Prepare an 11 page on criminal justice management and administration Research Paper

Prepare an 11 page on criminal justice management and administration - Research Paper Example The creation of organized policing marks the initiation of the development of administration of policing. The current policing system, which is paid by the government and is there to safe guard the interest of civilians, took place during 1829. During 1829, after a very lengthy and poignant debate, Metropolitan police act became a part of parcel of the English legal system. Before 1829, the activities conducted today by police and law enforcement agencies were conducted by ordinary civilians, volunteers, employees of justice system in America and England. When the law enforcement system was in the hand of these individuals, it provided very satisfactory results until the industrial revolution, during the revolution the crime rate of America and England escalated at a very fast pace. Under the Metropolitan police act, Sir Robert Peel gained the authority to assemble a force of policemen for the metropolitan region of London; Sir Robert Peel took this opportunity and instantly hired 10 00 individuals as cops. Sir Peel along with two police commissioners recognized as Robert Mayne and Charles Rowan experienced the same issues and challenges in managing and organizing the police station and its members as faced by commissioners and managers of police station in current settings. These issues mainly concerned communication and managing a huge police force, these issues included: how to manage and coordinate the activities of a very huge police force, how to ensure that all directions and protocols are being followed and how to inform a huge number of police men about their duties and roles. The solution to some of these challenges is available in the Peelian Reforms, according to these reforms; police system should be managed and directed as the military system, police should be provided proper training and police members should be retained, individuals interested in operating as policemen should be hired on probationary basis and those who

advantages and disadvantages of vaccinations

advantages and disadvantages of vaccinations Introduction Vaccination or immunization is a means of providing specific protection against many common and damaging pathogens by stimulating an organisms immune system to either produce humoral antibodies against the pathogen (or toxins produced by the pathogen) or T cells that can provide cell-mediated immunity (Ghaffar and Haqqi, 2010). Though ancient scientists did mention about prevention of infectious diseases through immunisation, it was Edward Jenner who developed the first vaccine. The vaccine was developed against small pox in the year 1796. The next vaccine came up almost a century later by Louis Pasteur. The vaccine was anti-rabies vaccine and was first used in 1885. The development of anti-rabies vaccine kindled hope for prevention of other infectious diseases, leading to immense research and development of several other vaccines (Shah, Nitin and Kukrej, 2007). The term vaccination was coined by Edward Jenner. Vaccination is the method of causing immunity to a disease by administration of an antigenic material into the body. The term vaccination is used interchangeably with immunity, which is derived from the Greek word immune which means to be protected. Several vaccines have been developed which either prevent or ameliorate several infectious diseases. The first disease for which vaccine was developed is small pox. Infact, even before Edward Jenner developed a proper vaccine against small pox, people in India and China inoculated fluids taken from small pox vesicles of patients suffering from mild course of disease. Despite the marked usefulness of vaccination in the prevention of infectious diseases, vaccination is still a much debated topic and has several medical safety, ethical, political and religious implications. In this essay, vaccination, types of vaccines, implications of vaccination and novel vaccines will be discussed with reference to recent literature. Mechanism of action of vaccines Vaccines act by developing immunity to the particular disease by inducing the development of antibodies. There are basically 2 types of immunity, innate immunity and acquired immunity. Innate immunity develops after actual exposure to the disease organism. Acquired immunity develops after exposure to vaccination. Acquired immunity may be active or passive immunity. Active immunity is that immunity that develops following exposure to antigenic stimulus, while passive immunity develops after direct injection of antibodies in the form of either sera or immunoglobulins, inside the body. The type of immunity rendered by vaccination is active immunity. Passive immunity confers temporary protection. The antibodies are taken from individuals or animals who are already infected with the disease. Active immunity renders long term protection (Ghaffar and Haqqi, 2010). A pathogenic infectious agent induces disease and at the same time triggers the immune system of the host to develop antibodies against the disease. These antibodies help in the recovery of the host from the disease and continue to offer protection to subsequent infections from the same pathogen. This principle has been used for vaccination. Through vaccination, antigens which mimic the original pathogen of the respective disease are introduced into the body. The antigens only trigger the immune response, but do not cause the disease. The immune response may be cell-mediated or humoral, or even both, depending on which series of T helper lymphocytes are stimulated. Stimulation of Th1 series leads to lymphocytic response, while stimulation of Th2 series leads to humoral response. The timing of vaccine is based on several factors, the most important of which is the susceptibility of the disease, reactogenecity and presence of maternal antibodies. Thus, BCG and OPV vaccines are given at birth, because the child can get exposed to tuberculosis and polio at birth due to absence of maternal immunity and risk of susceptibility at this age. Similarly, vaccines against diphtheria, tetanus, pertussis, hemophilus influenza are given in early childhood for maximum reactogenecity and protection against the diseases (Shah, 2007). Many vaccines are given together and this makes sense because concurrent administration of more than one vaccine does not interfere with the take of one another. It is important to give atleast 4 weeks time before the administration of second dose of the same vaccine (Shah, 2007). Types of vaccines The antigens in vaccines may be either live organisms, modified exotoxins, subunits of organisms or whole inactivated organisms. There are basically two types of vaccine: live vaccines and inactivated vaccines. In live vaccines, the pathogen, either virus or bacteria is weakened or attenuated. They act by causing non-clinical and self-limiting disease, thus triggering the immune system and inducing immunity. On administration, the pathogens multiply in the host and trigger immune response. The pathogens do not cause any disease because they are attenuated. However, in immunocompromised patients, live vaccines can cause disease. One major advantage with live vaccines is that a single dose is sufficient to confer long-term immunity. Examples of live vaccines are oral polio vaccine, measles vaccine, mumps vaccine and yellow fever vaccine (Ghaffar and Haqqi, 2010). Inactivated vaccines consist of either killed pathogens, subunits of pathogens or toxins released by pathogens. The killed vaccines are made up of pathogens which are grown in suitable culture, subsequent to which the pathogens, either bacteria or virus are killed either thermally or chemically with formaldehyde. More often than not, the polysaccharide immunogenic antigen is binded chemically with a protein molecule, to enhance the immunogenecity of the vaccine. Inactivated vaccines have to be given in multiple doses. The immunity is for a short period. Hence boosters doses are essential. Examples of inactivated virus vaccines are, hepatitis A vaccine, inactivated polio vaccine and rabies vaccine. Inactivated bacterial vaccines are whole cell killed typhoid vaccine and pertussis vaccine. Viral subunit vaccine is HBsAg vaccine. Toxoid vaccines are tetanus and diphtheria vaccines. Capsular polysaccharide vaccines are hemophilus influenza, typhoid Vi, pneumococcal and meningococcal vacc ines. In these vaccines, though the pathogens are destroyed and are not able to undergo replications, the capsid proteins, which are antigens are recognized by the immune system of the vaccinees, causing an immune response (Ghaffar and Haqqi, 2010). Bacterial subunit vaccine is acellular pertussis vaccine. Sub-unit vaccines are those which use purified components of the cell wall to initiate immune response in the vaccinee. Some of the examples of such vaccines are meningococcus, pertussis, hemophilus and pneumococcus vaccines. An interesting vaccine worth discussing at this juncture is the hepatitis-B vaccine which is developed by purification of the antigenic proteins that are manufactured subsequent to expression from a gene that is cloned into a vector like yeast (Ghaffar and Haqqi, 2010). Polysaccharide vaccines are basically weak antigens that are T-independent and hence cause IgM responses without development of immunologic memory that is critical for stable and long-term imm unity. In such vaccines, the immunogenecity is enhanced by conjugating the antigens with other proteins like meningococcus, hemophilus and pneumococcus that are T-dependent and induce immulogic memory (Ghaffar and Haqqi, 2010). The type of vaccination needed for a specific disease depends on the pathogenesis of the disease. For example, pathogens like diphtheria and tetanus cause the disease by releasing certain toxins called exotoxins. In these cases, antibodies which neutralise and prevent the binding of the exotoxin to respective receptors on the target cells prevent the disease. Thus vaccines against diphtheria and tetanus are toxoids. On the other hand, other pathogens have other pathogeneses, and consequently, antibodies which either react directly with the pathogen or eliminate the pathogen through either intracellular killing, complement mediated lysis or phagocytosis are essential. Pathogens like protozoa, viruses and intracellular bacteria which harbor inside the cells cannot be accessed by the antibodies and in such diseases, cells harboring the pathogens need to be destroyed (Ghaffar and Haqqi, 2010). Immunity conferred by a particular vaccine may be either lifelong or may last for few months. Examples of former type of vaccines are mumps, rubella, measles, tuberculosis, small pox and yellow fever. Cholera vaccine confers immunity only for few months and hence may be used only during outbreaks. Vaccines like diphtheria, tetanus, pertussis, polio and hemophilus influenza are part of primary immunization and must be given between 2-3 months of age. Mumps, measles and rubella vaccines must be given between 13- 15 months (Shah et al, 2007). Adjuvants Adjuvants are those chemicals which are added in the vaccine to enhance the immunogenecity of the vaccines. The most widely used adjuvants are aluminum salts, which are used in DPT. Other adjuvants which are in experimental stage include Freuds complete and incomplete adjuvants, certain oligonucleotides and some synthetic polymers. Certain bacteria also act as adjuvants and examples are Nocardia and BCG. Adjuvants increase immunogenecity by recognizing TOLL-like receptors, leading to activation of mononuclear phagocytes and induction of certain cytokines which enhance Th1 and Th2 responses (Ghaffar and Haqqi, 2010). Prophylactic and therapeutic immunisation Most of the vaccines are given as a prophylactic measures against their respective diseases, in the sense, the vaccines are given prior to exposure to the disease pathogen. In case of rabies and tetanus, the vaccination is given after exposure to the pathogen and this is known as post-exposure immunization. In some situations like tetanus, which has very short incubation period, both