Member Companies Research Articles

Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks.

The basis of pharmacovigilance is provided by the exchange of Individual Case Safety Reports (ICSRs) between the recipient of the original report and other interested parties, which include Marketing Authorization Holders (MAHs) and Health Authorities (HAs). Different regulators have different reporting requirements for report transmission. This results in replication of each ICSR that will exist in multiple locations. Adding in the fact that each case will go through multiple versions, different recipients may receive different case versions at different times, potentially influencing patient safety decisions and potentially amplifying or obscuring safety signals inappropriately. The present study aimed to investigate the magnitude of replication, the variability among recipients, and the subsequent divergence across recipients of ICSRs. Seven participating TransCelerate Member Companies (MCs) queried their respective safety databases covering a 3-year period and provided aggregate ICSR submission statistics for expedited safety reports to an independent project manager. As measured in the US Food and Drug Administration (FDA)'s Adverse Event Reporting System (FAERS), ICSR volume for these seven MCs makes up approximately 20% of the total case volume. Aggregate metrics were calculated from the company data, specifically: (i) number of ICSR transmissions, (ii) average number of recipients (ANR) per case version transmitted, (iii) a submission selectivity metric, which measures the percentage of recipients not having received all sequential case version numbers, and (iv) percent of common ISCRs residing in two or more MAH databases. The analysis reflects 2,539,802 case versions, distributed through 7,602,678 submissions. The overall mean replication rate is 3.0 submissions per case version. The distribution of the ANR replication measure was observed to be very long-tailed, with a significant fraction of case versions (~12.4% of all transmissions) being sent to ten or more HA recipients. Replication is higher than average for serious, unlisted, and literature cases, ranging from 3.5 to 6.1 submissions per version. Within the subset of ICSR versions sent to three recipients, a significant degree of variability in the actual recipients (i.e., HAs) was observed, indicating that there is not one single combination of the same three HAs predominantly receiving an ICSR. Submission selectivity increases with the case version. For case version 6, the range of the submission selectivity for the MAHs ranges from ~10% to over 50%, with a median of 30.2%. Within the participating MAHs, the percentage of cases that reside within at least two safety databases is approximately 2% across five databases. Further analysis of the data from three MAHs showed percentages of 13.4%, 15.6%, and 27.9% of ICSRs originating from HAs and any other partners such as other MAHs and other institutions. Replication of ICSRs and the variation of available safety information in recipient databases were quantified and shown to be substantial. Our work shows that multiple processors and medical reviewers will likely handle the same original ICSR as a result of replication. Aside from the obvious duplicate work, this phenomenon could conceivably lead to differing clinical assessments and decisions. If replication could be reduced or even eliminated, this would enable more focus on activities with a benefit for patient safety.

PSMA Sponsored Events Fuel Continuing Education and Knowledge Exchange [PSMA Corner

A driving goal of the Power Sources Manufacturers Association (PSMA) ( <uri xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">https://psma.com</uri> ) is to improve the knowledge of technological and other developments related to power sources and conversion devices. To achieve this goal PSMA sponsors multiple events throughout the year to assist member companies in aligning their product roadmaps to identify emerging trends and meet challenges.

Identification of Rodent Husbandry Refinement Opportunities through Benchmarking and Collaboration.

Expanding the use of methods that refine, reduce, and replace (3Rs) the use of animals in research is fundamental for both ethical and scientific reasons. The mission of the 3Rs Translational and Predictive Sciences Leadership Group (3Rs TPS LG) of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium) is to promote sharing and integration of science and technology to advance the 3Rs in the discovery and development of new medicines, vaccines, medical devices, and health care products for humans and animals. The 3Rs TPS LG is dedicated to identifying opportunities for member companies to share practices, enhance learning, promote discussions, and advance the 3Rs across the industry. One such opportunity was a benchmarking survey, conducted by the Contract Research Organization (CRO) Outreach Working Group, designed to share practices in rodent husbandry for drug safety research and to identify potential opportunities for refinement. IQ member companies and CROs in Asia, North America, and Europe were surveyed. Areas identified for potential alignment included provision of corncob bedding and wire-grid flooring, management of the nest at cage change, approaches to social housing for male mice, evidence-based enrichment strategies, and evaluating the effects of the timing of studies in relation to the animals' circadian rhythm and light-cycle, with consideration for how such extrinsic factors influence animal welfare and scientific outcomes. This manuscript presents the results of the benchmarking survey, including general trends in mouse and rat husbandry practices in toxicology studies, considerations for social housing, enrichment selection, and potential effects of bedding substrate, emphasizing opportunities for collaboration that can help to identify refinements to rodent husbandry practices.

