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CREATE Bio Guidance Documents

Knowing therapy development is a challenging process, NINDS asked its biologic consultant contractors to generate guidance documents to better prepare investigators.

Protein and Peptide Therapies

Guidance on the preclinical and clinical development pathway for protein and peptide therapies by Rho Federal Systems Division Inc.

roadmap_for_development_of_biologics_final_for_web_6_14_18_508c.pdf (539.33 KB)

Cell and Gene Therapies

Guidance on the preclinical to clinical development pathway for cell and gene therapies by Advanced Cell & Gene Therapy, LLC.

cell_and_gene_therapy_product_development_key_tasks_for_web_508c.pdf (105 KB)
development_matrix_general_20180215_508c.pdf (159.9 KB)
development_matrix_preclinical_pharm_tox_20180215_508c.pdf (141.25 KB)
development_matrix_cmc_20180215_508c.pdf (317.6 KB)
– CMC
development_matrix_clinical_20180215_508c.pdf (105.78 KB)