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The partnership will apply novel technologies to further enhance our bioreactor suspension production process. This will allow us to focus on developing new candidates for partnering while reducing the risk and cost of later-stage development. This relatively modest investment leverages the growing financial strength of the business, while adding significant additional value to the product as it progresses towards the clinic. Consequently, we are progressing to lease a large vacant facility near our Windrush Court headquarters to allow further expansion. An exciting future the past year has been a period of great transformation for Oxford BioMedica. With the success of our Novartis partnership and the signing of the Bioverativ agreement validating our technology and wider capabilities, 2018 promises to be another exciting year of progress. With demand growing for our proprietary lentiviral vector technology, we plan to further expand our portfolio of strategic collaborations, and conclude discussions with potential partners for our in-house development programmes. Our position in the sector is now firmly established, and we look forward to expanding our role as a world-leading gene and cell therapy business, both for patients and our shareholders. Analysts believe the breakthrough cell therapy has blockbuster potential, with predicted peak sales of at least $1. Novartis plans further regulatory filings in a number of additional countries in 2018. Oxford BioMedica plc Annual report and accounts 2017 Partnership portfolio During the year we also made progress in our wider portfolio of partnerships: - Orchard Therapeutics: we established our collaboration with Orchard Therapeutics in November 2016, focusing on the development of autologous ex vivo lentiviral gene therapies for primary immune deficiencies and inherited metabolic disorders. Orchard Therapeutics is responsible for the clinical development and commercialisation of the products. By out-licensing or spinning-out the products into special purpose vehicles, Oxford BioMedica has the potential to benefit from upfront fees or equity stakes, vector development and bioprocessing revenues, milestone payments and sales-based royalties, while reducing the risk and cost of in-house clinical development. In-house clinical development During the year we initiated discussions with a number of third-parties to advance our priority in-house product candidates into clinical development. During 2017 we completed manufacture of clinical trial materials for the study, and started working on preparing trial centres in Cambridge and London. The first patient is likely to receive the novel gene therapy in the first half of 2018 and we anticipate data from the first cohort of the study within one year. To facilitate the spin-out of our in-house ocular assets, we are looking to establish a dedicated legal structure in the first half of 2018.
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The competitiveness crisis of the 1980s suggested that Japan would surge ahead of us because they were better savers, innovators, workers, and managers. Samuelson indicates that he believes "the apparent American deficit in scientists and engineers is also exaggerated. Of greater importance, Samuelson concludes, is that the United States must continue to draw on the strengths that overcome its weaknesses: "ambitiousness; openness to change (even unpleasant change); competition; hard work; and a willingness to take and reward risk. R&D spending increased 140%, from $177 billion to $245 billion, in the same period. The United States spends significantly more than China on R&D in gross terms and in percentage of R&D. Rising Above the Gathering Storm: Energizing and Employing America for a Brighter Economic Future 74 3. Population (measured in thousands) and number of university researchers (measured in fulltime equivalents) refer to 1999. So if an article was written by authors from the United States and Switzerland, it would be included in the count for both countries. Other nations also are spending more on higher education and providing incentives for students to study science and engineering. To attract the best graduate students from around the world, universities in Japan, Switzerland, and elsewhere are offering science and engineering courses in English. In the 1990s, both China and Japan increased the number of students pursuing science and engineering degrees, and there was steady growth in South Korea. That deficit raises concern about our competitive ability in important areas of technology. From 1988 to 2001, world publishing in science and engineering increased by almost 40%,24 but most of that increase came from Western Europe, Japan, and several emerging East Asian nations (South Korea, China, Singapore, and Taiwan). Yet trends in publication could be a troubling bellwether about our competitive position in the global science community. Graduate students and postdoctoral scholars gain direct experience under the guidance of veteran researchers. The important link between graduate education and research that has been forged through a combination of research assistantships, fellowships, and traineeships has been tremendously beneficial to students and researchers and is a critical component of our success in the last half-century. In China, doctorate production was essentially zero until 1985, but 15 years later, 7,304 doctorates were conferred. They came first from Europe, fleeing fascism, and more recently they have come from China, India, and the former Soviet Union, seeking better education and more economic opportunity. They are working harder to attract international students and to encourage the movement of skilled personnel into their countries. Since 2001, the Indian government has been providing money ($5 billion in fiscal year 2005) for "soft loans," which require no collateral, to students who wish to travel abroad for their education. In 2002, India surpassed China as the largest exporter of graduate students to the United States. In addition to sending students abroad for training, emerging economic powers, notably India and China, have lured their skilled scientists and engineers to return home by coupling education-abroad programs with strategic investments in the science and engineering infrastructure-in essence sending students away to gain skills and providing jobs to draw them back.
