Readying students for careers in industry: A guided inquiry activity to prepare students for success in biotechnology and pharmaceutical industry positions.

While science students are well prepared for careers in biotechnology and pharmaceutical sciences in terms of technical expertise and critical thinking, they rarely have an opportunity to practice the due diligence required for success in industry in their coursework. This includes framing their expertise as solutions to challenges a company may be experiencing, an important skill for the interview process. As most academics have not applied for positions in industry, they may feel ill equipped to help students practice the important skills of framing their expertise within company goals and to discuss the business and financial concepts relevant to careers in scientific industry. Here, we describe an educational activity first developed by a leader in the biotech/pharmaceutical industry that was modified and given educational context by an academic in a class of upper-level undergraduate and graduate students. In this guided inquiry activity, students were instructed to select a start-up company in their field-ideally one to which they intended to apply for a job. Students were empowered by scaffolded hands-on exercises to research the company's scientific focus and finances, and to frame how their expertise could help companies achieve stated goals. Students compiled and delivered their research as an in-class presentation.

Receipt of training about medication for opioid use disorder from pharmaceutical manufacturers: A preliminary study of Florida criminal problem-solving and dependency court staff.

INTRODUCTION AND AIMS: People with opioid use disorder are prevalent in criminal problem-solving courts and dependency courts, which have rehabilitative aims. Medication for opioid use disorder (MOUD) is the standard of care. Court staff set treatment policies for court clients. They may receive training from MOUD manufacturers, but no studies have examined court staff receipt of such training. DESIGN AND METHODS: To examine receipt of training from MOUD manufacturers, we designed a cross-sectional survey for court staff. We distributed it online to all Florida court staff in criminal problem-solving or dependency courts (n = 585). Outcome variables were receipt of training from one or more MOUD manufacturers and training source. Covariates included dichotomous measures of court type, staff role, gender and rurality. Logistic regression models estimated the relationship between receipt of training and covariates. RESULTS: Twenty-one percent of Florida criminal problem-solving and dependency court staff completed the survey. The most common receipt of training was from the manufacturer of extended-release naltrexone (36%), followed by buprenorphine (24%) and methadone (11%). Fifty-seven percent of those who received training received it from more than one MOUD manufacturer. Criminal problem-solving court staff were more likely than dependency court staff to receive training from MOUD manufacturers. Court program co-ordinators were more likely than other staff roles to receive training from MOUD manufacturers. DISCUSSION AND CONCLUSIONS: A large minority of respondents received training from a MOUD manufacturer, primarily from extended-release naltrexone's manufacturer, raising concerns regarding information accuracy and conflicts of interest. Court staff should seek MOUD training from academic institutions and non-profit organisations instead.

Diálogos sobre medicalização da infância e educação: uma revisão de literatura / Diálogos sobre medicalización de la niñez y educación: una revisión de literatura / Dialogues about medicalization of childhood and education: a literature review

RESUMO Este trabalho teve como objetivo revisar a produção científica brasileira sobre medicalização no âmbito da educação. Foi realizada uma busca sistemática na literatura brasileira com as palavras-chave patologização da vida, a medicalização da educação, da aprendizagem, do ensino e da infância. Ao todo, foram selecionados para análise 40 artigos publicados entre 2010 e 2016, indexados na Scientific Electronic Library Online - SciELO. As informações foram analisadas com base na análise de conteúdo temática, proposta por Bardin. Os resultados evidenciaram uma diversidade de compreensões sobre o conceito de medicalização. Alguns artigos relataram a ocorrência de práticas educativas produtoras de sofrimentos e individualização da queixa escolar, evidenciando um descompasso entre a produção de literatura e o cotidiano da escola. Destaca-se ainda um significativo aumento de diagnósticos de TDAH e de terapias medicamentosas no tratamento da queixa escolar, expandindo, consequentemente, a indústria farmacêutica ao conceber a criança como um potencial consumidor de medicamento. Por fim, indicam-se novos estudos que possam ampliar as fontes de pesquisa, incorporando-se também teses e dissertações. Recomenda-se ainda pesquisas com crianças, familiares e comunidade escolar que possam analisar o impacto da medicalização na subjetividade e no desempenho dos estudantes.

