Disruptive technology either displaces established technology, shaking up the industry or standard practice in the process, or it creates a completely new industry altogether. Personal computing, for example, has been disruptive in many ways and has led to other disruptive technologies throughout its adoption. Disruption seems to occur when there is an aggregation of current technologies, creation of associated processes to adopt them, and people who know how to deploy them. This combination gives rise to a new way of doing things. Large pharma companies are notoriously slow at adopting new technologies; for instance, only now are continuous manufacturing methods starting to be used in place of discrete batch manufacturing.
I think the main factors associated with a reluctance to embrace change are:
- cost of change from an approved process/facility/method/diagnostic
- lack of detailed understanding of the new technology in quality and regulatory groups, and thus an inability to make a sensible assessment
- fear of losing licenses – it is easier to stick with known technologies;
- lack of well-established technology transfer methodology
I believe that some truly disruptive technology is on the way for the life sciences industry over the next decade. And companies will be forced to adapt. Computing power has continuously increased according to Moore’s law, which predicts that processing speed will double every two years (1). The advent of PCR to amplify DNA, the design of automated DNA sequencers, and an increase in computing power have all combined to create the disruptive technology known as gene sequencing, leading to the characterization of the first human genome in the 1990s (2) for around $3 billion (3). Today, you can have your genome mapped for less than $3,000 (4). That’s a one million times cost reduction in 15 years.
The lower cost is significant because it has finally brought the concept of individually tailored medicine within reach. I am not unique in proposing that the next fundamental change to medicine will be the widespread use of treatments tailored for the individual. The ‘one-size-fits-all’ approach to drug and device development of the past 75 years will surely decrease over time. Better outcomes for the patient will demand personalized treatments that are specific to the patient (or small patient groups categorized by genotype), their symptoms and physical attributes. Meanwhile, the quality and sensitivity of diagnostics are improving such that the diagnostic and the therapy are being developed in tandem to enable detection and treatment in personalized medicine. Perhaps the dawn of gene therapy could now be beginning to break the horizon (notably, some three decades after it was described as ‘the future of medicine’ when I was doing my Master’s Degree in Biochemical Engineering). Recent advances in clinical trial approaches (again driven by the increase in computing power) and the possibility of creating a ‘complete physiological human’ with all biochemical processes mirrored ‘in silico’ (5, 6) should lead to much quicker clinical trials – and replication of the phenotype of a specific individual.
Of course, once specified for the individual, each unique therapeutic molecule needs to be developed, tested and manufactured. And this is where big pharma will have to overcome its fears and commit to both the costs and regulatory uncertainty of creating individual treatments. As someone who helps life sciences companies stay compliant, especially in terms of new technologies, I see many hurdles that will need to be overcome if these new approaches are to be adopted. As well as further developing the technology itself, we need to work with regulators, encouraging them to understand new technologies whilst still addressing the need for patient safety. We also need to persuade quality and regulatory professionals in pharma to react and respond to new techniques with agility – the same kind of agility that has allowed fast yet controlled development of software over the past decade. One thing is certain; the people and companies who do not fear disruptive technology are those that will prosper from them.
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References
- Moore’s Law, http://www.mooreslaw.org Human Genome Project, http://www.genome.gov/10001772 Human Genome Project, “The Human Genome Project Completion: Frequently Asked Questions”, http://www.genome.gov/11006943 E. Zimmerman, “The Race to a $100 Genome” (25 June 2013) http://money.cnn.com/2013/06/25/technology/enterprise/low-cost-genome-sequencing Insigneo Institute, University of Sheffield http://insigneo.org/ European Commission, “Virtual Physiological Human”, https://ec.europa.eu/digital-agenda/en/virtual-physiological-human
