Leaders in innovation

Oxana Bzhadug, MD, PhD, is a Medical Monitor of Fortrea's global team, based in Moscow, Russia. Dr. Bzhadug has significant medical and pharmaceutical expertise with 14 years in the industry. Dr. Bzhadug received extensive scientific and clinical experience as a medical oncologist at Cancer Research Center (Moscow, Russia) for nine years. She has more than 23 years of experience in clinical trials, starting as sub-investigator in Phase I-III clinical trials and continuing in the industry supporting Phase I-IV trials within biotech (Amgen) and CRO. 

Dr. Bzhadug earned her Medical Degree in Moscow Medical and Dentist University and completed her Medical Oncology Fellowship in Cancer Research Center (Moscow). She has PhD degree in molecular biology of Breast Cancer. She joined our company in 2019.

Dr. Calabresi has more than 20 years of clinical experience and 16 years of industry experience with a strong track record of designing, conducting and reporting clinical studies in all phases of development in neuroscience. He has worked as a research physician and medical lead at CROs and major pharma companies across various neuroscience indications, including Acute (post-op) and Chronic (neuropathies: chemotherapy induced, diabetic peripheral, and post-herpetic) Pain, Multiple Sclerosis, Alzheimer’s Disease, Parkinson’s Disease, Spinal Cord Injury, Muscular Dystrophies, Mitochondrial Diseases and others across Phases I-IV.

Based in Siena, Italy.

Clare Campbell-Cooper joined Fortrea in February 2020 and serves as its Global Head of Digital Health and Innovation. Clare has over 25 years of industry experience and is a recognized leader within the field of digital health. Clare has a wealth of experience encompassing many disciplines within clinical research and has held management positions within Data Management, Clinical Monitoring, Phase I Operations, Strategy and Planning, Project Management and, most recently, Digital Health.

Clare is an active member a number of boards and associations and sees that working in a pre-competitive environment is critical to helping drive change within the industry. Clare is passionate about how we can change clinical trials for the better and is a member of the Fortrea Environmental Sustainability Committee and a founding member of the Fortrea Sustainable Future Chapter. Clare sits on the Kings College London Scientific Advisory Board, Centre for Pharmaceutical Medicine Research and is a visiting lecturer at KCL. In her role as Global Head of Digital Health and Innovation at Fortrea Clare is helping to change the face of how clinical research is developing. She specialises in strategy development for both internal and external partners. Clare's special interest lies in the relationship between the caregiver and physician team and how the use of digital technology can augment this.

Luca Cantini, MD, PhD, is Medical Director at Fortrea, based in Leiden, the Netherlands. Dr. Cantini has 8 years of experience in oncology clinical drug development from academia to CROs, dealing with all aspects of early and late phase clinical trials. As a Medical Oncologist, he has been actively involved in translational research in Immuno-Oncology with a special focus on thoracic cancers. He earned his medical degree from the University of Pisa, Italy and completed his medical oncology fellowship training at the Polytechnic University of Marche, Ancona, Italy. In 2020, he was awarded with the ESMO Translational Research Fellowship, to carry on a project titled “ENSURE study - dENdritic cell therapy combined with SURgEry in mesothelioma” at the Erasmus MC, Rotterdam, the Netherlands. During the Fellowship, he decided to pursue a PhD trajectory at the same Institution, which has been finalized in 2022. Besides the ESMO Fellowship, he has been awarded with the IASLC Early Career Education Award, the ESO Grant for participating to the “18th ESO/ESMO Masterclass in Clinical Oncology,” the ESMO Grant for participating to the “Translational Research Unit Visit,” the ESMO Travel Grant for participating to the “2022 European Lung Cancer Conference,” and the NRS Travel Grant. He has authored 53 manuscripts in peer-reviewed journals. He joined our company in December 2022.

Publications

• Determinants of 5-year survival in patients with advanced NSCLC with PD-L1≥50% treated with first-line pembrolizumab outside of clinical trials: results from the Pembro-real 5Y global registry
• Unraveling the link between cholesterol and immune system in cancer: From biological mechanistic insights to clinical evidence. A narrative review
• Differential impact of lipid profile according to neutrophil-to-lymphocyte ratio status in patients with advanced cancer treated with immunotherapy
• Biomarkers in head and neck squamous cell carcinoma: unraveling the path to precision immunotherapy
• Neoadjuvant therapy in hormone Receptor-Positive/HER2-Negative breast cancer

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.

Kristina Davis is a Director in Fortrea’s PaCE Team, which assists client companies with gathering patient-focused validity evidence and measurement regulatory strategy within the context of clinical development in the US and Europe. She has more than 15 years’ experience in the clinical sciences for regulated products including endpoint measure selection and adaptation, study design, statistical methods, regulatory strategy and communication, and development of novel outcome measures (PRO, ClinRO, PerfRO). Dr. Davis has experience in both medical devices (Class II and III) and pharma/biotech (Phases 1 – 4) and working in a variety of therapeutic areas, including rare neurodevelopmental disorders, muscular dystrophies, chronic pain, postpartum depression, urogynecology, sleep, dementia, among others. ​

Dr. Davis earned an MS and PhD in Experimental Psychology from Texas A&M University studying in their Behavioral and Cellular Neurosciences program.​

Michelle Dawson is a Senior Director in the Product Development Consulting team at Fortrea, based in the UK, with nearly 30 years of experience in pharmaceutical research and development. She has a strong track record in leading drug product development from early clinical phases through launch and post-approval lifecycle management.

Michelle began her career at Novartis Horsham Research Centre, working on dry powder inhaler development, and later spent over 20 years at GlaxoSmithKline research and development as a matrix leader in formulation development, primarily in respiratory medicine. She played a key role in the regulatory approval of multiple Ellipta® dry powder inhalers and later supported post-approval and lifecycle activities in Global Regulatory Affairs. Prior to joining Fortrea in 2022, she served as Director of Formulation Development at Pharmaron UK.

Michelle is a qualified pharmacist, holding a degree from the University of Manchester and a PhD in Pharmaceutics from Cardiff University.

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.

Marisa Dodulik, MS is an Associate Director of Regulatory Submissions at Fortrea with more than 20 years of pharmaceutical industry experience supporting global clinical development programs across all phases of drug development. She specializes in U.S. regulatory submissions, overseeing the planning, preparation and execution of high-quality IND applications and amendments to the FDA.

Marisa leads complex submission projects, provides regulatory guidance to cross-functional teams and clients, oversees eCTD publishing through DXC Technology, and serves as U.S. IND agent and primary FDA liaison for sponsors. Prior to joining Fortrea, where she has spent 19 years, she held roles in quality assurance and regulatory submissions at other CROs.

She holds a bachelor’s degree in sociology from The College of New Jersey and has completed a Drug Development Certificate from Temple University and a Women’s Leadership Certificate from Rutgers University.

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.