Dr. Jaclyn Bosco Global Head of Epidemiology & Database Studies 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.

Alicia Gilsenan, PhD, is Vice President, Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan’s primary area of expertise is pharmacoepidemiology and therapeutic risk management and the structured benefit-risk assessment of medications. Since joining RTI in 1997, she has applied state-of-the-art approaches to the design, conduct, and analysis of both retrospective and prospective epidemiologic studies, most recently focusing on consultation, design, and implementation of postauthorization safety studies in the US and in Europe in area of vaccine and drug safety. She is adjunct professor in Epidemiology at the UNC-Chapel Hill and teaches an intro to Pharmacovigilance course to graduate students biannually.

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.

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 the Americas region 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.

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.

Hetal Pansuria, Pharm.D., is an experienced regulatory professional and pharmacist with 20 years of experience in the health care industry. In her role as Vice President of Regulatory Affairs, Clinical, Nonclinical, and Ad-Promo at Pacira BioSciences, Hetal oversees the development and execution of regulatory strategies for clinical, nonclinical, and advertising-promotional reviews of drugs, biologics, and medical devices. Hetal works closely with senior leaders and cross-functional teams to develop effective regulatory strategies that optimize the development pathway for products in all stages of development, including early-stage assets & marketed products. She also oversees ad-promo reviews and labeling activities for all products.

Dr. Motiur Rahman is a Senior Epidemiologist and Policy Advisor in RWE Analytics within the Office of Medical Policy at CDER, FDA. He leads the consult service for reviewing RWD study submissions, leads international regulatory collaborations including ICH initiatives, and supports internal training and process development. He serves as FDA topic lead for the ICH E23 Working Group, contributes to FDA-funded demonstration projects, and is a core member of the RWE Subcommittee. Dr. Rahman joined FDA in 2022 after more than a decade of academic and industry experience conducting observational studies across diverse therapeutic areas. A pharmacist by training, he holds a PhD in Pharmacoepidemiology and a Master’s in Statistics.

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.

Lina Titievsky, MPH PhD, is a head of Hepatology Epidemiology in Global Epidemiology at GSK. Prior to joining GSK, Lina's professional journey included working in safety epidemiology across multiple therapeutic at Pfizer, leading a medical research organization at Intercept and RWE team responsible for cell and gene therapies at Vertex. In her current role, she leads a group of epidemiologists responsible for generating RWE in support R&D throughout the products' life cycle, ranging from pre-clinical needs all the way through the regulatory approval. Lina holds a PhD in Epidemiology from Columbia University and is an ISPE Fellow.

Sorcha McCrohan is a Senior Scientific Project Manager for Global Science at DIA. In her current role, she focuses on content development and strategy for DIA's meetings to improve and facilitate innovation in clinical research, drug development, and the fields of devices and diagnostics. Before joining DIA, she conducted COVID-19 research in Chiapas, Mexico, and worked in marketing within Pfizer's Global Vaccines franchise. Sorcha holds a BA in Sociology from Mount Holyoke College and an MSc in Global Health, Disease Prevention & Control from Georgetown University.

Lisa Charlton has ten years of experience in eClinical technology with an emphasis on eCOA solutions. Her career within the industry started in supporting consulting work for COA instrument development, linguistic validation, and regulatory interactions and then followed with a focus on eCOA implementation and process improvement. For the past two years, Lisa has led product development for participant solutions including ePRO, eConsent, and a participant portal. Lisa earned her PhD in Biological Chemistry from UNC and her MBA from Point Park University.

Aaron Crowley is Associate Director of Biostatistics at Genesis Research Group, where he leads statistical strategy for real-world evidence and health economics research. He has over a decade of experience in clinical trial and observational study design, with expertise in causal inference, externally controlled trials, and prediction modeling. Aaron is a member of the PHUSE RWE Working Group on Estimands for RWD/RWE and has co-authored over 150 peer-reviewed publications. His work supports regulatory, HTA, and market access initiatives across oncology, cardiology, immunology, and rare diseases.

Ben Ackerman is a Principal Scientist at Johnson & Johnson Innovative Medicine, where he provides support across therapeutic areas to design and analyze randomized trials, namely those that combine trial data with real-world data. He has expertise in causal inference methods to address various biases in both randomized trials and non-experimental studies. Previously, he worked as a Quantitative Scientist at Flatiron Health, an oncology real-world data vendor, where he oversaw the design of studies leveraging EHR data to improve cancer care in the United States. Ben holds a PhD in Biostatistics from the Johns Hopkins Bloomberg School of Public Health.

