Education in graduate school of pharmaceutical sciences

The report of the Council for the improvement in the education of pharmaceutical sciences and the recommendation of the Central Council for Education indicate that the 6-year education is required to develop pharmacists with high qualities as medical staff. Each college of pharmacy started the education and practical training based on the model core-curriculum with the original program. On the other hand, to develop a scientist for the development of novel medicines, 4-year education program is also required. Under these new education systems, what we should do in the education in the graduate school of pharmacy and pharmaceutical sciences has been discussed. Recently, the first report about the purpose and the strategy in the graduate school in the new generation was submitted. Here, I will comment on the details of this report.     

The Future of the Pharmaceutical Sciences and Graduate Education: Recommendations from the AACP Graduate Education Special Interest Group

Despite pharma''s recent sea change in approach to drug discovery and development, U.S. pharmaceutical sciences graduate programs are currently maintaining traditional methods for master''s and doctoral student education. The literature on graduate education in the biomedical sciences has long been advocating educating students to hone soft skills like communication and teamwork, in addition to maintaining excellent basic skills in research. However, recommendations to date have not taken into account the future trends in the pharmaceutical industry. The AACP Graduate Education Special Interest Group has completed a literature survey of the trends in the pharmaceutical industry and graduate education in order to determine whether our graduate programs are strategically positioned to prepare our graduates for successful careers in the next few decades. We recommend that our pharmaceutical sciences graduate programs take a proactive leadership role in meeting the needs of our future graduates and employers. Our graduate programs should bring to education the innovation and collaboration that our industry also requires to be successful and relevant in this century.     

Fifty-Eight Years and Counting: High-Impact Publishing in Computational Pharmaceutical Sciences and Mechanism-Based Modeling

With this issue of the Journal of Pharmaceutical Sciences, we celebrate the nearly 6 decades of contributions to mechanistic-based modeling and computational pharmaceutical sciences. Along with its predecessor, The Journal of the American Pharmaceutical Association: Scientific Edition first published in 1911, JPharmSci has been a leader in the advancement of pharmaceutical sciences beginning with its inaugural edition in 1961. As one of the first scientific journals focusing on pharmaceutical sciences, JPharmSci has established a reputation for publishing high-quality research articles using computational methods and mechanism-based modeling. The journal’s publication record is remarkable. With over 15,000 articles, 3000 notes, and more than 650 reviews from industry, academia, and regulatory agencies around the world, JPharmSci has truly been the leader in advancing pharmaceutical sciences.     

Challenges faced by the pharmaceutical industry: training graduates for employment in pharmaceutical R&D.

There is a shortfall between output from universities and demand by the pharmaceutical and health care industries for science and engineering graduates able to rapidly contribute to success in the business environment. Against a changing infrastructure of pharmaceutical research, the development of new chemical entities by major companies accounts for a high proportion of R&D expenditure. Allocation of staff is divided fairly evenly between discovery, non-clinical and clinical research activities and in all categories the new sciences are likely to be used extensively.In dealing with the shortfall the challenge comes from balancing education in basic science with training in the emerging areas of science and technology. There is a need for a 'partnership' that includes not only industry and academia but also government, since these three bodies have both synergistic and diverging interests in scientific education.On the education-training continuum, industry should recognise what it most values from academia and provide as much input and support as possible. At the same time universities must question their ability to fulfil their traditional educational role in the face of current rates of adoption of new sciences and technology. While disciplinary excellence remains vital for PhD students, multi-disciplinary programmes are becoming increasingly important to enable graduates to function effectively in the modern, globalised pharmaceutical industry.     

Pharmaceutical education in the wake of genomic technologies for drug development and personalized medicine.

The development of safe and effective new therapeutics is a long, difficult, and expensive process. Over the last 20-30 years, recombinant DNA (rDNA) technology has provided a multiple of new methods, molecular targets and DNA-based diagnostics to pharmaceutical research that can be utilized in assays for screening and developing potential biopharmaceutical drugs. In parallel, new innovative approaches to drug delivery systems were discovered and reached the market. Pharmaceutical biotechnology, pharmacogenomics, combinatorial chemistry, in close relation to high-throughput screening technologies, and bioinformatics are major advances that give a new direction to pharmaceutical sciences. To meet with the needs of this new dynamic era of pharmaceutical research and health care environment, pharmaceutical education has to set new priorities to keep pace with the challenges related to genomic technologies. The development of new initiative education programs, for both undergraduate and graduate curricula, in pharmacy has to be focused on preparing pharmacists oriented for both pharmacy practice and drug research and development. This can be achieved by providing future pharmacists with knowledge, skills and attitudes to be more competitive in the health care system, pharmacy practice-related fields, pharmaceutical industry and drug research and development areas, or finally in academia. Educators and pharmacy school members have the responsibility of deciding how, to what extent, by which methods, and/or in which way these changes and new directions in the education programs should be developed.     

