Positron emission tomography has become an important way to monitor therapies, but the trend towards molecular technologies has forced companies to expand their remit to maintain customer satisfaction. Eric Agdeppa, GE Imanet, explains how partnerships have created new competencies in anti-body fragments and non-imaging biomarkers.
In 2001 GE Imanet established a market-leading imaging service for the global pharmaceutical industry. At first, the network’s focus was on small-molecule tracers, used for imaging the central nervous system during studies into dose optimisation and neuroreceptors. A decade later, the network plans to maintain its prominent position by partnering with outside companies to create new competencies for its clients.
According to Eric Agdeppa, imaging solutions manager at GE Imanet, the new services that the network can deliver to the pharmaceutical industry constitute major changes.
"We’ve gone from having all our internal capabilities offered to pharma to partnering external companies to complement the core capabilities we’re missing," he says. "For example, we can provide clients with the antibodies and antibody fragments from ImaginAb, and the non-imaging techniques from Neuroimage. Those are just two examples of how we are broadening our capabilities by recognising that our core competencies in small-molecule PET need to be enhanced with outside capabilities."
Partnership keeps pace
Imanet’s partnership with ImaginAb, for example, has given it the capacity to supply recombinant antibody fragments as PET tracers, something that has kept it up to date with the new ‘molecular wave’.
"The genomic proteomic revolutions have created new molecular targets for diagnostic and therapeutic purposes in recent years," Agdeppa explains. "Pharma is now reducing its reliance on small molecules and antibody therapies are outpacing the growth rates of small molecules, therapeutic proteins and vaccines."
The company has increasingly leant towards the needs of the oncology function, previously partnering contract research organisations such as Quintiles, HMR and CDST, but now extends to other imaging technologists.
Imanet’s new partner Neuroimage enables clients to link non-imaging biomarkers with PET data in proof of mechanism, proof of concept and proof of principle studies. Likewise, its relationship with VirtualScopics will leverage the former’s portfolio of tracers with the latter’s advanced image analysis and modelling capabilities for the oncology facility.
Agdeppa believes that his field has changed in terms of increasing emphasis on using biologic targets, the use of biologics as therapeutics and the popularity of using macro rather than small molecules.
"The best way for us to provide our service is to partner those companies that already have expertise in macro molecules as opposed to spending lots of money and time ramping up our own know-how," Agdeppa explains. "We’re trying to be more nimble."
Sourcing these technologies from third parties rather than in-house R&D keeps costs down for Imanet’s customers.
Overcoming challenges
The company has spent ten years making PET trials less taxing for its customers, overcoming three main challenges: PET ethics, regulation and tracer stability. PET not only needs a radiation safety approval from each institution, according to Agdeppa, but also an institutional ethics review for the centre running the trial. Imanet’s three centres in the UK, Sweden and Finland have a strong working relationship with the radiation committees that regulate their work. "They’re familiar with us – we’ve done hundreds of trials that needed reviews, so many that the process has almost become trivial," says Agdeppa.
In human trials, PET tracers require government approval to be used in combination with therapeutic drugs. In the US, tracers need exploratory investigational new drug status and in Europe they need a PET micro-dosing package. Another reason that the company has become a preferred partner in drug trials is its established portfolio of over 40 PET tracers.
Furthermore, the radiotracers are produced using an automatic system rather than a manual synthesiser, which is, as Agdeppa explains, "almost like miniature chemical engineering".
The use of a computerised system reduces the number of lost or failed runs and stabilises the yield and purity of the tracers for the duration of the trial.
For ten years, the PET arm of GE’s Healthcare unit has built up experience and product range for its clients and, even during a period of intensive biotechnical change, this year is no different. This innovative service delivery model is just the thing to sharpen Imanet’s competitive edge.