The challenges of accessing clinical samples
Medicines Discovery Catapult launched their sample access capability following a report that was published called ‘State of the Discovery Nation’. The report was based on a survey of UK SMEs around the various challenges in R&D which revealed that whilst access to clinical samples was important, in practice it was challenging to achieve. Importance of […]
Biomarker identification
Why is biomarker identification so important? Clinical trials are expensive with each phase becoming more expensive as the number of subjects increases, and the attrition rate is high due to a lack of clinical efficacy. Data from the AZ pipeline have shown that programmes that have a Pharmacodynamic (PD) biomarker associated with them, where target […]
Designing a biomarker strategy
What is a biomarker strategy and why is it important? Within the drug discovery pipeline there are several steps a compound must progress through prior to the clinical stage – initial target identification and validation, lead identification and optimisation and pre-clinical stage. Even so, drugs that enter the clinic still have a high attrition rate […]
Challenges and Opportunities of Complex Cell Models for Toxicity Testing
Availability of safety data is critical in early studies and in later pre-clinical development. A key focus is to improve the safety related attrition in clinical studies which could be achieved using model systems closer to humans and therefore able to generate more reliable, translatable data. These data can then be used to reliably identify […]
How to get your molecule into humans
Understanding the main reasons for delay and maximising the opportunities available to improve the efficiency of the transition to first-in-man clinical trials are paramount to the success of a drug development programme. The ultimate aim for a non-clinical program is to ensure the safety of the clinical trial subjects but, to improve the efficiency of […]
Making safety part of drug design
The importance of safety in the drug discovery process The aims of safety in the drug discovery process are to develop an effective new medicine which can be given to patients quickly and safely. Studies have shown that clinical development attrition rates are high. A study analysing over 7,000 development programs with nearly 10,000 clinical […]
Go Native…Characterising therapeutic effect in primary cellular models
Clinical attrition due to lack of clinical efficacy during development remains an issue and can in part be attributed to inadequate pre-clinical target validation and/or suitable clinical translation data. Using relevant preclinical cell-based models can help ensure the clinical validity of the target & therapeutic effects prior to clinical efficacy studies and ensure a better understanding of […]
Strategies for target and pathway engagement in cellular assays
The importance of target engagement studies Key to the target validation process and improving clinical attrition is testing the biological hypothesis. It is important to establish if a lack of efficacy is due to the compound not engaging with the intended target or alternatively, engaging with the target but the target not modifying the disease […]
Use of preclinical models to deliver proof of concept efficacy
Sygnature Discovery is a leading independent provider of integrated drug discovery and pre-clinical resource and expertise. Sygnature offer fully integrated discovery project support, as well as discipline-specific support in medicinal and computational chemistry, bioscience, DMPK, in vitro pharmacology, and in vivo pharmacology, as needed by their collaborating clients. Sygnature’s primary focus is value creation for […]