Challenges faced by the pharmaceutical industry: training graduates for employment in pharmaceutical R&D

There is a shortfall between output from universities and demand by the pharmaceutical and health care industries for science and engineering graduates able to rapidly contribute to success in the business environment. Against a changing infrastructure of pharmaceutical research, the development of new chemical entities by major companies accounts for a high proportion of R&D expenditure. Allocation of staff is divided fairly evenly between discovery, non-clinical and clinical research activities and in all categories the new sciences are likely to be used extensively.In dealing with the shortfall the challenge comes from balancing education in basic science with training in the emerging areas of science and technology. There is a need for a ‘partnership’ that includes not only industry and academia but also government, since these three bodies have both synergistic and diverging interests in scientific education.On the education-training continuum, industry should recognise what it most values from academia and provide as much input and support as possible. At the same time universities must question their ability to fulfil their traditional educational role in the face of current rates of adoption of new sciences and technology. While disciplinary excellence remains vital for PhD students, multi-disciplinary programmes are becoming increasingly important to enable graduates to function effectively in the modern, globalised pharmaceutical industry.     

Historical sketch of modern pharmaceutical science and technology (Part 4). Post World War II 50 years

A short history of the pharmaceutical science and technology, postwar 50 years is divided into nine sections for the purpose of discussion. 1. Japan's postwar rehabilitation, Japanese pharmaceutical industries and newly developed pharmaceutical sciences and technologies. In 1945, the Japanese pharmaceutical industry was reconstructed. Production of penicillin was carried out with the strong support of the U.S. Occupation Forces. New sciences in pharmacy (biochemistry, biopharmacy, pharmacology, microbiology, physical chemistry, etc.) were introduced in this period. 2. Introduction age of foreign new drugs and technology (1951 to 1960s). Japan gained independence in 1951. Japanese pharmaceutical companies imported many new drugs and new pharmaceutical technologies from the U.S.A. and European countries in this period. Then, these companies were reconstruction rapidly. However, consequently Japanese pharmaceutical companies were formed as an imitation industry. 3. Rapid economic growth period for pharmaceutical companies (1956 to 1970s). In this period, many Japanese pharmaceutical companies grew rapidly at an annual rate of 15-20% over a period of 15 years, especially with regard to the production of active vitamin B1 analog drugs and some OTC (public health drugs). Some major companies made large profits, which were used to construct research facilities. 4. Problems for the harmful effects of medicines and its ethical responsibility. In the 1970s, many public toxic and harmful effects of medicines were caused, especially SMON's disease. In this time, many pharmaceutical companies changed to its security got development of ethical drugs. 5. Self development of new drugs and administration of pharmaceutical rules (1970s). During the 1970s, many pharmaceutical laws (GLP, GCP, GMP, GPMSP etc.) were enacted by the Ministry of Health and Welfare. In 1976, the Japanese Pharmaceutical Affairs Law was revised, which set forth standards regarding the efficacy and safety of ethical drugs and re-evaluation of drugs. Many facilities were built for the purpose of ensuring efficacy and safety, as shwon in Table 1. 6. Problems of Intellectual Property and followed the revisionist line of research and development for new ethical drugs. In 1976, Japanese pharmaceutical companies ceased to be an imitation industry, and increased research for the development of new drugs. 7. Pharmaceutical science and technology innovation (After 1985). Many of the pharmaceutical innovations during this period were as follows: 7.1) Technology innovation for evaluation of drug efficacy; 7.2) 1st to 3rd medical diagnostic technology innovations; 7.3) medical analytical methods and spectrometry technologies; 7.4) Computer-aided drug-design technology and drug information technology innovation; and 7.5) Drug delivery system and treatment drugs. 8. Recent research and development of new ethical drugs in Japan (1970 to 1995). Cephalosporine type beta-lactams (cefazolin, cefametazole, furomoxef, cefdinir), new quinolones (norfloxcin, ofloxacin, tosfloxcin), H1-Blockers (famotidine), Ca-antagonists (diltiazem, nicardipine), and other new drugs (pravastatine, taclolimus, leuprine) etc. came onto the market. 9. International Harmonization Age and Review toward 21 century. The rapid development and globalization of the pharmaceutical market has promoted international harmonization and rationalization of pharmaceutical regulatory affairs. In 1990, the Japan Pharmaceutical Manufacturers Association published a report toward 21 century, which described practical plans.     

