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Technology Commercialization Readiness Guide

The Stem Cell Network and CCRM work in close collaboration to move research forward. SCN supports innovative research and clinical trials leading to company creation, while CCRM seeks to create and incubate new biotech companies. Together, the two organizations have come together to  provide resource materials for Canada’s regenerative medicine community that will aid in the translation of research from bench to bedside to marketplace.

 

Technology Commercialization Readiness Guide: These documents are intended to familiarize academic investigators and highly qualified personnel (HQP) with some of the key considerations when planning to commercialize and translate regenerative medicine-based technologies into cell and gene therapies.

Early Considerations for Commercialization: This document serves as a guidance checklist of key topics to prepare and discuss with your Technology Transfer Office (TTO) either shortly before or after submitting an invention disclosure.

Technology Readiness Assessment and Case Study: This document will help to create awareness about the current maturity of a technology and the issues to consider to translate it into a commercial product.

FAQs: This document answers some of the key questions associated with making an invention and working with your institutionally-affiliated TTO.


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.


Safeguarding Your Research

Researchers, research organizations and government all have a role to play in safeguarding Canada’s research ecosystem. The Government of Canada is working with research partners to balance openness and collaboration with appropriate safeguards for Canadian researchers’ knowledge, data and intellectual property. For further information and tools to assist you in this objective, please consult the Safeguarding Your Research portal or book a Safeguarding Science workshop.