Hepatology
Pioneering liver trials with decades of applied experience
Optimize site selection and patient recruitment with our rich database of site-specific recruitment performance. Empower your liver disease clinical trials with our comprehensive medical, scientific and regulatory expertise.
Advance your clinical trials
Leverage comprehensive medical, scientific and regulatory expertise in liver disease.
Optimize site selection
Access our rich database of site- specific recruitment performance to optimize site selection and deliver patient recruitment.
Minimize screen failure rates
Support enrollment and minimize screen failure rates in clinical trials for liver indications.
Valuable insights from unparalleled liver data
Hepatology trials face many challenges, including low diagnosis rates, high screen failure rates, low recruitment rates and rare disease populations. We use proprietary clinical and diagnostic data to address these issues:
- Recruitment metrics from over 1,000 global hepatology investigators in 50 countries
- Site-specific data in cholestatic liver disease to identify the best recruiting sites
- Data from 20+ MASH studies with cross-trial investigator performance metrics to select consistently high-performing sites
Fortrea is an expert in design, conduct and management of liver disease trials including serving on several advisory boards and consultancy agreements.
Early engagement to accelerate your trial
Get and keep your trial moving through early engagement with our medical, regulatory and operational experts. We collaborate with you to:
- Address challenges in complex liver diseases, such as metabolic dysfunction-associated steatohepatitis (MASH/MASLD)
- Create a clinical development plan (CDP) to help with competitive clinical trial success
- Streamline inclusion/exclusion criteria
- Connect you with top KOLs for insights on current practice and future trends
We improve the lives of patients worldwide by advancing the field of liver disease research through cutting-edge clinical trials and innovative treatments.
Hepatology experience that matters
In the last 5 years, we have supported:
Top indications
- Metabolic dysfunction-associated steatotic liver disease (MASLD/MASH)
- Cholestatic liver diseases
- Liver cirrhosis and complications Acute liver indications
- Autoimmune liver diseases
- Alcoholic liver disease (ALD)
- Other rare liver diseases
Our Experts
Delivering hepatology leadership
An exceptional partnership starts with an experienced team. Browse the bios of our featured team members.
Claudia Filozof, MD, PhD
Vice President and Therapeutic Area Head in Obesity, MASH and Liver indications
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.
Marcelo Costa, MD
Senior Medical Director, Liver Therapeutic Area, CVMER (cardiovascular, metabolism, endocrine and renal)
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.
Peter Alfinito, PhD
Executive Director, Strategic Delivery and Growth
Peter has more than 20 years advancing drug development in the pharmaceutical industry and been with Fortrea (formerly Labcorp and Covance) for nine years. Peter has designed the clinical plan for more than 25 MASH/MASLD (metabolic dysfunction-associated steatohepatitis and metabolic dysfunction-associated steatotic liver disease) trials ranging from Phase Ib through Phase III/IV. He also brings experience in rare liver diseases such as Primary Sclerosing Cholangitis and Primary Biliary Cholangitis. Peter maintains key relationships for Fortrea with liver industry experts and networks to facilitate the smooth transition of trials, spanning the design stage to the operational stage.
Our areas of focus
- Metabolic dysfunction-associated steatotic liver disease (MASLD/MASH)
- Cholestatic liver diseases
- Liver cirrhosis and complications
- Acute liver indications
- Autoimmune liver diseases
- Alcoholic liver disease (ALD)
- Other rare liver diseases
Insights
Get the latest updates from our hepatology team
MASH trial design
Development pathways and trial design for liver cirrhosis secondary to MASH
Download White Paper
Conducting pediatric trials in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Conducting pediatric trials in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
Download White Paper