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
Olivier Goarnisson in Geneva and Francesca Blythe in London look at the benefits that were seen when some European countries temporarily permitted remote monitoring during the pandemic, and consider whether remote monitoring might have a long-term future if data privacy concerns are addressed.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Olivier Goarnissonhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngOlivier Goarnisson2022-05-27 11:53:042022-10-12 13:41:16Might the Remote Monitoring of Clinical Trials in Europe Continue after Covid-19 Despite Data Privacy Concerns?
Maarten Meulenbelt explains why even companies headquartered in China or California need to be aware that the trend for ‘replacement pharmacy compounding’ may spread.
Over the last few years, the Netherlands has begun to develop its own pharmacy-compounded products as an alternative to authorised products, and as a benchmark for pricing and reimbursement of the authorised products that they seek to replace. (more…)
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-15.png606833Maarten Meulenbelthttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaarten Meulenbelt2022-04-27 15:15:492022-05-10 11:29:09Why International Pharma Companies Need to Watch What Is Happening in the Netherlands
Life sciences companies are increasingly looking to the courtroom to resolve their disputes which were simmering during the pandemic. Ching-Lee Fukuda explains why litigation in the fields of biologics and medtech is now particularly likely, and how companies can best prepare for claims in these areas.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Ching-Lee Fukudahttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngChing-Lee Fukuda2022-04-27 15:14:272022-04-29 16:04:47How to Guard Against Biologics and Medtech Patents Litigation
Andrew Harper in San Francisco and Francesca Blythe in London look at some of the drivers that are fueling interest in digital health products aimed at women.
The term ‘Femtech’ was coined by the founder of a fertility app company in response to her experience that male investors often struggle with the specifics of discussing products focused on women’s reproductive health. However, Femtech covers a wider range of products than the purely fertility-focused, including all health software and tech-enabled products that cater to female biological needs and to the wider wellness market for all those who identify as women.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Francesca Blythehttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngFrancesca Blythe2021-12-20 15:01:472022-10-12 13:41:02Why Venture Capital Investors Are Focused on Femtech
China’s first dedicated law on personal data protection comes into effect this month. Sidley counsel Jing Lu looks at how the new Personal Information Protection Law (PIPL) differs from Europe’s General Data Protection Regulation (GDPR).
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Chen Yanghttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngChen Yang2021-11-23 15:02:312022-04-27 13:24:24If Your Company Is GDPR Compliant, Are You Ready for China’s PIPL?
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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
Might the Remote Monitoring of Clinical Trials in Europe Continue after Covid-19 Despite Data Privacy Concerns?
Olivier Goarnisson in Geneva and Francesca Blythe in London look at the benefits that were seen when some European countries temporarily permitted remote monitoring during the pandemic, and consider whether remote monitoring might have a long-term future if data privacy concerns are addressed.
(more…)
Olivier Goarnisson
Geneva
ogoarnisson@sidley.com
Francesca Blythe
London
fblythe@sidley.com
Why International Pharma Companies Need to Watch What Is Happening in the Netherlands
Maarten Meulenbelt explains why even companies headquartered in China or California need to be aware that the trend for ‘replacement pharmacy compounding’ may spread.
Over the last few years, the Netherlands has begun to develop its own pharmacy-compounded products as an alternative to authorised products, and as a benchmark for pricing and reimbursement of the authorised products that they seek to replace. (more…)
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
How to Guard Against Biologics and Medtech Patents Litigation
Life sciences companies are increasingly looking to the courtroom to resolve their disputes which were simmering during the pandemic. Ching-Lee Fukuda explains why litigation in the fields of biologics and medtech is now particularly likely, and how companies can best prepare for claims in these areas.
(more…)
Ching-Lee Fukuda
New York
clfukuda@sidley.com
Why Venture Capital Investors Are Focused on Femtech
Andrew Harper in San Francisco and Francesca Blythe in London look at some of the drivers that are fueling interest in digital health products aimed at women.
The term ‘Femtech’ was coined by the founder of a fertility app company in response to her experience that male investors often struggle with the specifics of discussing products focused on women’s reproductive health. However, Femtech covers a wider range of products than the purely fertility-focused, including all health software and tech-enabled products that cater to female biological needs and to the wider wellness market for all those who identify as women.
(more…)
Francesca Blythe
London
fblythe@sidley.com
Andrew Harper
Palo Alto, San Francisco
aharper@sidley.com
If Your Company Is GDPR Compliant, Are You Ready for China’s PIPL?
China’s first dedicated law on personal data protection comes into effect this month. Sidley counsel Jing Lu looks at how the new Personal Information Protection Law (PIPL) differs from Europe’s General Data Protection Regulation (GDPR).
(more…)
Chen Yang
Sydney, Hong Kong
cyang@sidley.com
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