RESUMEN En este estudio se tuvo como objetivo revisar la producción científica brasileña sobre medicalización en el ámbito de la educación. Se realizó una búsqueda sistemática en la literatura brasileña con las palabras clave patologización de la vida, la medicalización de la educación, del aprendizaje, de la enseñanza y de la infancia. En total, se seleccionó para análisis 40 artículos publicados entre 2010 y 2016, indexados en la ScientificElectronic Library Online - SciELO. La información se analizó sobre la base del análisis de contenido temático propuesto por Bardin. Los resultados evidenciaron una diversidad de entendimientos sobre el concepto de medicalización. En algunos artículos se relataron la ocurrencia de prácticas educativas productoras de sufrimientos e individualización de la queja escolar, evidenciando un descompaso entre la producción de literatura y el cotidiano de la escuela. Se destaca un significativo aumento de diagnósticos de TDAH y de terapias medicamentosas en el tratamiento de la queja escolar, expandiendo, consecuentemente, la industria farmacéutica al concebir al niño como un potencial consumidor de medicamento. Por último, se indican nuevos estudios que puedan ampliar las fuentes de investigación, incorporándose también tesis y disertaciones. Se indican también investigaciones con niños, familiares y comunidad escolar que puedan analizar el impacto de la medicalización en la subjetividad y en el desempeño de los estudiantes.

ABSTRACT This study aimed to review the Brazilian scientific production on medicalization in the field of education. A systematic search was carried out in the Brazilian literature with the keywords pathologization of life, medicalization of education, learning, teaching and childhood. In all, 40 articles published between 2010 and 2016, indexed in the Scientific Electronic Library Online - SciELO, were selected for analysis. The information was analyzed based on the thematic content analysis proposed by Bardin. The results showed a diversity of understandings about the concept of medicalization. Some articles reported the occurrence of educational practices that produce suffering and the individualization of school complaints, evidencing a disagreement between the production of literature and the daily routine of schools. There has been also a significant increase in diagnoses of ADHD and drug therapies in the treatment of school complaints, thus expanding the pharmaceutical industry by conceiving children as potential consumers of medication. Finally, new studies are indicated to broaden the sources of research, incorporating also theses and dissertations. It is also recommended the realization of research with children, relatives, and the school community so as to analyze the impact of medicalization on the subjectivity and performance of students.

Pharmaceutical industry in a global context elective course: implementation and preliminary outcomes.

OBJECTIVE: To describe the implementation of 'Pharmaceutical Industry in a Global Context' elective in a 4-year US pharmacy programme. METHODS: An anonymous questionnaire regarding student experiences with the course content and intention to pursue pharmaceutical industry summer internships and/or postgraduation fellowships was distributed to students at the end of the course. KEY FINDINGS: Fifty per cent of the students (n = 13) reported intention to apply for a pharmaceutical industry summer internships and/or industry fellowship postgraduation. CONCLUSION: The described industry course may be adopted by other educators to encourage pharmacy students' exploration into industry careers.

Dealing with the spiralling price of medicines: issues and solutions.

Escalating cost of medicines is rapidly becoming a serious threat to patients and health systems. This trend has been documented to impact patient outcomes adversely. As clinicians and tax payers, it is our responsibility to be aware of the potential detrimental effects spiralling costs have on our patients, our community and our health system and to mitigate these effects by exposing this issue to our respective professional societies, representatives of the pharmaceutical companies that we interact with, government regulatory bodies and to patients who we are caring for. Only through understanding and constructive actions will we be able to provide the best quality of care to our patients and continue to enjoy universal healthcare in our country.

Transfer of knowledge in international cooperation: the Farmanguinhos - SMM case.

OBJECTIVE: To analyze the influence of four mechanisms of knowledge transfer (training, technical visits, expatriation, and standard operating procedures) on the different dimensions (potential and realized) of absorptive capacity in international technical cooperation. METHODS: We examine the case of implementation of the Sociedade Moçambicana de Medicamentos. Data have been collected using semi-structured interviews (applied to 21 professionals of the Sociedade Moçambicana de Medicamentos, Farmanguinhos, FIOCRUZ, and Itamaraty) and official documents. The data of the interviews have been submitted to content analysis, using the software NVivo. RESULTS: Training and technical visits directly influenced the acquisition and, partly, the assimilation of knowledge. Expatriation contributed with the transformation of this knowledge from the development and refinement of operational routines. Finally, the definition of standard operating procedures allowed the Mozambican technicians to be the actors of the transformation of the knowledge previously acquired and assimilated and, at the same time, it laid the foundations for a future exploration of the knowledge. CONCLUSIONS: Training and technical visits mainly influence the potential absorptive capacity, while expatriation and standard operating procedures most directly affect the realized absorptive capacity.

AMCP Partnership Forum: Driving Value and Outcomes in Oncology.

