Not long ago, it was more or less conventional wisdom that E&L studies should be performed late in the development cycle—even after the final container/closure system is known. But current regulatory trends suggest that, like many things GxP, expectations for early E&L data are on the rise.
In recent years, multiple drug sponsors have been required by authorities to provide detailed E&L packages or address specific questions during phase I/II. It’s not only clinical trial material containers causing concern, but also the equipment used in manufacturing and dosing devices. As a result of these new expectations, several programs have been put on a clinical hold pending E&L data, causing significant delays and unplanned expense.
This presentation will address regulatory trends and how to design a phase-appropriate E&L program.
Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories
Dr. Wayland Rushing is a technical expert in Chemistry Manufacturing and Controls (CMC) program design, analytical development and regulatory submissions. Over his 14-year career, he has led CMC development programs for a wide array of bioPharmaceuticals, including parenterals, inhalation drugs, and other Pharmaceuticals with complex delivery systems. Dr. Rushing is a subject matter expert in HPLC and GC method development and validation, extractables and leachables program design and regulatory submission requirements; has drafted multiple IND and NDA submissions; and assists ABC clients in responding to FDA deficiency letters. Dr. Rushing currently serves on Parenteral Drug Association (PDA) advisory committees for Technology Transfer and Elastomeric Closures and Seals Defects.
Who Should Attend?
Senior level executives involved in the decision-making process for container disclosures or responsible for analytical chemistry, including:
- VP/Director/Manager of Research and Development
- VP/Director/Manager of Product Development
- VP/Director/Manager of CMC Operations
- VP/Director/Manager of Technical Operations
- Academic researchers
Established in 1968, Analytical Bio-Chemistry (ABC) Laboratories, Inc. is a Contract Research Organization that delivers a broad array of product development and analytical testing services to the Pharmaceutical, biotech, animal health, and chemical industries. The company supports all stages of large and small molecule drug development with expert analytical support, custom synthesis and radiolabeling, environmental assessments and drug development consulting services.