THE INFLUENCE OF RISK MANAGEMENT THEORIES ON THE USE OF DERIVATIVES IN THE ELECTRIC POWER INDUSTRY

The work explores crucial decisions on the use of the specific types of derivatives in the electricity price risk management by the member companies of the European Federation of Energy Traders (EFET). The survey has been motivated by volatile fuel prices on international markets and significant losses incurred due to the exposure of companies to such volatility. These trends are the reason why increasing attention is devoted to risk management in the energy sector. The work tests the validity of the assumptions relating to the justification of the risk management function and its impact on corporate value increase. It has been investigated if these theories, as well as the specific corporate characteristics, such as indebtedness, size, liquidity and investment value, influence the use of forwards, futures, options or swaps as tools designed to offset the risk of energy price changes. The findings of univariant and multivariant analyses have shown that the companies using forwards differ from the companies not using them due to their greater indebtedness and higher value of new investments. It can thus be concluded that the companies which are more engaged in capital investment and in this use higher amounts of bonded capital tend to use forwards to a greater extent. On the other hand, it is interesting to note the fact that the size of a company does not play a major role in the choice of this tool, which confirms that forwards are a risk protection tool in the broadest use among big and small companies alike. Likewise, it is indicative that the size of a company has proved to be an influential factor in the choice of futures, swaps and options as tools created to offset the risks of energy price changes.

Unequal access to justice: an evaluation of RSPO’s capacity to resolve palm oil conflicts in Indonesia

In 2009 the Roundtable on Sustainable Palm Oil (RSPO) established a conflict resolution mechanism to help rural communities address their grievances against palm oil companies that are RSPO members. This article presents the broadest ever comprehensive assessment of the use and effectiveness of the RSPO conflict resolution mechanism, providing both overviews and in-depth analysis. Our central question is: to what extent does the RSPO conflict resolution mechanism offer an accessible, fair and effective tool for communities in Indonesia to resolve conflicts with companies? Our aim is not only to provide a ‘reality check’ of this mechanism but also to contribute to the wider debate on how communities can seek access to justice when engaged in intractable conflicts with palm oil companies. For data collection, we took three steps. First, we used our own database of 150 conflicts between communities and companies in Indonesia. We identified 64 conflicts that involved RSPO member companies, of which 17 prompted communities to convey their grievances to the RSPO’s conflict resolution mechanism. Second, we used the database of the RSPO, which handled 85 complaints against companies in Indonesia in the period 2009–2020. Third, we conducted fieldwork, in total, about 6 months of fieldwork and extensive interviews on three conflicts involving RSPO companies to identify mechanisms leading to (and reasons for) both failed and successful instances of conflict resolution. For our assessment, we used three criteria to assess the conflict resolution mechanism of the RSPO: accessibility, procedural justice, and the outcomes of the process. We conclude that—on all counts—the conflict resolution mechanism is biased in favor of companies. The result of these biases is that the actual capacity of the RSPO’s mechanism to provide a meaningful remedy for rural communities’ grievances remains very limited. This unequal access to justice sustains conflicts between companies and communities over land.

