This panel will explore the pre-commercialization stage of developing novel therapeutic modalities, from early research to achieving regulatory approval. Panelists will dissect the critical elements of development and approval, offering insights into optimizing research outcomes, streamlining clinical trials, and successfully engaging with FDA. Topics of discussion will include:

• Designing effective clinical trials to accelerate timelines
• Implementing best practices for FDA pre-IND meetings and IND applications for novel therapeutics and regenerative medicines
• Understanding FDA’s guidance on novel therapeutic classifications and approval pathways
• Reviewing case studies of successful approvals
  • Detailing what works and potential pitfalls to avoid
• Preparing for market access challenges, including reimbursement strategies