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Patients who take longer-acting compounds or daytime doses of any hypnotic should be advised of the potential for impairment, even in the absence of subjective symptoms. These patients should also be advised to avoid driving, particularly during the initial phase of dosage adjustment(s). Benzodiazepines and other sedatives / anxiolytics Muscle relaxants Most skeletal muscle relaxants (e. Patients should be counseled about these side effects, and should be advised not to drive during the initial phase of dosage adjustment(s) if they experience side effects severe enough to affect safe driving performance. Residual effects of aaleplon 10 and 20 mg on memory and actual driving performance following administration 5 and 2 hours before awakening. Residual effects of zaleplon and zopiclone versus the effects of alcohol on actual car driving performance. The impact on car-driving performance of zaleplon and zolpiden administration during the night. Concentrations of scheduled prescription drugs in blood of impaired drivers: considerations for interpreting the results. However, the literature also indicates that physicians often undertreat pain in the general population and with older adults. Patients should be counseled about these side effects and advised not to drive during the initial phase of dosage adjustment(s) if they experience side effects severe enough to impair driving performance. As in other aspects of patient care, however, further research can lead to more effective care. We eagerly await further evaluation of in-office tools that can predict crash risk or determine fitness-to-drive, as well as improved ac cess to driver assessment and rehabilita tion. We also look forward to advanced technology in vehicles to assist drivers with navigation and safety issues. At the same time, we wish for safer roads, better transportation alternatives, in creased crashworthiness of vehicles, and other vehicular improvements that can help keep our patients safe on the road as long as possible. As this population continues to expand and live longer, we all have the challenge of keeping pace with its transportation needs. We encourage readers of this guide to use this list as a launching pad to boost your future plans and efforts. Improved physician tools for the assessment of driving safety Physicians need an assessment tool that reliably identifies patients who are at increased risk for a car crash. This test battery must assess the primary functions that are related to driving, and must form a basis for medical interventions to correct any functional deficits that are identified. In addition, this tool must be brief, inexpensive, easy to administer, and validated to predict crash risk and/or the ability to pass a performance-based, standardized, reliable and valid road test. Individual functional tests (such as the Trail Making Test, Part B; see Chapters 3 and 4) have been repeat edly shown to correlate with crash risk, yet there is still not a universal cut-off or score on these tests that can deter mine fitness-to-drive. The field has focused on heterogeneous groups of older adults with modest correlations in functional batteries.
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It can make a person reluctant to participate in conversation and avoid social situations, and can cause fatigue if visual and contextual clues are required to fill gaps between what was said and what was heard. Left untreated, hearing loss can cause delays in language development and gaps in education. Children with hearing impairment often require some form of special education or related services (10). Early intervention and academic support teams should work in conjunction with health care providers, such as audiologists and speech therapists, to identify intervention and academic needs. Section 504 of the Rehabilitation Act contains provisions for a school-aged child with hearing loss who needs accommodations, such as assistive listening devices, to access the educational curriculum, but who does not need one-on-one special education teaching or therapy services (12). Hearing aids Hearing aids are devices that make sounds louder, and are worn in or behind the ear. Hearing aids can be beneficial for all types of hearing loss (conductive, sensorineural, or mixed) and almost all degrees of hearing loss. The hearing aid directs amplified sound into the ear canal via the earmold, a plastic piece that is custom-made to fit each ear. Children require frequent replacement of their earmolds-as often as every 2 to 4 weeks during the first year of life, every 1. The receiver can be integrated into a hearing aid or used as a stand-alone listening device similar to a personal music player. Patients with moderate, severe, or profound sensorineural hearing loss are typically not candidates for middle ear surgery. In some patients, poor middle ear anatomy or middle ear fluid precludes surgical intervention. Middle Ear Surgery If the middle ear bones are immobile or absent, a surgical procedure called ossicular chain reconstruction can be performed to replace the defective or missing ossicle(s) with a prosthesis. If the ear canal is absent or very narrow, it can be reconstructed in a surgical procedure called canalplasty. The outer opening of the ear canal, called the meatus, is widened, and the outer edge of the skin graft is delivered through the meatus and sutured to the native skin of the pinna. In the general population, middle ear surgery improves conductive hearing loss in 75% to 90% of carefully selected candidates (14), but it is important to understand that not all patients with conductive hearing loss and associated middle ear abnormalities are candidates for surgery. Bone conduction hearing devices A bone conduction hearing device may be useful for patients with conductive hearing loss who cannot use conventional hearing aids due to problems such as a congenitally undeveloped ear canal, or for individuals who are not good candidates for traditional middle ear surgery (15).
