While open innovation may be seen as a way of cutting costs by shutting down in-house R&D in favour of promoting spin-offs, start-ups, and biotech SMEs, the open science movement aims to establish a completely new model for how to spur innovation. Eliminating intellectual property-related restrictions, open biology promises rapid and local production of biomaterials, dia­gnostics, or genome-edited crops in countries with no established IP system.

Modern biotechnology creates next generation therapies and cures, delivers value to patients and the economy, cuts greenhouse gas emissions, reduces reliance on fossil fuels, and generates higher crop yields with fewer resources. These critical activities and advances thrive only in an environment where biotechnology is supported by policies that maintain incentives for future innovation – including the form of intellectual property rights – while, at the same time, providing fair and equitable consumer access to innovative products. On both fronts, biotechnology enterprises face unprecedented challenges that, if not addressed, will slow the innovation engine. The consequent negative effects will be felt by all nations. Today, the biotechnology industry faces enormous challenges caused by deep public concern about pricing and access to medicines. The consequent political and public pressure is leading to rapid fire and poorly considered legislation. This, in turn, will likely result in an erosion of incentives to innovate, as it impacts return on investment and access to capital.

Every year, drug developers lose billions of euros because of late-stage clinical or postmarking safety problems with drugs. A recently kicked-off IMI consortium now wants to qualify a set of safety biomarkers that allow for the prediction of drug-induced injury of kidney, liver, vasculature, CNS, and pancreas. European Biotechnology spoke with Dr Michael Merz, the coordinator of the TransBioLine Project, and consortium member Prof Dr Stefan Wnendt about the plans and impact of the project.