cGMP Manufacturing at the CRU: Driving Efficiency for Early Phase I and Human AME Studies
Sponsored by: Covance
- Human Ame Studies
- Clinical Research Units
Date: 25 February
Time: 3PM London/10AM New York
Cost is a major factor in executing a clinical trial. Sponsors are continually seeking ways to reduce their financial risk in early Phase I and human absorption, metabolism and excretion (hAME) studies. Beginning a full CMC campaign only to have to cancel it or change formulation based on late toxicology results or safety data can add expensive delays. Regulatory changes are also impacting Phase I drug manufacture, where on-site cGMP capability can offer solutions in meeting the requirements while still being nimble with costs and timeline.
In these pivotal early Phase I studies, sponsors need timely access to key data to ensure quality of their manufacturer drug project. Clinical research units (CRUs) with in-house cGMP pharmacies are helping streamline the process and trim drug manufacturing costs, especially for challenging studies that require AME. But how do independent consultants help their sponsors get the data they need to align with scientific and regulatory requirements and determine the best path forward to reach their desired endpoints?
Join us in this educational presentation to learn about the requirements of hAME studies, regulatory oversight, and the role of the cGMP pharmacy to minimize risk during production. You will learn how CRUs with cGMP pharmacies compare to "traditional" CRUs and hear more about the process timeline from formulation decision to clinical preparation and dosing.
Marcus Stavchansky, PharmD,
Executive Director, Global Head Pharmacy Services, Covance Clinical Pharmacology Services
Marcus Stavchansky has more than 20 years of experience in pharmacy practice, the majority in research and development. He serves as a preceptor-faculty clinical professor at The University of Texas at Austin, College of Pharmacy since 2001, Clinical Assistant Professor of Pharmacy Practice, College of Pharmacy at Texas Tech University since 2012, as well as, Adjunct Associate Professor, Department of Pharmacotherapy, College of Pharmacy, at the University of North Texas since 2012. In 2018, Marcus received the LabCorp President’s Award Recipient. In addition, Marcus has also authored and co-authored a number of publications, presentations and abstracts at industry conferences.
Robert Kochan, PhD,
Senior Scientist & Radiation Safety Officer, Covance Clinical Pharmacology Services
Robert Kochan began his professional career as an Assistant Professor at the University of Wisconsin-Madison, where his responsibilities included establishing and funding a new exercise/diabetes research laboratory. Robert joined Covance/LabCorp Madison Clinical Research Unit in 1991. Since then, Robert has received numerous awards for his contributions to science, service and client solutions at Covance. Most recently, Robert was invited to visit the U.S. FDA to summarize the global-leading human AME experience at Covance and the applicability of specific/unique human AME data to independently generate mass balance, metabolite identification and/or absolute bioavailability information of investigational drug compounds.
Key Learning Objectives
- Get insights on optimizing early Phase I studies from a drug product perspective
- Learn about the challenges faced in the clinical research pharmacy services
- Hear how CRUs with cGMP pharmacies can achieve faster turnaround times
- Understand industry trends and U.S. regulatory requirements for hAME studies
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