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They are thought to increase the risk of liver cancer through inflammation that may result in liver cirrhosis. Baseline risks for liver cancer are much higher in Japan than in the United States, and rates of infection with hepatitis B and C undoubtedly contribute to this difference. The mechanistic arguments above and the limited epidemiologic data tend to support the use of the multiplicative transportation model. Tobacco smoke contains approximately 4000 specific chemicals, including nicotine, polycyclic aromatic hydrocarbons, N-nitroso compounds, aromatic amines, benzene, and heavy metals. Lung cancer is not thought to be attributable to any one chemical component, but rather to the effect of a complex mixture of chemicals in tobacco smoke, which may act at different stages of the carcinogenic process. Based on the mechanistic arguments above, this suggests that neither a pure absolute nor a pure relative risk transport model is appropriate. Pierce and colleagues (2003) evaluated the joint effect of smoking and radiation exposure on lung cancer risks in Abomb survivors and found that they were significantly submultiplicative and consistent with an additive model. Although data on miners were compatible with a multiplicative effect and not with an additive one, the estimated interaction was submultiplicative. The above considerations would therefore suggest that the preferred transportation model for breast cancer should be based on a multiplicative model. The female breast is one of the few cancer sites for which extensive epidemiologic data on predominantly Caucasian populations are available, and this makes it possible to base risk estimates directly on Caucasian data, avoiding the need to transport risks. Nevertheless, it is useful to evaluate what these data tell as about appropriate transportation models. Land and colleagues (1980) conducted parallel analyses of cancer incidence data in Japanese A-bomb survivors, Massachusetts tuberculosis fluoroscopy patients, and New York women treated with radiation for mastitis, and found that absolute risks were comparable for the three cohorts whereas relative risks were much larger in the Japanese cohort. This was recently confirmed in a pooled analysis of breast cancer incidence in several cohorts by Preston and coworkers (2002a). In this study, models that were similar in form could be used to describe breast cancer incidence in A-bomb survivors and in U. However, since fluoroscopy exposure is protracted and involves lower-energy photons than A-bomb exposure, these differences in exposures might confound the comparison. Little and Boice (1999) and Brenner (1999) provide additional discussion of these issues with a commentary by Ullrich (1999). In a case-control study of breast cancer among A-bomb survivors, Land and colleagues (1994a) evaluated the interaction of several risk factors for breast cancer with radiation and found that the relationship was better described by a multiplicative model than an additive one. In summary, mechanistic considerations and some epidemiologic data support relative risk transport. However, direct use of data on predominantly Caucasian populations results in estimates that are comparable to those based on A-bomb survivors on an absolute risk scale, but not on a relative risk scale. In summary, the absolute risk transport model has greater support for lung cancer than for stomach or liver cancer.
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Special Considerations Individuals susceptible to adverse effects: People with the following conditions are particularly susceptible to the adverse effects of excess niacin intake: liver dysfunction or a history of liver disease, diabetes mellitus, active peptic ulcer disease, gout, cardiac arrhythmias, inflammatory bowel disease, migraine headaches, and alcoholism. Supplements containing up to about 400 mg of niacin are available without a prescription in the United States. Bioavailability Niacin from meat, liver, beans, and fortified or enriched foods appears to be highly bioavailable, whereas niacin from unfortified cereal grains is bound and only about 30 percent available (although alkali treatment of the grains increases the percentage absorbed). Niacin added during enrichment or fortification is in the free form of niacin; foods that contain this free form include beans and liver. The conversion efficiency of tryptophan to niacin, although assumed to be 60:1, varies depending on a number of dietary and metabolic factors. The efficiency of conversion is decreased by deficiencies in some other nutrients (see "Dietary Interactions"). Individual differences also account for a substantial difference in conversion efficiency. Dietary Interactions There is some evidence that inadequate iron, riboflavin, or vitamin B6 status increases niacin needs by decreasing the conversion of tryptophan to niacin. Now it is occasionally seen in developing nations, such as in India, China, and Africa. Deficiencies of other micronutrients, such as pyridoxine and iron, which are required to convert tryptophan to niacin, may also contribute to the appearance of pellagra. But adverse effects may result from excess niacin intake from dietary supplements, pharmaceutical preparations, and fortified foods. Most of the data concerning adverse effects of niacin has come from studies and case reports involving patients with hyperlipidemia or other disorders who were treated with pharmacological preparations that contained immediate-release nicotinic acid or slow- or sustained-release nicotinic acid. The amino acid tryptophan is converted in part into nicotinamide and thus can contribute to meeting the requirement for niacin. The requirements for niacin are based on the urinary excretion of niacin metabolites. Also, pregnant females who are carrying more than one fetus or breastfeeding more than one infant may require additional niacin.
