Preclinical & Drug Safety
On the journey to a new drug for human disease, the first hurdle is ensuring that the preclinical candidate is of the absolute best quality in terms of physicochemical properties, pharmacology, DMPK/DDI profile and in vitro safety profiling. Partnering with Sygnature Discovery will ensure that all elements of drug discovery will be run in a genuinely integrated way with all these needs addressed and optimised during the medicinal chemistry phase.
Once a preclinical candidate has been nominated, the next stage is preparing for an Investigational New Drug (IND) application or Clinical Trial Application (CTA). These documents are required to be submitted and reviewed by the relevant global health authorities such as the FDA and EMA respectively to allow an investigational drug to be administered to humans. Key robust data that must be submitted include demonstrating how the drug is made and proof of its purity and potency, and the results of testing the compound in animals along with the detailed plans of determining and exploring exposure in humans as safely as possible. It is essential to get this preclinical phase correct, as high rates of attrition still plague the industry and the focus must be on human efficacy and safety as the absolute goal.
For some of the data above, this will have been started to have been gathered and projected in the drug discovery stage at Sygnature Discovery. For example, the projected efficacious dose in humans along with the projected human PK parameters will have been estimated which will feed into safety-margin calculations once the first toxicology studies are undertaken. Also, for CNS indications GLP substance abuse and dependence studies must be undertaken, and our scientists can run these in-house.
The key areas that will feed into the IND application or CTA are Chemistry, Manufacturing, and Control information (CMC), non-clinical pharmacokinetics, pharmacology, and regulatory toxicology studies, both in vitro and in vivo. Supporting functions will include formulation development for both toxicology studies and Phase 1 studies, compound route investigation and scale-up, non GMP and GMP manufacture and GLP bioanalytical assay validation.
Sygnature Discovery works closely with several trusted partners in this preclinical space, so please get in contact with a member of our team to discuss and optimise your route from preclinical candidate to “IND” ready in the best, most efficient and cost-effective way with maximum chance of success.
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