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European Biopharmaceutical Review
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Cellular therapies – such as treatment with mesenchymal stem cells (MSCs) or, recently, with genetically adapted T-autologous (Ta) cells – are coming of age and have exhibited their efficacy for selected indications in numerous preclinical trials. Many have received first approvals or are likely to in the near future. MSCs have been approved for selected indications in Canada as well as New Zealand, and at least one chimeric antigen receptor (CAR) T-cell product has gained a unanimous positive review by the FDA advisory committee.
The cross-section of medical devices and cellular therapies has been explored and utilised for some time; for example, cells have been embedded in collagenous foams to secure their location, or catheters have been employed to facilitate targeted delivery of cells.
For biologics and small molecules, this cross-section is perhaps not as clearly visible, yet it has transpired that combinations may yield massive improvements, as demonstrated in preclinical studies. Hence, this appears to be an opportunity worthy of exploration due to its benefits as well as its practical, quality and regulatory implications.
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News and Press Releases |
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Tempus Announces Agreement With Janssen R&D to Leverage AI/ML and Real-World Evidence to Enhance the Discovery and Development of Oncology Therapies
Tempus, a leader in artificial intelligence and precision medicine,
today announced the expansion of its multi-year agreement with Janssen
Research & Development, LLC (Janssen).
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White Papers |
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Systems Engineering for Complex Portable Medical Device Development
Phillips-Medisize
As the demand for complex, portable medical devices continues to grow, reducing risk and increasing efficiency during the development of these products should be paramount. Taking a systems-engineering (SE) approach to development provides a holistic, organized, and deliberate method for identifying as well as reducing both patient and business risks early in the process. Furthermore, it facilitates efficient progression throughout the entire product development life cycle.
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