active and passive immunisation may be necessary post-exposure (Shah, 2007). Strains used Only particular strains are used for the development of any vaccine. Danish 1331 and Copenhagen are the commonly used strains in the BCG vaccine. Both are strains of mycobacterium bovis. In each 0.1ml, 0.1- 0.4 million live viable bacilli are present. Each vial of OPV vaccine contains more than one million inactivated viruses 1,2 and 3. Measles vaccine is derived from live attenuated Edmonston Zagreb strain that is grown in the human diploid cell culture. MMR vaccine vaccine contains 1000 TCID50 of measles, 5000 TCID50 of mumps and 1000 TCID50 of rubella virus . There are several strains from which measles vaccine is developed and they are Edmonston Zagreb, Schwarz, Moraten and Edmonston B strains. The strains are grown in human diploid cell culture and live attenuated viruses are used to prepare the vaccine. Of these, Edmonston Zagreb strain is the most commonly used strain. The mumps strains used are Urabe AM9, Leningrad-Zagreb, RIT 4385 or Jerryl Lynn. The efficacy between various strains is similar. The strains are grown in chick embryo or human diploid cell cultures. For preparing the rubella vaccine, the strain used is RA 27/3 vaccine strain. The virus is grown in human diploid or chick embryo cell cultures. Live attenuated form of the virus is used for preparation of the vaccine (Shah, 2007). Market availability BCG vaccines are available in multi-dose dark colored ampoules. Single dose vaccine is not available. The vials are available as 10-dose vial and 20 dose vial. The 10 dose vial has to be reconstituted with 0.5 ml of normal saline and the 20 dose vial has to be reconstituted with 1ml sodium chloride solution (Shah, 2007). Storage Storage again, depends on the type of vaccine. Constituents of BCG vaccine are freeze-dried and can be stored at temperatures between 2-80 degree centigrade for one year. The preparation is vacuum sealed. Hence the ampoule must be opened carefully after gradual filing to avoid sudden entry of air and spillage of the contents. Reconstitution is done using normal saline. The vaccine has no preservative and thus the chances of bacterial contamination are high. Hence after reconstitution, the vaccine must be used within 4 hours and the left over vaccine must be discarded. Until those 4 hours, the vaccine has to be stored between 2- 8 degree centigrade. Oral polio vaccine contains stabilising agent magnesium sulphate and hence is stable after refrigeration. At state and district levels, the polio vaccine stocks must be stored at -200 degree centigrade. In clinics, it must be stored in the freezer. While transferring the vaccine to an outreach facility, the vaccine must be carried in prope r vaccine carriers loaded with ice packs to maintain temperature between 2- 80 degree centigrade. DPT vaccine has to be stored between 2-8 degree centigrade. The vaccine should never be frozen and any vial accidentally frozen must be discarded. Measles vaccine can either be frozen or stored in refrigerator compartment (Shah, 2007). Shelf life Shelf life varies from vaccine to vaccine. While some vaccines can be stored for several years, some others can be stored only for few months. For BCG, when stored under recommended temperatures in dark place, the shelf life is 24 months. Measles vaccine is supplied as freeze-dried and the shelf-life is 1-2 years or even more (Shah, 2007). Reconstitution While some vaccines like DPT and typhoid are ready-to-use vaccines, others like BCG, measles and hemophilus influenza vaccines are freeze dried need to be reconstituted with appropriate solutions. BCG vaccine has to be reconstituted with sodium chloride solution provided by the manufacturers. measles vaccine must be reconstituted with sterile water. The vaccine does not have any preservative and hence strict asepsis must be maintained while diluting and aspirating contents. Reconstituted vaccine must not be stored (Shah, 2007). Administration Site and mode of administration depends on the vaccine. For BCG, the vaccine can be given anywhere. However, the recommended site is the convex aspect of the left shoulder for the purpose of easy visualization of the scar. The most preferred site of injection is the site at which the deltoid inserts into the humerus. Injection at sites higher than this level on the arm are likely to develop keloid (CDC, 2009). Oral polio vaccine is administered orally. The principle behind oral vaccination is that high gut immunity levels prevent transmission of the wild or pathogenic polio viruses. DPT, Hemophilus influenza, inactivated polio , hepatitis A, hepatitis B, typhoid, and other such vaccine shave to be given intramuscularly and measles, mumps, rubella and varicella vaccines need to be given subcutaneously. The seroconversion rates of the oral polio vaccine are variable. For polio viruses type- 1, 2 and 3, the seroconversion rates after one dose of vaccine are 73%, 90% and 70%. Hence multiple doses are recommended to achive seroconversion of 90- 95 percent for all the 3 types of vaccine (Shah, 2007). Advantages of vaccination The advantages of vaccines are innumerous and hence all countries in the world have adopted vaccination in their public health policy. infact, vaccination is the best means of prevention of certain infectious disease, especially in new borns, infants and childrens who are vulnerable to certain diseases. In many cases, even if the vaccinee develops the disease for which he or she is vaccinated, the course of the disease is usally mild and recovery is fast. Attenuated vaccines trigger all phases of immune system and confer more stable immunity. Most live attenuated vaccines need no boosters. they are cheap and immunity develops quickly. The drugs are easy to transport. Some live vaccines like oral polio vaccine are easy to administer, can be given orally (Shah, 2007). Vaccines are useful not only to prevent disease, but also to eradicate the disease from the globe. Small pox, a deadly poxy disease was eradicated from the world only through vaccination. Currently, polio is on the verge of eradication because of oral polio vaccines and inactivated polio vaccine. However, there is ongoing debate about the continuing use of these vaccines with respect to community protection, as against individual protection. This debate arises in the wake of rising cases of paralytic poliomyelitis and vaccine derived polioviruses with oral polio vaccine (Thacker and Shendurnikar, 2003). Researchers are under the opinion that once poliovirus is eradicated, vaccine derived poliomyelitis will surge if oral polio vaccine administration is continued. To gaurd the development of this problem, inactivated polio vaccine which is administered in the form of injection is being introduced even in developing and underdeveloped countries (Shah, 2007). Bacillus Calmette Guerin vaccine or BCG vaccine is a vaccine against tuberculosis that was first developed in 1921 by Albert Calmette, a French microbiologist and Camille Guerin, a veterinary surgeon. Currently, BCG is the only vaccine against tuberculosis. The mechanism of immunity induced by this vaccine is cell-mediated immunity. The protective effect of this vaccine is not very good, especially for pulmonary tuberculosis ( Vaccines are a of immense economic value in the health care system and this is evident from the cost-benefit ratios (1:10) of poliomyelitis and measles (Mason et al, 2002). However, in developing and underdeveloped countries many people do not have the access to many vaccines due to lack of infrastructure, coordinated health policies and cost factor. Disadvantages of vaccination Vaccination is associated with many side effects. However the benefits of vaccination outweigh the disadvantages of vaccination. The safety of vaccines is always a disputed aspect, expecially by critics. However, vaccines are selected basically based on the necessity, safety and efficacy and they licensed only after undergoing 3 phases of trials. The first phase is on human volunteers for safety and tolerance aspects. The second trial tests immune response and safety in human volunteers and the third trial checks for field efficacy nd safety. After these trials, potency, purity and sterility tests are performed by both the manufacturer and the Drug controller of the country and only when these are satisfactory is the vaccine released into market. The efficacy of certain vaccines like BCG is doubted. While many studies have shown this vaccine to be efficacious, promoting its ised in Asian and African countries, the vaccine is not recommended for routine use in the United States because of the doubts casted on the benefits of the vaccine through some studies (CDC, 2009). Improper manufacturing of inactivated vaccines can result in infections due to intact pathogens. Booster doses are essential for inactivated vaccines because the antigens cannot reproduce and thus periodic reinforcement of immune response is mandatory (Ghaffar and Haqqi, 2010). Some previous studies published a causal relationship betwen measles-mumps-rubella vaccine and autism. However, the Institute of Medicine nd Immunisation Safety Review Committee (2004) investigated the relationship and rejected the causal relationship. Though vaccination against varicella is highly efficacious, many experts do not recommend the vaccine because naturally acquired immunity offers protection life long and prevents adult chicken more which is more severe than childhood chicken pox. Infact, some studies have shown that iniversant infant vaccination of chicken pox will cause a surge in chicken pox in adulthoos and during pregnancy. Based on these studies, experts are of the opinion that though chicken pox vaccination prevents economic loss due to loss of work time, health care costs may arise (Ferson, 1995). Some experts are of the opinion that the shift of surge in cases towards adulthood and oldage can be minimised by administering the vaccine in 2-3 doses, instead of single dose (Senterre, 2004). In some countries, a new combination vaccine consisting of vaccines against measles, mumps, rubella and varicella has been developed. While the argument as to whether universal vaccination against varicella continues, this co mbination vaccine is viewed from a critical point because of increased risk of febrile seizures. (Klein et al, 2010). Vaccine against Japanese Encephalitis, a zoonotic viral disease is widely used in countries in Asia. The vaccine is an inactivated vaccine developed from infected brain tissue of mouse. This vaccine is expensive and needs to be administered in 2-3 doses. Even booster dose is required for this vaccine. However the vaccine is associated with adverse reactions in significant number of people. In China and other regions like Korea, a cheap vaccine is used with strain SA 14- 14- 2. This vaccine is not associted with significant allergic reactions. Though the vaccine has been deemed effective, there are not many trials to support the safe and efficient use of this vaccine (Plesner, 2003). Some vaccines are very costly. For example, the vaccines against HPV virus, for the prevention of cervical cancer are around 100US dollars. The efficacy of the vaccine is 70 percent and hence screening for cervical cancer needs to be done even despite vaccination. The vaccine has to be given in 3 doses and many people cannot afford the price (Madrid-Madrina, 2009). Live attenuated vaccines are difficult to transport and have a risk of undergoing secondary mutation which can cause virulence. Also, these vaccines can cause disease in immunosuppressed persons, which makes them useless in those with immunocompromise. It is for these reasons that live oral polio virus vaccine, also known as the Sabin vaccine is being gradually replaced by inactivated polio vaccine or Salk vaccine. Almost all vaccines have some adverse effects. The most common adverse effect is soreness and redness at the site of injection. other adverse effects include fever, malaise, disconfort, allergic reaction or even neurological problems. The type of side effect depends on the vaccine. In BCG, adverse reaction in the form of papule and ulcer formation is an indication of successful vaccine administration. Soon after the vaccine is administered a wheal of atleast 5 mm develops which is an indication that the vaccine was administered in the most appropriate manner. After about 2-3 weeks, a small papule develops at the site of injection which gradually increases in size to about 4- 8mm by the end of 5-6 weeks. After about 6 weeks, the papule ruptures and an ulcer develops. This ulcer heals slowly and develops a scar after 6- 12 weeks. Other undesirable adverse reactions can occur in 1-10 percent cases. They are delayed healing of ulcer, lymphangitis, enlargement of ipsilateral cervical and axillary lymph nodes, abscess formation, osteomyelitis and rarely disseminated BCG vaccination. After DPT administration, side effects in noted in more than 40 percent of vaccinees. The most common adverse effect noted is pain and redness at the site of injection. The pain may be so severe that the child may not be able to move the limb and walk. Induration and swelling may also be present. Fever is also very common. It may last for 24- 72 hours and responds well to paracetamol. All children who have been administered this vaccine must receive paracetamol whether there is fever or not, for control of pain. Other systemic side effects include vomiting, anorexia, irritability, lassitude and excessive crying.The side effects are due to pertussis vaccine. Rarely, seizures can occur after administration of the vaccine. For vaccines like measles and varicella, rash and fever many occur (Shah, 2007). Some adverse effects can be nasty. For example, Swine flu vaccine is associated with Guillian barre syndrome, anaphylactic shock, vasculitis, paralysis and even death and this aspect is preventing many individuals from taking the vaccine.