Pharmaceutical Medicine最新文献

{"title":"The Evolution of In-Field Medical Affairs: Introducing the Strategic Scientific Advisor.","authors":"Lucía Regadera Anechina, Inmaculada Iglesias, Jorge A Marinich, Jesús Diago, Ana Pérez Domínguez","doi":"10.1007/s40290-025-00551-4","DOIUrl":"10.1007/s40290-025-00551-4","url":null,"abstract":"<p><p>The evolving landscape of healthcare demands a transformation in Medical Affairs (MA) to address new challenges and opportunities. This article presents the Strategic Scientific Advisor (SSA) role as a critical innovation within our MA department, aimed at enhancing early engagement with stakeholders and strategically positioning assets within the healthcare ecosystem. The SSA role was developed following a comprehensive external assessment and an internal review of the MA department's structure to integrate the CARABELA methodology, which serves as the foundation for SSA activities. CARABELA is a joint initiative between AstraZeneca and key scientific societies to optimize clinical practices in specific chronic diseases using a holistic strategy, whose implementation is monitored in each hospital by applying specifically designed indicators. The SSA role design, guided by the Strategic Scientific Area Plan Framework, emphasizes early proactive engagement, evidence generation, and a multidisciplinary approach to optimizing clinical practices. By fostering collaboration across internal teams and external partners, the SSA supports activities throughout the entire lifecycle of the product, facilitating early access strategies, and building tailored plans to address unmet medical needs. In contrast to traditional Medical Science Liaisons (MSLs), SSAs play pivotal roles in driving long-term healthcare outcomes, aligning with the Medical Affairs 2030 vision. The SSA is trained and evaluated to catalyze a strategic shift, enabling MA to address the complexities of healthcare ecosystems, improve clinical practices, and contribute to patient-centered innovations. This transformation underscores the critical need for MA professionals to expand beyond traditional responsibilities and lead initiatives that shape the future of healthcare.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"19-27"},"PeriodicalIF":3.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11880172/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143468761","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":"Author's Reply to Pongpirul: \"The Pharmaceutical Year that was, 2024\".","authors":"Anthony W Fox","doi":"10.1007/s40290-024-00544-9","DOIUrl":"10.1007/s40290-024-00544-9","url":null,"abstract":"","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"57-58"},"PeriodicalIF":3.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142882712","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":"Comment on: \"The Pharmaceutical Year that was, 2024\".","authors":"Krit Pongpirul","doi":"10.1007/s40290-024-00543-w","DOIUrl":"10.1007/s40290-024-00543-w","url":null,"abstract":"","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"55-56"},"PeriodicalIF":3.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142882713","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":"Understanding the National Healthcare Ecosystem to Position Medical Affairs as a Strategic Element: Lessons Learned from AstraZeneca Spain.","authors":"Inmaculada Iglesias, Jorge A Marinich, Lucía Regadera Anechina, Marc Cortés, Ana Pérez Domínguez","doi":"10.1007/s40290-024-00542-x","DOIUrl":"10.1007/s40290-024-00542-x","url":null,"abstract":"<p><strong>Introduction: </strong>The rapidly evolving healthcare landscape has prompted Medical Affairs (MA) departments within pharmaceutical companies to transition from their traditional role as information providers to becoming strategic partners in the healthcare ecosystem. Responding to the increasing complexity of patient needs and stakeholder dynamics within Spain's national health system, this shift emphasizes the importance of aligning MA functions with broader healthcare goals. Effective transformation requires in-depth assessments of stakeholder trends and expectations. The objectives of this study were to identify key stakeholders in the Spanish healthcare ecosystem, analyze their trends in detail, and evaluate ways in which our MA department should adapt to address them.</p><p><strong>Methods: </strong>To support this strategic transformation, we conducted a dual assessment focusing on the Spanish healthcare ecosystem. Using a combination of desk analysis and stakeholder research, we examined external and internal dynamics affecting the MA department's role. This approach identified the perspectives and needs of key stakeholders across three main communities: patients, healthcare professionals, and institutional bodies, offering insights into stakeholder-specific expectations and broader industry macrotrends.</p><p><strong>Results: </strong>The identification of 16 pivotal stakeholders in Spain's healthcare ecosystem underscores the complex array of needs and expectations that shape MA's evolving role. For the patient community, key trends include the demand for accessible information, emotional support resources, and tools to enhance treatment adherence and chronic disease management. Among clinicians and key external experts, there is an increasing need for current medical resources, digital integration in care processes, and collaborative research opportunities. Institutional stakeholders emphasize sustainable integration of therapeutic innovations, budget predictability, and public-private collaboration to enhance healthcare quality and access. Beyond these specific needs, transversal trends affecting all stakeholders were identified, including the acceleration of medical innovation, demand for value-added services, and the expansion of digital tools and data-driven decision making. Macrotrends within the pharmaceutical industry - such as patient-centric approaches, the growth of digital health, and data-focused business models - further shape the industry's response to evolving healthcare challenges. A unified organizational vision, reflected in shared objectives and priorities, is crucial for cohesive strategy implementation.</p><p><strong>Conclusion: </strong>This research underscores the essential role of MA departments in redefining their influence within healthcare systems. By aligning MA activities with stakeholder trends, pharmaceutical companies can reposition MA as a central pillar within the healthcare ecosystem. Our","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"39-50"},"PeriodicalIF":3.