"If we can predict, identify and prevent study drop-outs, we can reduce study time cycles and contribute to statistical integrity. In sum, AiCure makes clinical trials more effective and mitigates risk for pharma companies."
What challenges in the biopharmaceuticals space are AI and better data collection helping address?
The golden question is how to improve the operational process for pharma so as to shorten the time to market of their new medications and products. Artificial intelligence (AI) is enhancing data analytics and giving us access to a number of different modalities for data collection, such as wearables and mobile applications. It is also resulting in better insights and allowing for more assertive predictability. These two aspects are improving decision making. Historical information can be used to plot trends to inform executives what to expect, so that decisions can be made in advance. That is where the value of AI is contributing most to the drug development lifecycle.
We are working towards objective, numerically quantifiable indicators of how patients are doing over time. Ultimately, we should be able to identify subjects who are at risk of study dropout based upon their pattern of study drug ingestion. If we can predict, identify and prevent study drop-outs, we can reduce study time cycles and contribute to statistical integrity. In sum, AiCure makes clinical trials more effective and mitigates risk for pharma companies.
Can you give us an overview of your technology platform and explain how the data capture works?
We have a suite of adherence products, e-pro and digital biomarkers. AiCure provides software for mobile devices that we put into the hands of patients and subjects in clinical trials. We are able to support the patient through the process by ensuring they stick to the clinical trial protocol, by monitoring that they take medications on time and helping them to ingest the medication in the right way. For the pharmaceutical sponsors, we help corroborate that the clinical trial is conducted properly. Confirmation that the patient is ingesting the medication is the gold standard for what the industry is seeking. We can assure sponsors that their medication’s pharmacodynamics will have the best chance to manifest in their subjects as expected, and achieve this remotely from the comfort of patient’s homes.
It is about improving the richness of the data as much as the accuracy. We have for many years positioned ourselves not only as an adherence product, but also as a contributor to the understanding of human interaction with medical therapy. Why a person decides to take their medication or not is paramount to understanding how a medication will fare in the real world.
How receptive is the U.S. pharmaceutical industry to AI technology adoption?
Pharma has been able to adopt technology in a very robust and welcoming way. With that being said, pharma is a regulated industry and they have to take on new technologies with some caution to make sure that products are of medical grade.
It has become clear that there is both an interest and a need to define new clinical endpoints and methods for assessing patient outcomes. Pharma and regulators are eagerly seeking new ways of assessing disease that are more accurate and less subjective.
What are AiCure’s growth plans?
Our approach to business growth is to show value and return-on-investment to our partners. Simply put, we provide the foundations of the science and data that are needed to assess a new drug. Instead of a client-vendor relationship, we develop strong scientific collaborations.
In 2019, we launched a program called AiPEX™ (AiCure’s Partnerships for Excellence), in which Syneos Health™, the only fully integrated biopharmaceutical solutions organization which includes a contract research organization (CRO) and contract commercial organization (CCO), has been an exemplary partner. Together, we have made outstanding progress to create a unique offering for the market where we aim to deliver on a site network that is pre-qualified and trained to deliver unprecedented patient engagement, improved adherence, digital biomarkers and quantifiably better data.
What are the company’s main objectives and how do you plan to pursue them?
We want to make an impact on clinical outcomes and materially improve the way pharma handles new drug development. Our unique value chain begins with the fact that our technology interacts directly with the study subject every time they dose.