Case Study

Optimising Non-Clinical Drug Development

Fulcrum's client, an innovative pharmaceutical company, specialises in the discovery and development of novel therapeutics. They achieve this not only by discovering their own molecules but also by in-licensing other potentially interesting drug candidates from third parties.

Being a small group of scientists in the start-up phase of their company, the client decided not to invest in their own full drug development department but to use the collective expertise of a third party, and so approached Fulcrum.

In choosing to work with Fulcrum, our client gained immediate access to a group of highly experienced drug development specialists. The collective international experience at Fulcrum has been gained from many years working in a variety of companies (CROs, smaller and global pharmaceutical companies) and across the whole spectrum of drug development, from early research through to NDA and beyond. Between them, there is little in the unpredictable world of drug development that they have not encountered and mastered before.

The Fulcrum Effect

The client had in-licensed a promising compound and was planning to take it into Phase I in the USA. Difficulties arose as a result of the compound having changed ownership three times over its history. The non-clinical work had been performed by the original owners some 15 years previously; methods and study designs were not as state-of-the-art as they are today. This meant that, whilst the package of data was basically sound, there were some distinct issues that required solving and some gaps that needed filling, without which, the FDA would not approve the clinical trial programme.

Fulcrum performed due diligence on the existing non-clinical data and highlighted those areas that required attention. In collaboration with the client, and through negotiations with the FDA, an acceptable programme of non-clinical work was agreed and implemented.

The client had a large portfolio of potential lead candidates and obviously, not all of them could be taken forward into full development.  Working closely with the client, a process of lead selection/optimisation was put in place, and by using a screening cascade and selection matrix with well-defined criteria set for each parameter, a highly effective approach was used to compare potential candidates. A range (worst to best case) of target profiles was created, and the candidates compared against this.

By using these tools, combined with Fulcrum's collective knowledge and lessons learned from past drug development experience, the selected the best candidates for development, avoiding many pitfalls associated with this stage of development. Using the wider Fulcrum team, an initial development plan was drawn up and implemented for selected candidates.

In this way, only those candidates that fitted the target profile and criteria, and that had shown development potential were progressed, thereby using limited resources to maximum efficiency.

Using Fulcrums skills and knowledge in this area, the Client was able to use their limited internal resources to maximum affect. This allowed the Client to moved forward in-licensed and internal compounds into the development, maximising efficiency and use of their development budgets, while increasing their profile and the value of their company. Fulcrum continues to be involved in the programmes, through clinical and regulatory activities

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