Association for Human Pharmacology in the Pharmaceutical Industry conference 2022: impending change, innovations and future challenges

Abstract

The Association for Human Pharmacology in the Pharmaceutical Industry's annual meeting focused on current and impending challenges facing the United Kingdom's (UK) pharmaceutical industry and how these opportunities can inspire innovation and best practice. The UK pharmaceutical landscape is still evolving following Brexit and learnings from the coronavirus disease 2019 (COVID-19) pandemic. As such, the UK's clinical community is in a unique position to steer innovation in a meaningful direction. With the continuation of remote forms of working, further opportunities have arisen to support novel practices away from the clinic. The keynote speaker reflected on clinical development over the past 40 years and how the industry must continue to concentrate on patient welfare. The future of drug development was discussed regarding challenges associated with developing translational gene therapies, and the status of investment markets analyzed from a business strategy and consulting perspective. The patient viewpoint was a core theme throughout the conference with patient-centric blood sampling and decentralized clinical trials providing suggestions for how the industry can save costs and increase efficiency. Moreover, the patient perspective was central to a debate over whether ethics requirements should be the same for oncology patients taking part in first-in-human studies as those for healthy subjects. Discussions continued around the changing roles of the Qualified Person and Principal Investigators which underpins how sponsors may want to run future trials in the UK. Lessons learned from conducting challenge trials in healthy volunteers and patients were discussed following a presentation from the serving Chair of the COVID-19 challenge ethics committee. The current state of interactions with the Medicines and Healthcare products Regulatory Agency were also explored. It was considered how the immediate future for the UK clinical trials community is inevitably still linked with Europe; the newly implemented European Medicines Agency Clinical Trials Information System has been met with lukewarm responses, providing a promising opportunity to ensure UK Phase I units continue to play a vital role in global research.

Keywords: association for human pharmacology in the pharmaceutical industry; drug development; early phase clinical development; innovation; meeting report.

FIGURE 1

Current approaches to treating rare genetic diseases exploit stem cell lineage differentiation. By integrating gene therapy into hematopoietic stem cells, self-renewing and differentiating progeny produce the therapeutic molecule or protein in a range of immune cell subsets. These altered immune cells are then utilized to treat a variety of diseases throughout the body. MLD = metachromatic leukodystrophy; WAS = Wiskott-Aldrich syndrome; NK = natural killer; TDT = transfusion-dependent β-thalassemia; ADA-SCID = adenosine deaminase severe combined immunodeficiency; X-CGD = X-linked chronic granulomatous disease; MPS-I = mucopolysaccharidosis type I; MPS-IIIA = mucopolysaccharidosis type IIIA. Source: Orchard Therapeutics.

FIGURE 2

The number of clinical trial applications to the MHRA between September 2021 and September 2022. Data collected from Phase I units across the United Kingdom. Normalized by removing COVID-19 studies, and linear regression models fitted. (A) A downward trend was observed for the number of CTA applications in general. The majority of applications were commercial. (B) The number of applications of early phase trials with a Phase I element remained constant throughout the year. (C) There were slightly fewer applications for Phase I patient trials, whereas the number of applications for Phase I healthy trials steadily increased throughout the year. (D) The number of FIH study applications has notably declined over the past year. CTA = clinical trial authorization; FIH = first-in-human; MHRA = Medicines and Healthcare products Regulatory Agency.