Ginny Beakes – reading Johnson & Johnson discusses regulatory challenges

ACT: What are some of the biggest regulatory challenges right now that industry stakeholders, such as CROs and sponsors, should keep in mind? How can they be remedied?

Beakes – read: The greatest challenges include progress in science and technology; the use of new artificial intelligence tools, digital tools, cell and gene therapy, and therefore technological and scientific progress, and their appropriate integration into drug development and subsequent regulatory approval pathways. To deal with them, we need basic competencies. We need regulatory capacity, both in the regulatory framework and in the tools that they use, but also in the staff themselves, and this applies to regulators, this applies to businesses, this applies to all stakeholders. It’s really competence and staff.

ACT: Could you discuss the value to patients of the FDA’s accelerated approval plan?

Beakes – read: This is a topic I am very passionate about. When I first worked at the FDA, in 1998, the approval pathway was actually new at that point, having started in 1992, and the primary purpose of the accelerated approval pathway is to deliver promising new drugs to patients with high levels of unmet medical need and inadequate therapeutic options and to provide them with these products earlier, based on good, solid scientific evidence, but not wanting to achieve a definitive clinical benefit, but evidence that can predict that clinical benefit and provide it in time when necessary will be able to enjoy lives, prolong them and hope for even more therapies that may be approved in the post-accelerated approval period. And it’s really about delivering new products to patients in a timely manner.

ACT: What is the potential of cloud-based regulatory platforms? What benefits can patients and industry stakeholders see from them?

Beakes – read: Thank you. This is another great question. Cloud-based programs and platforms are really important when you think about global collaboration. We are developing medicines around the world, we are testing them around the world, we are trying to provide access to patients around the world and we need systems that help promote the global development of medicines, so that is the regulatory framework, that is collaboration and reliability and the ability to address the technologies that which you just asked me. There is also information and data exchange, so cloud-based systems can perform many tasks across the spectrum. Are you thinking about sharing data so that we can make decisions more effectively? You’re thinking about giving more health authorities around the world access to the same information in a timely manner, so that their patients and their countries can access it more quickly. It also helps to promote discussions between regulators and other stakeholders with regulators, i.e. businesses. Promoting this collaboration and this communication using tools such as cloud-based platforms is really key.