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Introduction to Business and Management
BMGT 110
Introduction to Business and Management
Spring 2014
Quiz #1
Chapters 1-5
INSTRUCTIONS:
Type your name on the answer sheet, below.
Scroll down to see the three questions that make up this quiz. Each question is worth up to 5 points.
Type your answer to each question on the page below the question. Your answer should be approximately 1 page in length, double-spaced, for each question.
Submit your answers in your Assignment Folder by the due date.
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Answer Sheet
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Question 1: Although most new businesses start out as sole proprietorships, few large businesses are organized this way. Why is the sole proprietorship such a popular form of ownership for new businesses? What features of sole proprietorship make it unattractive for growing businesses? What business forms would be more appropriate for a growing business?
A sole proprietorship is such a popular form of business for many different reasons. The most popular of which I believe is that a sole proprietorship can be started by one person with an idea. A sole proprietorship is easy to setup, and easy to maintain. There are no taxes on the business other than income generated from the business which is taxed directly to the owner. It can be a very popular form of business for someone who is interested in owning 100% of their company. Usually most startups form as sole proprietorships where the owner is the man with the ideas and the vision for the business.
Some of the advantages to owning a sole proprietorship involve the ownership of the business. The sole proprietor has complete control over what they would like to do with their company whether that be selling it, transferring it, or growing it. There are no corporate tax payments in a sole proprietorship, there are very few formal business requirements, and little legality involved in forming a sole proprietorship.
The disadvantages of a sole proprietorship include, but are not limited to several of the following details such as debts, employees, and responsibilities. When a sole proprietorship is formed the business owner is responsible for all business debts acquired through the business. Liabilities are the sole responsibility of the owner, and an owner will be responsible for any and all legal activities conducted by an employee of the business. It can be very difficult to acquire investors in a sole proprietorship because there is no room for the investor to grow their money other than to charge interest or royalties.
In growing a business I would first start with looking at a sole proprietorship and then look at moving to either a limited liability corporation or incorporating your business. Incorporating a personal business can really prove to protect the business owner from liabilities, and can serve to save you thousands of dollars in taxes.
Question #2: Explain how prices are determined in a free-market economy. During the recent recession, consumers were less willing and able to purchase products they had grown accustomed to buying. Describe how the supply and demand curves were affected by consumers’ decisions to pull back on their spending.
Prices in a free market economy are determined by supply and demand. When you have a great product that everyone is in need of, you can charge a higher price because of the demand for the product or service. When you are selling something that is a luxury item or good frequently it can be difficult to attract business when times become tough. In the free market economy there is competition, and competition is a good thing for businesses. It ensures that no one player gets too far ahead of the others. Prices in a free market will often fluctuate with the status of the economy, however they will stabilize over time becoming a system which works for both consumer and supplier.
When the recession hit America and other surrounding areas people started to hold onto their money more and more. This creates a cascading effect throughout the economy which can result in further damaging the economy. In order to stabilize the economy it is necessary to have the players in the economy spend money. When people start to spend money they tend to also make money, which represents the normal ebb and flow in the economy.
The supply and demand curves change drastically in an economic recession. The first step in the process is when the consumers begin to get tight on their cash. When a consumer feels that times are tight their demand for everyday goods begins to go down. As the demand goes down the price point on the supply side begins to move down with it until the economy is reestablished and people begin to become more comfortable spending money. This being said, we can conclude that what really begins to hurt the economy is when people start to save their money. When you save your money it forces others to save their money, which creates a vicious cycle where there isn’t enough cash flow into the economy to restore balance. This is why government programs like cash for clunkers are establish to make people spend money.
Question #3: Why would a U.S. company decide to form a strategic alliance with a company in another country? What kinds of ethical considerations might the U.S. company be faced with given possible differences in laws and standards between the two countries?
Generally a U.S. company decides to form a strategic alliance with companies outside of the U.S. because they can be make the U.S. companies more efficient. To understand what makes these businesses more efficient we have to understand what advantages are made by going outside of the U.S. There can be many reasons to partner up with an international company, and these usually include saving money on costs, and decreased price point for inventory creation and services. When a company that works within the U.S. is able to outsource their day to day menial tasks to a company in another country it generally means that they are taking advantage of the other companies lower operating costs. This can lead to a great relationship between both companies. The company in the U.S. begins to make more money than it did previously which can lead to more profits for the U.S. company. The foreign company gains a new customer which usually pays very well compared to if they were to do business with their own country alone.
