Early stage pharmaceutical and biopharmaceutical research offers the opportunity to deliver the next life-saving drug or therapy. The journey begins in the mind of a research scientist who asks the question, “What other uses can we derive from our existing line of therapeutics?” This includes those drugs or therapies that started in the lab and have advanced to approved use. What does this early stage research look like? It begins when a research scientist believes there is potential for an existing drug to provide a treatment or cure for something other than its original intended purpose, also known as indicative research.
Let’s take Gilead’s Remdesivir as an example. Remdesivir™ was originally developed to treat childhood respiratory diseases. Subsequent research was conducted for its use against the Ebola virus. “Though the drug ultimately failed in those intended uses, Gilead continued to research its potential.” Fortunately, continued research into Remdesivir™ has proven to be an effective therapeutic for Covid-19, and not a moment too soon. There is long track record of drugs developed for one purpose being used to successfully treat other health-related issues.
The first step of this research and development (R&D) journey is to query the Clinical Trial Management System (CTMS) for clinical trials related to the original approved drug for new indicative research. Prior clinical trials will have yielded a collection of human samples, i.e., blood and tissue samples that are stored in vast arrays of refrigerators and freezers for safe keeping. Once samples from a past clinical trial have been identified as potential for new research, a request will be made to clinical operations to determine whether the patient has consented their use beyond the original intended use. This type of consent is known as broad use and this is where the process bogs down.
A researcher will likely create a request for the multiple samples required for new research in Excel, populating rows with individual samples requests. This file will then be forwarded to clinical operations via email. Clinical operations will query their Laboratory Information Management System (LIMS) or Enterprise Content Management (ECM) for the signed consent forms. They must go one-by-one and consent-by-consent reading the forms to determine whether the requested samples meet the criteria of “broad use.” Once that process is complete, the package is sent to the ethics team for final approval. This process can take months for a single research request.
If you consider that about 70% of drugs never make it to market because they prove ineffective or too toxic, then early stage research is a multiple of the number of actual clinical trials. In other words, the current manual process of determining consent for reuse repeats itself many, many times before a new drug or therapy ever makes it to market, making it a big and expensive problem to solve. The speed of access and volume of data available to researchers for clinical analysis in early-stage research determine how much faster companies can deliver the next life-saving drug or therapy. Enter digital process automation (DPA). Through the application of DPA, the entire process can be containerized and dramatically accelerated.
Let’s look at this same process using a combination of microservices, artificial intelligence and DPA. Now, when a researcher makes a request, he or she can query CTMS, tag relevant trials and samples, and automatically send a request to clinical operations who will execute an automated query to LIMS or the ECM repository. Using natural language processing, the application will automatically pair requested sample requests to consent forms to determine intent. Clinical operations will validate whether broad use consent exists and automictically forward positive matches to the ethics team to review and provide final signoff. Because all of this happens within the digital container, auditing and reporting are included as part each research request. What took weeks to months can now take hours to days.
Early stage clinical research is the foundation of all new drug development. Through digital automation, we can remove time and cost from the equation so that pharmaceutical and biopharmaceutical companies can focus on life-saving research and development to deliver the drug to market cheaper, better and faster.