(Menzies et al, 2008). Pneumococcal vaccine can rarely can anaphylactic shock or even convulsions (Haber et al, 2009). Thus vaccination is associated with several risks and prior to administration of vaccines, the risks and benefits must be ascertained. Combination vaccines 2 ore more vaccines can be either given together at the same time. Currently, two or more vaccines are administered through the same injection. The combination depends on the vaccine and the manufacturers criteria. For several years, diphtheria, tetanus and pertussis were given as combination vaccine, known as DPT. Similarly measles, mumps and rubella are also available as combination vaccines. other recent combination vaccines include hepatitis A and B vaccines, DPT with hemophilus influenza and inactivated polio vaccine, etc. Combination vaccines are safe and reduce the number of injections that need to be given to the child. They do not decrease the efficacy of vaccination. They increase the compliance to vaccination (Shah, 2007). Novel vaccines Some novel vaccines have been developed and are under trial in the wake of debate between advantages and disadvantages of current vaccines available. Some of the important ones are DNA vaccines, immunodominant peptides and anti-idiotype molecules. of recent interest in the field of vaccination are plant-vaccines, which are erived from plants and can be administered orally or through oral mucosa (WHO, 2010). The vaccines derived thus are expected to be cheap with minimal side effects. research in plant vaccines is a result of revolution in proteomics and genomics, and greater understanding of the molecular basis of infectious diseases and advances in modern biotechnology. Edible plant vaccines employ a new strategy of combining plant biology with medical science. Research has shown that some variants of tobacco express hepatitis B surface antigen and streptomutans surface protein and infact the torch of research in plant-derived vaccines is taken from here. Novel vaccines have only su b-units of the pathogen and hence do not cause any virulence even in immunosuppressed patients. other than tobacco, other plants which are potential sources of vaccines are tomato, banana, alfalfa, legumes and certain cereals (Refer figure and tables below). Some research has pointed to the role of oral transgenic plant-derived vaccines in the prevention of diarrhoeal diseases by some pathogens like norovirus, enterotoxigenic Escherichia coli and cholera (Tacket, 2004). Plant-derived vaccines have several advantages. Besides lower cost of vaccination, another major advantages of the vaccines are that they are administered orally and hence the need for injection equipment is not needed. This decreases the risks associated with injections like unsafe injection, poor sterilization, misuse and reuse. The vaccines will need less rigorous formulations for manufacture and supply unlike injections. Another major advantage of plant-derived vaccines is heat stability which avoids the maintena nce of expensive cold-chains, and allows easy portability of the vaccine. Since most of the plant-derived vaccines are effective mucosally, it is an advantage because most infections are acquired through mucosa and mucosal immunity prevents entry of the pathogens into the host. Plant-derived vaccines can be given as combination vaccines. Plant derived vaccines can be given even for diseases not covered under regular vaccination like sexually transmitted diseases, dengue hookworm and HIV. The development of plant-derived vaccines is yet in cocoon stage due to return of investment doubts, uncertain licentures, limited human trials and lack of expertise (Arzten, 2002). Fig.1. Plant derived vaccine development strategy (Das, 2009). Table 1. Antigens produced in transgenic plants (Das, 2009) Protein Plant Hepatitis B surface antigen Rabies virus glycoprotein Norwalk virus capsid protein E.coliheat-labile enterotoxin B subunit Cholera toxin B subunit Mouse glutamate decarboxylase VP1 protein of foot and mouth disease virus Insulin Glycoprotein swine-transmissible gastroenteritis cornavirus Tobacco Tomato Tobacco Potato Potato, tobacco Potato Arabidopsis Potato Arabidopsis Table-2. Transient production of antigens in plants after infection with plant viruses expressing a recombinant gene (Das, 2009) Protein  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Plant  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Carrier Influenza antigen  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Tobacco  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚     TMV Murine zona pellucida antigen  Ã‚  Ã‚     Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Tobacco  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  TMV Rabies antigen  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚     Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Spinach  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   AFMV HIV-1 antigen  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Tobacco  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚     Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  AFMV Mink enteritis virus antigen  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Black eyed bean  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   CPMV Colon cancer antigen  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Tobacco  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   TMV Table-3 Antibodies and antibody fragments produced in transgenic plants (Das, 2009) Antibody  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚     Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Antigen  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Plant IgG (k)  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Transition stage analog  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Tobacco IgM (ÃŽÂ »)  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   NP(4-hydroxy-3-nitrophenyl)  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Tobacco   Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  acetyl hapten Single domain (dAb)  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Substance P  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Tobacco Single chain Fv  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Phytochrome  Ã‚  Ã‚     Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Tobacco Single chain Fv  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Artichoke mottled virus  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Tobacco   Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  coat protein Fab; IgG (k)     Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Human creatin kinase  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Arabidopsis IgG (k)  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Fungal cutinase  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Tobacco IgG (k) and SIgG/A  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   S. mutagens adhesin  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚     Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚     Ã‚  Tobacco hybrid Single chain Fv  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Abscisic acid  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Tobacco Single chain Fv  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Nematode antigen  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Tobacco Single chain Fv  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚     Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  ÃƒÅ½Ã‚ ²-glucuronidase  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Tobacco   Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  ÃƒÅ½Ã‚ ²-1,4 endoglucanase  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Single chain  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Atrazin, Paraquat  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚     Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Tobacco antibody fragment  Ã‚  Ã‚   IgG  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Glycoprotein B of  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Soybean   Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Herpes simplex virus  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Conclusion

Value of Health Care Essay -- United States Healthcare

The Value of Health Care The development of value based healthcare reimbursement systems between healthcare payers and healthcare providers is evolving from the need to provide patients with beneficial healthcare technologies under conditions of significant economic uncertainty. The concept examined centralizes on shifting the focus of the healthcare system from volume to value. Value is measured by outcomes achieved based on a full cycle of care not volume of services rendered based on each service performed. Summary of Article The article chosen for this assignment was published on December 23, 2010 in the New England Journal of Medicine (Porter, 2010). The author, Porter (2010) examines the role of value in the healthcare system in the United States. According to Porter (2010) â€Å"Value should define the framework for performance improvement in healthcare.† Porter indicates that value in healthcare should be measured by outcomes achieved not the volume of services rendered. According to Porter (2010), â€Å"The proper unit for measuring value should encompass all services or activities that jointly determine success in meeting a set of patient’s needs. Posistive and Negative Affects, Cost, Quality, Access, Trade-offs The national pay for value based system development has positive and negative aspects. System implementation will require multiple entity participation. Hospitals, physicians, outpatient centers, and clinics all will be responsible for collaboration in developing an integrated communication system which will present additional expense on the front end. Government mandates will be required; from implementation dates to specified circumstances in which assistive funding may be available. Multi provider ... ...g outcomes are important actions towards improving outcomes. True reform will require both moving toward restructuring the care delivery system and a national system of consistency, regulation and payment. References Lee, T.H. (2010). Putting the value framework to work. New England Journal of Medicine. 363:2481-2483 Porter, M.E., (2010). What is the value in healthcare? New England Journal of Medicine. 363:2477-2481 Porter, M.E., (2009) A strategy for helath care reform – Toward a value-based system. New England Journal of Medicine. 361:109-112 Carlson, J.J., Sullivan S.D., Garrison, L.P., Neumann, P.J., Veenstra, D.L. (2010). Linking payment to health outcomes: A taxonomy and examination of performance-based reimbursement schemes between healthcare payers and manufacturers. Health Policy, 96(3), 179-190. doi: 10.1016/j.healthpol.2010.02.005

