Table of Contents
Clinic Trials
The current clinical trial is being conducted by Cellular Dynamics International in collaboration with FUJIFILM Company. The two companies are trying to develop a collection of iPS cells which they term as the bank. These cells are immune-matched to a big percentage of the United States population as it contains the haplotypes in the country’s population. The study is being conducted to create a bank of iPS cells that all researchers around the globe can utilize for various purposes. The cells can be used in basic research, in the discovery of new medicines, creating new products and services useful for studying human diseases and developing new products that are based on the cells. This idea of using cells from human iPS cells to treat human diseases is of interest in medicine (Baghbaderani et al., 2015). One donor cell from this bank can be used to treat several people. These cells will be stored in the Cellular Dynamics International bank and they will be available for laboratory research or for clinical use in patients. The iPS cells can be generated from the donated blood and cells made from iPS cells can be of benefit to different patients and be applied in other research projects to understand human biology disease.
We can do it today.
The key steps of Human Induced Pluripotent Stem manufacturing process are four. The first stage involves the acquisition of tissue to get the fresh cord blood unit. The second step involves cell isolation from the cord blood; this is followed by reprogramming of the CD34+ cells into iPSC by using the Nucleofector system and episomal that is based on technology (Baghbaderani et al., 2015). The final step involves expansion and banking of the Induced Pluripotent Stem cells.
This initiative has been found to be effective in stopping the progression of diseases. For instance, Japanese who the man was the first to obtain cells from induced pluripotent stem cells which were donated by another individual. This type of treatment was found to be effective as it stopped the disease from progressing in the tissues (Baghbaderani et al., 2015). The same procedure has been used by two different people from Japan and the results proved positive thus this procedure can be used to the recipient. This procedure can help several people with similar problems to stop the progression of the disease. However, the banked cells must be a close match for the recipients to make it effective (Baghbaderani et al., 2015). The donors’ cells should have a close match to that of the patient for the treatment to be successful. Unmatched cells can cause problems to the patients.
A Japanese Nobel prizewinner Yamanaka who is a stem cell scientist was the pioneer of the iPS Cells. He also established the iPS cell bank that depends on matching donors to the recipients. His cells stock for the regenerative medicine has cell lines from a single donor. Yamakana and his colleagues are trying to create the cell lines from approximately 10 different donors which they believe can match around 50% Japan’s population. The Japanese government had authorized a team led by Masayo Takahashi at the RIKEN Center for Developmental Biology to obtain cells that they could use in a clinical iPS trial. This process has proven to be effective and can be applied in different clinical situations to help the patients. The transplants that have been conducted in Japan have proven successful thus the process is applicable and reliable.
These clinical trials conducted in Japan have proven to be successful and it can be of help in reducing the progression of diseases in patients. For instance one of the tests was conducted on one patient to save the cornea and this proved successful as the vision was restored and the disease did not progress in the patients’ eye. If thoroughly done the world can benefit from this discovery. The doctors will be in a position to prevent several complications that arise in patients due to some diseases. This discovery will help different patients who may have no medication to treat their conditions due to different reasons. Regenerating cells is important in today’s world since diseases are growing that are beyond drugs and other medications but through such initiatives, the patients can get relief from their disease. The doors are always selected by the company to help in donating the required specimen from which they manufacture the cells that they use in treating other to help in preventing progression of certain diseases
The Key Staff
There are different staffs in this company who hold different positions and responsibilities. Every staff has a special responsibility that helps them in achieving the company’s goal. Each and every one of them is focused on achieving the main goal of saving the world through their clinical trials and laboratory technology of generating cells. The staff is professionals from different fields but is united with one goal and vision by ensuring a healthy population free from diseases that can be prevented through their cell implantation.
Amanda Mack, Ph.D. is the director, iPSC reprogramming at Cellular Dynamics International. She is the leader in the development of induced pluripotent stem cell technology for the last ten years. The induced pluripotent stem cell technology is a significant competency at the Cell Dynamics International. Amanda is presently the leader of the ongoing efforts to develop GMP-compliant protocols for therapeutic grade induced pluripotent stem cell technology (Team, 2018). These protocols are matched with autologous and haplotype and they act as the initial stage of developing and manufacturing of different cell therapy products. Amanda is a significant figure in the company due to the responsibility she has for taking charge of the most significant department of CDI. The responsibility held by Amanda at this moment is critical since the department she is heading is the one now working on the current trial (Team, 2018). This process is an important one for the company at the moment and this calls for a director who is goal oriented. Her effectiveness as the department leader is what can bring success to the clinical trial.
