Leaders in innovation

Isagani (Gani) M. Chico, MD, is Vice President and Global Head for Oncology Therapeutic Expertise, Fortrea Clinical Development Services, based in Baltimore, Maryland. Gani has more than 35 years of experience in oncology clinical drug development from small and medium sized biotechnology companies, CROs and the FDA, focused on planning and execution global oncology clinical development projects from early phase to post approval, leadership of cross-functional strategic teams within medical affairs and clinical development organizations, and management of pharmaceutical, academic and regulatory interactions. Gani earned his medical degree from the University of the Philippines, completed his Internal Medicine residency at the Cook County Hospital in Chicago, and completed his Medical Oncology fellowship training 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 in countries across Europe, North America, Latin America and Asia. The oncology medical team executes program and study level medical oversight that span early phase clinical development through late-phase and post-marketing studies. Fortrea also offers a group of consultants that provide expertise in specific tumor indications, technologies and drug classes, including study protocol and clinical development planning and strategy, establishment of target product profiles, feasibility and risk assessment.

Dr. Chng has more than 15 years of drug development industry experience across broad indications including neuroscience. She has extensive experience supporting small and medium sized biotech companies in Asia-Pac to develop their assets from early phase development to late clinical phases. With her project management skills, Dr. Chng is able to provide and advise operational strategy to Asia-Pac clients and help expand their drug development outside of the Asia-Pac region. Her therapeutic knowledge encompasses neurodegenerative, rare neurology indications as well as psychiatry disease, with a particular focus on schizophrenia.

Marcelo Costa, MD, is a Board-Certified Gastroenterologist/Hepatologist with more than 25 years of experience in managing patients with diverse liver diseases, including Hep B, Hep C, MASH (formerly NASH), autoimmune and biliary disorders, liver fibrosis, cirrhosis, portal hypertension, hepatocellular carcinoma and liver transplantation. 

He has a robust leadership track record in pharma R&D, drug development and medical affairs (virology and metabolism therapeutic areas) in HCV, MASH, liver fibrosis and cirrhosis indications. His experience includes HCV protease inhibitors, RORγt oral inhibitors, SSAO/VAP-1 inhibitors and sGC activators. He has also worked in in-license business development teams that successfully resulted in development programs for a novel SSAO/VAP-1 inhibitor PXS-4728 from Pharmaxis, an siRNA HMGB1 inhibitor from Dicerna and a first-in-class IL-11 inhibitor antibody from Enleofen. 

Dr. Costa has a particular interest in the development of non-invasive tests (biomarkers, -omics and imaging) for patient screening, assessment of disease severity and treatment response to support both daily practice and clinical trial settings. 

After joining Fortrea (formerly Labcorp) in 2022, Dr. Costa has served as the lead project physician for two Phase II trials in MASH and one Phase II trial in a rare GI/liver disease indication.

Andrew Cwiertniewicz, MSN, RN, is an accomplished professional with extensive expertise in vaccine clinical development. Based in Pennsylvania, he serves as a Senior Delivery Director for Infectious Diseases and Critical Care. Throughout his career, Andrew has more than 20 years of experience working with pharmaceutical companies such as Pfizer and Sanofi, and within Contract Research Organizations (CROs). Prior to these roles, Andrew also worked directly with patients in various healthcare and research institutes providing him direct site experiences in research studies. 

Andrew's work has spanned the entire spectrum of vaccine clinical development, from infants to older adults, and his efforts have contributed to vaccine licensing on a global scale as well as notable efforts in several pandemics. He possesses in-depth knowledge of all phases of vaccine development, including clinical research and clinical trial strategy. 

Andrew earned his master's degree in nursing from Drexel University, bachelor's in nursing from Cedar Crest College and a graduate nursing degree from St. Luke's School of Nursing. Andrew served more than 15 years in the United States Army Reserve as a Lieutenant Colonel, Executive Officer for the 8th Medical Brigade (New York, NY). He is a veteran with more than 28 months on active duty for Operation Iraqi Freedom and Operation Enduring Freedom. He is a graduate of various military officer programs, military medicine programs and schools including chemical, biologic, nuclear and explosive warfare. Andrew joined Fortrea in July 2023.

