Hogan Lovells – Global Life Sciences and Health Care

The world of clinical trials is rapidly evolving, and staying up to date with regulatory changes is essential. Our latest collection of articles in the 2024 Life Sciences and Health Care Horizons brochure offers insights into the critical developments shaping the industry today. With the rise of decentralized clinical trials and the increasing role of AI, understanding these trends is key to maintaining compliance and driving innovation. Explore how recent regulations are making trials more patient-focused and discover the transformative potential of new developments. Equip yourself with the knowledge to navigate these changes and stay ahead of the curve. Dive into our comprehensive article collection today! https://lnkd.in/ekRP4Vc5 #ClinicalTrials #LifeSciences #RegulatoryInsights 

Join us on Wednesday 18 September in Boston for our Global Life Sciences and Health Care Horizons series. The event series is designed to help participants understand and tackle the issues shaping the future of the industry, for your local market and globally. We’ll delve into key topics such as health care investment, #BIOSECURE Act, product liability, Chevron, Loper Bright, #clinicaltrials and #AI. Presenting lawyers: Ina Brock Brian Carey Lauren Colton Kristin Connarn Susan Cook Mike Druckman Heidi Gertner Lynn Mehler Ashley Roberts Fabien Roy Joy Sturm Alice Valder Curran Hein van den Bos Ron Wisor, Jr. Lu Zhou Register your interest here: https://lnkd.in/etn97sDg

In the peer-reviewed medical journal, Trends in Biotechnology, Victoria Wallace and Suzanne Levy Friedman of Hogan Lovells author a roadmap for medical device innovators, highlighting the essential steps for regulatory authorization, market access, and reimbursement strategies in the U.S., with a focus on strategic planning for commercial success, underscoring the integration of regulatory and market access considerations from the initial development of a medical device. Learn more here: https://lnkd.in/euMbHAdB   #biotechnology #marketaccess #medicaldevice

We advised MorphoSys AG in connection with the conclusion of a delisting agreement with Novartis in relation to a public delisting tender offer by Novartis and the related revocation of the admission of MorphoSys shares to trading on the regulated market of the Frankfurt Stock Exchange as well as the delisting of its American Depositary Shares from the Nasdaq Global Market and the deregistration with the U.S. Securities and Exchange Commission. Our team was led by Frankfurt partner Prof. Dr. Michael Schlitt and Munich counsel Dr. Sebastian Biller. Learn more here: https://lnkd.in/gXkp_bBq #SEC #ADS #Novartis

Environmental, Social, Governance, or #ESG, is more than just a buzzword; it's impacting the entire industry. The pharma and medical device industries face unique challenges in implementing ESG rules, particularly with the supply chain. In our 2024 Life Sciences and Health Care Horizons guide, our lawyers delve into the impact of ESG and what companies must consider now. 🩺 Discover the latest ESG trends and insights: https://lnkd.in/epjrfMdW #Horizons2024 #Pharma #MedicalDevices #SupplyChain

Attending the 28th Annual GMP By The Sea? Connect with Hogan Lovells Director of Regulatory Sciences, Alex Smith during the workshop, “Application of Artificial Intelligence/Machine Learning Technologies in Regulated Life Sciences or Senior Director of Regulatory Affairs, Chris Middendorf who will present on Data Integrity Remediation Strategies. View the event details here: https://lnkd.in/eBUD6kXG #FDA #GMPByTheSea

Read the latest publication ‘Implications Of The EU AI Act For Medtech Companies’ from our Brussels Life Sciences team published in Law360. In this article the team analyze the implications of the #AI Act for the #medtech sector and provide key recommendations for manufacturers in preparation of the implementation of the AI Act. View the full article here: https://lnkd.in/eA2iCs6d #regulatorycompliance #aiact Authors: Hélène Boland, Anastasia Vernikou, and Fabien Roy

Legal challenges for innovative cell, tissue, and gene therapies (CTGTs) are mainly seen in the still evolving regulatory environment. However, it is also crucial for the manufacture and supply of CTGTs to have agreements in place with all apheresis and treatment centers (ATCs) in the respective launch markets. CTGT companies should be aware that the negotiating and execution of such agreements with (often public) hospitals and other health care organizations (HCOs) can be both challenging and time-consuming. Read our teams latest insights here: https://lnkd.in/eYWfVi7m #cell #tissue #genetherapymanufacturing Authors: Dr Joerg Schickert and Benjamin Goehl

Partner Fabien Roy was a guest speaker on the recent Medical Device made Easy Podcast where he shared thoughts on the challenges raised by the #AI Act for medical device companies. 📰 Listen to the full podcast here: https://lnkd.in/e-XN64pz #medicaldevice #regulatorycompliance #aiact

Leading health and life sciences lawyers Brian Carey and Erik Schulwolf have joined our Health practice in Boston. Brian and Erik have a combined two decades of experience in complex reimbursement issues for innovative molecular diagnostics and biopharmaceutical products. “We’ve been looking for the right fit to expand our Health practice into the key Boston market. With their combined extensive experience guiding leading life sciences companies through their most challenging regulatory, coverage and reimbursement hurdles and other compliance and policy issues, Brian and Erik are excellent additions to our team,” said Health Practice Area Leader Ron Wisor. Brian has more than 20 years of experience advising innovative life sciences companies and health care providers on federal, legal, regulatory and legislative issues affecting cutting-edge technologies. He guides biopharma and medical technology firms through intricate Medicare coverage and payment challenges, as well as compliance considerations for novel innovations. Erik focuses on advising molecular diagnostic laboratories and diagnostic test manufacturers on reimbursement, compliance, and other legal matters related to precision medicine diagnostics. He also advocates for clients with federal and state agencies and with private payers. Read more at our press release in the comments. #Collaboration #Health #Regulatory #Boston #Innovation