Tools for Cell Therapy Development
Navigating the world of health policy and regulatory systems can be daunting. It is not always clear how and where to start and the pathways are not always straightforward. SCN has partnered with regulatory expert Patrick Bedford, founder of weCANreg Consulting Group Inc, to develop two useful tools to help researchers simplify the process of transforming research plans to fit the regulatory requirements. Both documents are designed to augment research plans with regulatory knowledge and will add credibility to valuations of a cell therapy product that are based on market assessments.
The first document is a template and instructions for the development of a Target Product Profile (TPP). Completing a TPP will assist researchers in identifying target commercial goals for their cell therapy and can be a useful asset when tackling the regulatory activities necessary to meet your clinical plans.
The second document is a template and instructions for the development of a Quality Target Product Profile (QTPP). The development of a QTPP allows researchers to assess and understand the implications of the cell manufacturing decisions needed during the process of moving a cell therapy into the clinic.
These documents complement the webinar below that Patrick presented as part of SCN’s Stem Cells from the Sofa series on September 23, 2020.