Is filing an Investigational New Drug (IND) application the next step in advancing your company’s early stage drug development program? Do you have a solid plan in place to achieve IND acceptance?
Are you progressing through clinical development? Do you already have data in place and need to secure your plan to go to market? Understanding your product, manufacturing process and being prepared with all relevant information required to submit your New Drug Application (NDA) can be a critical step in the commercial launch of your innovative product.
With Big Pharma and VC firms competing for the acquisition of the most promising development assets, small Biotech companies are generally expected to demonstrate a clear blueprint for IND approval, preparation of a successful NDA submission and establishment of a reliable commercial supply chain for their product. This live-streamed event is designed to showcase strategies with the aim to increase success in potential critical aspects of the drug development process.
We will cover the following topics:
• Strategies for Preclinical Development for pharmacokinetics, drug metabolism and toxicology
• Designing First-in-Human trials to help highlight the qualities of your molecule
• Advice on IND requirements, Pre-IND meeting and documentation support
• Demonstration of Potential Key CMC strategies with the aim to balance cost, timelines and regulatory acceptance
• Performing development, validation and commercial manufacture for both Drug Substance and Drug Product
• Support through comprehensive analytical expertise in development, validation, Quality Control and Stability studies
• Independent QA oversight from FDA approved sites