Cancer drug discovery through collaboration

It has been two decades since cancer was first described as a genetic disease and researchers offered the promise of early diagnosis and targeted therapies. Today, most cancer patients still await life-saving treatments. Genomics and other '-omics' technologies have revealed a complexity among cancers that makes almost any tumour genetically unique; as a consequence, effective targeted therapies might be suitable only for small subgroups of patients. We suggest that by merging and organizing their core competencies, academia, biotechnology companies and the pharmaceutical industry can address existing bottlenecks in anticancer drug discovery and development.     

Outsourcing chemical synthesis in the drug discovery process

The positive effects of outsourcing chemical synthesis are enhanced if the provider offers, as the strategic partner, unique expertise and complements the existing internal competencies of pharmaceutical companies. The emerging cooperation model of leased competence offers additional access to high-level specialist knowledge: external service providers are temporarily integrated into internal R&D teams and can support R&D projects flexibly and quickly. Practice examples show that this cooperation model supports the efficient realization of milestones and, in the long-term, helps to build up a high internal competence level, especially in small pharmaceutical companies.     

Outsourcing to exploit a key asset

Much has been written and debated about the economic and organizational advantages of outsourcing a growing list of operations in drug discovery. In what has been described as a modular approach to drug discovery, whole sections of the process are now handled very effectively by a wide variety of specialist suppliers to the pharmaceutical industry. Here we report on a novel outsourced solution to the challenge of consolidating and managing some of the key assets residing within a major research organization - its chemical intermediates. At Johnson and Johnson Pharmaceutical Research and Development this resource has been built up over a period of more than 40 years, and is added to daily. The challenge was to provide the company's scientists with a single source for its own and externally procured intermediates; the solution was developed working in partnership with Sigma-Aldrich.     

Productive university, industry, and government relationships in preclinical drug discovery and development: considerations toward a synergistic lingua franca

Efficiency and productivity shortfalls conspire with subpar economic return to stigmatize the pharmaceutical industry and jeopardize its viability. This complex and costly innovation-to-commercialization failure, the formidable associated costs, and the relevance of various core competencies endemic to universities, the pharmaceutical industry, and government have been major drivers for establishing preclinical drug-discovery alliances involving these constituencies. Such cross-sector alliances have the potential to help restore at least some of the industry's former health by militating risk, enhancing productivity, and improving the quantity/quality of development candidates. This Editorial will highlight certain characteristics of pharma-industry and non-industrial settings that can jeopardize the effectiveness of these sectors for unified preclinical discovery campaigns capable of generating well-characterized drug candidates that merit human testing. Based on decades of research and development (R&D) and business experience spanning international big-pharma, biotechnology, and academic spheres, the author opines that a synergistic lingua franca is required among involved constituencies in order for such cross-sector discovery alliances to emerge as robust drug-discovery engines fueled by joint intellectual effort. Technology-transfer professionals, postdoctoral trainees, and consultants are discussed as resources for helping establish the university-industry-government triumvirate as a normative innovation network for preclinical drug discovery and development in the 21st century.     

Virtual drug discovery: beyond computational chemistry?

This editorial looks at how a fully integrated structure that performs all aspects in the drug discovery process, under one company, is slowly disappearing. The steps in the drug discovery paradigm have been slowly increasing toward virtuality or outsourcing at various phases of product development in a company’s candidate pipeline. Each step in the process, such as target identification and validation and medicinal chemistry, can be managed by scientific teams within a ‘virtual’ company. Pharmaceutical companies to biotechnology start-ups have been quick in adopting this new research and development business strategy in order to gain flexibility, access the best technologies and technical expertise, and decrease product developmental costs. In today’s financial climate, the term virtual drug discovery has an organizational meaning. It represents the next evolutionary step in outsourcing drug development.     