지역협회 단위 판유리 공동구매 및 수·배송 물류운영

Purpose This study aims to propose ways to reduce the cost of purchasing negative plate glass through the group purchase of required amounts under the leadership of local associations of processed plate glass and plans to improve the profit structure of local processed plate glass manufacturers through logistics management base on joint transportation and delivery. Methods A model was developed for the costs of purchasing negative plate glass, regular transportation and delivery cost, costs of returning vehicles to the starting point after regular transportation and delivery. Results A reduction in purchase price and logistics costs through the application and analysis of numbers in cases of group purchase and joint logistics for negative plate glass under the leadership of local association by zones proposed in the study compared with old cases in which the member companies of a local association purchased negative plate glass, transported and delivered and had vehicles returned after transportation and delivery separately. Conclusion Group purchase and logistics management based on joint transportation and delivery under the leadership of a local association of processed plate glass are expected to improve the profit structure through the reduction of purchase prices, transportation and delivery costs, and returning vehicle costs for the member firms.

인코텀즈 상 정형거래조건 변경으로 인한 수출입성과와 제약요인에 관한 연구

Recently, international commerce is expanding and logistics costs are rising rapidly. In this regard, the Korea International Trade Association recommends changing the international commercial terms under incoterms as a way to reduce logistics costs for import/export companies. This study tried to examine the constraint factors that appear in the process of changing international commercial terms.&#x0D; In order to achieve the research purpose, this study composed questionnaire items by conducting previous studies, expert interviews, and pilot studies. The questionnaire was distributed to random sample companies based on the list of member companies such as the Korea International Trade Association, the Korea Trade-Investment Promotion Agency, and the Korea Small and Medium Business Association. The survey period was from March 2, 2022 to June 30, 2022. About 1,200 copies of the total questionnaire were distributed and 244 copies were used for empirical analysis, and PLS-SEM was performed to derive the results.&#x0D; The results of this study are as follows. First, It was found that the internal rigidity and lack of expertise in determining international commercial terms in trade companies had a negative impact on the change of international commercial terms. Second, It was found that the change of international commercial terms in import/export companies improves trade performance.

Patented product remanufacturing and technology licensing in a closed-loop supply chain

In practice, the OEM may license technology to a remanufacturer to help the remanufacturer carry out remanufacturing activities while charging patent licensing fees. This kind of cooperative behavior has a significant impact on the environmental and economic benefits brought by remanufacturing activities. However, the patent licensing behavior will also improve the quality of remanufactured product produced by remanufacturer, and increase their competition with OEM’s products. So, how do consumers' quality preferences for products affect OEMs' patent licensing decisions? What kind of patent license contract can bring more profits to the OEM? Which patent license contract is more beneficial to environmental protection? To answer these questions, this paper examines the best production strategies and the best technology cooperation mode of the supply chain member companies, with considering the influence of consumers’ quality preferences. Via the Cournot duopoly model, three common licensing strategies are investigated and compared, and the following conclusions are drawn. (i) When the OEM does not license the patent, if the quality of the remanufactured product is relatively low compared with that of the new product, the remanufacturer will not enter the market to carry out remanufacturing activities. (ii) The OEM will benefit from the quality-improved remanufacturing patent license, and will be willing to license the patented technology to the remanufacturer only if the unit cost gap between the new and remanufactured products is not very large. The higher the quality of the remanufactured product prior to patent licensing, the lower the patent licensing fee that the OEM can charge, and the lower the profit that the OEM can obtain through the patent licensing. (iii) Two-part tariff licensing is always the best patent licensing strategy for the OEM, regardless of the quality level of the remanufactured product prior to patent licensing. This study elucidates the optimal patent licensing strategy options for the OEM and provides some theoretical contributions and practical implications.

