Drug giant Roche to offer clinical services

In what it believes is an industry first, Roche Pharmaceuticals will offer its clinical development services to outside customers, particularly non-government organisations (NGOs), according to the drug giant's global head of clinical pharmacology development, Prof Graham McClelland.

McClelland was in Melbourne today, where he addressed a BioMelbourne Network CEO boardroom lunch, sponsored by Nucleus Network, about Roche's novel approach to the structure of its applied clinical development services.

The services being offered by Roche will be in three main areas, McClelland told Australian Biotechnology News. "One is the actual conduct of studies in healthy human volunteers, clinical pharmacology studies, which includes the first time ever drugs are administered to human beings," he said.

Another area on offer will be Roche's sample handling activities for which it has a global distribution and tracking system. "So that's transport and management of samples from clinical trials, blood samples generally, plasma and so on," said McClelland.

The third Roche service will be the manufacture and supply of clinical trial materials, such as capsules and tablets for very early clinical trials. While this service will only be offered at Roche's largest facilities in France and the UK, the company also has a presence and staff in Switzerland, the US and New Zealand, and uses a contract organisation in Japan, so the other services will be offered worldwide, said McClelland.

"It's all very early days," said McClelland, "During this year we'll be setting up the financial and legal structures within the company, so my hope is that towards the end of this year, and early next year, we'll be proactively getting more involved seeking NGO partners."

While Roche's focus is on NGOs, McClelland said the company was willing to talk to Australian biotechs about opportunities, where trials might be carried out, and how Roche can provide some support and carry out the work. "We'd happily start talking to people even from now," he said.

McClelland said the nature of big pharma studies meant that Roche inevitably would have room in its schedule for other work. "When we're filling 80 per cent of our unit capacity for eight weeks, that means we have 20 per cent capacity available for eight weeks," said McClelland. "But we can't find the sort of work to fill that 20 per cent capacity. So if we can be paid our expenses for that, then we'll be happy."

McClelland said reports conducted by the Wellcome Trust and the London School of Economics showed that NGOs involved in developing new medicines for neglected diseases need to work with big pharma companies. "NGOs actually need us, they need our expertise," said McClelland. "These sorts of partnerships need to be set up and it's not normally available with big pharma companies."

Roche's services to NGOs will be a "fully loaded cost", said McClelland, "we have no intentions of putting any profits on that."

Partnerships with biotech

Asked about Roche's relationships with biotech companies, McClelland said that partnerships with biotechs are structured "literally as a partnership".

"Although we are a big pharma company with standardised processes, we do try and make sure that each project team has a significant amount of freedom to tailor those processes and to develop the processes that meet the needs of the drug," he said.

Roche is generally recognised as being a good partner to work and one of the quickest big pharma in the industry to develop drugs, said McClelland. "When you're talking about biotechs needing a return on their research investment, that's one of the attractions that people see about working with us," he said.

One of the reasons that Roche wants to offer services to NGOs is that it believes "all pharmaceutical companies are socially responsible," said McClelland.

In particular, one of the areas that McClelland has worked on at Roche is ethics and improving the informed consent process in clinical trials. Roche has changed the way it operates so that it can deliver the information that patients taking part in studies actually want, rather than what the company or the regulators think they want, he said.

"Even though the legal responsibility for consent in a clinical trial rests with the doctor at the hospital, we will still be perceived as having a responsibility by society," said McClelland.

McClelland said that Roche has been working on its corporate social responsibility initiatives quietly for some time.