With global healthcare budgets tightening due to growing demands on resources from an aging population, the pharmaceutical industry is under ever-growing pressure to ensure safe and effective medicines reach patients as cost-effectively as possible.
For developers, once resources are committed and the patent clock starts ticking, it’s essential that new products reach the market in the shortest possible time to maximize return on investment.
In the search for faster and more resource-efficient drug development, many companies are turning to external service providers to accelerate this process. Indeed, a 2016 Nice Insight survey of pharma and biotech industry representatives revealed spending on outsourcing is increasing year on year. Pharmaceutical outsourcing was worth $19.2 bn in 2016; it’s predicted this will double to $43.7 bn over the coming decade.
The traditional option for biotech companies was to license their compound to big pharma for development. However, this often meant giving up value and control. Increasingly, companies are using contract research organizations (CROs) to build value for their molecule early in development without being burdened by royalties and milestone payments.
Some developers entrust multiple specialist CROs to handle various aspects of drug development. For some routine projects (typically those with limited development challenges and well characterized APIs) this can be a satisfactory solution.
But for more complex projects, where the route to market isn’t quite so well defined, the use of two, three or more contractors might not be the most resource-efficient approach. The big risk for developers, particularly small biotechs and start-ups, is that isolated partners lose sight of the bigger picture. Fragmenting the drug development journey can mean critical decisions are made based on limited information, often leading to costly delays and development hold-ups.
Moreover, simply managing the logistics of a multi-partner approach can be time-consuming. With tight turnaround times and narrow project windows, even a small delay from a single project can quickly set back entire programs as partner projects are rescheduled, resulting in lost time and investment.
An alternative solution is to partner with a who can bring all the essential elements of a successful development program together under one roof. By putting an intense focus on interdisciplinary integration and expertly coordinating all aspects of drug development, the time between candidate nomination and regulatory submission can be routinely achieved in under 52 weeks.
When evaluating CROs for their ability to deliver against timelines, look for a proven track record of meeting milestones and project completion. If you’re considering a CRO that adopts an integrated approach to drug development (and here’s why you should be), consider the experience and expertise of the project manager who will run your program, as their role will be pivotal. Ideally, the CRO should also provide real-life examples and case studies of successful programs they’ve completed.
Before choosing the right outsourcing partner for your drug development project, research your options and speak to the team members who will be leading your project to establish whether you’ll be able to build an effective working relationship with them throughout your project lifecycle.
And most importantly, make sure you know the right questions to ask. To help you, we’ve prepared a handy eBook with some things you might want to consider when selecting the right outsourcing partner for you.