Leveraging Human Tissue Models with Preclinical and Drug Discovery CRO
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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.
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 high failure 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.
The Flawed Reliance on Animal Models
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: The Gold Standard, But Difficult to Access
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:
- Expert Support: A team of experienced scientists provide specialized guidance and support in working with human tissue models, ensuring optimal research outcomes.
- Streamlined Logistics: REPROCELL’s established networks and protocols facilitate the rapid acquisition of high-quality human tissue specimens.
- Extensive Clinical Networks: REPROCELL has established clinical networks across the USA and Europe, facilitating access to human ex vivo living tissues for research purposes.
- Experiments using human fresh tissues: REPROCELL offers assays across a wide range of endpoints in intact fresh tissues from numerous organs, including heart, skin, lung, stomach, intestine, uterus and bladder. Tissues can be sourced from both healthy or diseased organs.
- Experiments using bioengineered 3D tissue models: REPROCELL also utilizes innovative 3D cell culture technologies like Alvetex® to “grow” biologically relevant human tissues such as skin, lung and intestine. Both healthy or diseased models are available for use in tests conducted at our laboratories.
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 CRO:
A Bridge to Better Drug 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.
The REPROCELL Advantage: Reduced Costs, Faster Development, and Better Decisions
By partnering with REPROCELL's Preclinical and Drug Discovery CRO, pharmaceutical companies and biotech firms gain numerous advantages:
- Clinically-Relevant Models that are More Predictive: REPROCELL's human fresh tissues and engineered human tissues provide more predictive and translational preclinical data, leading to better-informed decisions earlier in the drug development process.
- Reduced Costs: By providing researchers with reliable and predictive information earlier, we help them make informed decisions that can significantly reduce overall development costs. Traditional preclinical development often leads to wasted resources on clinical trials for drugs that ultimately fail. Our data-driven approach helps to identify potential issues earlier, allowing for course correction and ultimately saving companies from the high costs associated with late-stage failures.
- Faster Bench-to Bedside Timelines: REPROCELL's technologies and streamlined processes can significantly shorten drug development timelines, getting life-saving therapies to patients faster.
- Improved Decision-Making: REPROCELL's team of experts offers guidance and support throughout the preclinical research process, empowering companies to make informed decisions that increase the chances of success going into clinical trials.
Conclusion: A Trusted Partner for a Brighter Future
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.
Ask us about our Predictive Drug Discovery Services
Author
Ella Cutter
Ella is REPROCELL Europe's Digital Marketing Manager. Hailing from an American background in journalism and publishing, she likes to read, run and try new restaurants in her free time. Connect with her on LinkedIn: www.linkedin.com/in/ellacutter.
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