Effect of cluster initiatives and natural clusters on business performance

PurposeThis study aims to determine how much company participation in a type of cluster affects its economic performance.Design/methodology/approachThis study includes companies operating in seven industries (automotive, engineering, textiles, information technology (IT) services, furniture, packaging and nanotechnology) in the Czech Republic. The companies are divided into three groups: members of institutionalized cluster, operating in the same region (natural clusters) and operating in other regions. Data envelopment window analysis is used to measure their performance for 2009–2019.FindingsResults show that the effect of clustering differs among industries. Companies in three industries (automotive, engineering, nanotechnology) reveal a positive impact of the cluster initiative on performance growth. Two industries (textile, packaging) with companies operating in a natural cluster show better performance than those in an institutionalized cluster. Moreover, the IT services and the furniture industries show no positive effect of clustering on corporate performance.Research limitations/implicationsThis research includes 686 companies from seven industries and monitored for 11 years. On the one hand, the sample includes a relatively high number of companies overall; but on the other hand, the sample is relatively small, especially for nonclustered companies. The reason is the lack of available financial statements for small companies.Practical implicationsFrom the perspective of practical cluster policy, the authors can recommend that monitoring the performance of member companies in clusters must be one of the criteria for evaluating the success of a cluster, such as cluster initiatives.Originality/valueThis study distinguishes between long-standing natural clusters in a given industry and institutionalized ones that have emerged because of a top-down initiative. An original database is created for clustered and nonclustered companies in seven industries, covering the entire Czech Republic.

Collaborative Partnerships - Conceptualization of Strategic Alliances for Sustainable Supply Chains

To achieve sustainability among supply chain partners, many actors along the supply chain are increasingly engaging in strategic alliances. This paper aims to create an overview of the phenomenon of alliances and the underlying behavior of the participants leading to collaborative partnerships. Based on a literature review, a framework for strategic alliances that address sustainability issues in the supply chains of member companies is conceptualized. Findings suggest motives, interdependence, and implementation as central aspects for the overview of alliances. It revealed that the motives for participating in an alliance mainly lay on efficiency through shared resources and organizational learning, as well as institutional pressure. Drawing on the social exchange theory, aspects such as reciprocity, trust, commitment, and power can be promoted through the organization of the governance structure, fair allocation of power and benefits, and communication. To reduce issues due to information asymmetry, the implementation relies on tools, practices, and structured information exchange. This research contributes to filling identified gaps and expanding knowledge about the phenomenon of alliances to improve collaborative partnerships. It combines previous findings and creates a framework that provides an overview of the topic.

Current Approaches for Predicting Human PK for Small Molecule Development Candidates: Findings from the IQ Human PK Prediction Working Group Survey.

Accurate prediction of human clearance (CL) and volume of distribution at steady state (Vd,ss) for small molecule drug candidates is an essential component of assessing likely efficacious dose and clinical safety margins. In 2021, the IQ Consortium Human PK Prediction Working Group undertook a survey of IQ member companies to understand the current PK prediction methods being used to estimate these parameters across the pharmaceutical industry. The survey revealed a heterogeneity in approaches being used across the industry (e.g., the use of allometric approaches, differing incorporation of binding terms, and inconsistent use of empirical correction factors for in vitro-in vivo extrapolation, IVIVE), which could lead to different PK predictions with the same input data. Member companies expressed an interest in improving human PK predictions by identifying the most appropriate compound-class specific methods, as determined by physiochemical properties and knowledge of CL pathways. Furthermore, there was consensus that increased understanding of the uncertainty inherent to the compound class-dependent prediction would be invaluable in aiding communication of human PK and dose uncertainty at the time of candidate nomination for development. The human PK Prediction Working Group is utilizing these survey findings to help interrogate clinical IV datasets from across the IQ consortium member companies to understand PK prediction accuracy and uncertainty from preclinical datasets.

Increasing the Reuse of Protein Non-Naïve Nonhuman Primates in Pharmaceutical Drug Discovery and Development: An Overview and Industry Position on the Challenges and Benefits.

The IQ Consortium NHP Reuse Working Group (WG) comprises members from 15 pharmaceutical and biotechnology companies. In 2020, the WG developed and distributed a detailed questionnaire on protein non-naïve NHP reuse to the WG member companies. The WG received responses from key stakeholders including principal investigators, facility managers, animal welfare officers and research scientists. This paper's content reflects the consolidated opinion of the WG members and the questionnaire responses on the subject of NHP reuse within nonclinical programs at all stages of research and development. Many of the pharmaceutical companies represented in the working group or participating in the questionnaire have already achieved some level of NHP reuse in their nonclinical programs, but the survey results suggested that there is significant potential to increase NHP reuse further and a need to understand the considerations involved in reuse more clearly. The WG has also focused carefully on the inherent concerns and risks of implementing protein non-naive NHP reuse and has evaluated the best methods of risk assessment and decision-making. This paper presents a discussion on the challenges and opportunities surrounding protein non-naïve NHP reuse and aims to stimulate further industry dialogue on the subject and provide guidance for pharmaceutical companies to establish roadmaps and decision trees enabling increased protein non-naïve NHP reuse. In addition, this paper represents a solid basis for collaborative engagement between pharmaceutical and biotechnology companies with contract research organizations (CROs) to discuss how the availability of protein non-naïve NHP within CROs can be better leveraged for their use within nonclinical studies.