Anthropology social relationships Essay

Social relationships in most cultures and societies impact heavily on how a person perceives their world. People create their social world but are also shaped by it, and part of this social world is the social relationships that are formed between individuals. These relationships vary in kind from family and kinship to friendship. Kinship and family are types of relationships that have been widely studied in the attempt to study and understand a culture or society. And whilst these are important, relationships of friendship also play a large part in the way the individual’s personality is shaped and how they view their social world. Relationships of kinship or family ties are generally unavoidable and are formed through generations of families or cultural ties. Tribes and small villages are a good example of this where the members of these social circles are in frequent contact with each other and are somewhat limited to the generations within the physical boundaries of their social world. The formation of these relationships does not require much effort and they are expected to continue even if transformed over time. Positive relationships can become negative and vice versa. Look more:  social process theories essay Within the classification of family ties and kinship, the individual’s ties’ with ones family would be described with him/her in the centre, his parents above, children and their descendants below and siblings to either side (Morgan, 1870, p.10). Kinship ties include those where an individual does not have close genealogical ties with another rather is related through an unexpressed social tie, marriage or other wider social circles. If you take rural villages as an example, the degrees of these relationships can be measured in a somewhat circular pattern, where immediate family is in the centre, followed by those related by marriage, and then the members of the village in various degrees of closeness. The ties of family are expected to continue even after death, i.e. the individual is still a son to his parents but is also a father to his children, a brother to his siblings, etc. If the ties of kinship are those of a wider social circle than that of family; then ties of friendship are to be considered in the somewhat grey area in the middle. Relationships of friendship are more informal yet private to some degree and are usually based on some common interest or sharing (Beer, 2001). This sharing is not limited to material objects, but also to thoughts and secrets; thus friendship is a relationship that is heavily dependant on mutual trust and loyalty as compared to blood ties of family or kinship. Aside from those with family, most other relationships can be created, sustained in some way or ended by the individual, and each relationship will have its effect on perception or the shaping of the individual and his/her world. It is as such a given that these relationships can be created or impacted on by the actions of the individual or both parties involved. In order for a social relationship to be established outside of the setting of ‘family’ many events and actions take place. Social relationships are important to the individual as well as their social world, these relationships are often the foundations of the individual personality. From a young age the first relationship would be with members of the immediate family, however as time passes, the social circle or boundaries per se, of the individual enlarge to include others. These relationships are created from different situations, a child’s first school friends, the relationships between parent and teacher, relationships of friendship between those who share mutual interest and those of work to name a few. These relationships can be established in several ways; the exchange of gifts, the sharing of interests, cultural beliefs and identity, or a shared interest. Gift giving being the easiest to understand can be condensed into the action of give and take between two or more parties. This process is not always a positive attempt towards the continuation, formation or beginning of a relationship as the refusal to reciprocate the gift giving can be also seen as an indication to end the relationship. Social relationships require a certain measure of give and take, gift exchange, secrets, conversation, and opinion. Gift exchange plays a large role in social relationships as it can be used in several ways; an indicator for the willingness to engage in a relationship, the intention to continue a relationship, etc. However, gift exchange has two parts, giving and receiving, and these actions have different results depending on the situation. Drawing on the article by Theodore Caplow (1982) on the connection between gift giving and relationships one can begin to understand the impact these actions have on relationships. Caplow describes the gift exchange as being mostly among kin, however he also mentions that gifts were also given among co-workers, friends and couples. Caplow described the gifts given and received between primary kin as being in a pattern where the gifts given from an older generation within family were likely to go downwards, i.e. more gifts were given by those older than 18 to those younger than 18. This process of gift giving and reciprocity is slightly uneven and occurs mainly among kin members. Parents do not expect much in the way of gifts from children and children only gift with what limited capability they have. However the gift giving changes in other relationships, for example, between couples who are dating or among friends. As such, the relationship between kin cannot be truly described as a relationship that is insomuch created as much as it is inherent simply to the birth of an individual, so when considering the process of creating social relationships, one must consider the relationships formed outside the circle of immediate family. Gift giving between individuals as mentioned above, is seen as a way to continue a relationship; one person gives a gift and expects one in return. To reciprocate and gift in return would indicate that one intends on continuing the relationship. Yet despite describing the action of gifting and reciprocity in the term of material gifts, it is not always material gifts that are exchanged. Gifts can be given to those one intends on keeping favour with the expectation of asking for something at a later date, which is not necessarily another material object, but it can be something like favour within a political setting. Positive social relationships also require ongoing maintenance and can be ended at any given moment by the actions of one or both parties involved for example in the case of two neighbouring Brazilian families in the town of Monte Verde where an old friendship ended in a feud (Descharmes et al. 2011, p349). In this case there remained a relationship, however it was a transformed, hostile relationship of revenge where one family would murder a member of the others and the opposing family would reciprocate with the same. This reciprocal opposition transformed the relationship from a positive relationship to one of revenge. In this case we see how a relationship is transformed, but transformations of social relationships can also be positive in weddings for example where two members of separate families are united and a new relationship is formed where those two individuals are now members of the others family. Marriage is a very common form of transformation for a relationship and is found in almost all societies and results in reciprocal rights between both parties whilst also creating a social process where new relationship are set up between the kin of both the husband and the wife (Brix, JH 2010, pp162). These transformations of social relationship occur often but with various results. In the formation of relationships of friendship, two individuals may move from being ‘acquaintances’ to ‘friends’. Beer makes the distinction between friendship and kinship; where kinship is usually used to describe close personal ties, not necessarily genealogical, and friendship is a relationship based on sharing of time, problems, plans, hopes and thought. As such with the sharing of secrets and personal thoughts, friendship is a social relationship that requires absolute loyalty and trust, as if the relationship is broken off; these secrets can be revealed to others. Over time, these factors affect a person and the way they shape their social world. If we consider that the individual shapes his/her social world and that this world in turn shapes them, we may also consider the effect social relationships have on this social world per se. Relationships between family or kin will shape a child in the early stages based on the culture and beliefs passed down from the parents or adults in the child’s kin circle. However as time passes, the social circle expands to include school peers and other adults. The biggest effect is usually from the friendships that are formed with others from a completely different kin circle to the individuals own. To go into a deeper understanding of the individual’s social world we must also understand their relationships. Drawing on the article by Ortner, 1993, on a high school graduate class, as a case study, we are given examples of some relationships that are formed and maintained. Ortner describes her high school graduate class and their sense of â€Å"community† during and after their school years. She goes on to describe the structure of â€Å"class† within the high school. this idea of a â€Å"class† system depicts the social circle or world that the members of these â€Å"classes† were a part of. These social circles are described as including members who had similar backgrounds or interests. Furthermore she goes on to describe the relationships that were maintained after high school. These relationships tended to run in the same circles as they had been during school years. So by analysing the social relationships of the individual we are given a deeper understanding of the way they shape their world. The social structure we give our world often is dependant on how we structure our relationships with others. The social relationships that alter the perception of social structure for one person may not always be applied with the same results for all people. This is due the many relationships we build and maintain with others over time. The formation of social relationships are created, sustained, transformed and ended with the actions of the individual and sometimes without. We may find ourselves in a relationship with others that has simply arisen through the relationship with kin or family. Yet these relationships help shape us and the way we crate our social world. These relationships are constantly in flux and changeable with the time that passes as a relationship can also change with the passing of time without many major or drastic changes. As such, these relationships play a major role in how we perceive our social world and inevitably our sense of self. Bell, S, Coleman, S 1999, The Anthropology of Friendship, Berg, USA Beer, B 2001, Friendship, Anthropology of, International Encyclopedia of the Social & Behavioral Sciences, Elsevier Science Ltd, USA Caplow, T. 1982 Christmas Gifts and Kin Networks. Sociological Review 47 (3): 383-392. Descharmes, B, Heuser, EA, Krà ¼ger, C, Loy, T 2011, Varieties of Friendship; Interdisciplinary Perspectives on Social Relationships, V&R Unipress, Germany Morgan, LH 1870, Systems of Consanguinity and Affinity of the Human Family, University of Nebraska Press, USA Ortner, Sherry 1997 Fieldwork in the Postcommunity. Anthropology and Humanism 22(1): 61-80. Turner, V. 1964 Betwixt and Between: The Liminal Period in Rites of Passage. in J. Helm (ed.) New Approaches to the Study of Religion Seattle: American Ethnological Society pp. 4-20. Vaughn, L 2010, ‘Marriage and the family’, in HJ Birx (ed.), 21st century anthropology: A reference handbook, SAGE Publications, Inc., Thousand Oaks, CA

