High School vs. College Essay

Stepping stones are like the baby steps into something greater, like high school and college. In high school, everyone says to focus yourself more into, because high school is the place to gain the knowledge that is nearly identical to the â€Å"actual world†. College, on the other hand, is when both the teachers and students can both relate to how the real world would function. So high school is the part of the baby steps that reach into college and as well as the real world. Although high school and college reading and writing become different, they also have some similarities, but in the end they’re both really important to everything that happens in people’s everyday lives. In my four years of being in high school English, I can say that it’s already really different from college. The reading in high school was always given and there were times that it included self-reading, but it was because we were given questions to answer. Other times, it was because we had to do journals on each chapter of the book; main idea, summaries, character changes, etc. Overall, it was really easy, because the teachers would do at least half of the work for you and then you would be given the rest as homework, as long as you don’t procrastinate. Being a freshman is college, it’s scary, because you hear stories from people saying how easy or hard it is being in college. There’s more self-reading that has to be done and during that time, you also have the process of taking notes and writing small responses when needed to on your own. It’s all about the independency and responsibility that any adult would have when entering through college. As much as I love the subject English, I was never a huge fan of writing, whether I’m in high school or college. The writing processes that happened in high school were usually the same. We would read something that the teacher had given to us, take notes, and from those notes, we would have had to write some form of paper or short response. All the information about the book and paper were given to us, made it that much easier to know what to write about and what the paper was required to have by the teacher. College is a whole new environment for those who are entering and sometimes it can take a while to get acquainted with everything. College is one of those things. The writing in college is very different, because the professors want something to be originally different form each student, rather than having to read all the class articles and they all end up sounding the same. Everything is different, because the formats that we have always stuck to throughout elementary and improved during high school is almost not needed in college. All those five paragraph essays won’t even be considered as an essay anymore, but if there are more paragraphs and as long as the topic is straight through, then that’s an essay. Reading and writing are really important things to be learned, because that’s basically what the whole world consists of; letters and words and paragraphs. You can’t learn how to write if you don’t how to read or else you wouldn’t know the meaning of those words and the sentence itself. The same concept goes for reading. Be glad that you know how to do both of these things, because some people aren’t as fortunate as we are. Where they come from, education is given differently, which doesn’t allow â€Å"everyone† to be able to have the same education as others. This is also another reason why some families travel to a country so that their children can have a better future than the parents or their families have had before them. This allows the not only the children new expectations, but also gives the families some new experiences as they travel through this journey. Writing and reading are two very important skills that are called Communication. For example, my major is Philosophy – Pre law. In pre-law it’s all about the debates and knowing how to communicate. Without these two main factors, then you wouldn’t be able to converse with others and be able to exchange ideas, because then how would you be able to learn and increase your knowledge to be able to win the debates? This is the main reason of why reading and writing are very important to all of us. Everyone has heard other people tell them that you must always prepare yourself when entering into the â€Å"real world†. Where we are at right now, whether it be high school or college, are considered as baby steps into reaching new experiences. First, there is high school, where we go to school and we gain more knowledge that is nearly identical to what we would be experiencing soon in the future. Then onto the next stepping stone, college, where it is the place that we can actually apply all those abilities that we learned before and into a place that the world would function similarly. So all in the end, it’s really important and maybe even critical that we all learn and know how to read and write since the entire world in made of mainly these two main factors.

