Bringing a drug to market has historically been a time-consuming and expensive process. Indeed, there aren’t too many products that can compare to bringing a drug to the market, which can often easily take more than ten years and rack up a bill that runs into the billions.
While it’s important to make sure that the drug is fully ready, there’s also pressure from investors and rival companies to get the drug to market as quickly as possible.
The modern approach is to speed things up as much as possible, without cutting corners — and pharma companies have gotten pretty good at ensuring that happens. In this post, we’ll run through some of the most common strategies that pharma companies use, which, when all combined, can speed up the process significantly.
Engaging With Regulators Early
The leading pharma companies see regulators as an ally, not a hurdle to overcome. They engage with them as early as possible, which not only helps to speed up approval but also reduces the risk of rejection. Pharma companies that don’t engage with regulators early are more likely to run into delays — rejections or requests for more information can easily add 2+ years to the timeline — or increase their chances of having to abandon drugs that might have been approved had they taken the right approach from the beginning.
Investing in Early-Stage Testing
Leading pharma companies recognize that they’ll run into a problem at some point and take steps to ensure that the problem is caught as early as possible. It’s a lot cheaper and faster to correct an issue that’s caught early on in the development cycle, rather than catching it when the drug is in manufacturing or even later. Companies that invest in robust early-stage testing, such as monitoring host-derived protein impurities, get a better understanding of their product and help to avoid more expensive problems further down the line. It’s not about avoiding issues altogether, just about making sure that they’re discovered early on.
Bringing in Outside Specialists
Anything that helps to bring down costs and speed up processes is highly valued by pharma companies, and that’s where CMOs — Contract Manufacturing Organizations — can come into play. These help to save pharma companies potentially millions of dollars by providing the facilities they need. By identifying which parts of the process can be outsourced, pharma companies can lower their expenses, improve their cash flow, and use their capital more efficiently.
Building on Past Knowledge
The road to bringing a drug to market can be long and nearly always contains errors that can provide valuable insights. The best companies capture these lessons and apply them to their future development cycles. Instead of starting from scratch each time, they’re able to both get a jump start on development and avoid the time-consuming or costly mistakes that they experienced last time. This is also one of the relatively low-effort ways to speed up time to market, since all that’s involved is using the data that’s already available.