Leaders in innovation

José Espinoza, MD, is a Senior Medical Director, Therapeutic Area/Oncology at Fortrea, based in Madrid, Spain. Dr. Espinoza has over 20 years of experience in drug development, which includes enrolling patients into cancer trials, helping design and executing studies, medical monitoring and data analysis of global trials, interfacing with regulatory bodies, and working with biotech and pharmaceutical companies to refine drug development strategies. 

As a European board-certified onco-hematologist, Dr. Espinoza holds a double specialization: Clinical Oncology (1992-97) and Clinical Hematology & Bone Marrow Transplantation (1997-2001), and has more than 20 years of clinical experience as Consultant Onco-Hematologist at public hospitals in Spain and Ireland. Dr. Espinoza joined in our company in October 2021.

Claudia is Board Certified in nutrition and metabolism and offers 20+ years of pharmaceutical and CRO experience in Phase II-IV clinical research. Claudia joined Fortrea (previously Labcorp Drug Development) in 2014 and started building the Liver Therapeutic Area. She is currently heading the Liver medical team, responsible for the medical oversight and for providing strategic medical consultation. She is also chairing the Innovative Study Design working group. Claudia has comprehensive experience in leading drug development programs with her main focus in metabolics and liver indications. 

Claudia is a member of the Liver and PSC Forum, AASLD steatohepatitis working group and EASL NAFLD group. She has authored multiple manuscripts, including five recent review papers about clinical development in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and adaptive design studies.

Jose Daniel Fanjul Fuente, MD, is a Medical Director, Oncology, for Fortrea, based in Madrid, Spain. He provides medical and scientific guidance and support to project teams and investigative sites on clients’ drug development projects, and reviews protocols, case report forms, clinical study reports and other data and materials. Dr. Fuente has more than 10 years of experience as a physician and medical director in clinical research and development specializing in oncology. 

Before his current position, he held medical director and manager positions in oncology with IQVIA and Bristol Myers Squibb in Buenos Aires, Argentina. At Bristol Myers Squibb, Dr. Fuente led scientific activities that gave impetus to the product line of the oncology therapeutic area (Nivolumab and Ipilimumab). He joined our company in October 2018.

Dr. Fuller has more than 20 years drug discovery and development experience across neuroscience, immunology and inflammation indications. Her 14 years clinical research experience across Phase I-III studies includes 11 years at Fortrea (formerly Labcorp and Covance), where she has supported development and implementation of Phase I and II clinical trials in patients with neurodegenerative diseases including Alzheimer’s disease. Dr. Fuller earned her Doctorate of Pharmacology from Northwestern Feinberg School of Medicine with a focus on Alzheimer’s drug discovery and development.

Dr. Gandia is a physician with more than 30 years of experience in clinical oncology and the pharmaceutical industry. He is a former senior clinical permanent staff member of the Institute Gustave-Roussy (Paris, France) under the supervision of Professor Jean-Pierre Armand. He joined IQVIA on 2016 as Medical Director in the Therapeutic Science and Strategy Unit for the US, Canada and Latin-America regions and worldwide clinical trials in 2021, serving as Senior Medical Director. He joined Fortrea in February 2023 as Senior Medical Director, MedSci Therapeutic Expertise-Oncology & Global Clinical Development. 

He is Board Certified in Medical Oncology, with a special interest in Melanoma, Lung, Head and Neck, Colorectal and Breast Cancer. He has been continuously working in clinical and academic settings for more than 25 years. Dr. Gandia has also served as Scientific Advisor and Medical Director in several Pharmaceutical Companies during his professional career. 

Dr. Gandia received his Medical Degree at the School of Medicine of the University of Buenos Aires, Argentina, and he underwent his postgraduate training in Internal Medicine and Clinical Oncology at the Sanatorio Guemes, Buenos Aires, completing his Oncology fellowship program in 1988 and spending one extra year as Chief Resident and Instructor at the Instituto Angel H. Roffo (the Argentinean National University Cancer Institute). 

At the Institut Gustave-Roussy, he produced several publications in peer-reviewed journals and meetings abstracts in early phases of oncology drug development. 

He was heavily involved in the drug development of irinotecan. Dr. Gandia was the first investigator who described the drug cholinergic acute syndrome, and also as the head, one of the investigators that described the use of high-dose intense Loperamide to control delayed diarrhea during the European Phase I study. 

Dr. Gandia's top skills are oncology, Phase I-III studies, study design, biology and molecular oncology, pharmacology, publishing papers and providing educational programs for professionals. He joined our company in February 2023.

Franklin Gaylis, MD, FACS, is a Urology Consultant at Fortrea. He also serves as Executive Medical Director of Unio Health Partners (UHP), the largest Urology group in California and as a voluntary Professor of Urology at the University of California, San Diego. 