• Over 35 years of experience in clinical research development with progressive positions in clinical operations starting as a CRA to leadership roles that led to NDA submissions 
• Conducted medical and scientific reviews across multiple therapeutic indications to identify study risks and provide solutions for trial implementation 
• Applies data-driven, analytic and innovative approaches in building the global clinical strategy and planning for Phases Ib-IV trials in renal therapeutic areas of various study designs and goals 
• Broad therapeutic expertise including rare glomerular and non-glomerular diseases, acute and chronic conditions, in-patient or out-patient studies, and outcome trials 
• Based in the United States

Begoña de las Heras, MD, is Senior Medical Director in the Oncology Therapeutic Area, based in Madrid, Spain. Dr. de las Heras has more than 23 years of national and international clinical/clinical research oncology experience including the pharmaceutical and CRO industry, focused on planning and execution of global oncology clinical development from FIH to registration. Dr. de las Heras has held regional and global positions of increasing responsibility in oncology clinical drug, being her main area of expertise the development of early phase oncology programs. She has provided significant contribution to INDs, orphan drug applications and one NDA submission. She has co-authored of 8 book chapters, authored/co-authored more than 20 papers in oncology and named as inventor of two patent applications, according to her contribution to the clinical trials. Dr. de las Heras earned her medical degree from the University Autonoma of Madrid and completed her oncology residence at La Paz Hospital in Madrid. She joined our company in 2016.

Margaret Dean, MBA, is Senior Director, Portfolio Oversight, of Fortrea's Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT). She has 19 years of experience across the product development life cycle from bench research through commercialization, including pharmaceuticals, medical devices and healthcare IT systems. Her therapeutic experience includes acute coronary syndromes in the catheterization lab setting, development of an EMR-based tool for decision support in oncology setting and the delivery of CRO services across multiple rare diseases. 

Margaret has broad functional experience spanning strategic planning, business development, deal negotiation, marketing, sales and program management. Her MBA program had a focus on entrepreneurship and venture capital management.

Frederick Derosier, DO, is the Head of Fortrea's Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT). He has 22 years of experience in the pharma/biotech industry and 10 years of clinical practice in Internal Medicine. He has focused broadly on neurosciences and concentrated exclusively within rare diseases for more than 12 years. 

His Phase I–IV expertise spans small molecules, combination products, biologics, RNA and gene therapies and he has experience leading global clinical development programs including clinical development strategy and planning, protocol development, regulatory and patient advocacy group interactions.

AnnMarie DiGiacomo is an Associate Director in Strategic Delivery & Growth for Infectious Diseases and Critical Care and is based in San Diego, California. AnnMarie has more than 25 years of clinical research experience including in academia, biotech/pharmaceutical and the CRO industry. Her expertise focuses on planning and execution of Infectious Disease, Vaccines and Critical Care with experience in clinical development from first in human to registration. She has held regional and global positions of increasing responsibility in program delivery, with primary focus in Interstitial Lung Disease (ILD) and more recently, COVID-19 trials. AnnMarie has provided significant contribution to the FDA approval of treatment for patients with Idiopathic Pulmonary Fibrosis. 

AnnMarie earned her bachelor's degree in biology from the University of Southern California. She joined our company in 2003.

Mark Dowling is a Senior Director of Strategic Delivery & Growth. He has more than 30 years of industry experience, 22 of which are with Fortrea. Mark offers extensive respiratory experience in both strategic and operational delivery.

Marco Durini, MD, PhD, is senior medical director of oncology for Fortrea, based in Milano, Italy. He brings more than 25 years of experience in clinical research for CRO and Pharma. Before joining the company, he held medic positions with Ipsen, Pfizer, Sanofi, Roche. His expertise in oncology ranges from biomarkers/precision medicine to immuno-target therapies and vaccines in solid and non-solid malignancies. Oncogenomics and Radiomics are latest areas of interest. 

Dr. Durini is board certified medical doctor at the Milan physician registry, and hold a business school training mastership at the SDA Bocconi Milan. He received his medical degree with summa laude from the University of Milan in Italy, and a granted post-degree research fellowship at ICP - University of Milan. He is author of papers submitted to ESMO/ASCO congresses. He joined Fortrea (formerly Labcorp) early 2019.

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.

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. オンコロジー領域の臨床研究開発において、医師、医療ディレクターとして 10 年以上の経験を持っています。 

現職の前にはアルゼンチン、ブエノスアイレスの IQVIA および Bristol Myers Squibb でオンコロジー部門の医療ディレクター兼マネージャーを務めました。 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.

Mary has over 30 years of experience with Fortrea (formerly Labcorp and Covance), including global project management experience and drug development experience in discovery, translational medicine and clinical development roles. Her clinical research experience includes range of neuroscience indications, such as schizophrenia (adult and pediatric), Alzheimer's disease, Parkinson's disease, anxiety, depression, bipolar disorder, sleep disorder, Tourette's and rare disorders. She has an extensive background in Phase I-III studies that require in-hospital patient settings and multiple department interactions. Mary also provides expert advice as she customizes sponsors' strategies to anticipate and mitigate risk, meet the needs of the target patient population and improve efficiencies and data quality.

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.