Pharmaceutical Medicine最新文献

{"title":"Utilization of Evidence Blueprint Initiative to Transform Capability Development in AstraZeneca Spain.","authors":"Jesús Medina, Joaquín Sánchez-Covisa, Javier Nuevo, Beatriz Palacios, Ana Roncero, Marta Alegría, Joana Gostkorzewicz, Antonio Velasco, Kristoffer Larsen, Marta Moreno, César Velasco, Ana Pérez Domínguez","doi":"10.1007/s40290-025-00575-w","DOIUrl":"https://doi.org/10.1007/s40290-025-00575-w","url":null,"abstract":"<p><p>The role of Medical Affairs (MA) has shifted from traditional evidence dissemination to an integrated process leveraging real-world data (RWD) and diverse data sources. To adapt and lead this shift, AstraZeneca (AZ) Spain recognized the essential need to identify gaps in evidence-generation capabilities and establish targeted strategies aligned with both global and local priorities. The objective of this work was to assess AZ Spain's current evidence-generation capabilities and identify areas for improvement by using the so-called \"Evidence Blueprint\" framework. To do this, we conducted a systematic self-assessment following the Blueprint to evaluate performance across ten core areas. An approach to identify gaps and enhance evidence-generation processes was undertaken in four phases: defining capabilities, assessing maturity, developing a roadmap for improvement, and implementing changes. The self-assessment identified five priority areas, including two focused priorities-Innovative Value Strategies/Payer Evidence and RWD Vision and Strategy-as well as three improvement areas-Evidence Planning and Value Team Implementation, Research/Evidence Partnerships, and Patient-Centric Evidence. Tangible actions included the development of processes to assess outcome-based agreements, comprehensive mapping of existing national and regional databases to strengthen RWD strategies, creating a cross-functional strategy for evidence planning, establishing research partnerships leveraging European funding, and adopting patient-centric methodologies such as ethnographic studies and patient-authored publications. The initiatives undertaken by AZ Spain demonstrate the transformative potential of an Evidence Blueprint framework in addressing gaps and enhancing evidence-generation capabilities. By aligning local strategies with AZ's MA 2030 vision, these efforts ensure continuous innovation, improvement of decision-making, and a more substantial contribution to the healthcare ecosystem.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144682842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment Persistence in Rheumatoid Arthritis Before and After Etanercept Biosimilar Introduction: A Nationwide Australian Real-World Study.","authors":"Chin Hang Yiu, Bella D Ianni, Richard O Day, Jacques Raubenheimer, Christine Y Lu","doi":"10.1007/s40290-025-00577-8","DOIUrl":"https://doi.org/10.1007/s40290-025-00577-8","url":null,"abstract":"<p><strong>Background: </strong>Australia has one of the highest rates of rheumatoid arthritis (RA) worldwide. Etanercept, a widely used biologic for severe RA, has had a publicly subsidised biosimilar available in Australia since 2017. However, real-world data on how biosimilar availability has affected treatment patterns remain limited.</p><p><strong>Objective: </strong>This study aimed to assess treatment persistence-a surrogate measure of long-term treatment effectiveness-with etanercept before and after public subsidy of its biosimilar for RA, utilising a national sample.</p><p><strong>Methods: </strong>This retrospective cohort study analysed national healthcare claims data from the Pharmaceutical Benefits Scheme (PBS) via the Australian Bureau of Statistics DataLab. Adults (age ≥ 18 years) initiating etanercept for severe RA were stratified into two cohorts: historical (before biosimilar PBS listing, comprising only originator users) and contemporary (after biosimilar PBS listing, comprising both biosimilar and originator users). Kaplan-Meier analysis and multivariate Cox regression were employed to assess treatment persistence. Subgroup analysis of older adults and sensitivity analysis limited to biologic-naïve individuals were also performed.</p><p><strong>Results: </strong>A total of 10,234 individuals initiating etanercept for severe RA were included, with 4461 in the historical cohort and 5773 in the contemporary cohort. The median time to treatment discontinuation was 10.0 months (95% confidence interval (CI) 9.7-10.6) in the contemporary cohort and 10.6 months (95% CI 10.0-11.4) in the historical cohort (p = 0.08). At 12 and 24 months, treatment retention rates were similar between cohorts. The adjusted hazard ratio for treatment discontinuation in the contemporary cohort was 1.00 (95% CI 0.96-1.05), indicating no significant differences. Subgroup and sensitivity analyses yielded similar results.