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Association for Human Pharmacology in the Pharmaceutical Industry conference 2022: impending change, innovations and future challenges
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 e...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10651721/ https://www.ncbi.nlm.nih.gov/pubmed/38026971 http://dx.doi.org/10.3389/fphar.2023.1219591 |
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author | Mundy, Charles Bush, James Cheriyan, Joseph Lorch, Ulrike Stringer, Steffan Taubel, Jörg Wydenbach, Kirsty Hardman, Timothy C. |
author_facet | Mundy, Charles Bush, James Cheriyan, Joseph Lorch, Ulrike Stringer, Steffan Taubel, Jörg Wydenbach, Kirsty Hardman, Timothy C. |
author_sort | Mundy, Charles |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10651721 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-106517212023-11-02 Association for Human Pharmacology in the Pharmaceutical Industry conference 2022: impending change, innovations and future challenges Mundy, Charles Bush, James Cheriyan, Joseph Lorch, Ulrike Stringer, Steffan Taubel, Jörg Wydenbach, Kirsty Hardman, Timothy C. Front Pharmacol Pharmacology 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. Frontiers Media S.A. 2023-11-02 /pmc/articles/PMC10651721/ /pubmed/38026971 http://dx.doi.org/10.3389/fphar.2023.1219591 Text en Copyright © 2023 Mundy, Bush, Cheriyan, Lorch, Stringer, Taubel, Wydenbach and Hardman. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Pharmacology Mundy, Charles Bush, James Cheriyan, Joseph Lorch, Ulrike Stringer, Steffan Taubel, Jörg Wydenbach, Kirsty Hardman, Timothy C. Association for Human Pharmacology in the Pharmaceutical Industry conference 2022: impending change, innovations and future challenges |
title | Association for Human Pharmacology in the Pharmaceutical Industry conference 2022: impending change, innovations and future challenges |
title_full | Association for Human Pharmacology in the Pharmaceutical Industry conference 2022: impending change, innovations and future challenges |
title_fullStr | Association for Human Pharmacology in the Pharmaceutical Industry conference 2022: impending change, innovations and future challenges |
title_full_unstemmed | Association for Human Pharmacology in the Pharmaceutical Industry conference 2022: impending change, innovations and future challenges |
title_short | Association for Human Pharmacology in the Pharmaceutical Industry conference 2022: impending change, innovations and future challenges |
title_sort | association for human pharmacology in the pharmaceutical industry conference 2022: impending change, innovations and future challenges |
topic | Pharmacology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10651721/ https://www.ncbi.nlm.nih.gov/pubmed/38026971 http://dx.doi.org/10.3389/fphar.2023.1219591 |
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