DaVita opens PI facility for kidney research
The centre – a 35,000 sq ft 80-bed amenity based in St.Anthony hospital campus in Colorado, US – will help sponsors assess how drugs pass through the kidney or how they interact with the liver.
The move extends DaVita’s total number of beds in North America to 122, and means the clinical research organisation (CRO) can for the first time recruit healthy volunteers as well as patient populations.
Speaking to Outsourcing-Pharma.com, VP of commercial development Kevin Goudreau said the expansion was a response to a rise in the number of renal trials as a result of increasing regulatory pressures.
“The regulators are putting more focus on understanding exactly how the drug works in vitro and as a result are putting more focus on this area,” he said.
VP of clinical services Amy Young added that 80 per cent or more of studies going through the US Food and Drug Administration (FDA) approval process at present are required to look at toxicity activity in the kidney, and an increasing focus on hepatic trials.
“Basically, there is an increase in pressure to do more early on in clinical trials,” she told us, adding that more than 90 per cent of trials need renal or hepatic data.
Niche offering
Goudreau admitted that the decision to open such a specified facility may seem unusual in the present climate, with the industry leaning towards bigger strategic deals rather than more niche offerings.
However he said it is those strategic deals that provide it with a large chunk of business.
“We don’t only go directly to pharma companies, we build relationships with CROs who have strategic relationships with these companies. When they need this sort of specialised activity, they come to us,” he said.
He added that renal and hepatic expertise is only part of the attraction for those looking to outsource, as patient access is also a big boon.
Young added: “It takes a different level of staff and expertise to manage these kind of trials. Finding the right patient population is exactly what companies are looking for, rather than cost.”
Goudreau however said that cost still does come into the equation, but that supply and demand for patients means that getting a bargain is not necessarily as important as in other service arenas.
“Any of the big partnership models forged between sponsors and CROs have really focussed on driving costs down over the past five years, but it’s crucial to have access to patients and often companies are all vying for the same patient,” he said. “Sometimes you have to beat five or more other companies to get access.”
