The Subcontractor shall perform the following tasks under this TO: A. Maintain their own IND or DMF for the agent and remain in compliance with the NCI requirements for trial drug supply. B. Required specifications are attached and detailed SOPs have been drafted that can assist in the development of the manufacturing and Quality Control. C. The subcontractor shall submit a plan for the work needed to file DMF or IND with a separate cost estimate for that portion of the work as well as a per-dose cost as delivered. D. Submit the following documentation 1. Site has successfully filed PET NDAs or ANDAs for clinical use or has active PET INDs or DMFs (not RDRC). Cover sheet for the most recent Annual Reports submitted for each one. If none yet, FDA acknowledgement letter of submissions. 2. Site has submitted latest FDA inspection report (Establishment Inspection Reports (EIR) and/or Form FDA-483) for their IND, DMF, NDA or ANDA to CIP if any have been conducted. 3. Site has an active DMF or IND for this PET agent. Copy of last Annual Report. If none yet, FDA acknowledgement letter. 4. Site can meet the specifications in the NCI IND including expiration dating. Specification Sheet submitted with a comparison of the specifications 5. Site makes consistent product. Analytical Test Results submitted for at least three passing lots. 6. Site provides NCI with Letter of Authorization to Cross Reference to Site’s DMF or IND. Site files letter with their application. NCI files letter with their IND for the Clinical Trial. E. Synthesize and distribute the Zr-89 avelumab (pure and suitable for administration to humans as per guidelines set forth in the U.S. Pharmacopeia <823> to the trial site at the NCI Clinical Center on a schedule to be determined, on a unit dose basis of 1-2 mCi at the time scheduled for administration to each patient. Up to 25 doses will be required.
Leidos Biomedical Research, Inc.
Proposal Due Date:
Monday, February 3, 2020
Research & Development Services & Subcontracts
NCI OA Contract Number:
75N91019D00024 – NCI-FFRDC
Please reach out to Josh Wynne (email@example.com) for the full solicitation, or with any questions. Thank you, and good luck!