Leaders in innovation

Carolina Dutra, MD, is a Medical Director for Fortrea Clinical Development Services, based in Brazil. She is medical oncologist by training and provides clinical and medical expertise to project teams and other Fortrea departments to advance clients’ drug development programs. Dr. Dutra performs medical and safety monitoring on assigned projects, develops and reviews protocols, case report forms and other data and materials, and contributes to the scientific strategic leadership of the oncology area at Fortrea. Dr. Dutra has more than 15 years of experience as a physician and principal investigator. She joined our company in May 2021.

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.

Publications

• The Evolving Landscape in Multiple Myeloma: From Risk Stratification to T Cell-Directed Advanced Therapies

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.

Dr. Audrey Finesso is a Global Senior Director and Clinical Regulatory Strategist at Fortrea with more than 25 years of experience in regulatory affairs and drug development. Based remotely in France near Switzerland, she provides clinical and regulatory strategy to support global development programs, with deep experience in oncology and rare and orphan diseases.

Prior to joining Fortrea, Audrey was Head of the Drug Development Unit at PharmaLex in France for five years, where she led clinical and regulatory strategy and coordinated interactions with major EU and U.S. health authorities, including the FDA, EMA, ANSM, and BfArM. Earlier in her career, she held regulatory affairs roles for more than 17 years at leading biotechnology and pharmaceutical companies, including Amgen, Biogen, Merck Serono, Gedeon Richter, MSD, and Janssen Cilag.

Audrey holds a PharmD from Claude Bernard University in Lyon and an MSc in International Drug Registration and Development from Paris-Saclay University.

Stephen Flach, Md, PhD, is a board-certified internist who has worked in Clinical Pharmacology since 2005 as a Principal Investigator, Medical Monitor, and Consultant on a wide range of early phase drug development projects. He has helped design and execute numerous renal and hepatic impairment studies since 2017. He is an author on over 40 peer reviewed publications. He was an internal medicine resident on the Osler Medical Service at the Johns Hopkins Hospital and subsequently was a fellow in General Internal Medicine at the University of Pennsylvania. Prior to working at Fortrea, Dr. Flach was on the faculty at the University of Iowa College of Medicine.

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 23 years drug discovery and development experience across neuroscience, immunology and inflammation indications. Her 17 years clinical research experience across Phase I-III studies includes 14 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.​

Richard has more than 27 years of industry experience from Pre-Clinical work in the Pharmaceutical sector to Data Management, CRA & Project Management, in multiple therapeutic areas, focusing on Ophthalmology over the last 8 years, joining Fortrea in 2000. Richard provides delivery leadership to both his clients and project teams at portfolio & study level.

Richard prides himself in building strong relationships with sponsors and sites, recognizing how reducing patient burden and supporting site needs can make Fortrea the CRO of choice, in competitive landscapes, getting new products to market by delivering studies quickly and with quality.

Richard is based in the UK.

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.

Therapeutic Area Lead with responsibility for leading therapeutic strategy, trial delivery, client engagement, and team leadership across global programs within Respiratory. Gemma serves as the executive therapeutic area expert and primary liaison for key clients and partners.  Gemma Gaunt has supported clinical development programs spanning pre-clinical research, Phase I healthy volunteer and patient studies, and later-phase clinical trials. She supports a culture of project management excellence, ensuring assigned staff perform consistently according to defined operational, financial, quality, and process performance standards.

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.

• 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.

Ileana Guerschman is an MD and Sr Director in Project Management, with 25 years CRO drug development experience. She has strong expertise in the management and oversight of complex global studies across various therapeutic areas and different phases. Ileana supports a culture of project management excellence, ensuring assigned staff perform consistently according to defined operational, financial and quality performance and process standards. Ileana acts as a senior point of contact for clients and serves as a liaison supporting the core team throughout the study duration, as needed, to ensure all study deliverables are achieved.

Brian has over 20 years clinical research experience, having worked at biotech companies, a global CRO and GlobalCare Clinical Trials. Brian joined Fortrea in 2020. He has hands-on experience in clinical operations, data management, medical writing, project management, portfolio management, line management, business development, contract execution, FDA/regulatory submissions and working with advisory boards. He has therapeutic experience in Ophthalmology, Neurology, Rare Disease, Oncology, Cardiovascular, Women’s Health and Trauma research and has spent the last 4 years dedicated to 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.

Brian is based in the US.