{"title":"Growing and nurturing a grassroots sustainability team in a clinical centre","authors":"Sarah Kabani, V. Chasseigne, Sihame Chkair","doi":"10.56012/wynp1520","DOIUrl":"https://doi.org/10.56012/wynp1520","url":null,"abstract":"","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138980614","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}
The advent of chimeric antigen receptor (CAR) T cell therapies follows a decades-long quest to personalise the treatment of disease. This article highlights the early research that paved the way for the field today, touching on early pioneers in the field and the biotechnological methods used to engineer CARs. With six CAR T cell therapies approved by US and EU regulatory bodies, and many more to come over the next decade, the field is challenged by slow manufacturing times and limited accessibility. Future CAR-based treatments will include additional cell types and indications, as well as automated and continuous manufacturing protocols that will help reduce the cost of goods.
嵌合抗原受体（CAR）T细胞疗法的出现是几十年来个性化治疗疾病探索的结果。这篇文章重点介绍了为今天的这一领域铺平道路的早期研究，涉及这一领域的早期先驱以及用于设计 CAR 的生物技术方法。目前，美国和欧盟监管机构已批准了六种 CAR T 细胞疗法，未来十年还会有更多疗法获得批准，但该领域面临着生产速度慢和可及性有限的挑战。未来基于 CAR 的疗法将包括更多的细胞类型和适应症，以及有助于降低商品成本的自动化连续生产协议。
{"title":"Living medicine: The story of the CAR T cell therapy","authors":"Avi Saha","doi":"10.56012/pxrs6694","DOIUrl":"https://doi.org/10.56012/pxrs6694","url":null,"abstract":"The advent of chimeric antigen receptor (CAR) T cell therapies follows a decades-long quest to personalise the treatment of disease. This article highlights the early research that paved the way for the field today, touching on early pioneers in the field and the biotechnological methods used to engineer CARs. With six CAR T cell therapies approved by US and EU regulatory bodies, and many more to come over the next decade, the field is challenged by slow manufacturing times and limited accessibility. Future CAR-based treatments will include additional cell types and indications, as well as automated and continuous manufacturing protocols that will help reduce the cost of goods.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138981659","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}
Medical writing is not easy, especially for new writers still learning the ropes. We are exposed to new documents, therapeutic areas, procedures, and challenges regularly and the fast-paced and ever-changing environment can be stressful. Nowadays, there are resources and initiatives available to equip writers with the right tools to get started, which is a tremendous development. Nevertheless, mistakes will happen, regardless of experience, and it is part of our professional journey to acknowledge, learn, and grow from them. In this reflection article, the authors shares the story of lessons learned from an earlier regulatory writing project.
{"title":"I did it so you don’t have to: Lessons learned as a young writer struggling with a regulatory document","authors":"Tiago Silva","doi":"10.56012/pbqs3811","DOIUrl":"https://doi.org/10.56012/pbqs3811","url":null,"abstract":"Medical writing is not easy, especially for new writers still learning the ropes. We are exposed to new documents, therapeutic areas, procedures, and challenges regularly and the fast-paced and ever-changing environment can be stressful. Nowadays, there are resources and initiatives available to equip writers with the right tools to get started, which is a tremendous development. Nevertheless, mistakes will happen, regardless of experience, and it is part of our professional journey to acknowledge, learn, and grow from them. In this reflection article, the authors shares the story of lessons learned from an earlier regulatory writing project.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138978783","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}
In today’s digital era, we’re more connected than ever, with endless opportunities at our fingertips. Yet, it was the sudden global pandemic that truly thrust us into the heart of this digital transformation. As medical writers, we found ourselves at an interesting intersection: our profession, rooted in evidence and detail, meets the ever-evolving world of digital tools. Three years since the pandemic began, it’s time to ponder: How has our digital work environment changed? How have we adapted, grown, and maybe even thrived in this new setting? While many of us smoothly transitioned into the digital world, some faced a steep learning curve, diving into unfamiliar tools and technologies. As 2024 nears, an important question remains: How can we optimise our digital workspaces? We need to ensure we’re not just equipped with the basics but also with the latest innovations suited for our profession and work-life interface.
{"title":"From the well-known to the cutting-edge: Tools to revolutionise your digital workspace in 2024","authors":"Federica Angius","doi":"10.56012/wkmb1498","DOIUrl":"https://doi.org/10.56012/wkmb1498","url":null,"abstract":"In today’s digital era, we’re more connected than ever, with endless opportunities at our fingertips. Yet, it was the sudden global pandemic that truly thrust us into the heart of this digital transformation. As medical writers, we found ourselves at an interesting intersection: our profession, rooted in evidence and detail, meets the ever-evolving world of digital tools. Three years since the pandemic began, it’s time to ponder: How has our digital work environment changed? How have we adapted, grown, and maybe even thrived in this new setting? While many of us smoothly transitioned into the digital world, some faced a steep learning curve, diving into unfamiliar tools and technologies. As 2024 nears, an important question remains: How can we optimise our digital workspaces? We need to ensure we’re not just equipped with the basics but also with the latest innovations suited for our profession and work-life interface.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138981335","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}
In September 2023, the Communicating with the Public Special Interest Group (SIG) held a Meet and Share session on the roles and responsibilities of ethics committees in the UK and the US, the first of a two-part series on “Protecting the public from undue harm during research studies”. The purpose of the series is to educate medical writers about how ethics committees function and how effective medical writing can add value to a submission to an ethics committee.
