Open-source innovation in drug development

In order to address the crucial challenges of pharmaceutical research and development (R&D), drug makers and biotechnology firms should be working harder to maximise the potential of open-source innovation. At least, this is the argument outlined in a new analytical report.

An idea borrowed from the information technology sector, where it was first adopted more than 30 years ago, open-source innovation is now being successfully embraced by companies across the pharmaceutical and biotech industries. According to the analysis by Frost & Sullivan, it helps promote drug discovery and boosts bottom lines.
 
However, there are numerous challenges which need to be overcome before the open-source approach can be more widely distributed across the scientific research sectors.

Frost & Sullivan explained how one of the key drivers in the UK's transition from closed to open-source innovation had been the Human Genome Project. This has thrown up vast amounts of data that require conversion to what is dubbed "actionable knowledge". Many expect this task to take several decades to complete.

"Better knowledge of the way the human system works has opened up far more complex areas of research to pharmaceutical and biotechnology companies, with potential benefits for patients and the industry but also the drawbacks of escalating R&D costs, loss of productivity and smaller drug pipelines," reported Pharma Times recently.

The analysts at Frost & Sullivan noted that the challenge for companies to develop and launch new drugs single-handedly is becoming increasingly difficult. This is arguably where open-source innovation can prove most useful. It follows the lead of other fledgling models, such as outsourcing drug discovery to contract research groups, to improve R&D efficiency and output.

Among the key benefits of open-source innovation outlined in the report are a number of factors which could provide a boost to Britain's struggling R&D sector. Firstly, there is the creative boost that comes from the greatest minds in niche areas collaborating to tackle issues concerning "extremely challenging" diseases, said the analysts.

Open-source research is also thought to allow significant gains in the speed of innovations, as the technique promotes more streamlined project management frameworks than conventional approaches. The ability for collaborating organisations to share risks can also be of benefit, making it easier for researchers to discontinue projects that seem to be heading nowhere.

There is also a possibility of improved affordability, with smaller organisations potentially able to access equipment and research talent normally available to just large pharmaceutical companies. One final benefit of open-source innovation is that it can allow the knowledge of scientists in developing countries to be harnessed. These individuals are likely to have closer contact with challenging diseases like malaria.

The main hurdle between British research teams and adoption of open-source innovation is an economic one, according to Frost & Sullivan. "Industry can invest in drug development costing over $1 billion because it expects to receive monopoly profits during the patient exclusivity period," explained Pharma Times. In particular, clinical trials demand "enormous resources to plan and execute", Frost & Sullivan notes.

In theory, open-source committees could potentially obtain some of their funding from the government. However, "if society is staking a large per cent of its GDP on funding open source, there will need to be a broader, more reliable decision process", the analysts added.

One potential solution put forward by the report was that the government could fund open-source programmes through universities. According to the analysis, these would function as co-ordinating arms, with an annual charge levied for membership to a database of open-source knowledge.
 
As Frost & Sullivan has pointed out, there are massive obstacles to overcome before open-source innovation can be embraced across the entire pharmaceutical and biotechnological industries, but with so many potential benefits, it may be in scientists' best interest to find ways of making it work.

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