DLA Piper Life Sciences Sector

Medicines Australia has released the latest edition of its Code of Conduct, setting new standards for ethical practices and transparency in the industry. This update emphasises the importance of integrity in interactions with healthcare professionals and patient organisations.   Nicholas Tyacke, Greg Bodulovic, Alexandra de Zwart and Hazel P. outline the key considerations in our latest article. Click the link below to read more.   #Pharmaceuticals #LifeSciences #MedicinesAustralia #Healthcare

At next Wednesday's Global Life Sciences Summit 2024 in London, delegates will have the opportunity to choose between nine breakout sessions, led by industry leaders and DLA Piper life sciences specialists. One of our breakout sessions will focus on life sciences M&A trends in the current environment. Victoria Rhodes and Andrew Gilbert will be joined by Gil Bar-Nahum, PhD (Jefferies International Limited), Michael Stewart (Sanofi) and Howard Taylor (Rosemont Pharmaceuticals) to discuss key issues including: - Current trends and state of the market; - How M&A has fared through a year of political change globally; and - Predictions for the next few years and beyond. If you would like to attend the session, please register your interest today https://lnkd.in/dVJYA-Ad

In the latest instalment of DLA Piper’s Genomics Series, the focus shifts to the regulatory landscape surrounding gene-edited plants and gene drives. As advancements in genomics continue to accelerate, Mikael Kurki, Pia Riemenschneider, LL.M. and Lisa W. delve into the complexities and evolving frameworks that govern these innovations. From the potential of gene-edited crops to revolutionise agriculture to the ethical and safety considerations of gene drives, this piece provides a comprehensive overview of the current regulatory challenges and future directions in the field. Click on the link to read the article: https://lnkd.in/efgSPeBN #Genomics #GeneEditing #Biotechnology #Regulation #GeneDrives #LifeSciences

Our Global Life Sciences Summit 2024 is now only 1 week away, taking place in London on 6 November. Our theme for the day is 'futureproofing for the next decade' and we have invited Lyndsey Olivia Hudson to share her insights on the key trends impacting the industry, related findings from our Life Sciences Index 2024 report, and how today’s trends will shape life sciences businesses and care delivery, in 2034 and beyond. There are only a few seats still remaining so if you would like to join your peers, please register your interest today.  https://lnkd.in/dVJYA-Ad

Richard Taylor and Nathan Davis from our UK Life Sciences team, share the latest update from the Department of Health and Social Care (DHSC) regarding their "Design for Life" road-map, aiming to transition the UK medtech sector towards a circular economy by 2045. 🔄🏥 #UKMedtech #CircularEconomy

Over the coming weeks, our Life Sciences blog - Cortex, will feature a series of articles to update you on the NIS2 Directive and its impact on the sector. The NIS2 Directive establishes a comprehensive framework to enhance cyber security across the EU, imposing key obligations on entities in critical sectors including healthcare, pharmaceuticals, and medical devices. The main requirements include: - Risk Management Measures: Companies must implement technical and organizational measures to manage cybersecurity risks, including incident response, supply chain security, and vulnerability handling; - Incident Reporting: Entities are required to notify authorities of significant cybersecurity incidents within 24 hours of detection, followed by detailed reports within 72 hours; - Supply Chain Security: Organizations must assess and manage risks associated with third-party service providers and suppliers; - Governance and Accountability: Senior management is mandated to oversee cyber security measures and may be held personally liable for non-compliance; - Cooperation with Authorities: Entities must collaborate with national cyber security authorities and share relevant information on threats and incidents. These obligations aim to improve resilience and establish a uniform level of cybersecurity across the EU. Our articles will explore the implications of these regulatory changes for the Life Sciences industry, covering key compliance requirements, risk management strategies, and practical steps to enhance resilience against cyber threats. Nicholas de Lacy-Brown, Cristina Criscuoli, Paula González de Castejón

Former US Senator Richard Burr and former European Commissioner Phil Hogan will join us for a fireside chat around the global political challenges facing the industry at our Global Life Sciences Summit on 6 November in London. Several elections have taken place across the EU in 2024, and the results of the upcoming US elections will likely be announced the day of the Summit. Delegates will gain key insights from two speakers who have been at the core of the political landscape for many years and can relay what the results mean – in the context of the current geopolitical dynamics – for the global life sciences industry. To join the discussion, please visit our website here: https://lnkd.in/eMK-mh5t

This week, in our DLA Piper Genomics series, Marion Abecassis, Lyndsey Olivia Hudson, Nicola Landolfi, Ranulf Barman and Marion de Galembert delve into the complex regulatory landscape surrounding cell and gene therapies. Highlighting the evolving guidelines, key compliance hurdles, and strategic insights for navigating this dynamic field, this is essential reading for professionals in the life sciences sector aiming to stay ahead in the era of advanced genomics. #Genomics #RegulatoryAffairs #LifeSciences

At this year's Global Life Sciences Summit 2024, delegates will have the opportunity to personalise their experience by choosing between 9 breakout sessions, led by industry leaders and DLA Piper life sciences specialists. One of our breakout sessions will focus on 'protecting innovation: regulatory incentives in the EU, US, and China'. Marco de Morpurgo, Stefano Marino and Ting Xiao will be joined by Victoria Kitcatt (Pfizer) and Geoffrey Levitt (argenx), to discuss key issues including: - The first administrative litigation concerning RDP in China - Key developments in the US; - Ongoing reform of regulatory incentives in the EU and potential improvements. To attend this panel or see our other breakout sessions, visit our website here: https://lnkd.in/eMK-mh5t

Ataikor Ngerebara shares her insights from the recent 2024 Pulse of the Sector Survey on UK Healthtech conducted by the Association of British HeatlhTech Industries and the Centre for Process Innovation. Ataikor discusses challenges ranging from #regulatory uncertainty to #AI implementation barriers.