This Request for Project Information (RPI) contains background material and guidance for the preparation of project information papers to the MTEC. Project information papers will be reviewed by the Sponsor and used in a manner that shapes a future MTEC solicitation that requests full project proposals. The results of the project information paper submission will serve as a means to assess the development landscape and potentially focus the proposal effort that will follow.
This call requests project information for cell therapies that can be used to treat the inflammatory complications that arise after traumatic injury. (Note, this request is not looking for cell therapies that can be used to achieve hemostasis.) The intent of this action is to forward at least one cell therapy prototype into a Phase II clinical trial. Therefore, the products being brought forth must be ready to enter the clinical stage within a short window and have all of the regulatory requirements for IND prepared for submission as a minimum. The focus of this effort is the actual clinical study and not the manufacturing of product, albeit the product must be made available under GMP standards to move forward. If manufacturing is required, that must be stated and the cost identified accordingly. The Project Information Papers will provide a means to judge the approach, maturity, and past history that supports clinical study engagement, readiness for clinical study, the capacity of the proposer to accomplish the clinical study, and the projected financial costs of taking the product forward.
This MTEC RPI is focused on the following major tasks:
- Produce clinical grade prototype cellular therapy agent in sufficient quantity to conduct a clinical assessment in a trauma patient population. Assessment needs to account for relevant regulations for prototypes to be administered to humans and ensure documentation of appropriate quality and process controls. The proposer will come forth with the appropriate protocol and surgical procedure that will serve as the basis for evaluation and supports labeling as a hemorrhagic shock therapeutic.
- Develop a clinical study to assess mechanistic and outcome based patient responses to administration of cellular therapies with appropriate controls for administration of cellular therapy (placebo control, potential confounding treatments (e.g. inclusion/exclusion, hemostasis and blood transfusion) and outcomes assessment (blinding as to treatment). Relevant outcomes may include inflammation and/inflammatory complications, organ function/injury scores, and mortality. In addition, all safety data and indications need to be identified for capture and review.
- Document sufficient patient population (number, severity, availability in the acute post injury phase, and ability to conduct exemption from informed consent) to ensure assessment of prototype cellular therapy is conducted in a timely manner.
- Consider capacity for future assessment of cellular therapies from a variety of sources (e.g. industry, academic labs, and international partners) in a well described clinical population as a reimbursable service.
Project information papers must be submitted by 11:59 pm on March 9, 2017 via email to email@example.com. Project information papers may be submitted by both MTEC members and non-members. Please note that MTEC membership is required for the submission of a full proposal in response to a future MTEC Request for Project Proposals (RPPs) for CTTHS.
Full RPI: click here.