Major Contributions Of Realism Essays - 19th-century Theatre

Significant Contributions of Realism Counting view, styles of acting, cosmetics, and discourse, authenticity contributed numerous things to theater. It includes precise delineations of ordinary individuals in achievable circumstances and was intended to supplant the fake sentimental style. Authenticity dismissed emotional shows that had existed since the start of dramatization. In the eighteenth century, David Garrick initiated the utilization of verifiably exact outfits and sets. In the sixteenth century in Italy, practical venues started to present the proscenium stage which is utilized universally today. Since by the mid nineteenth century practical gas lights uncovered the unnatural appearance of canvas settings, the sensible box set was made mainstream. Authenticity supplanted the very much made play and the declamatory acting of the time. Rather, it presented dramatizations which approximated in discourse a circumstance of the social and residential issues of regular daily existence. The on-screen characters talked and moved normally against view which duplicated with reliability the bizarre environmental factors of the individuals they speak to. One of the kinds of theater that rose out of authenticity is naturalism. Authenticity contributed numerous things to present day theater.

A Painful Lesson in Staying Calm :: Personal Narrative Writing

A Painful Lesson in Staying Calm Oh rapture, was I ever incensed! I was reviling up a tempest! â€Å"Damn ball! Where the damnation did it think it was going? Who the hellfire at any point let me figure out how to golf? They clearly were one damn moronic jerk to figure I would ever golf!† I energetically raged away from the tee-box, maddened that my ball was totally crazy as it had flown through the air a couple of moments prior. â€Å"Just go hell! Hit your fricken ball!† I seemed like a little pitiable youngster shouting at her mom since she had not gotten her way in a contention as I shouted indignantly at my sibling who was presently remaining on the tee-box prepared to send his ball to unimaginable lengths. As I pivoted to start the excursion towards my miserable shot, ignoring the undeniable error I was making, it hit me. The weight from the abrupt startling effect on the tip of my left elbow shot through my whole body rapidly and horrendously. The agony shot from my elbow, through my arm, down through my legs, at that point back up to my other arm, lastly to my head. The agony was solid and sharp. It felt just as I had fallen on an electric cows fence, and it had given me one in number electrical stun that overwhelmed my entire body with torment for a brief instant. In that brief moment I saw the world somewhat better. I felt as if I had been shot. My psyche delayed and snapped a picture of the view before me. I was just ready to take one snappy striking photo in my psyche however in light of the fact that everything occurred so rapidly. The sparkling green grass was blinding my eyes as the solid beams of daylight channeled downward on the fairway. There was a little chasm around fifteen feet from me where there was tall grass that resembled bits of green and earthy colored string standing out of the ground. A little fix of grass was absent by the gorge to uncover a little shining brook that streamed quickly. There was no wind to blow the strings, so they stayed there still. I saw the splendid green leaves of the trees that were totally encompassing me.

Saying Yes

Saying Yes In my most recent monthly newsletter, I offered a poll as to whether I should take a vacation from blogging or keep writing while I’m away at Dance Camp. The overwhelming majority of responders said I should take a vacation. Nevertheless, I wanted to share a quick thought from this week that might be valuable to you as you forge your life and career path. The Power of Yes There’s a computer room here at camp where I spend a couple of hours each morning. As I was getting up from my computer a couple of days ago, I audibly whacked my knee into the table leg. Ouch! “Do you want me to help you?” said a voice from the other side of the room. “I’m a trained massage therapist.” “I don’t think massage will help my bruised knee,” I responded, turning around to see a slim dark-skinned man I did not recognize. “Oh, I do Reiki too,” said the man, and I said “yes” to Reiki (a form of energy healing), which he gave to my knee. The knee stopped hurting almost immediately. The next thing I knew, this man from Ghana, whose name is Yaw, was giving healing to my rib area, where I still am having issues after my car accident, and showing me his electronic tools that he uses to help heal scar tissue (I have plenty of it internally from the various muscle tears in my abdominals that I’ve been dealing with for the past few months). I will be hiring Yaw for a full healing session in the next few days. Saying Yes in Business Also in the past week, I completed a questionnaire for Brava Magazine about, amongst other things, how my business got started. My interaction with Yaw and the way my business got off the ground have some parallels. When I first started my business, I became active on LinkedIn, where someone offered to help me and I said yes. A marketing professional, his idea was for me to offer free LinkedIn profile reviews to members. I said “yes,” which led to my writing articles about LinkedIn and being asked to lead webinars (I said “yes” to those requests too). I was open to what came into my life, and by saying “yes” eventually built a business and wrote my best-selling e-book, How to Write a KILLER LinkedIn Profile. The Alternative If I had said “no” to Yaw, or “no” to the marketer on LinkedIn, or “no” to the people who wanted me to deliver a webinar, my week at Dance Camp and my life would look much different right now. Of course it’s impossible to say yes to every opportunity that comes along, and I make choices all the time. But I wonder how many opportunities I let pass me by that would be a contribution to my life? What are you saying “yes” and “no” to in your life? Is there more room for “yes”? What have you said “yes” to that has led to something unexpected? I’d love to hear your thoughts and stories. And maybe I’ll take next week off…