It was the worst thunderstorm in 36 years

Wednesday night, 9th October 2002. It was the worst thunderstorm in 36 years. The rain was like stones hammering onto you from the pitch-black sky. Long streaks of bright lightning were jumping from the sky. A few seconds after each bright light there was a gigantic roar, like a furious lion. The weather was wet, cold, dull, dark and miserable with horrendous winds, travelling at the speed of a cheetah. There were two boys. Andy was quite tall and skinny with short blonde hair. He had legs like long twigs and hands the size of a giants, but very brittle. The other boy, Paul, was big and obese. He was built like a tank. His fists were like big balls of steel. But he was very shy. Andy and Paul were walking home through the fields. It was dark and windy. Paul pulled out a torch. He turned it on, but all it gave out was a dull light that kept flashing on and off every time lightning strikes. Andy started to get scared and he walked faster and faster. Paul was dragging his big heavy feet though the wet muddy grass. Andy started to run but they were getting no where. Paul was dragging behind and was having problems keeping up with Paul. Andy looked behind him and saw Paul in the distance. So Andy shouted â€Å"hurry up Paul, we gotta get outa here†. So Andy slowed down and waited until Paul caught up with him. Then continued running. Andy shouts, â€Å"I can see a house†. So they both started to run towards the house. They both stop. Every thing is silent. Paul and Andy walk towards the front door. Paul nocks on the door and it opened. Nobody was in the house. Andy said, â€Å"is any body in†. Nobody answered so they both carefully walk in the house. There was not a bit of dust in the house. Paul and Andy hung up there soaking wet coats on a hanger and closed the door. The house was bright and warm. The two boys walked into the living room, which was straight in front of them. In the living room the fire was lit and there was stuffed animals every where. There was a huge old wooden staircase. They decided to sit down on the big black leather sofa. They sat down for a while. Paul quietly said, â€Å"let's go up stairs†. So they both went up stairs. They got to the top of the stairs and went to open one of the doors in front of them. The lights started flicking on and off. Andy started shaking. All of a sudden the house went cold. Paul opened the door. A body fell from behind the door. Both of the boys jumped back. The front door creaked open and then slammed closed. A deep mans voice yelled up the stairs, â€Å"who the hell is in my house†. The man ran up stairs with a dead squirrel in one hand and an axe in the other. The boys were so scared that they could not move.

Vindication of the rights of women with structures on political and Essay

Vindication of the rights of women with structures on political and moral subjects - Essay Example One of the most important things to remember about this work is the fact that it was written following the French Revolution. The French Revolution was a much feared event in England, where Mary Wollstonecraft hailed from. The possibility of revolution was something that the English aristocracy feared to a great extent. This fear influenced many of their worldviews and beliefs. However, it was important to many members of the intelligentsia as a result of the liberal philosophy that it espoused. This work comes in the backdrop of the continuing French Revolution that was based on the ideals of liberty, equality and fraternity. It is also based on these ideals as it talks through several perspectives for the development of equality for women in regard to their male counterparts in the society. It also seeks to counteract those notions that enable such a denigration of the roles that women play in the society. This is then something that needs to be analyzed in a more minute manner. Th is paper shall look at the different issues that Wollstonecraft brings into her discussion of gender and her critique of patriarchal social relations as they existed in England during the time of her writing this work. The work also needs to be seen in terms of the legacy of the Augustan age when reason was considered to be the most important faculties of mankind. Wollstonecraft draws on reason as the basis of the society that she envisages for mankind and also looks at reason as the way out for the patriarchal conundrum that women were faced with. This is the basis of the rights that she envisages for women. This is significant as it is a break away from the tradition-oriented debates that were common in England at the time of the French Revolution. English conservative politicians had begun to extol the virtues of traditions at a time when they were being threatened by the revolutionary fervor that was present in France. This was detrimental to the condition of women as their righ ts were being curtailed in England as a result of this insistence on tradition as well. This is one of the reasons as to why it was important for a work of this kind to come out at this point of time in history, especially in England. This insistence on tradition is then countered using the notion of reason as it was prevalent in England. Despite having said this, the spirit of the work derived from the ideas of freedom that emanated from the French Revolution. It is in this relation that one needs to look at the arguments that are advanced in favor of education by the author. She talks of education as the means through which women can be empowered. She advances the notion that this would enable them to think independently and understand the value of reason and understanding. This would also, according to her, help women to nurture their children better. She says, Contending for the rights of woman, my main argument is built on this simple principle, that if she be not prepared by e ducation to become the companion of man, she will stop the progress of knowledge and virtue; for truth must be common to all, or it will be inefficacious with respect to its influence on general practice. And how can woman be expected to cooperate unless she

