Takeaways from our latest virtual breakfast briefing: Shaping the UK’s position in the international community- innovation and regulatory perspectives 28 Oct 2021
We enjoyed a very engaging session for our latest virtual breakfast briefing examining the UK’s role in the international community from innovation and regulatory perspectives. Dr Malcolm Barratt-Johnson of PharmaMedic was joined by Hassan Chaudhury of Healthcare UK and Dr Zubair Hussain of LE4D Global Regulatory Science.
Hassan began by asking whether the UK was still on the cutting edge of life sciences innovation. Our attendees addressed this question in a poll before the presentation and interestingly, 57% were unsure, 39% asserted that we did remain at the forefront, while only 4% answered in the negative.
With his digital health credentials, Hassan specifically discussed the data and digital considerations of innovation. He noted that within the global landscape, the US has always been able to scale and accelerate innovation but now has a strong competitor in China, who are generating impressive levels of innovative research.
Artificial intelligence and making the most of crucial data was a primary focus. Hassan highlighted how the UK’s rich health data is a substantial and promising asset. The NHS makes it feasible to collect health data on a large and diverse population and make national-scale improvements to health and care. Combined with unique research expertise, talent in the NHS and universities, and a vibrant life sciences industry, the UK has an opportunity to use data at scale to drive innovation, grow the UK industry base and advance healthcare.
We then heard invaluable insights from Dr Zubair Hussain about Project Orbis.
Project Orbis is a regulatory initiative coordinated by FDA Oncology Centre of Excellence (OCE) to fast-track approval of promising cancer treatments. The scheme involves Project Orbis Partners Australia, Canada, the United Kingdom, Singapore, Switzerland, and Brazil. Our in-meeting poll revealed that while 8% of our attendees had had some early experience with Project Orbis, 83% cited that they needed more knowledge.
Zubair highlighted the practicalities of the scheme, including the qualification criteria, which state that the drug under consideration should be intended to treat a severe condition and provide a significant improvement in safety or effectiveness. Importantly, in the UK, Project Orbis submissions must qualify with the Innovative Licensing and Access Pathway (ILAP) requirements discussed during previous breakfast briefings and in our articles.
Dr. Malcolm Barratt-Johnson then shared some of the early highlights from Project Orbis, including Amgen’s sotorasib (Lumykras), which received a “fast track” conditional MA in the UK in September 2021.
To wrap up, we enjoyed an engaging Q&A session that discussed whether the current regulatory capacity was up to scratch for artificial intelligence diagnostics, how well initiatives such as Project Orbis were translating into market access and the level of investment in PhDs for artificial intelligence. On the latter topic, an interesting, and related article shared by one of our attendees can be found here discussing agile education and its role in skills development.
If you missed the session, do catch up on the recording here.
We hope to see you at a future PharmaMedic virtual breakfast briefing.
If you would like to engage PharmaMedic’s support in navigating Project Orbis or other medical and regulatory affairs aspects, please do get in touch via firstname.lastname@example.org.