Kentucky Death Row Inmates Crimes and Mugshots

Othello the Tragic Hero Essay - 912 Words

Jealously, Often this trait takes people over, controls their thoughts and persuades them to do stupid things. William Shakespeare portrayed this flaw extremly well in the play Othello. IN the play, Othello, is a character who seems almost perfect, but his flaw jealousy is brought out but his trusted companion Iago. This trait makes Othello the tragic hero due to the fact that he sacrifices his life in good name. When being accused of â€Å"witchcraft† by Barbantio ( Desdemonas father) and senators he remains in control and courageous. â€Å" Most potent, grave, and reverend signors.... Rude I am in speech And little blessed with the soft phrase of peace†Ã¢â‚¬ ¦show more content†¦To be suspected, framed to make women false The Moor is a free and open nature That thinks men honest, but that seem to be so, And will as tenderly be led by th’ nose As asses are.† (Iago.1.3.440-445) This quote shows that Iago thinks that Othello he treats women unkindly and is an ass because he is extremly gullable. In act 3, Othellos jealousy is seen being brought on by Iago. He tells Othello that Desdemona is unfaithful to him, and that she is cheating on him with Cassio, his lieutenant. â€Å"Did Michael Cassio ... Burn like the mines if sulfur†. (IagoOthello3.3.105-337) This quote basically shows Iago covinving Othello that his wife is â€Å"strumpeting† with Cassio. Also in act 3 Iagos antagonistic side shows indefinitely when his wife (Emilia) brings him Desdemonas handkerchief , but doesn’t know why he wants it. Iago winds up placing it in Cassios room to frame him. Later on Iago tells Othello that he saw Cassio with the handkerchief â€Å" Have you not sometimes seen a handkerchief spotted with strawberries in your wives hand? ... Damn her, lewd minx O damn her, Damn her † (3.3. 493-542) In acts 4 and 5 the play comes to ends with deception, truth, and death. A lot of death. Act four starts out with Iago telling Othello that Desdemona and Cassio have been sleeping together. Othello gets enraged and wants to kill her with poison, but IagoShow MoreRelatedOthello: Othello a Tragic Hero1478 Words   |  6 PagesOthello: Othello A Tragic Hero If one reads Shakespeares Othello, they can come to the conclusion that it might be one of the his most tragic plays ever written by Shakespeare. Romeo and Juliet, is probably the most famous of his tragic plays, but Othello, has characteristics that, I think make it even more tragic then his other plays, and therefore for that reason, you can say that Othello is the most tragic hero. Othello is a noble man, one who has grace with the ladies but also possessesRead MoreOthello as Tragic Hero1578 Words   |  7 PagesIn what ways does Shakespeare present Othello as a typical tragic hero? Professedly, Shakespeare appears to present Othello as tragic hero, exposing his tragic flaw, which consequently leads to his downfall, through his use of language, structure and form. It could be argued ‘Othello’ appears to conform to Aristotle’s principles of tragedy, of the noble protagonist who undergoes perpetia and endures suffering, resulting in his ultimate downfall due to harmatia, which he eventually realises, providingRead MoreOthello As A Tragic Hero872 Words   |  4 Pagesof Venice, Othello is transformed into a crazy, senseless man. William Shakespeare uses the idea of a tragic hero in almost all of his dramas. A tragic hero can be described as a person of high status who is neither completely good nor completely evil, possesses a tragic flaw, and leaves this flaw to be the reason for his/her downfall. Othello believes he can trust one of his soldiers, Iago, who is determined to seek revenge on Othello for not promoting him to be a lieutenant. Othe llorsquo;s temperRead MoreOthello is Not a Tragic Hero Essay1481 Words   |  6 PagesOthello has been described as one of William Shakespeare’s most popular plays because the play focuses on its themes of good and evil, military, politics, love and marriage, religion, racial prejudice, gender conflict, and sexuality; but the controversy and debate surrounding Othello is â€Å"Why is Othello a qualification for a tragedy?† Most readers are aware of the many famous deaths or acts of death within the Shakespearean plays. And when the main characters die in Shakespeare’s plays, indeedRead MoreIs Othello a Tragic Hero? Essay1479 Words   |  6 PagesTo what extent can Othello be considered a ‘tragic hero’? The extent of which Othello is a tragic hero has been open to much debate; the basis on which he is judged falls to Aristotle’s established view of the crucial elements that distinguish whether a person is truly tragic. According to Aristotle, a tragic protagonist is a nobleman or person from high status, who contributes to his own demise and illustrates a flaw or weakness in judgment. The tragic protagonist must make a fall from a highRead More Othello - The Tragic Hero Essay796 Words   |  4 Pages Othello: The Tragic Hero In William Shakespeare’s Othello, Othello is the tragic hero. He is a character of high stature who is destroyed by his surroundings, his own actions, and his fate. His destruction is essentially precipitated by his own actions, as well as by the actions of the characters surrounding him. The tragedy of Othello is not a fault of a single villain, but is rather a consequence of a wide range of feelings, judgments and misjudgments, and attempts for personal justificationRead MoreWhy Is Othello A Tragic Hero1465 Words   |  6 Pagestragedy his protagonists are often given flaws in their character and hence, are suitably named tragic heroes. The downfall of these protagonists is often a result of their own character flaws and unfortunately, they suffer a doomed and unhappy ending. While the tragic hero is flawed they must also be honorable and worthy of the audience’s understanding and sympathy. On a quest for righteousness the tragic hero often goes through immense s uffering which is why the audience can feel bad for him. ForRead MoreOthello as a Tragic Hero Essay723 Words   |  3 PagesOthello is a tragic hero because of his greatnesses and his weaknesses. He is a noble man who possesses all the qualities of a military leader, which he is. He has control over himself and shows courage as well as dignity. Just as Othello is a virtuous man there are some flaws within him, these flaws complete him ff as a tragic hero. Othello is often blinded by trust and can not see a person for who they really are. He trusts the people around him even when they mean to afflict harm upon him. ThroughRead MoreShakespeare s Othello As A Tragic Hero1517 Words   |  7 Pageswonder, who is Aristotle and why does he label Shakespeare’s play, Othello, as a tragedy? Aristotle is a famous Greek philosopher who defines Shakespeare’s character, Othello, as a tragic hero. Many parts in Othello tell the readers that the play is a tragedy, such as jealous y, arguing, and death, which makes the play famous and delightful to read. Aristotle has identified many common traits or characteristics that a tragic hero requires. In Shakespeare s play, Aristotle defines many featuresRead MoreOthello : An Aristotelian Tragedy And Tragic Hero1604 Words   |  7 PagesOthello, an Aristotelian Tragedy and Tragic Hero When reading a story, specifically a tragedy, what stands out? Tragedy often enables its audience to reflect on personal values that might be in conflict with civil ideas, on the claims of minorities that it neglected or excluded from public life, on its on irrational prejudices toward the foreign of the unknown (Kennedy Gioia, 2103, p. 857). Readers feel sympathy for the characters, especially the tragic hero. Othello, the Moor of Venice is

Record Label and Napster S Strategy Free Essays

Napster, developed in 1999 by Shawn Fanning, is a program that allows music to be traded over the internet. People were able to share high quality digital copies of music recordings over the internet using Napster. Napster did not store the recordings, however. We will write a custom essay sample on Record Label and Napster S Strategy or any similar topic only for you Order Now It allowed its members who were logged onto the service to choose from an index of songs. Napster was one of the most popular sites on the internet. The site had some 15 million users in a year’s time. Many college students downloaded so many songs that many colleges had to block the site from their system. A year after its launch, Napster was sued by the Recording Industry Association of America (RIAA). The RIAA represents major recording companies. The RIAA claimed that copyright laws were violated by Napster for allowing users to swap music recordings for free. The RIAA sought to stop the downloading of copyrighted songs, as well as damages for lost revenue. Song swapping had cost the music industry more than $300 million in lost sales. A few months later, Napster was sued by a heavy metal band, Metallica, and rap star Dr. Dre. They were suing Napster for copyright infringement. In 2000, a judge granted the request of the RIAA and ordered Napster to stop making copyrighted recordings available for download. This would have shut Napster down. Napster was granted a last-minute reprieve until the lawsuits could be tried in court. Despite its many claims, Napster was found guilty of direct infringement of the RIAA’s musical recordings. The company was ordered to stop allowing its millions of users to download and share copyrighted material without properly compensating the owners of the material (Ferrell Hartline, 2008). Napster later offered $1 billion to the recording industry to settle the lawsuit. Napster also agreed that $150 million would be paid annually for the first five years to Sony, Warner, BMG, EMI, and Universal, and $50 million annually was allotted for independent labels. The recording industry refused the offer. The industry wanted Napster to shut down for good. Napster tried many times to compromise with the recording industry, but to no avail. Napster filed for Chapter 11 reorganization in 2002. The company also tried to reach a deal with Bertelsmann AG, their strategic partner. A few months later, a Delaware judge blocked the sale of the company to Bertelsmann. Napster then laid off nearly its entire staff and proceeded to convert its Chapter 11 into a Chapter 7 liquidation. Many music labels were dabbling in online music distribution. Napster had clearly beaten them to it and had done so efficiently, which was the main problem for the company. It was obvious to the record labels that online distribution was here to stay. Napster’s name and assets were purchased by a company called Roxio. Roxio was a company known for its CD-burning software. Roxio had intentions to relaunch Napster as a fee-based service. Napster was renamed Napster 2. in 2003. Apple was one competitor for Napster, holding 70 to 80 percent of the online music market. Rhapsody holds 10 to 15 percent of the market, and Napster holds 5 to 10 percent of the market. The remaining portion is divided among several different companies (Ferrell Hartline, 2008). Napster’s strategy focuses on being a subscription-based revenue model. Computer users could download as mu ch music as they wanted for a fee of $14. 95 per month. Napster created partnerships with BellSouth, Ericsson, and XM Satellite Radio as a means to connect with untapped markets. Napster partnered with Tower Records Japan and launched Napster Japan in 2006. The company also began a partnership with Japan’s largest mobile phone company. About 90 percent of music downloads in Japan occur through wireless phones (Ferrell Hartline, 2008). Napster has shown interest in being acquired by another firm. Napster hired UBS Investment Bank to help with the sale. A SWOT analysis structures the assessment of the fit between what a firm can and cannot do (strengths and weakness), and the environmental conditions working for and against the firm (opportunities and threats). The SWOT analysis for Napster would consist of the following (Ferrell Hartline, 2008): Strengths †¢Large music library †¢Convenient and easy to use †¢Strong brand name and reputation Weaknesses †¢Lack of compatibility †¢Pricing †¢Limited areas of differentiation Opportunities †¢New technologies †¢Decline in illegal file sharing †¢Rapidly growing market Threats †¢Powerful competition †¢New technologies †¢Potential for disintermediation Looking back at the weaknesses listed in the SWOT analysis, one point that should be worked out is the pricing of Napster services. Napster is set up on a subscription-based model. If the price per subscription was cheaper, more customers would subscribe to the site. Napster offers the same basic services as some of the other big names in the online music distribution industry. Another area to refine would be the lack of compatibility. Napster is not compatible with all MP3 players, especially the iPod. Those with an incompatible player will not want to purchase the service. New technology is emerging every day. Napster should work on creating avenues that will allow music to be downloaded to wireless devices, such as the smart phone, PDAs and other handheld devices. Napster should put forth efforts to keep existing customers happy while also trying to expand the customer market. Keeping existing customers happy should always be a company’s top priority. Having a solid core of customers to build on is very important to the stability and success of the company (Business KnowledgeSource. com, 2010). By keeping the existing companies happy, Napster could offer a free one month subscription for those members who have been loyal to company for a certain amount of time. Flyers or inserts could also be placed in the packaging of MP3 players. This advertisement would entice users to connect with Napster for all of their music downloads. With this deal, new users could download up to five songs for free before having to sign up for a subscription. Napster could offer discounts to new users for a certain period of time. For instance, a new user could get the first three months at a discounted rate before paying the regular price. There are many ways for Napster to expand their customer base. Finding out which plans work and which plans do not work is the key. How to cite Record Label and Napster S Strategy, Essay examples

