Only 5.1% of biologic cancer drugs (those made from a living organism or its products) successfully get from early development to approval and over half the 4,500 oncology drugs currently in development will be administered via IV. Making the right decisions to take risk out of development is critical to success, especially as you need to adhere to new regulations, such as USP<800>. But what are the right decisions and how do you get to your next milestone? This webinar will help you to:
• Anticipate interactions between your cancer drug and its packaging
• Plan the work upfront to remove unanticipated delays
• Scale up from concept, through clinical to commercial
• Understand how early product knowledge can enhance material choices
• Plan for success
This webinar will enable you to be proactive to minimize risk with your cancer drug rather than react when things go wrong. Comprehensive advice will be offered to help you understand individual components as well as potential interactions with your sensitive drug product, ultimately increasing your chances of being part of that 5.1% of successfully approved drugs.
Key Learning Objectives
- Understanding and establishing the drug needs (QTPPs) to enable long term packaging solutions to meet the patient’s needs.
- With regards your packaging, how to gain the technical expertise and knowledge to get you through BLA ensuring you know how your chosen packaging enhances your molecule, rather than detracts from it.
- How to use data to ensure compliance to USP<800> and CSTD use in the preparation of vial packed oncology drugs.
