At the Phacilitate Vaccines Forum, FierceBiotech sat down with representatives from ERA Consulting, a U.K.-based firm that advises companies on their regulatory strategy. We asked David Kirke (pictured), Senior Regulatory Affairs Project Manager, and Paul Cronin, Business Development Manager, to share what they've learned in working with companies from around the world about common mistakes companies make when building their European regulatory strategies. Cronin and Kirke tell us that it's important to build a regulatory strategy early on, but also understand that its something that evolves and changes over time.
"In terms of the economic standpoint, as we all know, I think there are a lot of companies out there struggling and I think the question has always got to be, 'how can we maximize the value of our product, our pipeline, in every possible way?'" Cronin explains. "Having a clear regulatory strategy from a very early stage--and recognizing that it's an evolving document that lives and breaths and can evolve--is another way you can add value."
Once you have begun designing your regulatory strategy, there are important things you must remember throughout the process.
1. Seek scientific advice early on
Without a doubt, the most important issue companies face in planning their regulatory strategy is the need to ensure that they engage with the regulatory authorities. There's no "one size fits all" when it comes to regulatory strategies, but seeking scientific advice from a regulatory agency can have a larger impact on the valuation of the company and its products.
"For example, if you're discussing with an investor your preclinical program and they ask, 'how do you know that this is going to suffice for a phase I clinical study?' You can say, ‘well, okay, we've had independent experts looking at it' and try and justify it to them on a scientific basis. But if you're able to pull out minutes from a scientific advisory agency, that's a way you can add significant value," Cronin explains.
Building a relationship with regulators is especially important with regards to advanced therapies and more innovative products. The agencies themselves may not have a lot of experience and expertise related to these products so they're interested in engaging with companies at an early stage of development and working with them throughout the process. "So as well as you're asking questions that you want answers to, it's a good opportunity to actually present your product to the agency," Kirke adds. "The first time they see your product isn't going to be your clinical trial application or your dossier, you can actually go in there, talk to the agencies and maybe try to get them on board."
While it's normal for companies to feel defensive of their work, it's especially important that they not treat the regulatory authorities as the enemy, Kirk warns. Companies should reach out to regulators as early as possible so they can work together to evolve the regulations to work properly.