The summit – held in New Brunswick, New Jersey earlier this month – brought together representatives from Big Pharma and the contract research sector in an attempt to establish a best practices approach to quality management and CRO oversight.
First up was PharmaNet/i3 CEO Jeff McMullen who said that quality - in Pharma-CRO relationship terms - covers not only obvious deliverables like clinical data analysis and trial reports, but also less tangible factors.
“Intangibles relate to the personnel, the quality of the relationship between clients and CROs… the environment we establish for patients and subjects…and quality of the sites we choose and the respect we show those sites.
“Both CROs and Pharma companies face the same challenges when it comes to quality. We are all confronted with increasing complexity of trials, increased regulatory scrutiny, increased globalisation of trials which results in using less experienced investigators…we are all in this together.”
Quality protocols
Similar points were made by Pfizer’s senior VP and worldwide head of development John Hubbard, who set the need for agreement on quality in Pharma-CRO relationships in the context of his experiences at the world’s biggest drugmaker.
“There’s nothing that will focus you more on quality than a warning letter, but you don’t want that to be the impetus” Hubbard quipped, cautioning that for sustainability, quality initiatives need to come from within and not be driven by negative events.
“We are all faced – whether you are on the Pharma or CRO side of the equation – with incredible pressure,” he continued, adding that “there is tremendous pressure to get products to market more quickly…and that sometimes creates a tension that favours speed or cost over quality.”
The tension can be seen – according to Hubbard – when research units are incentivised to move fast, which is why Pfizer has developed processes designed to engender sustainable quality and why – he said - meetings like the Avoca Summit are so valuable to the drug industry
“We implemented a very rigorous process around analysing the quality of the protocol and then look at the risk associated with that protocol…we are in very challenging therapeutic areas – transplant, oncology, rheumatology – so we can’t write protocols that are risk free, that’s not real world.
“What we can do, “ Hubbard continued “is understand the inherent risk and plan the quality we need from the beginning, which is critical whether you are outsourcing or insourcing work…where issue happen is when your partner really doesn’t understand your objective.”
“This opportunity with the [Avoca] Consortium really is a driving force for a best in class approach. As Jeff said it is important to recognise we are in this together. It will not be successful if this is just a Pharma or biotech initiative…it has to be an industry initiative that includes our partners whether they are FSPs or full service CROs.”
Quality lever
Jeffrey Kasher, Eli Lilly’s COO of global clinical development, was similarly focused on a collaborative approach, warning that failure to implement such a strategy could have dire consequences for the pharmaceutical industry.
“We have a big problem…the industry as we know and love it is not viable anymore. We are facing death. We’re too expensive, we’re too slow and we are not creating medicines that add value to society, and there’s no magic bullet that will turn that around, but there are a few levers that can… transform the industry and… quality is one of those key levers.”
“Quality can increase speed, quality will drive down costs and quality will increase the value of the medicines you are working on.”
Kasher also touched on the increasing regulatory scrutiny facing the industry, suggesting that this too can be a stimuli for the development of more effective quality management systems.
“They [regulators] want assurance that the quality of the clinical work – no matter where it is done or who it is conducted by – is up to appropriate standards and they are holding both the sponsors and the CROs accountable...we need consistency of these quality standards across the industry.
“Quality management and oversight systems are necessary but not sufficient and I would say that holds for every pharma and biotech company,” he said, reiterating that “what we need is consistency across our industries.”
Outsourcing-pharma.com will be reporting more of the discussions and debates that took place at the event over the next month.