Diagnostic Center of Excellence Team
Khaled Tolba MD, MBBS
Senior Medical Director (Oncology)
- Over 20 years of clinical expertise, provides subject matter expertise in support of advancing clinical trials and drug development.
- Managed several large registration trials for US-based cooperative groups including SWOG, as well as large pharmaceutical trials including LCMC-4.
- Provides subject matter expertise in support of advancing clinical trials and drug development.
- Contributes to key medical strategy and the execution of clinical programs.
- Provides medical and safety monitoring and data review.
- Develops, reviews, and revises protocols, CRFs, training materials, code/data tables, listings, and figures.
- Assists in preparations for investigator meetings.
- Participates in project risk assessment activities.
- Contributes to scientific strategic leadership for the Oncology therapeutic area.
- Partners with sales and supports business development efforts, including bid defense meetings and conferences.
Subject Matter Expert:
- Thoracic Oncology: Non-Small Cell Lung Cancer and Small Cell Lung Cancer
- Head and Neck Cancer
- Precision Oncology and Biomarker development for solid tumors
- Tumor Immunology, Checkpoint blockade
Laura Vidal, MD
Vice President, Therapeutic Strategy Leader (Oncology)
- Certified medical oncologist from Barcelona, Spain.
- Completed two fellowships in Clinical Drug Development from the Royal Marsden Hospital, London and the Princess Margaret Hospital, Toronto.
- 15 years in clinical and academic positions specializing in the field of oncology and drug development.
- Authored or co-authored dozens of peer-reviewed journal articles.
- Focused on early phase development, molecular and imaging biomarkers, and anticancer immunotherapy.
- Holds a thesis title from the London University on oncolytic viruses.
- Master of Immuno-Oncology from the University of Navarra, Spain.
- Master in Bioethics and Law from the University of Barcelona, Spain.
Isagani Chico
Vice President, Therapeutic area (Oncology)
- Gani has more than 35 years of experience in oncology clinical drug development from small and medium-sized biotechnology companies, CROs, and the FDA. His work has focused on planning and executing global oncology clinical development projects from early phase to post-approval, leading cross-functional strategic teams within medical affairs and clinical development, and managing pharmaceutical, academic, and regulatory interactions.
- Gani earned his medical degree from the University of the Philippines, completed his Internal Medicine residency at Cook County Hospital in Chicago, and completed his Medical Oncology fellowship at the National Institutes of Health in Bethesda, MD.
- At Fortrea, Gani leads a dedicated team of more than 50 oncology physicians with an average of 23 years of academic and industry-related clinical experience across Europe, North America, Latin America, and Asia. The oncology medical team provides program and study-level medical oversight across early to post-marketing phases. Fortrea also offers a group of consultants with expertise in specific tumor indications, technologies, and drug classes, supporting study protocol design, clinical development strategy, target product profile establishment, and feasibility and risk assessment.
Lisa Moore, PhD RN
Executive Director, Medical Device and Diagnostics
- >25 years working for Fortrea in the Device and Diagnostic space
- Doctorate in cell and molecular biology
- Postdoctoral work trained as an electrophysiologist working in ophthalmology, CV, and oncology
- Trauma, ICU, and Cath lab nurse
- Recently published work on prognostic genomic markers for metastatic melanoma, academic faculty until 2021
- Numerous industry talks and white papers in the imaging diagnostic and imaging review space with Fortrea legacy organizations
Mauricio Scarcello, MBA
Director, Strategic Delivery & Growth
- Over 20 years of experience in clinical operations from CRO (including dedicated device sponsor) and pharmaceutical companies across a wide range of roles (Global clinical operations and Quality) covering pharmaceuticals, vaccine research, devices, and diagnostics.
- Mauricio provides efficiencies and cost-effective operational strategies across medical devices and diagnostics projects, incorporating strategic focus on client needs, partnerships, risk mitigation, investigator relationships, and data intelligence.
- Global working experience in Brazil, Latin America, United States, Asia Pacific, and EU, bringing worldwide trial experience to projects.
- Therapeutic area experience includes oncology, cardiovascular, metabolic diseases, immunology, infectious diseases, neurosciences, and respiratory studies.
- Subject Matter Expert: Global Operations for Medical Devices, Diagnostics (IVD, CDx, Imaging), and Precision Medicine.
Ken Morrison
Global Head, Oncology Strategy and Planning
- Over 30 years of oncology preclinical and clinical experience between academia and industry sector in Pharma and CRO.
- Significant global operational experience in all phases of oncology development, including complex adaptive study designs and radiopharmaceuticals, understanding country/site strategy to operational successes.
- Global clinical leader experienced in all phases of clinical trials, from Phase I to pivotal Phase III studies and global multi-trial programs from biotech companies.
Shanthi Sundaramoorthy PhD
Senior Director, Strategic Delivery & Growth (Oncology)
- Shanthi is a Senior Director in the Strategic Growth & Delivery team in Oncology. She contributes to the development of the best operational strategy for new and existing clients by linking with all Fortrea business units and all applicable services and new initiatives the company has developed.
- Shanthi has more than 25 years of experience in clinical research in Oncology, primarily in both Investigational Drug and MDD trials.
