Panoramic: Automotive and Mobility 2025
Cell, Tissue, and Gene Therapies
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We have significant experience guiding clients around the world at the forefront of stem cell, regenerative medicine, and advanced therapy innovations. Our experience spans research and development; licensing deals between inventors, universities and companies; manufacturing; complex regulatory and commercialization questions; reimbursement; distribution; and intellectual property.
We combine our deep legal and regulatory expertise with your scientific and business acumen to solve some of the most interesting issues with tremendous potential to help patients. Working together, we can improve the health of patients around the world by applying cutting edge scientific breakthroughs.
Our capabilities at a glance
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Hear from our clients and industry leaders
The whole team is super smart. They are all really easy to work with and then know our business inside out. They come to us proactively with issues and are incredibly responsive.
Chambers & Partners, UK Guide, 2025
An intellectually brilliant and commercially astute public law team. One of the very best in the city.
Chambers & Partners UK 2025
Hogan Lovells has a high capability in solving complex issues that involve both legal and technical perspectives.
Chambers & Partners, Germany, 2025
The lawyers are just experts. They are there when you need them and happy to entertain all my questions. They understand the wider context and the politics and sensitivities of it.
Chambers & Partners, UK 2025
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.
Intellia Therapeutics in the launch of a new autologous and allogeneic universal CAR-T cell therapy company in collaboration with Blackstone Life Sciences and Cellex Cell Professionals GmbH, the parent company of GEMoaB.
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.
Spark Therapeutics on its US$161m IPO and on a wide range of regulatory, reimbursement, commercial, and compliance issues in connection with its development and product launch of Luxturna.
Valeant Pharmaceuticals on the sale of Dendreon Pharmaceuticals and its immunotherapy cell-based product Provenge to China-based SanPower Group.
Intrexon Corporation, a leader in synthetic biology, on the acquisition of Oxitec, a pioneer in biological insect control solutions.
Major universities, gene therapy inventors and numerous publicly traded companies on licenses and collaborations to develop therapies for the worldwide market.
Multiple clients in the CAR-T space on manufacturing clinical trial and quality agreements, and regulatory and launch planning.
Multiple clients on IP counseling, comprehensive FDA regulatory, reimbursement, and launch planning.
Tessera Therapeutics an early-stage life sciences company pioneering Gene Writing genetic medicine, on its IP needs including patent prosecution, strategy, and transactional matters.
Prepare for a Type B meeting with FDA to resolve issues with the development of anti-cancer vaccines based on the patients’ T-cell and the tumors’ immunological assessment.
A non-academic medical research institute on the current Good Tissue Practice requirements applicable to a contract laboratory performing tests on stem cells being used in clinical trials.
An international plasma protein therapeutic company on cGMP issues and in responding to FDA inspection findings.
A Mexican company developing therapies using allogenic pluripotent stem cells for repairing tissues and restoring their functions, focusing in particular on curing Parkinson’s disease.
An immune-oncology company on exporting its investigational cytotoxic T cell stimulating interleukin product to China for compassionate use.
Viventia Bio on its acquisition by Eleven Biotherapeutics to create a targeted protein therapeutics oncology company.
General Electric Company on its US$1.06bn acquisition of the cell culture, gene modulation, and magnetic beads businesses of Thermo Fisher Scientific Inc.
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