The evolving profile, role and relevance of the medical director in a pharmaceutical company

Over the last years, operations in Pharmaceutical Companies have become more complex, trying to adapt to new demands of the market environment. Overall, the observed change of paradigm requires adapting, mainly by the setting of new priorities, diversification of investments, cost containment strategies, exploring new markets and developping new sets of skills. In this context, new functions have been created, the relevance of some has diminished, and the importance of others has arisen. Amongst these, the medical structure within a Pharmaceutical Company, increased to meet demands, with companies adopting different models to respond to these needs, and becoming a pillar to the business. Assuming the leading role within a medical department, the medical director function often lies in the shadow. It is a key function within Pharma Industry, either on a country or on a Global basis. It has evolved and changed in the past years to meet the constant demands of a changing environment. The Medical Director is a highly skilled and differeniated professional who provides medical and scientific governance within a Pharmaceutical company, since early stages of drug development and up to loss of exclusivity, not only but also by leading a team of other physicians, pharmacists or life scientists whose functions comprise specificities that the medical director needs to understand, provide input to, oversee and lead. As the organization of Pharmaceutical Companies tends to be different, in accordance to values, culture, markets and strategies, the scope of activities of a Medical Director can be broader or may be limited, depending on size of the organization and governance model, but they must fulfil a large set of requirements in order to leverage impact on internal and internal customers. Key technical competencies for medical directors such as an MD degree, a strong clinical foundation, knowledge of drug development, project and team management experience and written and verbal skills are relatively easy to define, but underlying behavioural competencies are more difficult to ascertain, and these are more often the true predictors of success in the role. Beyond seamless proficiency in technical skills, at this level interpersonal skills become far more important, as they are the driver and the distinctive factor between a good and an excelent medical director. And this has impact in the business and in the people doing it.

The International <IR> Framework’s impact on the social and relationship disclosures in the healthcare industry

Abstract Background and Problem: The altering business world and the growing requests from stakeholders have resulted in the establishment of new reports. These are among others Sustainability reports and Integrated Reporting. On the contrary, traditional financial reports do not consider the significance of intangible assets in modern entities. The social and relationship capital has further shown to be important for firms, especially healthcare companies and pharmaceuticals, but is not as developed as other capitals within the <IR> framework and therefore not always included in annual reports. However too few disclosures within this area could lead to high liabilities. The IIRC launched the <IR> framework year 2013 as a solution, as it gives a more comprehensive view of the reporting entity. Within this framework there are six capitals: manufactured, human, financial, natural, intellectual and social and relationship.   Purpose: The purpose of this thesis is to find out how the International <IR> Framework has influenced the reporting of the social and relationship disclosures within the healthcare industry, to compare the reporting of the six medical firms chosen and to examine how the social concerns have been developed over time. Delimitations: This study is conducted over a period of three years, from year 2012 to year 2014. It only examines healthcare companies which use the International <IR> framework and it has solely focus on the social and relationship capital. All other capitals within the <IR> framework are excluded from the study. Method: This study has a qualitative research strategy and is based on information collected from published documents in form of annual reports. The annual reports from year 2010, 2011 and 2012 are used to find social and relationship disclosures and a disclosure scoreboard is used to find similarities, differences and patterns. Empirical Results and Conclusion: It has been found that the aggregated social and relationship disclosures have been reduced over time. The year followed by the release of the <IR> framework was seen to have the least disclosures and therefore conclusion was drawn that the <IR> framework had a negative influence on the social and relationship disclosures. There were also differences among the companies studied both in extent and content. The former could be linked to factors such as size and nationality and the latter could be linked to reputation preservation and legitimacy interests.

Accessing occupational exposure to fungi in a cork industry

Different forms of fungal diseases affecting the nose and paranasal sinuses are recognized, including invasive and non-invasive fungal rhinosinusitis. Penicillium glabrum complex is associated with respiratory diseases such as suberosis, a typical disease of cork industry workers. In addition, Chrysonilia sitophila has been described as causing occupational asthma, associated to prolonged exposure to high counts of spores. In this study we aimed to access fungal exposure in workers from one cork industry through the mycological analysis of their nasal exudate and the environmental fungal contamination of their surroundings as well.

