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European Biopharmaceutical Review
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To move away from ‘all-comers’ trials, the early identification of genetic factors influencing effectiveness in patient subpopulations is key. A recent increase in the use of predictive human tissue models led to the idea for a nationwide multidisciplinary collaboration that combined assays in fresh, diseased human tissues studied ex vivo, with whole exome sequencing. This allowed genomic markers to be recognised, distinguishing patients identified by the human tissue assays as ‘good’ or ‘poor’ responders.
This Scottish pharmacogenomics project has made great strides in the understanding of chronic obstructive pulmonary disease (COPD) and inflammatory bowel diseases (IBD) by using whole exome sequencing, bioinformatics and fresh human tissue assays to relate drug response to genotype. The study findings underpin a new framework for patient stratification in clinical trials that combines in vitro and molecular informatics to improve pharma success rates and accelerate the availability of effective medications.
The most common cause of drug failure is poor efficacy at Phase 1 or 3, which is, in part, attributed to clinical trials of entire patient populations, including both ‘responders’ and ‘nonresponders’ (1,2). Precision medicine can improve the prediction of clinical efficacy by selecting only those patient subpopulations likely to gain clear benefit for trials, but such forecasts require methods to identify patient subpopulations at an early stage, ideally during preclinical testing (2-4). Human tissue data generated in early discovery via a wide range of models – including stem cells, fresh human tissues and pathological specimens – is increasingly being used in preclinical testing (5-7). Tissue samples collected from the target patient population allow researchers to directly test the effect of new drugs in systems that closely reflect the in vivo situation, providing an early prediction of efficacy. The responses of tissues from different patients when studied in vitro can vary considerably, reflecting the clinical reality of responders and non-responders.
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News and Press Releases |
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Nosopharm Signs Partnership With Inrae and University of Montpellier to Develop New Anti-Infectives
Lyon, France, March 15, 2022—Nosopharm, specialized in exploring
unconventional sources of antibiotics to discover new drugs to fight
antimicrobial resistance, today announces that it has signed a
collaboration agreement with the DGIMI laboratory (UMR1333: Diversity,
Genomes and Insects-Microorganisms Interactions). DGIMI falls under
the authority of the French National Research Institute for Agriculture,
Food, and the Environment (INRAE) and the University of Montpellier.
The aim of this collaboration is to produce chemical libraries of new
bioactive molecules which will feed into Nosopharm’s anti-infective
screening campaigns against antibiotic resistance. ‘France Relance’, the
French government investment plan created following the Covid-19
pandemic, brings financial support to this new collaboration between
Nosopharm, INRAE and University of Montpellier.
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Successfully managing the unique demands of cell therapy supply chains
PCI Pharma Services
Cell therapy professionals joined a specialist webinar by industry experts from PCI Clinical Services and TrakCel, addressing the unique complexity of an autologous therapy supply chain. Hosted by European Pharmaceutical Manufacturer magazine, the webinar was delivered by Rachel Griffiths, Associate Director, Technical Services, PCI Clinincal Services, and Dr. Matthew Lakelin, Vice President, Scientific Affairs and Business Development, TrakCel . Here, we present the white paper from that webinar event.
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