It has two divisions: pharma- nostics cover a variety of diseases in scope buy cheap pravachol 10 mg, 5 order pravachol with visa,000 ceuticals and diagnostics buy pravachol visa. Roche did not disclose products in 39 of projects intended to address the needs of discovery or pre-clinical stages of development. A small proportion of its pipeline targets 21 high-priority product gaps with low commer- Roche has 19 medicines, 46 diagnostics and 11 cial incentive. Roche com- mitted to making its Cobas system available at Approximately half of Roche s portfolio is focused The company is developing products for fve lower prices in developing countries. The company publishes its policy positions thereby committing to investing in R&D that related to access to medicine, including biosim- aims to meet public health needs. Roche does not provide evidence that strengthening healthcare infrastructure; increas- includes the description of cases where conficts it shared its intellectual property with research ing awareness; and supporting patients. It tai- of interest may arise, and actions employees are institutions or neglected disease drug discovery lors its approach depending on local health- expected to take. In 2015, it rolled out the Access close information related to the political contri- in April 2016, the company did review its posi- Planning Framework, aiming to identify spe- butions it may make in countries within scope. Roche falls 9 places to 20th, Low transparency regarding stakeholder actions taken in response. R&D commitments not clearly linked to needs Targets needs to a degree through equitable Roche engages with local stakeholders on an ad within the scope of the Index. It publishes only general information, to R&D that addresses unmet product needs vant products have pricing strategies that target and provides no evidence that it incorporates within the scope of the Index. Roche makes no priority countries, reaching 70% of correspond- the outcomes of these activities into its opera- commitment to meeting the specifc needs of ing priority countries (disease-specifc sub-sets tions and strategies. Roche has policies in place is due to improvements in the structure of its and takes measures to ensure its in-house and No disease-specifc registration targets. Roche compliance system and to its public transpar- outsourced clinical trials are conducted ethically does not report disease-specifc registration tar- ency regarding lobbying activities and enforce- gets. Does not fully publish trial results; has system registration decisions, nor does it reveal where for making patient-level data available. Roche does not specify a timeframe for publishing has a code of conduct that includes ethical mar- the results of its clinical trials. Roche does not report keting provisions and that also applies to third provide scientifc researchers with access to having a drug recall policy. Roche does not pub- 154 Access to Medicine Index 2016 lish whether it has issued drug recalls during the considers fnancial sustainability and includes ters to measure blood sugar levels for all chil- period of analysis. In 2014, Roche adapted the packaging Phelophepa mobile health clinic in South Africa. Roche partners with information about several ad hoc donations, Roche supplied glucometers and testing strips 50 universities globally, but focuses on coun- including the outcome and impact reports. The company did not disclose any relevant partnerships with local Involved in donations following natural disas- research organisations to build R&D capacity in ters. Roche makes donated more than 180,000 vials of ceftriax- Commits to waiving patent rights in poor coun- a general commitment to build manufacturing one (Rocephin ), an antibiotic that treats a wide tries. Roche contributed to at least Roche Annual Report 2015; Roche corporate signifcant medical need be identifed. It has granted licences for the pro- ples of safety label updates for its medicines or duction of oseltamivir (Tamifu ) in order to pharmacovigilance-related information-sharing support increased production. Roche makes a public statement on Does not take a public position on the Doha counterfeiting, committing to cooperate with Declaration. Roche has not made a public state- authorities whenever a Roche product is con- ment about its position on the Doha Declaration cerned. Roche has not been found to have breached casting) regarding supply chain management competition law during the period of analysis. Roche is The company supports capacity building activi- involved in humanitarian aid donations, and has ties in countries in scope, such as training labo- a clear public commitment to engaging in prod- ratory technicians in sub-Saharan Africa through uct donations. In R&D, it commits to maintaining its investment in equitable pricing strategy for a disease in scope, and has no R&D overall at over 17% of net sales, and has clear targets to relevant registration targets. Its approach ing and lobbying is low, and it was found to have acted unethi- to intellectual property has improved, with a pledge not to fle cally twice. It is one of the biggest risers in Astellas does