Wouldn’t it be great to have a medication for diabetes which lasted longer than current treatments on the market?
A top 10 Pharma organization with years of innovation and leadership in diabetes care is in the process of developing a new oral formulation for type 2 diabetes that would do just that, last longer. If successful, the treatment would be easier to administer than current options available would make it a more attractive solution to patients. As the first of its kind on the market, it would also have significant commercial potential too.
Of course, the drug discovery and development process in getting this to market is easier said than done. To develop a molecule that has a desired, efficacious but yet safe effect in humans is a remarkable achievement which goes through an expensive and complex process. It may also be the case that non-clinical study programs have to be revisited even after moving into the clinical phase due to unforeseen circumstances, much like this particular organization developing a new treatment for type 2 diabetes.
This Pharma company had previously encountered a number of issues with the drug whereby it was not absorbed by the intestine well enough to be effective on its own. It required an expedient – namely Expedient X. In addition, no other expedients were capable of enhancing the drug’s absorption in the intestinal tract.
At the non-clinical phase of testing, the standard rodent toxicology studies resulted in side effects and mortalities. It was then clear that these side effects and mortalities were not related to the active ingredient. They were, however, related to Expedient X.
Consequently, the organization needed to carry out further non-clinical work with a Contract Research Organization (CRO) which would require a series of challenging experiments to be designed, in order to identify two key points: the mechanisms by which Expedient X induces its side effects, and the exact dose range at which these side effects occurred. This would enable them to move forward with their clinical program of work once more.
Designing a study program
In line with this, a CRO was called to work with the organization to outline a set of studies around absorption which would eventually help identify the mechanism by which Expedient X induced its side effects.
Utilizing expert support from a CRO
There are several benefits of partnering with a non-clinical CRO on a project such as this. A well-resourced and experienced CRO can help pharmaceutical companies of all sizes augment their existing capacity, capabilities and expertise when needed for both discovery and non-clinical drug development.
The benefit of a CRO in this case is the flexibility to scale when necessary without incurring the fixed costs of building extra facilities or hiring full-time staff.
This particular organization only needed assistance in one aspect of a non-clinical drug program. The implementation phase of these studies saw a large team of proven experts from respective scientific fields be assembled from a range of departments including pharmacology, bioanalysis, pathology and pharmacy as well as working closely with the organizations bioanalysis, electron imaging, formulation analysis and toxicokinetic teams.
Co-ordinating a complex project through good communication
A complex project such as this, involving a large number of people, requires effective management. Good communication is also very important. This is especially true when you’re dealing with different departments and individuals across two organizations. It is also essential that the teams involved identify issues and explore different avenues in order to solve problems. A CRO is well positioned to manage such communication.
Leveraging the resources of a CRO
The Pharma company developing this treatment was able to leverage the facilities of a CRO, without having to invest their own. They were able to gain access to science, program management and facilities which instigated a total of ten experimental studies being carried out over three years. These studies successfully identified the mechanism by which Expedient X induces its side effects and the exact safety margin to humans.
Furthermore, the comprehensive solutions allowed the organization to continue developing their treatment, which has since been accepted for clinical trials.
Learn more about the advantages of partnering with a non-clinical CRO.