The MATCH project: collaboration between academia and industry

The university sector offers innovative research initiatives which industry should be tapping. Michael Craven, Senior Research Fellow at the University of Nottingham, reports on a unique collaboration between academia and industry that is helping companies assess the value of medical technology.

Nanostructured smart materials as functional components of medical devices

The field of medical devices has experienced, more than others, technological advances, developments and innovations, thanks to the rapidly expanding scientific knowledge and collaboration between different disciplines such as biology, engineering and materials science. The design of functional components can be achieved by exploiting composite materials based on nanostructured smart materials, that due to the inherent characteristics of single constituents develop unique properties that make them suitable for different applications preserving excellent mechanical proprieties. For instance, recent developments have focused on the fabrication of piezoelectric devices with multiple biomedical functions, as actuation and sensing functions in one component for monitoring pressure signals. The present Ph.D. Thesis aims at investigating nanostructured smart materials embedded into a polymeric matrix to obtain a composite material that can be used as a functional component for medical devices. (i) Nanostructured piezoelectric material with self-sensing capability was successfully manufactured by using ceramic (i.e. lead zirconate titanate (PZT)) and (ii) polymeric (i.e. poly(vinylidene fluoride-trifluoro ethylene (PVDF-TRFE)) piezoelectric materials. PZT nanofibers were obtained by sol-gel electrospinning starting from synthetized PZT precursor solution. Synthesis, sol-gel electrospinning process, and thermal treatment were accurately controlled to obtain PZT nanofibers dimensionally stable with densely packed grains in the perovskite phase. To guarantee the impact resistance of the laminate, the morphology and size of the hosting filler were accurately designed by increasing the surface area to volume ratio. Moreover, to solve the issue relative to the mechanical discrepancy between rigid electronic materials/soft human tissues/different material of the device (iii) a nanostructured flexible composite material based on a network of Poly-L-lactic acid (PLLA) made of curled nanofibers that present a tuneable mechanical response as a function of the applied stress was successful fabricated.

Reasons For Brazilian Women To Switch From Different Contraceptives To Long-acting Reversible Contraceptives.

Long-acting reversible contraceptives (LARCs) include the copper-releasing intrauterine device (IUD), the levonorgestrel-releasing intrauterine system (LNG-IUS) and implants. Despite the high contraceptive efficacy of LARCs, their prevalence of use remains low in many countries. The objective of this study was to assess the main reasons for switching from contraceptive methods requiring daily or monthly compliance to LARC methods within a Brazilian cohort. Women of 18-50 years of age using different contraceptives and wishing to switch to a LARC method answered a questionnaire regarding their motivations for switching from their current contraceptive. Continuation rates were evaluated 1 year after method initiation. Sample size was calculated at 1040 women. Clinical performance was evaluated by life table analysis. The cutoff date for analysis was May 23, 2013. Overall, 1167 women were interviewed; however, after 1 year of use, the medical records of only 1154 women were available for review. The main personal reason for switching, as reported by the women, was fear of becoming pregnant while the main medical reasons were nausea and vomiting and unscheduled bleeding. No pregnancies occurred during LARC use, and the main reasons for discontinuation were expulsion (in the case of the IUD and LNG-IUS) and a decision to undergo surgical sterilization (in the case of the etonogestrel-releasing implant). Continuation rate was ~95.0/100 women/year for the three methods. Most women chose a LARC method for its safety and for practical reasons, and after 1 year of use, most women continued with the method.

Estimated Disability-adjusted Life Years Averted By Long-term Provision Of Long Acting Contraceptive Methods In A Brazilian Clinic.