not donate products for diseases in scope. Transfer knowledge of equitable pricing strate- access to these medicines, while ensuring their Astellas can make specifc access plans for each gies. Biotechnology and Diagnostics Industries on ting, during late stages of clinical development, Combating Antimicrobial Resistance. Astellas can expand this stakeholder Leverage R&D expertise in product adapta- engagement programme to low- and middle-in- tion for more diseases. Through partnerships, Build lasting improvements in local R&D capac- come countries where it has operations. Astellas can draw on its existing R&D activi- could lead to a structured approach to stake- ing products to meet specifc needs (as exhib- ties in countries in scope to build local research holder engagement. Americas Japan *Due to a change in company reporting practices, the numbers from 2011 are incomparable with following reporting years. Astellas has two R&D pro- Astellas portfolio is mainly focused on infectious jects that target high-priority product gaps with diseases, and includes seven broad-spectrum low commercial incentive: for Chagas disease 5 antibiotics registered for the treatment of multi- and schistosomiasis. This includes nilvadipine (Nivadil ), doxycycline and includes plans for access, e. Lags behind without a clear strategy for and for failing to provide accurate information. Has objectives for improving access, but they countries that the company has operations with. Astellas has dropped four places to 19th posi- are not aligned with the core business strategy. Maintains its performance while others drop Nevertheless, it does not report having an access behind. Astellas rises three positions in R&D: No eforts to facilitate its products rational strategy, nor does it explain how its objectives overall it has maintained its performance, and use. Astellas does not have dedicated incen- Astellas commits to conducting R&D for dis- from countries in scope. Such measures help tive structures in place for rewarding its employ- eases that have been neglected for commer- ensure products are used as intended. Nor does it have measures for track- ing its R&D commitments requires long-term Pricing guidelines provided to sales agents. The company does not have a structured Poor policy and transparency in collaborations.

At this endemic equilibrium the replacement number se is 1 pravachol 20 mg with visa, which is plausible since if the replacement number were greater than or less than 1 buy pravachol american express, the infective fraction i(t) would be increasing or decreasing order 20 mg pravachol fast delivery, respectively. Notice that the ie coordinate of the endemic equilibrium is negative for <1, coincides with the disease-free equilibrium value of zero at = 1, and becomes positive for >1. This equilibrium given by se =1/ and ie = ( 1)/ is unstable for <1 and is locally asymptotically stable for >1, while the disease-free equilibrium given by s = 1 and i =0is locally stable for <1 and unstable for >1. Thus these two equilibria exchange stabilities as the endemic equilibrium moves through the disease-free equilibrium when = 1 and becomes a distinct, epidemiologically feasible, locally asymptotically stable equilibrium when >1. The following interpretation of the results in the theorem and paragraph above is one reason why the basic reproduction number R0 has become widely used in the epidemiology literature. If the basic reproduction number R0 (which is always equal to the contact number when the entire population is susceptible) is less than 1, then the disease-free equilibrium is locally asymptotically stable and the disease cannot invade the population. But if R0 > 1, then the disease-free equilibrium is unstable with a repulsive direction into the positive si quadrant, so the disease can invade in the sense that any path starting with a small positive io moves into the positive si quadrant where the disease persists. The latter condition is used to obtain expressions for R0 in age-structured models in sections 5 and 6. This unrealistically short average lifetime has been chosen so that the endemic equilibrium is clearly above the horizontal axis and the spiraling into the endemic equilibrium can be seen. They unrealistically assume that the population is uniform and homoge- neously mixing, whereas it is known that mixing depends on many factors including age (children usually have more adequate contacts per day than adults). Moreover, dierent geographic and social-economic groups have dierent contact rates. By using data on the susceptible fractions so and s at the beginning and end of epidemics, this formula can be used to estimate contact numbers for specic diseases [100]. Using blood samples from freshmen at Yale University [75], the fractions susceptible to rubella at the beginning and end of the freshman year were found to be 0. For the 1957 Asian Flu (H2N2 type A strain of inuenza) in Melbourne, Australia, the fractions so = 1 and s =0. This approach is somewhat naive, because the average seropositivity in a population decreases to zero as the initial passive immunity declines and then increases as people age