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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., (© 2021 International Union of Biochemistry and Molecular Biology.)

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., (© 2020 Australasian Professional Society on Alcohol and other Drugs.)

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., (© 2018 Royal Pharmaceutical Society.)

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., (© 2017 Royal Australasian College of Physicians.)

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.

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.

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.

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., (Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

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.

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., (Copyright © 2016 Elsevier B.V. All rights reserved.)

Many recent articles have dealt with the future challenges in medicinal chemistry. Here, I discuss my concerns over the future of medicinal chemists, who have to be skilled and knowledgeable in many different fields, particularly in the context of the ever-growing requirements, the request for even broader diversification, and the substantial structural change in industrial drug discovery. In my opinion, we have to do the following in order to ensure sustained high quality and achievements: 1) to focus on superior design without excluding complex structures a priori; 2) to proactively shape the future of our discipline; 3) to discuss specialization; 4) to intensify exchange between academia and industry; and 5) to remodel education of the next generation of medicinal chemists. By providing my opinion on these aspects, I hope to stimulate discussions and change within the community., (© 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)

Many life sciences trainees in academia have limited exposure to how the biotechnology/pharmaceutical industry approaches drug discovery and development and what life is like in biopharma research. In this article, I will provide my perspectives on how to prepare for a successful career in biopharma research, focusing on technical background, an understanding of the drug discovery and development process, and personal and interpersonal keys to success., (Copyright © 2015. Published by Elsevier Ltd.)

Background: Pharmaceutical company representatives likely influence the prescribing habits and professional behaviour of physicians., Objective: The objective of this study was to systematically review the effects of interventions targeting practising physicians' interactions with pharmaceutical companies., Eligibility Criteria: We included observational studies, non-randomised controlled trials (non-RCTs) and RCTs evaluating legislative, educational, policy or other interventions targeting the interactions between physicians and pharmaceutical companies., Data Sources: The search strategy included an electronic search of MEDLINE and EMBASE. Two reviewers performed duplicate and independent study selection, data abstraction and assessment of risk of bias., Appraisal and Synthesis Methods: We assessed the risk of bias in each included study. We summarised the findings narratively because the nature of the data did not allow a meta-analysis to be conducted. We assessed the quality of evidence by outcome using the GRADE methodology., Results: Of 11 189 identified citations, one RCT and three observational studies met the eligibility criteria. All four studies specifically targeted one type of interaction with pharmaceutical companies, that is, interactions with drug representatives. The RCT provided moderate quality evidence of no effect of a 'collaborative approach' between the pharmaceutical industry and a health authority. The three observational studies provided low quality evidence suggesting a positive effect of policies aiming to reduce interaction between physicians and pharmaceutical companies (by restricting free samples, promotional material, and meetings with pharmaceutical company representatives) on prescription behaviour., Limitations: We identified too few studies to allow strong conclusions., Conclusions: Available evidence suggests a potential impact of policies aiming to reduce interaction between physicians and drug representatives on physicians' prescription behaviour. We found no evidence concerning interventions affecting other types of interaction with pharmaceutical companies., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

In recent decades, the pharmaceutical industry as built a high level of confidence thanks to innovative medicines that improve both duration and quality of life. Some recent scandals have however discredited this industry, now suspected of cheating or bribery. Even the scientific progresses are challenged on the ground of possible conflicts of interests and value uncertainty. This situation is deleterious. Simultaneously the economic crisis exacerbates the payers' expectations in terms of clinical value and value/price ratio. It also stimulates the demand for outcomes in real life. This induces a new economic approach for the market access of highly expensive reimbursable drugs. It consists in paying only for drugs actually proven effective in terms of actual outcomes, with a full or partial refund of the payer in case of failure, according to accurate and simple criteria in so called "performance agreement". Confidence is restored accordingly., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)

Interpreting data and communicating effectively through graphs and tables are requisite skills for statisticians and non-statisticians in the pharmaceutical industry. However, the quality of visual displays of data in the medical and pharmaceutical literature and at scientific conferences is severely lacking. We describe an interactive, workshop-driven, 2-day short course that we constructed for pharmaceutical research personnel to learn these skills. The examples in the course and the workshop datasets source from our professional experiences, the scientific literature, and the mass media. During the course, the participants are exposed to and gain hands-on experience with the principles of visual and graphical perception, design, and construction of both graphic and tabular displays of quantitative and qualitative information. After completing the course, with a critical eye, the participants are able to construct, revise, critique, and interpret graphic and tabular displays according to an extensive set of guidelines., (Copyright © 2013 John Wiley & Sons, Ltd.)

Integration of clinical and preclinical pharmacology in pharmaceutical companies could be improved by several key recommendations: Companies should ensure that there is an adequate pool of trained clinical pharmacologists and preclinical pharmacologists. Training should include topics that allow clinical pharmacologists to be cognizant of the methods, issues and challenges faced by the preclinical pharmacologists and vice versa. Companies should incentivize such integration internally by aligning objectives and metrics/incentives. In academic medicine and the NHS there should be support for involvement of clinical pharmacologists in basic academic research and industrial R & D and new ways of facilitating and incentivizing preclinical pharmacologists and clinical pharmacologists to move between these various environments should be sought., (© 2012 The Author. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society.)