Much Symbolism Essays - English-language Films, Allegory

Much Symbolism Nature's Symbolism Much symbolism is used in William Golding's Lord of the Flies. The nature on the island is used as the primary source of symbolism. There are three main uses of nature's symbolism: a pink conch shell, a pig's head, and fire. Nature is a symbol that parallels to the real world. It helps prove the author's theory that Humankind is foolish and evil in any situation. The first important part of nature's symbolism is a pink conch shell. At the beginning of the book, it was found by Ralph (13). The conch shell represents power and authority. Ralph uses it to call for the boys to come to the meeting (15). In the meetings, whoever has the shell has the power to speak. The conch shows how people use objects to give power, like a king and his scepter and crown, or other things which show who has power. It is also evident that objects don't give power when people choose not to obey it, like Ralph's conch. The pig's head, or Lord of the Flies, is another important use of symbolism through nature. Jack and his hunters killed a pig and cut off its head (125). To Jack, the head is a sacrifice for the beast (127). This object demonstrates that people make religions and rituals to control their world, even though what they think is not true. Lord of the Flies is a symbol of the Devil, or Satan. When Simon communicated with Lord of the Flies, he found out what real evil was, which is the evil in the hearts of people. The pig's head is a symbol of the thing we make up to be the cause for evil, when those things aren't the real reason. Fire is the last symbol of nature. It stands for hope and rescue. When the fire was burning bright, it was because the boys had hope and were working hard to get rescued. When the fire burnt out, it was because too many boys, like Jack, lost hope for being rescued. In the end, the fire that got the attention of naval officers was ironically not meant for rescue. It was there because Jack was trying to flush Ralph out of the forest by burning down the island (182). The fire at the end shows us that we sometimes get things from luck instead of hard work. Lord of the Flies is filled with symbolism through nature, which makes an important comment about Humankind. The objects parallel to things in the real world like power, religion, pride, hope, and authority. They help to show us that what happened in the story happen anyway, just in different ways. They prove Golding's belief that Humankind is foolish and evil under any circumstances. Book Reports

Introduction to the French Imperative Mood

Introduction to the French Imperative Mood   The imperative, called limpà ©ratif in French, is a verb mood which is used to: give an orderexpress a desiremake a requestoffer advicerecommend something Unlike all other French verb tenses and personal moods, the subject pronoun is not used with the imperative: Fermez la porte.Close the door. Mangeons maintenant.Lets eat now.Ayez la bontà © de mattendre.Please wait for me. Veuillez mexcuser.Please excuse me. The above are called affirmative commands, because they are telling someone to do something. Negative commands, which tell someone not to do something, are made by placing ne in front of the verb and the appropriate negative adverb after the verb: Ne parle pas!Dont speak! Noublions pas les livres.Lets not forget the books. Nayez jamais peur.Never be afraid. The imperative is not the only way to tell someone what to do in French - its how you give orders in French. French imperative conjugations are relatively simple. There are only three grammatical persons that can be used in the imperative:  tu,  nous, and  vous, and most of the conjugations are the same as the present tense - the only difference is that the  subject pronoun  is not used in the imperative. -ER Verbs Imperative Mood Conjugations   -ER verbs  (regular, stem-changing,  spelling change, and irregular): The imperative conjugations for  nous  and  vous  are the same as the present indicative, and the  tu  form of the imperative is the indicative minus the  final s:parler(tu) parle(nous) parlons(vous) parlezlever(tu) là ¨ve(nous) levons(vous) levezaller(tu) va(nous) allons(vous) allezVerbs which are conjugated like -ER verbs (meaning that in the indicative the  tu  form ends in -es), such as  ouvrir  and  souffrir, follow the same rules as -ER verbs.ouvrir(tu) ouvre(nous) ouvrons(vous) ouvrez -IR and -RE Verbs Imperative Mood Conjugations   -IR verbs  and  -RE verbs: The imperative conjugations for all regular and most* irregular -IR and -RE verbs are the same as the present indicative conjugations.finir(tu) finis(nous) finissons(vous) finissezattendre(tu) attends(nous) attendons(vous) attendezfaire(tu) fais(nous) faisons(vous) faites*Except for verbs conjugated like -ER verbs and the following four irregular imperative verbs:avoir(tu) aie(nous) ayons(vous) ayezà ªtre(tu) sois(nous) soyons(vous) soyezsavoir(tu) sache(nous) sachons(vous) sachezvouloir(tu) veuille(nous) n/a(vous) veuillez Negative Imperatives The order of words in a French sentence can be very confusing due to affirmative and negative imperative constructions and object and adverbial pronouns. Remember that there are two kinds of imperatives, affirmative and negative, and the word order is different for each of them. Negative imperatives are  easier  because their  word order  is the same as that of  all other simple verb conjugations: any object, reflexive, and/or adverbial pronouns precede the verb and the  negative structure  surrounds the pronoun(s) verb:Finis!  - Finish!Ne finis  pas!  - Dont finish!Ne le finis  pas!  - Dont finish it!Lisez!  - Read!Ne  lisez  pas!  - Dont read!Ne le  lisez  pas!  - Dont read it!Ne me le  lisez  pas!  - Dont read it to me! Affirmative Commands Affirmative commands are more complicated, for several reasons. 1.  The word order is for affirmative commands is different from that of all other verb tenses/moods: any pronouns follow the verb and are connected to it and to each other with  hyphens.Finis-le!  - Finish it!Allons-y!  - Lets go!Mangez-les!  - Eat them!Donne-lui-en!  - Give him some!2.  The order of the pronouns in affirmative commands is slightly different from all other verb tenses/moods (see table at the bottom of the page):Envoie-le-nous!  - Send it to us!Expliquons-la-leur!  - Lets explain it to them!Donnez-nous-en!  - Give us some!Donne-le-moi!  - Give it to me!3.  The pronouns  me  and  te  change to the  stressed pronouns  moi  and  toi...Là ¨ve-toi!  - Get up!Parlez-moi!  - Talk to me!Dis-moi!  - Tell me!...unless they are followed by  y or en, in which case they  contract  to  m  and  tVa-ten!  - Go away!Faites-my  penser.  - Remind me about it.4.  When a  tu  command is followed by the pronouns  y o r en, the final s is not dropped from the verb conjugation:Vas-y!  - Go away!Parles-en.  - Talk about it.

