So, you’ve got an asset that appears to have efficacy in your pre-clinical models with no immediate safety concerns. You’ve stood strong through at least 5 years of target ID, lead finding, and lead optimisation whilst entering funding rounds to keep the dream alive. The candidate for this debilitating disease is finally ready to enter the development stage. Now what?
The so-called ‘Valley of Death’ describes the jump that biotech and pharma companies make from the pre-clinical stage into the clinic. Such a jump can make or break an organisation but if successful, increases company evaluations by an average of 87%.
The translation from basic to clinical research or “bench to bedside” requires substantial collaboration from a wide range of stakeholders such as lab scientists, clinicians, clinical research professionals and regulatory affairs specialists. The immense complexity of the regulatory landscape and early clinical development stage is no doubt daunting for a company with limited clinical experience, particularly for start-ups and spinouts that are likely to have focused all their resources on pre-clinical lab work. Even knowing who to speak to initiate discussions can be a challenge.
Luckily for small life science enterprises, there are companies that can address these challenges, navigating the Valley of Death and coming out the other side unscathed with clinical trial authorisation, and regulatory and ethics approval on the horizon. Caritas Science Solutions is now proud to offer regulatory strategy and early clinical development consultancy packages so that your asset is ready for a clinical trial.
Our package of project management, a specialist director in the asset therapy area, and seasoned regulatory affairs personnel can collaborate to produce an early study design that has the MHRA and patients at the forefront, increasing the chances of your asset being successful in the clinic.
We don’t pretend to know all the answers, but we know the people that do. The assembly of a strategy panel will ensure expert advice from key opinion leaders, statisticians, medical writers, and clinical specialists. In addition to this, our knowledge of the life science investment landscape can assist with the funding of your clinical project.
Save yourself endless pain points and contact the Caritas team.