Challenge
An incoming lead investor needed to assess a proprietary platform technology for the oral delivery of biological drugs.
Solution
Our life science due diligence team took on the project, whose scope included assessing the:
- strength of preclinical data in comparison, as far as data was available, with competing approaches
- IP ownership and likely strength of patent protection
- clinical and regulatory strategy and execution; key risks and likelihood of success
- competitor landscape, including direct and indirect competition
- market potential
- manufacturing feasibility, investment needs and likely COGS
- overall budget to reach product registration and market launch
Given the core strategy was to repackage existing drugs, several interlocking factors were analyzed:
- clinical and health outcome impact of switching from an injectable to an oral delivery system
- potential for premium pricing over established injectable product
- likely level of switching from injectable to oral product for existing patients
- likely level of penetration in the new prescriptions segment
- scope for broadening the market by taking share from alternative products
The project was undertaken and completed over a two-week period and provided the client with an insight into key technical, regulatory and commercial risks facing the company.
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