Womens Liberation Movement †Definition and Overview

Women's Liberation Movement - Definition and Overview The womens liberation movement was a collective struggle for equality that was most active during the late 1960s and 1970s. It sought to free women from oppression and male supremacy. The Meaning of the Name The movement consisted of womens liberation groups, advocacy, protests, consciousness-raising, feminist theory, and a variety of diverse individual and group actions on behalf of women and freedom. The term was created as a parallel to other liberation and freedom movements of the time. The root of the idea was a rebellion against colonial powers or a repressive national government to win independence for a national group and to end oppression. Parts of the racial justice movement of the time had begun calling themselves the  black liberation. The term liberation resonates not just with independence from oppression and male supremacy for individual women, but with solidarity among women seeking independence and ending oppression for women collectively. It was often held in contrast to individualistic feminism. The individuals and groups were loosely tied together by common ideas, although there were also significant differences between groups and conflicts within the movement. The term womens liberation movement is often used synonymously with womens movement or second wave feminism, although there were actually many different types of feminist groups. Even within the womens liberation movement, womens groups held differing beliefs about organizing tactics and whether working within the patriarchal establishment could effectively bring about the desired change. Not Womens Lib The term womens lib was used largely by those opposing the movement as a way of minimizing, belittling, and making a joke of it. Womens Liberation vs. Radical Feminism   The womens liberation movement is also sometimes seen as being synonymous with radical feminism  because both were concerned with freeing members of society from oppressive social structure. Both have sometimes been characterized as a threat to men, particularly when the movements use rhetoric about struggle and revolution. However, feminist theorists overall are actually concerned with how society can eliminate unfair sex roles. There is more to womens liberation than the anti-feminist fantasy that feminists are women who want to eliminate men. The desire for freedom from the oppressive social structure in many womens liberation groups led to internal struggles with structure and leadership. The idea of full equality and partnership being expressed in a lack of structure is credited by many with the weakening power and influence of the movement. It  led to later self-examination and further experimentation with leadership and participation models of organization. Putting Womens Liberation in Context The connection with a black liberation movement is significant because many of those involved in creating the womens liberation movement had been active in the civil rights movement and the growing black power and black liberation movements. They had experienced disempowerment and oppression there  as women. The rap group as a strategy for consciousness within the black liberation movement evolved into consciousness-raising groups within the womens liberation movement. The  Combahee River Collective  formed around the intersection of the two movements in the 1970s.   Many feminists and historians trace the roots of the womens liberation movement to the New Left and the civil rights movement of the 1950s and early 1960s. Women who worked in those movements often found that they were not treated equally, even within liberal or radical groups that claimed to fight for freedom and equality. Feminists of the 1960s had something in common with feminists of the 19th century in this respect: Early womens rights activists such as Lucretia Mott and Elizabeth Cady Stanton were inspired to organize for womens rights after being excluded from mens anti-slavery societies and abolitionist meetings. Writing About the Womens Liberation Movement Women have written fiction, non-fiction, and poetry about ideas of the 1960s and 1970s womens liberation movement. A few of these feminist writers were  Frances M. Beal, Simone de Beauvoir, Shulamith Firestone, Carol Hanisch, Audre Lorde, Kate Millett, Robin Morgan, Marge Piercy, Adrienne Rich, and Gloria Steinem. In her classic essay on womens liberation, Jo Freeman observed the tension between the Liberation Ethic and the Equality Ethic, To seek only equality, given the current male bias of the social values, is to assume that women want to be like men or that men are worth emulating...  It is just as dangerous to fall into the trap of seeking liberation without due concern for equality. On the challenge of radicalism versus reformism creating tension within the womens movement, Freeman goes on to say, This is a situation the politicos frequently found themselves in during the early days of the movement. They found repugnant the possibility of pursuing reformist issues which might be achieved without altering the basic nature of the system, and thus, they felt, only strengthen the system. However, their search for sufficiently radical action and/or issue came to naught and they found themselves unable to do anything out of fear that it might be counterrevolutionary. Inactive revolutionaries are a good deal more innocuous than active reformists.

The Tiebout Model Essay Example | Topics and Well Written Essays - 1500 words

The Tiebout Model - Essay Example The main finding included the fact that inter-jurisdictional competition is a vital element of the mechanism. The key players in Tiebout’s model are individual citizens and governments. business firms are not an explicit part of the model (Brueckner 2004, p 138). It was meant to be applied to local governments and to a lesser degree, to state governments. The model assumes citizens have full knowledge of government revenue and expenditure packages, that there are a large number of communities among which individuals can choose to live, and that people will opt for the community that best satisfies their preferences. Moreover, the model assumes that government services exhibit no spillover effects (Billings 2008, p 45). Tiebout’s model made three additional assumptions; one, that jobs impose no locational constraint on individuals; two, that a community’s optimal size, meaning the size for which the average cost of producing a particular packages of public service s is minimized, can be determined; and three, that each community seeks to attain its optimal size (Feiock 2004, p. 76). The model envisions citizens sorting themselves out among available communities so that demands for government services within any particular community would become homogenous. In theory, Tiebout concluded that to the extent these rather restrictive assumptions are met, good and services provided by the local public sector will exhibit both allocative efficiency (the right amounts of the various good and services are produced ) and productive efficiency (they are produced at least cost) (Rivkin 2001, p. 206). In Tiebout’s model, community taxes would be benefit taxes, or proportional to the benefits citizens receive form public services, rather than taxes based on the ability to pay. Tiebout’s model implies that any redistribution of income is taken care of by the federal government (Rivkin 2001, p. 207). Despite all the pros of the Tiebout model, va rious changes in the finance systems of local governments over the last three decades, such as fiscal centralization, work against the establishment of Tiebout effects. This uniformity is undesirable and future reforms should target to encourage a greater diversity of service provision. Competition among local governments, cities and municipalities, as depicted in Tiebout’s model, most at times serve to improve efficiency and delivery of service and goods to the citizens. Based on Tiebout’s model, where there is competition, citizens will come together to take care of all types of demands for public goods and service (Widmer & Zweifel 2008, p. 5). Moreover, individuals will relocate to communities that best meets their demand for public goods and services and the productivity is improved and more efficient since shady and/ ineffective providers of public services and goods will not get any clients. Tiebout model has all the benefits of a competitive market (Feiock 2004 , p. 97). According to Tiebout, it is clear that decentralization of provision of public goods and services results in a positive influence on performance. The rationale is that citizens will procure from the providers who give them the best quotient between public service and tax paid. In a study on fiscal equalization, where disparities among local

Outline and critically assess Max Webers concept of the iron cage in Essay

Outline and critically assess Max Webers concept of the iron cage in relation to the rationalisation of work in the modern world - Essay Example assess it in relation to the rationalization of work in the modern world, the paper offers a consistent examination of Max Weber’s thought and teaching on rationality, bureaucracy and capitalism. Weber viewed bureaucracy as the natural stage of historical evolution and as the most efficient way of governing the modern world’s society. On the other hand, comparing it with â€Å"the iron cage† he underlined the drawbacks of bureaucratic machine and highly rational approach to life, and admitted that as a result we live in a â€Å"polar night of icy darkness." Bureaucratic approach being recognized as the out-of-date management style, the modern society tries to adopt new methods of work. Yet, work continues remaining highly rationalized. Weber’s â€Å"social action.† To understand Weber’s concept fully, one should turn to his methodology, throwing light at the way of Weber’s thinking. Weber based his methodology on the category of the ideal type, which is the interest of the epoch, â€Å"a utopia,† expressed in a form of theoretical construction, a scheme. This ideal type helps to understand the common rules of the events, proving basis for economic, esthetic and moral values of people. With the help of understanding, a sociologist should examine the actions of an individual, who puts some sense into all of his actions. An individual’s actions become social actions conditioned by two factors: subjective motivation and orientation towards others. This orientation towards others makes an action a social action. Social action can be carried out only by individuals. To understand the social processes taking place in a state, a family, or any other social group, it is necessary t o understand the motives of actions of the separate individuals composing the examined social group. Yet, understanding is not sufficient for a deep insight into social processes. Rational actions should serve the instrument of sociology. Weber offers a typology of social actions based on

