A significant boost to the Indian economy is expected over the next five years by the foreign and domestic investments being made in the preclinical CRO segment. In an interaction with BioSpectrum Dr Satinder Singh, Associate Director, DMPK Aragen Life Sciences, shared his insights about future growth drivers of preclinical CROs based out of India.
What is Preclinical CRO?
Preclinical is a stage of drug development that ensues before clinical trials (testing in humans) and during which drug potency, efficacy, pharmacokinetics, tolerability and safety data are collected, in laboratory settings to determine a starting, safe dose for FIH study, and forecast potential toxicity of the drug product in humans.
The preclinical phase utilises a range of in-vitro platforms and in-vivo animal models to simulating human physiology and generate valuable insights into the biological activity, pharmacological effects, and potential toxicity of investigational drug candidates. Most pharma companies do not want to invest their time and resources in this domain and rather opt for professional expertise extended by the preclinical CROs. Preclinical CROs offer their expertise in the multifaceted management of this initial stage of the compound screening and evaluation process, which includes selection of suitable invitro profiling platforms, animal models, and the execution of pharmacokinetic, efficacy, mutagenicity, genotoxicity and in-vitro and in-vivo toxicity assays.
At Aragen Life Sciences, we support discovery, preclinical profiling and clinical candidate selection of NCEs for example small molecules and TPDs and NBEs for example peptides, mAbs, Oligos, RNA Therapeutics or therapeutic proteins. This also includes drug testing in rodents and non-rodents like minipigs, rabbits, beagle dogs or non-human primates like rhesus or cyno monkeys for assessing the pharmacokinetics, efficacy and safety of lead compounds.
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