CRO Central Lab Expansion

Market demand broadens bundled services

By Kristin Brooks

The need to accelerate drug development has led to the rise of global clinical trials in search of large patient populations. Along with increasing trial complexity, which requires more esoteric testing to be done closer to the patient, this has spurred the CRO industry’s recent central lab expansion initiatives. Market demand for central lab services has increased dramatically during the past few years, particularly in developing regions such as India and China. CROs are taking full-service to a whole new level, building up the global central lab in an effort to provide faster turnaround and seamless global data to pharmaceutical and biopharmaceutical clients around the globe.

“MDS Pharma Services, the first CRO to establish a central lab in China, has had a presence for more than a decade in Beijing, where the business recently tripled its space and increased testing capacity five-fold,” according to a company statement.

“Central labs are fully outsourced by the pharmaceutical industry and, unlike core CRO services, no pharmaceutical company has its own central lab,” said Bob Scott-Edwards, president, ICON Central Labs. “The key drivers for central lab expansion are the same as for the CRO: more studies; more companies doing trials; the search for trial subjects; and the drive to complete registration dossiers for as many countries as possible as quickly as possible. CROs have become more interested in central lab services as a way of bundling their service offerings for their clients and providing a broad range of services.”

Expansion Activity

CRO central lab expansion has been considerable across the globe, but India and China have seen the most activity in the past couple of years. Either through establishing new labs or partnering with local labs in the desired region, CROs are rapidly responding to market demand.

• Quintiles expanded its Global Central Labs and Clinical development Services (CDS) units in Beijing and opened a Central Lab in Mumbai, India
• PPD expanded its Global Central Lab services into China
• MDS Pharma Services expanded Central Lab operations in China
• PRA opened a new office in Mumbai
• Eurofins opened a new Central Lab in Singapore
• Covance opened a Global Central Lab in Shanghai

“The number of trials in the Asia-Pacific region is increasing, and with that the use of more and more remote clinical sites. This, combined with some local regulatory issues around the shipment of human blood samples, is driving the need to have short (less than one day) shipping distances from clinical sites to lab testing facilities to ensure that samples can be rapidly tested in a central lab using globally standard equipment,” said Graham Bunn, vice president Global Partnerships, Medidata. Also, obtaining im-port/export permits can be a harrowing experience, according to Tom Wollman, senior vice president, Global Central Labs, Quintiles, particularly if you have to get them every year and you’re working on a four-year trial.

Increasing trial complexity requires more testing to be done closer to the patient to support screen turnaround times and sample stability. Also, being closer to the patient reduces transportation costs. Mr. Wollman said, “With a more complicated protocol you may need to do more testing, in India and China for example, where you’re using your testing as an inclusion/exclusion screening criteria. So you need to be able to do it quickly and closer to the patient, because either you don’t have the time to ship the samples or you may have regulatory restrictions against shipping them, as well as just the costs associated with shipping them.”

A major regulatory hurdle in China is that whole blood cannot be taken out of the country. “For this reason,” said Dr. Agostino Fede, senior vice president of PPD and head of PPD’s global central labs, “we partnered with Peking Union Lawke (PUL) to expand our global central lab services into China. As local experts, PUL has a strong understanding of the Chinese market and our partnership gives us access to PUL’s employees. PUL is running tests using our standard methods, which have been cross validated with our other locations to ensure we deliver global, combinable lab data. Through our partnership, we avoided the crucial time and cost delays that we would have incurred with independently opening a fully-owned lab.”

PPD was able to provide central lab services within five months of signing the contract with PUL. For CROs opening central labs on their own, navigating the regulatory and legal framework can take a lot longer. For these reasons, partnering can be beneficial with central lab expansion initiatives. In Japan, for example, Quintiles partnered with Medca Japan to provide central lab services to support trials in Japan. Partnerships also help to ease the cultural, regulatory and language barriers that can make setting up operations from scratch, a lengthy and challenging process.