The Importance Of Reward Management Business Essay

The Importance Of Reward Management Business Essay Reward management in a business organisation is basically the way in which that particular business forms and implements strategies and policies to reward the employees to a fair standard and in accordance with how the organisation values them. Reward management in a business organisation usually consists of the business analysing and controlling the employees remuneration and all of the other benefits for the employees. The main aim of reward management in a business organisation is to reward the employees fairly for the work that they have completed. The main reason reward management exists in business organisations is to motivate the employees in that particular organisation to work hard and try their best to achieve the goals which are set out by the business. Reward management in business organisations not only consist of financial rewards such as pay but they also consist of non-financial rewards such as employee recognition, employee training/development and increased job responsibility. Reward management in a business organisation deals with the design, implementation and maintenance of reward practices that are geared towards the improvement of the business organisations performance. The Importance of Reward Management The elements of reward management within a business organisation are all the things that they use to attract potential employees into their business which includes salary, bonuses, incentive pay, benefits and employee growth opportunities such as professional development and training opportunities. Having a reward management system in place provides the business with many advantages, especially in small to medium size organisations where the managers must have a good relationship with the employees. Reward programmes have proved to be very successful in motivating employees and in turn increase the performance of the organisation as a whole. Below are some of the reasons why a reward system is important: Mutually beneficial- A reward system is beneficial not only to the employee but also to the organisation. The employee will feel more motivated to work harder.by having a reward system in place the employee will feel more committed to their work and their productivity will increase. An increase in productivity will then benefit the organisation. Therefore a reward system is mutually beneficial to the employee and the organisation. Motivation-A reward system will motivate employees by reaching targets and organisational goals in exchange for rewards. A reward system is great at motivating employees but they will also be motivated to prove themselves to the organisation. Absenteeism-A reward system will reduce absenteeism in the organisation. Employees like being rewarded for a job well done and if there is a reward system in place, employees will be less likely to be ringing in sick and not showing up for work. Also by having a reward system in place the employees will be clearer about the targets and goals of the organisation as they will be rewarded when reach certain targets. So by having a reward system as an incentive they will be less likely to be absent from work. Loyalty-A reward system will increase the employees loyalty to the organisation. By a reward system being in place the employee feels valued by the organisation and knows that their opinion matters. If an employee is happy with the reward system, they are more likely to appreciate work place and remain loyal to the organisation Morale-Having a reward system in place providing employees with incentives and recognition will boost their morale. By encouraging employees to meet goals and targets it gives them clear focus and purpose which will their morale. By the employees morale being boosted this will increase the morale of the entire organisation. This is all down to a reward system in the organisation. Teamwork- The reward system will increase the teamwork spirit in the organisation. The reward system will promote teamwork to the employees. The employees will work together as part of a team to achieve their targets in return for rewards. Teamwork within the organisation will help increase efficiency and create a happier workplace. This is another reason why reward systems are important in business organisations. Types of Reward Systems There are several ways to classify rewards; the three most common types are as follows: Intrinsic Rewards Vs Extrinsic Rewards- Intrinsic rewards are the personal satisfaction you get from the job itself eg having pride in your work, having a feeling of accomplishment or being part of a team. If an employee experiences feelings of achievement or personal growth from the job, this would be labelled as an intrinsic reward. Extrinsic rewards would include money, promotions and other benefits. Extrinsic rewards are external to the job and come from an outside source, usually management. If an employee receives a salary increase or a promotion, this would be labelled as an extrinsic reward. Financial Rewards Vs Non-Financial Rewards- Financial rewards are those that will enhance the employees financial well-being directly eg bonus, increase in wages and profit sharing schemes. Non-financial rewards do not enhance the employees financial position directly but make the job more attractive. Some of the Non-financial rewards that a business organisation offer might include-an attractive pension scheme, access to private medical care, help with long-term sickness, crà ¨che facilities, counselling services, staff restaurant etc. Performance-Based Rewards Vs Membership-Based Rewards- The rewards that a business organisation gives to their employees can be based on either their performance or membership criteria. Performance-based rewards are exemplified by the use of commissions, piecework pay plans, incentive schemes, group bonuses, merit pay or other forms of pay for performance plans. Membership-based rewards would include cost of living increases, benefits and salary increase, seniority or time in rank, credentials or future potential. Case Study Tom Warner owned a plumbing, heating and air-conditioning business in Montgomery County,Maryland. In the early 1990s, he faced a major problem. His main customers were commercial property management businesses and they wanted to cut costs. In order to do this; these commercial property management businesses decided to end their contract with Tom Warner and hire their own handymen. Tom Warner didnt want to lay off any of his 250-person workforce. He decided to reconstruct his workforce into territories. He assigned each worker their own territory and told them to operate their territory as if they were running their own business. He put each area director through training in sales techniques, budgeting, negotiating, cost estimating and how to handle customer complaints. Warner believed that if he had technically superb, friendly, and ambitious employees, they could successfully operate like small-town handymen, even though they would be part of a large organisation. Tom Warners programme proved to be very successful. The area directors developed a strong sense of pride and ownership in their territories. Each employee was able to schedule their own work, handle their own equipment, develop their own estimates and advertising campaigns. These were the rewards that each employee desired. Tom Warners programed increased the employees wages. A typical employee working for Warner before he introduced the programme was earning $60,000.In the first year of the programme that employee was earning $100,000.In the second year he was earning $125,000. From a reward point of view, Warners employees are extremely happy and Tom Warners business grew by more than 200 per cent in 24 months. Literary Review According to the book Human Resource Management in Ireland 3rd edition by Patrick Gunnigle, Noreen Heraty and Michael j. Morley: Schuler (1995) outlines a number of core objectives that a business organisation should have in relation to the reward package that they offer. Schuler states that in order for a business organisations reward package to be successful it must meet the following objectives: It should attract potential employees- along with the organisations human resource plan and recruitment and selection techniques the reward package should make potential employees want to work there. The reward package including its mix of pay, incentives and benefits should serve to attract suitable potential employees. It should assist in retaining good employees- the reward package must be perceived internally by the employees as fair and equitable and it should be perceived externally as competitive. Internally the employees should feel happy with the reward package and they should know that in comparison to other businesses it is a very competitive reward package so they wont want to leave and seek employment elsewhere. It should motivate employees- the reward package should help and assist motivating employees to work harder. By linking rewards to performance it should motivate employees to work harder as there is an incentive element. It should contribute to human resource and strategic business plans- the reward package should create a rewarding and supportive climate to work in and therefore it should be perceived as an attractive place to work. This will benefit the business as it will be attracting the best applicants. Reward management in business organisations is extremely important as the reward package helps to attract employees, retain employees and influence performance and behaviour at work. According to the book People Management and Development; Human Resource Management at Work by Mick Marchington and Adrian Wilkinson: Lawler (1984) feels that a reward system within the business organisation can influence a number of HR processes and practices, which then have a direct impact on the organisations performance as a whole. Influence recruitment and retention: Lawler states that any business organisations that have a reward system in place will attract and retain the most people. If better performers are rewarded more highly than poor performers. This also will have an effect on recruitment and retention, so performance-based systems are more likely to attract high-performers. For Example: If a business organisation rewards their employees with high wages, they will attract more applicants which will allow the business more of a choice over selection and hiring decisions. This hopefully will reduce labour turnover in the organisation. Influence Motivation: Employees see that by having a reward system in place, it puts an importance on various activities and tasks. Reward systems therefore have a motivational impact on the employees. However the management must integrate the reward system with the behaviour they expect from the employees. Influence Corporate Culture: The way in which the employees are rewarded will have a huge influence on the corporate culture of the organisation. For example: If a business organisation has a reward system in place that provides benefits for long-serving staff, this will likely shape the existing culture into one where loyalty is seen as central to the business organisations ideology. In contrast, if a business organisation has a reward system in place that rewards the employees for innovative behaviour and ideas, this is more likely to shape the businesses corporate culture into one where creativity and innovation is important. Cost as an influence: Cost is a huge factor and influence in the reward system. Some business organisations may not be able to afford to set up and maintain the reward system; it may be too costly for them. On the other hand, some business organisations may not want to waste the money on a reward system. This may demotivate the employees as they will think that not worth it and this will have a direct impact on their performance in the organisation which in turn will in turn have a direct impact on the organisations performance as a whole. According to the book Human resource management in Ireland 4th edition by Patrick Gunnigle, Noreen Heraty and Michael j. Morley: Lawler (1977) highlights that in order for reward management to be successful the reward system needs to have the essential characteristics: Reward level- In order for reward management to be successful, the reward package must satisfy the employees basic needs for survival, security and self-development. Individuality- Along with satisfying the employees basic needs, the reward system should be flexible enough to meet the employees varying individual needs. Internal equity- The rewards must be seen as fair when compared to others in the business. The criteria and reasons for the allocation of rewards to employees should be equitable and clear to everyone in the organisation .The reason behind the allocation of rewards to employees should be communicated and accepted by all parties. The rewards should be applied consistently throughout the organisation. External equity- The rewards must be seen as fair when compared to those offered for comparable work outside the organisation. Trust- In order for reward management to be successful in the organisation, the management and the employees must believe in the reward system 100 per cent. The employees must believe and accept that will receive rewards when they meet the relevant criteria. The management should trust that the employees will perform at a high standard and the best to their ability in return for rewards. According to Lawler (1977) in order for a business organisation to be successful in reward management, he believes that a reward system must have the characteristics listed above. According to the book Human resource management 6th edition by De Cenzo and Robbins: Armstrong and Murlis (1998) offer some broad distinctions between the main types of reward system: Gain Sharing Schemes-the pay of a group of workers is linked to improvements in internal company productivity. Employee Stock Ownership Schemes (ESOPs)-The business organisation offers company stock (at a lower rate than normal) to certain employees. Profit-Sharing Schemes-The business organisation gives a certain percentage of the end of year profits to the employees. Skill-Based Pay Schemes-The business organisation rewards the employees with pay on the basis of job-related skills or competencies. Individual Incentive Schemes-The business organisation rewards the employees for reaching or exceeding specific established performance criteria. Piece- rate schemes are the most obvious form of individual performance related rewards. Group Incentive Schemes-The business organisation rewards groups of employees with the same principles they use on individual schemes. Used most commonly when group work or team work is present in the business organisation. Conclusion To conclude I am going to give a brief run through the topics I have covered throughout this report. I defined and explained the meaning of what reward management is and how organisations manage rewards in organisations. I then went on to discuss the importance of reward management within organisations, by doing this I pointed out the advantages of having reward systems in an organisation. These benefits included mutually beneficial, increases motivation, improves morale, increases the employees loyalty to the organisation, improves teamwork and reduces absenteeism. I looked at commonly used reward schemes. I looked at a case study about Tom Warner was forced to reward his employees with a huge amount of responsibility; however it had an extremely successful outcome for him. I then looked at the main aims that every reward system should have; attract potential employees, assist in retaining good employees, motivate employees, contribute to human resource and strategic business plans. I explained the direct impact a reward system can have on the organisation as a whole ie influence o n performance, influence on motivation, influence on the corporate culture. I looked at and explained the essential characteristics a reward system must have in order to be effective. This is important for management when designing their reward system. They should look at and evaluate their current reward system and make sure it possesses the right characteristics. I then differentiated between the most common types of reward schemes according to research I found on Armstrong and Murlis point of view on reward systems.

