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Virtual

Oct 25, 2021 10:00 AM - Oct 26, 2021 5:15 PM

(US Eastern Standard Time)

Real-World Evidence Conference

Translating Insights into Real-World Value.

Speakers

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.

Dorothee  Bartels, PhD, MSc

Dorothee Bartels, PhD, MSc

Chief Digital Officer, Aetion, Germany

Dorothee Bartels is Head of Real World Evidence (RWE) and Digital Sciences at UCB Biosciences. Previously she was Clinical and Real World Data Strategy Lead at X, Moonshot (Alphabet Inc), after 12 years with Boehringer Ingelheim as Corporate Head of Global Epidemiology and Chief Digital Science Officer in the innovation Lab, Bi X. She maintains appointments as Ass. Prof. for Public Health & Epidemiology (Hannover), as Adj. Prof. for Epidemiology & Biostatistics (McGill), and teaches in the Swiss course “Successful implementation of digital health” (Inst. for Communication and Leadership). Dorothee is a fellow of ISPE, 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

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.

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.

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

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States

Dr. Jingyu (Julia) Luan is a Senior Director of Global Regulatory Affairs in AstraZeneca, leading global drug development and regulatory strategies as well as innovative regulatory initiatives, eg, RWE. Prior to AstraZeneca, she worked at 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 President-elect of Chinese Biopharmaceutical Association and Board Member/Committee Co-chair of FDA Alumni Association.

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.

Delphine  Saragoussi, MD, MSc

Delphine Saragoussi, MD, MSc

Executive Director, Real-World Evidence, PPD, part of Thermo Fisher Scientific, France

Executive Director in the RWE group at Evidera, PPD, part of Thermo Fisher Scientific, in Paris, France. Dr. Saragoussi is a physician specialized in Public Health and epidemiologist. In the pharmaceutical industry during 12 years and then as a consultant for the past 5 years, she has developed and implemented various RWE plans to support market access. Her research methods expertise covers the collection of primary data as well as the use of electronic databases. It includes natural history studies, burden of illness evaluations, treatment patterns descriptions, PRO validations, real-world effectiveness studies. Dr. Saragoussi is also well versed in the generation of RWE to meet regulatory needs.

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 Pharmacovigilance, CBER, FDA, United States

Dr. Yun Lu is a Mathematical Statistician and real-world evidence (RWE) reviewer working for the Food and Drug Administration (FDA)/Center for Biologics Evaluation and Research (CBER)/Office of Biostatistics and Pharmacovigilance (OBPV). Dr. Lu received her Ph.D. in Biostatistics from Johns Hopkins Bloomberg School of Public Health. Dr. Lu joined FDA/CBER in 2010 and she has extensive experiences with reviewing RWE related submissions and conducting vaccine safety and effectiveness studies using real-world data (RWD) including Medicare claims data from the Centers for Medicare and Medicaid Services (CMS).

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

Chief Scientific Officer, Lumiio Inc., Canada

Dr. Hodgkinson is Chief Scientific Officer for Lumiio Inc. where she oversees the scientific management, operations, and coordination of national and global patient registries in rare diseases. Her expertise includes optimizing patient data collection programs through building and alignment of multi-stakeholder disease networks. She has participated in numerous studies provisioning rare disease RWE to regulatory and HTA bodies internationally. Additionally, Dr. Hodgkinson works with HTA bodies, such as CADTH, to support implementation of policies and best practices for use of registry data for regulatory decision-making and chairs a rare disease interest group with HTAi to improve value frameworks and RWE interpretation in rare diseases.

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, RWE & Reg Sci, Cardinal Health, United States

Kathleen  Aller

Kathleen Aller

Director of Market Strategy, Healthcare, InterSystems, United States

Nardin  Farid

Nardin Farid

, 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. John Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research, FDA. As an internist and epidemiologist, his responsibilities related to real-world evidence (RWE) include developing internal Agency processes, interacting with external stakeholders, and coordinating demonstration projects as well as guidance development. Dr. Concato joined FDA from Yale School of Medicine and the U.S. Department of Veterans Affairs, where he was a clinician, educator, independent investigator, research center director, and Professor of Medicine. He has a BE degree from The Cooper Union, MD & MS degrees from New York University, and an MPH degree from Yale University.

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 oversees Global Regulatory science and strategy 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 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

Deputy Director, OBPV CBER, FDA, United States

Richard Forshee is the Deputy Director for the Office of Biostatistics and Pharmacovigilance 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 M. Lederer, PhD, MS

Nirosha M. Lederer, PhD, MS

Head, US Government Partnerships; Senior Director, RWE Strategy, Aetion, United States

Nirosha Mahendraratnam Lederer, PhD is Head of US Government Partnerships at Aetion. In this role, she leads partnership opportunities with the US federal government and advises clients on RWE trends. Before joining Aetion, she led the RWE portfolio at the Duke Margolis Center for Health Policy including developing policies and strategies for increasing the usability and acceptance of RWD and RWE for regulatory and payment decision-making. She previously served as SME in Patient-Focused Drug Development at the US FDA Oncology Center of Excellence and worked at Avalere Health. Dr. Lederer served on Capitol Hill with the House Committee on Ways and Means Subcommittee on Health 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, 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 and RWE, 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

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science researches in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH E15, E16 and E17 Expert Working Groups, and Pharmacoepidemiology Discussion Group. He is also served as a member of the DIA Council of Regulators and a board member of the international society for pharmacoepidemiology as well as a visiting professor in Chiba University, Nagoya University and Nagoya City University.

Shirley  Wang, PhD, MSc, FISPE

Shirley Wang, PhD, MSc, FISPE

Associate Professor of Medicine, Harvard Medical School, United States

Dr. Wang is an Associate 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 Real World Evidence, European Medicines Agency, Netherlands

He is a medical doctor, specialist in epidemiology. He has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research, access and life-cycle product management. Dr. Verpillat has published over 70 articles in Medline referenced journals. He has been involved in many organisations such as ENCePP, ICH M14 working group, European pharma association (efpia) and ISPE.

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, Center for Observational Research, Amgen, United States

Rohini Hernandez, PhD, MPH, is a Director of Observational Research in the Center for Observational Research at Amgen. She leads a Pharmacovigilance Epidemiology team focused on leveraging real world data to support benefit/risk assessments globally and across therapeutic areas. Prior to her current role, Rohini worked in the oncology therapeutic area at Amgen, where she designed and led observational studies in support of bone health among patients with solid tumors. Her research interests include exploring methods for controlling biases in pharmacoepidemiology studies, with a specific focus on identifying opportunities for improved assessment of product safety during pregnancy. She received her PhD in Epidemiology from Boston University.

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.

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