The Japanese drugmaker has appointed Dr Lynn Kramer as its first Chief Clinical Officer, giving him oversight of clinical trial protocols and charging him with fostering cross pollination among its product creation units.
He told Outsourcing-pharma.com that: “Eisai is looking to get better at sharing information and ideas across its R&D organization. This is a way for Eisai to add ingenuity. Different eyes, experiences and perspectives can lead to innovations of similar changes in other areas.”
Kramer cited withdrawal designs and dichotomized endpoints (equivalent to survival in oncology) as examples of successful ideas sharing, explaining that these protocols developed for epilepsy studies in the 1980s are now common in pain and second-line cancer trials as a result of collaboration between different study teams.
The idea is to improve preclinical and clinical programmes both from an operational and methodological standpoint, he continued.
“First let’s think about the key transitions in drug development. Firstly, discovery research initiates the cascade then translational medicine and then later stage development. We have focused on the discovery for some time but want to focus more on the next two transitions, the translational aspect at POC and then the transition from that point into the key trials.
“The pivotal trial and its endpoints are the key building block for a dossier and require great care. The frequency of Phase III failures illustrates that point clearly.”
Eisai – like most drugmakers – needs to refill its pipelines in the face of patent loss for key products, namely the two former blockbusters Aricept and Aciphex.
The firm has also encountered its share of late-stage development setbacks, most notably the candidate cancer monoclonal antibody (MAb) farletuzumab – developed by its US subsidiary Morphotek – which failed to meet its primary endpoint in a Phase III trial in January .
One way to avoid such problems in future – according to Kramer – is to focus more effort on trial design and building expertise across wider development teams.
“We have established several forums of discussion and data review for the key people on our clinical project teams. Our objective for these forums is to help our project teams strengthen their expertise, explore different types of trial designs and make the best decisions possible.”
Site selection is one area to which the approach is already applied continued Kramer, explaining that Eisai has a forum where teams discuss where studies should take place and to develop tools that can identify those sites that are not performing effectively.
“We’ve had several examples already where analytic tools can help identify these issues early on and in retrospective analyses can see that the outcome improved due to these actions. In addition, to allow better early data review we’ve worked to establish standardized processes across our various product creation units for all clinical trials.”
Kramer’s oversight role will extend to the contract research organisations (CROs) according to Eisai, although this will be more focused on operational activities as the firm does “not rely on CROs to develop protocols.”