Moral Responsibility of a Leader Research Paper

Moral Responsibility of a Leader - Research Paper Example Intercultural impacts and massive communication facilities are leading us towards next major evolutionary step in human history, the world citizenship. Every individual involved in this process is required to lead an interconnected group in a subtle way. Hence every citizen of the planet is required to hone their leadership abilities like never before. Their leadership quality should be governed by ethics more than personal or group oriented preferences (Schmidt, 2007). But, the way the world works show we are treading in the exact opposite direction. No one ever takes responsibility of any mishap. Rush Kidder pinpoints the lack of this major moral responsibility as â€Å"Ethics Recession†. We will discuss the reasons for the situation, its adverse affects and the means to change into better leaders in this paper. Introduction Every moral leader is responsible not only for their actions but also the dealings they could have prevented doing for the welfare of everyone. Huge corporate companies and conglomerations which will lead this technological era should have iron willed leaders capable of choosing the best for both their company as well as the world in general. This is where ethics come is picture. Every good leader considers all the given options and its alternatives before taking any major decision. They analyze the consequences and the emotional impacts that might affect his crew and others in general. They take firm decisions which are profitable to the company and his employees. They also take the moral responsibility for any discomfort caused by this action (Taylor, 2000). They compensate groups or people affected in the required way and convince them to co-operate in the big picture of development, putting aside their personal grievances. This is exactly how moral leaders behaved for centuries. But the question here is ‘Why is there a sudden decline in such effective leadership?’ Every problem the world faces today, from economical recession to, terrorism and infiltration are a result of this lack of moral leadership (Anello, 2006). The US housing bubble, a major reason for the recession is the best example for what lack of work ethics will do. What happene d to our modern and moral citizens? Will world citizens be well dressed cannibals eating others opportunities whenever possible? If so is it development or a path to destruction? To find suitable answers to these questions we should first define â€Å"Morals† and â€Å"Ethics† The Enormous Responsibility of Leadership The word â€Å"Value† refers to something of importance. A commodity or a products value is determined based on its importance. Similarly the â€Å"Value† of a person is also determined based on his position or status. The decision taken by the ruler or the leader has more â€Å"Value† than the decision taken by a normal man. But every leader including the King was expected to follow some moral conducts known as â€Å"ethics† to maintain this â€Å"value† or their position in the ancient world. When the mob refused to follow its ethics, dictators arouse. When Kings failed to add â€Å"Value† to their decisions thr ough non ethical conduct, the church condemned them and revolutions arouse. The higher the position is the necessity to follow the code of conduct or ethics increases. Hence most of the nobles, church dignitaries and Kings

Labor Issue Essay Example | Topics and Well Written Essays - 1250 words

Labor Issue - Essay Example The overall psyche of United States administrations is developed to cut off their budgets at all levels including federal, state, and local levels. One of the major actions that the administrations generally take being a quick step to cut the expenditures is the slashing of the jobs. This measure simply ends up in getting rid of the â€Å"excess fat† from the existing jobs. However, this step brings in more depression and disappointments especially among those who are the direct victims of such actions. The end results of laying offs can prove to be rather severe especially in those areas where there is no room for any dismissal, in fact, more personnel are required to fill the potentially vacant jobs. Laying offs may provide some temporary benefits to the administrations in short rum but in long run it can sabotage morale of the fired employees by and large. In United States, there are many important departments, which operate their functions under local level administrations. These departments play a significant role in the normal day-to-day operations at the local city level. Policing department and firefighting service departments are some of those departments, which perform their operations under the direct supervision of the local administration. As mentioned above, currently US government at all levels is quite reluctant to boost its economic activities and due to this fact, all the administrations taking all the necessary steps to keep the expenditure level at its minimum. The fiscal budget of Detroit City is aimed at reducing the expenditure by some $250 million with the job cut of around 2,600 employees working in the local departments (FireRescue1, 2012). As far as the firefighting department of Detroit City is concerned, the administration has aimed to cut around $160 million, which is around 13% of the budget. In the same way, the City Mayor of

Decision Making in Paramedic - Reasoning Pathway of Each of the Crew M Assignment