What is the contribution of the provision, at no cost for users, of long acting reversible contraceptive methods (LARC; copper intrauterine device [IUD], the levonorgestrel-releasing intrauterine system [LNG-IUS], contraceptive implants and depot-medroxyprogesterone [DMPA] injection) towards the disability-adjusted life years (DALY) averted through a Brazilian university-based clinic established over 30 years ago. Over the last 10 years of evaluation, provision of LARC methods and DMPA by the clinic are estimated to have contributed to DALY averted by between 37 and 60 maternal deaths, 315-424 child mortalities, 634-853 combined maternal morbidity and mortality and child mortality, and 1056-1412 unsafe abortions averted. LARC methods are associated with a high contraceptive effectiveness when compared with contraceptive methods which need frequent attention; perhaps because LARC methods are independent of individual or couple compliance. However, in general previous studies have evaluated contraceptive methods during clinical studies over a short period of time, or not more than 10 years. Furthermore, information regarding the estimation of the DALY averted is scarce. We reviewed 50 004 medical charts from women who consulted for the first time looking for a contraceptive method over the period from 2 January 1980 through 31 December 2012. Women who consulted at the Department of Obstetrics and Gynaecology, University of Campinas, Brazil were new users and users switching contraceptive, including the copper IUD (n = 13 826), the LNG-IUS (n = 1525), implants (n = 277) and DMPA (n = 9387). Estimation of the DALY averted included maternal morbidity and mortality, child mortality and unsafe abortions averted. We obtained 29 416 contraceptive segments of use including 25 009 contraceptive segments of use from 20 821 new users or switchers to any LARC method or DMPA with at least 1 year of follow-up. The mean (± SD) age of the women at first consultation ranged from 25.3 ± 5.7 (range 12-47) years in the 1980s, to 31.9 ± 7.4 (range 16-50) years in 2010-2011. The most common contraceptive chosen at the first consultation was copper IUD (48.3, 74.5 and 64.7% in the 1980s, 1990s and 2000s, respectively). For an evaluation over 20 years, the cumulative pregnancy rates (SEM) were 0.4 (0.2), 2.8 (2.1), 4.0 (0.4) and 1.3 (0.4) for the LNG-IUS, the implants, copper IUD and DMPA, respectively and cumulative continuation rates (SEM) were 15.1 (3.7), 3.9 (1.4), 14.1 (0.6) and 7.3 (1.7) for the LNG-IUS, implants, copper IUD and DMPA, respectively (P < 0.001). Over the last 10 years of evaluation, the estimation of the contribution of the clinic through the provision of LARC methods and DMPA to DALY averted was 37-60 maternal deaths; between 315 and 424 child mortalities; combined maternal morbidity and mortality and child mortality of between 634 and 853, and 1056-1412 unsafe abortions averted. The main limitations are the number of women who never returned to the clinic (overall 14% among the four methods under evaluation); consequently the pregnancy rate could be different. Other limitations include the analysis of two kinds of copper IUD and two kinds of contraceptive implants as the same IUD or implant, and the low number of users of implants. In addition, the DALY calculation relies on a number of estimates, which may vary in different parts of the world. LARC methods and DMPA are highly effective and women who were well-counselled used these methods for a long time. The benefit of averting maternal morbidity and mortality, child mortality, and unsafe abortions is an example to health policy makers to implement more family planning programmes and to offer contraceptive methods, mainly LARC and DMPA, at no cost or at affordable cost for the underprivileged population. This study received partial financial support from the Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP), grant # 2012/12810-4 and from the National Research Council (CNPq), grant #573747/2008-3. B.F.B., M.P.G., and V.M.C. were fellows from the scientific initiation programme from FAPESP. Since the year 2001, all the TCu380A IUD were donated by Injeflex, São Paulo, Brazil, and from the year 2006 all the LNG-IUS were donated by the International Contraceptive Access Foundation (ICA), Turku, Finland. Both donations are as unrestricted grants. The authors declare that there are no conflicts of interest associated with this study.

Mastication Movements And Sleep Quality Of Patients With Myofascial Pain: Occlusal Device Therapy Improvements.

