Often perceived as the plumbers and pipefitters of the life sciences IT world, LIMS vendors sometimes find it difficult to make their products stand out in the toolshed of similar offerings, but newcomer BioPoint is betting that it can overcome that hurdle.
Although the Danvers, Mass.-based startup, which celebrated its official launch on Dec. 15, offers a LIMS as part of its flagship DiscoverTrac information management system, “we’re a wholly different animal than LIMS,” said COO Christopher Hill. “We’re not LIMS-plus — we’re in a whole different category.”
The difference, according to Hill, lies in several areas. For one thing, the company is focusing solely on the pre-clinical segment of the drug pipeline — drug discovery, investigational new drug submissions, and toxicology testing. Within that narrow area of focus, BioPoint’s system offers a range of data management capabilities, as well as the ability to integrate in-house and third-party data, and capabilities to ensure data integrity and data security — features of particular interest to firms keeping an eye on the FDA’s CFR part 11 regulations, according to BioPoint.
Many biopharma firms rely on LIMS to track and manage downstream clinical trials or manufacturing information, Hill said, but the CFR 11 regulation has placed “much more of a focus on making sure that you’re capturing data and the very beginning part of the [discovery] process,” he said. Currently, many companies still rely on Excel spreadsheets to manage their pre-clinical data, while LIMS vendors have been slow to adapt their downstream-oriented products to work with early-stage data. BioPoint, however, views that gap as its opportunity for market success.
From the SEC to the FDA
Hill and BioPoint’s two other co-founders, CEO Elery LeBlanc and CTO Rick Gabrielli, worked for years in the financial services IT industry before turning to life sciences. After cutting their teeth on the highly regulated banking and brokerage environment, Hill said, they hardly viewed the FDA’s regulatory requirements as insurmountable. “The FDA is still in flux in terms of what the requirements are for digital signatures at all, but the financial world has been dealing with SEC regulation for years,” he said. “What we’re doing is to take those sensibilities and bring them to the biotech world.”
Two years ago, the three founders began speaking to biotech and pharma companies to determine their IT needs, and soon signed services contracts with four clients to develop data management systems for pre-clinical data. The lessons learned from those consulting projects have been built into the DiscoverTrac system, Hill said. Speaking to those early clients, “We found that LIMS was handling the manufacturing process, but in the pre-clinical phase, we found that the new FDA compliance and auditability issue created a business momentum,” Hill said.
BioPoint held off on its launch until it was certain that DiscoverTrac was ready for the demanding biopharmaceutical market. “After running it for two years, we know it’s 80 percent there — not 100 percent, because there’s no such thing as an out-of-the-box, plug-and-play, shrink-wrapped product in this marketplace,” Hill said. “We provide professional services to get it to 100 percent.”
DiscoverTrac runs on a central Oracle database and archives raw data that can be submitted with regulatory submissions. Company managers can control user access in order to comply with CFR part 11 requirements. “You have to prove that people who should have access [do] have access, and that people who shouldn’t have access don’t,” Hill said. The system offers colony management capabilities for transgenic animals, and supports information on breeding, ancestor/descendent charts, animal profiles, and other information that can be linked to particular experimental data, drug and sample inventory, clinical observations, and third-party tools and data.
Pricing for the system depends on the number of users and the degree of customization required, but Hill said that a typical, 10-seat system would be licensed for about $75,000-$150,000, with additional maintenance and services fees.
While acknowledging that it’s often considered “dangerous” for a company to focus so narrowly on one particular area, Hill said that the “criticality of the data integrity” in the pre-clinical stage of the drug pipeline convinced BioPoint’s founders that there was a real business opportunity in an area that they saw as “ignored” by other products on the market.
BioPoint currently employs around 12 people. The company is privately funded, “but we anticipate a venture round probably in the next nine to 12 months,” Hill said.
Meanwhile, the focus is on marketing. “We’re starting with a product that has been in production now for over two years, so we’re not starting from scratch. That gives us the ability to be very aggressive,” Hill said.