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...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-11-01
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| Series: | Frontiers in Pharmacology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1219591/full |
| _version_ | 1827775463400931328 |
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| author | Charles Mundy James Bush Joseph Cheriyan Ulrike Lorch Steffan Stringer Jörg Taubel Kirsty Wydenbach Timothy C. Hardman |
| author_facet | Charles Mundy James Bush Joseph Cheriyan Ulrike Lorch Steffan Stringer Jörg Taubel Kirsty Wydenbach Timothy C. Hardman |
| author_sort | Charles Mundy |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-11T13:51:07Z |
| format | Article |
| id | doaj.art-51626447c4c045fea413a4054ce30cd8 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-03-11T13:51:07Z |
| publishDate | 2023-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-51626447c4c045fea413a4054ce30cd82023-11-02T09:06:56ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-11-011410.3389/fphar.2023.12195911219591Association for Human Pharmacology in the Pharmaceutical Industry conference 2022: impending change, innovations and future challengesCharles Mundy0James Bush1Joseph Cheriyan2Ulrike Lorch3Steffan Stringer4Jörg Taubel5Kirsty Wydenbach6Timothy C. Hardman7Niche Science & Technology Ltd., Richmond, United KingdomCovance Clinical Research Unit Ltd., Leeds, United KingdomCambridge University Hospitals NHS Foundation Trust, Cambridge, United KingdomRichmond Pharmacology Ltd., London, United KingdomAlwyn Consulting, Guildford, United KingdomRichmond Pharmacology Ltd., London, United KingdomWeatherden Ltd., London, United KingdomNiche Science & Technology Ltd., Richmond, United KingdomThe 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.https://www.frontiersin.org/articles/10.3389/fphar.2023.1219591/fullearly phase clinical developmentmeeting reportassociation for human pharmacology in the pharmaceutical industrydrug developmentinnovation |
| spellingShingle | Charles Mundy James Bush Joseph Cheriyan Ulrike Lorch Steffan Stringer Jörg Taubel Kirsty Wydenbach Timothy C. Hardman Association for Human Pharmacology in the Pharmaceutical Industry conference 2022: impending change, innovations and future challenges Frontiers in Pharmacology early phase clinical development meeting report association for human pharmacology in the pharmaceutical industry drug development innovation |
| 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 | early phase clinical development meeting report association for human pharmacology in the pharmaceutical industry drug development innovation |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1219591/full |
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