen Inc., United States

    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.

  • Harriet  Dickinson, PhD

    Harriet Dickinson, PhD

    • RWE Innovation and Women’s Health Lead
    • UCB Biosciences GmbH, United Kingdom

  • Pall  Jonsson, PhD, MS

    Pall Jonsson, PhD, MS

    • Programme Director - Data
    • National Institute for Health and Care Excellence (NICE), United Kingdom

    Dr Jonsson is Programme Director at the National Institute for Health and Care Excellence (NICE) where he heads up Data and Analytics. His team has a strategic role in ensuring NICE is at the forefront of harnessing new and emerging opportunities for using real world data to inform NICE’s guidance to the health and care sectors. Before joining the Data and Analytics team, he was Associate Director for Science Policy and Research, responsible for NICE’s portfolio of international research projects in areas such as big data and real-world evidence. Dr Jonsson has a PhD in bioinformatics from the University College London. Before joining NICE, he worked in academia, biotech and the pharmaceutical industry.

  • Matthew T Roe, MD, MHS

    Matthew T Roe, MD, MHS

    • Chief Medical Officer
    • Verana Health, United States

    Dr. Roe is Chief Medical Officer at Verana Health, leading the cross therapeutic medical team working to ensure the clinical validity & scientific integrity of the company’s research. He leads Verana’s regulatory strategy, focused on determining how data curated by Verana can be utilized for regulatory decision-making. A cardiologist & clinical researcher, he spent two decades at Duke University School of Medicine & Duke Clinical Research Institute, focused on research initiatives leveraging real-world data for observational & prospective studies. He was a co-principal investigator for the landmark ADAPTABLE trial & held leadership positions with several registries focused on the treatment & outcomes of patients with cardiovascular disease.

  • 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.

  • Yoshiaki  Uyama, PhD, RPh

    Yoshiaki Uyama, PhD, RPh

    • Director, Office of Medical Informatics and Epidemiology
    • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    Dr Yoshiaki Uyama is currently Office Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for all epidemiological activities in PMDA including the projects of MIHARI(Medical Information for risk assessment initiative) and MID-NET®(Medical Information Database Network). He has many experiences in regulatory science of benefit/risk assessment of a new drug, including the role in ICH as ICH Technical Coordinator (2004-2009), the topic leader of ICH E15 and E16, Rapporteur of ICH E17 Expert Working Group (2014-2017) and Rapporteur of ICH Pharmacoepidemiology Discussion Group (2019-).

  • Shirley  Wang, PhD, MSc, FISPE

    Shirley Wang, PhD, MSc, FISPE

    • Assistant Professor of Medicine
    • Harvard Medical School, United States

    Dr. Wang is an Assistant 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.

  • Shein-Chung  Chow, PhD

    Shein-Chung Chow, PhD

    • Professor, Department of Biostatistics and Bioinformatics, School of Medicine
    • Duke University, United States

    Shein-Chung Chow, Ph.D. is an Associate Director, Office of Biostatistics, CDER/FDA. Prior to joining FDA, Dr. Chow was a Professor of Biostatistics and Bioinformatics at Duke University School of Medicine, Durham, NC. He was also a special government employee (SGE) appointed by the FDA as an Advisory Committee member and consultant to the FDA. Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Editor-in-Chief of the Biostatistics Book Series at Chapman and Hall and CRC Press. Dr. Chow is Fellow of the American Statistical Association, who is the author or co-author of 300 methodology papers and 29 books.

  • William H. Crown, PhD, MA

    William H. Crown, PhD, MA

    • Distinguished Research Scientist, Heller School for Social Policy and Management
    • Brandeis University , United States

    William H. Crown, PhD is a Distinguished Research Scientist in the Heller School of Social Policy and Management, Brandeis University. He is an internationally recognized expert in real world data analysis, focusing upon research designs and statistical methods for drawing causal inferences from health care databases. He has an extensive record of empirical comparative effectiveness studies and methodological publications in clinical and health policy journals. Dr. Crown was 2013-14 President of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR). He currently co-chairs the ISPOR Task Force on Machine Learning and is particularly interested in the intersection of machine learning and causal inference methods.

  • Jessica  Franklin, PhD

    Jessica Franklin, PhD

    • Principal Consultant, Epidemiology and Real-World Evidence
    • Optum, United States

    Jessica M. Franklin joined Optum in 2020 after 10 years as faculty in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School, where she remains affiliated as a Visiting Scientist. Dr. Franklin has extensive experience in designing and leading studies of the effectiveness, safety, and utilization of medications from large healthcare databases, including health insurance claims and electronic health records. She led the development and application of a wide range of novel methods in pharmacoepidemiology and co-founded the FDA and NIH-funded RCT DUPLICATE project focused on producing an empirical evidence base for the validity of real-world evidence on medications.

