Cell, Tissue, and Gene
Therapies

Contacts
Michael N. Druckman,

We have significant experience guiding clients aroundthe 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 andcommercialization questions; reimbursement;
distribution; and intellectual property.
We combine our deep legal and regulatory expertisewith your scientific and business acumen to solve someof the most interesting issues with tremendous
potential to help patients. Working together, we can
improve the health of patients around the world byapplying cutting edge scientific breakthroughs.

Washington, D.C.

Kristin Anne Connarn,
BostonRandy J. Prebula,
Washington, D.C.

Robert F. Church,
Los Angeles

Practices
Pharmaceuticals andBiotechnology
Regulatory
Intellectual Property

Representative experience
Intellia Therapeutics in the launch of a new autologous
and allogeneic universal CAR-T cell therapy company incollaboration with Blackstone Life Sciences and Cellex
Cell Professionals GmbH, the parent company ofGEMoaB.
Spark Therapeutics on its US$161m IPO and on a wide
range of regulatory, reimbursement, commercial, andcompliance issues in connection with its development
and product launch of Luxturna.

Industries
Life Sciences and HealthCareMajor universities, gene therapy inventors andnumerous publicly traded companies on licenses andcollaborations to develop therapies for the worldwidemarket.
Multiple clients in the CAR-T space on manufacturing
clinical trial and quality agreements, and regulatory andlaunch 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 thecurrent 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 inspectionfindings.
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 acquisitionof the cell culture, gene modulation, and magnetic
beads businesses of Thermo Fisher Scientific Inc.

Latest thinking and events
NewsNew French template agreement for clinical trials: more
standardization, less simplificationNews
FDA promotes user fee waiver options for combination
products
NewsNegotiating cell, tissue, and gene therapy agreementswith health care organizationsNews
CMS issues updates regarding ASP: negative ASP,
radiopharmaceuticals, restatements, and skinsubstitutesInsights and Analysis
Q2/2024 Life Science Law Update – Key developmentsfor pharma & device companies in EU
Insights and Analysis
Drug research and development beyond earth’s gravity