Early-stage life sciences companies and the investors that back them are laser-focused on evidenced-based development and approval hurdles. However, even at early stages, failure to adequately prioritize more nuanced regulatory and compliance issues can have a significant impact on exit value and create potential liability for investors and acquirers. Geoffrey Levin, Torrey Cope, Marie Manley, Donielle McCutcheon, Andrew Shoyer, Michele Tagliaferri, and Julea Lipiz highlight eight key areas for focus.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
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.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
Life Sciences Companies See New Path Open for Challenging FDA Decisions
A U.S. Supreme Court ruling which overturned the famous Chevron ruling by deciding courts should not defer to an agency’s interpretation of the law is likely to usher in a new era of both opportunity and risk for life sciences companies seeking to review FDA decisions. Michael Varrone explains.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Michael Varrone
Washington, D.C.
michael.varrone@sidley.com
As U.S. Biosecure Act Passes the House, Four Things Biotechs Can Do to Prepare
The U.S. Senate may still reject the U.S. BIOSECURE Act , but the House of Representatives has now passed a version of the bill. Biotechs in both the P.R.C. and the U.S. therefore need to prepare for the new environment which it heralds. Michael Borden, Andrew Shoyer, and Ruchun Ji set out five steps to take now.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Michael E. Borden
Washington, D.C.
mborden@sidley.com
Andrew W. Shoyer
Washington, D.C.
ashoyer@sidley.com
Ruchun Ji
Beijing, Palo Alto
rji@sidley.com
Are the revisions to the EU’s ‘Bolar’ system compatible with TRIPS?
The EU’s proposal to speed up generic and biosimilar market access by expanding the “Bolar exemption” to pricing and reimbursement procedures raises significant international IP law concerns, as it is probably incompatible with its obligations under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Maarten Meulenbelt, Chris Boyle, Lauren Shapiro, Maryanne Kamau, and Alix Vermulst explain.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Lauren Shapiro
Maryanne W. Kamau
Brussels
mkamau@sidley.com
Alix Vermulst
Brussels
alix.vermulst@sidley.com
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.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Chad Ehrenkranz
New York, Miami
chad.ehrenkranz@sidley.com
How, When, and If the U.S. BIOSECURE Act Is Likely to Become Law
Both U.S. and P.R.C.-based biotechs are anxiously watching attempts to pass the U.S. BIOSECURE Act into law. Michael Borden and Andrew Shoyer explain what this month’s developments mean, and why the legislation, even with so much attention and publicity, may never actually become law.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Michael E. Borden
Washington, D.C.
mborden@sidley.com
Andrew W. Shoyer
Washington, D.C.
ashoyer@sidley.com
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.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Chad Ehrenkranz
New York, Miami
chad.ehrenkranz@sidley.com
EU Investigation Into PRC Public Procurement for MedTech May Impact EU Market Access for PRC Companies
Concerns about the PRC’s medical devices procurement practices have led the EU to launch an investigation which could lead to the EU subjecting PRC companies, including MedTech companies, to market access restrictions in the EU. Sven De Knop, Lei Li and Maryanne Kamau explain.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Sven De Knop
Brussels
sdeknop@sidley.com
Lei Li
Beijing, Shanghai
lei.li@sidley.com
Maryanne W. Kamau
Brussels
mkamau@sidley.com
Key Regulatory and Compliance Considerations for Early-Stage Life Sciences Companies and Their Investors
Early-stage life sciences companies and the investors that back them are laser-focused on evidenced-based development and approval hurdles. However, even at early stages, failure to adequately prioritize more nuanced regulatory and compliance issues can have a significant impact on exit value and create potential liability for investors and acquirers. Geoffrey Levin, Torrey Cope, Marie Manley, Donielle McCutcheon, Andrew Shoyer, Michele Tagliaferri, and Julea Lipiz highlight eight key areas for focus.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Geoffrey W. Levin
New York
glevin@sidley.com
Torrey Cope
Washington, D.C.
tcope@sidley.com
Maria Isabel Manley
London
mmanley@sidley.com
Donielle McCutcheon
Chicago
dmccutcheon@sidley.com
Andrew W. Shoyer
Washington, D.C.
ashoyer@sidley.com
Michele Tagliaferri
Brussels
mtagliaferri@sidley.com
Julea Lipiz
Washington, D.C.
jlipiz@sidley.com
Hong Kong’s Biotech Listings Emerge From Two-Year Downturn With 18As Booming
Biotech and medtech startups based in the People’s Republic of China (P.R.C.) are flocking to Hong Kong to float. Meng Ding explains how a combination of listing reforms and an explosion of innovation in the Greater Bay Area have led to Hong Kong’s 18A process being popular for life sciences.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Meng Ding
Hong Kong
meng.ding@sidley.com