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

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.

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.

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.

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).

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