Honour & Shame Essay

One Sunday morning I was driving my children back from their regular soccer game. It was a warm summer day, sun shining ever so brightly, making the uneven town picturesque. As I drove along in my Holden with rigid brown seats and the windscreen wipers that didn’t work, I looked over to my sixteen year old daughter sitting next to menodding and shaking her head rhythmically to, in her words, ‘legendary’ music band One Direction. An image of Asreen flashed through my mind†¦ †¦Ã¢â‚¬Å"Kiran?† the voice on my mobile phone was barely more than a whisper. â€Å"Kiran? Is that you?† .The train ride back home was a typical for Friday eveningIt was very busy Friday evening train ride back from work, â€Å"Are you able to speak up a little?† I asked, raising my own voice overagainst loud chatterschatters from fellow passengers and rattling noise from the train. â€Å"I found your number in Indus Age, My – † the line went suddenly went dead. Indus Age is a local monthly newspaper. iIt has largest circulation to Indian and South East Asian community in the country. I was interviewed a week ago concerning about my plight with honour based violence. After two years of lengthy legal proceeding over evidence of injury which included tampered medical records I managed to get a divorce. I was sure that such crimeshonour based violence against women was prevalent and practiced behind closed doors, after my divorce I wanted to assist other women in similar situation and have my phone number published in the newspaper. I thought I lost her but then, few minutes later, she was back. â€Å"Sorry I had to hang up I thought someone was coming. My parents are forcing me to marry a 35 year old man who I don’t even know. I am a prisoner in my own house. I can’t take it any longer. I need help.† She stopped for breath. â€Å"Please help me,† she said in a trembling voice. She sounded frantic; it seemed that she was at the mercy of her family. I didn’t know who I was talking to but I knew I had to help. I spoke quickly, â€Å"Can you get out? There are all sorts of help available if you can get out.† I knew from my own experience that if a girl has made up her mind to run she usually finds a way to do it. This woman could be anywhere in the country but she was desperate and I had to reassure her. â€Å"There is help for you,.† I said. â€Å"There are women refuge houses, people to support. I would support you. You’ll be okay.† â€Å"But how†¦Wait, that’s Dad. He’s coming. I have to go† Her phone went dead. I felt anxiousiety, my pulse shot up as I tried as best I could to get on with my daily household choresroutine and parental responsibilities. Later in thethat evening while I was preparing dinner my phone rang again. I tried hard to understand but couldn’t make out anything except the gasping sound panting. I turned off my range-hood and enquired, â€Å"Hello?† â€Å"It’s me, Asreen,† she spoke, her voice penetrating as if she was right next to me. â€Å"I did it, I ran away† â€Å"Where are you?† â€Å"Redfern.† â€Å"Asreen, you have to call the police. DailDial 000† I had put my phone on speaker as I washed my hands. â€Å"No, I don’t want police. My family will never see me again. My community will disown me,† she said claimed almost hysterical. I could imagine why Asreen didn’t want police to be involved. She was in a state of fear and frustration. Her parents who loved her dearly until very recently changed overnight and now consider family’s honour more important than that of their daughter’s well-being and happiness. â€Å"Meet me at Redfern railway station in 45 minutes,.† I said cleaning up my kitchen. â€Å"Please don’t be late,.† she hung up. I called on my children and explained them that I need to go out on an emergency. I drove as fast as I could past the motorway speeding up to maximum limit. I reached Redfern at 8 p.m. it was crowded, people pushing one another to get ahead in line. Few country trains hurried past while the intercity trains stopped at the platform for passengerss dark and deserted. I walked across the automatic ticket machine to find myself staring at a tall slim woman leaning against the closed door humming what I could understand a very popular song. from Justin Beiber. She looked no more than sixteen dressed in a traditional outfit her head was covered in a veil. I caught her eye and she smiled and then waved at me. â€Å"Kiran,† she said enthusiastically. â€Å"Yes.† I walked closer I could see her eyes swollen lips dried smeared make up over her face. I offered her a bottle of water and walked with her to my car. No one spoke, the two minute walk felt like an eternity. Breaking the silence she spoke softly, â€Å"Thank – thank you Kiran. You saved my life. I read your story and only after I spoke to you I found courage to leave my house.† I didn’t know what to say, I was in a state of shock. I felt rage I could barely focus on my driving I wanted to say something. Asreen continued, â€Å"There were bolts on all doors and someone from the family was always home. I didn’t know how to get out. And if I did, where would I go?† We talked about family, food, school, fashion and many other issues on our way back. We talked as if we were best friends and had known each other for many years. I introduced Asreen to my children Maya and Vicky and offered her rice and lamb curry for dinner. It was close to midnight she looked very tired and fell asleep as soon as she sat on the lounge. I imagined her situation; it was her mother who arranged her marriage. She grew up knowing that one day the subject of her marriage would come up but didn’t expect it when she was sixteen. She was one of the smartest girls in her school; she wanted to become a psychiatrist. One day when her parents woke her up and told her that she was going to get engaged Asreen said bluntly, â€Å"But I don’t want to.† For the next few days I enquired at women’s refuge centre, department of community services, legal aid and other community based organisations. What followed was another court proceeding lasting more than 12 weeks. I became Asreen’s foster parent while she continued her education. Later that year Asreen and I started Honour to help other women from South East Asian family facing honour based violenceI sat next to her contemplating on the events of the day. I wanted to help Asreen and reach out to other women in similar situations confronting criticism and oppression from inside their communities and often close family members for not being obedient to the traditional rules set by men for thousands of years. â€Å"Are you alright?† Asreen said waking up suddenly. I realised that I accidentally dropped my glass on the wooden floor breaking it into pieces. â€Å"Why can’t I live like any other sixteen year old girls? Why can’t I have boy-friends like girls from my school?† she cried while cleaning up broken pieces of glass. It was close to two, I was so exhausted I could barely feel any strength in my legs. I could hear Asreen’s voice slowly fading away. With my eyes closed I tried to seek explanation for such acts against own daughter. The issue of status of women is always in question in a patriarchal society. For thousands of years people from Indian sub-continent had considered daughter a painful burden, a potential source of shame to her father. Family is vital principal group and marriage hallowed as sacred. Women are deprived of their freedom and those who rebel or go against the norms faces threat the people of the community so much so that they are even killed for honour. †¦perhaps this comes out as it makes it like a newspaper article, not a narrative. †¦ As we arrived home I hugged my daughter tightly and said with tears running down my cheeks, â€Å"I love you.† The time frame here doesn;’t work, you’ve already taken the story on years but now go back to the present†¦

Treatment of Solid Tumors including Metastatic Breast Cancer - Free Essay Example