Dr. Gaylis is a fellow of the American College of Surgeons, member of the American Urological Association and diplomat of the American Board of Urology. He lectures nationally and internationally on the subject of medical quality and implementation science and is considered a leader in the field. His research has been published in clinical journals such as Urology, Journal of Urology, Urology Practice, American Journal of Medical Quality, and the New England Journal of Medicine. Dr. Gaylis’ practice of more than 30 years has been focused on treating early and late stage prostate and bladder cancer including surgical procedures as well as clinical trials, Phases I-IV. He has participated in numerous clinical trials over the past 30 years, serving as PI in many and has 40 publications, 30 of which he is first author. Dr. Gaylis has a deep interest in data mining from the EMR and oversees UHP’s healthcare informatics program. He has experience with “big data” analytics and is exploring the feasibility for developing synthetic/external controls in Urology at Fortrea. Dr. Gaylis provides urological guidance for therapeutics, diagnostics and biomarker clinical trials and has conducted several advisory boards for sponsors seeking guidance regarding protocols in development.

Michael George, MBBS, MRCP, MFPM, is the Global Therapeutic Area Head at Fortrea. 

His areas of expertise include global strategic clinical drug development and portfolio and program management across multiple therapeutic areas, including immune-mediated inflammatory diseases (IMIDs), cardiovascular and metabolic diseases and women’s health. 

He has more than 25 years of experience in the pharmaceutical and CRO industry, having held numerous posts of increasing seniority across all phases of clinical drug development in various therapeutic areas and pharmacovigilance with both regional and global responsibility. At Fortrea, Michael is responsible for medical portfolio oversight, executive governance and clinical business development. He has authored several articles in the areas of IMID development, hypertension, heart failure, diabetic retinopathy and neuro-endocrine modulation.

Jonathan has over 20 years of clinical trial experience in early clinical and late-stage studies holding roles within Clinical Operations and Project Management. He brings diverse therapeutic experience with primarily focus on CVMER trials that include advanced CV imaging (e.g. MRI, CCTA), CVOTs, renal / hepatic impairment, core lab management, and collaboration with academic and commercial sites around the globe. In his leadership role as Delivery Director, Jonathan provides oversight of project development and execution while serving as a senior point of contact for his clients. Jonathan has a Bachelor of Science degree in Biology and earned a MBA from Harding University. Jonathan is a Certified Project Manager (via Project Management Leadership Group) and has completed a Midlevel Leader Excellence Program (via Harvard Business Publishing).

Diane is a Board-Certified endocrinologist and Senior Medical Director supporting the Cardiovascular, Metabolic, Endocrine and Renal therapeutic areas at Fortrea. Dr. Gesty-Palmer completed her internal medicine training and endocrinology fellowship at Duke University. She has over 20 years of clinical and translational research experience in broad range of endocrine therapeutic indications including T1D, T2D, obesity, MASH, cardiovascular outcomes.

Maria Paula Ghirardi, MD, is Medical Director of Oncology for Fortrea Clinical Development Services, based in Buenos Aires, Argentina. Dr. Ghirardi has 6 years of Oncology clinical research experience in both pharmaceutical and CRO industry. She provides clinical and medical expertise to project team and other Fortrea departments to advance clients’ drug development programs and contributes to the scientific strategic leadership of the Oncology therapeutic area. She has experience leading important launches of hematology-oncology compounds for multiple myeloma, AL amyloidosis, non-Hodgkin’s lymphoma, and chronic lymphocytic leukemia. 

Dr. Ghirardi earned her medical degree from the University of Buenos Aires and completed her internal medicine residency at the Hospital Ramos Mejia in Buenos Aires and Hematology residency at the Hospital de Clinicas in Buenos Aires and Sociedad Argentina de Hematologia. She joined our company in October 2022.

Vice President & Therapeutic Strategy Leader at Fortrea, Board Certified Nephrologist, Adjunct Professor at University of North Carolina, Division of Nephrology & Hypertension and past Associate Medical Director at local dialysis units. 

Board of Directors (2018-2023) for the Kidney Health Initiative (a public-private collaboration between the FDA and the American Society of Nephrology). Co-chair of Steering Committee for APOL1 Kidney Disease; work group member (and publication co-author) for Endpoints in IgAN, FSGS, C3G, Peds IgAN and CVO Trial challenges in CKD patients. Steering Committee for NFK CKD Patient Registry (Patient Network) and serves on multiple Advisory Boards and Stakeholder Committees (e.g., NephCure and International Society of Glomerular Disease’s PARASOL for FSGS Endpoints; PREPARE-NS for PROs; NKF Scientific Workshops for Renal Endpoints in Early CKD; Medical Ad Board for Regional NKF, NephCure MN Consensus Group, PCORI, SONG) and invited faculty speaker at many global nephrology conferences. 