and are exposed to infectives. The incidence rate at the endemic equilibrium is iese, so that ie is the incidence rate constant, which with exponential waiting time implies that the average age of infection (the mean waiting time in S) is A =1/ie =1/[ ( 1)]. Data on average ages of infection and average lifetimes in developed countries have been used to estimate basic reproduction numbers R0 for some viral diseases. Because disease-acquired immunity is only temporary for bacterial diseases such as pertussis (whooping cough) and diphtheria, the formula R0 = =1+L/A cannot be used to estimate R0 for these diseases (see section 8 for estimates of R0 and for pertussis). Herd immunity occurs for a disease if enough people have disease-acquired or vaccination-acquired immunity, so that the introduction of one infective into the pop- ulation does not cause an invasion of the disease. Intuitively, if the contact number is, so that the typical infective has adequate contacts with people during the infectious period, then the replacement number s must be less than 1 so that the disease does not spread. This means that s must be less than 1/, so the immune fraction r must satisfy r>1 1/ =1 1/R0. Using the estimates above for R0, the minimum immune fractions for herd im- munity are 0. Although these values give only crude, ballpark estimates for the vaccination-acquired immunity level in a community required for herd immunity, they are useful for comparing diseases. For example, these numbers suggest that it should be easier to achieve herd immunity for poliomyelitis and smallpox than for measles, mumps, and rubella. This conclusion is justied by the actual eectiveness of vaccina- tion programs in reducing, locally eliminating, and eradicating these diseases (eradi- cation means elimination throughout the world). The information in the next section veries that smallpox has been eradicated worldwide and polio should be eradicated worldwide within a few years, while the diseases of rubella and measles still persist at low levels in the United States and at higher levels in many other countries. For centuries the process of variolation with material from smallpox pustules was used in Africa, China, and India before arriving in Europe and the Americas in the 18th century. Edward Jenner, an English country doctor, observed over 25 years that milkmaids who had been infected with cowpox did not get smallpox. In 1796 he started vaccinating people with cowpox to protect them against smallpox [168]. Two years later, the ndings of the rst vaccine trials were published, and by the early 1800s, the smallpox vaccine was widely available. Smallpox vaccination was used in many countries in the 19th century, but smallpox remained endemic. Smallpox was slowly eliminated from many countries, with the last case in the Americas in 1971. The last case worldwide was in Somalia in 1977, so smallpox has been eradicated throughout the world [23, 77, 168]. Most cases of poliomyelitis are asymptomatic, but a small fraction of cases result in paralysis. In the 1950s in the United States, there were about 60,000 paralytic polio cases per year. In 1955 Jonas Salk developed an injectable polio vaccine from an inactivated polio virus. This vaccine provides protection for the person, but the person can still harbor live viruses in their intestines and can pass them to others. In 1961 Albert Sabin developed an oral polio vaccine from weakened strains of the polio virus. This vaccine provokes a powerful immune response, so the person cannot harbor the wild-type polio viruses, but a very small fraction (about one in 2 million) of those receiving the oral vaccine develop paralytic polio [23, 168]. The Salk vaccine interrupted polio transmission and the Sabin vaccine eliminated polio epidemics in the United States, so there have been no indigenous cases of naturally occurring polio since 1979. In order to eliminate the few cases of vaccine-related paralytic polio each year, the United States now recommends the Salk injectable vaccine for the rst four polio vaccinations, even though it is more expensive [50]. In the Americas, the last case of paralytic polio caused by the wild virus was in Peru in 1991. Most countries are using the live-attenuated Sabin vaccine, because it is inexpensive (8 cents per dose) and can be easily administered into a mouth by an untrained volunteer. Measles is a serious disease of childhood that can lead to complications and death. For example, measles caused about 7,500 deaths in the United States in 1920 and still causes about 1 million deaths worldwide each year [47, 48]. Measles vaccinations are given to children between 6 and 18 months of age, but the optimal age of vaccination for measles seems to vary geographically [99]. But the replacement number R remained above 1, so that smallpox per- sisted in most areas until the mid-20th century. In 1966 smallpox was still endemic in South America, Africa, India, and Indonesia. Because the goal of a rubella vaccination program is to prevent rubella infections in pregnant women, special vaccination strategies such as vaccination of 12 to 14-year-old girls are sometimes used [98, 101].

