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 to IND for Protein and Peptide Therapies(pdf, 552 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 Matrix-- Key Tasks(pdf, 108 KB)
Cell and Gene Therapy Product Development Matrix – General(pdf, 164 KB)
Cell and Gene Therapy Product Development Matrix – Preclinical Pharmacology/Toxicology(pdf, 145 KB)
Cell and Gene Therapy Product Development Matrix(pdf, 325 KB) – CMC
Cell and Gene Therapy Product Development Matrix – Clinical(pdf, 108 KB)