Outsourcing drug discovery to India and China: from surviving to thriving

Global pharmaceutical companies face an increasingly harsh environment for their primary business of selling medicines. They have to contend with a spiraling decline in the productivity of their R&D programs that is guaranteed to severely diminish their growth prospects. Outsourcing of drug discovery activities to low-cost locations is a growing response to this crisis. However, the upsides to outsourcing are capped by the failure of global pharmaceutical companies to take advantage of the full range of possibilities that this model provides. Companies that radically rethink and transform the way they conduct R&D, such as seeking the benefits of low-cost locations in India and China will be the ones that thrive in this environment. In this article we present our views on how the outsourcing model in drug discovery should go beyond increasing the efficiency of existing drug discovery processes to a fundamental rethink and re-engineering of these processes.     

Virtual drug discovery: beyond computational chemistry?

This editorial looks at how a fully integrated structure that performs all aspects in the drug discovery process, under one company, is slowly disappearing. The steps in the drug discovery paradigm have been slowly increasing toward virtuality or outsourcing at various phases of product development in a company's candidate pipeline. Each step in the process, such as target identification and validation and medicinal chemistry, can be managed by scientific teams within a 'virtual' company. Pharmaceutical companies to biotechnology start-ups have been quick in adopting this new research and development business strategy in order to gain flexibility, access the best technologies and technical expertise, and decrease product developmental costs. In today's financial climate, the term virtual drug discovery has an organizational meaning. It represents the next evolutionary step in outsourcing drug development.     

Productive university,industry, and government relationships in preclinical drug discovery and development: considerations toward a synergistic lingua franca

Efficiency and productivity shortfalls conspire with subpar economic return to stigmatize the pharmaceutical industry and jeopardize its viability. This complex and costly innovation-to-commercialization failure, the formidable associated costs, and the relevance of various core competencies endemic to universities, the pharmaceutical industry, and government have been major drivers for establishing preclinical drug-discovery alliances involving these constituencies. Such cross-sector alliances have the potential to help restore at least some of the industry's former health by militating risk, enhancing productivity, and improving the quantity/quality of development candidates. This Editorial will highlight certain characteristics of pharma-industry and non-industrial settings that can jeopardize the effectiveness of these sectors for unified preclinical discovery campaigns capable of generating well-characterized drug candidates that merit human testing. Based on decades of research and development (R&D) and business experience spanning international big-pharma, biotechnology, and academic spheres, the author opines that a synergistic lingua franca is required among involved constituencies in order for such cross-sector discovery alliances to emerge as robust drug-discovery engines fueled by joint intellectual effort. Technology-transfer professionals, postdoctoral trainees, and consultants are discussed as resources for helping establish the university–industry–government triumvirate as a normative innovation network for preclinical drug discovery and development in the 21st century.     

Core competencies for research training in the clinical pharmaceutical sciences

Objective

To identify and apply core competencies for training students enrolled in the clinical pharmaceutical scientist PhD training program at the University of Pittsburgh School of Pharmacy.

Design

Faculty members reached consensus on the required core competencies for the program and mapped them to curricular and experiential requirements.

Assessment

A rubric was created based on core competencies spanning 8 major categories of proficiency, and competencies of clinical versus traditional PhD training were delineated. A retrospective evaluation of the written comprehensive examinations of 12 former students was conducted using the rubric. Students scored above satisfactory in 11 out of 14 comprehensive examination metrics, with a mean score greater than 3.8 on a 5-point scale.

Conclusions

The core competencies identified will provide an essential foundation for informed decision-making and assessment of PhD training in the clinical pharmaceutical sciences.     

Pharmacy and public health: A pathway forward

ObjectiveTo identify a pathway forward for practicing pharmacists in supporting public health initiatives by applying the five core competencies of public health.SummaryThe pharmacist is well positioned to improve population health. Until now, increased impact of pharmacists has been based on the expansion of patient services rather than guided by a population approach to health. To increase their effectiveness and breadth of impact, pharmacists would benefit from applying the five core competencies of public health (social and behavioral science, health policy and administration, epidemiology, biostatistics, and environmental health sciences) to the practice of pharmacy. This article aims to explain how each of the core competencies applies to pharmacy practice and how pharmacists might apply public health skills in a more specific manner.ConclusionWith increased clarity of the role of public health, and mastery of the five core competencies of public health, pharmacists can make unique and valuable contributions to the health of the public.     