Decision Making in Paramedic - Reasoning Pathway of Each of the Crew Members - Assignment Example Joshua in making his decision concerning the diagnosis of Samuel settles on the diagnosis to be a severe asthma attack with possible musculoskeletal involvement. Intuitively, this decision could be influenced by his learning and work exposure. As a volunteer firefighter, Joshua might have probably been influenced by the cases he had witnessed in other paramedical emergencies that befitted the same diagnosis. Tanya in her decision of settling on the diagnosis of Samuel to be an asthma attack could be influenced by the pattern reasoning based on policy guidelines that she has been part of its development. This could equally be influenced by the fact that Tanya had not been exposed to a significant number of situations where asthma exists with other comorbid conditions (Frederick 2005, pp.25–42). Hypothetico-deductive reasoning can be used in the situation of Samuel as a means of elimination of other potential diagnoses. Hypothetico-deductive reasoning model employs the scientific model in the elimination of the unfavourable or undesirable decisions. The model involves the setting of hypothesis then testing the feasibility of the hypothesis to arrive at a decision (Sprenger 2011, pp.497). Application of hypothetico-deductive reasoning would first entail the use of experience in making the diagnosis. The decision maker would consider the problem and attempts to make sense out of the situation. The person then gathers data and look for the previous explanation that may be related to the problem. The second step is the formation of hypothesis; prediction of the feasibility of the hypothesis is then determined to ascertain its accuracy. The process then resolves with testing of the hypothesis. Testing of the hypothesis is done by looking for evidence and through observation that will help in eliminating other potential diagnosis and helps the decision maker to arrive at the best possible diagnosis. Application of Hypothetico-deductive reasoning in the case of Samuel would help the paramedics to eliminate the potential diagnosis of angina and asthma as they would be distinctively be eliminated through hypothesis testing process (Guerrero et al. 2005, pp.1343).  Ã‚  

Sommers Essay Example | Topics and Well Written Essays - 750 words

Sommers - Essay Example Considering these aspects, I think Sommer is a little accurate about me as even I face dilemmas while thinking in terms of morale. But fortunately only at rare times, I believe, have I been in situations that have made me helpless to make confident moral judgments.  Sommer has suggested that adults, especially teachers should improve the youth’s knowledge and comprehension of moral values and they should guide the youth into believing in these values and ideals. â€Å"Teachers with integrity are viewed as morally sound models for young people to follow† and so I believe that teachers play a significant role in molding the children’s character and moral behavior. â€Å"Moral Conservatism† is what she thinks the society needs. She believes that people live in a moral environment and that they should respect and preserve it. She emphasizes the need to value and respect the traditions that we have inherited. She also wants to encourage the institutions, whic h promote moral teachings along with academics. The essay in total has a very interesting appeal to it. It does not present facts in a boring way like most essays do. However, the thing that interested me the most is the story about the hippies as I am coming across it for the first time. Also her phrases such as "hole in the moral zone," "social fabric" etc seem very unique and unique things. I am very grateful for being given this assignment, as it has helped me learn new facts and has inspired me to be more responsible towards my ethics.

Terrorism Essay Example | Topics and Well Written Essays - 1750 words

Terrorism - Essay Example Though terrorism has been part of various societies of the globe for the last several centuries, yet the contemporary world has become the most despondent victim of such obnoxious assaults and threats. The horrible victimization of terrorism of the modern world is partly due to the invention of latest dreadful and destructive weapons, techniques and strategies, which has taken the entire world into the awkward clutches of terrorism. Additionally, fast increasing gulf of hatred and detestation between the cultures, faiths and civilizations is also inviting violent clashes and conflicts on the very face of the earth, and the political authorities and governments appear to be helpless in combating with this curse even. Consequently, collective measures are being introduced on the concrete foundations of multicultural and inter-faith co-operation to defeat and crush the widespread terrorist nuisance with collective efforts. The theorists, intellectuals and philosophers blame social injus tices and inequalities as the root-cause behind the expansion of terrorism in the world. They cite Marxist perspective that declares conflict between haves and haves-not as the by-product of chaos, confusion and anarchical state of affairs in human societies. The theorists are of the opinion that rejection of granting opportunities, resources and privileges to the developing countries is creating frustration in the minds of the masses, which always results in the form of violent reaction to the injustices and inequalities observed and promoted by the elite stratum of society on the one hand, and the powerful states of the world on the other. Hence, it is social inequalities that give birth to violent struggle against exploitation. Marx lauded the basic premise that the labor was the source of all wealth, and the profit of the capitalist was based on the exploitation of the laborers. â€Å"The capitalists performed the rather simple trick of paying the workers less than they deserve d, because they received less pay than the value of what they actually produced in a work period.† (Ritzer & Goodman, 2003:22) The modern terrorism is also the part of the same ideology created and implied out of sheer frustration and injustices. The present paper aims to identify the problem of terrorism in the light of the ideology, claimed and presented by various terrorist organizations, where these groups try to justify their actions and violent attacks against their opponent forces and groups to set the haves-not free from the exploitation of capitalism and imperialism. The groups under analysis including Baader-Meinhof of Germany, the Liberation Tigers of Tamil Elam in Sri Lanka, and Iranian state-sponsored terrorism reveal one and the same motif, which has been analyzed in the following lines 1. GERMANY A. Background and Facts related to Creation of RAF: World War I had drawn a clear and indelible boundary line between the nations on the basis of their economic positio n. Consequently, the conflict between the prosperous and poor states started widening to a great extent. The Germans had commenced World War II as revenge against the humiliating terms of Versailles Treaty of 1919, but the War culminated in favor of the capitalist societies, and thus added fuel to fire in the further demarcation between the rich and poor countries. Consequently, many extremist groups raised their heads as reaction to the growing exploitation prevailing in the imperialistic