</p><p><strong>Conclusion: </strong>This large, population-based study found no significant difference in treatment persistence following the introduction of the etanercept biosimilar in Australia. These findings support the real-world integration of biosimilars into routine care. Further research should include direct comparative analyses of originator and biosimilars to inform long-term treatment strategies, clinician confidence, and sustainable healthcare policy.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144650054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pioneering the Future of Medical Affairs: A Strategic Transformation to Meet the Spanish Healthcare Ecosystem's Evolving Trends.","authors":"Ana Pérez Domínguez, Jorge Marinich, Gema Monteagudo, Carmen Moreno, Lucía Regadera, Inmaculada Iglesias","doi":"10.1007/s40290-025-00574-x","DOIUrl":"https://doi.org/10.1007/s40290-025-00574-x","url":null,"abstract":"<p><p>The role of medical affairs (MA) in the pharmaceutical industry is undergoing a profound transformation, driven by the increasing complexity of healthcare ecosystems, the rise of digital technologies, and the need for enhanced stakeholder engagement. In alignment with the MA 2030 vision, AstraZeneca Spain has implemented a forward-thinking transformation strategy, positioning MA as a strategic healthcare partner through a structured, data-driven, and patient-centered approach. Our transformation journey has been anchored in five strategic priorities: boosting MA leadership, integrating end-to-end data and analytics, refocusing resources using data-backed strategies, aligning evidence generation with stakeholder needs, and orchestrating omnichannel scientific engagement. To achieve this, we developed and implemented innovative methodologies such as regional archetyping, healthcare account characterization, and stakeholder mapping to systematically analyze and tailor engagement strategies across different healthcare settings. A core component of this strategy is the CARABELA initiative, a structured approach aimed at fostering the optimization clinical pathways, promoting public-private collaborations, and driving practice-changing interventions to improve healthcare efficiency. In addition, we have transitioned from descriptive to predictive analytics through advanced real-world evidence models, ensuring that MA-led initiatives remain proactive and impact-driven. This transformation serves as a scalable framework for MA evolution globally, reinforcing its role as a catalyst for healthcare innovation. By integrating real-world data, digital engagement, and strategic collaboration, MA departments should position themselves to navigate the evolving healthcare landscape while delivering tangible benefits for patients, healthcare professionals, and systems worldwide.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144619729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Combating Antimicrobial Resistance: Role of Key Stakeholders with Focus on the Pharmaceutical Sector.","authors":"Sangeeta Sharma, Maneesh Paul Satyaseela, Ranga Reddy Burri, Ratnakar Palakodeti, Deepika Pamarthy","doi":"10.1007/s40290-025-00572-z","DOIUrl":"https://doi.org/10.1007/s40290-025-00572-z","url":null,"abstract":"<p><p>Antimicrobial resistance is a pressing global health threat fueled by a complex interplay of biological, social, and economic factors. Despite widespread recognition of its impact, the antimicrobial resistance crisis continues to deepen because of inadequate innovation, poor access to effective treatments, and irrational antimicrobial use. Effectively combating antimicrobial resistance requires a multisectoral, multistakeholder, and multidimensional approach, with the pharmaceutical industry playing a pivotal role in new antimicrobial discovery along with diagnostic and other stakeholders. This review critically examines the central role of the pharmaceutical industry in addressing antimicrobial resistance, focusing on drug discovery, manufacturing practices, and stewardship efforts. While the industry has made notable contributions through the development of new antimicrobials and alternative approaches such as drug repurposing, artificial intelligence-driven discovery, and improved diagnostics, major challenges persist-including a declining antibiotic pipeline, limited access in low- and middle-income countries, antimicrobial pollution, irrational fixed-dose combinations, and the prevalence of substandard or falsified drugs. To overcome these barriers, this review explores strategic directions, including public-private partnerships, delinked incentive models, small-molecule innovation, ethical marketing, and equitable access strategies. It also underscores the industry's responsibility in promoting antimicrobial stewardship, participating in global surveillance systems, and educating prescribers and the public on responsible use. Future directions highlight the need for diversified funding, global collaboration, and the adoption of the \"triple shield\" approach-integrating infection prevention and control, antimicrobial stewardship, and robust surveillance to combat antimicrobial resistance. This review presents an integrated analysis of pharmaceutical accountability, highlighting actionable pathways that align innovation with equitable access, environmental safety, and ethical governance. By bridging gaps between discovery and delivery, the pharmaceutical sector can become a driving force in the global response to antimicrobial resistance.