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11880095/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142882716","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":"Knowing is Half the Battle: The Factors Leading to Efficient Recruitment of Representative Samples in Schizophrenia Research.","authors":"Joohyun Yoon, Megan R Mayer, Tala Berro, Stephanie Brazis, Joshua T Kantrowitz","doi":"10.1007/s40290-024-00545-8","DOIUrl":"10.1007/s40290-024-00545-8","url":null,"abstract":"<p><strong>Background and objectives: </strong>Drug development in schizophrenia is limited by the differential scaling of the active treatment and placebo arms of a study, such that, as the number of sites increases, the magnitude of placebo response disproportionately increases. The objective of this article was to identify factors conducive to efficient recruitment as a step towards trial designs allowing recruitment of more participants per site, leading to reduced variability, and potentially a smaller placebo effect.</p><p><strong>Patients and methods: </strong>Using the information of 554 individuals, we calculated the percentage of individuals who were screened, consented, and retained in our research, along with rationale for nonconsent. Independent t tests and Chi-squared tests were performed to compare participant characteristics.</p><p><strong>Results: </strong>Out of the 273 individuals who were fully screened, 84 did not progress to the consented stage owing to various reasons, leading to a total of 189 individuals who were screened and consented and a total of 365 individuals who were either incompletely screened or not consented into a study. Individuals with an externally validated medical history showed the highest yield in being consented and retained in research as new participants. In particular, chart reviews from clinics were highly efficient (25.8%) in facilitating new participants' enrollment, even when these individuals were not actively/prospectively seeking research. The most common reason for nonconsent was difficulty in telephone or email contact. Consenting and nonconsenting participants were similar in demographics, and recruitment sources only differed in their reported substance use.</p><p><strong>Conclusions: </strong>Referrals and chart reviews from known clinics were the most efficient method in retaining new participants, highlighting the importance of external validation and communication between research and clinical staff within a system. Consenting participants showed no significant differences from the database as a whole, demonstrating that the study samples were representative. Future studies should aim to confirm the present findings at other academic and commercial research centers.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"29-38"},"PeriodicalIF":3.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142966110","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":"Contraception Requirements in Early Clinical Trials: Considerations Towards an Evidence-Based Approach.","authors":"Tatyana Dubich, Ad F Roffel","doi":"10.1007/s40290-025-00555-0","DOIUrl":"10.1007/s40290-025-00555-0","url":null,"abstract":"<p><p>Enrollment of women of childbearing potential in clinical trials from early stages of drug development allows the gathering of relevant safety and pharmacokinetics data in the representative disease population. However, risk mitigation strategies are needed to ensure the safety of the developing embryo in case of unintended pregnancy in female study participants or in female partners of male study participants. These risk mitigation strategies often include contraception requirements, however we observed that such requirements vary widely across sponsors and trials. Some sponsors and contract research organizations adhere to the strictest precautions by default, assuming a worst-case scenario for each new compound's risk assessment. In this review, we provide an overview of the risks addressed by and introduced by contraception requirements in clinical trials. We critically discuss the 'worst-case' approach, and we present a holistic, risk-based approach that takes into account all relevant data, the pros and cons of using hormonal contraceptives, and subject burden.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"5-17"},"PeriodicalIF":3.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476714","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":"Pricing and Impact: Understanding Sales Trends and Price-Volume Distributions of Antihypertensive Drugs in Europe, USA, and India.","authors":"Gautam Satheesh, Swagata Kumar Sahoo, Stephen Jan, Andrew E Moran, Anthony Rodgers, Abdul Salam","doi":"10.1007/s40290-024-00546-7","DOIUrl":"10.1007/s40290-024-00546-7","url":null,"abstract":"","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"51-54"},"PeriodicalIF":3.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143009444","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":"Mitigating the Nocebo Effect in Biosimilar Use and Switching: A Systematic Review.","authors":"Elif Car, Yannick Vandenplas, Teresa Barcina Lacosta, Steven Simoens, Isabelle Huys, Arnold G Vulto, Liese Barbier","doi":"10.1007/s40290-024-00541-y","DOIUrl":"10.1007/s40290-024-00541-y","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;In the context of biosimilar use and switching, a patient's negative perception of a biosimilar might trigger a nocebo effect, where negative expectations unrelated to its pharmacologic action may lead to worsened symptoms, resulting in less perceived therapeutic benefit or worsened adverse events. Considering the crucial role biosimilars have in reducing health care costs and expanding access to safe biologics globally, it is essential to develop and implement effective strategies to mitigate the possible occurrence of such nocebo effects.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aim of this systematic literature review was two-fold: (i) to review strategies that have been applied and/or tested for minimising the nocebo effect in clinical practice, within and outside the context of biosimilar switching, and (ii) to propose recommendations on useful mitigation strategies to minimise the occurrence of the nocebo effect in the context of biosimilar switching.