Preclinical and Translational R&D Insights – Full SpotlightPublished: February 28, 2020
GUEST EDITOR: Karen Kozarsky, PhD, Founder & CSO, SwanBio Therapeutics
Cell & Gene Therapy Insights‘ first Spotlight of 2020 focuses on the numerous challenges faced by cell and gene therapy developers seeking to move their products forward into first in human studies. This wide-ranging edition examines strategic do’s and don’ts, delivers regulatory insights, and examines progress in the design and development of novel preclinical modelling and other enabling tools with the potential to increase predictivity of clinical success or failure.
- In vivo and in vitro tools in application – which ones are providing the greatest depth of insight in terms of predicting clinical safety and efficacy?
- How to address the shortfalls in current hPSC-based preclinical models?
- How to optimise integration of bioprocess development with preclinical R&D?
- Regulatory and operational best practice for preclinical-clinical translation of cell & gene therapies
- How are regulators’ expectations and requirements changing as knowledge and experience continues to build in cell & gene therapy?
- What to outsource and what to keep in-house?
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