Following the successful navigation of a drug lead through late lead optimization, there are a few options as to where to go and what to do with your lead. Perhaps the most straightforward option is to use the data incurred throughout the drug development process to create an attractive package in order to sell the compound, normally to a large pharmaceutical company with the expertise and resources to push it through to the clinical trial stage. It is worth noting though that data packages must be comprehensive and well planned before being pitched to large pharmaceutical companies, in order to secure a deal.
Alternatively, there are more options available in terms of partnerships, funding from venture capitals (VC), or selling to large pharmaceutical companies if the lead has been taken through to proof of concept under your control. Getting proof of concept is no easy feat, however, and involves getting the drug through phase I of clinical trials. This is a lengthy and costly process, which involves the safety testing of the drug with small numbers of volunteers or patients. Phase II involves larger groups of people, and is concerned jointly with both the safety and efficacy of the drug. These processes may require applications for additional funding to help progress the lead.
Large pharma partnerships
The acquisition or licensing of promising leads is obviously of interest to large pharma, particularly if they have passed the proof of concept stage. It allows for the reduction in risk associated with taking a novel lead right through to clinical trials and beyond – only 1 in 10 candidates reaching the market following trials. competition is fierce however, meaning it is vital that the data package presented is attractive and is what the company is looking for.
Starting your own company
Finally, starting your own drug development company in order to take drug candidate(s) through the entire clinical trials process is an option worth exploring. To do this, funds need to be available for registration of the company, and depending on the territory the company is registered in, there is an array of legislation that is to be adhered to. Along with the various start-up costs, there always an element or risk associated with starting a new company. However, if the lead is pushed through and is taken to market, then this can be a very profitable venture indeed!
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