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For example, in the first trial,228 the proportions of patients with headache in 20 mg and 10 mg tadalafil arms were 17. In the second trial,230 numerically more patients who received 20 mg tadalafil had headache compared with those who received a 10 mg dose (8. In one trial,227 compared with those who received 10 mg of tadalafil, patients receiving a 20 mg dose experienced numerically higher rates of dyspepsia (22. The incidence of back pain was numerically slightly higher in patients receiving 20 mg versus those receiving 10 mg of tadalafil in one trial (4. Of the eight trials comparing the efficacy/safety profiles of 20 mg and 10 mg tadalafil, the absence or presence of serious adverse events could not be ascertained for six trials. In the same trial, patients on 20 mg tadalafil had a faster erectogenic response (starting 16 minutes post-dose) than those on 10 mg of tadalafil (starting 26 minutes post-dose). For example, there was a statistically significant higher mean perpatient proportion of successful intercourse attempts (i. Two trials214,232 compared the efficacy/safety of two dosing regimens of 20 mg tadalafil (on demand therapy versus scheduled therapy). In the first trial,214 the rate of any adverse events (percentage of patients with at least one adverse event) did not differ between groups who were given tadalafil either on demand or 3 times per week (21. The proportion of patients who withdrew from the on-demand and the 3 times per week dosing regimens were 4. In the second trial,232 the most frequent adverse events were dyspepsia, headache, back pain and myalgia, observed in two of the 20 patients. The other trial evaluated whether 20 mg tadalafil dosing regimens (on demand versus scheduled on alternate days) differed in improving endothelium-dependent vasodilation of cavernous arteries (e. There was also a statistically significant improvement in regard to morning erections observed in patients treated with the 61 scheduled dosing regimen (90 percent of the patients; p <0. In general, in these trials, all three therapies were well tolerated and had similar safety profiles. There were no statistically significant differences in the incidence of any adverse events between tadalafil- and sildenafil-treated groups of patients. In the tadalafil arms the proportion of patients with at least one adverse event across the four trials ranged from 27. In one trial,103 the incidence of serious adverse events did not differ between the tadalafil (5 patients had prostate cancer, purpura, pulmonary edema, gastric cancer) and sildenafil groups (4 patients had cardiac biopsy, chest pain, perianal abscess). Three remaining trials118,121,163 did not report the occurrence or absence of serious adverse events. The total number of withdrawals due to adverse events across the four trials ranged from two121 to 12 patients. In general, results of the four trials103,118,121,163 regarding the measures of erectile function (i. The mean time (in hours) between dosing and sexual attempt was found to be longer for tadalafil than for sildenafil (5. In one trial,118 73 percent of the patients preferred tadalafil and 27 percent preferred sildenafil (p <0.
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Rapid method for determination of riboflavin in urine by highperformance liquid chromatography. A brief photochemically induced oxidative insult causes irreversible lens damage and cataracts. The effects of vitamin C, vitamin B6, vitamin B12, folic acid, riboflavin, and thiamin on the breast milk and maternal status of well-nourished women at 6 months postpartum. The effects of a riboflavin supplementation on the nutritional status and performance of elite swimmers. The influence of sleep, work, diuresis, heat, acute starvation, thiamine intake and bed rest on human riboflavin excretion. Vitamin and mineral status of trained athletes including the effects of supplementation. Observations on induced riboflavin deficiency and the riboflavin requirement of man. Pharmacokinetics of orally and intravenously administered riboflavin in healthy humans. The evaluation of erythrocyte thiamin diphosphate as an indicator of thiamin status in man, and its comparison with erythrocyte transketolase activity measurements. Transketolase activity and urinary excretion of thiamin in the assessment of thiamin-nutrition status of Indians. Blood pyruvate curves following glucose ingestion in normal and thiamine-deficient subjects. Deficiency diseases in prisoners-of-war at Changi, Singapore, February 1942 to August 1945. Intestinal absorption of thiamin in man compared with folate and pyridoxal and its subsequent urinary excretion. Thiamine requirement of eight adolescent boys, as estimated from urinary thiamine excretion. The normal requirement for thiamine; some factors influencing its utilization and excretion. Dietary intake and thiamin, iron, and zinc status in elite Nordic skiers during different training periods. Lack of association between indices of vitamin B1, B2, and B6 status and exerciseinduced blood lactate in young adults. The level of vitamin B-complex in the diet at which detectable symptoms of deficiency occur in man. Thiamin status of incarcerated and nonincarcerated adolescent males: Dietary intake and thiamin pyrophosphate response. A comparison of thiamine synthesis and excretion in human subjects on synthetic and natural diets. Vitamin B1, B2 and B6 deficiencies in geriatric patients, measured by coenzyme stimulation of enzyme activities. Report of the Committee on Nutritional Aspects of Ageing, Food and Nutrition Board, Division of Biology and Agriculture.