Risks and Benefits of Generative AI for Pharma Supply Chain Management
As the life sciences sector grapples with complex challenges around sustainability and Environmental and Social Governance (ESG) compliance, Generative AI (GenAI) is emerging as a potentially powerful tool for enhancing efficiency and sustainability. Michele Tagliaferri, Eva von Mühlenen, and Anna-Shari Melin explain. (more…)
European Regulator Clarifies Guidance on the Use of AI in the Medicinal Product Lifecycle
The European Medicines Agency (EMA) has published a final reflection paper on the use of AI in the drug lifecycle, which provides important insights into the expectations from the EMA to clinical trial sponsors, as well as marketing authorization (MA) applicants and holders who use AI systems. Josefine Sommer and Zina Chatzidimitriadou explain.
How to Secure Investment as a Healthcare AI Innovator
For both small startups and R&D departments within larger companies, making investment funds work for an AI-based product is not just about securing initial funding but about making sure the investor understands the challenges of the healthcare sector. Chad Ehrenkranz talks to physician-executive and startup advisor Rick Abramson, MD, about the challenges.
Investor Attitudes to Healthcare AI Technologies
Investors are eyeing up the opportunities to invest in healthcare AI as it pushes the healthcare industry into new and exciting territory. R&D is currently focused on genomic sequencing, mapping, understanding populations and the treatment of rare diseases and hereditary cancer. AI applications are fundamentally altering how such R&D is conducted, as well as changing healthcare services to improve patient experience and outcomes. The advent of AI has dramatically altered the cost of capital, with private equity firms prepared to invest substantial sums into early adopters. These evolving opportunities raise important questions.
Medicines and Healthcare Products Regulatory Agency: The Road to Medical Device Reform
The Medicines and Healthcare Products Regulatory Agency (MHRA) has recently published three policy developments as part of its overhaul of medical device regulation in the UK. The AI Airlock, announcement of international recognition procedure for medical devices, and consultation on technical specifications for the In Vitro Diagnostics Regulation (IVDR) signal the MHRA’s continued focus on reform and international alignment in this area. Industry stakeholders should take note and engage with the regulator where possible to have their voices heard as part of the process.
Private Equity Investors’ Attitudes Towards Healthcare AI Investment Opportunities
Sidley’s Chad Ehrenkranz and UK-based U.S. investor Chris Yoshida consider which AI-based healthcare applications are of most interest to private equity investors, and the way in which healthcare AI lies in a desirable spot between startups and government uses of AI.
China’s Generative AI Measures Could Affect Life Sciences Companies That Make Apps
Those medtech companies which embed AI into an app allowing healthcare professionals or patients to ask questions and to receive a response will probably need to comply with China’s new Interim Measures for the Management of Generative Artificial Intelligence Services (the “Measures”). Lianying Wang explains.
AI-Powered Drug Discovery Efforts Could Lead to New Treatments
Stephen Abreu, Sidley partner, talks to Colin Hill, CEO and Co-Founder of AI-powered drug discovery company Aitia, about how the use of AI is revolutionizing the biotech space.
Europe’s Regulatory Approach to Continuous Learning AI
The regulation of continuous learning models involves the challenge of navigating the future. The EU is striving to stay ahead of the game with its forthcoming AI Act and harmonised standards. Eva von Mühlenen, Oliver Haase of Validate, and Leon Doorn of Aidance discuss.
Innovation, Collaboration, and Access to Capital: Key Takeaways from the Sidley Healthcare Investment Conference
At Sidley’s Healthcare Investment Conference on 12 September, speakers analysed the flow of capital across the global life sciences and healthcare ecosystem in panels discussing collaborative deals, sources of funding, the regulatory scrutiny of deals, and women’s health.
