Leaders in innovation

John Carlsen, MHA, is a Vice President who leads the Reimbursement Strategy & Payer Insights service within Fortrea’s Market Access Consulting and HEOR group. He specializes in assessing the impact of changes to Medicare and managed care payment systems on the reimbursement of drugs, biologics, and devices. He has collaborated with manufacturers on market access strategy projects across many therapeutic areas and has over 25 years of experience with coding, coverage, and payment issues in various settings of care.

John closely follows the latest health care policy developments. Most recently, he has worked with clients in the areas of Medicare drug coding and payment policies, Medicare hospital payment systems (inpatient and outpatient), the Inflation Reduction Act, Most Favored Nation (MFN) payment models, discarded drug and 340B modifiers, and biosimilars. 

Before joining Fortrea (formerly Labcorp and Covance), John worked at the Ohio State University Medical Center in Columbus, Ohio, where he focused on financial management and medical information management.

John earned an MHA in Health Services Management and Policy from Ohio State University’s Graduate Program and a BA in Economics with a minor in Psychology from Duke University.

Dr. Chng has more than 18 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.

Julie is a Delivery Director partnering closely with sponsors and stakeholders across our core Renal Therapeutic team. Julie is accountable to her portfolio of clients, overseeing large scale global projects, putting quality of delivery and cohesion of vision foremost. Julie is based in the UK with a career spanning over 25 years in clinical research, joining Fortrea in 2017 as a Project Director. Prior to that she held a variety of Project management roles at GW Pharma, Premier Research, and Johnson and Johnson. Her experience encompasses Phase I FIH, Ib POC - III project management in complex global nephrology, infectious disease, neurology, IPF, Hepatology, GCT and rare disease studies. Julie started her career as a CRA with a top 10 Pharma company, before moving into project management with a portfolio of dialysis and oncology supportive care studies. Julie earned her Bachelor’s degree in Biochemistry and Toxicology at the University of Surrey, UK.

Frank is a medical director at Fortrea. He has earned his degree in Medicine at the University of Amsterdam and has a bachelor’s degree in biomolecular science. He has more than 20 years of experience in clinical development both in pharmaceutical companies as CROs, with expertise in conducting and reporting clinical studies in all phases of development and joined Fortrea in 2012. He has experience in preclinical work, phase I – IV clinical studies as a research physician and medical lead for neuropathic pain studies, cardiovascular and main focus on nephrology for the last 12 years, which included studies for treatment of IgA nephropathy, FSGS, hypertensive and diabetic nephropathy, hyperkalemia, palatability, studies in dialysis and non-dialysis CKD patients and paediatric nephrology studies. Furthermore, he was involved as medical lead in pivotal phase 3 studies in CKD pts with anaemia; first in class drug, HIF-PHI until market approval.

Sam Colman, MSc, is a Senior Director and real-world evidence (RWE) biostatistician who co-leads the RWE & Analytics service within Fortrea’s Market Access Consulting and HEOR group. He provides biostatistical leadership for real-world evidence (RWE) studies, health economic studies, and clinical outcome assessments, with a focus in Asia-Pac.

He has over 20 years of experience in various clinical trial and RWE study designs including randomized, parallel, cross-over, case-control, cross-sectional, prospective, and retrospective. He has also been involved in risk evaluation and mitigation strategies and PBAC submissions in Australia.

Sam brings detailed knowledge of FDA requirements related to data and analysis and has experience in complex statistical methods including multiple imputation, marginal structural modeling, non-parametric methods, propensity score methods, ROC curves, meta-analysis, and indirect comparisons. He is well published with over 80 publications in more than a dozen therapeutic areas.

Prior to joining Fortrea (formerly Labcorp and Covance), Sam was a Senior Project Statistician with Eli Lilly and worked in government, academia, and the pharmaceutical industry.

Sam earned an MSc in Biostatistics from the University of Sydney and a BS in Economics and a BS in Science (Honours in Statistics) from the Australian National University.

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.

Gordon Cummins, MS, is an Executive Director who leads our Integrated Evidence Platform service area in Fortrea’s Market Access Consulting and HEOR group.  He specializes in real-world data and integrated evidence to support regulatory requirements and economic and humanistic value messaging for medical products.

Gordon has over 30 years of experience with primary and secondary data from clinical trials, observational studies, cross-sectional surveys, administrative claims, and electronic medical records. He is well published with over 50 manuscripts and conference presentations in more than a dozen therapeutic areas.

Before joining Fortrea, Gordon led the development of real-world evidence at Science37.  He also worked at Quintiles/IQVIA in the consulting, digital patient and real-world evidence units.

Gordon earned an MS in Statistics and a BS in Mathematics from Missouri State University.

Dr. Paulina Czajka-Francuz is a clinical oncologist with more than 25 years of experience in clinical trials. Acute hematological malignancies, as well as mechanisms of cancer resistance, have always been her main scientific interests. At Fortrea, Dr. Czajka-Francuz is primarily involved in Phase I and II hematological and oncological clinical trials.

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.

Ashok Deenabandu MD is a Medical Director for Oncology at Fortrea, based in India supporting Asia-Pacific and EU region. With over 20 years of experience-including 14 years in global clinical development-Ashok has led numerous drug and device trials across leading CROs and product companies. He has served as Medical Lead for multiple global studies for both large pharmaceutical sponsors and emerging biotech firms.

His domain expertise includes both Immuno oncology and Cell/gene therapies, with focussed interest in lung cancer,hepatocellular carcinoma,gastric cancer,sarcoma,radiopharmaceuticals-in neuroendocrine,prostate cancers and early-phase trials involving CAR-T and CAR-NK cell therapies targeting solid tumors.

As a core member of the Global Oncology Team at Fortrea, he focuses on advancing clinical operations in India and the Asia-Pacific region. His role integrates scientific leadership with strategic oversight, supporting regulatory compliant trial design, cross-functional process optimization, and engagement with investigators and key opinion leaders (KOLs) to ensure successful study delivery.Throughout his career, he has demonstrated a consistent ability to translate regulatory insights into actionable business strategy, supporting global submission efforts, and shape internal frameworks that enhance operational excellence and client engagement.

Ashok is board certified Physician with specialist training in Radiology and Clinical Oncology from TN Dr MGR Medical University,India.He has also completed Fellowship in Epidemiology and Biostatistics from the University of New South Wales, and holds an advanced training credential in Cell and Gene Therapy from Yong Loo Lin School of Medicine/ACTRIS, Singapore, thereby broadening his expertise in translational research and cutting-edge therapeutic modalities.

Frederick Derosier, DO, is Fortrea’s Vice President for Rare Diseases, Advanced Therapies, and Pediatrics and additionally serves as Therapeutic Strategy Lead for Cell and Gene Therapies. Dr. Derosier has 24 years of pharmaceutical/biotech experience and 10 years of clinical practice experience in Internal Medicine; he has been focused exclusively on medicines development in rare diseases for the past 15 years. He supports Fortrea clinical teams across the rare diseases and in CGT strategies. His Phase I – IV experience spans small molecules, combination products, biologics, and cell/gene/RNA therapeutics, and he has experience leading global clinical development programs covering clinical development strategy and planning, protocol development, and regulatory and patient advocacy group interactions.

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.

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.

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.