Dr. David Martin works across therapeutic areas as the Head of the Patient Centered Clinical Outcomes Center of Excellence at Novartis. Previously, he led Global RWE at Moderna, with accountability for provision of enterprise real world data and analytics as well as oversight for deliverables oriented toward regulators, payers, providers, and patients. He retired as a Captain after completing 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 RWE group to drive the agency's scientific, guidance, and submission review responses to the RWE provisions of the 21st Century Cures Act.

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.

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.

Dr. Diane Gubernot is a Health Scientist in the Office of Biostatistics and Pharmacovigilance at the Center for Biologics Evaluation and Research (CBER) of the USFDA. She conducts regulatory reviews of RWE/RWD submitted in biologic product applications and performs research to help support RWE policy development as well as other public health initiatives. Dr. Gubernot has been with the FDA for more than 30 years and has worked as an Investigator in the Office of Regulatory Affairs, a Team Lead Epidemiologist in the Office of the Commissioner, and a regulatory product reviewer at CBER.

Dr. Rachele Hendricks-Sturrup is the Research Director of Real-World Evidence (RWE) at the Duke-Margolis Institute for Health Policy in Washington, DC, strategically leading and managing the Institute's RWE Collaborative and RWE policy research portfolio and education. As an engagement expert, biomedical researcher, bioethicist, and policy practitioner with over 18 years of experience, her work centers on addressing implementation, regulatory, and ethical, legal, and social implications (ELSI) at the intersection of health policy and innovation. She presently partners with Duke University faculty, scholars, students, and external practicing experts to advance the Institute's biomedical innovation work.

Camille Jackson is the Director and Head of Regulatory Policy at Flatiron Health, bringing nearly 20 years of experience within policy and program management across various corners of the life sciences sector. Earlier in her career, Camille held roles at Clarivate, Sanofi, PhRMA, The World Bank, NIH, The George Washington University, and the American Academy of Child and Adolescent Psychiatry.

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

Sarah currently serves as senior director of global regulatory policy for oncology at Lilly. She previously served as senior director of science and regulatory advocacy for the Pharmaceutical Research and Manufacturers of America (PhRMA) where she led their regulatory advocacy efforts on key issues including real-world evidence, clinical development, human drug review program, and CGTs. Sarah also worked for the American Association for Cancer Research (AACR) where she led their efforts to modernize the regulatory process and engage in the development and implementation of programmatic and policy initiatives with the US FDA Oncology Center of Excellence.

Brittany Avin McKelvey serves as the Director of Regulatory Affairs at Friends of Cancer Research (Friends). Friends is an advocacy organization based in Washington, DC that drives collaboration among partners from every healthcare sector to power advances in science, policy, and regulation that speed life-saving treatments to patients. Brittany supports the development and implementation of the organization’s research and policy agenda. She leverages her patient advocacy and scientific background to generate scientific evidence and policies to advance progress in oncology care. She collaborates with diverse stakeholders to inform policy objectives and execute evidence-based research projects.

Keri Monda, PhD, is an Executive Director of Observational Research and Head of the Data & Analytics Center within the Center for Observational Research (CfOR) at Amgen. In her role, she leads a team of epidemiologists and data scientists responsible for generating real-world evidence in support of programs from research and early development through launch and end of patent expiry, and oversees a large, integrated real-world data and analytics ecosystem. Prior to her time at Amgen, Keri was a genetic epidemiologists on faculty in the Department of Epidemiology at the University of North Carolina, Chapel Hill.

Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant regulatory and health policy changes, seamlessly integrating relevant content into the development and advancement of DIA conferences and courses. Her responsibilities extend to overseeing content development and strategy within the Americas region.

Kelly Magee, FNP-BC is a Senior Clinical Director at Flatiron Health. In this role, Kelly brings her clinical background as a nurse practitioner in oncology to develop novel approaches for using electronic health record data to understand the experiences and outcomes of people with cancer. She has deep expertise in real-world data and evidence generation; including a focus on endpoint development and validation, and experience with use cases across the drug development lifecycle.

