Hot topics in BioMedTech – will the law get in the way of progress?
James Fry, partner at Mills & Reeve, looks at three hot topics in BioMedTech and highlights potential legal and regulatory roadblocks that could threaten rapid progress.
Big data and genomics
As the collection and analysis of increasing quantities of data becomes an everyday reality, new possibilities around the prediction, diagnosis and treatment of disease open up.
The UK’s Life Sciences Sector Deal, published in December, sees up to £210 million from the Industrial Strategy Challenge Fund committed to the ‘Data to early diagnostics and precision medicine’ programme.
In genomics, the 100,000 Genomes Project offers ground-breaking advances for patients with ambitious large-scale sequencing plans. Working with partners like Illumina, Genomics England progress projects like this in a way that would be challenging without a centralised healthcare system.
Microsoft Research Cambridge has reinforced its focus on healthcare research within its Cambridge base. And harnessing new sources of health data, in combination with AI, has the potential to bring digital transformation to healthcare.
In the context of the operating theatre, Cambridgeshire-based precision medicine business Cydar brings cloud computing into live surgery.
But central to realising the potential of patient data is safeguarding privacy. The National Data Guardian’s 2016 review of data security highlights the need to retain public trust by adhering to data privacy law and best practice particularly when making use of data collected through the NHS.
Some instances of poor practice have led to adverse press comment and even a public backlash against the use of NHS data. The advent of the General Data Protection Regulation in May 2018 will make the controls over use of personal data even tighter, and significantly raise the price of failure.
Fines of up to €20m, or four per cent of worldwide turnover if higher, will potentially be added to the reputational cost of falling short.
Compliance will require privacy to be designed in from the outset, with anonymisation and tight security measures increasingly important for those holding and using information about individuals. Meeting the new requirements is possible, but requires careful planning and awareness.
The Cambridge cluster offers a range of expert teams bringing their insights and technology to bear on the challenge of antimicrobial resistance. Bicycle Therapeutics has recently been selected by Innovate UK to receive a grant to tackle this global challenge using its innovative bicyclic peptides approach.
Auspherix, at the Stevenage Bioscience Catalyst, brings its organogold chemistry platform to bear, with a focus on complicated urinary tract infections.
Although tackling AMR is a globally recognised healthcare priority, incentivising new antimicrobials presents an unusual challenge. Unlike other medicines, antimicrobials have greatest effect when used sparingly, and any new agents are likely to be reserved for last-line use when other treatments have proved to be ineffective.
Lord O’Neill’s 2016 Review “Tackling drug-resistant infections globally” vividly highlighted this issue, explaining that “for antibiotics, the commercial return on R & D investment looks unattractive until widespread resistance has emerged against previous generations of drugs, by which time the new antibiotic may no longer have patent protection or may soon lose it.”
The O’Neill report proposed a new system of market entry rewards of around $1bn for effective new treatments.
An incentivisation programme along the lines of this radical proposal seems ambitious, but support like that offered by Innovate UK can help to bridge the gap. And healthcare payers will have to recognise that the cost of innovative new anti-microbials will be high to justify the investment in their creation.
CRISPR-Cas9 has revolutionised life sciences, with many areas impacted by this powerful gene-editing technology.
A joint team taking in scientists from the University of Cambridge, the Wellcome Trust Sanger Institute, and Bourn Hall Clinic recently demonstrated the power of the technique to understand gene function in human embryos. And Horizon Discovery offers CRISPR as part of its suite of powerful genome engineering tools.
But while offering great therapeutic potential as well as a research tool, ethical and safety concerns will need to be addressed through regulation of CRISPR-based therapies.
The troubled tale of the first attempts at gene-therapy in the 1990s will underline the need for a cautious approach by regulators.
Alongside these concerns, the difficult patent landscape for CRISPR-Cas9 will act as a drag on the commercial use of the technology. With rival teams building their own international patent portfolios, and fighting hard over territory, the picture for licensees is at best confusing.
Initiatives to set up a single licensing body have made some progress, but for now users face a difficult picture in seeking to establish freedom to pursue their plans.