Drug development can sometimes feel a little like a ski holiday in the Swiss Alps: an inherently costly and risky venture. Indeed, even a well-seasoned developer can soon find costs have snowballed, timelines have slipped, and a veritable mountain of resources has been invested in a program that has prematurely fallen by the wayside.
However, with some expert guidance, the application of appropriate techniques, and a bit of timely preparation, it’s possible to guard against risk and maximize the likelihood of success. So whether you’re working with an experienced outsourcing partner, or taking on development in-house, here are our top three strategies to reduce risk in drug development and ensure programs don’t go off piste.
Implement decision gates into your drug development program: treat your project like a slalom course
For many small pharma and biotech businesses, time and budget are precious resources. Efforts spent optimizing a clinical formulation, only to find your molecule shows critical toxicity, are a waste of both. To make the best use of resources, it’s essential that only molecules with a real chance of success at the clinical stage should be allowed to progress further.
By breaking down drug development into a series of stages separated by decision gates, developers need not commit to a large program of work unless the route ahead is worth the investment. Here, one of the advantages of partnering with an experienced CRO is the years of knowledge they can bring to the table. Based on a thorough assessment of the data, they can offer open and honest guidance on whether the program should be taken to the next stage.
Get to know your lead molecule... or you'll be skating on thin ice
Full-scale pre-clinical trials can be very resource intensive and often require a large amount of API to work with. The discovery of undesirable effects at this relatively late stage can pose a significant challenge for developers, putting a significant strain on budgets, and even causing some programs to fall through.
To minimize the potential for loss of investment, it’s essential to recognize the cracks in the ice as early as possible. Before committing time and resources to formal pre-clinical studies, make sure you test the water: conduct an appropriate late lead optimization program, incorporating early ADME and toxicology studies. Likewise, before embarking on a formulation program, have an understanding of the basic properties of the API in order to characterize the biopharmaceutical class.
Stop and listen: collaboration in drug development is key (yes, we're still doing the ice puns)
Bringing a drug to market has always been a team sport: from optimizing synthesis routes, through to establishing delivery form and dosage, it relies on specialists with expertise in a number of areas. Yet these groups shouldn’t work in isolation. Whichever way you run your drug development program, the knowledge and insight gained at one stage will ultimately be used by others further down the hill. In other words, we’re all in this metaphorical bobsleigh together.
Ensuring project groups are able to collaborate closely and communicate freely enables them to maneuver around unexpected development challenges more easily. Moreover, interdisciplinary integration reduces the likelihood of issues occurring in the first place. With team leaders invested in a program from the outset, issues can be anticipated and appropriate strategies developed in good time. This kind of collaborative working and forward thinking ensures critical decisions can be made based on what’s right for the program as a whole – minimizing risk and maximizing the chances of success.
Want to learn more about the best ways to manage risk and reduce attrition in drug development? Download our article for more expert advice.