The COVID-19 pandemic has brought unprecedented challenges in clinical development. Travel restrictions, social distancing and the fear of contracting the disease are impeding conventional trial conduct. Typically, routine patient and monitoring visits to healthcare facilities are now the exception, study coordinators and site staff have increased demands on their time and, in some cases, layoffs have rendered some sites incapable of continuing as usual. To help keep patients safe and allow trials to progress, regulatory authorities worldwide have issued guidance for industry, investigators and institutional review boards. Exceptional measures are rapidly being put in place in different countries. As a consequence, we have witnessed a range of responses from sponsors on clinical trial activity, such as delaying trial starts, halting screening/enrollment in most ongoing studies and changing Investigational Medicinal Product (IMP) distribution and site visits.
Our ability to adapt our approach in this ever-changing environment is critical and as a company Covance is at the forefront of partnering with specific vendors who are able to assist us in virtual technologies. These technologies enable virtual patient visits through telemedicine and phone interviews, shipping, storage and self-administration of IMP at patients’ homes and remote CRA monitoring visits. Trials that are targeting a Q3 or Q4 2020 start could accelerate the start-up period by activating all sites prior to First Person In (FPI), enabling a large proportion to start screening and enrolling simultaneously once the hold is lifted. These suggestions could help trials move forward in the face of quarantine and travel limitations, clinical site closures and altered supply chains.
The objective of this webinar is to present a current perspective on how COVID-19 is creating challenges specifically for NASH clinical trials, and discuss advantages and limitations of the proposed methodologies to overcome these challenges.
- Challenges in Clinical Development: The Size of the Problem
- Maintaining Patient Safety and Data Integrity of NASH Clinical Trials During the SARS-CoV-2 Pandemic: The PI Perspective
- COVID-19 Impact on the Conduct of Clinical Trials – U.S. FDA Regulatory Perspective
- Decentralized Clinical Trials: Supporting Success in NASH
- Considerations for Accelerating Trial Re-start Under a “New Normal”
- A Regulatory Perspective for Starting New Trials After the Pandemic
- Panel Discussion
Claudia Filozof, MD, PhD ,Vice President, Liver Therapeutic Area Head Global Clinical Development, Covance
Dr. Claudia Filozof joined Covance in 2014 and consults on nonalcoholic fatty liver disease and steatohepatitis (NAFLD/NASH) research projects, as well as provides medical oversight. She is board-certified in nutrition and metabolism and has broad expertise in diabetes, obesity and related metabolic disorders, including in NAFLD/NASH. Her career spans almost 20 years in academic research, as well as 15 years of experience in the pharmaceutical industry.
Dr. Filozof led multiple drug development programs in obesity and other metabolic diseases and has been actively involved in NASH clinical development since 2011. She is an active member of the Liver Forum, member of the American Association for the Study of Liver Diseases steatohepatitis working group and the European Association for the Study of Diabetes NAFLD group. She has published multiple manuscripts on obesity, lipids, diabetes and four recent review articles in clinical development in NASH.Message Presenter
Naim Alkhouri, MD, Director, Texas Metabolic Center; Texas Liver Institute Hepatologist; Director of Pediatric Liver Disease Program at UT Health San Antonio; Associate Professor of Medicine at UT Health San Antonio
Dr. Naim Alkhouri is the Director of the Texas Metabolic Center at the Texas Liver Institute. He was most recently Assistant Professor of Medicine at the Cleveland Clinic Digestive Disease and Surgery Institute and Director of the Metabolic Liver Disease Clinic.
Dr. Alkhouri completed his medical degree at the University of Damascus in Syria before completing his internal medicine and pediatric residency at Albert Einstein Medical Center in Philadelphia. Dr. Alkhouri completed his pediatric gastroenterology, hepatology and nutrition fellowship at Cleveland Clinic and finally an adult transplant hepatology fellowship at the Digestive Disease and Surgery Institute, Cleveland Clinic.
Among many research awards, Dr. Alkhouri received the American College of Gastroenterology Junior Faculty Development Award to study the analysis of breath volatile organic compounds to diagnose nonalcoholic fatty liver disease. He also received the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition Fellow Research Award for his prospective evaluation of the pediatric NAFLD fibrosis index and ELF markers in children with fatty liver disease.
Dr. Alkhouri has over 100 publications and presents his work at both national and international medical conferences. His specialty interests include nonalcoholic fatty liver disease, viral hepatitis, autoimmune hepatitis, alpha 1 antitrypsin deficiency and liver transplantation.
Dr. Alkhouri is a member of several professional organizations, including the American Association for the Study of Liver Disease, the European Association for the Study of the Liver, American College of Gastroenterology and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.Message Presenter
Penny Piper, PhD, PMP, Executive Director & Department Head, Project Management Cardiovascular, Metabolic, Endocrine & Renal, Covance
Dr. Penny Piper has worked in the pharmaceutical industry for over 25 years and for Covance for 10 years, predominantly within Cardiovascular Disease. With a background in Phase I – IV, Dr. Piper now focusses on phase II-IV, specializing in Liver Disease (including NASH), Nephrology and Cardiovascular Disease (anti thrombotic, heart failure, HRVD) and has become a leader in the field of CV Outcomes studies within Covance.
Dr. Piper now leads a team of 100 Senior Directors, Project Directors and Project Managers in the Cardiovascular, Endocrine, Metabolic and Renal (CVMER) Therapeutic Area. Dr. Piper’s team are at the forefront of the delivery of studies in NASH/NAFLD and PBC with over 15 studies actively running in this therapy area.Message Presenter
Peter Alfinito, PhD, Senior Director, Operational Strategy & Planning Cardiovascular, Metabolic, Endocrine and Renal, Covance
Since joining Covance in 2015, Dr. Peter Alfinito has led clinical plan design, feasibility and site identification to optimize study placement, minimize cost and maximize recruitment potential. Dr. Alfinito has focused on NAFLD/NASH over the last 5 years and is supporting 14 active NAFLD/NASH trials from phase Ib – phase III/IV. He also maintains strong relationships with KOLs and external networks in the NAFLD/NASH space to stay abreast of current trends in the field and provide customized solutions to Covance’s sponsors.
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.Message Presenter
Beatriz Rocha, MD, PhD, Vice President, Head Global Regulatory Affairs and Strategic Product Development Consulting, Covance
Dr. Beatriz Rocha has more than 30 years of professional experience that spans from academia and government to industry. During the last 15 years, her work includes clinical practice in anesthesia and pain management, clinical research, basic research and regulatory affairs.
Dr. Rocha has also led regulatory strategy and interactions with multiple regulatory agencies. Dr. Rocha currently heads Global Regulatory Affairs (GRA) and the Strategic Product Development Consulting group that offers overall regulatory and medical consultancy across the entire continuum of drug and medical device development.Message Presenter
Who Should Attend?
- Chief Medical Officer
- Chief Executive Officer
- Senior Medical Director
- Medical Director
- Clinical Development Director
- Research and Development Director
- Operational Director
- Senior Operational Director
- Clinical Director
- Senior Clinical Director
- Research Director
What You Will Learn
- Identify current challenges in clinical development during the COVID-19 pandemic
- Understand how innovative technology can support patient safety and clinical trial delivery
- Discuss the potential strategic actions to accelerate the restart of trials on hold
- Understand the regulatory perspective of the COVID-19 pandemic in ongoing and planned clinical trials
Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives.
Covance is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical, and regulatory expertise. We generate more safety and efficacy data to support drug approvals than any other company, supporting our clients’ complete lifecycle management.
Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Visit us at www.covance.com.