Area of focus

Cell, Tissue, and Gene Therapies

You create new products at the speed of innovation. And regulators race to keep pace. Commercial success and compliance can sometimes seem at odds.

The lawyers at Hogan Lovells uncover opportunity and mitigate risk for clients regarding cell, tissue, and gene therapies. From responding to U.S., EU, and Asian regulators, to ...

Representative experience

We have advised human tissue companies on how to transition a product from 361 HCT/P status to licensure as a biologic under section 351 of the Public Health Service Act.

We have assisted leading pharmaceutical companies in determining the appropriate classification of their tissue products in the EU.

We have advised gene therapy companies on genotyping programs.

We obtained Healthcare Common Procedure Coding System (HCPCS) codes for cellular therapies.

Assisted a client developing a gene therapy product for an orphan condition convince FDA to relinquish burdensome clinical trial endpoint requirements.

Counseled a gene therapy company and a company developing a drug to treat genetic obesity on genotyping programs and subject recruiting and patient identifying programs.

Counseled U.S. biotech companies seeking EU marketing authorization for advanced medicinal therapies, including issues involving clinical trials and patient identification.

Press Releases

Hogan Lovells advised Jazz Pharmaceuticals on its acquisition of Cavion

Silicon Valley, 12 August 2019– International Law firm Hogan Lovells represented global biopharmaceutical company Jazz Pharmaceuticals, plc in the acquisition of Cavion, Inc. through a...

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Blog Post

FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid...

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Hogan Lovells Publications

View from the Horizon: Digital Health and Cell, Tissue, and Gene Therapies in Boston

On April 30 our new global series, Life Sciences and Health Care Horizons, kicked off in Boston with two panel discussions that focused on the challenges and opportunities that our lawyers...

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Hogan Lovells Events

Boston: Life Sciences and Health Care Horizons 2019

The fast pace of innovation in the life sciences and health care industry is quickly transforming the health and vitality of the world we live in. It can be a challenge to keep up, let...

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Hogan Lovells Publications

Life sciences and health care horizons 2019

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