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 and Sharon Flanagan 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 09:26:422026-04-28 12:37:50Seven 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
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 and Sharon Flanagan 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
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
Resources
Upcoming Events
Hong Kong Life Sciences Roundtable
Bay Area Life Sciences Roundtable
Swiss MedTech 2026
MedTech in Recalibration: Staying Ahead in Regulation, AI, and the Deal Landscape
Sidley Healthcare Investment Conference 2026
Archives
Categories