Describe the global issue of TB and the impact it has on the health Assignment

Describe the global issue of TB and the impact it has on the health system of the most affected region - Assignment Example It is third biggest cause of death, after HIV/AIDS and ischemic heart disease in the age group of 15-59 years. There are many undeniable reasons to urgently improve TB control. While millions of people transverse countries and continents every day by crossing borders, global security is at stake. Introduction Tuberculosis (TB) is an airborne, potentially fatal infectious disease, acquiring pandemic proportion affecting almost all countries, is indeed a major global health concern. A third of the world’s population carries latent TB infection, which can appear at any time as symptomatic and at times life threatening disease when the immune systems of the infected persons are compromised. While many will never become ill, those who get are often suffer due to inadequate and incomplete treatment with an undesirable outcome because of their vulnerable and fragile health systems. A major cause of death, TB ranks as the eighth leading cause of death in low and middle income countrie s. It is third biggest cause of death, after HIV/AIDS and ischemic heart disease in the age group of 15-59 years (Lopez et al. 2006). TB, generally, is a curable disease; people with drug-sensitive type can be cured in six months. However, treatment of multidrug-resistant TB (MDR-TB) that are resistant to isoniazid and rifampicin, the two most important first-line drugs used in treatment of TB, is really challenging. There is around 0.4–0.5 million cases of MDR-TB each year. It requires use of second-line drugs that are costlier with severe side-effects, and treatment has to continue for longer period may be up to two years. Even then prognosis is not always very good for, with success rate of 50% to 70% (WHO 2010). Countries most affected by TB and populations most at risk According to the WHO (2010) each year, there are around 9 million new cases of TB, and about 2 million deaths due to TB infection. Almost every country of the world is affected by the TB, however, most cas es (85%) occur in Asia (55%), and Africa (30%) with India and China alone account for 35% of all cases. Of all the world’s TB cases, 80% of the cases are reported from 22 countries (Afghanistan, Bangladesh, Brazil, Cambodia, China, the Democratic Republic of the Congo, Ethiopia, India, Indonesia, Kenya, Mozambique, Myanmar, Nigeria, Pakistan, Philippines, the Russian Federation, South Africa, Thailand, Uganda, the United Republic of Tanzania, Vietnam and Zimbabwe), which are known as high-burden countries (HBCs) and have been given special attention in TB control (WHO 2010). Patients suffering from HIV/AIDS, TB infection is more fatal though such incidence is low, just over 10% of the TB cases that occur each year are among people living with HIV. Africa alone has 80% of such cases. The HIV epidemic caused a major rise in TB cases in Africa during the 1980s and 1990s with highest numbers reached in 2004, and have since begun to decline. There were around 1.3 million deaths fr om TB among HIV-negative people and around 0.4 million deaths from TB among HIV-positive people in 2009 (WHO 2010). TB is not restricted to low and middle income countries; it has affected the United States as well. According to Centers for Disease Control and Prevention (CDC)’s (2010) report in 2010, a total of 11,181 (a rate of 3.6 cases per 100,000 population) tuberculosis (TB) cases were reported in the United States which was a

