Autologous Progenitor Cells For Treating Hematologic Malignancies (Research Paper Sample)
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.
Stem cells therapy development plan group research project not reprogramming or genetic manipulations
Autologous progenitor cells for treating hematologic malignancies
Autologous progenitor cells is potentially effective for treating the hematologic malignancies and the essential requirements for developing are reviewed to evaluate the likelihood of developing the therapy intervention made by the Janus process. Emerging evidence shows that using autologous progenitor cells is a viable alternative to reprogramming or genetic manipulations to generate new stem cells. There is growing interest in using autologous progenitor cells as the therapeutic efficacy of this option is more effective as there is low risk of rejection compared to using cells from donors. Patel & Rameshwar (2011), highlighted that cellular therapies that are focused on patient-specific factors are more successful as the genomic factors are the same.
FDA Approval: Center for Biological Evaluation and Research (CBER)
The Center for Biological Evaluation and Research (CBER) is involved in regulating various compliance and surveillance undertakings during the lifecycle of the biological products CBER will first ensure that pre-license and pre-approval of the manufacturing facilities and therapy products is carried out. The FDA authorizes factory inspections, which is necessary to ensure that the required standards are adhered to, and also shows that the firm will be able to maintain capability meeting the stated commitments. The FDA has outlined the various regulatory and safety guidelines, which have been reviewed and updated to provide relevant instructions on what is to be expected
Design and synthesis stage
At synthesis stage there is focus on ensuring that the therapy safe and efficacious, so that it achieves the desired results. There is target identification, and since the therapy is not repurposing approval may take time, but there is still emphasis on reproducing data that shows that the drug is effective. There are expanded clinical applications for the autologous progenitor cells, which is a therapeutic option. The synthesis focuses on ensuring that there is accurate and reliable chemical composition of stem cell therapy option, as chemical stability ensures that the therapy can be used as intended.
Pre-clinical efficacy testing
The safety and efficacy properties are reviewed, and this extends to preclinical models of hematologic malignancies using autologous progenitor cells that are evaluated for treating hematologic malignancies (Halme & Kessler, 2006). The observations will also be translated to show that the therapy is potentially effective. Stem cell transplantation remains one of the most effective curative treatments for hematologic malignancies, especially in cases that are resistant to chemotherapy. In the case of transplantation of cells or tissues, there is a need to demonstrate that this poses no risk of disease transmission (Halme & Kessler, 2006).
Formulation and manufacturing
There have been changes in the approval of biologic products before they reach the bedside, and the products do not pose great risk to people (Halme & Kessler, 2006). As such, there is less extensive manufacture and clinical trial study for the product characterization. Before the approval of YESCARTA, there was product description and manufacturing summary details highlighting what was to be expected from the product and how it affected the human autologous T cells. The main source for autologous transplants is the blood progenitor cells, and collecting the idea...
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