Menu Back toSpeakers

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.

  • 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.

  • Simon  Dagenais, PhD, MSc

    Simon Dagenais, PhD, MSc

    • Senior Director, RWE Center of Excellence
    • 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 lead for Internal Medicine in the RWE Center of Excellence 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, 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.

  • Brad  Jordan, PhD

    Brad Jordan, PhD

    • Senior Director, Head of Regulatory Affairs Policy
    • Flatiron Health, United States

    Dr. Brad Jordan is a Head of Regulatory Affairs Policy at Flatiron Health, where his team works to advance the use of Real-World Evidence for regulatory decision-making. Brad was at Amgen for 15 years prior to joining Flatiron, where he led Global Regulatory and R&D Policy for Oncology and for Biosimilars and Biologics.

  • 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.

  • 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 working for the Food and Drug Administration (FDA)/Center for Biologics Evaluation and Research (CBER)/Office of Biostatistics and Pharmacovigilance (OBPV)/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/OBPV more than 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.

  • Jingyu (Julia)  Luan, PhD

    Jingyu (Julia) Luan, PhD

    • Senior Director, Global Regulatory Affairs, 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, 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, United States

    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 for 12 years and then as a consultant, 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.

  • 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.

  • Sandy  Leonard

    Sandy Leonard

    • Senior Vice President, Partnerships and Real-World Data Solutions
    • HealthVerity, United States

  • Anna  Swenson

    Anna Swenson

    • Senior Epidemiologist
    • OM1, United States

  • Anna  Vlahiotis, MA

    Anna Vlahiotis, MA

    • Director, Oncology/Precision Medicine RWE Scientist, RWE Center of Excellence
    • Pfizer, United States

    Anna is a Director and RWE Scientist in the RWE Center of Excellence at Pfizer, where she designs RWE strategy and works with teams across the drug development lifecycle to generate RWE in support of organizational decision making and regulatory engagement. Anna has more than 15 years’ experience utilizing real-world and clinical data to conduct healthcare research. Her prior work includes leading study teams in the design and implementation of outcomes research studies in the payer space, and on behalf of pharmaceutical and medical device companies in support of regulatory submission and post-marketing commitment. Over the course of her career, Anna has published extensively, and won the AMCP Award for Research Excellence.

  • Jonathan  Assayag, PhD, MSc

    Jonathan Assayag, PhD, MSc

    • Director, RWE Scientist Oncology, RWE Center of Excellence
    • Pfizer, Canada

    Jonathan is a Director and RWE Scientist in the RWE Center of Excellence at Pfizer, where he designs and executes on RWE strategy and works with teams across the drug development lifecycle. Jonathan has more than 10 years’ experience utilizing real-world and clinical data to conduct and communicate healthcare research. His prior work includes working in medical affairs where he also led RWE education initiatives for Pfizer colleagues. Jonathan holds a PhD from McGill University in Pharmacoepidemiology where he is also currently an instructor in the department of Medicine.

  • Jaclyn  Bosco, PhD, MPH, FISPE

    Jaclyn Bosco, PhD, MPH, FISPE

    • Vice President and Global Head of Epidemiology
    • IQVIA, United States

    Dr. Jaclyn Bosco Global Head of Epidemiology in Real World Solutions at IQVIA, is responsible for driving real-world evidence (RWE) generation for regulators, clinicians, patients and payers using passive and primary data collection through clinicians and person-generated health to support the safety and effectiveness of drugs, biologics, and medical devices from early clinical development through the post-approval phase. She identifies the best approach for capturing data on a global scale as well applies local approaches to address market-specific needs. As a thought leader in real world research, she is invited to speak at international congresses and sits on scientific advisory boards and committees.

