04/05/2024 | News release | Distributed by Public on 04/05/2024 07:29
The translation of preclinical findings to effective therapies requires overcoming a set of hurdles. These challenges are faced by all entities engaged in therapeutic drug discovery. Whether they follow the traditional pharmaceutical chemistry approach or use biotechnology to manufacture new molecules, they need to identify and test promising drug candidates, and to progress them though preclinical and clinical trials to prove that they can effectively and safely meet medical needs.
REPROCELL's contract research services use human living tissues to better predict drug safety and efficacy.
This is where outsourcing to REPROCELL comes in. Our niche expertise covers the whole drug development pathway,from target identification and validation, lead identification and optimization, pre-clinical safety and finally, clinical trials.
One of the primary challenges in drug discovery lies in the current approach to drug development itself. The highfailure rate of drug candidates in clinical trials is often a consequence of poor preclinical prediction of efficacy in treating human diseases. Traditional methods,such as animal studies and 2D cell culture assays,lack the complexity of human biology. These models often fail to accurately assess drug efficacy, safety, and pharmacokinetics in humans. This shortcoming then leads to significant delays, wasted resources, and setbacks in drug development programs.
Each of these steps in the drug development pathway is essential, but many companies specializing in developing new molecules do not have the in-house expertise for preclinical and clinical trials. Nor do they have capability to apply techniques that would more accurately reflect human biology, such as ethically sourcing and performing assays on human fresh tissue-which has more benefits than animal testing for a variety of different reasons.
Traditionally, animal testing for preclinical safety has been a mainstay of preclinical drug development. However, a critical challenge is the over-dependence on these models. Animal physiologies often differ significantly from human physiology, leading to inaccurate predictions of drug responses in humans. While hundreds of thousands more animal tests have been conducted in comparison to human tissue testing, these tests may not accurately translate to human response. Furthermore, the shift towards human relevant assays aligns with growing ethical concerns surrounding animal testing, such as the recent removal by the FDA of the mandatory requirement to test drugs in non-human species prior to clinical trials. This approach has the potential to significantly reduce the number of animals required in drug development.
Human fresh tissue is considered the gold standard for non-clinical models as it offers a more accurate representation of human biology and drug response. There are however practical challenges that often limit its accessibility. REPROCELL bridges this gap by providing researchers and scientists with a reliable and efficient way to outsource research in human fresh tissues and engineered human tissue models:
By overcoming the key challenges associated with human fresh tissue, REPROCELL empowers researchers to leverage the gold standard in drug discovery and development.
REPROCELL's Preclinical and Drug Discovery Contract Research Organization (CRO) offers a comprehensive suite of services and platform technologies to address the limitations of traditional preclinical models and leverage the power of human tissue for drug development.
When it comes to drug efficacy, safety, and pharmacokinetics (ADME), REPROCELL's Centre for Predictive Drug Discovery is a Contract Research Organization (CRO) that specializes in ethically sourcing human fresh tissue and expertly performing human tissue assays on various platforms. Our scientists are constantly working on investigational new drug (IND) project collaborations with innovative pharma, biotech, and cosmetics companies around the world, including the top pharma companies.
By partnering with REPROCELL's Preclinical and Drug Discovery CRO, pharmaceutical companies and biotech firms gain numerous advantages:
REPROCELL's Preclinical and Drug Discovery CRO serves as a valuable partner for pharmaceutical companies and biotech firms striving to overcome the hurdles of drug development. By leveraging innovative technologies, ethically sourced human fresh tissue, the latest techniques in tissue engineering and world-class expertise, REPROCELL bridges the gap between traditional preclinical models and the promise of human-based testing. This approach empowers researchers to develop safer, more effective therapies, and ultimately, bring them to the patients who need them most.
REPROCELL's contract research services use human living tissues to better predict drug safety and efficacy.