General Biorepository Development for Solid Organ and Stem Cell Transplant Specimens

Project: Research project

Description

Northwestern University Comprehensive Transplant Center (NUCTC) as a Partner to Sponsors in all matters relating to the research and development of diagnostic and/or predictive biomarkers designed to improve the health and outcomes of transplant patients.

Activities include:
1. Sponsors get access, via an ‘intake committee’ made up of NUCTC and Sponsor members, to all necessary existing and future samples (obtained while Agreement is in place) in the CTC biorepository needed for discovery and/or validation of existing or new diagnostic and/or predictive biomarkers. The intake committee reserves the right to amend the scope or type of requested samples if deemed beyond what is necessary to complete a project.
2. Sponsors get access to all other necessary information, including histological, clinical and laboratory data elements needed to use said samples needed for discovery and/or validation of existing or new diagnostic and/or predictive biomarkers.
3. Sponsors get access to necessary bioinformatics and biostatistics, within its existing capabilities needed for discovery and/or validation of existing or new diagnostic and/or predictive biomarkers.
4. Sponsors get access to all relevant faculty and staff, as determined by the PI needed to deliver on the proposed ‘offering’.
5. Sponsors get access to ‘executive committee’ plus ‘ad-hoc’ individuals as needed to deliver on the proposed offering including but not limited to quarterly f2f planning and review meetings, monthly calls, and ad-hoc calls as needed.
NUCTC shall respond to a Sponsor request for samples and/or clinical information within ten (10) business days of a request. NUCTC shall deliver requested samples and/or clinical information to Sponsor(s) within thirty (30) days of their response to a request. NUCTC shall not unreasonably deny a request for samples and/or clinical information from Sponsor(s) and will communicate any projected delays to the above timeline to the sponsor in a timely manner.
6. NUCTC will consult with Sponsors prior to agreeing to any pursuit of biomarker discovery and/or validation outside the intended scope of this Agreement. Sponsors will get first right of refusal by providing an LOI of existing or planned conflicting pursuits within 60 days of NUCTC’s request.
Current Ongoing studies in progress include the two studies listed below. This SOW will not be amended to include each future study initiated.

Study #1: Northwestern University Comprehensive Transplant Center as a Partner to Sponsors Towards Development and Commercialization of Biomarker Tests for Kidney and Liver Transplant Recipients
Services included:
1. Working out and ironing out logistics of sending a sample and receiving a report for a biomarker test, and supporting other aspects of CLIA lab service operation as needed.
2. Access to precision-phenotyped patient samples for the purpose of ongoing test QA/QC or troubleshooting, and discovery and validation of any other biomarker in development.
3. Access to input on clinical aspects of integrating biomarker tests into patient care.
Study #2: Northwestern University Comprehensive Transplant Center as a Partner in the Transition of the TruGraf test following a M&A agreement between Sponsors
Activities include:
1. Working out logistics of sending a sample and receiving a report for a biomarker test, and supporting other aspects of CLIA lab service operation as needed.
2. Provision to Sponsors of precision-phenotyped patient samples (including, but not limited to, samples obtained by Northwestern during the Term) and as
StatusActive
Effective start/end date10/18/1910/17/24

Funding

  • Viracor-IBT Laboratories (Agmt 10/17/19)

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Stem Cells
Transplants
Biomarkers
Biostatistics
Computational Biology
Patient Care
Kidney
Liver
Health
Research