  • Daniel A. Ollendorf, PhD, MPH

    Daniel A. Ollendorf, PhD, MPH

    • Director, Value Measurement & Global Health Initiatives
    • Center for the Evaluation of Value and Risk in Health, United States

    Dan Ollendorf is Director of Value Measurement and Global Health Initiatives at the Center for the Evaluation of Value and Risk in Health (CEVR). His research interests include expanding the use of health technology assessment in low- and middle-income economies, as well as refinement of value assessment tools in the US. Prior to joining CEVR, Dr. Ollendorf was Chief Scientific Officer for the Institute for Clinical and Economic Review (ICER) for over 10 years, where he was responsible scientific oversight of all clinical and economic aspects of the health technology assessment process. He holds a PhD in clinical epidemiology from the University of Amsterdam and an MPH in Epidemiology and Health Services from Boston University.

  • Pallavi  Tiwari, PhD

    Pallavi Tiwari, PhD

    • Assistant Professor of Biomedical Engineering, School of Medicine
    • Case Western Reserve University , United States

    Dr. Pallavi Tiwari is an Assistant Professor of Biomedical Engineering and the director of Brain Image Computing Laboratory at Case Western Reserve University. Her research interests lie in machine learning, data mining, and image analysis for personalized medicine solutions in oncology and neurological disorders. Her research has so far evolved into over 50 peer-reviewed publications, 50 peer-reviewed abstracts, and 9 patents (4 issued, 5 pending). Dr. Tiwari has been a recipient of several scientific awards, most notably being named as one of 100 women achievers by the Government of India for making a positive impact in the field of Science and Innovation. In 2020, she was awarded the J&J Women in STEM (WiSTEM2D) scholar award.

  • Patrice  Verpillat, DrMed, MD, PhD, MPH

    Patrice Verpillat, DrMed, MD, PhD, MPH

    • Head of Global Epidemiology
    • Merck Healthcare KGaA, Germany

    Dr Verpillat has started in the pharma industry in 2003 (H. Lundbeck A/S, Sanofi-Aventis Group, Boehringer Ingelheim GmbH, and currently at Merck KGaA/EMD Serono), in departments such as Epidemiology, Pharmacovigilance, Market Access, always dealing with real-world data and non-interventional studies, to support research, access and life-cycle product management. Dr Verpillat has published over 60 articles in Medline referenced journals. Since 2014, he is the efpia Observer to the ENCePP Steering Group. He is also contributing to the ICH Pharmacoepidemiology Discussion Group as efpia topic lead since 2019, and finally since 2020 is an active member of the ISPE RWE Task Force.

  • Dan  Gebremedhin, MD, MBA

    Dan Gebremedhin, MD, MBA

    • Partner
    • Flare Capital Partners, United States

    Dan Gebremedhin, MD is a Partner at Flare Capital Partners and serves on the Board of Flare portfolio companies Somatus, Eden Health, Oui Health, and Votive Health. Prior to joining Flare Capital, Dan served as a Health Plan executive and practicing physician.

  • Rohini  Hernandez, PhD, MPH

    Rohini Hernandez, PhD, MPH

    • Director of Observational Research
    • Amgen, Inc., United States

  • Morgan  Romine, MPA

    Morgan Romine, MPA

    • Chief of Staff
    • Duke University, United States

    Morgan Romine, MPA, is Chief of Staff at the Duke-Margolis Center. In this role, he helps to guide and implement the Center’s strategic priorities across its research portfolio by serving as a coordination and communications bridge within the Center and with external collaborators. This includes oversight of a number of strategic projects and policy efforts, development of key public and private sector relationships, and the occasional all-hands hijinks. Prior to Duke-Margolis, Morgan worked as a researcher at the Brookings Institution in Washington, DC, and the Stowers Institute for Biomedical Research in Kansas City, MO.

  • Jeff  Allen, PhD

    Jeff Allen, PhD

    • President and Chief Executive Officer
    • Friends of Cancer Research, United States

    Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). During the past 25 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. As a thought leader on many issues related to Food and Drug Administration, regulatory strategy and healthcare policy, he is regularly published in prestigious medical journals and policy publications, and has contributed his expertise to the legislative process on multiple occasions. Dr. Allen received his Ph.D. in cell and molecular biology from Georgetown University, and holds a Bachelors of Science in Biology from Bowling Green State University.