Jay Jariwala in Washington, D.C. and Josefine Sommer in Brussels talk to Raj Pai about how they expect the EU’s new revised Annex 1, EudraLex Volume 4 (GMP), to affect the manufacturing of sterile medicinal products. They discuss how the update reflects changes in the manufacturing environment and how the new Annex 1 is likely to be considered within the U.S. regulatory framework. Prior to joining Sidley, Jay worked for the Office of Compliance at the Center for Drug Evaluation and Research, a branch of the U.S. Food and Drug Administration, and he brings this experience to bear in considering the impact of Annex 1.
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.
Korean Biotechs Share Their Insights With Sidley At J.P. Morgan Healthcare Conference 2023
Josh Hofheimer reports the takeaways from Sidley’s co-hosted pitch day with KoreaBio and BioCentury at the J.P. Morgan Healthcare Conference. The session included key insights on entrepreneurial developments and an investor panel on macroeconomic 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.
Josh Hofheimer
jhofheimer@sidley.com
7 Key Trends for the Global Life Sciences Industry in 2023
Sidley’s 2023 Global Life Sciences Trendspotting Report maps out seven key trends in the life sciences industry globally, and identifies some regional trends in the U.S., China, and Europe which are likely to have global ramifications during the coming year.
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.
GLS Blog Contributor
sidleyglsblog@sidley.com
Navigating Decentralized Clinical Trials In the EU and the UK
Decentralized clinical trials are on the rise in the EU and the UK. This month, new EU level guidance on how to conduct them has supplemented existing guidance on the topic. Zina Chatzidimitriadou, Lauren Cuyvers and Bronwyn Tonelli give seven considerations for decentralized trial sponsors in the region.
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.
Lauren Cuyvers
Brussels
lcuyvers@sidley.com
Bronwyn Tonelli
Trainee Solicitor
btonelli@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
The U.S. Department of Justice may clamp down on life sciences companies that share board members with alleged competitors
The Biden administration is conducting investigations into potential antitrust violations to which the life sciences industry may be particularly vulnerable because having board members sit on more than one company is relatively common. Benjamin Nagin and Kristina Gliklad 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.
Benjamin Nagin
New York
bnagin@sidley.com
Kristina Gliklad
New York
kgliklad@sidley.com
Biden Administration Moves to Boost the Bioeconomy
A new Executive Order in the U.S. aims to ease the path to market for products that use synthetic biology or genome editing. Emily Marden explains the thinking behind the announcement and its efforts to streamline the current U.S. framework for biotech.
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.
Emily Marden
San Francisco
emarden@sidley.com
Remote Regulatory Assessment Oversight Tools Piloted During the COVID-19 Pandemic Are Here to Stay
Chris Fanelli explains what the U.S. Food and Drug Administration’s new draft guidance on remote regulatory assessments means for site inspections in the future, and how manufacturing facilities can prepare for requests for Remote Regulatory Assessments.
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.
Christopher A. Fanelli
Washington, D.C.
cfanelli@sidley.com
Unprecedented Sanctions Against Russia Continue to Impact Pharma Supply Chains
Justine Fassion considers how the various sanctions against Russia are impacting pharmaceutical supply chains, and explains why pharma companies will be affected despite the existence of humanitarian exceptions.
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.
Justine Fassion
Brussels
justine.fassion@sidley.com
Podcast: How the EU’s New Revised Annex 1, Eudralex Volume 4 (GMP), Will Affect the Manufacturing of Sterile Medicinal Products in the EU and U.S.
Jay Jariwala in Washington, D.C. and Josefine Sommer in Brussels talk to Raj Pai about how they expect the EU’s new revised Annex 1, EudraLex Volume 4 (GMP), to affect the manufacturing of sterile medicinal products. They discuss how the update reflects changes in the manufacturing environment and how the new Annex 1 is likely to be considered within the U.S. regulatory framework. Prior to joining Sidley, Jay worked for the Office of Compliance at the Center for Drug Evaluation and Research, a branch of the U.S. Food and Drug Administration, and he brings this experience to bear in considering the impact of Annex 1.
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.
Raj D. Pai
Washington, D.C.
rpai@sidley.com
Jay Jariwala
Washington, D.C.
jjariwala@sidley.com
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Could the European Health Data Space Push the EU Above Other Key Markets Such As the U.S. and China?
Eva von Mühlenen and Alejandro Bes of Novartis consider how the proposed European Health Data Space may speed up research for medicinal products by increasing access to health data, with the help of data scientists within the EU. This development is likely to generate five sticking points that the life sciences industry will need to address, they add.
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.
Eva von Mühlenen
Geneva
evonmuehlenen@sidley.com
The Top Three Pandemic Manufacturing Inspection Techniques That Are Here to Stay
With many pharmaceutical manufacturing facilities unaccustomed to in-person GMP inspections since the pandemic, Arif Noorani, Josefine Sommer, and Daniel Roberts examine how inspection techniques have evolved.
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.
Arif S. Noorani
Washington, D.C.
anoorani@sidley.com
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Daniel J. Roberts
San Francisco
droberts@sidley.com