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This is unlikely to take place at the manufac- Future therapies involving regenerative medicine will turing sites of pharmaceutical companies buy pravachol 10 mg free shipping. Instead purchase 10 mg pravachol free shipping, ini- require tools 10 mg pravachol with mastercard, techniques and agents that can be used tial processing will probably occur at the bedside in the in-house to ensure their broad availability and use. The procedure involved involving instruments and agents will be needed, and will require special training and investment in the nec- will be provided by the medtech industry. Or will peer-to-peer collaboration models investment both in infrastructure and in the education with Big Pharma succeed? Today, the race seems open and training of qualifed personnel is therefore re- and it also involves competing biotech companies and quired if patients are to be treated with regenerative leading research-driven healthcare providers. Regenerative medicine is a new and valuable treatment op- consortium HemAcure addresses a far more frequent disease, tion for more and more acute and chronic clinical conditions. HemAcure consists of aca- to signifcantly improve such chronic conditions as cartilage demic groups from Germany, Italy and the United Kingdom, defects or malignant melanomas. It is even possible to cure and uses a medical device supplied by a Canadian medtech certain diseases, such as some types of leukemia and a rare company. In terms of transplants, scientists have managed to tissue engineer the One European biotech company is even further along the frst autologous organ parts when donors were lacking. They road, with an allogenic stem-cell injection currently in the ap- have successfully constructed bladders, blood vessels, skin proval process. In fact, it is not impossible that we will see dis- An ex-vivo gene therapy approach has also been chosen by eases become extinct for which patients used to take daily another partnership between academia and industry. B: Regenerative medicine is set to transform the healthcare ecosystem Patient Payer Promises a cure Healthcare provider vs. The question must be answered separately for each treatment, based on the W e foresee far more target population size and the severity of the disease. However, the problems it raises and the need for nego- complex and integrated tiation between payers and providers of such therapies will be the same in each case. Unfortunately, this is not the way pharmaceu- tives will also be needed for the clinical laboratories tical remuneration works. Healthcare systems will sim- and hospital pharmacies involved in the event that ply not be capable of paying such linear extrapolations therapies need to be partially delivered on site. At some point, the fnan- Designing commercial models for these complex, cost- cial value will grow more slowly than the value the ther- ly therapies is likely to determine whether or not they apy provides to the patient. It also represents an The truth is that current reimbursement models are enormous chance for healthcare systems to work to- not ready for regenerative medicine. Roland Berger gether with the pharmaceutical and medtech industry foresees far more complex and integrated commercial to develop sophisticated win-win models that beneft remuneration models developing for regenerative everyone: pharmaceuticals and medtech suppliers, medicine in the future. This may be the only way to ensure that the providers of the therapy are sufciently reimbursed to keep them committed to it in the long run. Possible remuneration models for stem-cell and gene therapies include shared cost models, special fnanc- ing plans, milestone payment models and repayment models in the event of failure. Regenerative medicine Roland Berger Focus 13 The advent of regenerative medicine is a game changer