UBC Continues Rapid Growth in Specialized Services

Who is UBC?

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).

How do you differ from global CROs?

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 executives in the brand and commercial side of pharmaceutical companies. There is a growing recognition that post-approval research is going to become a critical part of the commercialization plan and that evidence will gain increasing share of the traditional promotional or commercial budgeting process.

Do you also work with smaller companies?

Yes, our second area of focus is drug development services customized for the needs of small, emerging companies. They are discovering that our size enables us to be nimble and responsive to our clients in a way that is difficult for the giant global players.

The smaller companies often need our input at the beginning of the product life cycle, so they value the fact that we can take them from Phase I to the marketplace, helping with regulatory strategy, reimbursement strategy and science-based market strategy.

How do you define emerging companies?

Pretty broadly. It can range from the six-person 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 fewer than 100 people. The common denominator is that these companies are operating on very aggressive timelines with talented but limited resources.

The growth of the biotechnology industry is not exactly a new phenomenon.

True. However the growth is accelerating a staggering pace. Total funding to emerging companies averaged over $11 billion per quarter in 2006, up almost 40% from 2005. We did an internal survey of more than 30 emerging companies and there were a couple of powerful conclusions.

First, emerging companies want one partner that that can provide end-to-end development services. These companies simply do not have the management overhead or bandwidth to pursue the pure “functional outsourcing model” that many of the big pharma have successfully implemented.

Second, there is consistent disappointment with the service level received from the major global contract research companies. There is a perception, rightly or wrongly, that the most experienced resources and the highest attention get allocated to their large, global clients. Given the scarcity of resources in our industry, it is hardly a criticism of the global CROs to say that they are focused on their largest clients and those projects that can “move the needle” in meeting their financial goals. However, for a company like UBC, it opens up a great opportunity.

What does UBC bring to the table other than a focus on the marketplace?

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 as I mentioned, 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 intensive users of technology. And probably most important, we are obsessive about open and frequent communication.

You mentioned technology. How important is EDC (electronic data capture) for the emerging company?

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.

What types of sponsors are most aggressive users of EDC?

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 have the resources to dedicate a team of people 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.

How do you see the market shaking out?

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?

How does UBC help its clients navigate the EDC shoals?

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.

What if your client has standardized on an EDC vendor?

We have worked with most of the prominent vendors and can integrate with any of them. That’s a requirement for doing business.

UBC uses the phrase, “Evidence Matters.” What do you mean by that?

The world is changing rapidly for developers and marketers of medical products. Not that many years ago, pharmaceutical and biotechnology companies could view the FDA as the last hurdle. If your product got approval, than you were pretty much home free. Now a new drug has to prove that it is safe in the “real world,” not just in the pivotal randomized phase III trial. Now that Part D is law, the US Government is the largest insurer for drugs. There is much speculation that government will establish new objective “hurdles” to qualify for reimbursement. The bottom line is that standards in the post approval world are rising and these standards will be based on evidence. UBC is dedicated to bringing the best resources to assist companies in gathering the evidence they need to clear these hurdles.

How is the UBC culture unique?

Through our acquisitions, we have on our team many of the founders of these well-respected companies who care deeply about the scientific integrity of the work. They share this passion with their teams – this focus on meeting the clients’ needs, on providing the most thoughtful, strategic solutions.

I think that’s why we have 90%+ repeat business and less than 10% turnover in our employees.

As a company, we support science. With well over 1100 publications, our scientists often speak at major conferences and serve on government and industry boards.

In addition, as an entrepreneurial company ourselves, we recognize the need to be both smart and efficient. Our information systems team works hard to find ways to add precision, while saving time and cost, for projects of all scopes – from patient recruitment programs to massive registries. We build projects using the most innovative and cost-effective techniques to handle integrating advanced data collection, data warehousing, clinical study management and post-market surveillance technology.