Pharmaceutical Sciences' Manpower Supply and Internal Rate of Return

A pharmacy student has many career options upon graduation. These options include graduate education in one of the pharmaceutical sciences and a retail pharmacy position. The attractive salaries offered by chain pharmacies play an important role in the recent graduate's career decision-making process. The purpose of this study is to provide a comparative assessment of the internal rate of return (IRR) for different pharmaceutical science career options as related to chain-store pharmacist earnings. Additionally, this study analyzes the effect of the IRR on the applicant pool size and composition for graduate study in pharmaceutical sciences. Income/age profiles were developed using public domain income data derived from salary surveys sponsored by professional associations. Based on these income/age profiles, IRRs were estimated for the pharmaceutical science disciplines, clinical pharmacy, pharmaceutics, medicinal chemistry, and pharmacy administration, and further differentiated for industry versus academic careers. The IRRs are the highest for Pharm.D.'s in academic careers (16.0%), followed by pharmaceutical scientists employed by pharmaceutical industry (8.13%). The IRR of pharmaceutical scientists in academia is lower than the return on other financial investment vehicles. Other authors have established a relationship between the IRR of a profession and a rise or decline in the applicant pool. The IRRs calculated here imply that this association can also be observed for the pharmaceutical scientist applicant pool. Low IRRs should result in a declining applicant pool. However, the last decade has shown an increase of 66% in the number of Ph.D.'s granted, while the percentage of Ph.D.'s granted to nonpharmacists or non-Americans has not increased significantly over the same time period. The supply of pharmaceutical scientists has increased, yet these increases have been outpaced by increases in demand. Improvement in support levels for graduate studies may increase the applicant pool in the pharmaceutical sciences.     

Future training needs in the pharmaceutical sciences: Academia – Industry

The markets for the traditional output of schools of pharmacy, namely education, research and graduates, are changing. The main private client in these markets, the pharmaceutical industry, is moving fast to become more efficient, under pressure from overly costly drug development. The challenges to the industry that emanate from the fantastic rate of advances in the biomedical sciences and pharmaceutical development are considerable. The many agents that were unheard of 10 years ago, such as gene-regulators, together with new technologies, all require new approaches to fundamental pharmaceutical issues.

The concept of disciplines in graduate education may have to be reconsidered in the light of the multidisciplinary problems to be tackled. In addition, graduates will need to acquire a range of non-disciplinary skills, such as better communication or team working, in order to be effective in the commercial market place.

The concept of ‘research schools’ following either a local or network model may provide the way forward to help academia meet the graduate education needs of industry. The objectives and mission of such institutions must be clearly defined to ensure that the current scientific environment is embraced fully.     

Proceedings of clinical pharmacy research with the cooperation of community and hospital pharmacist and pharmacy school

The new pharmaceutical education system starts in Japan, those constructions are performed at a lot of universities aiming at the execution of a common examination and the clinical training, and the workshop for directive pharmacists have been held actively since last year. Moreover, various educational lectures, open lectures, and the training lectures for on-site pharmacist's upskilling are carried out. However, a technical training and the lecture for research approach that supports the pharmacist in a pharmaceutical clinical research are little at the chance to learn the research methods. Now, many joint researches with university initiative or a university is performed, and the institution of presentation inexperience at academic society also exists in terms of a regional element, a staff arrangement side, etc, and also when the continuation is difficult, it looks mostly. It is necessary that the teacher of pharmacy school almost arranged in the whole country support positively a clinical research by the nearby pharmacist, and also it seems that a clinical teacher's role is large in the cooperation of pharmacy school and the medical institution. Moreover, in order to elucidate the scientific basis (mechanism) of a problem suggestion in the clinical spot, basic research in a pharmacy school is also required. We always need to advance a pharmaceutical clinical research by considering the basic research by pharmacy school in medical institution, considering clinical research by medical institution in pharmacy school, while cooperating mutually. In this article, I show how to advance pharmaceutical clinical research.     