Innovation in cancer treatment has provided a wealth of recently available therapeutic agents and a healthy drug pipeline that promises to change the way we approach this disease and the lives of those affected in the years to come. However, the majority of these new agents, many of which are targeted to specific genomic features of various tumors, may challenge the health care system's ability to afford cancer care. This innovation drives the need to focus on the value of the treatments provided to patients with cancer and on methods to optimize the efficiency of the dollars we spend, in addition to the clinical value itself. The Academy of Managed Care Pharmacy (AMCP) convened a Partnership Forum to address how to improve value and outcomes in cancer care. In this multistakeholder forum, several areas were addressed: current methods for assessing the value of oncology products, the need for balancing population management with precision medicine, and the outlook for value-based contracting for oncology medications in managed care settings. Participants recommended ways in which stakeholders can work toward solutions in these areas. The forum brought together stakeholders from health plans, integrated delivery systems, pharmacy benefit managers, clinical practice, biopharmaceutical industry, and laboratory companies. Also participating were representatives from trade and professional associations. During this 1.5-day forum, participants identified current challenges, readiness, and ways to address value and improve outcomes in cancer therapy. Some of the challenges identified include choosing a viable (and practical) outcome target for value-based contracting in oncology, the development and use of value frameworks and clinical pathways, managing cancer diagnostics, utilization of alternative payment systems, moving from a large evidence base to a small clinical trial base in considering targeted treatments, and lack of best practices in value-based payment arrangements. Addressing these challenges could lead to improving cancer treatment. DISCLOSURES: The AMCP Partnership Forum titled "Driving Value and Outcomes in Oncology" and the development of this report were supported by AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Foundation Medicine, IntrinsiQ Specialty Solutions, Janssen Oncology and Johnson and Johnson Health Systems, Eli Lilly and Company, National Pharmaceutical Council, Novartis Pharmaceuticals Corporation, Pharmaceutical Research and Manufacturers of America, Sanofi, Takeda Oncology, and Xcenda.

European experience of regulating distance selling of medicines for Ukraine.

INTRODUCTION: Some countries have already tried and tested mechanisms of regulating distance sales as form of distribution of medicines that have been used more or less effectively for a fairly long time. Herewith, so far, the approach of the competent authorities of some countries including Ukraine can be called prevailing in quantitative terms under which the official prohibition on distance sales of medicines is set. AIM: The aim of this study is a detailed examination of the nature of the prohibition of the medicines distance selling in Ukraine, namely the an analysis of advantages and disadvantages of this form of distribution of medicines and identification of appropriate ways for gradual repeal of the prohibition in terms of regulatory reform in Ukraine in the sphere of circulation of medicines due to the process of adaptation of statutory regulation in this area to the EU legislation. MATERIAL AND METHODS: This study is based on Ukrainian regulation acts, Council Directives 97/7/EC, 2000/31/EC, 2001/83/EC, scientific works and opinions of progressiveminded people in this sphere. Such methods as dialectical, comparative, analytic, synthetic and comprehensive have been used in the article. CONCLUSION: Reception of the described experience of regulation in EU will allow a further review of the principles of regulation in Ukraine in the sphere of medicines with a shift in the main emphasis in the direction of ensuring adequate consumer rights in this area and preventing the risks of patients' and public health.

Transfer of knowledge in international cooperation: the Farmanguinhos - SMM case / Transferência de conhecimento na cooperação internacional: o caso Farmanguinhos - SMM

ABSTRACT OBJECTIVE To analyze the influence of four mechanisms of knowledge transfer (training, technical visits, expatriation, and standard operating procedures) on the different dimensions (potential and realized) of absorptive capacity in international technical cooperation. METHODS We examine the case of implementation of the Sociedade Moçambicana de Medicamentos. Data have been collected using semi-structured interviews (applied to 21 professionals of the Sociedade Moçambicana de Medicamentos, Farmanguinhos, FIOCRUZ, and Itamaraty) and official documents. The data of the interviews have been submitted to content analysis, using the software NVivo. RESULTS Training and technical visits directly influenced the acquisition and, partly, the assimilation of knowledge. Expatriation contributed with the transformation of this knowledge from the development and refinement of operational routines. Finally, the definition of standard operating procedures allowed the Mozambican technicians to be the actors of the transformation of the knowledge previously acquired and assimilated and, at the same time, it laid the foundations for a future exploration of the knowledge. CONCLUSIONS Training and technical visits mainly influence the potential absorptive capacity, while expatriation and standard operating procedures most directly affect the realized absorptive capacity.

