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On 3 February 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation asking for stakeholders’ views on  draft guideline in relation to the regulation of individualised mRNA cancer immunotherapies (Draft Guideline).

The aim of the proposed guideline is to establish a clear and streamlined regulatory pathway to authorisation so that these highly innovative products can be made available to patients quickly, without compromising any assessment of safety. While the primary focus of the Draft Guideline is individualised messenger Ribonucleic Acid (mRNA) cancer immunotherapies, MHRA suggests that the regulatory and scientific principles considered might be broadly applicable to other disease indications (including rare diseases) or technologies that could benefit from personalisation or individualisation. It also states that the Draft Guideline will be updated when experience of other technologies (peptides, non-integrative DNA and polymer deliver systems) is available.  

In terms of regulatory assessment of individualised mRNA cancer immunotherapies, the Draft Guideline provides clarification of the data which should be included in marketing authorisation (MA) applications and, importantly, confirms that an individualised medicine may, in some circumstances, be granted an MA under the Human Medicines Regulations 2012 (HMRs), even where the product includes an individualised component tailored to the requirements of a specific patient.

There is currently substantial interest in the use of mRNA technology to develop individualised treatments for cancer. The current consultation is therefore of interest to companies focussing on this and other individualised therapies.Continue Reading The UK’s MHRA launches consultation on draft guideline on individualised mRNA cancer immunotherapies

A new report commissioned by Arnold & Porter, based on a survey of 100 senior executives and department heads from biopharmaceutical, digital health, diagnostics, and medical device companies, shows that artificial intelligence (AI) adoption is accelerating across the industry as companies implement it to accelerate product discovery and development, optimize manufacturing and the supply chain, improve marketing and sales strategies, and more.

However, as with any disruptive innovation, risks need to be managed. The report also highlights looming governance and compliance needs as companies seek to mitigate the risks associated with AI technologies, particularly in areas like data privacy, cybersecurity, and intellectual property.

The Arnold & Porter report found that AI use is still in its early stages for many in the life sciences industry, with around 75% of respondents beginning implementation less than two years ago. Despite this, 86% of companies currently integrating AI plan to fully deploy these tools within the next two years, reflecting a significant acceleration in AI adoption.Continue Reading The Convergence of Life Sciences and Artificial Intelligence: Seizing Opportunities While Managing Risk

In the last month, both the European Data Protection Board (“EDPB”) and the Court of Justice of the European Union (“CJEU”) provided their interpretation of key data protection concepts that are crucial for ensuring compliance with Regulation (EU) 2016/679 (“GDPR”).

In Opinion 22/2024, the EDPB provided guidance to data controllers on how to effectively oversee the activities of their (sub-)processors in a GDPR-compliant manner. The opinion was requested by the Danish data protection authority and likely related to the enforcement actions against Danish hospitals which allegedly failed to oversee processors (see our blog – https://www.biosliceblog.com/2024/02/proposed-fine-against-danish-hospital-for-failure-to-supervise-data-processors/).

In early October, the CJEU provided an answer to a key question raised by the courts in the Netherlands – can the legitimate interests legal basis be used for processing of personal data for commercial purposes (e.g., sharing with third parties for advertising and promotion) (Case C‑621/22).Continue Reading Notable developments in the interpretation of key GDPR concepts – why should Life Sciences companies care?

On 14 October 2024, the day of the International Investment Summit, the UK government published its green paper ‘Invest 2035: The UK’s Modern Industrial Strategy’, a ten-year plan designed to promote growth in the UK, with a focus on growth-driving sectors, including the Life Sciences and the Digital and Technologies sectors.

The Industrial Strategy will be informed by the new Industrial Strategy Advisory Council, which is to be chaired by Clare Barclay, CEO of Microsoft UK. The green paper explains that the Advisory Council will be led by evidence and “empowered to advise, make recommendations, and monitor Industrial Strategy policy”. The creation of the Advisory Council is intended to prevent frequent policy changes and ensure “stability and long-termism” and the government has committed to making it a permanent and independent statutory body.

This green paper comes less than a week after the UK Government announced the launch of the Regulatory Innovation Office noting that more plans for boosting growth were to be expected.Continue Reading UK government launches new Industrial Strategy and Advisory Council to boost economic growth