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.
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Zina Chatzidimitriadouhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngZina Chatzidimitriadou2022-08-01 11:21:542022-08-01 11:21:54How to Create a More Enabling Environment for Digital Health in Europe
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.
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. (more…)
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Eva von Mühlenenhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngEva von Mühlenen2022-07-12 11:37:102022-07-12 11:37:10The Challenges Facing Artificial Intelligence and Machine Learning Solutions in the FemTech Space
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-09.png606833Maurits J.F. Lugardhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaurits J.F. Lugard2022-07-01 13:01:352023-12-11 17:00:37New European Focus on Medicine Supply Chains Means More Disclosure
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Raj D. Paihttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngRaj D. Pai2022-07-01 11:14:022022-09-21 11:08:44Making Manufacturing Sites Inspection-ready After the Pandemic Gap
September 24The Francis Crick Institute, 1 Midland Road, London, NW1 1AT, UK
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‘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.
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.
(more…)
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.
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. (more…)
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.
(more…)
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.
(more…)
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.
Raj D. Pai
Washington, D.C.
rpai@sidley.com
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