Vision and business Values

The goal of developing Ultrastatin was to assure that persons with hypertension and obesity would have a lower death rate and enjoy comfortable lives. To save lives and improve patients' ability to manage their hypertension, ultrastatin will offer a fast way to remove fat from the blood arteries that feed the heart with blood. The drug's makers want to make sure that the affected people worry less about their life and instead use that time to conduct useful tasks. In the current state of affairs, people with extreme hypertension always concern themselves and their families when they take on emotionally and physically straining activities because they are prone to heart attacks and other complications related to the disease. The new drug will provide a fats relief that will be specific and therefore efficient.



Three Core Business Values



Three core business values will drive the achievement of the vision and mission of the new drug. One of the values is setting high ethical standards. The creation and the selling of the drug will be led by high moral standards that should always drive the pharmaceutical industry. It is essential to understand, as an entrepreneur, the selling of the drug will aim at making profits. However, the idea is to let customer satisfaction and excellent quality be the key to making the profit (Abrams, R. 2012).



Another critical business value is accountability.



The business will be based on taking responsibility to ensure that customers only get good quality drugs. Providing good quality of products will protect the company from lawsuits and losses that may come from selling low-quality products and not taking responsibility (Abrams, R. 2012).



The business will also be customer centered.



Thus, the concerns of the customers will be considered in the development and consequential improvement of the product for the market. The last core value will be showing passion. The business will ensure to invest not only the material resources to the fullest to achieve the improvement of humanity, but also the emotions because all people in the world are affected by hypertension in one way or another. For a person to be a member of the team whether in development or business, they must have a story that motivates them.



Need for the Drug



Ultrastatin is needed in the market. Hypertension has a very high prevalence in the united states of America and the world in general. Two agencies that give data about how widespread the disorder include the Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO). According to the CDC, 1 in 3 people in the united states has hypertension. The number totals to about 75 million people in the US alone. Out of the 75 million, the CDC estimates that only 54 percent of the patients can control their blood pressure. The rest are left exposed to health risks that result from hypertension. People who are unable to control the pressure of their blood are at risk of getting strokes and heart attacks. CDC lists hypertension and stroke as two of the most common causes of fatality in the united states (CDC, 2017). According to the WHO, hypertension is responsible for about a third of all deaths in the world every year. The organization estimates the deaths at approximately 17 million annually (WHO, n.d.). Also, the WHO says that hypertension causes about 45 percent of the deaths that result from heart disease and 51 percent of mortalities from strokes. From the data, it is clear that the united states and the world are in dire need of a more active drug. It is clear that although statins are working, they are not very efficient and therefore, there is a need for another drug to save the millions of lives that are lost annually. Ultrastatin will fill the gap of the medicine needed to save lives both in the USA and the rest of the world.



Business Model



Due to the complexity of the pharmaceutical industry, the company will apply the integrated business model to sell a new drug. The integrated business model as employed in the pharmaceutical industry means the application of strategies that are characteristic of both the blockbuster model and the diversification model. The blockbuster model usually involves selling a small number of drugs or products to a large market (Chesbrough & Schwartz, 2007). In the case of Ultrastatin, the drug has the potential of selling a lot as hypertension is a very serious problem that people are in dire need of a solution. The introduction of the drug to the market is likely to displace statins as the first line of defense against stroke and heart disease (Taylor et al., 2011). In the united states alone, the drug has the possibility to sell to the more than 50 percent of patients who are unable to control their blood pressure because of the low activity of statins as compared to Ultrastatins. Also, the drug.



Therefore, an element of the business model will focus on marketing the drug as the primary defense against stroke and hypertension due to its uniqueness and fats activity. The other component of the integrated business model is the diversification (Chesbrough & Schwartz, 2007). Being a pharmaceutical company, the firm may also produce other products such as generic drugs and pharmaceutical equipment and tools that may be used together with the drug or for other functions. However, it may be important also to sell products like syringes that are specifically designed to deliver the drugs to the systems of the patients. The production of a product that is used with the drug will cause synergy and therefore enhance the sales of the company. Also, being a patented drug, the company may also sell rights to produce the drug by a limited number of pharmaceutical companies in markets that it will not target. For example, in markets like Africa where the company staff has limited experience in marketing, it may be wise to license a pharmaceutical company that already has experience the health sector to produce the drug. Nevertheless, in markets like the USA and Europe where obesity, hypertension and other lifestyle diseases are very prevalent, the company will not license other producers to ensure that it gets back the money invested in research and designing of the drug. The integrated business model will ensure that the company gets its return on investment as soon as possible and cushion it from any uncertainties that may arise from the introduction of similar products from other companies.