Patient safety training simulations based on competency criteria of the Accreditation Council for Graduate Medical Education

This report reviews and critically evaluates the development of 3 movements in healthcare that have had a profound impact on changes occurring at all levels of medical education: patient safety, healthcare simulation, and competency-based education (exemplified by the Accreditation Council for Graduate Medical Education). The authors performed a critical and selective review of the literature from 1999 to 2011 to identify uses of simulation to address patient-safety issues aligned according to the Accreditation Council for Graduate Medical Education 6 core competencies: (1) patient care; (2) medical knowledge; (3) interpersonal and communication skills; (4) professionalism; (5) practice-based learning; and (6) systems-based practice. The research synthesis is reported to inform and provide evidence about how simulation is used to train and evaluate learners on a range of patient-safety issues for each of the core competencies: There is emerging evidence that simulation can be used in training efforts to reduce medical errors related to medical knowledge and patient care (particular invasive procedures as well as improved communication and teamwork skills). There remains limited evidence on its impact to improve patient safety related to more complex competencies of practice-based learning and systems-based practice. Simulation-based learning can lead to positive patient outcomes and reduction of medical errors particularly when used for individual skills. However, particular attention needs to be placed on the organizational context in which it is implemented if improvements in practice-based learning and systems-based practice are to be realized.     

Incorporation of institute of medicine competency recommendations within doctor of pharmacy curricula

Objectives. To determine the extent of implementation of Institute of Medicine (IOM) recommendations for 5 core competencies within the doctor of pharmacy (PharmD) curricula in US colleges and schools of pharmacy.Methods. A survey instrument that used IOM language to define each of the recommended competencies (patient-centered care, interdisciplinary teaming, evidence-based practice, quality improvement, and informatics) was sent to 115 US colleges and schools of pharmacy.Results. Evidence-based practice and patient-centered care were the most widely implemented of the 5 core competencies (in 87% and 84% of colleges and schools, respectively), while informatics, interdisciplinary teaming, and quality improvement were implemented to a lesser extent (at 36%, 34%, and 29% of colleges and schools, respectively).Conclusions. Significant progress has been made by colleges and schools of pharmacy for inclusion of IOM competencies relating to evidence-based practice and patient-centered care within curricula. However, the areas of informatics, interdisciplinary teaming, and quality improvement are lagging in inclusion.     

Pharmacoepidemiology: defining the field and its core content

PURPOSE: Emerging interests in pharmacoepidemiology make it important to define the profession's core content. The International Society for Pharmacoepidemiology (ISPE)'s Education Committee sought to develop a consensus on its core disciplines. This report recapitulates their efforts and conclusions. METHODS: The survey for skill inventories conducted characterized the field of pharmacoepidemiology by five categories of core competency/knowledge (pharmacovigilance, exposure data, epidemiology, clinical pharmacology, and medical product regulation) plus communication and leadership in these areas. It was sent to pharmacoepidemiology units within the industry, academia, and government representing the membership worldwide. RESULTS: After three waves, 125 members responded (~10% of the membership). Respondents were from North America (61%), European Union (23%), and the remainder from Asian Pacific and South American regions, representing the full spectrum of ISPE membership. Pharmacovigilance, analysis of exposure data, epidemiologic methods, and communication skills were the competencies identified as essential. Fourteen competencies were judged to be "essential" by >80% of the respondents; a further 26 had "essential" as the most frequently rated category but represented <80% of the respondents. Six items had "desirable but not a core competency" as the most commonly selected. None of the proposed competencies scored as "not a core competency" by >25% of the respondents. Only five of the competencies were suggested as "not core" by 10% or more. CONCLUSIONS: This survey identified a wide range of content relevant to the field of pharmacoepidemiology. This list will likely evolve over time. A curriculum around these areas will help prepare the next generation of pharmacoepidemiologists. Copyright ? 2012 John Wiley & Sons, Ltd.     