THE EFFECT OF CORPORATE GOVERNANCE ON THE FINANCIAL PERFORMANCE OF COMPANIES LISTED ON THE TEHRAN STOCK EXCHANGE

The present study investigated the effect of corporate governance on the financial performance of companies listed on the Tehran Stock Exchange. In this study, the duality of CEO duties and financial performance were considered as corporate governance mechanisms. Indicators like return on assets, return on equity and net operating profit after tax have been used to measure financial performance. The studied period was 2013 to 2017 and samples were member companies of Tehran Stock Exchange. The findings revealed that corporate governance and financial performance of companies listed on the Tehran Stock Exchange had a favorable significant association. With the ROE index, there was a significant positive association between board accountability and corporate performance. With the TQ index, there was a positive significant association between board accountability and company performance, and with the ROE index, there was a positive significant relationship between transparency level and firm performance. There was also a substantial positive link between the amount of transparency and business performance as measured by the TQ index, as well as a significant positive relationship between the audit committee and company success as measured by the ROE index.

Avaliação de Práticas de Sustentabilidade das Empresas do Complexo Industrial e Portuário do Pecém

Brazilian ports are extremely important to the economy, acting between production systems and consumption centers. This research aims to evaluate the sustainability practices of AECIPP member companies, as well as the dissemination of these practices to interested parties, to study them by branches of economic activity. The adopted research is classified as exploratory-descriptive with a qualitative approach and the population is composed of 31 member companies of the AECIPP. For data collection, secondary documentary research was used. The data collection instrument was a checklist consisting of six questions that assess the adoption and disclosure or not of sustainability practices by companies. To assess and classify the performance of each company and branch of activity in relation to their sustainability practices, the sum of the valuations attributed to the items in the checklist was carried out. With the results obtained, there is an indication that 8 companies have a great performance in relation to the adoption of sustainability practices and their disclosure, the others already show a trend towards change, a fact that should be mentioned is that the corporate policies of these companies that often represent their intentions towards society begin to encompass terms that refer to sustainable development.

Absorption, Distribution, Metabolism, and Excretion of Therapeutic Proteins: Current Industry Practices and Future Perspectives.

Therapeutic proteins (TPs) comprise a variety of modalities, including antibody-based drugs, coagulation factors, recombinant cytokines, enzymes, growth factors, and hormones. TPs usually cannot traverse cellular barriers and exert their pharmacological activity by interacting with targets on the exterior membrane of cells or with soluble ligands in the tissue interstitial fluid/blood. Due to their large size, lack of cellular permeability, variation in metabolic fate, and distinct physicochemical characteristics, TPs are subject to different absorption, distribution, metabolism, and excretion (ADME) processes as compared with small molecules. Limited regulatory guidance makes it challenging to determine the most relevant ADME data required for regulatory submissions. The TP ADME working group was sponsored by the Translational and ADME Sciences Leadership Group within the Innovation and Quality (IQ) consortium with objectives to: (1) better understand the current practices of ADME data generated for TPs across IQ member companies, (2) learn about their regulatory strategies and interaction experiences, and (3) provide recommendations on best practices for conducting ADME studies for TPs. To understand current ADME practices and regulatory strategies, an industry-wide survey was conducted within IQ member companies. In addition, ADME data submitted to the U.S. Food and Drug Administration was also collated by reviewing regulatory submission packages of TPs approved between 2011 and 2020. This article summarizes the key learnings from the survey and an overview of ADME data presented in biologics license applications along with future perspectives and recommendations for conducting ADME studies for internal decision-making as well as regulatory submissions for TPs. SIGNIFICANCE STATEMENT: This article provides comprehensive assessment of the current practices of absorption, distribution, metabolism, and excretion (ADME) data generated for therapeutic proteins (TPs) across the Innovation and Quality participating companies and the utility of the data in discovery, development, and regulatory submissions. The TP ADME working group also recommends the best practices for condu-cting ADME studies for internal decision-making and regulatory submissions.

