Registries: Supercharging Real-World Evidence for Drug Development and Approval

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Drug Discovery & Development, Commercialization & HEOR,
  • Thursday, June 06, 2024

Discover an informative webinar that focuses on the evolving role of registry data in product development, approval and post-marketing value demonstration, as well as the advantages they offer.

The use of real-world evidence (RWE) in drug development has been fueled by the increased acceptance of RWE by stakeholders such as regulatory agencies, health technology assessment bodies and payers, as well as the plethora of real-world data (RWD) sources.

Protocolized disease registries are purpose-built for research, making them one of the most clinically rich sources of RWD. Registries allow the collection of fit-for-purpose data and are an acknowledged source for observational RWE generation, especially in rare diseases where a small number of patients are distributed across broad geographies.

Registries are most often used to fulfill post-approval safety commitments, to monitor or compare treatment patterns and effectiveness outcomes in the real world and to describe the natural history of diseases. In this webinar, the speakers will focus on the following topics:

  • The type of RWD that can be collected in registries
  • How RWD can be used to conduct nested, customized registry-based studies
  • Within one registry, how can it be ensured that data are collected consistently across patients, practice settings, geography and time?
  • Is there an existing registry that collects the required data or is a bespoke registry required?
  • What do regulators say about using RWD from registries to inform their decision-making?
  • Can registry data be used and linked to other data sources?
  • How can you go from data to actionable insights?

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Registries also offer unique and rich data solutions to provide differentiated insights throughout the drug development process from identifying unmet needs and market potential to optimizing clinical trial design, contextualizing safety outcomes and serving as external control arms to supporting regulatory requirements and differentiation in therapeutic effectiveness.

The growing demand for regulatory-grade RWD provides exciting opportunities for researchers seeking rich clinical data to fill RWD gaps inherent to electronic medical records (EMRs) and payer claims. Yet, this new landscape has to be carefully navigated to ensure the right investment is made.

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Register for this webinar to gain insights into how RWE and RWD from registries enhance clinical development, approval and post-marketing analyses, particularly for rare diseases.

Speakers

Peter Wahl, PPD clinical research business, Thermo Fisher Scientific

Peter Wahl, MLA, MS, ScD, Vice President and Global Head of Scientific Affairs, CorEvitas, part of the PPD clinical research business of Thermo Fisher Scientific

Dr. Peter Wahl is Vice President and Global Head of Scientific Affairs for CorEvitas, a leading provider of regulatory-grade, real-world evidence for approved medical treatments and therapies.

Dr. Wahl leads scientific partnerships with pharmaceutical and biotechnology companies and guides strategy on new registry targets and leverages registry and other real-world data to support clinical development and post-approval programs, including regulatory drug safety.

Prior to joining CorEvitas, Dr. Wahl developed and ran patient research programs to drive drug discovery and development, including the ClinicoGenomics program within the Digital Research Network at Optum Life Sciences.

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In addition, Dr. Wahl has served in advisory, management and research roles in the private sector as well as in academia, including the Center for Clinical Epidemiology at the University of Pennsylvania School of Medicine, and the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at the Brigham and Women’s Hospital and Harvard Medical School.

Dr. Wahl earned his doctoral degree in pharmacoepidemiology at the Harvard School of Public Health, dual master’s degrees from the University of Pennsylvania College of General Studies and the School of Medicine, respectively, and his undergraduate degree from Cornell University.

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Message Presenter
Heather J. Litman, PPD clinical research business, Thermo Fisher Scientific

Heather Litman, PhD, Vice President of Biostatistics, CorEvitas, part of the PPD clinical research business of Thermo Fisher Scientific

Heather J. Litman, PhD, is Vice President of biostatistics at CorEvitas, a leading provider of regulatory-grade, real-world evidence for approved medical treatments and therapies. She currently oversees the CorEvitas biostatistics team of more than 40 MS- and PhD-level biostatisticians. As a biostatistician, she provides statistical expertise and guidance on study design, protocol and statistical analysis plan development and writing for projects, including post approval safety studies mandated by regulators.

She earned her PhD in biostatistics from the Harvard School of Public Health and has worked as a biostatistician for over 20 years. Prior to joining CorEvitas, Dr. Litman held a faculty position at Harvard Medical School and performed collaborative work at Boston Children’s Hospital.

She also worked as a biostatistician at New England Research Institutes and Dana-Farber Cancer Institute providing study design, analysis and reporting for grant-funded and pharma-initiated clinical and observational studies.

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Delphinie Saragoussi, Evidera, a part of PPD clinical research business, Thermo Fisher Scientific

Delphine Saragoussi, MD, MScPH, Executive Director, Real-World Evidence, Epidemiology and Scientific Affairs, Evidera, part of the PPD clinical research business of Thermo Fisher Scientific

Delphine Saragoussi has a deep understanding of strategic RWE needs throughout the development lifecycle and has developed and implemented various peri- and post-approval, RWE plans to support successful market access.