Dr. Marci is a physician, scientist, entrepreneur, and author of the book, Rewired: Protecting Your Brain in the Digital Age (Harvard University Press, 2022). He is currently the Chief Clinical Officer and Managing Director of Mental Health and Neuroscience at OM1, a venture backed health technology and data company based in Boston, MA. He is also a board-certified psychiatrist part-time at Massachusetts General Hospital and Assistant Professor of Psychiatry at Harvard Medical School and advises several investment groups and early-stage health companies. He is the 2024 winner of the PharmaVoice100 leaders award, the 2025 Marconi Science Award and is a member of the Aspen Global Leadership Network as a 2014 Henry Crown Fellow.

As an entrepreneur and scientist, Mayur has concentrated on advancing medicine with high-noise, big data analysis. Before founding Droice, he played key roles in several startups, including co-founding a biotechnology firm in the diabetes space. He earned his BTech at IIT Kanpur and his MS and PhD at Columbia University, focusing on the computational physics of disease.

Shashi Shankar is the co-founder and CEO of Novellia, Inc., an award-winning, AI-enabled data partner trusted by leading biopharma companies to uncover hidden insights in real-world patient data. With a background in healthcare and a passion for leveraging AI and data analytics, Shashi leads Novellia’s strategy and business development to transform health data integration for improved patient outcomes. Prior to founding Novellia, Shashi spent nearly a decade at Genentech and Roche, where his personal experience with fragmented health data deeply motivated him to pioneer solutions that give both patients and researchers a more complete, accessible, and actionable view of healthcare data.

Conor Wyand is the Vice President of Partner Growth at Truveta where he leads a team responsible for engaging with potential new life science customers. Prior to joining Truveta in 2021, Conor spent six years in various leadership positions at Optum Life Sciences, working with pharmaceutical and medical device manufacturers across the value chain to generate real-world evidence for therapeutics and devices. Conor graduated from Brown University.

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.

Ulka Campbell is an epidemiologist and the Head of Scientific Strategy at Aetion, a Datavant 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.

Gracy holds a Ph.D. in Molecular Oncology from King’s College Hospital, an M.Sc. in Biomedical Research from King’s College. She did her postdoctoral training at Oxford (UK) and at MIT (USA). Gracy brings broad experience in clinical research, medical affairs and health outcomes within the pharmaceutical industry. She currently works as a Regulatory Policy Lead at Roche Pharmaceuticals, focusing on RWD Policy.

Kirk Geale is the CEO and Board Director of the Quantify Research group. With expertise spanning economics, RWD/E, epidemiology, and strategy, he brings a unique interdisciplinary perspective to the life sciences industry. Dr. Geale holds a PhD from Umeå University (Sweden), an MSc in Economics from Lund University (Sweden), and a B.Comm in Management Economics & Finance from the Gordon S. Lang School of Business and Economics at the University of Guelph (Canada). He is also a graduate of Stanford University's Executive Program for Growing Companies (USA) and the Karolinska Institute's Interdisciplinary Graduate School in Register-Based Research (Sweden).

Juhaeri Juhaeri, Ph.D., is Vice President and Global Head of Epidemiology and Benefit-Risk at Sanofi. An epidemiologist and statistician, he has held global leadership roles in Medical and Pharmacovigilance functions for more than two decades in the pharmaceutical industry. A passionate leader, he has built and developed different new teams at Sanofi and led successful programs leading to products’ approval and maintenance. He has led different working groups in various public-private partnerships in benefit-risk evaluation, pharmacovigilance, real-world evidence, and patient preference. He holds adjunct faculty positions at the School of Public Health, University of North Carolina Chapel-Hill.

Dr. Red Thaddeus Miguel is an executive and sought-after researcher with expertise in regulatory science, evidence-based healthcare, survey methodology, and health economics. He holds an MSc in Evidence-Based Health Care from the University of Oxford, MD–MBA dual degrees, and RAC and RCC certifications. As CEO of Thera-Business, he leads complex regulatory, research, and real-world evidence projects for life sciences clients. He has published widely and received multiple awards, including Ottawa’s Forty Under 40 in 2024 for his business leadership, professional expertise, and community impact.

Dr. Robert Reynolds is Vice President, Global Epidemiology at GSK, where he leads the group responsible for epidemiology and RWE in support of R&D and regulatory decision-making. He has published extensively on design and methods for RWE and pragmatic trial designs, including numerous studies evaluating medicine safety and effectiveness. He has extensive experience in collaborative international engagements with regulators, industry peers, and other stakeholders. He is a Fellow of ISPE and an Adjunct Associate Professor of Epidemiology at Tulane. Dr. Reynolds holds an AB in Biology from Bard College and a MSc in Epidemiology and ScD in Population/International Health from the Harvard T.H. Chan School of Public Health.