Kazuyoshi Hirao is the chief executive officer of and the president of Cellular Dynamics International. He is responsible for the overall success of the company and makes the most important managerial decisions. Before any plan is executed, it must pass through the chief executive officer and his decision is final in the company (Team, 2018). He also meets and discusses with the organization’s stakeholders on issues affecting the company. Hirao also oversees the activities that go on in the organization with the help of other managers.
The responsibility of spearheading the company’s long-term strategies also lies with Hirao. As the CEO he leads in the development of short- and long-term strategies. This helps in giving direction and controlling the firm’s activities. Another important role of this individual is assessing the work of other executive leaders. Achieving the company’s goal requires the chief executive officer to b alert all the time and since he works in collaboration with other it is important for him to ensure that all those under him adhere to the rules and regulations and that they perform as required of them. The chief executive officer is also responsible for ensuring that the company’s activities are aligned with the rules and regulations pertaining to clinical trials. This is important since if an error occurs in the process, the company can be sued and this can tarnish its name. It is therefore important that the CEO ensures that the company adheres to this the regulations. He is also responsible for setting the goals; these should be achievable. The goals are always set after several deliberations with the concerned parties.
Takashi Okada chief technology officer has the responsibility of directing and coordinating activities of those engaged in conducting the clinical trials. The staff in every department needs coordination to ensure proper work (Team, 2018). Without direction and coordination, there may cause confusion which may be of harm to the company since all the processes in the organization require proper direction to prevent errors that may occur. If any error occurs it may affect a big number of people (Team, 2018). This indicates that the chief technology officer holds a very critical position that needs a lot of strictness. Apart from coordination and giving direction, he also oversees the performance of test fields in the areas of study. This is also important since if the field is not supervised errors may occur that may affect the company in different ways.
The chief technology officer also assigns duties to the involved staff. Assigning the duties helps in preventing possible confusions and lack of coordination within the firm. It is important for all the personnel to be aware of their roles and responsibilities within the organization as this leads to excellent performance among them. The laboratory requires lots of pieces of equipment and supplies that are used in conducting the clinical trials. One should be responsible for the purchase of these items.
The chief technology officer is in charge of purchases of the equipment and supplies used in the company’s laboratory. He takes reports of what is required and takes charge of the purchase process. The most important responsibility of the chief technology officer is to review the test results to ensure quality control. The results released by the company must be of quality since they are involved in human health and if anything goes wrong it may result in serious issues that may affect a bigger population. This makes it necessary for the chief technology officer that all the results released are of quality before releasing them to be applied in any area. He also coordinates and conducts education and training programs for medical technology personnel. The training in the department is necessary as it helps in equipping the personnel with new skills and knowledge they require to conduct their activities in the company.
The staff in this company are dedicated and professionals from various fields of study. This helps in ensuring professionalism in every area of work within the firm. The personnel can coordinate and work together for the benefit of the larger population since whatever they are doing is for the benefit of everyone. The leaders who are in charge of the company are also people who are goal oriented and ensures that all things that are done are of quality and that they adhere to laws and regulations to avoid unnecessary issues that may arise due to errors that occur in such fields. The team contains people who are also goal oriented and are after quality work. The personnel is all focused on achieving the goals of ensuring good health to those in need of such services.
The work done by these people is not easy and thus it calls for more attention. The staff working here are all professionals but they keep on studying to help them keep up with the current clinical situations that require their attention. This helps them in conducting their activities with professionally. The CDI is a place of quality and excellence when it comes to medical and clinical trials. They come up with developments that are important to the world as they can change the face of the medical world.
- Baghbaderani, B. A., Tian, X., Neo, B. H., Burkall, A., Dimezzo, T., Sierra, G., Rao, M. S. (2015). cGMP-Manufactured Human Induced Pluripotent Stem Cells Are Available for Pre-clinical and Clinical Applications. Stem Cell Reports, 5(4), 647–659. http://doi.org/10.1016/j.stemcr.2015.08.015
- Team. (2018). Retrieved from https://opsistx.com/team/