Her research methods’ expertise covers the collection of primary data and use of electronic databases (European and US claims and electronic medical records databases) and includes burden of illness evaluations, treatment patterns descriptions, PRO validations, and real-world effectiveness studies. Her vast experience also includes the design of post-authorization safety studies to meet European regulatory and pharmacovigilance evidence needs.

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She has previously served as a global therapy area lead in the real-world evidence and epidemiology department at Lundbeck where she led psychiatry and neurology research. She has also worked in academic research units in semi-private health insurance companies and in the French Drug Agency.

She is a physician who specializes in public health and social medicine and offers more than 15 years of applied experience in epidemiology and pharmacoepidemiology. Trained in medicine at the Universidad de Paris V Descartes, Delphine also earned a Master’s degree in methodology and statistics in biomedical research from the Faculté de Kremlin Bicêtre, University Paris — XI.

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Nahila Justo, Evidera, a part of PPD clinical research business, Thermo Fisher Scientific

Nahila Justo, PhD, MBA, Executive Director, RWE Integrated Solutions, Evidera, part of the PPD clinical research business of Thermo Fisher Scientific

Nahila Justo is responsible for leading cross-functional teams focused on real-world evidence generation and insights, especially the use and analysis of large data sets, such as clinical registries. She is active in industry collaborations, such as the GetReal Institute, and focused on advancing the adoption and implementation of real-world evidence in healthcare decision-making.

With over 15 years of industry experience, she has designed and led numerous outcomes research studies, including retrospective database analyses and chart reviews, literature reviews, health economic models, strategic consulting and stakeholder engagement. Her experience spans a wide range of therapeutic areas, including multiple cancer indications (breast, lung, prostate, ovarian and sarcoma), hematological malignancies, cardiovascular diseases, immune-moderated diseases and the central nervous system (dementia, insomnia, Alzheimer’s disease and multiple sclerosis).

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Nahila earned a PhD from Karolinska Institute, holds a MBA from the Stockholm School of Economics, an MPhil in European studies from the University of Salamanca, an MSc in economics from the Inter-American Development Bank and the University Torcuato Di Tella and a BA and MA in political science and international relations from the National University of Rosario.

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Javier Cid, Evidera, a part of PPD clinical research business, Thermo Fisher Scientific

Javier Cid, MD, DrPH, MBA, Senior Research Scientist, Data Analytics, Evidera, part of the PPD clinical research business of Thermo Fisher Scientific

Javier Cid is a healthcare professional with more than 20 years of experience, 11 of which were spent working for two major pharmaceutical companies, mainly in the areas of pharmacoepidemiology and drug safety. He worked as a senior epidemiologist, medical advisor and study medical expert, with global responsibilities in the areas of neuroscience (neurology and psychiatry), anti-inflammatories, hematology and solid tumor oncology.

Javier has contributed to several therapeutic risk management plans and has interacted with health authorities internationally, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Agence française de sécurité sanitaire des produits de santé (AFSSAPS). He has experience in the planning, implementation and analysis of several drug and disease registries and databases, as well as in the development and implementation of signal detection for pharmacovigilance. He has a particular interest in gerontology and comparative effectiveness research

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Javier earned his MD from the University of Zaragoza Medical School in Zaragoza, Spain; his MPH from the National School of Public Health in Madrid; his DrPH from Johns Hopkins University School of Hygiene and Public Health in Baltimore; his corporate MBA from the ESADE Business School in Barcelona; and his MSc in health economics and pharmacoeconomics from the Universitat Pompeu Fabra in Barcelona. He is also a certified specialist in preventive medicine and public health.

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Who Should Attend?

This webinar will appeal to professionals in the following fields:

  • Safety
  • Real-world Evidence
  • Real-world Data
  • Evidence Generation
  • HEOR
  • Medical Affairs
  • Clinical Development
  • Value Development
  • Regulatory
  • Market Access

What You Will Learn

In this webinar, attendees will learn about:

  • The various type of registries and what differentiates them
  • The type of questions that can be answered with registry data at various stages in drug development
  • Key points in identifying the right data for your needs
  • The application of scientific methods and analysis to transform registry data into usable real-world evidence

Xtalks Partner

Evidera

Evidera, part of the PPD clinical research business of Thermo Fisher Scientific, is a leading provider of evidence-based solutions to demonstrate the real-world effectiveness, safety, and value of biopharmaceutical and biotechnology products from early development through loss of exclusivity. We provide integrated scientific expertise and global operational capabilities to help you generate the evidence needed to optimize the market access and commercial potential of your products. Evidera has over 35 years of leadership and experience in strategic consulting, health economics and outcomes research, and real-world evidence planning and generation.

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