Successful and sustainable businesses in the Regenerative Medicine industry need to incorporate strategies to address key factors beyond individual business boundaries. These include legal, ethical and financial frameworks, distribution and logistics, and end users willingness to adopt and ability to pay. Business models need to be well adapted to the needs of this market and wil vary depending on whether the end product is a cellular therapy, a delivery system for cells, genes or small molecules or enabling tools and technologies for stimulating endogenous repair. The value systems for each of these types of products are likely to have unique features but will also need to be compliant with global regulatory and legal frameworks.
The REALISE project brings together a UK wide consortium of business and academic partners, with experience of working in innovative technologies and a background in road mapping, assessing, funding and commercialising Regenerative Medicine products. It builds upon some pre-existing work but seeks to create a novel product for wider use.
REALISE is developing a set of software based tools to analyse each step of the value chain from Discovery, through Development to Delivery to the market and impact on the economy. These tools will be validated on a small but diverse set of regenerative medicine products with which the consortium is directly involved so as to define value systems for a more diverse set of products in future.
A generally applicable analysis method, the Therapy Pathway Realisation Tool (TRPT), is being created and its findings made available to the UK Regenerative Medicine industry, its investors and stakeholders to use in developing the value systems, assessing the impact of investment and as an aid to defining business models for its products and services.
The outputs for this project will be
- Generic business models and business plans and development strategies for three regenerative medicine products which are close to commercialisation.
- A generally applicable Therapy Pathway Realisation Tool, a software based road mapping and decision making tool. This will allow projects to define their best suited business model, and the opportunity, through interrogation of the Therapy Pathway Realisation Tool, to make Impact Assessments which allow decision making based on issues of strategic and economic impact.
- Insight into the interaction between business models and regulatory influences within the UK and global value systems.
- Determination of the availabiliby and influence of private and public sector funding and identifying potential short falls.
The £444,000 award was made under the Technology Strategy Board Regenerative Medicine Programme: Value Systems and Business Models.