As a U.S. company it dealing with companies outside of the U.S. can lead to ethical differences and standards from country to country. For instance when outsourcing product creation to China we may find that children under the age of 14 are often being used to do the labor for your company. This can definitely become an ethical issue for the company especially if the children are underpaid and working for far less than what they should be making. This can lead to bad press, and can even lead to entire companies being shut down that rely too heavily upon outsourcing to other countries. Generally it is for reasons such as these that often companies go to great lengths to stay within the U.S. to proudly wear the stamp “Made in the USA”.
Kymriah to Treat B-Cell Cancer
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Kymriah to Treat B-Cell Cancer
Kymriah is a chimeric antigen receptor (CAR) T-cell therapy that was developed by Novartis. The drug is able to produce prolonged complete responses with minor side effects in adults with relapsed or those with refractory diffuse large B-cell lymphoma (DLBCL). The drug is also used in the treatment of the B-cell acute lymphoblastic leukemia in the patients who are aged 25 years and below. It is used to treat individuals whose cancer treatment has not gotten better with other therapies or has relapsed for two or more times. Further studies are ongoing to test the efficiency of the drug I the treatment of different types of cancer. Kymriah is a drug that was developed using the patients T-cells, which happens to be one of the immune system cells. According to Gill, a gene for a specific receptor, chimeric antigen receptor, is added to the T-cell in the laboratory and the changed T-cell now the CAR T-cells are cultured in large numbers in the laboratory, and they are provided to the patients by infusion. The drug, Kymriah binds to the protein CD 19, that is found in some Lymphoma and Leukemia patient cells, aiding the body’s immune system in destroying the cancer cell.
Kymriah was the first cell-based gene therapy to obtain validation by the United States Food and Drug Administration (FDA). In accordance with Gardner views, the CAR-T drug was meant for the treatment of relapsing or refractory acute lymphoblastic leukemia and non-Hodgkin’s lymphoma among the pediatric and young adult patient of 25 years and below. Acute lymphoblastic leukemia is the most frequent type of leukemia in children. Acute lymphoblastic leukemia is marked by the bone marrow producing too many white blood cells, the lymphocytes to which fail to develop correctly. The excess development of the abnormal white blood cells causes swellings and damage to the internal organs preventing the body from producing other blood cells. The prevention of the formation of different blood cells especially the red blood cells that are responsible for the transport of oxygen around the body tissues, result to anemia and as well dampened immune response. It is in a similar manner that the diffuse large B-cell lymphoma, which is the most common form of non-Hodgkin’s lymphoma is an aggressive cancer of the lymphatic system that is caused by the accumulation of the abnormal B-cells.
The new analysis of the trial data on the Novartis Kymriah CAR-T therapy that were presented at the 59th American Society of Hematology annual meeting indicates that the drug sustained complete responses at six months in adults with a difficult to treat the form of leukemia cancer. The CAR-T therapy offers a new treatment approach in the sense that it is specially produced for the treatment of an individual patient. During the process of treatment, the T-cells are drawn from the blood of the patient and then reprogrammed in the laboratory to develop the T-cells to which are genetically programmed to hunt and kill the patient’s cancer cells.
According to the data obtained from the Juliet’s trail that was led by the researchers from the University of Pennsylvania indicate an overall response rate (ORR) of 53% in the patients taking the Kymriah medication, with 40% achieving a complete response (CR) and 14% achieving a partial response (PR) (Wohlfarth). At six months, 30 percent of the patients were in complete response, with a 74 percent relapse-free rate onset of response, while the median duration of response was not reached. According to the principal investigator, Stephen J. Schuster, at the time of the trial enrollment, the patients with the DLBCL had been through multiple rounds of chemotherapy, and a significant number had unsuccessful stem cell transplants, and this left the patients with few options and poor prognosis. With the availability of the Kymriah drug, the team was able to significantly increase the chances of achieving and maintaining a sustained response without the stem cell transplant, and this was a demonstration of the benefit caused by the Kymriah drug in the treatment of the lethal blood cancer.
Concerning safety, the cytokine release syndrome (CRS) that can result when engineered cells get activated into the body of the patient, occurred in 58 percent of all the treated patients with the Kymriah drug, with 23 percent of them experiencing three-quarters cytokine release syndrome. 21 percent of the patients experienced any grade neurologic events, and 12 percent of the patients possessed three-quarters neurologic adverse events that were managed by supportive care. Grade three-quarters cytopenias lasting more than 28 days, grade three-quarters infection and grade three-quarters febrile neutropenia occurred in 27 percent, 20 percent and 13 percent of the patients respectively. According to Samit Hirawat, while the immediate response to the treatment by the drug is a marker for efficacy, the physicians and patients require treatment options that provide sustained reactions over time with as consistency in the safety profile.