Troy Astorino, co-founder and Chief Technology Officer of PicnicHealth, holds degrees in Aerospace Engineering and Physics from MIT. At PicnicHealth, Troy spearheads the development of technologies transforming unstructured medical records into research datasets. His team has pioneered AI for data standardization, enabling large-scale observational studies. Troy’s work focuses on enhancing data quality and interoperability in real-world evidence generation. He has implemented systems for continuous data auditing, significantly improving research reliability. PicnicHealth collaborates with pharmaceutical companies and research institutions to accelerate drug development and improve patient outcomes.

Lisa Ensign is a VP of Statistics and Regulatory Science Innovation at Medidata. Her recent work is focused on creating robust analytical approaches to improve and transform the efficiency and rigor of clinical trials, centered on the use of external controls in areas of unmet medical need. Lisa began her career at MD Anderson Cancer Center and has extensive academic, industry. regulatory and entrepreneurial experience in the life sciences sector. She received her MS in biostatistics from Harvard University and her PhD in clinical science from the University of Colorado, where she teaches graduate courses on ethics and the responsible conduct of research.

Dr. Gabriel Innes is a Health Science Policy Analyst on the Real-World Evidence (RWE) Analytics Team in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), FDA. Responsibilities on the RWE Analytics Team include internal consults related to RWD and the generation of RWE, development of guidance documents related to RWE, as well as internal activities and policy related to the organization, analysis, and reporting of RWD/RWE. Dr. Innes joined OMP after completing the Centers for Disease Control and Prevention’s Epidemic Intelligence Service Fellowship. He holds a PhD from the Johns Hopkins Bloomberg School of Public Health, and a VMD from the University of Pennsylvania School of Veterinary Medicine.

Mehdi NajafZadeh, PhD, is Senior Director at Medidata AI. Before joining Medidata AI, he was an Assistant Professor of Medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, and the PI of large NIH and FDA funded projects that aimed at linking RCTs to RWD.

Dan Riskin is the founder and CEO of Verantos, the global leader in high-validity real-world evidence at scale. Recognized across the globe as an expert in healthcare AI, Dr. Riskin has developed products that influence the care of millions of patients annually. His advocacy includes testimony before Congress on the 21st Century Cures initiative and serving on the Health Advisory Committee for two presidents. He is Clinical Professor of Surgery at Stanford University.

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 6+ 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 in terms of safety and effectiveness.

Lina Titievsky, MPH PhD, is a head of Hepatology and Classic and Established Products Epidemiology in Global Epidemiology at GSK. Prior to joining GSK, Lina has worked across multiple therapeutic areas including drugs, vaccines, and cell & gene therapies. Prior to joining GSK, Lina's professional journey included her work as an epidemiologist at Pfizer, Intercept and Vertex. In her current role, she leads a group of epidemiologists responsible for generating evidence ranging from support of discovery and pre-clinical through regulatory approval. Lina holds a PhD in Epidemiology from Columbia University.

Jenna Wong, PhD, is an Assistant Professor in the Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. She received her PhD in Epidemiology from McGill University and previously worked at the Institute for Clinical Evaluative Sciences in Ontario, Canada. She has nearly 15 years of experience conducting epidemiological studies using real-world data from linked electronic health databases. Her research uses machine learning techniques for different predictive modeling applications in epidemiology, where she is currently using machine learning and artificial intelligence to extract information from unstructured text to enhance the ability to use real-world data to study off-label drug use.

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.

Melinda Baker, PhD is the Director of Dataset Strategy and Commercialization at PicnicHealth. Melinda is passionate about empowering patients to take ownership of their medical records and helping life science partners infuse patient-centric methods into their research practices. She has dedicated her career to building new technologies and products that help researchers accelerate medical discoveries. Before moving to industry, Melinda obtained a doctorate from Princeton University and completed post-doctoral research at the University of Medicine and Dentistry of New Jersey. Her academic interests focused on using systems and structural biology techniques to understand signaling pathways of cellular motility and gene transfer.

