iBiomatics develops drug development portal for DevCo Pharmaceuticals
iBiomatics's portals are designed to provide drug development companies with access to analysis-ready data from ongoing and past clinical trials via the Internet. According to Scott Neuville, CEO of iBiomatics, the portal establishes data standards, enables collaboration among virtual teams and, by making real-time analysis possible, allows researchers to make faster, more informed decisions about a drug development project.
Innovative pharmaceutical companies see the Internet as a way to transform drug development, said Neuville. Solutions that leverage companies's most valuable assets data and documents about drugs under development will make this complex process more efficient and cost effective.
Scientific advances have created a backlog of compounds waiting to enter development. But the increasing cost of bringing these drugs to market has forced companies to make tough choices about how many compounds to pursue, leaving many to linger without funding.
It's a ripe environment for a company with a business model like DevCo's. The company, which has just nine employees worldwide, licenses compounds stalled in development and carries them through the early stages of the development process, assuming financial risk for the project. The company that discovered the compound can pay for the completed process later and market the new drug, or can choose not to reacquire the license, leaving DevCo free to sell the compound to a third party.
With six major compounds a number that rivals most top-tier pharmaceutical companies DevCo has nearly as many drugs in development as it has employees. Therefore, to make the most of the expertise of its small workforce, DevCo maintains project management responsibilities, but outsources the actual development process to qualified CROs (contract research organizations) across the globe.
With mounds of data coming in from the organizations that originally discovered the compounds, and mountains of additional data being generated by a battery of CROs facilitating the ongoing development process, DevCo needed a way to bring valuable information from many disparate sources together in an analysis-ready format.
We chose iBiomatics to develop the portal because clearly the tools that the pharma industry uses for analyzing raw data are SAS tools, said Virinder Nohria, Project Team Director for DevCo. They define the standard in the pharma industry. If we'sre going to start a new project, where ultimately the customer is the FDA, we would prefer to use tried and true, validated tools accepted by the regulatory authorities.
As a subsidiary of SAS, iBiomatics inherits a rich history of expertise in data warehousing and mining technologies. Neuville credits Jim Goodnight, SAS CEO, Chairman and co-founder, and Andre Boisvert, SAS President, COO and Chairman of the Board of iBiomatics, with the foresight to dedicate an independent business unit to the unique needs and applications of the life science industry.
iBiomatics's business partners are getting the best of two worlds, said Neuville. In addition to all of the tools iBiomatics is developing, our clients have access to all of the SAS tools. And currently, SAS has the only FDA-approved data standard for e-submissions. Our close ties and valuable relationship with our parent company, SAS, set us apart from other companies and greatly benefit our clients.
The DevCo portal has been under development since iBiomatics's launch in May last year. To date, the portal contains clinical data from 80 patients participating in studies on just one of DevCo's compounds. Data on a second compound, representing almost 40 clinical studies involving more than 2,000 patients, is now being entered into the portal.
The portal will help DevCo gain efficiencies in its business in a variety of ways. Perhaps the most obvious application is to facilitate the huge task of collecting and analyzing data from the company's broad range of CRO partners.
We want our CRO partners to use their own processes and ways of doing things, said Wayne Alves, Project Team Director for DevCo. They'sve built their organizations around those processes and they'sre most adept and efficient when they do things the way they know how. Quality comes from process. The virtue of this portal is being able to bring all that disparate information back into the system.
In addition, when discovery companies don'st re-acquire the license to market a fully developed compound, DevCo will use the portal for the due diligence phase of out-licensing to a third party. Instead of photocopying thousands of pages of data and trucking it to potential buyers, DevCo will simply hand out passwords to its iBiomatics portal.
In fact, one of DevCo's compounds is up for sale and currently being examined in this way by several of the world's largest pharmaceutical companies. DevCo hopes, with the help of the portal, they'sll be able to close the sale of this compound within two months, rather than the six-month timeframe this process usually takes.
The ability of companies to perform due diligence on a drug or medical device through an iBiomatics portal validates part of our business plan, Neuville said. Online data can be analyzed immediately to evaluate safety and efficacy, which is more efficient than flipping through pieces of paper. Potential buyers will be able to make fast, confident decisions.
Ultimately, Nohria predicts, the tool is going to become a browsing and review tool for the FDA. Once it's refined sufficiently, I see it as a real-time access to our database for the FDA, allowing the FDA to see what we'sve done with the data, he said.
Some of the innovation that has taken place at the FDA as they'sve handled translating the Modernization Act into their processes has set the stage for this, Alves added. I think they'sre out there ahead of the tools right now, but the interest is unprecedented. To have access to the data as we develop it in real-time I can imagine the help we can gain as we put an IND or NDA together.
We'sll have greater opportunities to deliver information and data to the reviewers in a way that makes sense to them, helping them to do their jobs better just as it helps us to do ours better, he continued. It's a heartening experience so far. All of these things are starting to converge and we have the greatest hope that this is the wave of the future in terms of e-pharma.
iBiomatics is working with a number of other undisclosed pharmaceutical companies to develop similar portals. The real goal is to save time and money on the drug development process, so that we can produce life-saving drugs and devices in a more timely fashion, making them readily available to the marketplace sooner rather than later, said Neuville. And eventually, we believe that the work we'sre doing is going to save lives and help humanity as a whole.
For more information about iBiomatics, visit the company's Web site at www.ibiomatics.com. To learn more about DevCo Pharmaceuticals, visit the company's Web site at www.devcopharma.com.