Out-Law Analysis | 08 Jan 2019 | 4:44 pm | 1 min. read
Beyond Brexit, the predominant theme of 2019 for life sciences companies will continue to be reorganisation and restructuring. The sector has already seen some significant mergers and acquisitions as companies seek to add agility, flex the cost structure and better support the industry's continuing commitment to a patient-focused approach to innovation and collaboration.
Linked to that, we also expect new entrants will continue to disrupt the traditional health delivery and drug development models. There is likely to be continuing interest in partnering with organisations that can harness technology to develop and provide trust-based patient-centric solutions to disease management.
Cost curtailment and a moving concept of value and other industry pressures will continue to push life sciences companies to find the right patients for new drugs and to provide full service ‘beyond the pill’ solutions.
Data-driven artificial intelligence (AI) or machine learning solutions are already part of the life sciences landscape and underpin some of the best innovation in the sector. This trend is likely to continue in 2019.
However, data and technology alone are not the ‘silver bullet’. Automation will augment not replace human intervention and the skill and experience of clinicians. AI will unlock the value of health and other patient data and will drive the shift towards more personalised medicine.
We anticipate there will be a new focus on ethical AI this year. This will require companies to operate AI transparently and ensure decisions taken by computers are auditable. We expect this will translate into a need to explain AI models and decisions and to show how data is collected and represented so as to demonstrate quality.
The continuing rise in AI based innovations in the life sciences field will challenge existing intellectual property strategies and pose new questions for patent offices globally this year.
Legal and regulatory compliance will continue to be high up board agendas in 2019. Globally transparency requirements continue to evolve as the industry continues to attract scrutiny from regulators including tax and competition authorities. The wave of cases on excessive pricing look set to continue and further discussions on how this can be tackled outside the competition arena are to be anticipated.
Helen Cline is an expert in life sciences at Pinsent Masons, the law firm behind Out-Law.com.