Stephen Abreu explains how licensors can make sure they do not give a licensee unintended rights to biological targets arising out of their own internal research, or from separate collaborations with third parties.
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.
Why Companies Globally Should Start Preparing Now for the European Health Data Space
Zina Chatzidimitriadou and Francesca Blythe explain how a revolutionary EU regulation, expected to come into force in 2025, will allow life sciences companies to request health data for secondary re-use, but will also expose them to more data requests.
Read more
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.
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
Francesca Blythe
London
fblythe@sidley.com
‘Ring-fencing’ Biological Targets in Collaboration Agreements
Stephen Abreu explains how licensors can make sure they do not give a licensee unintended rights to biological targets arising out of their own internal research, or from separate collaborations with third parties.
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.
Stephen Abreu
San Francisco
sabreu@sidley.com
How to Create a More Enabling Environment for Digital Health in Europe
At our recent Digital Health App’ero, Zina Chatzidimitriadou led a discussion with key industry players Aleksandra Appelfeld of Philips and Megan Coder of the Digital Therapeutics Alliance on what changes the industry would like to see in order to make Europe more hospitable to digital health products. We set out the top five themes that emerged, and a space to watch for the next decade.
Read more
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.
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
Five Global Bellwether Trends for Clinical Trials
Scott Bass explains why taking a multi-disciplinary, multi-continent approach to the planning of clinical trials will help you anticipate regulatory changes and ward off investigations.
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.
Scott Bass
New York, Washington, D.C.
sbass@sidley.com
The Challenges Facing Artificial Intelligence and Machine Learning Solutions in the FemTech Space
Sidley’s Eva von Mühlenen in Geneva and Josefine Sommer in Brussels talk to oncologist Wolfgang Hackl — the founder of a FemTech startup that guides doctors in the treatment of breast cancer — about regulation, research and development (R&D), and the vast potential of artificial intelligence in the field of health technology for women. Read more
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
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Are China-only Clinical Trials Enough for U.S. Approvals?
Torrey Cope looks at the recent FDA emphasis on the challenges of a China-only trial strategy. He explores the FDA concern that a China-only clinical trial will be unable to prove that a drug is suitable for the U.S. population, and considers the regulatory requirements for U.S. approvals based on ex-U.S. trial data.
Read more
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.
Torrey Cope
Washington, D.C.
tcope@sidley.com
New European Focus on Medicine Supply Chains Means More Disclosure
Maurits Lugard and Anna-Shari Melin examine the new era of supply chain scrutiny and explain how the EMA’s new critical medicines lists will work.
Read more
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.
Maurits J.F. Lugard
Brussels
mlugard@sidley.com
Anna-Shari Melin
Munich
amelin@sidley.com
Making Manufacturing Sites Inspection-ready After the Pandemic Gap
Due to COVID-19, many pharmaceutical manufacturing sites have not experienced a regulatory inspection in several years. Raj Pai discusses how to ensure that Good Manufacturing Practices are in place.
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
Key Questions To Ask When Conducting Due Diligence of an Emerging Cellular or Gene Therapy Company
Following our recent post highlighting potential compliance risks at emerging cellular and gene therapy companies, Stephen Abreu and Chris Fanelli provide some questions and topics to explore when considering an investment or acquisition in this space. Read more
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.
Stephen Abreu
San Francisco
sabreu@sidley.com
Christopher A. Fanelli
Washington, D.C.
cfanelli@sidley.com
Buyer Beware: Compliance Risks at Emerging Cellular and Gene Therapy Companies
Chris Fanelli explains how emerging cellular and gene therapy companies present unique challenges and unique opportunities from a compliance perspective. He explores some of the tools that buyers can use to assess GxP compliance at the due diligence and post-acquisition stages.
Read more
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