Macbeth Relationship Analysis Essay Example for Free

Macbeth Relationship Analysis Essay I found the relationship between Macbeth and Lady Macbeth very interesting in the play. In Act I they are completely devoted to each other. Love, respect and trust are the contents of their relationship. The trust in the relationship is revealed right at the beginning when Macbeth sends his wife a letter telling her about the witches and the predictions â€Å"This have I thought good to deliver to thee, my dearest partner of greatness, that thee mightst not lose the dues of rejoicing by being ignorant of what greatness is promised thee. † (I, v, 10-13). The affection between the two is clearly shown when Macbeth salutes his wife with â€Å"My dearest love† (I, v, 58) and also on the letter where he says â€Å"†¦my dearest partner of greatness†¦Ã¢â‚¬  (I, v, 11). The respect comes when Macbeth listens to his wife, which talks about the murder. He respects her opinion and gives her a polite answer â€Å"We will speak further.† (I, v, 71). In Act I, ii we see that King Duncan considers Macbeth a brave soldier and good man â€Å"O valiant cousin, worthy gentleman!† (King Duncan, I, ii, 24). This can be considered a weakness or, perhaps, strength in the relationship, it depends on the point of view. It is a weakness if we analyze Macbeth’s side. He is â€Å"†¦too full o’ the milk of human kindness†¦ that wouldst thou holily; wouldst not play false†¦Ã¢â‚¬  (I, v, 16 21). It is strength if we analyze Lady Macbeth’s side. She has a very strong nature and knows Macbeth’s weak points, therefore manipulating and controlling the relationship. She uses of a great argument in Act I, vii accusing Macbeth for not having the courage to do what he wants â€Å"Wouldst thou have that which steem’ st the ornament of life, and live a coward in thine own steem, letting â€Å"I dare not† wait upon

