Precision Oncology in Practice: Strategies to Drive the Next Generation of Oncology Studies

Sumitra Smith, Project Management, Medical Device & Diagnostics, Fortrea

Sumitra Smith brings over 20 years of clinical research experience across oncology and general medicine, with extensive expertise in clinical operations and end-to-end project management of Phase I–IV investigational medicinal product trials. Four years ago, she transitioned into the Medical Device and Diagnostics division at Fortrea, expanding her leadership into the evolving device and diagnostics landscape.

She has demonstrated sustained engagement in regulatory affairs and quality assurance, contributing to the organizational implementation of the EU CTR, EU MDR and EU IVDR through collaboration with the Regulatory Intelligence Office. She provides strategic oversight across a diverse portfolio of medical device and diagnostic studies, ensuring operational excellence, regulatory alignment and consistent delivery of high-quality outcomes.

Khaled Tolba, MD, MBBS, Senior Medical Director (Oncology), Fortrea

Khaled Tolba serves as Senior Medical Director in Oncology and brings 25 years of combined clinical and basic science oncology research experience, along with clinical practice, as both an Academic Medical Oncologist and an Industry Subject Matter Expert. He spent 10 years as an NCI-funded Physician-Scientist focused on tumor immunology and innate immunity at academic NCI-designated cancer centers and 20 years as an Academic Thoracic Oncologist engaged in Phase I–III clinical research in lung and head and neck cancers.

He has served as a Site Disease Leader for Thoracic Oncology at an NCI-designated cancer center and has industry experience in biomarker development and genomic profiling, including next-generation sequencing, RNA sequencing and homologous recombination deficiency signatures. His background includes broad experience developing and managing clinical trials across multiple oncologic subspecialties, including lung, head and neck, gastrointestinal and breast cancers.

Cori Ragan, MS, Regulatory & Quality Systems Director, Fortrea

Cori Ragan is the Regulatory and Quality Systems Director with 20 years of experience in medical device and diagnostic regulations. She holds a Master’s degree in Software Engineering and a Bachelor’s degree in Electrical Engineering. Her experience spans global medical device regulatory frameworks across the United States, Canada, the European Union, the United Kingdom and Australia. She also has expertise in diagnostics, including in vitro diagnostics, companion diagnostics and imaging, as well as digital health technologies such as software as a medical device, software in a medical device, medical device software and clinical decision support systems.