Pharmaceutical companies should also adapt their or- for Big Pharma. Given the challenges it presents to ganizational model and people strategy to ensure the their established business model, we recommend that availability of appropriate skills, capabilities and ca- companies carry out an audit to determine their "ft" pacities in the new development, manufacturing and with the new world of regenerative medicine. Out-of-the-box thinking will come data and so on) and its overall organizational be necessary to secure their position in the future model and people strategy. They will need to fnd ed as necessary, depending on the specifc business and answers to some difcult questions: Should they ex- nature of the company. Based on the gaps identifed in pand their activities to include healthcare provision? What is the best way to steer their regenerative medi- Pharmaceutical companies have a number of aspects cine business in parallel with their traditional drug to consider. How can they engage more in sensors, devic- tablish ways to identify threats from products with es and diagnostics? What tools should they provide to substitution potential for their own therapeutics. They physicians and clinical staf to simplify medical treat- should also establish a mechanism for identifying the ments and the measurement of outcomes? Equally changes must be made to their legal structure or orga- important are searching for potential biochemical tar- nizational setup? This is an opportunity they cannot aford to bring their clinical development model into line with miss. Given the severity of interventions, they must place a special focus on long-term studies of safety. Thilo Kaltenbach Morris Hosseini Partner Partner +49 89 9230-8651 +49 30 39927-3342 thilo. Bastian Eulenstein Koen Besteman Senior Consultant Principal +49 89 9230-8151 +31 20 796 0619 bastian. The reader should not act according to any information provided in this publication without receiving specifc professional advice. Roland Berger GmbH shall not be liable for any damages resulting from any use of the information contained in the publication. Regenerative medicine Roland Berger Focus 15 About us Roland Berger, founded in 1967, is the only leading global consultancy of German heritage and European origin. With 2,400 employees working from 34 countries, we have successful operations in all major international markets. Navigating Complexity Roland Berger has been helping its clients to manage change for half a century. Looking forward to the next 50 years, we are committed to supporting our clients as they face the next frontier. We help our clients devise and implement responsive strategies essential to lasting success. There are a lot of applications in artificial intelligence domain that try to help human experts offering solutions for a problem. This paper describes an expert system developed in order to make some predictions regarding the hepatitis infection. There are a lot of tools which try to reduce the risk of error apparition in medical life. It is the first step from a set of therapeutic actions; an error at this level can have dramatic consequences. The tech- nology doesn t replace human experts in this point of medical assistance; it only tries to help them, implementing systems that are able to select or to generate data which are relevant for the physicians. It is made using the main two branches of artificial intelligence: the traditional one, represented by expert systems (based on logical and statistical inference); the connexionist one, where the most common forms used are artificial neural networks. The goal of the system is to offer predictions about patients infected with hepatitis virus. A correct diagnosis and an adequate treatment could reduce the risks of liver cancer apparition. The first step is to decide, using logical inference, what type of hepatitis virus is present.

