ACT: What are currently some of the greatest regulatory challenges industry stakeholders such as CROs and sponsors should be keeping top of mind? How can they be addressed?
Beakes-Read: Some of the biggest challenges are advances in science and technology; use of the new artificial intelligence tools, digital tools, cell and gene therapy, so technological and scientific advances, and the incorporation of them appropriately into the drug development and then the regulatory approval pathways. With respect to how to address them, we need the core competence. We need regulatory capabilities, both within the regulatory framework and the tools that they’re using, but also just the staff themselves and that is true at regulators, that’s true at companies, it’s true at all stakeholders. It’s really competence and staff.
ACT: Could you discuss the value that FDA’s accelerated approval plan brings to patients?
Beakes-Read: This is a topic that I’m very passionate about. When I first was at FDA, back in 1998, the approval pathway was actually kind of new at that point, it started in 1992 and the whole goal of the accelerated approval pathway is to get promising new drugs to patients with high unmet medical need and not-sufficient therapeutic options, and to get those products to them earlier, based on good, solid scientific evidence, but shy of that ultimate clinical benefit, but the evidence that can predict that clinical benefit, and give it to them in time where they can enjoy their lives, extend their lives, have hope for even more therapies along the way that may come to be approved during the time period after the accelerated approval. So really, it’s to deliver new products to patients in a timely way.
ACT: What is the potential of cloud-based regulatory platforms? What are the benefits patients and industry stakeholders could see from them?
Beakes-Read: Thank you. That’s another great question. Cloud-based programs and platforms are really important when you think about global collaboration. We’re developing drugs globally, we’re studying them globally, we’re trying to deliver access to patients globally, and we need to have systems that help to promote that global drug development, so that’s the regulatory frameworks, that’s the collaboration and reliance, and being able to address the technologies that you just asked me about. There’s also sharing of information and data, so the cloud-based systems can do multiple things along that whole spectrum. You think about sharing data so that we can get to decisions more effectively. You think about getting more health authorities globally to have access to same information in a timely way, so that their patients and their countries get access more quickly. It also helps to promote discussion amongst regulators and amongst other stakeholders with the regulators, so the companies. Promoting that collaboration, that communication through tools such as cloud-based platforms is really crucial.