Ulka Campbell is an epidemiologist and the Head of Scientific Strategy at Aetion, a healthcare technology and research services company, providing methods and regulatory support across therapeutic areas and leading research to inform regulatory RWE best practices. Previously, she was at Pfizer for 14 years leading regulatory studies and serving as the Head of Safety Surveillance Research, overseeing a team responsible for post-approval safety studies obligated to FDA and EMA. She has co-authored several publications and taught courses on pharmacoepidemiology, standards for decision-grade real world studies, causal inference, and epidemiologic methods, and is an Adjunct Assistant Professor of Epidemiology at Columbia University.

Sarah Dutcher is the lead epidemiologist on the Sentinel Core Team in the Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration. In this role she manages the scientific components of the Sentinel System, CDER’s active surveillance system for regulated medical products. Dr. Dutcher is a pharmacoepidemiologist and health services researcher with expertise in analysis of drug use and health outcomes in electronic healthcare data. Her background is multidisciplinary, involving the fields of epidemiology, pharmacy, health behavior, gerontology, economics, and health policy.

Sarah Ferko is a Senior Managing Consultant and Project Management Professional (PMP) in IBM’s Artificial Intelligence and Analytics service line within the Data and Technology Transformation practice area supporting US Federal projects within IBM Consulting. Sarah has supported multiple offices at the FDA since 2017, including CDER OB, OSP, OCS, and OND. Sarah holds a B.S./M.S. in Applied Mathematics from the University of Akron in Akron, Ohio.

Dr. Hampp is a Senior Director, Pharmacoepidemiology at Regeneron Pharmaceuticals, Inc., where he leads the oncology and hematology therapeutic areas. Before joining Regeneron in 2021, he worked for over 10 years as a senior epidemiologist in the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research. Dr. Hampp is also an Affiliate Clinical Associate Professor at the University of Florida, College of Pharmacy. He received his pharmacy degree from Saarland University in Germany, and a PhD in pharmacoepidemiology from the University of Florida.

Dr. Jingyu (Julia) Luan is an Executive Regulatory Science Director in AstraZeneca, overseeing the global regulatory strategy and supporting the research, development and commercialization of CVRM products. She is a core member of CVRM Regulatory Leadership Team. Prior to AZ, 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 of Chinese Biopharmaceutical Association 2023-2024.

Susant Mallick comes up with 23+yrs of Pharma and IT background on building disruptive solutions/products in Clinical and Regulatory space. He is technology evangelist on cutting edge technology like (Artificial Intelligence, Machine Learning, IoT, Cloud etc) and an industry leading speakers across geographies. He has been working with various customers and partners in pharma and healthcare to drive digital transformation in clinical and regulatory landscape. He was instrumental in implementing/building many Regulatory solutions using advanced technology. Innovation and Digital Transformation in Healthcare and Life Sciences are two key focus areas.

David Pritchard is a Director, Data Management & Statistics at Target RWE, where he is responsible for overseeing the statistical methodology utilized for and implemented in Target RWE's collaborative research projects. David's research interest include causal inference, negative control outcomes, machine learning with health care outcomes, and statistical software systems.

Jeffrey Brown, PhD, Chief Scientific Officer at TriNetX and Lecturer (parttime) at Harvard Medical School (HMS), is an internationally recognized expert in the use of real-world data to support the evidentiary needs of regulatory agencies and medical product sponsors. He has 25+ years of research experience using real-world data, most recently as an Associate Professor in the Department of Population Medicine (HMS) and a trusted consultant to numerous research groups and pharmaceutical companies. At HMS he served as the Lead Data Scientist for the FDA Sentinel Operations Center and as PI for several multi-site pharmacoepidemiologic studies to support FDA and EMA regulatory requirements.