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Biomedical databases PubMed and Embase were screened up until the end of April 2023 with a search string consisting of the following search terms \"nocebo\", \"biosimilar\", \"mitigation\", \"strategy\", and \"prevention\" and related synonyms. The search strategy was supplemented by snowballing of the included studies. The quality of the studies was assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Systematic Reviews and Research Syntheses, the Scale for the Assessment of Narrative Review Articles, and the Mixed Methods Appraisal Tool.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Of the 1617 identified and screened records, 60 met the inclusion criteria. Among these, 10 (17%) were conducted within the context of biosimilar switching, 7 of which specifically tested strategies to mitigate the nocebo effect. Among the remaining 50 studies conducted outside the biosimilar switching context, 46 tested mitigation strategies. Across the included studies, 13 distinct mitigation strategies were identified, which can be employed within the context of biosimilar switching: (i) open non-verbal communication, (ii) positive framing, (iii) empathic communication, (iv) validating communication, (v) shared decision making, (vi) self-affirmation, (vii) education of patients and health care professionals about the nocebo effect, (viii) education of patients and health care professionals about biosimilars, (ix) soft-skills training for health care professionals, (x) personalised information, (xi) supporting information, (xii) multidisciplinary approach, (xiii) organisation of the switch.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;This review has identified a set of strategies that have been tested to mitigate the nocebo effect, which can be applied by health care professionals in the context of biosimilar switching with the aim of mitigating the occurrence of a nocebo effect. We recommend implementing a combination of mitigation strategies for patients and ","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"429-455"},"PeriodicalIF":3.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11625068/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142751372","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":"European Pharmaceutical Industry Medical Information: A Role to Play in the Provision of Medicine-Related Information to Patients.","authors":"Ana Barrias, Esther Di Lauro, Sarah Dunnett, Franziska Flick, Patricia Smerdka, Fiona Wardle, Jill Voss","doi":"10.1007/s40290-024-00534-x","DOIUrl":"10.1007/s40290-024-00534-x","url":null,"abstract":"<p><p>European pharmaceutical companies have a professional and legal obligation to provide objective, factual and non-promotional medicine-related information to both healthcare professionals (HCPs) and patients on request and have established Medical Information services to fulfil this need. Also, medicines are supplied with a package leaflet for patients and/or users-this usually includes the contact details for the company's Medical Information service. There is a large scale of patient enquiry interactions across the European region. A survey conducted in 2021 by the Medical Information Leaders in Europe (MILE) association revealed that 21% of all enquiries managed by Medical Information services in 2020 were from non-HCPs. Eighteen companies collectively managed over 140,000 non-HCP enquiries-while supporting so many patients, this is also a potentially rich source of insights to real-life patient experiences. When interacting with patients, companies are cautious not to interfere with the relationship between the patient and their HCP. This can limit the information provided, with many being referred to their busy treating physicians. Unfortunately, this approach can fall short of patients' expectations or needs. MILE recognises the potential to be more helpful and companies are keen to evolve to deliver more patient-centric support. MILE member companies have collaborated in the collation and publication of best-practice principles for handling unsolicited requests for medicine-related information from patients, caregivers and members of the general public (MOPs). This will help improve accessibility to quality information support, harmonise the patients' experience and build confidence in the pharmaceutical industry services. MILE continues to invite stakeholders, including patient associations, HCPs, pharmaceutical companies, regulators and national industry associations to engage and help advance these core principles for handling patient enquiries. This publication does not constitute legal advice; decision making and accountability remains with each pharmaceutical company.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"399-405"},"PeriodicalIF":3.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11625064/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142625725","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":"Transdermal Drug Delivery Systems: Different Generations and Dermatokinetic Assessment of Drug Concentration in Skin.","authors":"Rahul Kushwaha, Narahari N Palei","doi":"10.1007/s40290-024-00537-8","DOIUrl":"10.1007/s40290-024-00537-8","url":null,"abstract":"<p><p>Transdermal drug delivery systems (TDDS) are a highly appealing and innovative method of administering drugs through the skin, as it enables the drugs to achieve systemic effects. A TDDS offers patient convenience, avoids first-pass hepatic metabolism, enables local targeting, and reduces the toxic effect of drug. This review details several generations of TDDS and the advancements made in their development to address the constraints associated with skin delivery systems. Transdermal delivery methods of the first generation have been consistently growing in their clinical application for administering small, lipophilic, low-dose drugs. Second-generation TDDS, utilizing chemical enhancers and iontophoresis, have led to the development of clinical products. Third-generation delivery systems employ microneedles, thermal ablation, and electroporation to specifically target the stratum corneum, which is the skin's barrier layer. Dermatokinetics is the study of the movement of drugs and formulations applied to the skin over a period of time. It provides important information regarding the rate and extent to which drugs penetrate skin layers. Several dermatokinetic techniques, including tape stripping, microdialysis, and laser scanning microscopy, have been used to study the intricate barrier properties and clearance mechanisms of the skin. This understanding is essential for developing and improving effective TDDS.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"407-427"},"PeriodicalIF":3.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471879","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}