Our long standing collaborator and a client, a Biotechnology Company based in the USA approached IAG to discuss the development of their asset. Their concern was that over the last 20 years there were no treatment approved in this particular therapeutic area. All trials which attempted to prove efficacy of the drug have failed to meet their primary endpoint.
It was important for the Company to conduct an exploratory study of their platform targeting this particular therapeutic area, however the budget and resources were restricted. Further investment was possible once certain milestones were met.
IAG’s Strategy and experts have designed a what we called a Phase 0 (or a proof of concept) study, which helped to explore the potential of the new treatment in healthy volunteers. The study was designed in such a way that we were able to gather further efficacy data. While the data was limited, it still gave us an indication of what biomarkers (clinical and imaging) would be the most reflective of the asset efficacy.
From the technical and budgetary view point we suggested to automate some of the labour intensive and human error prone processes. This would require working closely during the trial to collect sufficient data to enable the automation.
Our initial engagement included building into our data management platform DYNAMIKA some of the study-specific functionality to handle complex imaging datasets. As we moved from Phase 0 to Phase I, we collaboratively worked with the Company on optimizing the way the data is quality controlled and read. We ultimately designed an image acquisition protocol and a procedure around it, which allowed us to deploy fully automated QC to all imaging data acquired at sites.
By the time we have started Phase II, we had enough imaging data to automatically detect certain body parts in these imaging scans, e.g. automated segmentation (though using earlier data for training of a machine learning algorithm). Automating many manual processes of imaging data management has reduced data redundancies and allowed direct integration of the data from the investigator sites into the trial database.
In Phase II, we were able to reduce the budget by 35% and improve the quality of reads through achieving 95% reproducibility between the expert readers, who now used pre-segmented images to make their judgement.
We also recorded the highest investigator satisfaction through significantly reducing/eliminating paperwork, providing state-of-the-art easy to use infrastructure including eCRFs, automated quality assurance routines, monitoring dashboards and other tools for real-time communication between the sites, the Sponsor and all other stakeholders.
The Company is currently in the final stages of their phase II trial and budgeting for phase III, where the automation introduced in earlier phases will ensure tight budgets, the highest quality control and truncated timelines.
IAG is a strategic partner to bio-pharmaceutical companies developing new treatments to improve patients’ lives. Our dynamic Strategy, Trial Solutions and Bio-Partnering divisions work closely to meet critical needs of biotechnology companies: funding, clinical development and monetization of their assets. We fuse decades of therapeutic insights, risk-sharing business model and agile culture to accelerate novel drug development. IAG broadly leverages its core imaging expertise, proprietary technology platform DYNAMIKA and capabilities to support an objective early go no/ go decision and drive excellence for tomorrow’s innovative therapeutic agents with speed. www.ia-grp.com