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S5 - E12.5 - MASH Drug Development: Combining With Old Drugs And Shortening Time To Approval

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This wrap-up conversation about MASH Drug Development covers two issues: combination therapies with old drugs and using NITs to speed and smooth the path to approval.
Louise Campbell starts this final conversation by asking whether we are paying sufficient attention to old drugs that might have value in MASH. She points to a recent study demonstrating that low-dose aspirin significantly affects liver fat and suggests that we are not thinking broadly enough about use of older agents in MASH. Jörn Schattenberg comments that without robust NITs, it will be difficult to prove these effects, particularly, as Roger Green adds, for a drug that will not produce sufficient revenue for BioPharma to conduct a larger trial.
After a brief digression over whether we know how to shorten the time to drug approvals (short answer: not until we have better approaches to using NITs), Roger asks his closing question: how will having a drug approved affect the conduct of trials going forward? Answers vary and present a complex picture. You'll have to listen to learn

  continue reading

960 episódios

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Manage episode 415080775 series 2901310
Conteúdo fornecido por SurfingNASH.com. Todo o conteúdo do podcast, incluindo episódios, gráficos e descrições de podcast, é carregado e fornecido diretamente por SurfingNASH.com ou por seu parceiro de plataforma de podcast. Se você acredita que alguém está usando seu trabalho protegido por direitos autorais sem sua permissão, siga o processo descrito aqui https://pt.player.fm/legal.

This wrap-up conversation about MASH Drug Development covers two issues: combination therapies with old drugs and using NITs to speed and smooth the path to approval.
Louise Campbell starts this final conversation by asking whether we are paying sufficient attention to old drugs that might have value in MASH. She points to a recent study demonstrating that low-dose aspirin significantly affects liver fat and suggests that we are not thinking broadly enough about use of older agents in MASH. Jörn Schattenberg comments that without robust NITs, it will be difficult to prove these effects, particularly, as Roger Green adds, for a drug that will not produce sufficient revenue for BioPharma to conduct a larger trial.
After a brief digression over whether we know how to shorten the time to drug approvals (short answer: not until we have better approaches to using NITs), Roger asks his closing question: how will having a drug approved affect the conduct of trials going forward? Answers vary and present a complex picture. You'll have to listen to learn

  continue reading

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