Phase I is the lifeblood or new medicines. The UK’s Phase I representative body, the Association for Human Pharmacology in the Pharmaceutical Industry’s (AHPPI’s) annual 1-day meeting, was held in London on 7 December 2022, bringing together stakeholders from a broad range of backgrounds to discuss how current and impending challenges in early phase drug development are inspiring future innovations in the pharmaceutical industry. The meetings proceedings are published today in Frontiers in Pharmacology [1].
Will the UK be able to move on from the problems caused by Brexit and seize the chances that come up because of advances in science and industry, which lead to new ideas and better ways of doing things? There was no doubt that the event showed that the UK pharmaceutical industry is still changing after Brexit and the lessons learned from the COVID-19 outbreak.
People who took part were told that the UK's clinical community has a unique chance to guide progress in a useful way. With the continued use of remote work, more chances have opened to support new practices outside of the office. But at the meeting, there were also serious concerns raised about the current performance of the UK's regulatory agency, the Medicines and Healthcare Products Regulatory Agency, as well as the government's knowledge of and commitment to the pharmaceutical industry.
The keynote speaker talked about clinical development over the past 40 years and how the industry must continue to focus on patient welfare. They were positive about our historical input to drug development. The future of drug development was talked about in terms of the difficulties of creating translational gene therapies. The state of the funding markets was also looked at from the point of view of business strategy and consulting.
The meeting was mostly about the patient's point of view. Ideas like patient-cantered blood sampling and decentralised clinical trials were brought up as ways for the industry to cut costs and work more efficiently. Also, the patient's point of view was very important in a discussion about whether the ethical standards for oncology patients taking part in first-in-human studies should be the same as those for healthy people.
The changed roles of the Qualified Person and Principal Investigators were still being talked about. This is important for sponsors who want to run future trials in the UK. After this, the current Chair of the COVID-19 challenge ethics committee gave a presentation after which the audience talked about what they had learned from doing challenge trials on healthy subjects and patients.
It was also looked at how relations with the MHRA are going right now. It was talked about how the UK's clinical trials community will still be connected to Europe in the near future. The European Medicines Agency's new clinical trials information system has been met with mixed reactions, but it does offer a promising chance to make sure that UK Phase I units continue to play an important role in global research.
References
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