[HTML][HTML] New regulatory thinking is needed for AI-based personalised drug and cell therapies in precision oncology
B Derraz, G Breda, C Kaempf, F Baenke… - NPJ Precision …, 2024 - nature.com
Until recently the application of artificial intelligence (AI) in precision oncology was confined
to activities in drug development and had limited impact on the personalisation of therapy …
to activities in drug development and had limited impact on the personalisation of therapy …
[HTML][HTML] Financing and reimbursement models for personalised medicine: a systematic review to identify current models and future options
R Koleva-Kolarova, J Buchanan, H Vellekoop… - … Health Economics and …, 2022 - Springer
Background The number of healthcare interventions described as 'personalised
medicine'(PM) is increasing rapidly. As healthcare systems struggle to decide whether to …
medicine'(PM) is increasing rapidly. As healthcare systems struggle to decide whether to …
[HTML][HTML] Evolution of mesenchymal stem cell therapy as an advanced therapeutic medicinal product (ATMP)—an indian perspective
S Muthu, M Jeyaraman, MB Kotner, N Jeyaraman… - Bioengineering, 2022 - mdpi.com
Stem cells can be defined as the cells that have the capacity to both self-renew and give rise
to differentiated cells. Under the right conditions and signals, depending on their origin and …
to differentiated cells. Under the right conditions and signals, depending on their origin and …
Health inequity in genomic personalized medicine in underrepresented populations: a look at the current evidence
Improvements in sequencing technology coupled with dramatic declines in the cost of
genome sequencing have led to a proportional growth in the size and number of genetic …
genome sequencing have led to a proportional growth in the size and number of genetic …
[HTML][HTML] Cell and gene therapy regulatory, pricing, and reimbursement framework: With a focus on South Korea and the EU
SK Lee, JH Lee - Frontiers in Public Health, 2023 - frontiersin.org
Ever since relevant bioengineering technologies have sufficiently matured to the
platformizable commercialization stage, a slew of money has flocked to the cell and gene …
platformizable commercialization stage, a slew of money has flocked to the cell and gene …
[HTML][HTML] Navigating Gene Therapy Access: The Case of Bulgaria in the Context of the EU Regulatory Landscape
K Kostadinov, Y Marinova, K Dimitrov… - Healthcare, 2024 - mdpi.com
Gene therapies (GTs) have recently emerged as revolutionary personalized therapeutic
options. Despite their promising potential, challenges such as uncertainty regarding long …
options. Despite their promising potential, challenges such as uncertainty regarding long …
[HTML][HTML] Towards Better Pharmaceutical Provision in Europe—Who Decides the Future?
D Horgan, T Spanic, K Apostolidis, G Curigliano… - Healthcare, 2022 - mdpi.com
Significant progress has been achieved in human health in the European Union in recent
years. New medicines, vaccines, and treatments have been developed to tackle some of the …
years. New medicines, vaccines, and treatments have been developed to tackle some of the …
Perspective from developers: Tissue-engineered products for skin wound healing
MM Godoi, EM Reis, J Koepp, J Ferreira - International Journal of …, 2024 - Elsevier
Tissue-engineered products (TEPs) are at the forefront of developmental medicines,
precisely where monoclonal antibodies and recombinant cytokines were 30 years ago …
precisely where monoclonal antibodies and recombinant cytokines were 30 years ago …
Cell and gene therapy products in Malaysia: a snapshot of the industry's current regulation preparedness
EYX Loh, PS Goh, AMM Mannan, NM Sani, A Ab Ghani - Cytotherapy, 2021 - Elsevier
Background aims Cell and gene therapy products (CGTPs) are anticipated to bring many
benefits for the treatment of conditions with limited or no satisfactory treatment options …
benefits for the treatment of conditions with limited or no satisfactory treatment options …
[HTML][HTML] Integrating public participation, transparency and accountability into governance of marketing authorisation for genome editing products
Public participation, transparency and accountability are three of the pillars of good
governance. These pillars become particularly important for innovative, personalised health …
governance. These pillars become particularly important for innovative, personalised health …