  • Tarry  Ahuja, DrSc, MSc

    Tarry Ahuja, DrSc, MSc

    • Director, Post Market Drug Evaluation (PMDE)
    • CADTH, Canada

    TARRY AHUJA, PhD is currently the Director of the new Post-Market Drug Evaluation Program at CADTH, the leading HTA agency for Canada. Prior to this he was a senior medical real-world evidence scientist for Eli Lilly for Europe and Canada. He has worked for over 10 years in the hospital setting in the area of sleep disorders and he has over 10 years of clinical research in the areas of otolaryngology, Alzheimer’s, stroke and ischemia with the National Research Council of Canada. He holds a PhD in Neuroscience with a specialty in electrophysiology and pharmacology, and has been a lecturer at Carleton University teaching “Biological Foundations of Addictions” and “Health Psychology” for over 15 years.

  • Raymond  Harvey, MPH

    Raymond Harvey, MPH

    • Senior Director, Data Science
    • Janssen Pharmaceutical Companies of Johnson & Johnson, United States

    Mr. Harvey has over 20 years of experience in epidemiology and biostatistics. He has worked for academic institutions, government entities (NIH/NIAID), and now industry. In his role at Janssen, he provides thought leadership on generating RWE for regulatory decision-making and is motivated by the innovative approach of linking clinical trial data to real-world data. In prior roles, Ray provided onsite subject matter expertise for large multicentered, multinational infectious disease clinical trials and epidemiological studies focused on HIV and TB while working and living in Kampala, Uganda. This was a pivot period as it coincided with the initial phase roll out of The President's Emergency Plan for AIDS Relief (PEPFAR).

  • Rob  Kalesnik-Orszulak, PharmD

    Rob Kalesnik-Orszulak, PharmD

    • Senior Director, Regulatory Innovation Lead for RWE & Data Science
    • Bristol Myers Squibb, United States

    Rob Kalesnik-Orszulak is the Regulatory Innovation Lead for Real World Evidence (RWE) and Data Science at Bristol Myers Squibb (BMS). In this role, he is responsible for establishing the regulatory department's expertise, capabilities, and strategy around RWE from a regulatory perspective. As an experienced regulatory professional, Rob has served as a people manager for global regulatory leads in high impact disease areas and has also led the regulatory strategy for multiple global filings/programs. A strong believer in the promise of technology in healthcare, Rob is passionate about the future of health.

  • David  Moeny, MPH

    David Moeny, MPH

    • Director, Division Epidemiology 2, Office of Surveillance and Epidemiology, CDER
    • FDA, United States

  • Kenneth  Quinto, MD, MPH

    Kenneth Quinto, MD, MPH

    • Senior Medical Advisor for Real World Evidence Analytics, OMP, CDER
    • FDA, United States

    Physician/Epidemiologist for Real World Evidence Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research at the FDA. My main duties include leading demonstration projects intended to support the agency’s evaluation of real world evidence, evaluating real world evidence use cases, and contributing to medical policy development mandated by the 21st Century Cures Act. Key focus areas include FDA-Catalyst and PCORI pragmatic trials as well as replication of clinical trial results with non-interventional study designs.

  • Jillian Mae Rockland, MPH

    Jillian Mae Rockland, MPH

    • Director, Regulatory Strategy
    • Flatiron Health, United States

    Jillian Rockland leads Flatiron Health’s Regulatory Strategy team, which supports Flatiron Health’s life science partners in using RWD/E for regulatory decision-making. Previously, she oversaw Flatiron RWE product and operations, managing the scoping, creation and delivery of research-question specific real-world datasets to partners for regulatory use. Prior to joining Flatiron, Jillian managed clinical research teams in executing industry-sponsored, multi-site clinical trials and then led strategy and development for several healthcare technology products. Jillian received her undergraduate degree in Neuroscience from Northeastern University and her MPH in Epidemiology and Biostatistics from Columbia University.

  • Lucy  Vereshchagina, PhD

    Lucy Vereshchagina, PhD

    • Vice President, Science and Regulatory Advocacy
    • PhRMA, United States

    Dr. Vereshchagina is the Vice President, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA represents the country’s leading innovative biopharmaceutical research companies, which are devoted to researching and developing medicines that enable patients to live longer, healthier, and more productive lives. She leads the Regulatory Advocacy team with the focus on the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), as well as other regulatory policy and advocacy issues. Dr. Vereshchagina was the lead PhRMA negotiator for both PDUFA VII and BsUFA III.