Gainesboro Machine Tools Corporation Essay

Kendle International Inc. We looked at the competitive landscape and, based on what was happening, knew we were either going to sell Kendle, grow or disappear. It was May 1997, and Candace Kendle, the chairman and chief executive officer of Kendle International Inc. (Kendle), and her husband Christopher C. Bergen, the president and chief operating officer, were reviewing the strategic options for their Cincinnati, Ohio based company. Kendle, a business they had founded over 15 years previously, conducted clinical trials for pharmaceutical and biotechnology companies to test the safety and efficacy of their new drugs. The company had grown successfully to $13 million of sales and had attracted significant business from major pharmaceutical and biotechnology companies. Kendle was competing, however, with several larger contract research organizations (CRO), many of which had an international presence that allowed them to do clinical studies outside the United States and gave them an advantage when competing for major projects. To compete more effectively, Candace and Chris had embarked on a plan to grow through acquisition, particularly internationally, and to finance this growth through a public offering of equity. Toward this end, by the spring of 1997 Kendle had lined up two potential European acquisitions—U-Gene, a CRO in the Netherlands with 1996 sales of $12.5 million, and gmi, a Germanbased CRO with $7 million in sales. To finance these acquisitions, Kendle had worked out possible debt financing with Nationsbank and was working with two investment banks on an Initial Public Offering (IPO) that would repay the bank debt if successful and provide the equity base for future acquisitions. It was now time to decide whether to go ahead with the full program of two acquisitions, a large debt financing and an equity issue. Kendle History Candace and Chris met in 1979 while working at The Children’s Hospital of Philadelphia. Candace had received her doctorate in pharmacy from the University of Cincinnati, then taught in North Carolina and Pennsylvania. Her scientific specialty was virology. At the Children’s Hospital, Candace was serving as the director of pharmacy, working as an investigator on a study of an antiviral drug for the pharmaceutical company Burroughs Wellcome. Chris, a Wharton MBA, was a senior administrator at the hospital. Research Associate Indra A. Reinbergs prepared this case under the supervision of Professors Dwight B. Crane and Paul W. Marshall as the basis for class discussion rather than to illustrate either effective or ineffective handling of an administrative situation. Copyright  © 2000 by the President and Fellows of Harvard College. To order copies or request permission to reproduce materials, call 1-800-545-7685, write Harvard Business School Publishing, Boston, MA 02163, or go to http://www.hbsp.harvard.edu. No part of this publication may be reproduced, stored in a retrieval system, used in a spreadsheet, or transmitted in any form or by any means—electronic, mechanical, photocopying, recording, or otherwise—without the permission of Harvard Business School. 1 Looking for something new, Candace and Chris began to discuss the idea of going into business together. One day in early 1981 Candace received an unexpected visit from a new physician, replacing the usual medical monitor for her project with Burroughs Wellcome. This physician was a pioneer in the  contract clinical research business. As he described how his business worked, Candace became more and more intrigued. When he left that day, she immediately called Chris and said, â€Å"I’ve got a business idea!† The concept was to set up a small research consulting firm that would take on outsourced research and development (R&D) work on a contract basis from large pharmaceutical and biotechnology companies. Based on the positive response she received from potential clients, Candace left her job at the hospital in June 1981 and Chris left his job in December 1981. Kendle International Inc. was incorporated in Cincinnati, Ohio in 1981, with Candace taking 55% of the shares, and Chris 45%. Candace had strong ties to the Cincinnati area. Her grandfather, a coal miner, had moved there from Appalachia, and the clan had grown to about 140 members, including Candace’s two sons from a previous marriage. By January 1982, Candace and Chris were working from Candace’s parents’ home. Kendle started as a small company with a few contracts, and business grew slowly through referrals from professional colleagues. Kendle suffered the usual bumps of a start-up business, particularly in the late 1980s when it suffered a loss for two years and ran up $1 million in bank debt on a $250,000 line of credit. Afraid that its bank would call the loan, the company went through a bankruptcy scare. Fortunately, Kendle succeeded in attracting business from a new client, the pharmaceutical company G.D. Searle & Co. (Searle). By the early 1990s, the company was turned around and it generated annual sales of about $2.5 million. Candace and Chris were married in 1991. The Pharmaceutical Lifecycle The clinical research process was influenced by government regulations that required drugs to pass through a series of steps before they could be marketed for public use. In the United States, the Food and Drug Administration (FDA) regulated pharmaceuticals. To receive FDA approval, a drug had to meet safety and efficacy standards for a specific indication (medical diagnosis). A drug for hypertension, for example, would have to lower blood pressure by a certain statistically significant amount without  producing unacceptable side effects. The entire FDA approval process could take from 8 to 15 years and involve several thousand patients.1 After a pharmaceutical company discovered a new drug and completed pre-clinical testing on animals in the laboratory, an Investigational New Drug application was filed with the FDA. The drug then passed through three phases of clinical testing on humans. Before beginning each subsequent phase, the drug company had to submit additional regulatory information to the FDA. Phase I Phase I studies were primarily concerned with assessing the drug’s safety. This initial phase of testing in humans was done in a small number of healthy volunteers (20 to 100), such as students, who were usually paid for participation. Phase II Once Phase I testing had proven the drug’s safety, Phase II tested its efficacy in a small number of patients (100 to 300) with the medical diagnosis. It was specifically designed to determine the likely effective dose in patients. Phase III In a Phase III study, the drug was tested on a larger patient population (1,000 to 3,000) at multiple clinical sites. The purpose was to provide a more thorough understanding of the drug’s effectiveness, benefits, and the range of possible adverse reactions. Most Phase II and Phase III studies were blinded studies in which some patients received the experimental drug, while control groups received a placebo or an already approved drug. Once a Phase III study was successfully completed, a pharmaceutical company requested FDA approval for marketing the drug by filing a New Drug Application, which averaged about 100,000 pages. †¢ 200-033 Phase IV Post-marketing testing (of at least 300 patients per trial) was sometimes conducted for high-risk drugs to catch serious side effects (liver toxicity) and monitor them for long-term effectiveness and cost-effectiveness. The pharmaceutical companies traditionally designed and conducted their own clinical trials. They selected the research sites and recruited investigators to conduct the trials of the new drug. Investigators were often medical school professors at teaching hospitals, but they could also be professional investigators who conducted clinical trials at dedicated centers or occasionally regular physicians who ran trials, particularly Phase IV trials, out of their private practices. These investigators then recruited patients, sometimes with the help of the pharmaceutical company, to participate in the study. After patients were recruited, there was a considerable amount of data collection by the investigators, monitoring of the process and data retrieval by the pharmaceutical company, and analysis of the data to determine whether the statistical criteria for safety and efficacy were met. Finally, there was the complicated process of compiling the data and preparing the long report for the FDA. The Contract Research Business In the 1970s, large pharmaceutical concerns in the United States began to look for ways to outsource their clinical testing work as their R&D budgets grew. At the beginning, contract research was a small cottage industry and the work was awarded on a piecemeal basis. As Chris recalled, â€Å"For years, there had been companies conducting animal testing and Phase I, but there was no one managing the entire research and development process. The acronym ‘CRO’ (contract research organization) did not exist, pharmaceutical companies gave out only small contracts, and did not have much confidence in for-profit research managers.† The growth of the CRO industry was stimulated by pricing pressures on drug companies that led them to try to transfer the fixed costs of clinical research into a variable cost through outsourcing. As Chris described, The general problem that drug companies face is balancing a variable workload with a fixed workforce. The problem is that you don’t know when the guy in the white lab coat will come running down the hall, beaker in hand, shouting, ‘Eureka, I’ve got it, it’s going to cure disease X’. When he does that, you know your workload is going to spike. Your workload is impacted by the rate of discovery, the number of projects killed in vitro and, subsequent to that, how many studies get cancelled due to safety or efficacy problems in human testing. Pure CROs like Kendle derived their income solely from the outsourced portion of the R&D budget of pharmaceutical clients. In theory, any part of the clinical testing process could be outsourced. While most pre-clinical discovery was conducted in-house by drug companies, the trend in the 1990s was for CROs to receive contracts to manage the entire clinical research piece, especially 3 Phases II and III. The whole process was an incredible race against time, as every day for which FDA approval was delayed could cost the pharmaceutical client over $1 million in lost revenues. Pharmaceutical contracts ranged in duration from a few months to several years. For multi-year contracts involving clinical trials, a portion of the contract fee was paid at the time the trial was initiated, with the balance of the contract fee payable in installments over the trial duration, as performance-based milestones (investigator recruitment, patient enrollment, delivery of databases) were completed. Contracts were bid by CROs on a fixed-price basis, and the research was a labor-intensive business. The contract bids depended on careful estimation of the hourly labor rates and the number of hours each activity would take. The estimation process involved statistical algorithms, which took into account the length of the study, frequency and length of site visits, the number of sites involved, the number of patients involved, and the number of pages per report form. A premium would be added for more complicated therapeutic testing. As the chief financial officer Tim Mooney described the business, The way that Kendle makes money is like any professional service firm—We focus on maximizing labor utilization, especially at the operational level. We assume a 65% to 70% utilization rate, so profit margins are higher if we have a higher utilization rate of personnel. We have the same assumed profit margin on all levels of people, but we can charge higher rates for contracts where we have specific therapeutic