James Browning, MPH, is a Director of Biostatistical Programming in the Center for Observational Research (CfOR) at Amgen Inc. He has over 15 years of experience conducting observational studies in multiple therapeutic areas with the majority concentrated in oncology. He is skilled in statistical analysis, data visualization and data management with a focus on RWE used for regulatory decision-making. Currently, he leads multiple programming teams focused on generating RWE to support the development and continuous benefit:risk assessment of Amgen’s medicines. He also has an interest in the new regulatory guidelines for generating RWE and is exploring processes and standards to align with the evolving framework.

Dr. Salinas is a pharmacoepidemiologist, with a doctorate in Epidemiology from the University of Washington, currently working in late stage and postmarketing clinical development at Eli Lilly and Company. She has expertise in real-world data analysis and causal inference focusing on drug development and the comparative safety of medications, particularly for auto-immune disorders. In previous work she was engaged in prostate cancer research, including evaluation of genetic risk factors from inflammatory pathways. Her current interests include linkage of RWD and clinical trial data to enhance the evaluation of drug safety. She is an advocate for communication about pharmacoepidemiology careers in industry and welcomes trainee questions.

Dr. Krista Schroeder is a pharmacoepidemiologist with 20 years of diverse research experience in the pharmaceutical industry spanning all phases of drug development from pre-clinical to post-marketing. Her expertise includes designing and executing real world evidence (RWE) observational studies for both reimbursement (health outcomes) and regulatory (pharmacoepidemiology) purposes. She is a recognized subject matter expert in the design of studies using secondary data and has multiple publications in this space. She is the principal scientist responsible for several post-authorization safety studies executed as commitments to regulatory bodies globally.

As the Head of Innovative RWD Analytics at Parexel, I have the privilege of collaborating broadly on the frontiers of using real-world data, emphasizing the importance of context within the 'data generation process.' My recent collaborations intersect machine learning, causal inference, and reproducibility in research. Working within the evolving regulatory landscape, which is increasingly open to modern, established methods, I aim to help advance the field of real-world data analytics. I hold an adjunct appointment at the University of Utah and maintain affiliations with various institutions to maximize collaborative opportunities.

Since 2016, Dr. Gordon has been a lead for data standardization efforts including those for pharmaceutical quality, manufacturing, and labelling, as well as real-world data derived from health information technology for use in clinical research and pharmacovigilance. Before arriving at FDA, Dr. Gordon received his core scientific training with a Ph.D. in Molecular Microbiology from Tufts University Medical School, entered the public health domain in 2005 working on public health emergency preparedness and from 2011 with a focus on public health informatics.

Dr. Yun Lu is the Deputy Division Director for the Food and Drug Administration (FDA)/Center for Biologics Evaluation and Research (CBER)/Office of Biostatistics and Pharmacovigilance (OBPV)/Division of Analytics and Benefit-Risk Assessment (DABRA). 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).

Emilie Scherrer is the Head of Health Economics & Outcomes Research at Tempus AI and is a member of the RWE Alliance. Emilie was previously the Global Director of Health Economics and Outcomes Research at Seagen. She has worked in biopharma (Amgen, Merck, Seagen, Pfizer) for a decade in roles across HEOR and RWE positions. She has extensive knowledge in designing and executing non-interventional, observational research studies for external dissemination (40+ publications) and regulatory submissions. Emilie earned an undergraduate degree from USC and a Masters in Health Economics from the London School of Economics / LSHTM.

Mina is an assistant professor at the Leslie Dan Faculty of Pharmacy at the University of Toronto and the Tier 2 Canada Research Chair in Pharmaceutical Policy and Real-world Evidence. He is also co-director of Pharmaceutical Policy and Pharmacy Practice at the Ontario Drug Policy Research Network (ODPRN) and ICES adjunct scientist. Mina leads research focused on evaluating drug policies and post-marketing surveillance of medications. He works closely with policymakers and uses large data sets to answer questions about real-world safety and effectiveness and improving the optimal use of medications.