Patients with myofascial pain experience impaired mastication, which might also interfere with their sleep quality. The purpose of this study was to evaluate the jaw motion and sleep quality of patients with myofascial pain and the impact of a stabilization device therapy on both parameters. Fifty women diagnosed with myofascial pain by the Research Diagnostic Criteria were enrolled. Pain levels (visual analog scale), jaw movements (kinesiography), and sleep quality (Epworth Sleepiness Scale; Pittsburgh Sleep Quality Index) were evaluated before (control) and after stabilization device use. Range of motion (maximum opening, right and left excursions, and protrusion) and masticatory movements during Optosil mastication (opening, closing, and total cycle time; opening and closing angles; and maximum velocity) also were evaluated. Repeated-measures analysis of variance in a generalized linear mixed models procedure was used for statistical analysis (α=.05). At baseline, participants with myofascial pain showed a reduced range of jaw motion and poorer sleep quality. Treatment with a stabilization device reduced pain (P<.001) and increased both mouth opening (P<.001) and anteroposterior movement (P=.01). Also, after treatment, the maximum opening (P<.001) and closing (P=.04) velocities during mastication increased, and improvements in sleep scores for the Pittsburgh Sleep Quality Index (P<.001) and Epworth Sleepiness Scale (P=.04) were found. Myofascial pain impairs jaw motion and quality of sleep; the reduction of pain after the use of a stabilization device improves the range of motion and sleep parameters.

Motivating Medical Students To Learn Basic Science Concepts Using Chronic Myeloid Leukemia As An Integration Theme.

To report on the use of chronic myeloid leukemia as a theme of basic clinical integration for first year medical students to motivate and enable in-depth understanding of the basic sciences of the future physician. During the past thirteen years we have reviewed and updated the curriculum of the medical school of the Universidade Estadual de Campinas. The main objective of the new curriculum is to teach the students how to learn to learn. Since then, a case of chronic myeloid leukemia has been introduced to first year medical students and discussed in horizontal integration with all themes taught during a molecular and cell biology course. Cell structure and components, protein, chromosomes, gene organization, proliferation, cell cycle, apoptosis, signaling and so on are all themes approached during this course. At the end of every topic approached, the students prepare in advance the corresponding topic of clinical cases chosen randomly during the class, which are then presented by them. During the final class, a paper regarding mutations in the abl gene that cause resistance to tyrosine kinase inhibitors is discussed. After each class, three tests are solved in an interactive evaluation. The course has been successful since its beginning, 13 years ago. Great motivation of those who participated in the course was observed. There were less than 20% absences in the classes. At least three (and as many as nine) students every year were interested in starting research training in the field of hematology. At the end of each class, an interactive evaluation was performed and more than 70% of the answers were correct in each evaluation. Moreover, for the final evaluation, the students summarized, in a written report, the molecular and therapeutic basis of chronic myeloid leukemia, with scores ranging from 0 to 10. Considering all 13 years, a median of 78% of the class scored above 5 (min 74%-max 85%), and a median of 67% scored above 7. Chronic myeloid leukemia is an excellent example of a disease that can be used for clinical basic integration as this disorder involves well known protein, cytogenetic and cell function abnormalities, has well-defined diagnostic strategies and a target oriented therapy.

Weight Variation In Users Of Depot-medroxyprogesterone Acetate, The Levonorgestrel-releasing Intrauterine System And A Copper Intrauterine Device For Up To Ten Years Of Use.

