Back
8 June 2018

IP Advising for Precision Medicine Diagnostics

Written by Colin G. Miller

 

Problem

As new owners of the IP rights for a new oncology diagnostic molecular MRI contrast agent, an academic spinoff sought help bringing the device into the clinic.  The management team also wanted guidance on determining which companies to approach as future licensees. 

Solution

A complete review, including a SWOT analysis, was conducted of the MRI contrast imaging market and the opportunity for this new technology.

Regarding licensing, the IP was not strong, and based on the current state of development of the novel agent, the advice to this small company was to cease the development or pass it on to another company through licensing or acquisition. Further advice:

  • The clinical development required for diagnostics that would include studies of dosing and proof of concept as well as trials that would measure efficacy and superiority over existing agents.

  • In the event of the company choose to out-license the agent, potential licensing partners were identified, with connections to be made between these companies and the academic spinoff.

Outcome

Having reviewed the potential market for this product and having evaluated the IP and lack of IP protection, the recommendation was to not pursue the development of the product.  The company dropped the product, saving them millions of dollars on a product that was unlikely to provide a significant return on investment.

RECENT CASE STUDIES

Supporting Biotech and Pharma Companies Using Imaging Endpoints in Clinical Trials

The use of imaging endpoints in clinical trials has steadily increased over the last 30 years...

Navigating Critical Regulatory Requirements in Alignment with Sponsors' Unique Challenges and Goals

Careful, timely, and strategic navigation of regulatory requirements is essential for sponsors who..