[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 …

[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 …

[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 …

Health inequity in genomic personalized medicine in underrepresented populations: a look at the current evidence

SM Tawfik, AA Elhosseiny, AA Galal… - Functional & Integrative …, 2023 - Springer
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 …

[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 …

[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 …

[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 …

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 …

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 …

[HTML][HTML] Integrating public participation, transparency and accountability into governance of marketing authorisation for genome editing products

J Nielsen, L Eckstein, D Nicol… - Frontiers in Political …, 2021 - frontiersin.org
Public participation, transparency and accountability are three of the pillars of good
governance. These pillars become particularly important for innovative, personalised health …