Translation of Safety in the Clinic
Duration: 1 hour 46 mins
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About this item
| Description: | (No description) |
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| Created: | 2023-07-19 10:27 |
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| Collection: | Cambridge Academy of Therapeutic Sciences |
| Publisher: | University of Cambridge |
| Copyright: | Taha Firdous Shah |
| Language: | eng (English) |
| Abstract: | The workshop discussed lessons learned from gene therapy and cell therapy and leveraging data to get an early indication of risk. It included two sessions on Preclinical to clinical translations and pharmacovigilance in the clinic. These sessions discussed current approaches for advanced therapy medicinal products, modelling safety preclinically: CAR-T cell case study, clinical monitoring and translation in early development for new modalities, pharmacovigilance: MHRA perspective and the Yellow Card biobank, collecting genomic data in clinical trials to inform safety and efficacy: a case study and clinical drug safety in Cell Therapy trials. |
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