Gene Therapy Product definition

Gene Therapy Product means an AAV that delivers one or more therapeutic transgenes to a patient.

Gene Therapy Product means any [***] product that delivers [***] for purposes of [***].

Gene Therapy Product means a pharmaceutical product (or proposed or prospective pharmaceutical product) that inserts one or more functional genes into a patient’s cells using an AAV. For clarity, Gene Therapy Products do not include (a) [*] or (b) [*].

Examples of Gene Therapy Product in a sentence

• For details regarding duration of the follow-up monitoring for RCR and methods, please refer to the document “Testing of Retroviral-Based Human Gene Therapy Product for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry” dated July 2018.We recommend that GT products with transposon elements be monitored in a similar way as gammaretroviral or lentiviral vectors.

• The First Approved Gene Therapy Product for Cancer Ad-p53 (Gendicine): 12 Years in the Clinic.

• For details regarding duration of the follow-up monitoring for RCR and methods, please refer to the document “Testing of Retroviral-Based Human Gene Therapy Product for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry” dated July 2018.

• Work on the Mobilisation plan will commence in earnest once Financial Close and scheme approvals are in place and will run throughout the construction phase and continue during the first 12 months of the scheme being in place.

• Sangamo Continues Progress of Its First Gene Therapy Product With Edwards, SGMO, 2/23/01 680.

More Definitions of Gene Therapy Product

Gene Therapy Product means any product containing a virus-based vector that delivers one or more transgenes to a human or animal subject.

Gene Therapy Product means a Virus Vector, including without limitation AAV, that delivers a polynucleotide to certain cells of a patient for a purpose in the Field. Gene Therapy Products include, but are not limited to, Development Candidates, other Collaboration Candidates and Collaboration Products.

Gene Therapy Product means a pharmaceutical product which has the following characteristics:

Gene Therapy Product means, with respect to a pharmaceutical product, that such pharmaceutical product inserts one or more functional genes into a patient’s cells using an adeno associated virus. For clarity, gene therapy products do not include genome editing, in which genetic engineering is used to insert, delete or replace DNA in the genome of an organism using engineered nucleases. *** Confidential Treatment Requested ***

Gene Therapy Product means the administration of genetic material to modify or manipulate the expression of gene product or to alter the biological properties of living cells for therapeutic use;

Gene Therapy Product means a pharmaceutical product (or proposed or prospective pharmaceutical product) that inserts one or more functional genes into a patient’s CNS or PNS cells using a parvovirus vector, including but not limited to an AAV. For clarity, Gene Therapy Products may include [*], but do not include [*]. For clarity, this provision shall not be construed to affect [*].”

Gene Therapy Product means one of an ADA SCID Product, an LCR-EFS Platform Product, an MPS1 Product, a Perforin Deficiency Product or a [***] Product, and “Gene Therapy Products” means two or more of the foregoing;