RESUMO OBJETIVO Analisar a influência de quatro mecanismos de transferência de conhecimento (treinamentos, visitas técnicas, expatriação e procedimentos operacionais padrão) sobre as diferentes dimensões (potencial e realizada) da capacidade absortiva na cooperação técnica internacional. MÉTODOS Examina-se o caso da implementação da Sociedade Moçambicana de Medicamentos. Os dados foram coletados por meio de entrevistas semiestruturadas (aplicadas a 21 profissionais da Sociedade Moçambicana de Medicamentos, Farmanguinhos, Fiocruz e Itamaraty) e de documentos oficiais. Os dados das entrevistas foram submetidos à análise de conteúdo, com uso do software NVivo. RESULTADOS Os treinamentos e as visitas técnicas influenciaram diretamente a aquisição e, parcialmente, a assimilação do conhecimento. A expatriação contribuiu para a transformação desse conhecimento, por meio do desenvolvimento e refinamento das rotinas operacionais. Por fim, a definição dos procedimentos operacionais padrão permitiu que os técnicos moçambicanos fossem os atores da transformação do conhecimento adquirido e assimilado previamente e, ao mesmo tempo, criou as bases para uma futura exploração do conhecimento. CONCLUSÕES Os treinamentos e as visitas técnicas influenciam, principalmente, a capacidade absortiva potencial, enquanto a expatriação e os procedimentos operacionais padrão impactam mais diretamente a capacidade absortiva realizada.

The Use of Animated Videos to Illustrate Oral Solid Dosage Form Manufacturing in a Pharmaceutics Course.

Objective. To evaluate the impact of animated videos of oral solid dosage form manufacturing as visual instructional aids on pharmacy students' perception and learning. Design. Data were obtained using a validated, paper-based survey instrument designed to evaluate the effectiveness, appeal, and efficiency of the animated videos in a pharmaceutics course offered in spring 2014 and 2015. Basic demographic data were also collected and analyzed. Assessment data at the end of pharmaceutics course was collected for 2013 and compared with assessment data from 2014, and 2015. Assessment. Seventy-six percent of the respondents supported the idea of incorporating animated videos as instructional aids for teaching pharmaceutics. Students' performance on the formative assessment in 2014 and 2015 improved significantly compared to the performance of students in 2013 whose lectures did not include animated videos as instructional aids. Conclusions. Implementing animated videos of oral solid dosage form manufacturing as instructional aids resulted in improved student learning and favorable student perceptions about the instructional approach. Therefore, use of animated videos can be incorporated in pharmaceutics teaching to enhance visual learning.

An Opportunity for Industry-Academia Partnership: Training the Next Generation of Industrial Researchers in Characterizing Higher Order Protein Structure.

Training researchers for positions in the United States biopharmaceutical industry has long been driven by academia. This commentary explores how the changing landscape of academic training will impact the industrial workforce, particularly with regard to the development of protein therapeutics in the area of biophysical and higher order structural characterization. We discuss how to balance future training and employment opportunities, how academic-industrial partnerships can help young scientists acquire the skills needed by their future employer, and how an appropriately trained workforce can facilitate the translation of new technology from academic to industrial laboratories. We also present suggestions to facilitate the coordinated development of industrial-academic educational partnerships to develop new training programs, and the ability of students to locate these programs, through the development of authoritative public resources.

Strategic framework for education and training in Quality by Design (QbD) and process analytical technology (PAT).

The regulatory and technical landscape of the pharmaceutical field is rapidly evolving from one focused predominantly on development of small molecules, using well established manufacturing technologies towards an environment in which biologicals and complex modalities are being developed using advanced science and technology coupled with the application of modern Quality by Design (QbD) principles. In order that Europe keeps pace with these changes and sustains its position as major player in the development and commercialization of medicines, it is essential that measures are put in place to maintain a highly skilled workforce. A number of challenges however exist to equipping academic, industrial and health agency staff with the requisite knowledge, skills and experience to develop the next generation of medicines. In this regard, the EUFEPS QbD and PAT Sciences Network has proposed a structured framework for education, training and continued professional development, which comprises a number of pillars covering the fundamental principles of modern pharmaceutical development including the underpinning aspects of science, engineering and technology innovation. The framework is not prescriptive and is not aimed at describing specific course content in detail. It should however be used as a point of reference for those institutions delivering pharmaceutical based educational courses, to ensure that the necessary skills, knowledge and experience for successful pharmaceutical development are maintained. A positive start has been made and a number of examples of formal higher education courses and short training programs containing elements of this framework have been described. The ultimate vision for this framework however, is to see widespread adoption and proliferation of this curriculum with it forming the backbone of QbD and PAT science based skills development.