Additional analysis of the data obtained from the ELIANA clinical trial indicates impressive results in the 75 patients that were treated with the Kymriah drug (Thomas et al.). The investigation found the overall remissions rate within three months was 81 percent, the rates of the event-free survival were 73 percent at six months and 50 percent at 12 months. The overall survival rate was 90 percent and 76 percent over the same time intervals. The follow-up analysis of the results that were obtained from the ZUMA-1 trial that investigated the effectiveness of axicabtagene ciloleucel in the patients with the refractory non-Hodgkin’s lymphoma also indicated impressive outcomes. According to the analysis, more than one year after the treatment, 42 percent of the 108 patients enrolled in the ZUMA-1 trial had maintained remission while 40 percent of the patients exhibited no evidence that pointed them to have cancer. Besides more than half of the patients were alive at the median follow up of 15.4 months, and that is more than double the median survival for 6.6 months for the patients treated with the conventional therapy aside from the Kymriah therapy. Therefore the efficacy of the Kymriah drug can be said to be high, and that’s why the Food and Drug Administration opted to license the drug for commercial use.
The Kymriah drug just like other drugs has it is own mechanism of action. The primary purpose of the CAR-T therapy is to eliminate the CD-19 expressing malignant and normal cells with specificity and increased chances of remission. According to Anton, the Tisagelecleucel also known as CTL019 is a CD19 that is directly genetically modified immunotherapy that is genetically targeted to the treatment of specific patients. CTL019 is an adoptive immunocellular cancer therapy that is programmed to use the autologous peripheral blood T- cells that have been coded with a transgene encoding in chimeric antigen receptor (CAR) to identify and eliminate the CD19 cells that express that malignant and non-malignant cells. The CAR is comprised of a murine single-chain antibody fragment that recognizes the CD19 cells and is fused to the intracellular signaling domains from the 4-1BB (CD137) and CD3-zeta. The CD3-zeta component is significant for the initiation of the T-cell activation and anti-tumor activity while the 4-1BB enhances the expansion and most fundamentally the persistence of the tisagenlecleucel. Upon the binding to the CD19 expressing cells, the CAR transmits a signal to promote the T- cell expansion, activation, target cell elimination as well as the persistence of the tisagenlecleucel. The transduced T-cells expand in vivo to engage and as well eliminate the CD19 expressing cells and may inhibit immunological endurance to assist in supporting a long-lasting remission.
Concerning dosage, the treatment course consists of the fludarabine and cyclophosphamide lympho-depleting chemotherapy that is followed by the infusion of Kymriah drug. According to the directions provided by Bachmeier, Kymriah is provided as a single dose unit that contains the chimeric antigen receptor (CAR) viable positive T- cells. The dosage is based on the patient’s weight that is reported at the time of leukapheresis that includes: For the patients below 50kgs, the dosage is 0.2 to 5.0 x 106 CAR-positive T-cell per kg body weight while for the patients above 50kgs the standard dosage is 0.1 to 2.5 x 108 CAR-positive viable T cells. For the Lympho-depleting chemotherapy: Fludarabine (30 mg/m² intravenous daily for four days) and cyclophosphamide (500 mg/m² intravenous daily for two days starting with the first dose of fludarabine). Infuse Kymriah drug for 2 to 14 days after completion of the lympho-depleting chemotherapy.
Despite the effectiveness of the Kymriah drug, there are lots of side effects are said to accompany its administration such as cytokine release syndrome, hypogammaglobulinemia, fever, decreased appetite and infections of unspecified pathogens. A headache, bleeding episodes, low blood oxygen, vomiting fatigue, delirium, and acute kidney injuries are just among the side effects of the administration of the Kymriah drug in accordance with Jones.
The advancement in the field of medicine has enabled and as well led to the development of drugs that are capable of curing diseases that for a long time disturbed and threatened the extinction of the human race. The Kymriah drug, as a chemotherapy for cancer treatment, is one of the many such drugs that have restored hope to the people especially the patients of cancer. Kymriah is a drug that was manufactured by the Novartis Company, directed to the detection and elimination of the CD19 cells. The clinical trials have proved the efficacy of the drug with over 80 percent success, and this led to its approval by the Food and Drugs Administration proving it safe for commercialization. The Kymriah as well can increase the risk of life-threatening infections that may lead to death and therefore it is advisable to seek medical attention upon the development of symptoms such as fever, chills or bleeding just after the drug use.
Work Cited
Gill, Saar, and Carl H. June. “Going viral: chimeric antigen receptor T‐cell therapy for hematological malignancies.” Immunological reviews 263.1 (2015): 68-89.
Gardner, Rebecca A., et al. “Intent to treat leukemia remission by CD19CAR T cells of defined formulation and dose in children and young adults.” Blood (2017): blood-2017.