Feasibility Study



Technical Requirements The production and sale of Ultrastatin require the use of biotechnological tools and knowledge to conduct the human trials. The drug molecules have gone through the first and second phases successfully and show a lot of potential of going through the third stage successfully. The development of the drug through the third step will require statistical software and tools that the members of the team already have. It will also need the use of diagnostic devices as well as data collection and analysis methods to ensure that accurate data is gotten. Although the third phase is a gamble, if the drug succeeds in the stage and is patented, it will be worth the costs and time (Hult, 2011). The company has computers and software that can be used in the third phase. Also, the Research and Design Department is well informed on biotechnological tools required to carry out the clinical trials. Also, bioinformatic tools such as molecular docking have already shown the potential of the drug to succeed in the phase. Apart from the third phase of trials, for the drug to be produced in large quantities, the firm will have to establish a factor with fermenters, a batch system, and information technology.



Legal Requirements



The research concerning the drug and the production of the drug needs certification from various boards. The boards that have to certify the drug for it to be used include the Food and Drug Administration and the WHO Research Ethics Review Committee (ERC) (WHO, n.d.). So far, the procedures taken to create the drug are in line with the provisions of both bodies. The human aspects will be conducted with high ethical standards. The company also has a team of lawyers that will ensure that all regulations are followed. Market gap As seen in the prevalence data of hypertension, over 75 million people in the USA alone have hypertension. Also over half of the number is unable to control their blood pressure. Therefore, there is an urgent need for a drug that is more efficient and Ultrastatin will fill the gap.



Research and Design



The R&D time will be a maximum of two years as the drug has already gone through all the other stages successfully. Based on the success rate, by 2020, the drug will be on the shelves. Customer Usage Ultrastatib is a drug that will be used to treat a chronic illness. Therefore, once it is available, customers will have to use it frequently because it will be a need rather than a want. Also considering that it is expected to be better acting and safer than the existing drugs, the usage of the drug is estimated to be around by more than 30 million in the USA alone (CDC, 2017). Intellectual Property The company will patent Ultrastatin, and therefore other industry players will be barred from producing it unless through licensing. The intellectual property rights of Ultrastatin will expire after 20 years. Considering the need for the drug, it will have a good return on investment. The intellectual property rights will protect the company from unfair competition and therefore give it time to make profits from the invention.



Pricing



The pricing of the drug will be 18 dollars per packet of 30 tablets. The price is competitive as compared to the existing and conventional version of statins called Simvasatin. The significantly low prices are because there is competition and the high usability of the drug will offer a good return on investment. Also, the price enables the drug to be covered by Medicare and therefore be paid for by the government plan through the Affordable Care Act. The amount will further make the drug available to all patients in the United States of America and other countries while at the same time allowing it to offer a good return on investment. Limitations The intellectual property rights will expire after 20 years, and after then, other companies will be free to make their versions of the product (WHO, n.d). Therefore, the competition will be very tight after the expiry of the intellectual property rights. Another barrier is the distribution of the drugs in other places like Europe. The company is a startup and therefore does not have an established distribution network. Thus, exporting may present a problem. Also, the giant pharmaceuticals producing statins have control over policymakers, and therefore, they may try to cripple the entry of Ultrastatin into the market. The changes in the healthcare bills in the United States may adversely affect the use of the drug in the USA.



Generating revenue



Revenue will come from the direct sales of the drug and the pharmaceutical complements that go with it. Also, revenue may be gotten through licensing other producers of the drug in the industry. Data Analysis Based on the data from CDC, 75 million people have hypertension. Out of the 75 million, 46 percent are unable to control their blood pressure. Therefore, the sales of the drug within the USA will focus on the 46 percent (CDC, 2017). Thus, the estimated number of patients that are expected to take up Ultrastain is 34.5 million people. In the world in general, the World Health Organization estimates that over 17 million people die from hypertension-related deaths (WHO, n.d.). Therefore, there is a good export potential for the drug. The drug will be needed all over the world.



References



Abrams, R. (2012). Entrepreneurship: A real-world approach. Palo Alto, CA: PlanningShop.



CDC. (2017, September 05). High Blood Pressure. Retrieved October 18, 2017, from https://www.cdc.gov/bloodpressure/index.htm



Chesbrough, H., & Schwartz, K. (2007). Innovating business models with co-development partnerships. Research-Technology Management, 50(1), 55-59.



Electronic Financial Worksheets. (2012). Palo Alto, CA: PlanningShop.



Hult, G. T. (2011). Market-focused sustainability: Market orientation plus. Journal of the Academy of Marketing Science, 39(1), 1-6.



Taylor, F., Ward, K., Moore, T. H., Burke, M., Davey Smith, G., Casas, J. P., & Ebrahim, S. (2011). Statins for the primary prevention of cardiovascular disease. Cochrane database Syst rev, 1(1).



WHO. (n.d.). Ethical standards and procedures for research with human beings. Retrieved October 18, 2017, from http://www.who.int/ethics/research/en/



WHO. (n.d.). Hypertension. Retrieved October 18, 2017, from http://www.who.int/topics/hypertension/en/

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