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144608996","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Shifting Paradigms in Medicines Development as a Profession: To Be or Not To Be.","authors":"Soneil Guptha, Domenico Criscuolo","doi":"10.1007/s40290-025-00570-1","DOIUrl":"10.1007/s40290-025-00570-1","url":null,"abstract":"","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"213"},"PeriodicalIF":3.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144111556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Challenges to Establishing Pharmaceutical Medicine as a Profession: Needs for Professional Identity and a Career Pathway: Role of Education and Training.","authors":"Honorio Silva, Varvara Baroutsou, Domenico Criscuolo, Soneil Guptha, Anna Jurczynska, Sandor Kerpel-Fronius, Heinrich Klech, Ingrid Klingmann","doi":"10.1007/s40290-025-00569-8","DOIUrl":"10.1007/s40290-025-00569-8","url":null,"abstract":"","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"245-248"},"PeriodicalIF":3.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12245926/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144554131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Professional Competencies and Capabilities in the Development of Medicines.","authors":"Peter D Stonier, Stuart A Jones","doi":"10.1007/s40290-025-00550-5","DOIUrl":"10.1007/s40290-025-00550-5","url":null,"abstract":"<p><p>The medicines development workforce has grown to be a multidisciplinary, interprofessional global body of broadly qualified graduate professionals working with and around the biopharmaceutical industry. To satisfy their demands of fitness for work, they must meet the changes and challenges of a rapidly developing technological and competitive field. This has generated a need for a harmonised, mutually recognised vocational programme of competencies and capabilities, based on an academic foundation, which for the adult learners in medicines development goes above and beyond their original medical and scientific specialisms. This review proposes that professional competencies and capabilities developed in pharmaceutical medicine, a specialty concerned with the discovery, development, evaluation, registration, monitoring, and commercialisation of medicines and medical products, provides a comprehensive solution for the educational needs in medicines development. To justify this proposition, it summarises the 60-year evolution of education and training in pharmaceutical medicine. It demonstrates how expanding the pharmaceutical medicine syllabus has aligned it with almost every aspect of the development process of modern medicines. This perspective proposes a vision for the future where pharmaceutical medicine professional competencies and capabilities fill the educational void for the medicines development workforce. This is suggested to pave the career path that supports the professional identity of physicians, scientists, and other professionals working to develop medicines.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"225-234"},"PeriodicalIF":3.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12245975/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143432488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Shifting Paradigms in Medicines Development as a Profession: To Be or Not To Be.","authors":"Soneil Guptha, Domenico Criscuolo","doi":"10.1007/s40290-025-00565-y","DOIUrl":"10.1007/s40290-025-00565-y","url":null,"abstract":"","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"209-212"},"PeriodicalIF":3.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144015961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Value and Importance of a Professional Ethical Code for Medicines Development: IFAPP International Ethics Framework.","authors":"Sandor Kerpel-Fronius, Alexander L Becker","doi":"10.1007/s40290-024-00547-6","DOIUrl":"10.1007/s40290-024-00547-6","url":null,"abstract":"<p><p>Pharmaceutical medicine professionals have to face many ethical problems during the entire life span of new medicines extending from animal studies to broad clinical practice. The primary aim of the general ethical principles governing research conducted in humans is to diminish the physical and psychological burdens of the participants in human drug studies but