The long way from identifying a compound to entering the market
Moving a novel compound through the various stages of development is a lengthy and costly process. The design of each phase needs to be right at first try because repeating studies is not only time consuming but in many cases can stretch the financial situation of a company to a point where projects may need to be put on hold due to lack of funds.
While every study can lead to negative results, the reason for a failed study should not be poor design or sub-optimal predictability of results in one study for the chance of success in the next. Choosing a CRO that is an expert in a particular field to be studied certainly allows to minimize risk at each step. The experts at the CRO can consult on study design and optimal planning of a study. Being able to offer this type of expertise is certainly a big advantage of a boutique CRO spezialized in a small number of indications as compared to offering services in many areas without a clear focus.
Nevertheless, one major step of uncertainty in any developmental plan is the transition from pre-clinical studies to clinical trials. It is well known that animals, although similar to humans in many aspects, will exhibit different behavior, molecular pathways, side effects and other difficult-to-plan eventualities as compared to humans. This is of course also the case for the development of anti-diabetic drugs. Profil, with its vast experience in the design, planning, submission and conduct of clinical trials in diabetes and obesity research is the ideal partner when it comes to obtaining the best support for clinical trials in this realm. Profil has now decided to offer its customers support in making the transition from the pre-clinical to the clinical stage, by partnering with a pre-clinical CRO specialized on diabetes and metabolism, Physiogenex.
Profil and Physiogenex are partners specialized on metabolic disease
As both companies are boutique CROs with immense expertise and experience in the area of metabolic diseases, they by themselves can offer their clients optimal study design and conduct for their particular focus area. The companies offer a wide range of relevant and sophisticated methods (Profil, Physiogenex) that offer potentential for synergies. The pooling of expertise will allow both companies to offer their customers a more seemless transition from pre-clinical to clinical stage of development in the future. Not only can joint discussions between the pre-clinical and clinical parties start early on in order to optimize study design, but the two CROs intend to co-develop methods and validate the predictability of methods in the animal model for its use in human trials. All this will hopefully lead to a lower failure rate of trials in the future, faster study timelines and even more reliable study designs, ultimately having the potential to save the clients time and money.
Joint Online Seminar to kick off scientific collaboration
The two CRO's plan to kick off this new collaboration with a joint online seminar, titled:
"Of mice and men: Studying insulin sensitivity in preclinical and clinical trials."
Profil and Physiogenex will present the current view on studying insulin sensitivity in their respective models. While Physiogenex is recognized for glucose clamping in mice, Profil is the global leader in automated glucose clamping in humans. It will be exciting to compare both approaches and to discuss predictability of results from studies in mice for the design of subsequent human trials. While this online seminar for its attendees will certainly be one of the most interesting online seminars hosted by Profil thus far, both companies are excited to use the results of the discussions from the online seminar to further align and refine future collaborative activities.
Does this online seminar sound interesting to you? Then click here and sign up today, as spots are limited.