Close
Highlighting important considerations during the "Therapeutic Design & Development" stage of the Biologics translational pathway.
IDEA:
Target Product Profile (TPP) – captures the ‘benefit’ of the proposed therapeutic and key considerations in the strategic development of the product (incl. technical, scientific and medical information required to satisfy key stakeholders (regulators and funders)).
UCL Support:
The Biologics Therapeutic Innovation Network (TIN) draws upon a wide range of disciplines spanning life sciences, engineering, chemistry and health economics to create a strong and diverse pipeline of biological therapies and supporting technologies.
UNMET CLINICAL NEED:
As part of the Target Product Profile (TPP), comprehensively research and define the potential for benefit of the proposed therapeutic over current ‘standard of care'.
UCL Support:
The Translational Research Group (TRG) have extensive knowledge of the biologics landscape, and can provide advice on early considerations such as intended use and drug description etc, to guide development, as well as longer-term considerations for adoption i.e. help you produce and develop your TPP.
INTELLECTUAL PROPERTY:
Engage with Business experts to ascertain if you have a novel invention, ensure freedom to operate and to protect foreground/arising intellectual property.
UCL Support:
If you believe you have an innovative, patentable technology, it’s important you contact UCLB before any form of public domain disclosure.
UCLB are experts that provide confidential support for researchers at UCL, to understand the value of your invention and the best approach to protecting your intellectual property (IP), advising on strategies to commercialise your research such as through forming a spin out company or licensing to a third party.
All researchers with potentially commercialisable research results should fill out a confidential Invention Disclosure Form (IDF) and submit it to their UCLB Business Manager: http://www.uclb.com/for-researchers/do-you-believe-you-have-a-novel-invention/
PATIENT & PUBLIC INVOLVEMENT (PPI)
Understanding the patient and clinician needs - Does your TPP meet all of the essential requirements expressed by frontline clinical care providers, patient and public contributors (PPI)?
Important PPI actions:
- Research is carried out ‘with’ members of the public as advisory members of a project steering group.
- Early PPI engagement will help raise awareness of the therapeutic during development and potentially facilitate patient recruitment for subsequent clinical evaluation, possibly even financial investment.
- Timely identification of future needs or opportunities.
Further information on PPI can be found via INVOLVE: www.invo.org.uk/
UCL Support:
The UCL Translational Research Office (TRO) can help with the timely identification of future needs or opportunities for diversifying, as well as advising on appropriate patient groups and charities to consider.