Accelerated Pathways for Authorisation of Drugs

Accelerated Pathways for Authorisation of Drugs Mary Treasa Lohan Abstract and Summary Every year, thousands of chemical and biological entities are developed in the hope of making it to the shelf. The drug development process is the progression by which drugs will either be approved or not approved for use, and spans from discovery and preclinical testing to Phase IV of Clinical Trials (post marketing surveillance). The underpinning aim is to ensure the safety and efficacy of a drug before it can be approved for use. Given that only one in every 5,000 to 10,000 compounds that enter preclinical testing are approved for marketing, and that an average of 15 years is required to take a drug through the complete process, the drug development process is a long and costly one. The two main regulatory bodies in the world are the FDA (USA) and the EMA (EU) and while the drug approval process varies from the EU to the USA, the basic regulation process remains the same. Figure 1 Basic drug development regulation       (Kashyap et al., 2013) 1.1. Drug approval process in the US In brief, the process of drug approval in the US first involves the submission of an Investigational New Drug application by the Sponsor. This allows the Clinical Trials to commence once the data from the Preclinical trials shows that the drug is safe. Once the drug is shown to be safe and effective (Clinical Trials data), a New Drug Application is filed which is essentially an application to manufacture and sell the drug (Rick, 2009). 1.1. Drug approval process in the EU The application process for the EU, similar to the US, requires two steps. The first step is a clinical trial application to an individual member state, and then a marketing approval. The marketing approval in the EU can take one of three approaches The centralised procedure The mutual recognition procedure The decentralised procedure As mentioned before, the purpose of the drug development process is to ensure safe and effective drugs are available to the patient. However, both the US and EU processes are very lengthy procedures and often do not provide rapid patient access to drugs. There is of course a balance to be struck between providing patients with rapid access to medicines and ensuring adequate information is available regarding the risk-benefit factors of the drug, sometimes termed the evidence versus access challenge (Eichler et al., 2015). 1.2. Improvements In recent times however, much has been done to try and improve the situation (Baird et al., 2014). In the EU, there are two means to fast track approval of a drug; Accelerated assessment and Conditional marketing authorisation. The Conditional marketing authorisation process allows the approval of a medicine that address unmet medical needs of patients on the basis of less comprehensive data than normally required. The available data must indicate that the medicines benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future (EMA, 2015). In 2014, the EMA initiated a pilot project for a new model of drug testing and marketing called Adaptive Pathways (also known as Adaptive Licensing, or more recently the terms Medicines Adaptive Pathways (MAPs) or Medicines Adaptive Pathways to Patients (MAPPs) have been used). This concept allows new drugs that would treat unmet medical needs to be launched on the market faster, based on an incomplete data set (Davis et al., 2016). This project aims to discuss Adaptive Pathways in general, the different types of Adaptive Pathways, as well as the types of drugs that are suitable for these pathways. Finally, the Adaptive Pathway approval strategies in the EU and the US will be discussed. 2.1. Adaptive Pathways 2014 saw the introduction of a pilot program by which drugs could potential to make it to the market faster in order to fulfil unmet medical needs, the Adaptive Pathway. The idea was to ensure timely patient access to new drugs, while ensuring adequate risk benefit information was available. The Adaptive Pathways model presented by the EMA is not a new route of marketing authorisation but rather makes use of existing regulatory approaches such as the conditional marketing authorisation or the standard marketing authorisation. Using this pilot program, drugs could be authorized conditionally or in a staggered fashion using data gathered throughout the life of the product. The three key principles of Adaptive Pathways are; Iterative development Gathering real-life evidence Early involvement of stakeholders Bearing in mind that drugs are approved through adaptive pathways based on incomplete data and are given market approval earlier in the development process, iterative development refers to the gathering of data to increase knowledge after authorisation. It is a staggered approach to widen the target population or expand the indication. The data collected can also be used to reduce any uncertainties that were present at the early approval stage. A key component of Adaptive Pathways is a well-defined prospective plan for collecting real-life data that can be used in conjunction with the Clinical Trials data to enhance the risk benefit ratio (Eichler et al., 2012). Communication between stakeholders is critical and helps to decide what medicines are suitable, and are also responsible for creating an agreed prospective plan required for data gathering throughout the lifecycle of the product. Stakeholders are involved from a very early stage and can include health technology assessment (HTA) bodies, patients, as well as regulators and healthcare professionals. 2.2. Benefits and challenges of Adaptive Pathways The obvious advantage of the Adaptive Pathway is that the patient can potentially have access to a drug in a much shorter time period than if the drug had to go through the standard application process. If the drug shows a good risk benefit outcome, the drug can be approved at an earlier stage, while real-life data is gathered at predefined intervals from patients to confirm effectiveness. There is also the opportunity for drugs to be fully approved within a shorter timeframe than normal.   