Julie Trim was Director of Exploratory Projects at Shire, managing the company’s strategic alliances, until she left to set up her own consultancy a month ago. “Shire is entirely virtual,” she told Outsourcing-Pharma.com.
“It has no labs – all its work is based on contract research, contract manufacturing and contract development. I was brought in to set up drug discovery on contracts. This was unheard of; the company had based its pipeline on acquisition.
“It was harder to do drug discovery without laboratories. The problem initially was turnaround time and the fact most CROs were regulated with GLP and GMP status. So trying to do non-regulated work in a regulated environment was difficult.
“A lot of my time was building relationships with contract houses so we could do development.”
Pharma ‘arrogance’
The first hurdle was attitudes, said Trim. “There can be a certain arrogance by pharmaceutical staff towards contract houses. But just because you’re in a contract house doesn’t mean you’re less of a scientist.”
Although this is changing, especially as “lots of people who were made redundant by Shire are going into contract houses,” alliance managers still need to practise diplomacy, Trim told us.
“There needs to be a respect. When we were running studies, especially pharmacology and PK [pharmacokinetics], contract houses fed back they were uncomfortable with the ethics [of our trials], especially around animals.”
Trim’s job was not to shut down contract scientists’ concerns but to negotiate a compromise. “It’s saying, ‘Ok, so you’re not happy with animal numbers or dosing regime,’ and asking what they suggest – treating them like part of the team.”
The snobbiest offenders are “smaller companies that don’t know how to work with contract organisations,” Trim told our reporter.
“Start-up companies – their whole operation is dreadful.” While they have “ideas” and “spark,” she said, “actually making it happen” was a challenge that requires project relationship management.
“Especially if they are from an academic spin-out or if they’ve come out of big pharma like GSK or Pfizer where they’ve not had to use contract houses before.”
In the worst cases, people view outsourcing like ordering from Amazon, she said. “‘I’ve ordered this pharmacokinetic study and expect everything to be perfect.’ You still need to have a big role in setting up the protocols, explain what you want to get out of it. They see the contract no differently from ordering a drum of sodium chloride.”
‘Dabbling’ scientists cause delay
Research timelines and deadlines also need to be properly managed according to Trim, who said that sponsors often want data sooner than contractors can provide it.
Drug development firms are “desperate to get our data”, said Trim but turnaround expectations differed widely, from the six-month studies contractors were used to, to pharma companies expecting results within one day.
This discrepancy arises because contract researchers, used to working to GLP standards, are busy preparing long write-ups, while sponsors are not clear initially about not wanting a full report. It is the task of alliance managers to “be the diplomat” in these cases and broker communication.
Drug development from initial feasibility through to pre-clinical candidate usually takes around 18 months. Shire’s request for shorter lead times was met with suspicion – “to start with they were quite dubious. They thought we were mad” – but the outsourcing model eventually reduced this to the point “all of them [the contract companies] are marketing it now.”
“I think when you’ve got your own labs it’s easy for scientists to dabble. When every contract counts – and the finance department [is firm], that speeds up.”