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
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. (more…)
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Stephen Abreuhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngStephen Abreu2022-06-21 13:40:292022-06-21 13:44:57Key Questions To Ask When Conducting Due Diligence of an Emerging Cellular or Gene Therapy Company
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-05.png606833Christopher A. Fanellihttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngChristopher A. Fanelli2022-06-10 11:38:022022-06-10 11:40:39Buyer Beware: Compliance Risks at Emerging Cellular and Gene Therapy Companies
September 24The Francis Crick Institute, 1 Midland Road, London, NW1 1AT, UK
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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
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. (more…)
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.
(more…)
Christopher A. Fanelli
Washington, D.C.
cfanelli@sidley.com
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Swiss MedTech 2024: Harnessing Market Dynamics for Profitability
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Sidley Healthcare Investment Conference 2024
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