Non-Alcoholic Steatohepatitis (NASH) Liver Disease Drug Development Solutions
Address the urgent unmet need for NASH liver disease treatments with our unique combination of cross-functional expertise and programmatic experience.
Meeting today’s unmet needs in NASH (Non-Alcoholic Steatohepatitis) treatment requires more than an ideal drug candidate to reach the market. Accelerating your NASH program demands specialized support that encompasses several key success factors:
- Forming a strategic clinical development plan
- Designing a customized protocol
- Finding specialized sites to work with liver biopsy, imaging and biomarker needs
Let Covance help you execute a comprehensive strategy that addresses the unique challenges of NASH and meets your requirements—at every stage of development.
Don’t let site selection and patient recruitment challenges hamper your progress. We can keep your NASH drug development timeline on track through site-specific recruitment plans, drawing on our strong network of referral network, key opinion leaders and patient advocacy groups.
With our proprietary Xcellerate® Informatics Platform, including the industry’s largest clinical knowledgebase and outreach across more than 600 global sites across 26 countries, we’ll help you find the right locations for your trial to reach your rapid study start-up goals and employ ongoing initiatives that proactively manage patient retention.
NASH holds many uncertainties in its diagnosis, evaluation, management and progression, but one thing is certain: a dedicated partner with relevant NASH experience can increase your chance of tackling this disease.
Count on our global history of trials in Type 2 Diabetes, Obesity and Lipids, along with expertise in liver biopsy, novel biomarkers, imaging methods and adjudication for outcomes trials to deliver valuable insights across your program. Together, we can create new possibilities for your NASH study and forge a path for more thoughtful, efficient development.
NASH represents a rapidly developing field with several potential therapeutic options in the pipeline and many more on the horizon, yet none have made it to market. At Covance, we recognized this opportunity to harness our regulatory, medical, scientific and operational expertise and transform results in the field.
Our investment started with active participation with the NASH scientific community, the Liver Forum and other diabetes-related professional associations to understand the needs of sponsors from multiple perspectives. We’re ready to meet your near-term NASH goals as part of our ongoing commitment to change the outlook and make a difference to sponsors and patients.
Regulatory agencies support efforts to expedite the development of drugs that address unmet medical needs, like NASH. With many different approaches to reduce your product’s time to marketing approval, rely on our expertise to help you choose and incorporate the most optimal strategy.
We work with NASH experts to shepherd indications and advise submissions to meet global, regional and local approvals. Building off our foundation of strategic preclinical and clinical trial methodologies, we can fully support your approval process—and create the maximum value for your novel NASH product.
As a global CRO that supports novel development with hundreds of sponsors each year, we know how to advance compounds to the clinic and the market. NASH development relies on proven processes, along with additional strategies to:
- Apply adaptive trial designs to improve study efficiency and advance your program
- Incorporate specialized operational experience with novel imaging methods and coordinated interpretation of liver biopsies
- Identify and manage risks with risk-based monitoring
- Meet rapid study start-up timelines and retain patients
- Support global testing and biomarker development
- Leverage advanced informatics tools and employ electronic data collection forms
With our medical and regulatory team solely devoted to NASH, deep scientific experience and key operational solutions to overcome development hurdles, we’ll help you make an impact in this competitive landscape.
We know NASH and what it takes to get ahead. Now, get to know us to discuss how we can reveal new opportunities for your critical studies.
If you have a question for one of our NASH experts, please click the button below.
Claudia Filozof, MD, PhD
Executive Medical Director, CVMER (cardiovascular, metabolic, endocrine, renal) group
Dr. Claudia Filozof joined Covance in 2014 and is responsible of the medical oversight and consultant for NAFLD/NASH projects. She is board-certified in nutrition and metabolism and has broad expertise in diabetes, obesity and related metabolic disorders, including in non-alcoholic fatty liver disease and steatohepatitis (NAFLD/NASH). Her career spans almost 20 years in academia and 15 years of service in the pharmaceutical industry.
Dr. Filozof led multiple development programs in obesity, lipids, diabetes and has been actively involved in NASH since 2011. She is a member of the liver forum, AASLD* steatohepatitis working group and EASD** NAFLD group and has published multiple manuscripts in obesity, lipids, diabetes and NASH.
*AASLD – American Association for the Study of Liver Diseases
**EASD – European Association for the Study of Diabetes
Peter Alfinito, PhD
Senior Director, Strategy and Planning, CVMER (cardiovascular, metabolic, endocrine, renal) group
Since joining Covance in 2015, Dr. Peter Alfinito has led clinical plan design, site identification and protocol feasibility to optimize study placement, minimize cost and maximize recruitment potential. Prior to Covance, he worked for IMS Health and several large pharmaceutical companies including Merck Research Laboratories, Bristol-Myers Squibb and Wyeth Pharmaceuticals, where he cultivated a broad background in drug development with leadership roles in clinical development, translational medicine and drug discovery groups.
Through his career experience as a basic research scientist and clinical development strategist, Dr. Alfinito has gained valuable scientific and operational insight to help build data-driven strategies to deliver efficient, cost-effective and optimized solutions for studies.
Margery A. Connelly, PhD, MBA
Strategic Director, NMR R&D, LabCorp
Joining LabCorp in 2013, Dr. Margery Connelly has over 20 years of experience in academia and the pharmaceutical industry. She has spent the last three years applying her scientific expertise toward the development and clinical validation of new NMR-based biomarkers for various disease indications, including cardiovascular disease, inflammation and metabolic disorders such as metabolic syndrome, diabetes, obesity, NAFLD, non-alcoholic steatohepatitis (NASH) and liver fibrosis.
Her deep experience includes leadership roles during her 8 1/2 years at Johnson & Johnson, identifying and validating type 2 diabetes and heart failure targets and managing all stages of discovery of novel treatments for atherosclerosis, diabetes and obesity for both small and large molecule programs as well as four years at LabCorp, overseeing the NMR assay/product pipeline, from R&D initiation to IVD launch. Dr. Connelly also taught medical and graduate level courses in pharmacology, pathology and immunology as a research assistant professor at Stony Brook University.
Richard N. Williams, PhD, JD
Executive Strategist, Global Regulatory Affairs
Since joining Covance in 2013, Dr. Richard Williams has advised clients on global, regional or local regulatory strategy associated with preclinical or clinical study design and regulatory agency interactions. He has substantial experience in the cardiovascular and metabolic space, including NASH, T1DM and T2DM, and has more than 20 years of experience in strategic drug development.
In addition to leading and managing successful programs in multiple therapeutic areas, he has also interacted directly with regulatory agencies in the United States, Europe, Japan and India. He is an advocate for applying contemporary science to strategic drug development and is active member in several scientific societies such as the American Society for Clinical Pharmacology and Experimental Therapeutics, the American Society for Gene & Cell Therapy and the American Heart Association. Dr. Williams is especially interested in the integration of business with science, particularly with regard to the changing global landscape for product development.