expertise that is in demand. Margins can also be higher on some large projects when we can share overhead costs across more sites. The business of contract research entailed several types of business risk. With contracts running at an average of $1 million for companies of Kendle’s size, client dependence was a major risk. Project cancellation by the client and â€Å"change orders† to reduce project costs were also increasingly frequent in the CRO industry, as healthcare cost pressures intensified. On the other hand, product liability for medical risks was borne by the pharmaceutical company. Competition in the 1990s By the mid-1990s, contract research had evolved into a full-service industry, recognized by both the pharmaceutical/biotech industries and the financial community. In 1995, worldwide spending on R&D by pharmaceutical and biotechnology companies was estimated at $35 billion, with $22 billion spent on the type of drug development work that CROs could do. Of the $22 billion, only $4.6 billion was outsourced to CROs in 1995. While R&D spending by pharmaceutical companies was growing at 10% a year, CROs were growing at twice that rate.2 Specialized CROs could manage increasingly complex drug trials—in the previous decade, the number of procedures per trial and average number of patients per trial had doubled—far more efficiently than their pharmaceutical clients.3 Kendle participated in this growth in clinical research. Its net revenues grew 425% from $2.5 million in 1992 to $13 million in 1996. From a loss of $495,000 in 1992, its net income rose to $1.1 million by 1996. By 1996, Kendle had conducted clinical trials for 12 of the world’s 20 largest pharmaceutical companies. Kendle’s three largest clients were G.D. Searle, Procter & Gamble, and Amgen, which generated 48%, 19%, and 13% of Kendle’s 1996 revenues, respectively. (See Exhibits 1 and 2 for Kendle’s income statements and balance sheets.) 2 J.C. Bradford & Co., analyst report, January 15, 1998, pp. 5-6. 3 The Economist, â€Å"Survey of the Pharmaceutical Industry,† February 21, 1998, p. 4.200-033 The contract research industry was very fragmented, with hundreds of CROs worldwide. In the 1990s, in response to the increased outsourcing of pharmaceutical R&D, and a demand for global trials, consolidation among the CROs began. A few key players emerged and went public, creating a new industry for Wall Street to watch. Many CRO start-ups were founded by former drug company executives who decided to form their own operations. After a period of internal growth, some of the start-ups began growing through a financial â€Å"roll-up† strategy. An industry publication listed 18 top players in North America, with total contract research revenues of $1.7 billion. The top five public companies, ranked by 1996 revenues, were Quintiles Transnational Corp. ($537.6 million), Covance Inc. ($494.8 million), Pharmaceutical Product Development Inc ($152.3 million), ClinTrials Research Inc. ($93.5 million), and Parexel International Corp. ($88 million).4 (See Exhibit 3 for recent sales and p rofit data on CROs.) With its talent pool of scientists at the Research Triangle and U.S. headquarters of the pharmaceutical giants Glaxo and Burroughs Wellcome (later merged as Glaxo Wellcome), the state of North Carolina quickly became the center of the burgeoning CRO industry. Two of the â€Å"big five† companies, Quintiles and Pharmaceutical Product Development, were started there by academic colleagues of Candace’s. Quintiles Transnational was considered to be the †gold standard of the industry.† Quintiles was founded in 1982 by Dennis Gillings, a British biostatistician who had worked at Hoechst and was a professor at the University of North Carolina, where Candace completed her postdoctoral work. After raising $39 million in a 1994 IPO, Quintiles went on an acquisition spree, adding other professional service businesses. For example, the firm provided sales and marketing services to support the launch of new drug products. By the end of 1996, Quintiles was the worldâ€⠄¢s largest CRO, with 7,000 employees in 56 offices in 20 countries. A typical clinical study managed by Quintiles was conducted at 160 sites in 12 countries, involving 10,000 patients. Quintiles was more diversified than many of its CRO competitors, with about 65% of revenues derived from the  core CRO business and 35% from other services.5 Pharmaceutical Product Development (PPD) was founded in 1989 by Fred Eshelman, a colleague of Candace’s from the postdoctoral program in pharmacy. Like the founder of Quintiles, Eshelman had worked in drug research for several pharmaceutical firms, including Glaxo and Beecham. PPD’s revenues jumped 500% between 1990 and 1994, based on such work as multi-year contracts for AIDS research for the National Institutes of Health. PPD conducted a successful IPO in March 1996, with its stock jumping from $18 per share to $25.50 per share on the first day of trading. PPD bought a U.K. Phase I facility in November 1995, and in September 19 96 merged with another leading CRO. Their combined net revenues exceeded $200 million. Kendle at the Crossroads To Candace and Chris, it was clear that certain competitive capabilities were necessary for companies of Kendle’s size to compete successfully with the major CROs: therapeutic expertise (in specific medical areas) broad range of services (pharmaceutical companies wanted to work with fewer CROs, with each offering a wide range of services across multiple phases of the R&D process); integrated clinical data management (the ability to efficiently collect, edit and analyze data from thousands of patients with various clinical conditions from many geographically dispersed sites); 4 â€Å"Annual Report: Leading CROs,† R&D Directions, September 1997, pp. 28+. 5 William Blair & Co. LLC analyst report, Quintiles Transnational Corp., June 20, 1997, p. 3. international, multi-jurisdictional presence (to speed up drug approval, tests were being launched in several countries at once); With the exception of international presence, Candace and Chris felt comfortable with their ability to meet these criteria. Kendle’s staff had scientific expertise in multiple therapeutic areas, including cardiovascular, central nervous system, gastrointestinal, immunology, oncology, respiratory, skeletal disease and inflammation. The company also had broad capabilities, including management of studies in Phases II through Phase IV. It did not consider the absence of Phase I capabilities to be an issue, since this activity was quite separate. (See Exhibit 4 for a comparison of CRO geographical locations.) To build an integrated clinical data management capability, Chris had directed the development of TrialWare ®, a proprietary software system that allowed global data collection and processing and the integration of clinical data with clients’ in-house data management systems. TrialWare ® consisted of several modules including a database management system that greatly reduced study start-up costs and time by standardizing database design and utilizing scanned image technology to facilitate the design of data entry screens, the point-and-click application of edits from a pre-programmed library, and workflow management (parallel processing). Other modules included a system that coded medical history, medication and adverse event data and a touch-tone telephone system that was used for patient  randomization, just-in-time drug supply and collection of real-time enrollment data. Against the backdrop of a changing industry, Candace and Chris felt the need to develop additional business skills and focus Kendle’s strategy. To clarify their management roles, Candace and Chris switched their existing responsibilities. Chris pointed out, â€Å"Candace became CEO as we realized that her focus was long-range and I took over as Chief Operating Officer to focus on the short-range. In addition, the marketing strength of our competitors was propelling them further and further ahead of Kendle. Candace brought her science background and entrepreneurial skills, while I brought my management. The problem was that we were relatively weak in sales and marketing.† To broaden their skills, Candace went off in 1991 to the Owner/President Management Program (OPM), an executive education program run by Harvard Business School for three weeks a year over three years. Chris followed her to OPM in 1994. After completing the OPM program, Candace assessed the situation, We have to be big enough relative to our competitors to take on large, international projects. When Searle was looking for CROs for international work, all we could do was possibly subcontract it out to small shops. In contrast, Quintiles had six overseas offices of its own. Furthermore, when Searle calls and says, ‘I just got off the phone, Quintiles will cut their price by a million dollars,’ if you’re too small, you’re not going to be able to respond to that. Candace and Chris realized that Kendle could not grow fast enough internally to keep up with its peers and did not have the cash for acquisitions. They entertained the thought of selling Kendle, and were approached several times about a sale. But by nature, they were a competitive, athletic couple. Chris got up to play squash every morning at 7 AM, and Candace was an avid rower, recently winning a gold medal in a Cincinnati regatta. Perhaps not surprisingly, Candace and Chris decided to grow the firm and take it public rather than sell. As Candace described their motivation, â€Å"We were not driven to be a public company as such, but primarily to be bigger, and for this, we  needed public financing to succeed in the new competitive landscape. The whole target was not to let the big guys get too far out ahead of us.† Preparations for Growth By 1994, Kendle had grown to $4.4 million in revenues. Candace, the driving force throughout the IPO process, sought advice from an old college friend, a well-known Cincinnati businessman. He advised her, â€Å"before you go public, practice being a public company.† Candace therefore formulated a plan for Kendle to go public in 1999. Kendle began hiring key managers to build up functional units. Between 1994 and February 1997, new directors of clinical data management, information technology, biostatistics, finance, mergers and acquisitions, regulatory affairs, and human resources were hired. As Chris described, â€Å"the plan was to put this infrastructure in place to look and act like a public company— communications, IT, finance. The idea was hire at the top and they’ll fill in their organization.† Many of these new managers had previously worked together at other companies. To prepare for Wall Street scrutiny, Kendle began issuing internal quarterly fi nancial statements and sharing them with employees in an open-book management style. Candace and Chris tried to make the growing number of employees feel like â€Å"part of the family† in other ways, too. The Kendle â€Å"photo gallery† displayed professional portraits of employees with their favorite hobbies. In 1995 Chris led the development of a corporate mission statement and a document on strategic plans that was shared with all employees. Kendle was organized in a matrix fashion (see Exhibit 5 for organizational chart). Each department was treated as a strategic business unit (SBU) with a director who established standards and carried profit responsibility. At the same time, each research contract was managed by a project manager who assembled a team from across the various SBUs. Clinical trials involved five functional SBUs at Kendle: 1. Regulatory Affairs recruited investigators, helped them with FDA registration forms, and obtained approval from ethics boards. Regulatory Affairs maintained a database of 5,000 investigators. 2. Clinical Monitoring sent clinical research associates (CRA) out to the testing sites (every 4 to 6 weeks) to enforce Good Clinical Practice regulations. The CRAs were typically young, single health care professionals who spent a significant amount of their time on the road. The CRA would collect data from investigators, resolve queries generated by Clinical Data Management, and promote patient enrollment. 