The Effect of Industry Type, Company Size, Profitability, Leverage and Environmental Performance on Environmental Disclosure (Empirical Study on PROPER Participating Companies in 20182020)

Thei purpose of this study is to describe thei influence of industrial types, company size, profitability, leverage and environmental performance against Environmental Disclosure. The level of measurement of environmental disclosure is a chousier using GRI. There are 95 ratings scores in the detection of Disclosure environmental. The reference for this research is a study conducted by Burgwal and Vieirra (2014) conducted changes and improvements. The population in this study is a non financial company listed on the IDX in 2018 2020. The selected company for this study was 35 companies. The data collection used is purposive sampling, with the selection of Proper member companies. The data analyzed totaled 105 data. The main analysis of this study is multiple linear regression analysis. The results of the study show that industrial type variables, company size, profitability and environmental performance have a significant effect on environmental disclosure environment. While the leverage variable“does not significantly influence the environmental disclosure. Based on the regression results simultaneously obtained that 86.92% variations in industrial type variables, company size, profitability, leverage and environmental performance have a significant significantly influence on the environmental disclosure. Suggestions for companies should pay attention and improve the disclosure of environmental responsibilities. The government is also expected to consider environmental disclosure standards. And for further research it is necessary to develop other factors as an influence of environmental disclosure and use the measurement of other environmental disclosures.

Streamlined life cycle assessment of single use technologies in biopharmaceutical manufacture

The rapid growth of biologics as the preferred modality in several therapeutic areas has led to changes in the environmental profile of pharmaceutical manufacturing for some companies. The increased use of single use technologies (SUT) in biologics manufacturing has been accompanied by a greater public awareness of plastics waste, but the full life cycle environmental impacts of SUT have had limited study. Therefore, a segment of American Chemical Society Green Chemistry Institute Pharmaceutical Roundtable member companies undertook a streamlined cradle-to-gate life cycle assessment on a biological bulk drug substance (BDS) manufacturing process utilizing SUT at the 2000 L scale. The goal of this study was to highlight where pharmaceutical companies, and biologics producers in particular, can reduce the environmental impact of their drug substance manufacturing. The results have shown that the largest contribution to the life cycle environmental impact for SUT was found to be the electricity used to operate the plant. Interestingly, across all impact categories, the contribution to the environmental footprint from end-of-life due to the use of plastic SUT was extremely small. Although not quantified in this study, these findings and others suggest operational changes that increase process efficiency and decrease time in plant are among the best strategies for reducing the life cycle environmental impact of biologics manufacturing.

Nacionalni kapacitet zavarivanja (NWC) u srbiji i njegov značaj za ciljeve održivog razvoja UN (SDGs)

