CROs must swipe the lion’s share of clinical development work from Big Pharma for innovation to happen, according to a PCT panel.
During the discussion experts from contract research organisations (CROs), consultancy firms, biopharmas and pharmas came together to discuss whether vendors will take over clinical development entirely.
Though the panellists said Big Pharma once conducted most clinical trials, the general consensus was that there is a shift towards outsourcing most operational work – especially to large CROs. Furthermore the speakers welcomed the change in the interests of pushing innovation through from smaller companies.
Ann Wang, VP of clinical operations and data management for GSK’s Human Genome Sciences said: “I think from a small company’s perspective it’s a necessary evil because you can’t have the global footprint the Big Pharmas have in order to conduct your work.”
Emiliano Rial Verde, a management consultant for McKinsey, added that though large CROs will take up the biggest chunk of work because their wide geographic footprints and broad range of capabilities will allow them to run entire programmes, smaller providers will also “fill a niche”.
“The way I see it that the smaller the player the more specialised it will be,” he said.
I would expect large CROs who partake in entire programmes with large CROs will participate earlier and earlier.”
As for pharma firms, the panellists believe aspects of clinical development not related to operations – for instance oversite, trial planning and regulatory strategy – will be their main functions.
Gilead Sciences’ associate director of clinical operations Steve Martin said: “I think on the clinical operations side of things, we have always operated through CROs and aren’t capable of running in-house trials in the regions we need to.
“I can see CROs here they would take the lion’s share of business for operational, but not for clinical development as a whole.”
A change in paradigm
However although those involved in the discussion – held at this month’s Partnerships in Clinical Trials Europe – welcomed the idea of CROs conducting the majority of operations functions, there was a call for a change in the entire clinical trial business model if the changes are to work.
Dan Perlman, CEO of RPS, branded the current model outdated, saying: “If you look at CROs the model is one-size-fits-all. There might be a price difference, but it’s give it to me and I’ll give it back to you. That’s always the model.”
Wang agreed adding “we’re still trying to do the work in the 21st century using a 20th century model. The challenge is how can we do this differently?”
The solution? More long term strategic partnerships between pharma and sponsor which are flexible and have the ability to evolve, according to Rial Verde.
Wang added that, in terms of infrastructure, long term deals are the only way forward, and that “once you start to work with someone and build an infrastructure like shared metrics that will go some way towards doing this. If you change your partners and everyone has different level of technology it won’t work.”