3. Clinical Data Management produced a â€Å"locked† database that could be submitted to the FDA. Data from case report forms were input into a computer system and â€Å"cleaned† through a manual review of the forms and an automated check of the databases. The challenge was to lock a database quickly while maintaining data quality. 4. Biostatistics would â€Å"unblind† the locked database and analyze it to determine if the data confirmed that the test results met the criteria for safety and efficacy. Biostatistics also defined the scope of new studies. 5. Medical Writing generated â€Å"the truckload of paper submitted to the FDA† for a New Drug Application, including a statistical analysis, a clinical assessment, preclinical and clinical data, a description of the manufacturing process, and the supporting patient documentation. 1996: The Celebrexâ„ ¢ Study, Filing Preparations, and European acquisitions 1996 was a busy year for Candace, Chris, and Kendle’s new management team. They simultaneously began conducting a major drug study, working with underwriters on IPO preparations, and looking for overseas acquisition targets. In 1996 Kendle managed 62 clinical studies at 4,100 sites involving approximately 20,000 patients. Celebrexâ„ ¢ Study In January 1996, Kendle began working on a major drug called Celebrexâ„ ¢ (celecoxib). Its client Searle was engaged in a neck-and-neck race with Merck, the largest U.S. drug company, to be the first to market a COX-2 inhibitor. A COX-2 inhibitor was a new type of anti-inflammatory drug that promised low incidence of bleeding ulcers in long-term, high-dosage users such as arthritis patients. The Searle-Merck race was closely followed in the business press. Searle awarded the international portion of the Celebrexâ„ ¢ contract to another CRO, since Kendle only had facilities for testing in the United States. However, Kendle did win the contract to conduct all the U.S. Phase II and III trials. The Celebrexâ„ ¢ contract was a â€Å"huge feather in our cap,† recalled the chief financial officer. â€Å"In order to beat Merck, we worked very hard and kept compressing the timelines.† To head the Celebrexâ„ ¢ project, Kendle hired Bill Sietsema, PhD, as assistant director of clinical research. A therapeutic expert in skeletal diseases and inflammation, Sietsema had worked at Proctor & Gamble for 12 years. While Sietsema served as overall program director, Chris acted as the operational project manager, meeting with his Searle counterpart in Chicago on a monthly basis. In early 1997, Kendle also set up a new regional office in Chicago, close to Searle headquarters. For Kendle, the Celebrexâ„ ¢ project was a chance to â€Å"show what we could do and to develop a reputation as a leader in the field of skeletal disease and inflammation.† Kendle actively helped investigators recruit arthritis patients, running television advertisements, directing interested volunteers to a call center. Three hundred  investigators enrolled over 10,000 patients, producing over one million pages of case report forms. Most importantly, through close integration of information systems with Searle, Kendle was able to beat an industry standard. Instead of taking the typical six months to one year, the time span between the last patient in Phase II and the first in Phase III, which began in June 1996, was only 22 days. Preparation for SEC Filing By the time the Celebrexâ„ ¢ program rolled around, Candace and Chris felt that they might have to go public earlier than intended because of the competitive landscape. The new chief financial officer, Tim Mooney, took a leading role in the preparations. Prior to joining Kendle in May 1996, Mooney had worked as CFO at The Future Now, Inc., a computer reseller and Hook-SupeRx, a retail drugstore chain. At Kendle, Mooney replaced the controller with an audit manager from Coopers & Lybrand to beef up his staff. Mooney also led the building of many of the other financially related departments at Kendle. To act as the lead underwriters on the IPO, in August 1996 Mooney chose two regional investment banks, Chicago-based William Blair & Company, L.L.C., which had handled the 1995 IPO of Kendle’s competitor Parexel, and Wessels, Arnold & Henderson from Minneapolis. William Blair began putting Kendle through the paces of preparing to file a preliminary prospectus with the U.S. Securities and Exchange Commission (SEC). The process of going public generally took from 60 to 180 days. One of the key steps in the process was the conversion of Kendle from a subchapter corporation to a C corporation at the time of the IPO. (Subchapter S corporations were entities with 35 or fewer shareholders that were treated like partnerships for tax purposes. Corporate income tax was passed through tax-free to the owners who then paid personal income taxes due.) U-Gene In October 1996 Mooney hired Tony Forcellini, a former colleague, as director of mergers and acquisitions (M&A). Tony had worked at Arthur Andersen in the tax department, and then as a treasurer at Hook-SupeRx with Mooney. The search for European acquisition targets was mainly conducted by Candace and Tony Forcellini, with back-up support by Tim Mooney and Chris. All the while, Chris and Bill Sietsema were working away on the Celebrexâ„ ¢ program. Forcellini’s first decision was easy—whether to pursue an offering memorandum that landed on his desk shortly after he arrived. The company for sale was U-Gene Research B.V. (U-Gene), a CRO based in Utrecht, the Netherlands. U-Gene was represented by Technomark Consulting Services Ltd. (Technomark), a London-based consulting firm uniquely specializing in the healthcare industry. Technomark had an extensive database on European CROs and was primarily in the business of matching its pharmaceutical company clients’ tria ls with appropriate European CROs, but it also had a small investment banking division. U-Gene, a full-service CRO, was an attractive target for Kendle. The venture capitalist owners were actively looking for buyers. With a 38-bed Phase I facility in Utrecht and regional offices in the United Kingdom and Italy, U-Gene could increase both Kendle’s service offering and geographic presence. Since its founding in 1986, U-Gene had served more than 100 clients, including 19 of the world’s largest pharmaceutical companies. In 1996, U-Gene participated in 115 studies at approximately 500 sites involving approximately 4,700 patients and recorded net revenues of $12.5 million, a 37% increase over the prior year, and operating profit of $1.3 million, a 47% increase over the prior year. Because of its U.K. and Italian offices, U-Gene viewed itself as on the way to becoming a pan-European CRO.  (See Exhibit 6 for U-Gene financial statements.) With momentum building, in November 1996, Forcellini seized upon U-Gene as Kendle’s possible entry into Europe and subm itted a bid, offering cash and private stock. Unfortunately, Kendle lost out on this bid to a competitor, Collaborative Clinical Research, Inc, as U-Gene’s owners either wanted a full cash deal or stock from a public company. Collaborative was a competitor slightly larger than Kendle ($25.7 million in revenues) that had gone public in June 1996 and had established a software partnership with IBM. Although it had access to investigators outside the United States, Collaborative also viewed U-Gene as the establishment of a European presence. On February 12, 1997 Collaborative announced that it had signed a letter of intent to acquire U-Gene in exchange for 1.75 million newly issued shares. While this put Kendle out of the picture, the prospects of a deal were not completely killed. On the same day, February 12, 1997, Collaborative also announced that its first-quarter 1997 earnings would be significantly below expectations. On the next day, on analyst speculation that a major client contract had been lost, their stock fell by 27.3%, closing at $9.00.6 This put Collaborative’s UGene deal in jeopardy. Underwriter Concerns About two weeks after Collaborative’s announcement, on February 25, 1997, another CRO, ClinTrials, also suffered a drop in stock price. ClinTrials’ stock lost more than half its market value,  dropping 59%, to $9.50 per share. The fall began when an analyst from Wessels Arnold downgraded the ClinTrials stock to â€Å"hold† from â€Å"buy,† citing a number of key management departures, and continued after ClinTrials announced that its first-quarter earnings would be half its year-earlier profit. The reason for the unexpected earnings decline was the cancellation of five projects totaling $37 million, with the possibility of even lower earnings due to an unresolved project dispute with a client.7 ClinTrials’ negative performance began to affect other CRO stocks, including that of Quintiles.8 With client concentration an issue in ClinTrials’ stock performance, William Blair developed doubts about the timing of Kendle’s IPO. Although Kendle was close to filing its preliminary prospectus, on the day after ClinTrial’s stock dropped, William Blair analysts had a meeting with Kendle’s management and told them that they had decided to withdraw as lead underwriters in the IPO. Candace was resolved to keep going. She said, â€Å"There’s no way out of the concentration issue. We can’t buy our way out of it, because we can’t do M&A deals until we have a public currency, and every day Searle is bringing us more work, we won’t tell them no.† She then asked Mooney to find new investment bankers, and he thought, â€Å"what am I going to do now?† Hoping for a lead, Mooney called up a former security analyst from Wessels Arnold who had gone to work at Lehman Bros. Although Kendle was smaller than Lehman’s usual clients, Lehman agreed to underwrite Kendle’s IPO, with the reassurance that â€Å"we think we can sell through the client concentration issue.† After an agreement with New York-based Lehman was reached, Mooney searched for a regional firm because, as he decided, â€Å"I didn’t want two New York-size egos. J.C. Bradford, based in Nashville, Tennessee, had a good reputation in the industry , and struck us as a nice regional bank. They were more retail-oriented than institutional-oriented, so they wouldn’t directly be competing with Lehman in types of clientele.† Bradford had managed the IPO of the first large CRO to go public (ClinTrials, in 1993) and Lehman had led the IPO of PPD in January 1996. Gmi and U-Gene revisited At the same time, Forcellini was moving ahead on the acquisition search. In January 1997 he tasked Technomark with using its CRO database to generate a list of possible European acquisition targets that met the following criteria: â€Å"ideally a CRO with United Kingdom headquarters; $5 million to $7 million in revenues; no Searle business; certain types of therapeutic expertise; strong in phases II through IV; and certain country locations.† The initial list had 50 European CROs, which Kendle narrowed down to 14 prospects. Technomark then contacted these 14 prospects to sound out their willingness to sell, bringing the number down to five candidates: three CROs in Germany, two in the United Kingdom, and one in the Netherlands (not U-Gene). To assess the prospects, Kendle used information from Technomark on comparable M&A deals. Candace and Tony Forcellini then traveled around Europe for a week visiting the five companies. They decided to further pursue two companies: a small, 15-person monitoring organization in the United Kingdom and one in Germany. The U.K. prospect was quickly discarded because of an aggressive asking price and accounting problems. Kendle then moved on to the German target, a company named gmi. Its full name was GMI Gesellschaft fur Angewandte Mathematik und Informatik mbH. Founded in 1983, gmi provided a full range of Phase II to IV services. gmi had conducted trials in Austria, the United Kingdom, Switzerland and France, among other countries, and had experience in health economic studies and 7 â€Å"ClinTrials Predicts Sharply Lower Profit: Shares Plunge 59%†, The Wall Street Journal, February 26, 1997, p. B3. 