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Case studies for drug development outsourcing
Adding Value
A young biotechnology company discovered a novel therapeutic agent that demonstrated strong in vivo activity and was seeking finance to support the molecule’s preclinical development. The CEO decided that is was not in the company’s best interest to advance the project internally as the cost and timeframe necessary to build an operational team was not compatible with the company’s challenging development goals. He therefore decided to outsource the management of all the preclinical and clinical development activities. This approach would allow an immediate programme start by ensuring that a fully experienced team was in place and operational, from day one.
The CEO contacted L2D and a confidentiality agreement was signed prior to discussions that allowed us to fully understand the objectives of both the company and the programme. We provided strategic advice and a highly competitive, but realistic, quote for all of the development management tasks. Both the CEO and the Board of Directors of the biotechnology company were unanimous in selecting L2D as their development management partner for this programme.
We generated a development plan and budget that was incorporated into the client’s Business Plan. The quality of the Business Plan gave the investors sufficient confidence to fund the programme, with the release of funds dependent upon the achievement of key preclinical milestones.
Immediately following the financing round, we took over the operational management of the preclinical programme. We now work in close liaison with our client, fulfilling the role of an internal development department including regular presentation of the project progress to their Board of Directors. Our team’s proactive management and problem solving skills have allowed a number of major production issues to be resolved and the programme is progressing well, on schedule and within budget.
Accelerating Early Stage Development
A biotechnology company approached L2D with a request for a rapid and independent due diligence review of an exciting in-licensing opportunity. They wanted our support to highlight the potential hurdles in the preclinical development of this early stage programme, in order to achieve the first-in-man study. Our due diligence exposed a number of critical CMC and regulatory issues. This gave our client a strong negotiating position and enabled them to finalise a licensing agreement in which milestone payments were included, based on the successful completion of these CMC and regulatory tasks.
In discussion with our client it was clear that they wanted to advance this programme rapidly. We therefore proposed that we established the preclinical and clinical development plan (addressing the CMC and regulatory issues) and identified the service providers, whilst the remaining in-licensing discussions were ongoing. This represented a slightly increased financial risk, but meant that the development programme was launched on the same day that the in-licensing deal was signed. Our client was able to make a highly significant financial and time gain in advancing this programme, which could not have been achieved internally due to other project commitments. This is just one example of the risk management approach that we advocate, which resulted in a win-win situation for our client.
Enabling a Rapid Decision
A pharmaceutical company had an internal programme that they considered to be interesting but of high risk. They decided to externalise the project in order to maintain the focus of their internal resources. They therefore contacted L2D to request the management of this preclinical development programme.
We defined a series of critical studies and identified laboratories that could realise them rapidly and cost effectively. The results of these experiments demonstrated that the pharmaceutical company’s NCE showed a low in vivo therapeutic index compared to the current standard of care in the proposed indication. This allowed our client to make an informed decision not to continue this project.
Our ability to design a programme that critically assessed the potential of the NCE compared to competitor compounds enabled a rapid and clear conclusion to be drawn allowing the pharmaceutical company’s financial resources to be redirected to alternative programmes.
Turn to L2D - LeadsToDevelopment - for your drug development outsourcing requirements - we deliver non-clinical development expertise to clients who wish to outsource their preclinical development plan, non-clinical studies and preclinical evaluation activities.
