By Dr. Kurt Sales, CSO
Preclinical toxicology studies are an essential part of the drug development process as they provide insight into the tolerability and toxicity of a new drug before it is tested in man. These studies play a crucial role in determining the “reasonably safe” first in human (FIH) dose, appropriate dose ranges and dose escalation regimens for the initial human trials plus indications of potential side effects. They also provide valuable insights into the absorption, distribution, metabolism and excretion of the drug to inform pharmacokinetic modeling and clinical study design. Having a robust preclinical toxicology program and trusted provider is thus critical for success as your drug moves through development and into the clinic.
With many companies still feeling the effects of a global funding downturn, speed and cost have now more than ever become a priority and Australia’s streamlined approval process for initiating human trials has become globally accepted as one of the fastest ways to regulatory approval. However, speed into the clinic only works if all the appropriate preclinical toxicology has been completed. Here Agilex Biolabs, Australia’s largest and longest established Toxicology and bioanalytical provider, comes to the fore.
Agilex has access to a local animal ethics committee for approval of our animal studies, which operates on a rolling monthly approval schedule. Application approval is received within 2-3 weeks and the turnaround time for approval of animal use is about 6 weeks. Animals are available on a weekly basis from our supplier, so we can initiate the study within 6-8 weeks from signing the contract, subject to availability of test article. The fast startup of preclinical studies at Agilex means that data are generated faster and available sooner to start those pivotal first in human studies.
Why choose Agilex for your preclinical toxicology?
In addition to fast startup of studies, conducted to a global GLP standard, with SEND data format available for FDA submission, Agilex’s study director and toxicologist staff have extensive experience, training and formal toxicology qualifications to ensure that studies are designed and executed to the highest standard. Agilex can support exploratory studies in rodents, non-GLP maximum tolerated dose and dose range finding, (MTD/DRF) studies, single dose extended toxicity studies, followed by 28-day, 3-month and 6-month GLP toxicology studies to create a full IND enabling package. In addition, Agilex can support acute, subchronic and chronic studies (7, 14, 28 and 90 day and 6 month duration) in non-rodents as well as rat carcinogenicity studies. We have an established Program Management Team who ensure smooth running of complete toxicity packages, ensuring a turn-key solution for clients wanting to get data fast.
What type of drugs can Agilex support?
Agilex can support a wide range of therapeutic modalities and routes of administration. Our recent studies range from small molecule chemical entity drugs to oncolytic virus, psychedelics and vaccines. Agilex has a local license to hold highly regulated drugs, which include US Schedule 1 drugs (known as Schedule 9 drugs in Australia) such as cannabinoids and psychedelic drugs with high potential for abuse. We can add regulated drugs to our license within 2-3 weeks versus 6 months for US DEA approval. Our BSL2 OGTR accredited facilities enable us to work with GMOs, with approval for the use of GMOs obtained through our local biosafety committee within 4-6 weeks of application submission.
Another benefit to conducting drug development studies with Agilex in Australia is the cost. Companies with a turnover of less than $20 million AUD can receive a cash rebate for eligible expenses incurred within Australia, which includes preclinical studies and toxicology. Furthermore, offshore study expenses can be eligible for a cash rebate if the service is not available in Australia. The cash rebate, along with additional cost savings stemming from more efficient timelines and favorable exchange rate allows developers to extend their funding further whilst capitalizing on speed to get their data faster to get into the clinic.
With over 26 years of experience supporting and accelerating preclinical and clinical trials from around the world, Agilex has become the trusted provider for high quality toxicology services in Australia. In addition, Agilex’s in-house bioanalytical service ensures fast and efficient sample analysis to ensure TK/PK/PD data is available faster for moving your study into the clinic.
To learn more about how Agilex can expedite your drug development program, Contact us today for a confidential discussion.
