The New York Times’ headline on December 17, 2014, “Pharmacy Executives Face Murder Charges in Meningitis Deaths,” has been a wake-up call to regulators and industry alike. You may think the tragedy that engulfed the New England Compounding Center won’t happen in a clinical trial environment; however, agencies such as the FDA are taking notice. In anticipation of regulatory changes for Phase I manufacturing, Covance has recently opened two current Good Manufacturing Practice (cGMP) pharmacies at their Dallas, TX and Madison, WI clinical research units.
The FDA’s focus remains on quality and safety. In their 2008 guidance for industry: cGMP for Phase I investigational drugs, the FDA can exercise oversight of the study drug under general cGMP authority. They also assert that innovation should not be impeded due to risk and costs to sponsor companies. Phase I investigational drug product is typically manufactured at a contract manufacturing organization (CMO) under cGMP; therefore, the quality is high. But so are the costs and financial risks.
What, then, are the benefits to a cGMP pharmacy?In this webinar, you will learn how cGMP pharmacy labs offer a flexible solution at a manageable size, which allows services to be customized to meet your needs. With small scale comes lower cost and faster turnaround, while ensuring cGMP through a robust Quality Management System, cGMP-specific SOPs, and trained professionals to execute your manufacturing protocols. A cGMP pharmacy is also nimble, allowing cancellations in situations such as compound failure at minimal cost, unlike the CMO.
Join Marcus Stavchansky, PharmD, as he shares his top 3 benefits for Phase I manufacturing in a cGMP pharmacy and provides specific examples of how you can save time and money while still ensuring quality. Register today to gain unique insights and inspiring solutions to your Phase I manufacturing needs.
Marcus Stavchansky, PharmD
Director, Pharmacy Services North America, Global Clinical
Pharmacology
Dr. Marcus Stavchansky is the Director of Pharmacy Services for North America at Covance where he leads a team of 21 pharmacy staff across four clinic pharmacies. In his role, he is responsible for providing information, service and knowledge regarding the pharmaceutical aspects of clinical trials at all stages in their design and execution within the Clinical Pharmacology group. In addition, Dr. Stavchansky focuses on growth strategy for future services including the manufacturing of sterile and non-sterile investigational drug product as well as ensuring clinical trial material is prepared and dispensed according to each study protocol at each clinic. Dr. Stavchansky received his Doctor of Pharmacy degree from The University of Texas College of Pharmacy and has over 20 years of community pharmacy experience as a clerk, technician, and continues as a relief pharmacist mainly with H-E-B Pharmacy. He also has extensive training in health outcomes, pharmacoepidimiology and pharmacoeconomics.
- Understand the key differences between cGMP and non-cGMP pharmacy environments
- Improve Phase I development programs
- Learn which clinical pharmacology studies offer the greatest benefits from a cGMP pharmacy
- Apply customized solutions that save time and money while still ensuring quality
- Head of Clinical Development
- Head of Clinical Pharmacology
- Medical Director
- Project Director
- Global Clinical Leader
- Clinical Director
- Scientist
- Clinical Scientist
- Clinical Manager
- Project Manager
