For a while now, Attentive has been working with Agilex in supporting some of their contract work if and when larger test systems are required. Agilex chose to collaborate with Attentive because even though we are a boutique organization operating with the flexibility of a small, nimble organization, Attentive is uniquely positioned to support virtually any test system required for IND-enabling studies.
After working with one another for a period of time, it occurred to both Attentive and Agilex that perhaps not all our clients and sponsors out there realize the resources they can tap into that are available in Australia. So Attentive is uniting with Agilex to present a webinar on Feb 9th titled “Did you know Australia does Toxicology?”
Australia is a highly attractive destination for first in-human clinical studies to support the development of novel therapies and vaccines. The streamlined regulatory environment includes a requirement for Human Research Ethics Committee (HREC) approval and notification to the Therapeutic Goods Administration (TGA). First-in-Human (FIH) data can be obtained much earlier in development through a world-class regulatory process. Australia has an advanced clinical trials industry and clinical trial data generated in Australia is globally acceptable to the FDA, EMA, PMDA, and Health Canada Regulatory Bodies.
Another significant advantage of Australia as a clinical trial destination is potential for significant cost savings. Australia’s favorable Research and Development (R&D) Tax Scheme encourages international biotechnology companies who are eligible to take advantage of the 43.5% cash rebate to conduct their studies in Australia. With world class infrastructure to support early phase clinical research studies with speed, quality and cost advantages, Australia is also the ideal destination to conduct non-GLP and GLP toxicology studies to support FIH regulatory approval.
WHAT WILL YOU LEARN?
• How eligible biotechnology companies can access Australia’s R&D Tax Scheme where sponsors can take advantage of 43.5% cash rebate on nonclinical activities supporting clinical trials in Australia.
• Agilex Attentive Australian Advantage that offers sponsors full IND-enabling toxicology services to support first in human trials.
• Pros and cons of conducting non-GLP and GLP toxicology in Australia
• Hear from an experienced Human Research Ethics Committee (HREC) reviewer on nonclinical data requirements and approval process to access one of the most efficient regulatory approval processes in the world for first in human studies.
• Learn how Australia’s world class clinical research infrastructure supports early phase clinical research studies with speed, quality, and cost advantages.
WHO SHOULD ATTEND?
All scientists and business executives who are looking to embark on their non-clinical IND enabling toxicology programs in an agile and attentive manner.
Along with our friends at Agilex, Attentive would like to invite you to join us on Feb 9th to learn about the resources available via Kansas and Australia!