The R&D market is diversifying innovation, with increased out/in licensing of technology, partnerships, and mergers. Improvements in evaluation have also been credited with helping the sector grow at an impressive eight per cent, with long-term objectives now being considered at earlier stages within the development process, according to the findings of CPhI Worldwide Pharma Insights report on R&D.
Furthermore, the industry is evolving its model, maintaining innovative output whilst also standardising approaches to measuring effectiveness, and crucially, returns on investment- with 40 per cent using QbD for analytical and tech, 18 per cent using 6 Sigma, 15 per cent stage gate and 12 per cent lean techniques to evaluate effectiveness.
Unsurprisingly, with the milestone nature of moving between clinical stages, balancing long and short-term goals was seen as a major challenge (53 per cent) and improving efficiency (38 per cent) also highlighted the growing efforts to improve ROI between stages. However, a clear trend has emerged from this with more and more companies involving commercial side at an earlier and earlier stage with 30 per cent beginning in pre-clinical and a further 30 per cent prior to phase iii.
Almost a quarter of respondents sighted cancer as a major focus area for 2014, with antibiotics (13 per cent), cardiovascular (12 per cent) and CNS (12 per cent) targets also featuring notably. Additional evidence for the cancer-focus also emerged from the novel areas companies are working on, with 37 per cent researching combination drugs and 20 per cent personalised medicines. Outside of cancer, it appears that improved drug delivery mechanisms are targeted as 17 per cent were investing in nanotechnology and 12 per cent directly in drug devices.
However, the source of innovation is increasingly diverse with growing partnerships (75 per cent), mergers 20 per cent, and out/in-licensing of technology (55 per cent and 60 per cent respectively). Clearly, a major factor in competitiveness both now and in the future is access to technology, and we are seeing a more collaborative approach. This is an important trend and one that should enable the industry to continually innovate, with cross-pollination of projects, where even the smallest biotech can access crucial technology that enable them to move projects forward.
“With product development processes being increasingly managed through quality and control methods, the cost of and access to technology will be the essential access point on many projects ultimate viability.” Chris Kilbee, Group Director Pharma.
Highlighting the need for access to new techniques and technologies, 33 per cent of respondents were partnering with research institutes, a further 15 per cent with research-focussed companies and 10 per cent with universities.
Drawing all these findings together the report concludes there is a clear desire amongst all companies to ensure future R&D spend is prudent and focused on bringing future products to market faster- and not just innovative targets. Monitoring processes more prescriptively and standardising approaches should enable a quicker transfer between phases. Most interesting for the future, we are now witnessing an ‘open innovation approach’ to technology- which will enable reduced R&D timelines and better results.
“What we are now seeing is the maturation of the R&D sector having gone through a period of change over the last few years with innovation moving down stream from big pharma. However, we are now at a point where innovation is coming in from new and more diverse fields as different areas of science collaborate and bring new techniques into pharma production. This trend coupled with a commitment to tackle long term project viabilities, alongside standardised methods for practice, should help reduce bottlenecks in the pipeline and bring more targets to market in a more cost effective manner. It is a really exciting period for the R&D sector with new ideas, nanotechnology and manufacturing techniques and process bringing a new rigour and commercial focus to future projects,”Chris Kilbee added.