Clinical Development Stage and Product Registration Sample Clauses

Clinical Development Stage and Product Registration a. Goals: (i) to use the Ventana IUO to determine patient eligibility in Clinical Trials of BLU-554, and collect data from those trials to demonstrate clinical utility of the Assay for FDA approval; (ii) conduct Inter-laboratory- Reproducibility study, a diagnostic clinical study needed for FDA submission; (iii) to seek product approval and/or registration with global regulatory authorities.
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Clinical Development Stage and Product Registration. The Ventana IUO will be transferred to commercial laboratories and used as an enrollment Assay for global Clinical Trials of BLU-554 in HCC. For clarity, while the Ventana CAP/CLIA laboratory is qualified to be a testing lab for pivotal studies, it is Ventana’s recommendation that the Ventana IUO be transferred to a commercial laboratory(ies) other than Ventana’s CAP/CLIA certified laboratory for use in registrational Clinical Trials. If the Ventana IUO is not ready to be transferred to commercial laboratories for the start of an BLU-554 pivotal study, Blueprint and Ventana will negotiate in good faith the terms of separate Project Schedules (i) for patient screening using the prototype Ventana Assay at Ventana’s CAP/CLIA laboratory and (ii) any resulting bridging studies that are required for the Ventana Assay to gain Regulatory Approval. The Ventana IUO will be transferred and validated at those labs, and the lab pathologists trained and qualified by Ventana prior to enrollment for those pivotal Clinical Trials. A diagnostic clinical trial protocol will be written and a clinical site initiation visit (“SIV”) will be completed at the start of each Clinical Trial, to ensure proper data capture and operations to support the clinical development of the IUO. Following Clinical Trial start and throughout the duration of the enrollment portion of the Clinical Trial, Ventana will monitor the performance of the testing lab, collecting data for the PMA submission. [Confidential Information of Blueprint and Ventana] In addition to the Clinical Trials involving BLU-554, a separate inter-laboratory reproducibility study (ILR) will be designed and completed (“ILR”). The ILR is a purely diagnostic Clinical Trial that does not need BLU-554 treated patients or samples. The Clinical Trial is designed and executed solely by Ventana and the data are required for a PMA application. Near the end of the BLU-554 registrational Clinical Trial(s), Ventana will submit a modular PMA application to the FDA. Modules 1, 2, and 3 are focused primarily on the analytical performance of the Ventana Assay and the system components, and Module 4 brings in the clinical utility data to BLU-554. In addition and if needed, Ventana will prepare and submit necessary document to the Roche Diagnostics Germany Regulatory group, which will determine whether Roche may self-declare conformity to CE rules for companion diagnostics. Following declaration of conformity, Ventana may register the assay as a...
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Related to Clinical Development Stage and Product Registration

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