Literature DB >> 35659866

Planning for progress: A US regulatory approach to advancing the clinical development of gene therapies.

Mantej Chhina1, Daniela Drago2, Adora Ndu3.   

Abstract

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Year:  2022        PMID： 35659866      PMCID： PMC9263300          DOI： 10.1016/j.ymthe.2022.05.005

Source DB:  PubMed          Journal:  Mol Ther        ISSN： 1525-0016            Impact factor:   12.910


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  7 in total

Review 1.  Innovation in Chemistry, Manufacturing, and Controls-A Regulatory Perspective From Industry.

Authors:  Nina S Cauchon; Shirley Oghamian; Soraya Hassanpour; Michael Abernathy
Journal:  J Pharm Sci       Date:  2019-02-19       Impact factor: 3.534

Review 2.  Development challenges associated with rAAV-based gene therapies.

Authors:  Michael W Bolt; Joseph T Brady; Lawrence O Whiteley; K Nasir Khan
Journal:  J Toxicol Sci       Date:  2021       Impact factor: 2.196

3.  Enhancing gene therapy regulatory interactions.

Authors:  Peter Marks
Journal:  Expert Opin Biol Ther       Date:  2022-04-03       Impact factor: 5.589

Review 4.  Challenges in the market access of regenerative medicines, and implications for manufacturers and decision-makers: a systematic review.

Authors:  Tingting Qiu; Michał Pochopień; Eve Hanna; Shuyao Liang; Yitong Wang; Ru Han; Mondher Toumi; Samuel Aballéa
Journal:  Regen Med       Date:  2022-01-19       Impact factor: 3.806

Review 5.  Global regulatory progress in delivering on the promise of gene therapies for unmet medical needs.

Authors:  Daniela Drago; Betsy Foss-Campbell; Keith Wonnacott; David Barrett; Adora Ndu
Journal:  Mol Ther Methods Clin Dev       Date:  2021-04-05       Impact factor: 6.698

Review 6.  Improving translatability of preclinical studies for neuromuscular disorders: lessons from the TREAT-NMD Advisory Committee for Therapeutics (TACT).

Authors:  Raffaella Willmann; Joanne Lee; Cathy Turner; Kanneboyina Nagaraju; Annemieke Aartsma-Rus; Dominic J Wells; Kathryn R Wagner; Cristina Csimma; Volker Straub; Miranda D Grounds; Annamaria De Luca
Journal:  Dis Model Mech       Date:  2020-02-07       Impact factor: 5.758
  7 in total

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