Sample details Pages: 9 Words: 2828 Downloads: 5 Date added: 2019/02/06 Category Medicine Essay Level High school Topics: Breast Cancer Essay Did you like this example? Citizen Petition Reconsider Issuance of RMAT Designation for Therapeutic Armed Activated T Lymphocytes Treatment of Solid Tumors including Metastatic Breast Cancer The undersigned submits this petition under to request the Commissioner of Food and Drugs to reconsider issuing a Regenerative Medicine Advanced Therapy (RMAT) designation to autologous T-lymphocyte therapies for patients with malignant advanced stage solid tumors, specifically stage IV metastatic breast cancer, on the basis that it can meet an unmet medical need as substantiated by new clinical trial evidence resulting from trial involving OKT3 x Herceptin Armed Activated T Cells, Low Dose IL-2, and GM-CSF, as relevant to section 506(g) of the Federal Food, Drug, and Cosmetic Act (FDC Act), as added by section 3033 of the 21st Century Cures Act (Cures Act). A. Action Requested The Expedited Programs for Regenerative Medicine Therapies for Serious Conditions Draft Guidance for Industry states that in order for an investigational drug to receive a Regenerative Medicine Advanced Therapy (RMAT) designation it must fulfill the following criteria1:. Don’t waste time! Our writers will create an original "Treatment of Solid Tumors including Metastatic Breast Cancer" essay for you Create order It meets the definition of regenerative medicine therapy (see section I of [draft guidance] document) It is intended to treat, modify, reverse or cure a serious condition; and Preliminary clinical evidence indicates that the regenerative medicine therapy has the potential to address unmet medical needs for such condition The Expedited Programs for Regenerative Medicine Therapies for Serious Conditions Draft Guidance for Industry states that the definition of regenerative medicine therapy is1: †¢ Cell therapies, therapeutic tissue engineering products, human cell, and tissue products, and combination products using any such therapies or product And Gene therapies, including genetically modified cells, that lead to a durable modification of cells or tissues may meet the definition of a regenerative medicine therapy. In said draft guidance, unmet medical need is defined as: †¢ An unmet medical need is a condition whose treatment or diagnosis is not addressed adequately by available therapy. An unmet medical need includes an immediate need for a defined population (i.e., to treat a serious condition with no or limited treatment) or a longer-term need for society (e.g., to address the development of resistance to antibacterial drugs). We, the undersigned, petition the Commissioner of Food and Drugs to reconsider issuing an RMAT designation to autologous T-Lymphocyte therapies for solid tumors, and we offer new clinical trial data from the trial named Treatment of Stage IV Breast Cancer With OKT3 x Herceptin Armed Activated T Cells, Low Dose IL-2, And GM-CSF (NCT00027807) as clinical evidence that indicates the potential to meet an unmet medical need thereby fulfilling the requirement â€Å"that the regenerative medicine therapy has the potential to address unmet medical needs for such condition† listed in The Expedited Programs for Regenerative Medicine Therapies for Serious Conditions Draft Guidance for Industry.1 B. Statement of Grounds Cancer is the second leading cause of death in the United States, with breast cancer following lung cancer as cancers with the highest mortality rates. While there have been a number of cancer therapies found to either treat or cure early-stage cancers, late-stage solid t umors tend to elude these therapies, and as a result, there are very few therapies that can attempt to treat them. Breast cancer is a disease that affects 1 out of 8 women, with 10% of all cases eventually metastasizing 5 years after the patient has received therapy for it.2,3 Many patients receive a form of therapy for breast cancer that may involve surgery with adjuvant chemotherapy, or even in the case of high-risk breast cancer high-dose chemotherapy with a stem cell transplant. Unfortunately, relapse rates after these therapies remain high, and often times the cancer has metastasized at that point. 55-87% of women who have primary breast cancer with 10 or more axillary lymph nodes relapse within 5 years of when they were diagnosed. 4 Stage IV metastatic breast cancer represents an unmet medical need, as it is not being met by current treatments or therapies. Additionally, there is research that indicates that combination therapies would work in a more effective manner against metastatic breast cancer than a single therapy.4 Some of the therapies that are currently being considered in clinical trials involve chimeric T cells, others are looking at armed activated T cells (aATC), and others are considering antibodies.3,4 The trial in question that we are using as the basis for our petition analyzes the combination immunotherapy consisting of HER2Bi armed activated T cell infusions, IL-2, and GM-CSF.3,4 The HER2Bi or BsAb consists of two monoclonal antibodies that were heteroconjugated and used to arm the T cells. These two monoclonal antibodies were Trastuzumab (Herceptin, Genentech) and an anti-CD3 (OKT3, Centocor, Ortho-Biotech) that were prepared under Current Good Manufacturing Practice (cGMP) regulations as enforced by the Food and Drugs Administration.5 Trastuzumab or the brand name Herceptin has been approved for use in the treatment of breast cancers that overexpress the HER2/neu receptor, which is a tyrosine kinase transmembrane epidermal growth factor receptor family member.3 The HER2/neu receptor is overexpressed in many breast, ovarian, gastric, lung, prostate and oral cancers. This overexpression of HER2/neu makes it an ideal therapeutic target. 3,4 Moreover, women with HER2- cancers have fewer therapeutic options, but the trial demonstrated a positive result in those patients as well, which further supports the claim that this therapy can fulfill an unmet need for a serious condition. The OKT3 or anti-CD3 antibody targets the CD3 T cell receptor. Together they form the HER2 Bispecific antibody (HER2Bi), which is engineered to direct cytotoxicity at tumor cells that overexpress the HER2/neu receptor. In this trial, they combined the HER2Bi with Interleukin-2 and the granulocyte macrophage colony-stimulating factor (GM-CSF). Interleukin-2 is a cytokine produced by leukocytes, which increases the growth and activity of other T lymphocytes and B-lymphocytes, as well as affecting the development of the immune system. GM-CSF is another cytokine that helps create additional white blood cells specifically granulocytes, macrophages, and cells that become platelets.3 The primary endpoints of the trial were to determine the safety and maximum tolerated dose. The highest dose that was administered consisted of 20 x 10^9 aATC, and the maximum tolerated dose level was not reached, nor were there any dose-limiting toxicities observed at this dosage level. The secondary endpoints of the study were assessments of response rates: complete response (CR), stable disease (SD), partial response (PR), and no evidence of disease (NED), time to progression (TTP), and overall survival (OS). TTP and OS were measured from the date of enrollment in the trial.3 The study consisted of 23 women with stage IV metastatic breast cancer, of both HER2+ and HER2- patients, in a traditional 3+3 dose escalation design. One patient in the study died from digoxin toxicity related congestive heart failure, and the autopsy of the patient did not show any myocardial T cell infiltrates. The remaining 22 patients were evaluated at 14.5 weeks. Results showed 59.1% (13/22) of patients had SD or better (NED, PR, or SD) and 40.9% (9/22) of patients had PD. The overall survival rate of the 22 evaluable patients was 36.2 months. Within the overall survival rate, the breakdown was an overall survival rate of 57.4 months for HER2+ and 27.4 months for HER2-. The results of t his study showed that there were no major negative side effects associated with this aATC therapy. There were no cytokine storms, which has been a problematic side effect in past T-cell therapies, but there were however what the researchers designated cytokine flurries.3 And while a number of patients had to have their aATC washed to reduce side effects, not a single patient had to have their dose lowered. The main side effects observed were grade 3 chills and grade 3 headaches. The incidence of chills was 8.6%, 20.8%, and 43.1% at dose levels 1, 2, and 3, respectively. The incidence of headaches was 3.1%, 8.3%, and 19.6% at dose levels, 1, 2, and 3. Two patients were hospitalized to manage other side effects that included nausea, hypotension, vomiting, and dehydration, but after the successful resolution of these side effects they resumed the trial and continued to receive the infusions of the aATCs. In this trial, the innate cytotoxicity of T cells was redirected by the formation of the aATC (can be prepared with either CD4+ or CD8+,). Normal patients and cancer patients who rec eived this combination therapy of aATC with HER2Bi combined with IL-2 and GM-CSF both exhibited specific cytotoxicity towards target cells, and the cytotoxicity increased as the dosage amount of the aATC increased. 