Our client is a leading T Cell Receptor (TCR) biotechnology company, focused on delivering first-in-class biological therapies for serious diseases. The client wanted to understand whether it had the capabilities to launch its lead product if it were to receive accelerated approval without partnering with larger companies and asked Alacrita for commercialization assistance. The overall objective of the project was to ensure the client was adequately prepared for the eventuality of an early commercialization event for the product. This included an assessment of the regulatory pathway for the product and any obstacles that had to be considered.
Solution:Our assessment comprised three umbrella categories:
- Marketing approval pathway and data requirements: As a prerequisite for commercialization, the marketing approval pathway and data requirements were evaluated based on the sponsor’s interactions with relevant regulatory authorities and development plans. Having a preferred marketing approval pathway agreed with the agency(ies) and well-defined data requirements and desired labelling for the application reduces risk to achieving a timely approval and, in turn, market launch, for a commercially viable product.
- Regulatory strategy plans and execution: The second group of criteria evaluated organizational capabilities to analyze and mitigate development risks and to adequately resource, plan and execute a regulatory strategy leading to marketing approval.
- Processes for post approval compliance: Lastly, the regulatory assessment examined the organization’s preparedness to support post-approval compliance requirements to maintain a product license.