The increase in global emergencies and the need to prepare for health threats – from emerging infectious diseases to bioterrorism, radiological, nuclear and chemical threats (CBRN) – advocates for regulatory and scientific pathways for licensing...
This reflection paper aims to provide an overview of the scientific and regulatory considerations for non-human primate use in safety testing of human medicinal products. It highlights the existing flexibility within published guidelines to incorporate...
FDA has issued a draft guidance which provides recommendations regarding assuring the safety, quality, and identity of materials of human and animal origin used in the manufacture of cellular and gene therapy (CGT) and tissue-engineered products (TEP)....
After years of jostling with industry, failed legislative efforts, and some false starts, the US Food and Drug Administration (FDA) has unveiled its plan to bring laboratory developed tests (LDTs) into its regulatory fold over...
The Non-clinical Working Party (NcWP) was set up by the Committee for Medicinal Products for Human Use (CHMP) to provide advice and recommendations directly or indirectly related to non-clinical issues. In 2022, the NcWP took over...
New funding brings UKRI investment into the National Mouse Genetics Network to £25 million. Age-related illnesses such as dementia are some of the most challenging disease areas we face. New UK Research and Innovation (UKRI)...
A review by The Cell and Gene Therapy Catapult sets out the key factors that should be considered when selecting an animal model to be used in non-clinical studies for adeno-associated virus (AAV) based gene...
The European Medicines Agency’s (EMA) Non-Clinical and New Approach Methodologies European Specialised Expert Community is a platform for information-sharing and interactions between experts in the non-clinical field, including on new approach methodologies. It supports EMA’s two working...
The Foundation for the National Institutes of Health (FNIH) has announced its plans to prioritise eight rare diseases to provide industry standards for manufacturing, preclinical testing and product analytical testing for gene therapy development. The eight...
NHS Blood and Transplant (NHSBT) is today [Friday, March 10] opening a state-of-the-art facility which will contribute greatly to the UK’s ability to develop and manufacture new gene and cell therapies. It will manufacture products...