  • 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.

  • Jennifer  Christian, PharmD, PhD, MPH, FISPE

    Jennifer Christian, PharmD, PhD, MPH, FISPE

    • Vice President and GM Medical and Scientific Services, Real World Solutions
    • IQVIA, United States

    Jennifer Christian is Vice President of Clinical Evidence & Epidemiology at IQVIA, an adjunct faculty member at Weill Cornell Medical College, and a Fellow of the Institute of Medicine. At IQVIA, her research focuses on strengthening clinical effectiveness and safety evaluations of treatments and advancing the use of RWE for regulatory decision-making. She has led the design and conduct of registries, direct-to-patient extension studies, pragmatic trials, and external comparator studies for new drug applications and label extensions. She is also actively engaged on projects through Friends of Cancer Research, Duke Margolis Health Policy Center, and the National Academy of Medicine.

  • Laura  Esserman, MD, MBA

    Laura Esserman, MD, MBA

    • Director, Breast Care Center; Professor of Surgery and Radiology
    • UCSF, United States

    Laura Esserman, MD, MBA is director of the UCSF Breast Care Center. She is recognized as a thought leader in cancer screening and over-diagnosis, as well as innovative clinical trial design. She led the creation of the University of California-wide Athena Breast Health Network, a learning system designed to integrate clinical care and research as it follows 150,000 women from screening through treatment and outcomes, and the PCORI-funded WISDOM Study, which tests a personalized approach to breast cancer screening in 100,000 women. She is also a leader of the innovative I-SPY TRIAL model, designed to accelerate the identification and approval of effective new agents for women with high risk breast cancers.

  • Wei  Hua, PhD

    Wei Hua, PhD

    • Acting Deputy Director, Division of Epidemiology, OSE, CDER
    • FDA, United States

    Dr. Wei Hua is currently Acting Deputy Director of Division of Epidemiology-I in the Office of Surveillance and Epidemiology, CDER, FDA. She received her medical degree from China and PhD from the Johns Hopkins School of Public Health. Her areas of expertise include infectious disease epidemiology and pharmacoepidemiology with experience in both experimental and observational studies using primary and secondary data in the U.S. and through multi-site international collaborations. Over the past ten years, Dr. Hua has held multiple roles in the FDA centers for biologics and drugs leading and overseeing epidemiological research and review in the regulatory setting.

  • Tzu-Chieh (Jay)  Lin, PhD, MPharm

    Tzu-Chieh (Jay) Lin, PhD, MPharm

    • Observational Research Director
    • Amgen, United States

    Dr. Lin was a clinical pharmacist by training and Ph.D in Pharmacoepidemiology. Before joining Amgen, he had his postdoctoral training in Harvard Medical School in the U.S. He is currently a director in Center for Observational Research, Amgen and leading global real-world evidence generation for bone and nephrology therapeutic areas. He also serves as an adjunct assistant professor in National Cheng Kung University in Taiwan. Dr. Lin’s research interests include real-world drug utilization research and comparative effectiveness/safety research. In recent years, he’s been leading several large real-world study to support regulatory decision-makings, including post-marketing safety study and drug effectiveness for label expansion.

  • Daniel  Malone, PhD, RPh

    Daniel Malone, PhD, RPh

    • Professor, Department of Pharmacotherapy
    • Skaggs College of Pharmacy, Univeristy of Utah, United States

    Daniel C. Malone, PhD, FAMCP, is a Professor at the University of Utah College of Pharmacy. Dr. Malone has conducted and published over 220 articles in peer reviewed literature on health economics and outcomes research, including cost-effectiveness analyses, burden-of-illness studies, patient reported outcomes studies, and numerous evaluations of healthcare interventions in real-world environments. He was President of the ISPOR from 2015 to 2016. Dr. Malone is a Fellow of the Academy of Managed Care Pharmacy and the American Foundation for Pharmaceutical Education. His awards include Excellence in Pharmacy Award , Professional Achievement Award from the University of Colorado (awarded twice), and two Distinguished service awards from ISPOR.