{"title":"Meet and Share session on protecting the public from undue harm during research studies: A report","authors":"Sampoorna Rappaz","doi":"10.56012/qxky3990","DOIUrl":"https://doi.org/10.56012/qxky3990","url":null,"abstract":"In September 2023, the Communicating with the Public Special Interest Group (SIG) held a Meet and Share session on the roles and responsibilities of ethics committees in the UK and the US, the first of a two-part series on “Protecting the public from undue harm during research studies”. The purpose of the series is to educate medical writers about how ethics committees function and how effective medical writing can add value to a submission to an ethics committee.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138979023","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}
This Medical Writing issue focuses on the crucial role of medical writing and communications in biotechnology and product development in healthcare. In the pharmaceutical and medical device industries, biotechnology uses biological systems and living organisms in R&D and production processes for product development. Some biotechnologies include biologic and biosimilar pharmaceuticals, vaccines, and advanced therapy medicinal products, including gene and cell therapies and tissue engineered products.
{"title":"Medical Writing explores the many faces of biotechnology","authors":"Jennifer Bell","doi":"10.56012/zskr5275","DOIUrl":"https://doi.org/10.56012/zskr5275","url":null,"abstract":"This Medical Writing issue focuses on the crucial role of medical writing and communications in biotechnology and product development in healthcare. In the pharmaceutical and medical device industries, biotechnology uses biological systems and living organisms in R&D and production processes for product development. Some biotechnologies include biologic and biosimilar pharmaceuticals, vaccines, and advanced therapy medicinal products, including gene and cell therapies and tissue engineered products.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138979544","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}
Before the European Medical Writers Association (EMWA) and the American Medical Writers Association (AMWA), there was the Mississippi Valley Medical Editors Association (MVMEA). Most medical writers are unaware of the history of MVMEA and of how it turned into AMWA and EMWA. Here, I chronicle the life of Harold Swanberg, MD, who founded the MVMEA and, when it faltered, reinvented it as AMWA. The story begins shortly after the American Civil War, when medical journals were becoming more respected as sources of information and when editors began to be employed as paid, part- or full-time editors. It continues with the rise and fall of the MVMEA and its rebirth as AMWA. Swanberg’s death coincided with the end of his vision for AMWA. However, the new vision for the association – and an international tragedy – allowed AMWA and EMWA to become key forces in developing modern medical writing as a profession.
{"title":"Harold Swanberg, MD: Why and how EMWA should remember him","authors":"Tom Lang","doi":"10.56012/tyzx5803","DOIUrl":"https://doi.org/10.56012/tyzx5803","url":null,"abstract":"Before the European Medical Writers Association (EMWA) and the American Medical Writers Association (AMWA), there was the Mississippi Valley Medical Editors Association (MVMEA). Most medical writers are unaware of the history of MVMEA and of how it turned into AMWA and EMWA. Here, I chronicle the life of Harold Swanberg, MD, who founded the MVMEA and, when it faltered, reinvented it as AMWA. The story begins shortly after the American Civil War, when medical journals were becoming more respected as sources of information and when editors began to be employed as paid, part- or full-time editors. It continues with the rise and fall of the MVMEA and its rebirth as AMWA. Swanberg’s death coincided with the end of his vision for AMWA. However, the new vision for the association – and an international tragedy – allowed AMWA and EMWA to become key forces in developing modern medical writing as a profession.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138979713","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}
Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-Cas9 is a genome editing tool that helps scientists modify the DNA of living organisms selectively and precisely. The discovery of this system has led to changes in the approaches to gene therapy. In this article, I delve into the role of CRISPR-Cas9 in the development of treatment using gene therapy and the drawbacks of this system. Also, I discuss the role of medical writers in the dissemination of information and research on CRISPR-Cas9 and gene therapy.
{"title":"Advances in the CRISPR-Cas9 system and gene therapy","authors":"Archana Nagarajan","doi":"10.56012/lzwz4471","DOIUrl":"https://doi.org/10.56012/lzwz4471","url":null,"abstract":"Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-Cas9 is a genome editing tool that helps scientists modify the DNA of living organisms selectively and precisely. The discovery of this system has led to changes in the approaches to gene therapy. In this article, I delve into the role of CRISPR-Cas9 in the development of treatment using gene therapy and the drawbacks of this system. Also, I discuss the role of medical writers in the dissemination of information and research on CRISPR-Cas9 and gene therapy.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138981059","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}
EMWA’s fall conference was a virtual event, but with a twist – local hubs were established to permit a face-to-face experience for participants in Benelux, France, Germany, Italy, Portugal, Serbia, and Switzerland. In this EMWA President’s column, Maria Kołtowska-Häggström discusses the fall conference and the inspiring talk given by Ivan Oransky, MD, who is co-founder of Retraction Watch, editor-in-chief of Spectrum, and distinguished journalist in-residence at New York University’s Arthur Carter Journalism Institute. She also discusses other highlights from the most recent conference.
{"title":"Moving to the virtual space…","authors":"Maria Kołtowska-Häggström","doi":"10.56012/choi1701","DOIUrl":"https://doi.org/10.56012/choi1701","url":null,"abstract":"EMWA’s fall conference was a virtual event, but with a twist – local hubs were established to permit a face-to-face experience for participants in Benelux, France, Germany, Italy, Portugal, Serbia, and Switzerland. In this EMWA President’s column, Maria Kołtowska-Häggström discusses the fall conference and the inspiring talk given by Ivan Oransky, MD, who is co-founder of Retraction Watch, editor-in-chief of Spectrum, and distinguished journalist in-residence at New York University’s Arthur Carter Journalism Institute. She also discusses other highlights from the most recent conference.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138981471","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}
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