Recently we discussed the important role that outsourced bioanalytical partners now play in the drug development process, and the significant impact that CRO selection can have on the ultimate success of a sponsor’s study. Large molecule bioanalysis is complex, and ideally you want to work with a partner that has the expertise to navigate scientific and regulatory challenges as they arise – or that is adept enough to avoid them all together. But in such a specialized and rapidly evolving field of study, the reality is that this level of experience can be hard to find.
So what happens when you have a project with an outsourced partner, and find it slipping in its timeline or stalling out completely? The CRO may say the assay is to blame, and that it simply cannot generate the results that are needed. In some cases this may be true, but experience has shown us that more oftentimes it is due to a lack of proper knowledge and tools to ensure the assay is optimized for robust, precise, and accurate output. In these situations, it won’t be your assay that needs to change.
Promising studies can be saved from getting shelved if you can move them to the right kind of experts. We discuss what to look for in a “rescue project” partner below:
The Expertise to Address Assay Deficiencies
When it comes to turning a project around, there can be no shortcuts – especially when quality has already been an issue. More time and costs can easily be lost if the assay is left in less than capable hands, and proper vetting of your rescue project partner’s expertise will be critical to giving an innovative but challenging drug candidate the best chance of success. It will take a scientific and QA team that truly understands the root cause of past problems and that can not only identify, but also properly execute, the type of interventions needed. For biologics rescue projects, that means finding a CRO with proven specialization in large molecule bioanalysis, backed by a strong regulatory track record as well as a history of applying ingenuity to assay challenges for new gains in sensitivity, precision, etc.
The Platforms to Deliver Required Results
Bioanalytical technology is evolving at a rapid pace, and platforms are giving scientists new capabilities they have never had before. Common immunoassays can be dramatically boosted to improve sensitivity, precision, and reproducibility by multiple factors; detection of drug-induced antibodies can now reach target sensitivities in the low nanogram or even picogram range; and automation tools are enabling scientists to make huge gains in time-savings without compromising quality of results.
Applying these advanced platforms in a stalled out study could quickly put the assay back on track. Finding a rescue project partner that is committed to investing in state-of-the-art technologies, including those that you current CRO may not have available, can give you access to new tools that will enable your assay to achieve the desired output. In addition to having the right platforms on hand, the right partner will be well-versed in their use and how to quality assure the platform’s performance.
The Commitment to Turn Things Around
Above all, your rescue project partner needs to enjoy problem-solving. If an assay has failed elsewhere, it is unlikely to be an easy fix, and therefore you need a CRO that is dedicated to taking on and overcoming the challenge. It will require a team that can collaborate and share insights into methods that they’ve used in the past, and that has the creativity to apply those approaches in new, evolved ways for the benefit of your assay. The CRO should share the sponsor’s commitment to a successful outcome. This will naturally help keep project timelines on track, as the outsourced partner will be equally invested in finding the answers to push your promising study forward efficiently.
A knowledgeable and committed CRO partner can make all the difference for a project in need of rescue, which in the right hands could go on to become a life-changing therapeutic innovation. In our next blog, we’ll share a story of a recent rescue project that our team worked on, so you can see how BioAgilytix approaches assay challenges and applies our proven combination of people, platforms, and processes to get promising studies back on track.