  • Motiur  Rahman, PhD, MPharm, MS

    Motiur Rahman, PhD, MPharm, MS

    • Senior Epidemiologist
    • FDA, CDER, OMP, United States

    Motiur Rahman, MPharm, MS, PhD, is an Epidemiologist at Real-World Evidence (RWE) Analytics in the Office of Medical Policy, CDER, FDA. His responsibilities include developing guidance, improving internal Agency processes, stakeholder engagement, collaborating on Agency-funded demonstration projects, and providing consultancy on RWE study submissions. He joined FDA in April 2022 after working as an epidemiologist in industry settings.

  • Wendy  Turenne, MS

    Wendy Turenne, MS

    • Senior Vice President, Real World Data & Delivery Operations
    • Aetion, United States

    Wendy Turenne is a healthcare analytics specialist with 20 years of experience building bridges between data, analytics, and business strategy. As SVP, of RWD & Delivery Operations, Wendy leads client engagement, data strategy and integration, and operational performance for Aetion. Previous to joining Aetion, Wendy partnered with biopharma companies of all sizes on RWE and HEOR collaborations with Cardinal Health and DaVita. Prior to that, she held analytics and leadership positions across multiple settings: government, population health, hospital, payer, and provider organizations. She holds a BS from the University of Virginia and an MS in Biostatistics from the University of North Carolina, Chapel Hill.

  • Catherine  Cohet, PhD

    Catherine Cohet, PhD

    • Pharmacoepidemiology Senior Specialist, Data Analytics and Methods Task Force
    • European Medicines Agency, Netherlands

    Catherine joined EMA in 2020 as senior pharmacoepidemiologist in the Data Analytics & Methods Task Force. She previously held various positions in the pharma industry, generating RWE across all phases of development. She also worked as an epidemiologist at the Centre for Public Health Research and the Malaghan Institute for Medical Research in Wellington, New Zealand, and the WHO International Agency for Research on Cancer in Lyon, France. Her work at EMA focuses on all aspects of RWE, including vaccine evaluation and applying lessons learnt to public health crisis preparedness. Catherine is the ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance) co-chair and is part of the ICH M14 Working Group.

  • 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.

  • Nicholaas  Honig, JD

    Nicholaas Honig, JD

    • Associate Regulatory Counsel
    • Aetion, United States

    Nicholaas Honig is an Associate Regulatory Counsel at Aetion. In this role he advises clients on regulatory approaches involving Real-World Evidence and analyzes FDA approval decisions to understand RWE precedent. Prior to joining Aetion, Nicholaas worked at Pfizer in the company's Chief Business Office. He also has practical experience with FDA's Office of Chief Counsel and the Massachusetts General Assembly's Joint Committee on Healthcare Financing. Nicholaas has a JD from the Boston University School of Law and a BA from Hobart College

  • Michele  Jonsson Funk, PhD, FISPE

    Michele Jonsson Funk, PhD, FISPE

    • Associate Professor of Epidemiology; Director, Center for Pharmacoepidemiology
    • University of North Carolina at Chapel Hill, United States

    Dr Jonsson Funk is an Associate Professor of Epidemiology and Director of the Center for Pharmacoepidemiology at UNC. Her research focuses on improving methods for the study of drug safety and effectiveness using real world data including understanding the impact of measurement error in studies using claims and EHR data, methods for generalizing treatment effects from clinical trials to real world populations, and evaluating treatment effect heterogeneity. As principal investigator for the DETECTe Demonstration Project, she led a team that evaluated the performance of approaches to assessing and addressing the threat of unmeasured confounding. Dr Jonsson Funk has 120 peer-reviewed publications spanning multiple therapeutic areas.