Eichler also suggests that this process may reduce the overall cost of development by allowing better-informed decisions on product viability to be made earlier in the development process (Eichler et al., 2012). Eichler has published an article detailing the enablers of this new concept (Eichler et al., 2015). However, since the publication of the EMAs final report in July following the completion of the pilot program, a number of articles have been published which criticise the new concept (Eichler et al., 2012) (Woodcock, 2012). Unlike the standard authorisation, the Adaptive Pathway uses preliminary data and omits a number of steps that were designed to protect patients from unsafe and ineffective drugs and, this raises concerns as to whether this can potentially lead to increased risk to the patient. For adaptive Pathways to work, it is critical that evidence obtained after initial approval be taken into consideration. However, it has been found that healthcare professionals are often slow to abandon unsafe methods (Tatsioni et al., 2007). This is worrying as the basis of Adaptive Pathways is that reliable data is generated after authorisation that will shed more light on the risk benefit to the patient. Another serious concern relates to the life cycle management of the new drug (Davis et al., 2016). As mentioned earlier, a key principle of the Adaptive Pathway is gathering real-life evidence in post-marketing studies that would be used to update the risk benefit information. However, it would seem that in the case of conditionally approved drugs, the regulatory bodies have failed to ensure post-marketing study commitments are followed through (Banzi et al., 2015). It has also been suggested that where undesirable findings are encountered, companies may dispute these as unreliable results (McCabe et al., 2010) or may discount them because there are large financial gains or reputations at risk (Prasad et al., 2012). Moreover, the willingness of stakeholders to participate in a program that involves more uncertainty, and correspondingly perhaps more risk, than before will be one of the greatest challenges to the Adaptive Pathway. 2.3. Suitable drugs for Adaptive Pathways The report issued by the EMA suggests that drugs that treat infectious diseases, Alzheimers disease, degenerative diseases and rare cancers are potential candidates for this process with the objective of furthering their development and that suitable for the Adaptive Pathways would be those that treat rare diseases, where clinical data is not that common. The EMA have provided a flowchart to help companies determine if a product is an appropriate candidate or not, (Figure 2). Based on this, the key features of a drug that could be deemed suitable for this Adaptive Pathways approach are; iterative development, collaboration with HTA, and the use of real time data for regulatory purposes. Figure 2 Adaptive Pathway product eligibility flowchart While there is no strict restriction on what type of drugs are eligible for the Adaptive Pathways, the EMA states that this route is not to be applicable to all medicines, but only to medicines that are likely to address an unmet medical need(EMA, 2016). During the pilot, 62 applications were received from a variety of therapeutic areas with cancer therapies accounting for a large proportion (33%). It is worth noting that Orphan designated drugs are suitable candidates, with 5 making it through to Stage 1 Meetings (15 drugs had been given Orphan drug designation by the European Commission at the time of submission) (EMA, 2016). (EMA, 2016) 2.5. Adaptive Pathway approval strategy in the USA Within the USA, there are four approaches to getting drugs on the market as rapidly as possible, and in each case the drug must be intended to treat a serious condition. A serious condition is defined as a disease or condition associated with morbidity that has a substantial impact on day-to-day functioning Fast Track Breakthrough Therapy Accelerated Approval Priority Review Fast Track refers to the process, approved in 1992 under the Prescription Drug User Fee Act, by which drugs needed to treat serious conditions or to fulfil unmet medical needs are rapidly approved. According to the FDA, filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy (FDA, 2014). This strategy means more communication with the FDA regarding the drug development plan, data collection and clinical trials design. In addition, a Fast Track designated drug is potentially eligible for Accelerated Approval and Priority Review if it meets the applicable criteria. Breakthrough Therapy designation accelerates the development of drugs needed to treat serious conditions that have shown substantial advantages over existing treatments in early clinical studies (Poirier and Murphy, 2016). This strategy utilises a surrogate endpoint. A surrogate endpoint is a marker used to determine effectiveness of a drug, such as the shrinking of a tumour and is often used rather than actual clinical endpoints, such as survival rates. Another example would be a significantly improved safety profile compared to available therapy (FDA). In addition to the Fast Track designation benefits, Breakthrough Therapy drugs receive a vast amount of guidance with the drug development program. References   BAIRD, L. G., BANKEN, R., EICHLER, H. G., KRISTENSEN, F. B., LEE, D. K., LIM, J. C. W., LIM, R., LONGSON, C., PEZALLA, E. 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The Impact of Breakthrough Therapy Designation on Development Strategies and Timelines for Nononcology Drugs and Vaccines. Clinical Pharmacology Therapeutics, 100, 603-605. PRASAD, V., CIFU, A. IOANNIDIS, J. P. A. 2012. Reversals of established medical practices: evidence to abandon ship. Jama, 307, 37-38. RICK, N. 2009. Drugs from discovery to approval., John Wiley & Sons, Inc. TATSIONI, A., BONITSIS, N. G. IOANNIDIS, J. P. A. 2007. Persistence of contradicted claims in the literature. Jama, 298, 2517-2526. WOODCOCK, J. 2012. Evidence vs. Access: Can Twentyà ¢Ã¢â€š ¬Ã‚ Firstà ¢Ã¢â€š ¬Ã‚ Century Drug Regulation Refine the Tradeoffs? Clinical Pharmacology Therapeutics, 91, 378-380. staggered or conditional marketing authorization AL is expected to involve a trade-off between earlier access for some patients vs. an increased level of acceptable uncertainty about benefits and risks, although the degree of uncertainty is expected to diminish with additional evidence generation. One of the main purposes of the AL scheme is to get more robust and more relevant data earlier and throughout product development. Any attempt to move toward a more adaptive approach would have to be complemented by appropriate communications to key stakeholders and assurance that the appropriate post-initial authorization capabilities exist for ongoing monitoring of medical products for which AL has been applied