ACCP Clinical Pharmacist Competencies

The purpose of the American College of Clinical Pharmacy (ACCP) is to advance human health by extending the frontiers of clinical pharmacy. Consistent with this mission and its core values, ACCP is committed to ensuring that clinical pharmacists possess the knowledge, skills, attitudes, and behaviors necessary to deliver comprehensive medication management (CMM) in team‐based, direct patient care environments. These components form the basis for the core competencies of a clinical pharmacist and reflect the competencies of other direct patient care providers. This paper is an update to a previous ACCP document and includes the expectation that clinical pharmacists be competent in six essential domains: direct patient care, pharmacotherapy knowledge, systems‐based care and population health, communication, professionalism, and continuing professional development. Although these domains align with the competencies of physician providers, they are specifically designed to better reflect the clinical pharmacy expertise required to provide CMM in patient‐centered, team‐based settings. Clinical pharmacists must be prepared to complete the education and training needed to achieve these competencies and must commit to ongoing efforts to maintain competence through ongoing professional development. Collaboration among stakeholders will be needed to ensure that these competencies guide clinical pharmacists’ professional development and evaluation by educational institutions, postgraduate training programs, professional societies, and employers.     

Measuring clinical competence in preregistration trainees by OSCEs

Objective structured clinical examinations can be developed to assess patient‐focused competencies in preregistration trainees Preregistration trainees have limited clinical skills at beginning of the postgraduate training year Clinical performance has been shown to improve Deficiencies remain in some core skills at the end of the year There are wider implications for employers in relation to their expectations of newly qualified pharmacists     

跨国药企研发模式及发展趋势

制药业是研发投入占其销售总额比例最高的行业。通过透视目前全球新药研发现状与跨国医药企业研发的总体特征,对运行模式进行较为深入的分析探讨,将其归纳成7种研发模式：独立研发、专利授权、投资及收购、双方联合研发、项目外包、多方合伙利益分享风险分担及风险投资、外包企业与跨国药企知识产权的合作方式,分析其特点并分别提出具体的案例。指出了跨国药企日后的发展趋势：精简研发部门、建立小而灵的药物研发执行单元、扩大向公司外部寻求创新支持、加大研发外包等,分析了全球化对我国制药业的影响,进而提出我国医药产业全球化竞争和实施国际化的应对策略。     

Career management: an active process

The self-assessment, goal-setting, and career-planning techniques of career management are discussed, and the organization's role in career management is discussed. Career management is a planned process, initiated and carried out by an individual with the assistance of others. Because work and nonwork activities are so interrelated, career and life management planning can maximize a pharmacist's personal success. The career- and life-management process begins with the development of a personal definition of success. A self-assessment must be made of one's values, needs, interests, and activities. The next step of the process involves setting goals and establishing a plan or strategy to achieve them. Establishing a career path requires researching alternate career goals. Career competencies are identified that can increase an employee's chances of success. The employer shares the responsibility for career development through coaching, job structuring, and keeping the employee aware of constraints. Through the integration of the roles of the individual and the organization in the career-management process, employees can optimize their contribution to an organization. Pharmacists can successfully manage their careers by applying the techniques of self-assessment, goal setting, and career planning.     

Patent citation analysis of Allergan pharmaceutical patents

This is the second in a series of articles that apply patent citation analysis techniques to pharmaceutical patents. Co-citation clustering was used to identify the core pharmaceutical technological competencies of Allergan, Inc. and the technology fronts that this company is advancing. The analysis covers all US pharmaceutical patents assigned to Allergan issued between 1981 and June 30, 1998. The pharmaceutical patents were further classified as new chemical entities (NCEs) and non-NCEs. The main conclusion is that Allergan has three core technological competencies in pharmaceuticals: compounds with retinoid-like activity, ocular hypotensive agents and furanones as anti-inflammatory agents. In each of these areas, the company has developed a significant number of inventions that are closely related to each other and build on each other. At this time, Allergan appears to be pursuing the areas of retinoids and ocular hypotensives with the most vigour.