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A step closer to ‘clinical trial in a dish’ for Alzheimer’s  

Drug Discovery World

Grown in vitro, these cells can provide patient specific human brain models from a large cohort of AD patients – to create a ‘clinical trial in a dish’. sAD has no specific family link and is caused by a combination of genetics, the environment and a person’s lifestyle.

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High risk, high reward – the future of CAR-T therapy in CLL

Pharmaceutical Technology

In 2010, two patients with end-stage refractory chronic lymphocytic leukaemia (CLL) were administered Novartis’ autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, Kymriah (tisagenlecleucel), as part of a Phase I trial.

In-Vitro 279
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CDER regulatory science division touts 2020 accomplishments

The Pharma Data

DARS also greatly expanded its clinical trials operations, running three clinical trials related to streamlining biosimilars development and studying safety questions related to opioids and over-the-counter drugs,” Strauss wrote. Posted 03 May 2021 | By Michael Mezher . 2020 was a challenging year.

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Closing the translation gap in oncology drug development

Drug Discovery World

The recent passage of the FDA Modernization Act, which removed the requirement for animal testing when suitable alternatives are available, has highlighted the inadequacy of animal models most often used for in vivo research. Fewer than 5% of oncology drugs that enter clinical trials in the US receive US FDA approval.

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Stem cells’ versatility in drug development  

Drug Discovery World

Through the use of human induced pluripotent stem cells (iPSCs) derived cells, we can improve translation and reduce risk of clinical failure. Select mature stem cell lines can then be used in small-scale in vitro assays, and proven biochemical and phenotypic screens supporting target validation and deconvolution studies.

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FDA-approved drug sensitises brain cancer cells to radiotherapy

Drug Discovery World

Researchers have discovered a clinical drug that sensitises glioblastoma (GBM) cells to radiotherapy and could replace the current standard of care. In addition, they discovered that cladribine, a clinical drug, activates DGKB and inhibits DGAT1. GBM is a WHO grade IV brain tumour with dismal prognosis.

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Are organ-chips the future of preclinical research?

Drug Discovery World

Organ-chips combine cell culture with microfluidics to emulate the biological forces of different organ tissues and/or disease states, allowing pharmaceutical researchers to determine a drug candidates’ efficacy and toxicity ahead of clinical trials. Could organ-chips replace other research methods? Not yet, according to Ewart.