overlooks many additional social and ethical problems faced by medicine developers. These arise mainly at the interface connecting the profit-oriented pharmaceutical industry and the healthcare-centered medical profession cooperating in medicines development. In 2002, the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine developed the International Code of Ethical Conduct for Pharmaceutical Physicians for providing ethical advice for their members to manage the frequently competitive goals characteristic for their specialty. The ethical framework compiled by the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine serves its members by presenting morally acceptable or inacceptable behaviors in frequently encountered controversies arising from competing industrial and healthcare interests in medicines development. The authors selected this format to encourage reflection and debate for finding optimal moral conclusions in specific issues. Many recent examples of serious scientific-ethical misconduct, such as the oxycodone tragedy, the recommendations of unproven useless occasionally dangerous therapies during the coronavirus disease 2019 pandemic, and the withdrawal of many papers containing non-reproducible results, contributed to the increasing loss of trust by the public in science including pharmaceutical medicine. We are convinced that the ethical guidance developed by the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine will encourage its members to reflect intensively on optimal ethical behavior in drug development for strengthening the trust of society in innovative new medicines. Finally, considering the increasingly active participation of non-medically trained scientists in producing and applying complex biological medicines, distant monitoring methods coupled together with artificial intelligence technology in innovative clinical trials, the Ethics Working Group recommended already in 2017 measures to optimize their smooth cooperation and underlined their joint ethical responsibilities in guarding the safety and human dignity of trial participants.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"249-257"},"PeriodicalIF":3.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12245974/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143053131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Challenges to Establishing Pharmaceutical Medicine as a Profession: Needs for Professional Identity and a Career Pathway: Role of Education and Training.","authors":"Honorio Silva, Varvara Baroutsou, Domenico Criscuolo, Soneil Guptha, Anna Jurczynska, Sandor Kerpel-Fronius, Heinrich Klech, Ingrid Klingmann","doi":"10.1007/s40290-025-00559-w","DOIUrl":"10.1007/s40290-025-00559-w","url":null,"abstract":"<p><p>Pharmaceutical Medicine (PM) was defined by its founding pharmaceutical physicians as a \"medical/scientific discipline concerned with the discovery, development, evaluation, registration, monitoring, and medical aspects of the commercialization of medicines, for the benefit and the health of the community.\" Conceived as a medical specialty, the discipline encompassed several health-related professions and occupations, such as medicine, pharmacy, clinical pharmacology, drug safety and pharmacovigilance, pharmaceutical sciences, biology, health economics and others. Historically, non-medically qualified medicines development scientists from health-related disciplines have gradually grown into the medical roles within pharmaceutical organizations, regulatory agencies, and contract research organizations and today physicians and non-physicians lead drug development groups. Medicines Development Sciences (MDS) has been accepted as an alternative name. The practice of the disciplines involved in PM/MDS has evolved from an occupation to be accepted as a distinct profession, by meeting well established criteria. Despite thousands of health professionals participating today in medicines development, their awareness of the existence of this discipline, and its evolution from occupation to profession is low. The lack of professional identity and a clear career path have been identified as key factors limiting the advancement of this profession. This position paper aims to consolidate PM/MDS as an advanced profession in health sciences and propose a career path that is envisioned and championed by educational standards setting organizations like the International Federation of Association of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP), PharmaTrain, and Global Medicines Development Professionals (GMDP) Academy with education and training as pillars for its achievement.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"235-244"},"PeriodicalIF":3.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12245956/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144034472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}