Pharmacy,pharmacists and society--pharmaceutical science and practice with philosophy

In Japanese pharmaceutical community, there seems to be a lack of "Science of Science" and "Research on Research" which are to utilize unit sciences and research for the benefit of human being. In other words, pharmaceutical people in Japan should have much more pharmaceutical philosophy. The late Professor Komei Miyaki, founder Editor-in-Chief of FARUMASHIA, the monthly membership magazine of Pharmaceutical Society of Japan, under whom I worked as one of editorial board members, taught me that scientists should have their own philosophy of their sciences. Such a pharmaceutical philosophy as mentioned above should be established on the basis of complete separation of medical profession between doctors and pharmacists, which form the most important and necessary issue in safety assurance for patients with the complete zero defect (ZD action), as there is a long history for that in Europe since the separation was completed by King Friedrich II in 1240. Therefore, we have to learn the social status of European/American pharmacist practitioners who are the great No. 1 among all the professions. European pharmacists guarantee the safety of every chemical used for human body and pets, such as medicines, cosmetics, foods, tooth stuffs and so on. Regarding the pharmaceutical sciences in Japan also there seems to be a lack of pharmaceutical philosophy, as pharmaceutical scientists have no identity in research object that may be similar to basic scientists who are non-pharmacy graduates. Japanese sciences generally have developed along the lines of the Western model, reaching the current high level. We now not only should receive profits from the outside but also should embark on a mission to support pharmaceutical sciences throughout the world, especially Asian courtiers. At the present, we do not seem to be fulfilling our mission to do that, even though general activity includes significant international exchange. We have to make much more effort for international contribution/participation. For that, the most important and necessary issue is to make change in fundamental sense in Japanese pharmaceutical community, though an internationalization of technological issues is usually taken into consideration. In this connection, regarding the new drug development, we must have a change in the sense to establish pharmaceutical philosophy and jump up in conception from the existing one. Based on the above mentioned pharmaceutical philosophy, seven star pharmacists should be educated as described in 2000 FIP Statement of Policy: Good Pharmacy Education Practice, who could be a (1) care giver; (2) decision maker; (3) communicator; (4) leader; (5) manager; (6) life-long learner; (7) teacher.     

Effect of the resolution of measurements in the behavior of the shewhart control charts for means

Measurements of limited resolution change the behavior of a Shewhart average chart in two ways. The standard deviation of measurements differs from process standard deviation due to rounded values and discreteness of values of subgroup averages. The probability of getting a point in control depends on the position of accessible values relative to the position of control limits. In many processes of the pharmaceutical industry, Shewhart control charts are very useful tools. In this paper, one example about the use of these charts in the abovementioned industry is given. Resolution requirements of a measurement system for successful operation of an average Shewhart control chart are presented. Recommendations are given for acceptable criteria about the resolution of the measurement system when an average control chart is implemented, and are compared with already existing literature. LAY ABSTRACT: It is vital for the pharmaceutical industry to deliver safe medicines to patients. Quality control is a part of the quality management that is oriented to control raw materials, processes, and finished products. This constitutes a usual activity of pharmaceutical companies that use for that purpose different chemical, physical, and biological assays. Any control method will use measurement devices. The measurement devices require a certain measurement capability and must be fit for the purpose of controlling the quality of pharmaceutical products. The equipment capability includes, among other elements, the resolution, which means the smallest change in a quantity being measured that causes a perceptible change in the corresponding indication. Control charts have been extensively used for statistical process control and for its proper operation, measurement equipment of the adequate resolution is needed. Based on a case of the pharmaceutical industry and simulation tools, this paper studies the proper resolution of measurement devices for use in control charts.     

Genetics of osteoarthritis and potential for drug development

Genome-wide linkage scans for the mapping of osteoarthritis susceptibility loci have come to the fore in recent years, driven by the failure of candidate gene association studies. Four scans have been published, with several strong linkages reported. These do not encompass the major cartilage structural genes that many consider the most likely susceptibility loci. This has increased the probability that the biological pathways responsible for susceptibility are modifiable by drug treatment, which one would not reasonably expect for a structural protein. This in itself has stimulated the interest of several pharmaceutical companies. Such interest will be to the benefit of patients, but will require candid co-operation between academics and industry if the delay in transferring research findings from the laboratory to the clinic is to be minimised.     

