So you've discovered a really promising therapeutic. You’ve run efficacy studies, and it looks to be auspiciously efficacious. The question now is “Do you have a drug?” Is the therapeutic you’ve developed “druggable”? Differences in bioavailability among formulations of a given therapeutic/drug can have clinical significance - knowing whether drug formulations are equivalent is essential.
This is where Attentive comes in to help you evaluate further pharmacokinetic properties of your therapeutic agent. Most likely, you are past your very early target identifications screening within your pipeline - or perhaps you’re still in the middle of them - but what you're looking for now is to find a way to increase the ability of your therapeutic agent to be better absorbed and distributed.
When clients come to us, they might have a poorly absorbable compound. So, they're looking to increase the absorption and/or create a better alternative - one that is more standard within the future studies that the regulatory agencies requires. At Attentive, we always take it from the approach of “What does the client need?” So, if you are looking to optimize absorption and/or solubility of your test article, we use different vehicles to investigate and help improve the bioavailability properties of your therapeutic agent. And sometimes clients are also wanting to scale up; you want to determine “What is the PK profile at this scaled up level? Which will be the best therapeutic?” Sometimes clients want to scale up a little bit and see if they can begin to reveal some of those end points that might fall into toxicology, to give them some preliminary data before they begin their Tox program - so our screening services can be with different formulations and/or with different concentrations.
Ultimately, you want to develop a drug that can be taken conveniently i.e., orally at home (as opposed to a more complicated option such as being injected). So, one of the best ways for us to help our clients is to help them evaluate the different routes of administration for their therapeutic with the hope that an oral dose would show good bioavailability. As an example, we had a client who had recently performed a study as an injectable and used X as a carrier, but we worked with them to evaluate alternative carrier Y and we are able to find an oral formulation that was absorbable and more convenient to the end user.
There are others out there who offer these types of services, but they tend to be much more rigid in what they offer and how they offer it. In this particular space of formulation screening, our clients expect us to be very flexible. They need us to be able to take a set of compounds, run the appropriate studies, and return the data to them so they can make decisions on changing the carrier, or duration of dosing to get to that end point of better absorption. Flexibility is key when it comes to formulation screenings, and yes, you are allowed to change your Statement of Work a few times.
In addition to flexibility, clients need us to move quickly to get answers so they can move right along to their next set of regulatory studies. When you move into your Tox studies, you want to maximize your exposure of the drug, so that you can determine those toxic points as quickly as possible. Clients need us to be flexible, fast and accurate so that they can move right along to their next stage of development and testing in the way that best fits their program. Attentive is proud to say that we embody all of those things.