Collaborating with sponsors since 2006 on renal clinical development programs across 20+ indications in both CKD and End Stage Kidney Disease and associated complications

• Senior Medical Director at Fortrea.  Board certified internist and nephrologist
• 15 years clinical experience as internist and renal physician including serving as in-house nephrologist at dialysis centers.
• Clinical trial industry related experience since 2009.   Collaborating with sponsors serving as project medical lead and scientific advisor on various therapeutic indications including CKD and End Stage Kidney Disease, Lupus Nephritis, hemodialysis study and associated complications

Walter Gonzalez is the Associate Director of Digital Health and Innovation Delivery, boasting over 13 years of pioneering experience in Clinical Trial systems across pharmaceutical, healthcare IT, and CRO industries. Walter's expertise spans Phase I through Phase IV trials, with a strong focus on strategic planning, business development, and program management. He is a leader in leveraging cutting-edge DHT platforms, including eCOA, consent, telehealth, EDC, and Wearables, to drive transformative innovation and efficiency in clinical trials.

Brian is based in Chicago, Illinois, USA and has over 19 years clinical research experience, having worked at several biotech companies, a global CRO and GlobalCare Clinical Trials (acquired by Covance/Labcorp). Brian joined Fortrea in 2020 as a part of the GlobalCare acquisition. He has worn many hats in those years and has hands-on experience in clinical operations, strategic planning and growth, data management, medical writing, project management, portfolio management, line management, business development, contract execution, FDA submissions and working with advisory boards. He has therapeutic experience in Ophthalmology, Women’s Health, Neurology, Rare Disease, Oncology, Cardiovascular and Trauma research and has spent the last 3 years solely focused on Ophthalmology. 

Brian is passionate about patient centric clinical trials and finding creative solutions to reduce site and patient burden in a space filled with complex and debilitating disorders.

Dr. Gutiu is a board-certified neurologist with more than 15 years of clinical experience in a hospital setting across a wide range of neurological and psychiatric indications. He spent 10 years in academia as Assistant Professor of Neurology and attended doctoral courses in neuropharmacology. His 25 years of clinical research experience includes roles as an investigator, medical monitor and medical leadership positions spanning Phase I-IV studies. 

He has broad range of experience across product modalities, including biologics and cell and gene therapies as well as medical expertise in neuro and psychiatric diseases, including, but not limited to, neurodegenerative, pain, neuromuscular and demyelinating.

Brian Hamilton, MD, PhD, is Senior Medical Director for Fortrea, based in Newton, Massachusetts. He serves as Fortrea Subject Matter Expert for cellular immune-oncology, CAR-T and gene therapy. He also serves as global lead project physician on clients’ drug development projects. Dr. Hamilton has more than 35 years of experience in pediatric medicine, immunology, hematopoietic stem cell transplantation, and clinical research and development. Before joining Fortrea, he served as Executive Medical Monitor for Chiltern International. He has also held senior-level medical director, director physician, regulatory affairs and clinical research positions with Galena Biopharma, AstraZeneca, Onyx Pharmaceuticals, Wyeth Oncology, and other pharmaceutical and biotech firms. Dr. Hamilton joined our company in August 2018.

Konstantin Haradinov, MD, is a Medical Director, Oncology for Fortrea, based in Sofia, Bulgaria. He contributes to the development of Fortrea policies involving medical, safety and therapeutics; serves as global lead project physician and provides medical and safety monitoring on assigned projects; reviews medical data and provides clinical and medical expertise to project teams and other Fortrea departments, and performs safety trend analyses. 

Dr. Haradinov has more than 15 years of experience in clinical research as a medical director and physician/oncologist. Before joining Fortrea he served as Medical Officer, Oncology, for Chiltern International in Sofia, Bulgaria. Dr. Haradinov joined our company in April 2019.

Dr. Hoelscher is based in Austin, Texas with 24 years of CRO industry experience in a wide variety of therapeutic areas, most recently in the past 16 years focusing on medical monitoring in ophthalmology indications including: 

• Retinal: dry/wet AMD, Non-infectious Uveitis, DME, Macular edema in uveitis, Vitreomacular traction, Proliferative/non-proliferative diabetic retinopathy 
• Anterior indications: dry eye, Glaucoma/POAG 
• Gene therapy: wet AMD, Batten’s disease 
• Rare disease: Batten’s disease, choroideremia, Stargardt’s disease, Retinitis Pigmentosa, Leber’s amaurosis 

While in medical school, he participated in Parkland Hospital’s “Mavericks in Ophthalmology” program, leading to a long fascination with research and the clinical practice of vision care.