Recent progress in drug delivery

Drug delivery systems (DDS) are defined as methods by which drugs are delivered to desired tissues, organs, cells and subcellular organs for drug release and absorption through a variety of drug carriers. Its usual purpose to improve the pharmacological activities of therapeutic drugs and to overcome problems such as limited solubility, drug aggregation, low bioavailability, poor biodistribution, lack of selectivity, or to reduce the side effects of therapeutic drugs. During 2015–2018, significant progress in the research on drug delivery systems has been achieved along with advances in related fields, such as pharmaceutical sciences, material sciences and biomedical sciences. This review provides a concise overview of current progress in this research area through its focus on the delivery strategies, construction techniques and specific examples. It is a valuable reference for pharmaceutical scientists who want to learn more about the design of drug delivery systems.     

Research schools in pharmacy. 6. Gunther Wagner and his students

The aim of this article is to trace the historical development of Günther Wagner and his research school. Wagner is an idealy teacher. The scientific programme is represented by 2 books, 502 papers and 54 dissertations. It has some main roots: synthesis of potential active substances and pharmaceutical analytic. Wagner had 991 students (pharmacists), 45 made their doctor graduate under Wagner and 6 are becoming professor. The research conditions in Leipzig were good and the research school of Wagner has an important public and social recognition in the GDR and in other countries.     

Pharmaceutical Scientists’ Perspectives on Capacity Building in Pharmaceutical Sciences

With the anticipated health challenges brought by demographic and technological changes, ensuring capacity in underlying workforce in place is essential for addressing patients’ needs. Therefore, a timely identification of important drivers facilitating capacity building is important for strategic decisions and workforce planning. In 2020, internationally renowned pharmaceutical scientists (N = 92), largely from the academia and pharmaceutical industry, with mostly pharmacy and pharmaceutical sciences educational background were approached (through a questionnaire) for their considerations on influencing drivers to facilitate meeting current capacity in pharmaceutical sciences research. From a global view, based on the results of the questionnaire, the top drivers were better alignment with patient needs as well as strengthening education – both through continuous learning and deeper specialisation. The study also showed that capacity building is more than simply increasing the influx of graduates. Pharmaceutical sciences are being influenced by other disciplines, and we can expect more diversity in scientific background and training. Capacity building of pharmaceutical scientists should allow flexibility for rapid change driven by the clinic and need for specialised science and it should be underpinned by lifelong learning.     

Role of the development scientist in compound lead selection and optimization

The R&D process for bringing drugs from discovery laboratories to the marketplace is undergoing rapid change, as enabled by new technologies and as demanded by the global pharmaceutical business environment. One consequence of the accelerated R&D paradigm is a blurring of the traditional discovery-development interface, which in turn impacts the traditional roles of discovery and development scientists. R&D organizations must find ways to screen out rapidly compounds that have relatively poor probability of successful registration. Quality of development candidates can be favorably influenced by early consideration of "developability" criteria along with receptor-based potency and specificity. Computational approaches and/or high-throughput experimental determinations will be used increasingly to profile compound characteristics which influence "developability." If such criteria are considered at the time of lead selection and optimization, the compound attrition rate during later development should be decreased from the historical norm. This article discusses the emerging role of development scientists during small-molecule lead selection and optimization. The changing role of development scientists also has implications for graduate curricula in the pharmaceutical sciences.     

From pharmacovigilance to pharmacoperformance.

The pharmaceutical industry is going through a period of enormous upheaval, as new sciences, technologies and commercial pressures reshape the way in which it performs research and development. PwC Consulting estimates that the top 20 companies will each need to launch between four and six times the number of drugs they currently produce, as well as improving the quality of those drugs, merely to maintain shareholder returns. This has huge implications for pharmacovigilance departments. More drugs means more trials, more patients and -- of course -- more safety reports for evaluation. The pharmacovigilance teams in most big companies are ill prepared for this transition being already stretched to the limit. But as demand for patients to participate in clinical trials increases -- with shorter development times, higher success rates in discovery and greater productivity -- so companies with a poor reputation for safety will suffer. What is it then that companies should be doing to remain compliant and be seen to be safe in the eyes of the consumer? Can pharmacoepidemiology support both molecules in the marketplace as well as those in research and development and what is really needed to enable this? Key to success will be the ability to capture, analyse and evaluate data (from disparate sources) in real time and to make rapid decisions on the appropriate course of action. Putting better structures, processes and technological platforms in place to cope with a big increase in throughput is only a short-term solution yet is it enough to fulfil the objective in the long-term of ensuring compliance and patient safety?