Dr. Kassa Ayalew serves as the Division Director for the Division of Clinical Compliance Evaluation within the Office of Scientific Investigation at the FDA’s Center for Drug Evaluation and Research. In this role, he oversees the evaluation of the integrity of efficacy and safety data submitted to the FDA and ensures the protection and welfare of human research subjects. He is board certified in Pediatrics and Infectious Diseases and holds an active medical license in the state of Virginia. In addition to his regulatory work, Dr. Ayalew provides clinical care to both pediatric and adult patients at an urgent care facility. He has delivered numerous didactic lectures and has published research in peer-reviewed journals.

Sherrine is the Global Head of Epidemiology, RWE and Observational Research and an Ethics Ambassador at SAS with over 25 years of experience.  She leads RWE thought leadership efforts and contributes to Trustworthy AI and Responsible Innovation at SAS Institute, Inc. Leveraging her experience in global health, public health, healthcare outcomes research and Teva Pharmaceuticals where she supported Regulatory, Safety, Late Phase and Post-Marketing activities across therapeutic areas using clinical data and RWE, Sherrine has co-authored over 100 peer-reviewed articles and has been cited over 1000 times, has been a guest on the SAS Health Pulse Podcast, and been invited to be a keynote or plenary speaker over 50 times.

Trevan Locke is a Director of Global Regulatory Policy and Intelligence at Amgen with a focus on real-world evidence, trial innovation, and oncology. Prior to Amgen, he held a role at Duke-Margolis overseeing policy workstreams on evidence generation including work under the Duke-Margolis Real-World Evidence Collaborative. Previously, he worked at the American Association for Cancer Research on regulatory issues impacting cancer care and the development of cancer therapies, including considerations for equitable clinical trial enrollment. Dr. Locke completed a Bachelor of Engineering in Chemical and Biomolecular Engineering at Vanderbilt University and a PhD in Chemical and Biochemical Engineering at Rutgers University.

Christian Reich is CSO of Nemesis Health, a Cancer Real-World Evidence company based on the OHDSI approach. He is also Professor of the Practice at the Roux Institute at Northeastern University, where he is responsible for OHDSI Center and the Real-World Master’s Program. He is also Principal Investigator at OHDSI, a global Open-Source and Open-Science collaborative generating comprehensive evidence about disease, healthcare delivery and the effects of medical interventions through large-scale analytics. Christian has more than 15 years of experience in life science research and medicine.

Michael Rozycki started his career in basic research, earning his Ph.D. in Biochemistry from Cornell University and holding post-doctoral research and research appointments at the University of Geneva (Switzerland) and Princeton University. He then moved into management consulting in the pharmaceutical and financial services industries before beginning his Regulatory Affairs career at Merck. Mike then went on to positions of increasing responsibility in Regulatory Affairs at Aventis, Bayer, Allergan, and Pacira, where he currently holds the position of Senior Vice President, Regulatory Affairs.

Mingyang Shan is a Senior Director of Statistics and the lead of the Real-World Analytic Capabilities team at Eli Lilly and Company. His current focus is on developing methodology and best analytical practices to leverage evidence from real world data in drug development. His research focus includes external control design and analysis methods, data integration, Bayesian analysis, data linkage, and target trial emulation. He has supported trials across immunology, neuroscience, and cardiometabolic health. He is a co-PI on an FDA U01 grant to develop methodology to enhance the robustness of hybrid externally controlled trials using RWD.

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.

Xiang Zhang is the Head of Medical Affairs and HTA Statistics and a co-lead of the Forum for Observational Research Excellence at CSL. He leads a team of statisticians, epidemiologists, and RWE scientists to support RWE generation across drug life cycle including clinical development, regulatory submissions, product launches, and commercialization. This team also provide statistical support for HTA submissions and other peri-launch activities to secure market access for CSL products. He has authored or co-authored over 40 peer-reviewed publications and a book in causal inference in RWD analysis. He is a member of both RWE and HTA scientific working groups under the American Statistical Association.

Julie Schneider is a Senior Director at Johnson & Johnson Innovative Medicine, where she leads initiatives related to Real-World Evidence (RWE) and Reliance Policy. Previously, she served as Associate Director for Research Strategy and Partnerships at the FDA Oncology Center of Excellence (OCE). At FDA, she founded and led the OCE Scientific Collaborative, the agency’s first coordinated oncology regulatory science initiative. This program focused on exploring how emerging data sources—such as RWE, AI/ML, biomarker development, and trial innovation—can be integrated into regulatory decision-making. Julie holds a PhD in molecular biology and genetics from the University of Oxford and a BA in biology from Yale University.