CREATE Bio Guidance Documents

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.

car on road with sign overhead with words IND on it guiding driver to destinationProtein 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, 540 kb)

 

neuron cell and DNA helix with matrix backgroundCell 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, 105 kb)

Cell and Gene Therapy Product Development Matrix – General (pdf, 160 kb)

Cell and Gene Therapy Product Development Matrix – Preclinical Pharmacology/Toxicology (pdf, 141 kb)

Cell and Gene Therapy Product Development Matrix – CMC (pdf, 318 kb)

Cell and Gene Therapy Product Development Matrix – Clinical (pdf, 106 kb)