The CRO

Mark P Clein, President and Co-Founder of the United BioSource Corporation, takes our eight questions challenge.

“The reality is that an emerging company wants to spend its time on drug development, not software selection”

NGP. Who is UBC and how do you differ from global CROs?
MC. UBC, United BioSource Corporation, helps pharmaceutical and biotechnology companies develop and commercialize new medicines and therapies, from molecule to market.

We have more than 700 people in offices around the world and can provide end-to-end drug development and commercialization solutions. When people first learn about us, they are surprised by our depth of scientific talent. Approximately one-third of our more than 700 employees hold advanced degrees (Masters, PhD, MD).

We are focused on two market segments that have historically not been areas of top priority for global CROs.

Our first area of focus is very late stage and post-approval research. We have world-class expertise in safety, epidemiology, economics and outcomes – this is increasingly the differentiator in successful post-approval research. Our clients in this area are typically the large pharmaceutical and major biotech companies. Safety has really been driving the growth of this area and our interaction both on Capitol Hill and at the FDA indicate that this is likely to accelerate. We are also starting to see serious interest in evidence-based programs from the brand and commercial side of our clients. There is growing recognition that post approval research is going to be a critical part of the commercialization plan and that it will gain increasing share of the promotional or commercial budgeting process.

Our second area of focus is drug development services customized for the needs of small emerging companies.

NGP. How do you define emerging companies?
MC. Pretty broadly. It can range from the start up with an initial round of funding to extremely well funded companies with one or two marketed products. There are also several significant foreign pharmaceutical companies that operate in the US with a “small company” model, developing drugs in the US with a total staff size under 100 people. The common denominator is that these companies are operating on very aggressive time lines with talented but limited resources.

NGP. What does UBC bring to the table other than a focus on the marketplace?
MC. Several things. First is capital. We have over $150 million in equity capital and no debt. We are in a position to aggressively invest to support our clients.

Second is professional resources. We have employees in offices throughout the US, the UK and Continental Europe. And one third of our employees hold advanced degrees which is probably triple the industry average. Our scientific and medical experts are not consultants; they are employees.

Third, our systems and culture are designed around intensive responsiveness. Access to metrics and project status are real time. We are aggressive users of technology. And probably most important, we are obsessive about open and frequent communication.

NGP. You mentioned technology. How important is EDC (electronic data capture) for the emerging company?
MC. There is enough noise in the marketplace to make a VP of R&D’s head spin. The reality is that an emerging company wants to spend its time on drug development, not software selection. Executives of emerging companies want lower costs and higher integrity to the collection and organization of their clinical data, and that is the attraction of EDC.

The challenge is that to realize these benefits, the software needs to be integrated into a full service data management solution. Software vendors are not set up to provide this level of service and the service vendors are still coming down the learning curve with the technology.

NGP. What types of sponsors are most aggressive users of EDC?
MC. In our customer base, we are seeing traction in companies of all sizes, but on balance there is more momentum in the large companies. These organizations are able to dedicate resources to evaluate the landscape and put EDC through a “functional outsource” process and then standardize on a platform. The smaller companies want their CRO to bring this resource to the table or to manage the resource if the sponsor has invested the time to select a product.

NGP. How do you see the market shaking out?
MC. We see EDC more as a tool for a market than as a market per se. Like most innovative technologies, there will be a shake out of vendors and commoditization of the products. Something that today looks exotic and innovative will become taken for granted. How many people today agonize over their email vendor or Internet access carrier?

NGP. How does UBC help its clients navigate the EDC shoals?
MC. We are fortunate in that we have a very strong technology group. We are one of the leading merchant vendors of IVRS (integrated voice response systems) and have over 25 software developers in house.

About 18 months ago, we dedicated a team to integrate electronic data capture into our data management system, starting first with late stage trials and registries. This is a proven system that has been delivered successfully in several projects. The system is now being rolled into our phase I-III systems for emerging companies.

NGP. What if your client has standardized on an EDC vendor?
MC. We have worked with most of the prominent vendors and can integrate with any of them. That’s a requirement for doing business.

UBC, United Biosource Corporation, is a global pharmaceutical services company that partners with companies to develop and commercialize new medicines and therapies.