- Before joining Fortrea, she was a Senior Director in Strategy at ICON and prior to that at IQVIA. Shanthi joined Fortrea in 2019.
Cori Ragan
Director, Regulatory and Quality Senior Principal Advisor, Medical Device and Diagnostics
- Over 15 years of experience in regulatory affairs working with medical device regulations worldwide.
- Master’s degree in software engineering. Bachelor’s degree in electrical engineering.
- Experience with all medical device classifications (US, Canada, EU, UK).
- Experience with Diagnostics (IVDs, CDx, Imaging).
- Experience with Digital Health Technologies including:
- Software as a Medical Device / Medical Device Software
- Artificial Intelligence / Machine Learning (AI/ML)-Based Software
- Clinical Decision Support Software (CDSS)
Jason Retzlaff
Regulatory/Quality Systems Senior Specialist, Medical device and Diagnostics
- 9 years of experience in quality regulatory affairs working with medical device regulations worldwide, with a focus on Structural Heart implantable and Class III devices.
- Bachelor’s degree in English.
- Experience with all medical device classifications (US and EU), including submissions and Performance Evaluation Reports.
- Experience with Diagnostics (IVDs, CDx, Imaging).
- Experience with Reimbursement Landscape Assessments for device and diagnostics.
Moez Benali, MD
Senior Medical Director
- Dr. BENALI earned his medical degree at Kremlin Bicetre in Paris in 2001, completed his oncology board certification in the famous Gustave Roussy institute, and obtained his PhD in Molecular Biology and anti-cancer drug development in Paris in 2007.
- Dr. BENALI has more than 20 years of oncology clinical development and medical affairs experience through his different strategic roles in big biopharmaceutical companies (J&J, GSK, BMS, SOBI, and Novartis).
- As a well-rounded medical affairs strategist, he was able to lead activities across most life cycle management of drugs, registered and launched 11 drugs at EMA, nine of them being standard of care, engineer of the first-in-class checkpoint inhibitor, epigenetic drug HDAC inhibitor, and CARTc. He is considered as the pioneer of the precision medicine field.
- He is President of the “oncologues sans frontier” and a member of the Scientific Committee IPCS Saint Louis Hospital, member of the European Leukemia Network and chairman of the AML MRD scientific council, member of the EORTC, ESMO, EHA, ASCO, and EHA.
Luca Cantini, MD, PhD
Medical Director
- Medical Director & Medical Oncologist with 10 years of experience in oncology clinical drug development.
- Medical Lead at Fortrea (formerly Labcorp), overseeing multiple Phase I-III clinical trials in multiple indications (mainly thoracic malignancies and breast cancer).
- Expert in clinical trial design, medical data review, and patient safety monitoring.
- Key responsibilities include protocol development, investigator engagement, medical risk assessment, and regulatory interactions.
- PhD in Immunotherapy for Lung Cancer & Mesothelioma from Erasmus MC, supported by the ESMO Translational Research Fellowship.
- Author of 60+ peer-reviewed publications and presenter at leading oncology conferences (ASCO, ESMO, IASLC).
Paulo Nunes, MSc, MD
Medical Director
- Dr. Nunes is a medical oncologist and epidemiologist based in Porto Alegre, Brazil with more than 10 years of experience in oncology clinical and epidemiological research both as an investigator and medical monitor and has worked both in the academic setting as well as in cooperative oncology groups.
- His main areas of scientific interest are early-phase clinical trials, epidemiological studies, and gynecological cancers. Dr. Nunes earned his medical degree from the Federal University of Rio Grande and completed his internal medicine residency at the Hospital de Clínicas de Porto Alegre, medical oncology residency at Hospital São Lucas da PUCRS, and a fellowship in gynecological cancer and phase I clinical research at McGill University, Montreal, Canada.
- He holds a master's degree in Epidemiology from the Federal University of Rio Grande do Sul. He joined Fortrea in March 2022.
Yulianna Tymovska, MD, PhD
Senior Medical Director
- Yulianna Tymovska, MD, PhD, is Senior Medical Director based in Brisbane, Australia, with 20 years of clinical experience specializing in Oncology, including breast, head and neck cancer, melanoma, and gynecological malignancies. She has also conducted research on tumor resistance to anti-cancer treatment and immune oncology.
- Dr. Tymovska has 19 years of clinical research experience as a clinical trial investigator and medical director, providing medical oversight, study design expertise, and working with cross-functional teams on all phases of clinical trials.
- She earned her medical degree and completed clinical oncology postgraduate training at Bogomolets National Medical University in Kyiv, Ukraine, and her PhD at Kavetsky IEPOR of NAS of Ukraine. Dr. Tymovska joined Fortrea in January 2023.
Maria Elvira Parellada
Medical Director, Oncology – Hematologic Malignancies
- Certified Hematologist – Onco Hematologist from Argentine Society of Hematology.
- Completed a Fellowship in Clinical Research at FUNDALEU – Buenos Aires, Argentina.
- Over 5 years in Clinical and Academic positions specializing in the field drug development for Hematology and Onco-Hematology.
- Robust experience as medical monitor of clinical studies, with special focus on early-phase trials.
- Leader of the scientific and operational strategy for cellular therapies at Fortrea, including CAR-X therapies, T-cell engagers, stem cell-derived therapies.