  • Nicole  Kellier-Steele, PhD, MPH

    Nicole Kellier-Steele, PhD, MPH

    • Senior Director - Global Patient Safety
    • Eli Lilly and Company, United States

    Nicole Kellier-Steele is a Senior Director in the Global Patient Safety group at Eli Lilly and Company. Nicole has expertise in epidemiological methods and has worked in the Lilly Global Patient Safety group for over 12 years. Nicole received her PhD from Florida International University and her MPH in Epidemiology from George Washington University. Her experience includes design, analysis, execution of non-interventional studies across multiple therapeutic areas. Nicole supports cross-functional teams and provides epidemiological expertise to for regulatory strategies and obligations for compounds in development, new product launches and marketed products.

  • Kraig  Kinchen, MD, MS

    Kraig Kinchen, MD, MS

    • Associate Vice President, Value, Evidence, and Outcomes, Diabetes Business Unit
    • Eli Lilly and Company, United States

    Following the completion of his residency and fellowship (RWJ Clinical Scholars Program), Kraig Kinchen joined the outcomes research group at Eli Lilly and Company. After serving in both technical and supervisory roles focused on RWE, he spent ten years as a clinical research physician and senior medical director in a variety of therapeutic areas in clinical development. He returned to outcomes research in 2019 to lead Lilly's Center of Expertise in Global Patient Outcomes and Real World Evidence. Currently, he is the Associate Vice President for Value, Evidence, and Outcomes in the Diabetes Business Unit. Kraig received his undergraduate degree from Tulane, his MSc from Oxford and his MD from Harvard Medical School.

  • Sarah  Sheehan, MPA

    Sarah Sheehan, MPA

    • Program Lead
    • Digital Medicine Society (DiMe), United States

    Sarah Sheehan is a Program Lead for the Digital Medicine Society (DiMe) where their work focuses on the use of digital health tools to enable high-quality clinical evidence generation. Previously, Sarah was an Assistant Research Director at the Duke Margolis Center for Health Policy leading biomedical innovation and regulatory science programming. At Duke, they oversaw a portfolio of work related to clinical trial modernization and improved evidence generation, with core efforts on the integration of clinical research and routine care using digital health tools and real-world data, the engagement of community health systems in research, and approaches to achieving representative clinical trial enrollment.

  • Curran  Sidhu, MS

    Curran Sidhu, MS

    • Senior Consultant, Value & Access
    • Evidera, United States

    Curran Sidhu, MBS is a Senior Consultant with the Value Access Consulting team at Evidera, a PPD business, and is based in California. He has over five years’ consulting experience in the global market access space. His therapy area experience includes diabetes, neurology, rare diseases, and oncology and encompasses medical devices as well as gene and cellular therapies. Additionally, he has published thought leadership pieces evaluating US payer perception of digital health technology coverage and management, and the impact of ICER on US payer decision making. Curran graduated from Keck Graduate Institute with a Master of Business and Science and from Georgia Institute of Technology with a Bachelor of Science in Biomedical Engineering.

  • Rachele  Hendricks-Sturrup, DrSc, MA, MSc

    Rachele Hendricks-Sturrup, DrSc, MA, MSc

    • Research Director, Real-World Evidence
    • Duke-Robert J. Margolis, MD, Center for Health Policy, United States

    Rachele Hendricks-Sturrup, DHSc, joins Duke-Margolis as the Research Director leading the Center’s Real-World Evidence (RWE) portfolio, including managing its RWE Collaborative. She is a scientist/researcher, health policy and industry professional, journalist, and academician within the fields of health policy, business, and health innovation.

  • 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

  • Peter  Mol, PharmD, PhD

    Peter Mol, PharmD, PhD

    • Principal Clinical Assessor, University Medical Center Groningen; Member SAWP
    • CBG-MEB (Dutch Medicines Evaluation Board), Netherlands

    Peter Mol is a principal assessor at the Dutch Medicines Evaluation Board and a member (vice chair) of EMA’s Scientific Advice Working Party. He is chair of the EMA Cross-Committee Task force on Registries. He is also a professor of drug regulatory science at the University Medical Center Groningen. His research interest is in the area of regulatory science; from new tools to optimize regulatory decision-making (especially impact of personalised medicine and real world evidence), to improve knowledge transfer and with a specific interest in safety communication.