Autologous Progenitor Cells For Treating Hematologic Malignancies
This is a group research project from a sponsor company that require us to describe the development plan for a new stem cell generating technology that does not use reprogramming or genetic manipulations.
There are four people doing this project. We divided the work into two part, the literature review and timeline & approval process. I am doing the timeline & approval process with another mate. Since what he found so far has dealt with the FDA approval process and what happens afterwords. I could look for what the company would need to do before they get FDA approval.
I am already attached our rough draft, the timeline start on page 12. Please do not disclose any informations about this project to anyone since this project is confidential. If you still have any question or concern, please do not hesitate to reach me.
This project needs us to: Describe the development plan for a new stem cell generating technology that does not use reprogramming or genetic manipulations which can be used to treat hematologic malignancies. Autologous progenitor cells thus generated can substitute for blood stem cells usually isolated from bone marrow of the patient or an allogeneic donor.
Problem to be solved: Describe the plan and timeline for developing a new method of treating hematologic malignancies using autologous progenitor cells made by the Janus process. What are the clinical requirements and prior precedents for approval of treatments for hematologic malignancies that can be applied to this approach which provides a safer and more efficacious autologous bone marrow transplant option.
Expectation: A development plan and timeline and supportive information and precedents for clinical study and approval of autologous progenitor cells using the Janus technology for the appropriate hematologic malignancy identified in questions above.
Ultimate goal: For company, a draft development plan and timeline and relevant clinical examples. For students, an opportunity to work on real world problems for a breakthrough medical technology with very experienced (>25 years medical products experience) executive.
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