Data on record regarding weight variation in depot-medroxyprogesterone acetate (DMPA) and levonorgestrel-releasing intrauterine system (LNG-IUS) users are controversial. To date, no studies have yet evaluated weight variation in DMPA and LNG-IUS users in up to ten years of use compared to non-hormonal contraceptive users. A retrospective study analysed weight variations in 2138 women using uninterruptedly DMPA (150 mg intramuscularly, three-monthly; n = 714), the LNG-IUS (n = 701) or a copper-intrauterine device (Cu-IUD; n = 723). At the end of the first year of use, there was a mean weight increase of 1.3 kg, 0.7 kg and 0.2 kg among the DMPA-, LNG-IUS- and Cu-IUD users, respectively, compared to weight at baseline (p < 0.0001). After ten years of use, the mean weight had risen by 6.6 kg, 4.0 and 4.9 kg among the DMPA-, LNG-IUS- and Cu-IUD users, respectively. DMPA-users had gained more weight than LNG-IUS- (p = 0.0197) and than Cu-IUD users (p = 0.0294), with the latter two groups not differing significantly from each other in this respect (p = 0.5532). Users of hormonal and non-hormonal contraceptive methods gained a significant amount of weight over the years. DMPA users gained more weight over the treatment period of up to ten years than women fitted with either a LNG-IUS or a Cu-IUD.

Mentors, students, and the undergraduate medical course: a virtuous circle

BACKGROUND: Mentoring Programs have been developed in several medical schools, but few studies have investigated the mentors'perspective. PURPOSES: To explore mentors'perceptions regarding their experience. METHODS: Mentors at a medical school were invited to participate in an in-depth interview including questions on satisfaction, difficulties, and perception of changes resulting from the program. RESULTS: Mentors' satisfaction and difficulties are strongly associated with students'involvement in the activity. Mentors believe changes observed in students were more related to life issues; for some mentors, there is no recognition or awareness of the program. However, most of the mentors acknowledged important changes in relation to themselves: as teachers, faculty members, and individuals. CONCLUSION: Attendance is crucial for both the mentoring relationship and strengthening of the program. Students involved in the activity motivate mentors in teaching and curriculum development, thereby creating a virtuous circle and benefiting undergraduate medical education as a whole.

Avaliação manométrica anal de crianças com encoprese

INTRODUÇÃO: A constipação crônica é doença comum na infância, ocorrendo em 5 a 10% dos pacientes pediátricos, considerada a segunda maior causa de procura nos consultórios de pediatria, sendo a encoprese decorrente de constipação grave associada à impactação fecal no reto. Dentre os exames diagnósticos, a manometria anal é utilizada para a avaliação de pacientes com distúrbios funcionais, como a constipação intestinal e a incontinência fecal, em alguns serviços para a avaliação de pacientes com encoprese, pois pode trazer informações sobre o mecanismo evacuatório e possíveis lesões esfincterianas anais. OBJETIVO: Verificar alterações manométricas em pacientes com encoprese. MÉTODOS: Foi realizado estudo de 40 manometrias anais de crianças constipadas com encoprese (G1) e 12 crianças constipados sem encoprese (G2). Foram obtidos os seguintes dados: pressões de repouso, contração e evacuação do canal anal e ampola retal, ponto de maior pressão, reflexo inibitório anal e sensibilidade retal. As manometrias foram realizadas com o aparelho Alacer de perfusão com 8 canais. RESULTADOS: Não foram encontradas diferenças nas pressões de repouso, contração e evacuação do canal anal entre os grupos. Chamou-nos a atenção a ausência de necessidade de maior volume retal para desencadear o reflexo inibitório anal. Não houve diferença da incidência de anismus entre os dois grupos, demonstrando que não se trata de fator importante na manutenção da encoprese, mas sim da constipação. CONCLUSÃO: Não houve necessidade de maior volume para desencadear o reflexo inibitório anal. O anismus não foi diferente entre os dois grupos, não sendo importante na manutenção da encoprese.

