Diverse donors, consistent results
Why we need increased diversity in preclinical testing
Preclinical testing is a critical phase in drug development as it provides essential insights into the efficacy and safety of potential therapeutics. Historically, preclinical studies have predominantly focused on male subjects and in limited genetic backgrounds. However, representation of male and females diverse backgrounds gives essential insight as to how a new drug will behave against the genetic, physiological, behavioural, and environmental factors that differ among individuals.
Cytochroma provide male and female stem cell models that represent the world diverse population to provide greater information early on in drug development to accelerate safer and better medicines for all.
Regulatory requirements
Regulatory bodies are increasingly emphasizing the importance of including both genders and diverse genetic backgrounds in preclinical studies. Agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued guidelines encouraging more representative preclinical research. Complying with these guidelines not only expedites the drug approval process but also ensures that the drug's safety and efficacy are thoroughly evaluated across varied populations.
The FDA Modernization Act 2.0 has driven the use of cell based systems to predict toxicity and replace animal systems where possible. Cytochroma is a pioneer in providing the most diverse selection of stem cell models for testing and we are working towards approval for our cells to help replace early animal models.
Incorporate diversity into your drug development journey
Contact us to find out more about our diverse stem cell library and how it can help de-risk drug development, identify adverse reactions and ensure clinical success.
Read about our collaboration with the Medicines Discovery Catapult and our diverse cardiac models.
Cytochroma’s iPS cell bank
Male and female donors, with unique polymorphisms found in a global population.
We are expanding our bank and conducting Whole Genome sequencing to provide greater detail on genomic ancestries.
Please enquire for custom lines and let us know if you have any special requests.