Pharmaceutical firms attribute high prices and high profits to costs associated with researching and developing the next generation of life-saving drugs. Using data from annual reports, this article tests the validity of this claim. We find that while pharmaceutical firms do invest in R&D, they also enjoy strong rents; between 1988 and 2009, pharmaceuticals enjoyed profits of 3 to 37 times the all-industry average, depending on the years, while investing proportionately less in R&D than other high-R&D firms. Costs of pharmaceutical drugs have successfully flown below the radar in much of the current health care debate, with producers managing to obstruct alternative sourcing as well as payment cuts. While health care is examined for savings in other areas, sustained high pharmaceutical profits suggest that as a new health care policy develops in the U.S., the pharmaceutical industry should not be excluded from examination for significant savings in health care costs.

Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses.

This article explores the utility of actor-network theory (ANT) as a tool for socio-legal research. ANT is deployed in a study of the evolution of divided regulatory responsibility for tobacco and medicinal nicotine (MN) products in the United Kingdom, with a particular focus on how the latter came to be regulated as a medicine. We examine the regulatory decisions taken in the United Kingdom in respect of the first MN product: a nicotine-containing gum developed in Sweden, which became available in the United Kingdom in 1980 as a prescription-only medicine under the Medicines Act 1968. We propose that utilizing ANT to explore the development of nicotine gum and the regulatory decisions taken about it places these decisions into the wider context of ideas about tobacco control and addiction, and helps us to understand better how different material actors acted in different networks, leading to very different systems of regulation.

Toxicologic pathologists contribute significantly to the development of new biopharmaceuticals, yet there is often a lack of awareness of this specialized role. As the members of multidisciplinary teams, toxicologic pathologists participate in all aspects of the drug development process. This review is part of an initiative by the Society of Toxicologic Pathology to educate scientists about toxicologic pathology and to attract junior scientists, veterinary students, and veterinarians into the field. We describe the role of toxicologic pathologists in identifying candidate agents, elucidating bioactive pathways, and evaluating efficacy and toxicity in preclinical animal models. Educational and specialized training requirements and the challenges of working in a global environment are discussed. The biopharmaceutical industry provides diverse, challenging, and rewarding career opportunities in toxicologic pathology. We hope that this review promotes understanding of the important role the toxicologic pathologist plays in drug development and encourages exploration of an important career option.

Pharmacogenomic Innovative Solutions Ltd (PGXIS) was established in 2007 by a group of pharmacogenomic (PGx) experts to make their expertise available to biotechnology and pharmaceutical companies. PGXIS has subsequently established a network of experts to broaden its access to relevant PGx knowledge and technologies. In addition, it has developed a novel multivariate analysis method called Taxonomy3 which is both a data integration tool and a targeting tool. Together with siRNA methodology from CytoPathfinder Inc., PGXIS now has an extensive range of diverse PGx methodologies focused on enhancing drug development.

Globally, it is possible that less than half of all patients are treated in compliance with guidelines and more than half of all patients fail to take their medicines as prescribed or dispensed. Such inappropriate use is wasteful of resources and causes patient harm in terms of lack of satisfactory outcome, serious adverse events and increased antimicrobial resistance. Combating inappropriate use of medicines involves four major steps: measuring the use of medicines; identifying the determinants of inappropriate use; developing, implementing and evaluating the impact of interventions to improve the use of medicines while taking into account the factors underlying inappropriate use; and working towards an enabling policy framework that encourages appropriate use. Global evidence on how to effectively combat inappropriate use of medicines is discussed herein, with reference to the aforementioned four steps. Most interventions undertaken to combat inappropriate use of medicines have been educational in nature, have had a relatively small impact and have not taken into account the determinants of behavior. A combination of interventions, involving managerial as well as educational components, appears to be more effective than a single intervention. Less than half of countries have a policy framework that actively encourages appropriate use of medicines. Since health systems are varied and complex, a nationally coordinated package of interventions and policies, contextualized to each country, will be needed to have any substantial impact on medicine use. There is now increasing global awareness of the need to strengthen health systems, to have national coordination to combat inappropriate use of medicines and to have coordination of international aid to developing countries in order to ensure it contributes to combating inappropriate use of medicines. The opportunities this presents for combating inappropriate use of medicines are discussed in this article.

Economic historians have focused research effort on accounting for the growth and significance of Britain's pharmaceutical industry, but little effort has so far been directed at the veterinary medicine industry, which formed an important part of the wider sector. This article addresses that gap. Factors responsible for that sector's relative insignificance until the 1950s included a general tendency to slaughter rather than to treat sick animals, the absence of advanced medicines until the innovation of sulpha drugs and antibiotics, and difficult relations with the wider pharmaceutical industry. Thereafter output of veterinary medicines increased dramatically, arising from an exponential growth in the demand for intensively farmed poultry meat. Since the 1980s a decline in the use of drugs in agriculture has caused the industry to concentrate on the health needs of domestic animals rather than those of livestock.