The International Institute of Welding (IIW) through its IIW Board of Directors Working Group Regional Activities and Liaison with Developing Countries (WGRA) introduced in 1994 the unique IIW WeldCare Programme to assist developing countries to improve their national welding capabilities particularly through the establishment and/or growth of a not-for-profit national welding organisation. Since then, IIW WGRA has assisted many countries freely through the holding of IIW technology innovation workshops, governance workshops and International Congresses as well as providing them with information, experiences and documentation on successful activities particularly from experiences in South Africa, Australia and globally. As an extension and expansion of the IIW WeldCare Programme through IIW WGRA, a project "Establishing a National Welding Capability (NWC)" was created and managed by the author. Several very successful NWC workshops have been held since then to assist not only developing countries but also developed countries which could utilise them to improve their national welding capabilities. These have included Romania, Bulgaria, Serbia, Greece, Hungary, South Africa, India, New Zealand and Thailand amongst others. Based on feedback from the workshops and International Congresses held, the need for 11 comprehensive guidance notes with links to a knowledge resource bank were identified. Improving a country's National Welding Capability can make a significant contribution to, and have a very positive effect on, many national and international programmes including the United Nations Sustainable Development Goals (SDGs). When one considers the networks which the IIW, its 50 Member countries, universities, colleges, research organisations and companies involved in welding have, bringing all the available welding resources to assist in achieving the SDGs can have a remarkable positive effect globally on all countries. UNESCO published a report titled "Engineering for Sustainable Development: Delivering on the Sustainable Development Goals". There is no reason why a similar initiative could not be undertaken for the welding field. This paper can serve as a catalyst, and the National Welding Capability Project as the basis, for such a report. It is hoped that this paper will stimulate ideas amongst the international welding community for feedback to the author and dissemination into countries to improve their SDGs.

Introduction of Industry-driven pre-competitive consortium activities to promote Microbiome Based Drug Discovery in Japan

The human microbiome is an emerging research area of interest with a series of reports on associations with various diseases and health, mainly due to advances in comprehensive analysis with the advent of next-generation sequencers. Fecal microbiota transplantation, a powerful method for modulating gut microbiota, has been reported to be surprisingly effective for certain disease populations that cannot be treated with conventional drugs. These results provide the possibility of microbiome modulation as a new approach for drug discovery. In the United States, the Human Microbiome Project was initiated in 2010 and many human microbiome data have been acquired, archived, and published. This has led to the emergence of a number of biopharmaceutical companies with clinical stage pipelines. Some of the most advanced pipelines are in the late clinical stage. However, issues such as the variability of data generated by different assays/protocols and the lack of data from healthy individuals as a reliable reference dataset should be addressed to further facilitate microbiome research and drug discovery based on human microbiome research. In Japan, in particular, established pharmaceutical companies tend to be reluctant to use these new approaches, as seen in human genome-based drug discovery. This may result in increased barriers to entry into emerging markets and a potential loss of opportunity. Since human microbiome research, especially gut microbiome research, has long been addressed by various research groups in Japan, microbe expertise and technology is high mainly in academia. It is important for Japanese industry to utilize the existing expertise of academic research groups. To accelerate the industrial use, Japan Microbiome Consortium (JMBC) was established in 2017, and its member companies include 33 pharmaceutical, chemical, food, and testing companies in Japan, including major companies and bio-venture companies. In this lecture, I will introduce the background of the establishment of JMBC and share the activities of the project for establishment of the measurement infrastructure and the project for construction of the database of healthy persons, which have been common goals. I would like to summarize the recent global trends and activities on drug discovery based on the human microbiome, as well as issues for obtaining approval and launching the drug. We would also like to discuss how we can activate drug discovery activities as one of JMBC's activities and lead to the creation of innovative new drugs.

Dynamic Communities: Plotting a New Course

Dynamic Communities was a company that forms and administers Software User Groups. Each group had a thriving membership which shared knowledge and information among each constituent in the community. Active participation by employees of member companies led to stronger competency in the software and eventually higher return on software investment for their employer. Programs and features of membership in a User Group ranged from online aspects (such as interactive discussion forums and downloadable content libraries) to in-person events (including training, certifications, and large-scale conferences). Companies joined in membership, paying an annual membership fee, to allow its employees access to the programs and features of the community. Through the first twelve years of existence, Dynamic Communities counted on double-digit growth in revenue from membership fees. However, it flattened. As technology evolved and social media became more pervasive, it had become easier and easier for individuals to replicate many of the learning features that made membership in a Dynamic Communities User Group exclusive. Persons found highly specialized information just by working the search engines. No longer was Dynamic Communities able to simply put online content behind a firewall and expect members to pay to access it. Revenue from membership fees made up about 19% of the company’s annual revenue but was eroding. Dynamic Communities executive team was faced with a dilemma of trying to revise its membership model in an environment of significant change while still maintaining its revenue sources. This case challenges the reader to assess price and product mix strategies.