Drug consumption among medical students in São Paulo, Brazil: influences of gender and academic year

OBJECTIVE: To analyze alcohol, tobacco and other drug use among medical students. METHOD: Over a five-year period (1996-2001), we evaluated 457 students at the Universidade de São Paulo School of Medicine, located in São Paulo, Brazil. The students participated by filling out an anonymous questionnaire on drug use (lifetime, previous 12 months and previous 30 days). The influence that gender and academic year have on drug use was also analyzed. RESULTS: During the study period, there was an increase in the use of illicit drugs, especially inhalants and amphetamines, among the medical students evaluated. Drug use (except that of marijuana and inhalants) was comparable between the genders, and academic year was an important influencing factor. DISCUSSION: Increased inhalant use was observed among the medical students, especially among males and students in the early undergraduate years. This is suggestive of a specific behavioral pattern among medical students. Our findings corroborate those of previous studies. CONCLUSION: Inhalant use is on the rise among medical students at the Universidade de São Paulo School of Medicine. Because of the negative health effects of illicit drug use, further studies are needed in order to deepen the understanding of this phenomenon and to facilitate the development of preventive measures.

Breast phantom with silicone implant for evaluation in conventional mammography

With the increased incidence of cancer and a similarly increased number of surgeries for insertion of silicone breast implants, it is necessary to assess the effect of such material within the breast tissue, particularly in mammography, because of the reduction in the power of breast cancer diagnosis. In this work, we introduce a breast phantom with silicone implants in order to evaluate the influence of the implant on the visibility of the main mammographic findings: fibers, microcalcifications and tumor masses. In this proposed phantom, the breast tissue was simulated using gel paraffin. In the optical density of phantom mammograms with implants, a reduction in breast tissue visibility was seen corresponding to 23% when compared to a phantom without silicone implants. This poor visibility was due to the X-ray beam scattering on silicone material; this effect produced a loss of visibility in the areas adjacent to the implant. It is expected that the proposed phantom model may be used as a device for the establishment of a technical standard for these types of procedures.

Evaluation of Cadaveric Renal Vein Lengths and Their Extension Loss with Three Types of Ligature and Section

Background and Purpose: The right kidney has been less frequently used in live donor nephrectomy, because of the shorter length of the right renal vein (RRV) that is associated with technical difficulties and higher rates of venous thrombosis. In live open donor or deceased donor transplant nephrectomy, an additional cuff of the inferior vena cava is usually removed, but this is a more difficult and risky maneuver in laparoscopic nephrectomy. For this reason, laparoscopic right nephrectomy (LRN) for renal transplantation (RT) is not frequently performed in most medical institutions. We evaluate the difference between RRV and left renal vein (LRV) lengths in cadavers, as harvested for RT by three clamping methods. Our objective was to obtain information that could clarify when LRN for RT should be encouraged or avoided with regard to conventional surgery. Materials and Methods: Ninety adult fresh unfrozen cadavers were randomly divided into three groups of 30, according to the clamping device used: Satinsky, stapler, and Hem-o-lok clip. The abdominal viscera were removed through a median xyphopubic incision, and the veins were measured on the bench. Two lateral limits were used: The renal hilum and the tangential line of the renal poles. As for medial limits, the inferior vena cava or the laparoscopic clipping device on the RRV were used on the right side, while on the LRV, the medial border of the emergence of the adrenal vein was considered. After section of the renal vein, a slight traction of the extremity was applied for the measurement. All measurements were obtained three times using a metallic millimetric ruler, and the arithmetic mean was considered. The chi-square, one-way analysis of variance, and paired t tests were used for statistical analysis. Statistical significance was accepted at P <= 0.05. Results: The groups of cadavers were homogeneous in demographic characteristics. Regardless of the clamping method and considering the useful length of the LRV, the RRV was statistically smaller. The evaluation of the vein length did not depend on the lateral limit considered. Independent of the clamping method, on both sides, the lengths after the vein section were larger than before the section, a fact attributed to traction. Use of a stapler and a single Hem-o-lok presented the same waste of vein length on the right side. On average, the RRV was 13.7% shorter than the LRV. Conclusions: With the wide acceptance of laparoscopic live donor nephrectomy, the length difference between the veins of both kidneys is an important issue, and the right kidney is therefore used less than the left, compared with conventional surgery. This article represents the first step to quantify the anatomic length of renal veins in different situations. Certainly, more imagenologic or surgical studies should be carried out before decisions can be made for better selection of patients for LRN.