4 The cytotoxicity persisted for more than 54 hours towards the target cells, and other cytokines including IFN-?, TNF- ?, and GM-CSF were induced when the tumor antigen was bound to the aATC.4 This capability of the aATC to induce IFN-? when it binds to a tumor antigen may be clinically beneficial, as other studies have already shown in preclinical and clinical studies that cytotoxic T cells produce IFN-? and that IFN-? is tumoricidal.6,7 Another advantage of this particular therapy is that it does not require large quantities of HER2Bi unlike other infusional therapies that do require large doses of bispecific antibodies. In fact, billions of armed activated T cells can be armed with just milligrams of the HER2Bi antibody. The aATCs proved to be cytotoxic even towards breast cancers that had a low expression level of HER2 receptors, such as the MCF-7 breast cancer cell line. 4 The SK-BR-3 cell line, which has higher levels of HER2 receptors, had even more susceptibility to cytotoxic effects from the aATC, causing greater amounts of tumor cells to be lysed.4 This indicates that even a small amount of the combination of the anti-CD3 and anti-HER2 antibodies that are used to arm activated T cells can mediate high levels of cytotoxicity that is directed at tumor cells. Even when the levels of the tumor antigen expression is low as in the case of the MCF-7 cell line, and are able to mediate cytotoxicity in vivo for many days after infusion of the aATCs.4 The fact that that the maximum tolerated dose was not reached, that there were no dose-limiting toxicities, nor was there any evidence of a life-threatening cytokine storm, and all other side effects were relatively mild and successfully resolved supports the idea that multiple infusions of aATC in combination with IL-2 and GM-CSF were both safe and technically feasible. The results of this study showed that combining antibody targeting and T cell-mediated killing could greatly augment cytotoxicity that can be directed towards cancer cells and provides a rationale to develop new nontoxic immunological approaches that can eradicate any residual tumor cells. 4 Ultimately the researchers have concluded that multiple intravenous infusions of the HER2Bi aATC are feasible, and most of them would go to the lungs and then migrate to, and settle, in the spleen, bone marrow, and liver. This is advantageous because many breast cancers metastasize to these locations, which would make the targeting of these metastases by the aATC easier. The authors of this study had intended on moving forward with a Phase II trial, and the results supported the rationale for moving forward. However, this trial ultimately did not move forward to a Phase II trial, but it did provide the rationale for further clinical trials on similar immunotherapies. A separate trial studied the HER2Bi armed activated T cells in HER2+ colorectal cancer, both in vitro and in vivo. The aATC exhibited increased cytotoxicity against HER2+ tumor cells, and showed significant suppression of colorectal carcinoma cells in comparison to unarmed ATC. Similar to the above-mentioned breast can cer trial, researchers were able to reach these results by using a very low dose of HER2Bi, which eliminated previously seen side effects of Herceptin which included cardiotoxicity that manifested as left ventricular dysfunction and heart failure in a different research project. 8 Much like the trial conducted on metastatic breast cancer, the data in this trial also showed that aATC induced IFN-? secretion levels that were higher than those induced by unarmed ATC, As such the researchers of this trial concluded that â€Å"HER2Bi?armed ATCs with anti?tumor effects may provide a promising immunotherapy for colorectal carcinoma for the future†.9 Another Phase I trial examined the HER2Bi aATC in metastatic castrate-resistant prostate cancer. They also found an increased level of IFN-? as well as no dose-limiting toxicities that were associated with this immunotherapy. 3 out of 7 patients in this trial showed a decrease in their prostate-specific antigen (PSA) and pain levels. The results of this trial provided strong rationale to continue onto a Phase II trial.10 Furthermore, there is another trial in progress that is also researching HER2Bi armed activated T cells combined with pembrolizumab, which blocks the PD-1 pathway, in patients with metastatic bre ast cancer. The trial (NCT03272334), sponsored by the University of Virginia is currently recruiting patients, but we look forward to seeing if it reaches its primary endpoints, which are evaluating the side effects and best dose for this treatment without reaching any dose-limiting toxicities. 11 While we need to keep a watchful eye on more severe side effects such as the possibility of life-threatening cytokine storms in future trials, the fact that the trial on metastatic breast cancer only had cytokine flurries is an encouraging sign. Novel immunotherapies including T-cell therapies are making headway as therapeutics for solid tumors and is a field that holds great promise because it can boost patients preexisting tumors responses, in a nontoxic manner, specifically in tumors that have no current successful therapy options.12 We would request that the Commissioner of Food and Drugs reconsider issuing an RMAT designation to autologous T-Lymphocyte therapies for solid tumors based on the preclinical trial data as covered above from the trial Treatment of Stage IV Breast Cancer With OKT3 x Herceptin Armed Activated T Cells, Low Dose IL-2, And GM-CSF (NCT00027807). We feel that this data, along with the fact that metastatic breast cancer is a serious condition that has very few therapies available to treat, and as such is an unmet medical need, fulfills all the requirements of an RMAT designation which are listed as: It meets the definition of regenerative medicine therapy (see section I of [draft guidance] document) It is intended to treat, modify, reverse or cure a serious condition; and Preliminary clinical evidence indicates that the regenerative medicine therapy has the potential to address unmet medical needs for such condition C. Environmental Impact The petitioner hereby states that the action requested in this petition will have no environmental impact and that, therefore, an environmental assessment is not required under 21 CFR 25.30. D. Economic Impact Not applicable; this section has not been requested by the Commissioner. E. Certification The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition. References 1. Food and Drug Administration. (2017, November). Expedited Programs for Regenerative Medicine Therapies for Serious Conditions Draft Guidance for Industry. Retrieved December 11, 2018, from https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/cellularandgenetherapy/ucm585414.pdf 2. American Cancer Society. (n.d.). How Common Is Breast Cancer? Retrieved from https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html 3. Lum, L. G., Thakur, A., Al-Kadhimi, Z., Colvin, G. A., Cummings, F. J., Legare, R. D., . . . Rathore, R. (2015). Targeted T-cell Therapy in Stage IV Breast Cancer: A Phase I Clinical Trial. Clinical Cancer Research, 21(10), 2305-2314. doi:10.1158/1078-0432.ccr-14-2280 4. Sen, M., Wankowski, D. M., Garlie, N. K., Siebenlist, R. E., Epps, D. V., Lefever, A. V., Lum, L. G. (2001). Use of Anti-CD3 Ãâ€" Anti-HER2/neu Bispecific Antibody for Redirecting Cytotoxicity of Activated T Cells Toward HER2/ neu Tumors. Journal of Hematotherapy Stem Cell Research, 10(2), 247-260. doi:10.1089/15258160151134944 5. Center for Drug Evaluation and Research. (n.d.). Manufacturing Facts About the Current Good Manufacturing Practices (CGMPs). Retrieved from https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm 6. Ogawa M, W-G Yu, K Umehara, M Iwasaki, R Wijesuriya, T Tsujimura, T Kubo, H Fujiwara and T Hamaoka. (1998). Multiple roles of interferon-gamma in the mediation of interleukin 12-induced tumor regression. Cancer Res 58: 2426–2432. 7. Quian J-H, JA Titus, SM Andrew, D Mezzanzanica, MA Garrido, JR Wunderlich and DM Segal. (1991). Human peripheral blood lymphocytes targeted with bispecific anti- bodies release cytokines that are essential for inhibiting tumor growth. J Immunol 146:3250–3256. 8. Babar, T., Blomberg, C., Hoffner, E., Yan, X. (2014). Anti-HER2 Cancer Therapy and Cardiotoxicity. Current Pharmaceutical Design,20(30), 4911-4919. doi:10 .2174/1381612820666140604145037 9. Han, H., Ma, J., Zhang, K., Li, W., Liu, C., Zhang, Y., . . . Gao, B. (2014). Bispecific anti-CD3 x anti-HER2 antibody mediates T cell cytolytic activity to HER2-positive colorectal cancer in vitro and in vivo. International Journal of Oncology,45(6), 2446-2454. doi:10.3892/ijo.2014.2663 10. Vaishampayan, U., Thakur, A., Rathore, R., Kouttab, N., Lum, L. G. (2015). Phase I Study of Anti-CD3 x Anti-Her2 Bispecific Antibody in Metastatic Castrate Resistant Prostate Cancer Patients. Prostate Cancer,2015, 1-10. doi:10.1155/2015/285193 11. ClinicalTrials.gov. National Library of Medicine (U.S.). (n.d.). Her2-BATS and Pembrolizumab in Metastatic Breast Cancer (Breast-47)r. Retrieved from https://clinicaltrials.gov/ct2/show/NCT03272334 12. Melton, C. (2018, November 28). Novel T-Cell Therapies Make Inroads Into Solid Tumors. Retrieved December 17, 2018, from https://www.onclive.com/publications/oncology-live/2018/vol-19-no-22/novel-tcell-therapies-make-i nroads-into-solid-tumors?p=1

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