The time it takes for a new medicine to arrive to patients can be the difference between life and death.
Getting a new drug to market can take up to 15 years, as U.S. Food & Drug Administration (FDA) testing requirements are extensive. The new cloud-based SaaS platform GxPaaS streamlines the process—focusing especially on one key stage late in development—with the aim to get medicine to patients as quickly and efficiently as possible.
Based out of Raleigh, the startup enables life science professionals to store and access testing results and documentation quickly and easily in one centralized location. GXPaaS recently participated in the CED-led GRO Incubator among other startups like Rbundle, Jobvious, Reed Ag Solutions and Solib Solutions. (Here are our earlier features on RBundle and Jobvious.)
GxPaaS Founder and CEO Andy Robinson said the idea behind his platform is that when the drug manufacturing facility begins operating more quickly, patients get their medications sooner. In other words, he wants to get chemotherapy medicine to your mom or daughter two or three months earlier than he otherwise would have.
Even after a drug has been approved for patients, extensive equipment and software testing must be performed on the manufacturing facility before it can start producing the drugs at scale. For decades, scientists and researchers recorded their testing results (for this stage and others) using a pen on a printed-out test, but it’s not just a simple check box. It is an extensive amount of information to write down.
Robinson said you can easily reach more than 1,000 pages during the drug development process.
It is inefficient, he said. Delays due to formatting errors and illegible handwriting are attributed to the fact that it’s recorded on paper versus recorded electronically.
Robinson’s platform replaces the manual process of pen and paper with something entirely electronic. All you need is a laptop or tablet. Describing itself as a ‘paperless validation platform, built on the cloud, for the modern life sciences company’, the GxPaaS platform allows the user to:
- Focus on content and not formatting when creating documents and tests
- Record test evidence electronically to minimize human error and allow for speedy real-time reviews
- Organize attachments, observations, and tasks with ease
- Efficiently collaborate on reviews and approvals
With Robinson’s platform, you can focus on what is important: getting a new medicine into the hands of the patients who need it as quickly and safely as possible.
“Focus on the content,” he said. “What are the important steps to test this thing? Don’t worry if you’re using the wrong font, or the right size, or the numbering.”
Having worked in chemical engineering, system integration and equipment manufacturing, Robinson is well-versed in all aspects of drug development. He saw the lack of innovation towards the end of the drug development chain and thought perhaps that’s where he could help.
“I don’t know if I could create a revolutionary new type of machine that no one’s ever seen before, but what I do know, and what I’ve been sort of dwelling on for 15 years now, is this spot here,” he said.
There are few competitors in the life sciences digital validation software space, such as Kneat and ValGensis.
Even though they have been around for a long time, Robinson said that does not necessarily indicate they have captured the market. Rather, they have captured the mindshare.
“I’m grateful for the fact that they’re trailblazers, but I think I’m bringing something better to market,” he said.
By the end of this year, Robinson hopes to release the first version of the platform and have three to four customers.