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Thus purchase genuine pravachol, postmarketing surveillance is essential to the discovery of unexpected adverse drug effects discount pravachol 20 mg with visa. However 20 mg pravachol sale, one estimate is that only 1% of adverse drug reactions are voluntarily reported to pharmaceutical companies and the U. Using MedWatch, the reporting individual does not have to prove absolutely an association between the drug and the adverse reaction. When reported, the information becomes part of a large database and can be investigated further. Voluntary reporting led to the observation that ventricular arrhythmias, such as torsades de pointes, may occur when terfenadine is administered with erythromycin or ketoconazole (13). Reporting adverse reactions to MedWatch Most adverse drug reactions do not have an allergic basis. What follows is a discussion that primarily focuses on those reactions that are, or possibly could be, mediated by immunologic mechanisms. Allergic drug reactions account for 6% to 10% of all observed adverse drug reactions. It has been suggested that the risk for an allergic reaction is about 1% to 3% for most drugs. However, as many as 15% believe themselves to be or have been incorrectly labeled as being allergic to one or more drugs and, therefore, may be denied treatment with an essential medication. At times, it may be imperative to establish the presence or absence of allergy to a drug when its use is necessary and there are no safe alternatives. Although many patients with a history of reacting to a drug could safely receive that drug again, the outcome could be serious if that patient is truly allergic. Physicians should carefully analyze adverse drug reactions to determine their nature because this will influence future use. For example, a drug-induced side effect may be corrected by simply reducing the dose. On the other hand, an allergic reaction to a drug may mean that drug cannot be used or may require special considerations before future administration. Not included in this classification are those reactions that are unrelated to the drug itself but are attributable to events associated with and during its administration. Such events are often mistakenly ascribed to the drug, and the patient is inappropriately denied that agent in the future. Particularly after parenteral administration of a drug, psychophysiologic reactions in the form of hysteria, hyperventilation, or vasovagal response may ensue. Some of these reactions may be manifestations of underlying psychiatric disorders ( 15). They are a result of the disease under treatment and may be incorrectly attributed to the drug, for example, the appearance of viral exanthems and even urticaria during the course of a treatment with an antibiotic. Although it may be difficult to characterize a particular drug reaction, a helpful classification is shown in Table 17. Classification of adverse drug reactions Overdosage: Toxicity The toxic effects of a drug are directly related to the systemic or local concentration of the drug in the body. Such effects are usually predictable on the basis of animal experimentation and may be expected in any patient provided a threshold level has been exceeded. It may be due to accumulation as a result of some abnormality in the patient that interferes with normal metabolism and excretion of the drug. The toxicity of morphine is enhanced in the presence of liver disease (inability to detoxify the drug) or myxedema (depression of metabolic rate). The toxicity of chloramphenicol in infants is due to immaturity of the glucuronide conjugating system, allowing a toxic concentration to accumulate. In the presence of renal failure, drugs such as the aminoglycosides, normally excreted by this route, may accumulate and produce toxic reactions. They are therapeutically undesirable, but often unavoidable, pharmacologic actions occurring at usual prescribed drug dosages. A drug frequently has several pharmacologic actions, and only one of those may be the desired therapeutic effect. The first-generation antihistamines commonly cause adverse central nervous system effects, such as sedation. Their anticholinergic side effects include dry mouth, blurred vision, and urinary retention. Other side effects may be delayed in expression and include teratogenicity and carcinogenicity. Methotrexate, which has been used in some steroid-dependent asthmatic patients, is teratogenic and should not be used during pregnancy. Immunosuppressive agents can alter host immunity and may predispose the patient to malignancy (17). They may be interpreted as the appearance of another naturally occurring disease rather than being associated with administration of the drug. Some appear to be due to the drug itself, creating an ecologic disturbance and permitting the overgrowth of microorganisms. In the presence of antimicrobial (notably ampicillin, clindamycin, or cephalosporins) exposure, Clostridium difficile can flourish in the gastrointestinal tract in an environment in which there is reduced bacterial competition. Toxins produced by this organism may result in the development of pseudomembranous colitis (18). Antimicrobial agents may be associated with another group of reactions that may mimic hypersensitivity, but appear to be disease associated. The reaction is believed to result from the release of microbial antigens, endotoxins, or both ( 19). This has usually followed penicillin treatment of syphilis and leptospirosis, but also has been observed during treatment of parasitic and fungal infections. With continued treatment, the reaction subsides, thus confirming it is not an allergic response. Unfortunately, treatment is often discontinued and the drug blamed for the reaction. Another example would include the high incidence of skin rash in patients with the Epstein-Barr virus treated with ampicillin. Drug Drug Interactions A drug drug interaction is generally regarded as the modification of the effect of one drug by prior or concomitant administration of another. Fortunately, drug drug interactions of major clinical consequence are relatively infrequent ( 20). It is also important to recall that not all drug interactions are harmful, and some may be used to clinical advantage. As the number of drugs taken concurrently increases, the greater the likelihood of an adverse drug interaction.

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