Cell, Tissue, and Gene Therapies

Guiding clients around the world at the forefront of stem cell, regenerative medicine, and advanced therapy innovations.

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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 experience spans research and development; licensing deals between inventors, universities and companies; manufacturing; complex regulatory and commercialization questions; reimbursement; distribution; and intellectual property.

Pharmaceuticals and Biotechnology Regulatory

Medical Device

Health Law

Clinical Trials

Intellectual Property

In a sector defined by regulation, competitive pressure, and payer pushback, we help pharma companies accelerate market entry and sustain competitive advantage.

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Bringing a medical device to market means tackling financing, patents, approvals, manufacturing, and distribution. We see the whole picture – helping you accelerate entry, innovate through change, and protect your advantage.

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In the health sector, regulation never stands still. We help you anticipate change, adapt with confidence, and seize opportunity.

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We help clients bring new drugs, biotechnology products, and medical devices to market.

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We are a leading global intellectual property practice – solving our clients most important issues across IP counseling, transactions, and litigation – meeting our clients where they need us most.

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Key contacts

Michael N. Druckman

Partner

Michael N. Druckman

Partner

Washington, D.C.

Kristin Anne Connarn

Partner

Kristin Anne Connarn

Partner

Boston

Meet the Cell, Tissue, and Gene Therapies team

Representative experience

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.

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.

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.

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.

General Electric Company on its US$1.06bn acquisition of the cell culture, gene modulation, and magnetic beads businesses of Thermo Fisher Scientific Inc.

Other ways we can help you

Resources

Horizons 2025 Life Sciences and Health Care Edition

Our Horizons edition brings together insights from across our global Life Sciences and Health Care team to explore the issues and developments shaping the future of the industry.

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AI Hub

As innovation surges, the AI landscape is evolving rapidly. Our interactive AI Hub serves as a central resource covering the latest trends and developments. Explore the Hub to find our recent thought leadership, navigate new laws and regulations, and to get in touch with our AI market-leaders.

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Talking the Cure Podcast

Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover cutting-edge topics such as AI, digital health, diversity in clinical trials, supply chain, inflation reduction act, and more.

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