Clinical trials benefit everyone. Patients benefit from the end product and the manufacturers make profit and provide employment, and thus a boost to the economy.
According to a report by Cutting Edge Information, pharma companies typically expect to spend $80,000 or less per patient during adaptive phase 1 studies. This is as opposed to an average of $57,500 per patient during the non-adaptive equivalent.
In order for the drug manufacturers to be able to claw back some of the required initial investment, they have started to look at a new way of working – by working in partnership with Clinical Research Organisations, research universities, and other relevant organisations, drug producers can look to attract investors to provide capital in the early stages.
So how should the partnerships be formed and what are the key steps needed to attract the required investment and ensure collaborations are successful?
1. Identify clinical trials
Drug manufacturers face tough choices about which trials will be attractive to external investors and which will prove profitable once on the market. Packaging multiple trials of complementary products/therapies will help reduce upfront costs.
2. Find partners for funding
Finding the best investors will take multiple approaches. Those approached will most likely include venture capitalists, not-for-profit organisations and maybe even patient groups with an interest in a specific area.
3. Developing bespoke operational models and structures
A legal structure and financial arrangement must be agreed upon. The setting of clear goals for all partners and the completion of an extensive risk assessment will ensure that the venture is secure and that each partner knows their responsibilities.
If you are looking for a well-regarded company to assist you in your adaptive early phase studies, then take a look at a website such as http://www.richmondpharmacology.com/adaptive-phase-i-studies.php to see an example of what assistance is available.
4. Operational awareness
Consider the following areas before operations begin:
• Technical – are protocols in place to provide the clinical data required?
• Is the drug going to be profitable even if costs are over budget?
• Cultural – have all partners agreed ways of working to ensure progress and a smooth exit after the investment value is realised?
A well established process for ending the trials, realising value as per the contract and effectively dealing with accrued assets.