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Patricia Anderson on Muck Rack

Patricia Anderson

Ann Arbor
As seen in: Wiley Online Library, Taylor & Francis Online, Science Magazine, The Australian, Grand Island Independent, Chest, Future Medicine, Future Oncology, Greene County Messenger, Herald Standard and
This was the livetweeting account for @pfanderson. Have been locked out & am unable to access help from @TwitterSupport Librarian, LongCOVID March 2020
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Articles

Statistical analysis plan considerations for autologous cell and cell-based gene therapy clinical trials

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By Patricia Anderson, Revathi Ananthakrishnan, Zhenzhen Xu
| Taylor & Francis Online
ABSTRACT By early 2023, there were over 100 gene, cell and RNA products approved globally (Chancellor et al. Citation2023). The way in which autologous cell and cell-based gene therapy products are administered can include multiple treatment stages, at times including leukapheresis, optional bridging therapy during manufacturing, conditioning regimen, and one or more doses of product.
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Pivotal trial design considerations for new and next generation cell and gene therapies

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By Patricia Anderson, Zhenzhen Xu, Evgeny Degtyarev
| Taylor & Francis Online
ABSTRACT The past decade has seen significant advancements for cell and gene therapies (CGTs). FDA lists more than 30 approved CGTs on their Approved Cellular and Gene Therapy Products website as of August 2024. With the promising treatment effect brought by the currently approved CGTs, there are noticeable limitations, such as, manufacturing delays and durability of response, that encourage continued development in this field.
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Estimands for long-term follow-up trials in gene therapy products

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By Shihua Wen, Patricia Anderson, Ran Duan, Oleksandr Sverdlov
| Taylor & Francis Online
Gene and genetically modified cell therapies offer incredible potential but may come with certain risks and unknowns of delayed adverse events due to unique characteristics of these products. Major regulatory agencies all require long-term follow-up (LTFU) trials, which can be as long as 15 years, to monitor potential delayed adverse events and the durability of effectiveness.
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