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