8 David Ranii, â€Å"Investors avoiding Quintiles,† The News & Observer, Raleigh, NC, February 27, 1997, p. C8. professional training programs. In 1996, gmi participated in 119 studies at multiple sites and recorded net revenues of $7 million, a 32% increase over the prior year, and operating profit of $1.4 million, a 16% increase over the prior year. At March 31, 1997, gmi’s backlog was approximately $9.6 million. gmi considered itself to be especially good at Phase III trials. (See Exhibit 7 for gmi financial statements.) While Candace and Forcellini were narrowing down European targets, Mooney was hunting for cash. In February 1997 Kendle met at a special lunch with its existing bankers, Star Bank (later renamed Firstar), in Cincinnati. Mooney recalled the conversation vividly: â€Å"After Candace and Chris described their plans, Star Bank’s CEO made a proposal, ‘If you keep Kendle a private company and avoid the hassles of being public, we’ll lend you the money you need for acquisitions.’† With the financing in hand, Candace and Forcellini visited gmi in Munich. While gmi’s owners were willing to talk, they did not have much interest in selling. As Mooney described it, â€Å"gmi was a classic case of having grown to a certain size, had a comfortable level of income, but weren’t interested in putting in the professional systems to grow beyond that level.† After several conversations in March, it was not clear that Kendle and gmi’s owners w ould be able to reach a mutually agreeable price. At this point in early April 1997, the possibility of U-Gene as an acquisition candidate heated up. After the U-Gene deal with Collaborative Research began to collapse, Kendle had initiated a carefully structured inquiry about U-Gene’s interest in renewed discussions. This inquiry led to further discussions and a request in April for Kendle to meet in Frankfurt to try to reach an agreement. With the gmi deal in doubt, Kendle agreed to try to reach closure with U-Gene. After some discussion, both sides agreed on a price of 30 million Dutch guilders, or about US$15.6 million, $14 million of which would be paid in cash, and the remaining $1.6 million would be in the form of a promissory note payable to the selling shareholders.  U-Gene wanted to complete the transaction within the next several weeks, so it would have to be financed at least initially by borrowings. Even if Kendle went ahead with an IPO, the equity financing would not be completed until the end of the summer. Discussions with gmi continued through this period since Kendle was confident about its ability to obtain financing from Star Bank. Ultimately, Kendle’s team was able to agree upon a price with gmi. The owners were willing to accept a price of 19.5 million Deutsche marks, or about US$12.3 million, with at least $9.5 million in cash. They would accept shares for the remaining $2.8 million, if Kendle successfully completed an IPO. The owners were willing to hold off the deal until the IPO issue was resolved. Closing the Deals and IPO Decision To complete both the U-Gene and gmi deals, Kendle would need to borrow about $25 million to $28 million, so financing became critical. Mooney went back to Star Bank to take the bankers up on their promise. He described their reaction: â€Å"Star Bank said they couldn’t lend $28 million to a company that only has $1 million in equity. Nobody did that. They might be willing to finance one acquisition, with the help of other banks, but there was no way that they would provide $28 million.† Mooney was quite angry, but had no choice but to look for other sources of financing. He first tried to get bridge financing from Lehman and Bradford, but they refused, saying that they had â€Å"gotten killed on such deals in the 1980s.† There was also a possibility of financing from First Chicago Bank, but this did not materialize. Finally, in late April 1997, Mooney contacted NationsBank, N.A., which was headquartered in Charlotte, North Carolina and provided banking services to the CRO industry. Nationsbank expressed interest, but only in a large deal. Even $28 million was a small amount to Nationsbank. In 11  a few short weeks, Nationsbank ended up structuring a $30 million credit for Kendle, consisting of a $20 million, three-year revolving credit line and $10 million in five-year, subordinated notes. The interest rate on the credit line was tied to a money market base rate plus 0.50% (currently totaling 6.2%), and the subordinated debt carried a 12% rate. †So NationsBank stepped up in a pretty big way. They could have ended up with Kendle as a private company, with $30 million in debt.† Because of the risk, Nationsbank would also take warrants giving the bank the right to purchase 4% of Kendle’s equity, or up to 10% if the IPO was delayed and Kendle had to borrow the full amount to do both acquisitions. Lehman Brothers was confident about an IPO. The underwriters felt Kendle could raise $39 million to $40 million at a price between $12 and $14 per share, and that Candace and Chris could sell some of their shares as well. Premier Research Worldwide Ltd., a CRO with $15.2 million in 1996 revenues, had raised $46.75 million from its recent IPO in February 1997. Kendle felt they had a much better track record than Premier. Kendle now faced some difficult decisions. It could do the full program, including both acquisitions, taking the $30 million Nationsbank deal, and planning for an IPO in late summer. The successful acquisitions of gmi and U-Gene would establish Kendle as the sixth largest CRO in Europe, based on total revenues, and one of only four large CROs able to offer clients the full range of Phase I through Phase IV clinical trials in Europe. The pricing on the two acquisitions of 8 to 10 times EBITDA seemed in line with recent CRO deals (see Exhibit 8). And, once the IPO was completed, Kendle would have both a cash cushion and stock as a currency to help finance future growth and acquisitions. Assuming an IPO of 3 million new shares at a price of $13.00, Kendle would have a cash position of about $14 million and no debt in the capital structure. (See Exhibits 9 and 10 for pro forma  income statements and balance sheets showing the impact of the acquisitions and the IPO.) A related issue was how many of their shares Candace and Chris should sell if an IPO were done. Their current thinking was to sell 600,000 shares. Thus, a total of 3.6 million shares would be for sale at the time of the IPO, including a primary offering of 3 million shares and a secondary offering of 600,000 shares. This sale would reduce holdings controlled by Candace and Chris from 3.65 million shares (83.1% of the shares currently outstanding) to 3.05 million shares (43.4% of the new total outstanding). Doing the full IPO and acquisition program, however, was unprecedented among Kendle’s peers. â€Å"Nobody does this combination all at once—an IPO, senior- and sub-debt financing, and M&A deals,† as Mooney described the situation. Furthermore, the stock prices of public CROs had been falling since last February (see Exhibits 11 and 12 for stock market valuation and price information). If Kendle bought into the full program and the market crashed or the IPO was unsuccessful, the company would have almost $30 million of debt on its books with a very modest equity base. Perhaps it would be better to do just the U-Gene acquisition and use Star Bank to finance it. After completing this acquisition, it could then pursue the IPO. This approach was safer, but of course Kendle might miss the IPO window and miss the opportunity to acquire the second company. Indeed, instead of discouraging Kendle from doing an IPO, the fall in CRO stock prices might be taken as a signal th at Kendle should forge ahead before the window closed completely.

SEABURY CONSTRUCTION CORP. V. DEPARTMENT OF ENVIRONMENTAL PROTECTION E

SEABURY CONSTRUCTION CORP. V. DEPARTMENT OF ENVIRONMENTAL PROTECTION E SEABURY CONSTRUCTION CORP. V. DEPARTMENT OF ENVIRONMENTAL PROTECTION COMMENT The price preference program for minority-owned and woman-owned business enterprises and qualified joint ventures in public works procurement projects with the City of New York was declared invalid by the New York State Supreme Court of New York County.1 The City had implemented a price preference procurement program under the authority of the New York City Charter (?NYC Charter?), which generally requires that all competitive procurements using sealed bids be awarded to the lowest responsible bidder. Section 313(b)(2) of the NYC Charter has an exception to the general rule: The agency letting the contract ? shall ? award the contract to the lowest responsible bidder, unless the mayor shall determine ? that it is in the best interest of the city that a bid other than that of the lowest responsible bidder shall be accepted. In 1991, a new NYC Charter section was added which required the Department of Business Services to promulgate rules to ensure meaningful participation of minority-owned and woman-owned businesses in the City?s procurement procedures. The rules which were promulgated established a 10 percent ?target percentage? for minority-owned and woman-owned businesses, and qualified joint ventures. If a bid from a minority-owned or woman-owned business, or a qualified joint venture was not the lowest bid, but was within the target percentage of the lowest bid, then the purchasing agency would forward that bid and the lowest bid to the Mayor for a determination as to whether it was in the best interest of the City to award the contract to other than the lowest responsible bidder. In early 1993, the Department of Environmental Protection awarded three projects to two companies that were qualified joint ventures. The lowest responsible bidder for these contracts had been submitted by Seabury Construction Corporation (?Seabury?). The two companies awarded the contracts submitted bids which were higher than Seabury?s bids, but were within the 10 percent ?target percentage.? The City?s Chief Procurement Officer, acting for the Mayor, had determined that it was in the City?s best interest to accept the higher bid from the qualified joint ventures. Seabury then sued the City, claiming that NYC Charter ? 313(b)(2) violated section 103(1) of the General Municipal Law (?GML?). The relevant part of GML ? 103(1) reads as follows: Except as otherwise expressly provided by an act of the legislature or by a local law adopted prior to September first, nineteen hundred fifty-three, all contracts for public work involving an expenditure of more than twenty thousand dollars ? shall be awarded by the appropriate officer, board, or agency of a political subdivision ? to the lowest responsible bidder?. The court turned its attention to NYC Charter ? 313(b)(2) in an effort to determine whether that section of the NYC Charter was adopted prior to September 1, 1953. However, both counsel and the court appear to have overlooked a key statutory construction analysis which could have provided a colorable, though likely unsuccessful, argument contrary to the court?s conclusion. GML ? 103 was enacted in 1953.2 The relevant part of the original statute read as follows: Except as otherwise expressly provided by an act of the legislature, or except in an emergency, all contracts for public work involving an expenditure of more than twenty-five hundred dollars ? shall be awarded by the appropriate officer, board, or agency of a political subdivision ? to the lowest responsible bidder?. The phrase, ?or by a local law adopted prior to September first, nineteen hundred fifty-three? is conspicuously absent from the original legislation. The department memorandum relating to the bill includes the following remarks: The primary objective of this bill is to harmonize and to extend the application of laws relating to public bidding on contracts let by counties, cities, towns, villages, school districts and district corporations?. Section 103 will apply ?except as otherwise expressly provided by an act of the legislature?. The quoted phrase was inserted in view of provisions in city charters and other laws of limited application which may prescribe different requirements with respect to public bidding.? The law was then amended in 1955.3 The amended law read as follows: Except as otherwise expressly provided by an act of the legislature or by a local law adopted prior to September first, nineteen hundred fifty-three, or except