The new 96-bed facility – known as Clinical Pharmacology Unit (CPU) - is designed for Phase I studies and houses a pharmacy, processing labs and patient recruitment staff for both the recruitment and screening of study subjects.
By the end of the year the contract research organisation (CRO) plans to complete work on reference and bioanalytical labs it is also building at the facility.
Medpace president August Troendle said: “The vision for a state of the art campus began in 2008 with the construction of the existing CRO and global headquarters building” adding that “the CPU and the labs complete the fully integrated campus.”‖
The new facility - which doubles privately-owned Medpace’s capacity for Phase I trials – is the second purpose built early-phase unit to open in the US this month behind the one set up by CRI Lifetree in Marlton, New Jersey last week.
Similarly UK-based Synexus opened a new in-patient facility in South Africa - its fourth in the country - earlier this week that will conduct Phase II studies as well as later-stage research.
Whether this timing indicates the beginning of a trend – a possible pick-up in demand for early-phase studies? - or is simply a coincidence remains to be seen, but the fact both firms stressed their new units’ capacity for complex trials is interesting.
In September last year Kevin Olsen, president of market intelligence firm ISR Reports, told Outsourcing-pharma.com that in contrast with the claims of Big CRO that have cut Phase I capacity, demand for Phase I studies is stable but sponsors are choosing to work with specialists.
“[Large CROs] think the Phase I business has simply gone downhill but we’ve found demand is at least stable”, Olsen said, suggesting that what big CROs see as a slump is actually a shift in outsourcing spend towards niche providers.
Olson based his claim on a survey of more than 100 Phase I decision makers at pharmaceutical and biotech companies. More than four-fifths of respondents said early stage trials are increasingly complex, with patients now included more often, and this is affecting outsourcing choices.