Dr. Jaclyn Bosco Global Head of Epidemiology & Scientific Strategy in Real World Evidence 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. 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.

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.

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.

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.

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.

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.

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, 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.