Drug regulation and industry

This channel is devoted to bringing you the latest information on drug regulation from the FDA and EMA, as well as providing updates from the industry and a monthly round-up of newly approved drugs. 

Narrowing the translational research gap: what needs to be done?

We all seem to agree on one thing, the path through the valley of death, which defines the gap between initial discovery at the bench to the drug at the patient’s bedside, is long, costly, and frustratingly inefficient. At the Academic Drug Discovery conference (Cambridge UK) this year, Tim Hammonds proposed that the formation of effective alliances between academia and industry could enable us to break down the barriers of translational research and bridge the valley of death – but is this really possible? Academia and industry have never interacted in the past. Their language differs. Their mindset differs too. The academic world, historically, has always had the freedom to search for the unsearchable or to invest in the non-investable. This freedom, considered risky in industry, has been the main source of mistrust between the two bodies. Dahlin, Inglese and Walters call this freedom ‘curiosity driven research’. I call it ‘free’ research’ – that is ‘free’ as in ‘free will’, not ‘free of charge’. The input and influence that academia and industry have in the multi-step process of drug development has always differed greatly. Typically, academia is of great value during the very first stages of drug discovery, while industry, on the other hand, is crucial in the later stages, leading to approval. It is thus quite incongruous that academia, a pillar for innovation and discovery and a force in the early stages of discovery and target identification, has still so little power or say in translational medicine. Phenotypic and target-based screening have paved the way to two seemingly distinct approaches to drug discovery that while very different, they are intrinsically related. One can observe the forest and examine changes in foliage structure, color or health. Conversely, one can treat the roots of the trees hoping to see changes in foliage. For targeted discovery we need to develop better methodologies such as selective and biologically significant target-based cellular assays. For phenotypic discovery we need reverse chemical genetics and proteomics combined with genomic methodologies. Targeted and phenotypic discovery can, if used together, help narrow the gap, as can the collaborative efforts of academia and pharmaceutical industry. For the full article, please go to http://www.future-science.com/doi/full/10.4155/fmc.15.123
Go to the profile of Roland Wolkowicz
Nov 05, 2015