Being on the ground in emerging markets such as China can also prove beneficial with patient enrollment and retention. Proximity to the patient increases the window investigators have to see patients, according to Mr. Wollman at Quintiles, and if you’re working on a trial in India and you have to ship the sample to Europe, time becomes critical. “Say for example, Wednesday at 2pm you have to stop the site from seeing patients, otherwise the samples are going to get stuck in customs over the weekend and they won’t be able to make it in stability. If we run the testing in the region, we can allow the investigators to see patients through the week and even Saturday if they need to. I think that’s very important,” Mr. Wollman remarked. This also helps resolve potential scheduling conflicts with patients.

Future central lab expansion plans for Quintiles include Russia, while PPD sees India on the horizon. “The final frontier we are looking at, depending upon client demand, regulatory and economics, is Russia. We can handle western Russia today, Moscow and St. Petersburg, reasonably well, but if trials go further into East Russia, we need to be able to deal with that,” said Mr. Wollman.

And, according to Dr. Fede at PPD, the China partnering model will probably follow in India once there is a dedicated volume. “Right now we solve this very well out of Brussels because logistics is short — we get most of the specimen in Brussels within 48 hours — but as the market evolves we are also considering India,” said Dr. Fede.

Central Lab Services

Central labs no longer only provide safety, hematology, and chemistry testing services. Esoteric testing in areas such as biomarker and bioanalysis, pharmacokinetics (PK), pharmacodynamics (PD), and genomic testing are in great demand these days. According to Dr. Fede, almost every study they provide services for involves a biomarker and more than 50% of their workload is specialty service related. Sample collection and management for downstream pharmacogenetic testing are now coming to the forefront as well.

Most central labs do work with third party specialty labs when necessary for specific tests, or in a situation where the specialty lab has an Intellectual Property (IP) patent on a certain technology. These services might include highly specific antibiotic resistance tests and molecular biology for very sophisticated markers such as oncology and osteoporosis. For the most part, however, global central labs are broadening their capabilities to include these special tests; ICON Central Labs’ in-house menu, for example, offers more than 450 tests. These include routine safety testing as well as a broad range of esoteric testing including a system to support global flow cytometry testing, polymerase chain reaction (PCR), DNA / RNA extractions and the capabilities for assay development and transfer. And, according to Mr. Scott-Edwards, “Our aim is to bring up any assay that is required in-house to retain control and consistency. Only about 2% of our work is referred out to specialists.”

CRO/Central Lab Partnership

With CROs and their respective central labs working together, the full-service model takes on new meaning. The potential synergies and efficiencies created though such an alliance would be tempting for any sponsor looking to save time and money with development projects.

Within Quintiles, the CRO and Central Labs work hand-in-hand, according to Mr. Wollman. The central lab, the CRO business and data management all report to the chief operating officer of Quintiles. “Organizationally, they’re all within a product development group. We are working hard on some integration between our CRO and our Lab. We believe there is much efficiency we can gain to reduce timelines and cost and also have a kinder, gentler, better offering from a site perspective. For example, where we’re going to get site information once and do closing queries in one aggregated way vs. each side doing closing queries,” said Mr. Wollman. Taking into account that a central lab produces about 60% of the data in a NDA, according to Mr. Scott-Edwards, strong data management is key.

“The link between CRO and central labs is significant. There is a lot of synergy between our Phase II-IV and our central labs. We share a lot of common trials and the client benefits from that,” Dr. Fede at PPD commented. “As a result, all of the data management is done in-house from the same database, which significantly cuts development time. We meet and sometimes beat the deadline for database lock by having the databases together. Also, for project management, it’s easier to have one point of contact for the sponsor. Then there are the obvious efficiencies in terms of volume and financials. When the central lab and CRO work together, it brings significant benefit to the client. Not only financially as a one-stop-shop, but operationally for time gains and cost savings, as well as less headaches for the client.”

“Market expectations have gone up a lot in project services and project management, and sponsors are expecting labs to be much more like a CRO, expecting us to be proactive, to manage their budgets, develop contingency plans, etc. One of the biggest changes I’ve seen is a significant raising of the bar on the services side by the market,” said Mr. Wollman. As the CRO/central lab relationship unfolds, we can expect to see many more global central labs along with their clinical trial counterpart offering the ultimate in “bundled” services.

Kristin Brooks is associate editor at Contract Pharma.