Pharma companies are looking to better understand how Generative AI (GAI) can facilitate innovation. Early adopters can gain distinct advantages while properly managing the top-of-mind potential risks discussed below. Francesca Blythe and Steve McInerney explain the corporate governance principles that should be considered.
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 Blythe2023-08-31 10:20:502025-09-26 15:56:17Five Governance Steps To Consider When Using Generative AI Within A Pharma Company
The impending EU Corporate Sustainability Due Diligence Directive (“CS3D”) means most EU and some non-EU life sciences companies should begin to assess their wider human rights and environmental impacts and rethink compliance programmes. Michele Tagliaferri explains.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Michele Tagliaferrihttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMichele Tagliaferri2023-08-03 14:02:412025-09-26 15:57:30Start Thinking About Human Rights and Environmental Impact of Subsidiaries and Value Chains
Developing a cell or gene therapy (CGT) involves a range of regulatory considerations and challenges. Emily Marden and Jaclyn Fonteyne point to some key factors that are currently the focus of FDA attention and may merit consideration by sponsors early in the development process.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Emily Mardenhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngEmily Marden2023-07-25 09:17:032025-09-26 15:57:57Four Tips for Successful Development of Cell and Gene Therapies
The life sciences industry has recently seen a proliferation of Contingent Value Rights (CVRs), the public M&A equivalent of the earnout used in private deals. Sally Wagner Partin, Sharon Flanagan, and Hannah Brown explain what you need to know about them.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-02.png606833Sally Wagner Partinhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngSally Wagner Partin2023-06-29 09:26:422025-09-26 15:58:28Seven Things Life Sciences Buyers and Sellers Should Know About CVRs
Sites making animal drugs need to be inspection-ready, as a single inspection report can now be relied upon by regulators in both the U.S. and some EU member states. Multi-jurisdictional regulatory actions could ensue. Christopher Fanelli, Chris Boyle and Yuzhi Hu explain.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Christopher A. Fanellihttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngChristopher A. Fanelli2023-06-20 09:26:422025-09-26 15:58:56U.S. and EU Expand Mutual Recognition Agreement to Include Animal Drugs
Bringing a sophisticated digital health product comprised of a combination of hardware and software to market can be tricky. Meena Datta and Deeona Gaskin advise on how to do so successfully by factoring in FDA marketing and reimbursement pathways, including insurers and employer-sponsored health plans.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Meenakshi Dattahttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMeenakshi Datta2023-06-08 14:01:322025-09-26 15:59:26Five Tips for Bringing a Complex Digital Health Product to Market
The U.S. government has expressed concern over misleading marketing by some Medicare Advantage and Part D plans. Now, a much wider range of marketing materials will need to be approved by the government prior to distribution. Jon Zucker and Taylor Andelman explain the changes.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2023/05/Telehealth-2.jpg606833Jon S. Zuckerhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngJon S. Zucker2023-05-26 09:28:122025-09-26 15:59:52CMS Now Needs to Approve Medicare Ads That Mention Plan Benefits
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Five Governance Steps To Consider When Using Generative AI Within A Pharma Company
Pharma companies are looking to better understand how Generative AI (GAI) can facilitate innovation. Early adopters can gain distinct advantages while properly managing the top-of-mind potential risks discussed below. Francesca Blythe and Steve McInerney explain the corporate governance principles that should be considered.
Francesca Blythe
London
fblythe@sidley.com
Stephen W. McInerney
Chicago
smcinerney@sidley.com
Start Thinking About Human Rights and Environmental Impact of Subsidiaries and Value Chains
The impending EU Corporate Sustainability Due Diligence Directive (“CS3D”) means most EU and some non-EU life sciences companies should begin to assess their wider human rights and environmental impacts and rethink compliance programmes. Michele Tagliaferri explains.
Michele Tagliaferri
Brussels
mtagliaferri@sidley.com
Four Tips for Successful Development of Cell and Gene Therapies
Developing a cell or gene therapy (CGT) involves a range of regulatory considerations and challenges. Emily Marden and Jaclyn Fonteyne point to some key factors that are currently the focus of FDA attention and may merit consideration by sponsors early in the development process.
Emily Marden
San Francisco
emarden@sidley.com
Jaclyn G. Fonteyne
Washington, D.C.
jaclyn.fonteyne@sidley.com
Seven Things Life Sciences Buyers and Sellers Should Know About CVRs
The life sciences industry has recently seen a proliferation of Contingent Value Rights (CVRs), the public M&A equivalent of the earnout used in private deals. Sally Wagner Partin, Sharon Flanagan, and Hannah Brown explain what you need to know about them.
Sally Wagner Partin
San Francisco, Palo Alto
swagnerpartin@sidley.com
Sharon Flanagan
San Francisco, Palo Alto
sflanagan@sidley.com
Hannah Brown
San Francisco
hbrown@sidley.com
U.S. and EU Expand Mutual Recognition Agreement to Include Animal Drugs
Sites making animal drugs need to be inspection-ready, as a single inspection report can now be relied upon by regulators in both the U.S. and some EU member states. Multi-jurisdictional regulatory actions could ensue. Christopher Fanelli, Chris Boyle and Yuzhi Hu explain.
Christopher A. Fanelli
Washington, D.C.
cfanelli@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Yuzhi Hu
Five Tips for Bringing a Complex Digital Health Product to Market
Bringing a sophisticated digital health product comprised of a combination of hardware and software to market can be tricky. Meena Datta and Deeona Gaskin advise on how to do so successfully by factoring in FDA marketing and reimbursement pathways, including insurers and employer-sponsored health plans.
Meenakshi Datta
Chicago
mdatta@sidley.com
Deeona R. Gaskin
Washington D.C.
dgaskin@sidley.com
CMS Now Needs to Approve Medicare Ads That Mention Plan Benefits
The U.S. government has expressed concern over misleading marketing by some Medicare Advantage and Part D plans. Now, a much wider range of marketing materials will need to be approved by the government prior to distribution. Jon Zucker and Taylor Andelman explain the changes.
Jon S. Zucker
Washington D.C.
jzucker@sidley.com
Taylor Andelman
Washington, D.C.
tandelman@sidley.com
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