Wohlfarth, Philipp, Nina Worel, and Georg Hopfinger. “Chimeric antigen receptor Tcell therapy—a hematological success story.” memo-Magazine of European Medical Oncology (2018): 1-6.
Hirawat, Samit, and Langdon Miller. “Methods for dosing an orally active 1, 2, 4-oxadiazole for nonsense mutation suppression therapy.” U.S. Patent No. 9,877,952. 30 Jan. 2018.
Thomas, Xavier, and Etienne Paubelle. “Tisagenlecleucel-T for the treatment of acute lymphocytic leukemia.” Expert opinion on biological therapy just-accepted (2018).
Anton, Roman. “Advances in Cancer Immunology and Immunotherapy.” Global Journal of Medical Research (2018).
Bachmeier, Christina. “Tisagenlecleucel Kymriah Novartis Pharmaceuticals Corp.—all entries with PAPs.”
JONES, DOW. “Novartis: receives first ever FDA approval for a CAR-T cell therapy, Kymriah (TM)(CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice.”
The biological perspective of depression argues that depression is as a result of an imbalance of the brain chemicals, the ne
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The biological perspective of depression argues that depression is as a result of an imbalance of the brain chemicals, the neurotransmitters. Various compounds are used by the brain as messengers to communicate with other parts of the brain as well as the nervous system. The neurons communicate through the chemical messengers, and they are in constant communication through the exchange of the neurotransmitters. The neurons communication is essential to the brain as it aids the brain to carry out its functions. The imbalance of neurotransmitters can be articulated to the development of depression. The monoamine hypothesis has the suggestion that the lowered levels of the brain chemicals such as serotonin, dopamine, and norepinephrine to which result in the symptoms of depression.
The imbalance of serotonin levels is said to influence a person’s mood and eventually lead to depression. There are possible problems that are associated with the imbalance of the serotonin levels, and this includes reduced brain cell production of serotonin, the inability of the serotonin to reach the receptors and as well can be attributed to the shortage of the chemical trypan from which serotonin is made. In case any of the above biochemical problems do occur, it is believed that one has a high probability of being depressed.
Depression can also be related to abnormalities in the circadian rhythm. Such examples include the rapid eye movement sleep, a stage in which dreaming do occur, may be intense and quick to arrive in people with depression. Rapid eye movement sleep relies on decreased serotonin levels in the brain stem. The serotonin levels are impaired by the compounds such as the antidepressants, to which increase the level of serotonin levels in the brain stem structures. The serotonergic system tends to be least active during sleep and most active during wakefulness. Continued wakefulness due to the deprivation of sleep tend to activate the serotonergic neurons, and this leads to the same effect that is caused by the therapeutic effect of anti-depressants like the selective serotonin reuptake inhibitors (SSRIs). The depressed people exhibit a significant elevation in the moods after deprivation of sleep The selective serotonin reuptake inhibitors may directly depend on the rise of the central serotonergic neurotransmission for their therapeutic effect, the same effect to which alter the cycles of being awake and that of sleep.
According to research, the effects of light therapy on the seasonal affective disorder suggest that light deprivation is related to the lowered activity in the serotonergic system as well as to the abnormalities in the sleep cycle that include insomnia. The exposure to light as well targets the serotonergic system and therefore provide more support for the essential role to which the serotonergic system play to the development of depression. Light therapy and sleep deprivation target the same brain neurotransmitter system and brain sites the same way the antidepressant drugs and therefore, they are also used in the treatment of depression.
The increase as well as the decrease in sleep length also play a significant role and can be a significant risk factor for the development of depression. The patients who are diagnosed with major depressive disorders sometimes may manifest diurnal and seasonal variations of symptoms severity, even during the no-seasonal depression. The daily mood improvement is associated with the activity of the dorsal neural networks, and as well a rise in the mean core temperature is observed. A proposition made by one of the hypothesis indicates that depression is as a result of a phase shift. The exposure to daylight leads to decreased serotonin levels due to reduced transport activity, and this may underlie the seasonal development of depression in individuals. In short, the biological perspective of depression is of the opinion that depression is due to a reduction or alteration of the serotonin levels which result in mood swings to which lead to the development of depression resulting from the abnormalities in the circadian rhythm.
Reference
Demirkan, A., Penninx, B., Hek, K., Wray, N., Amin, N., Aulchenko, Y., Middeldorp, C. (2011). Genetic risk profiles for depression and anxiety in adult and elderly cohorts. Molecular Psychiatry, 16(7), 773–783.
Silberg, J., Maes, H., & Eaves, L. (2010). Genetic and environmental influences on the transmission of parental depression to children’s depression and conduct disturbance: An extended children of twins study. Journal of Child Psychology and Psychiatry, 51(6), 734–744.