As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which contain sensitive and confidential information about company intellectual property including, but not limited to, its manufacturing methods, drug composition, names of suppliers, and future development plans. Many manufacturers are examining their processes to minimise references to this confidential data during the document authoring process and how they track and identify confidential information throughout the study lifecycle. This has created a catalyst for medical writing, transparency, legal, and regulatory teams to collaborate and enhance their processes to minimise disruption to the trial approval process while embracing the opportunities to share more with the public.
{"title":"Overcoming confidential information challenges faced by study sponsors today","authors":"Elliot Zimmerman","doi":"10.56012/rjfu6501","DOIUrl":"https://doi.org/10.56012/rjfu6501","url":null,"abstract":"As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which contain sensitive and confidential information about company intellectual property including, but not limited to, its manufacturing methods, drug composition, names of suppliers, and future development plans. Many manufacturers are examining their processes to minimise references to this confidential data during the document authoring process and how they track and identify confidential information throughout the study lifecycle. This has created a catalyst for medical writing, transparency, legal, and regulatory teams to collaborate and enhance their processes to minimise disruption to the trial approval process while embracing the opportunities to share more with the public.","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":"138978998","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}
At a time when the scope of One Health is expanding, the term “biomanufacturing” has taken on new significance as a new route to more sustainable manufacturing in the face of the current overwhelming reliance on fossil resources for fuel, energy, and materials. This article looks at how One Health and biomanufacturing interact from policy, technical, and societal viewpoints. The biofoundry is explored as a missing link in the design phase of biomanufacturing and examples are given where the potential of biofoundries can be enhanced in selected environmental and human health applications.
{"title":"Biomanufacturing and One Health","authors":"Jim Philp","doi":"10.56012/mrpm2606","DOIUrl":"https://doi.org/10.56012/mrpm2606","url":null,"abstract":"At a time when the scope of One Health is expanding, the term “biomanufacturing” has taken on new significance as a new route to more sustainable manufacturing in the face of the current overwhelming reliance on fossil resources for fuel, energy, and materials. This article looks at how One Health and biomanufacturing interact from policy, technical, and societal viewpoints. The biofoundry is explored as a missing link in the design phase of biomanufacturing and examples are given where the potential of biofoundries can be enhanced in selected environmental and human health applications.","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":"138980923","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}
Search engine optimisation (SEO) is the process of optimising your writing so that it can be found easily on the internet. There are five key steps that you can take to increase the discoverability of your work, which will be discussed below. These are: 1. Choose your keywords carefully; 2. Optimise your title; 3. Optimise your abstract; 4. Use your keywords throughout your article; and 5. Build links to your work. It is important to consider SEO when creating all types of medical writing that will be available on the internet. However, while SEO is important for the discoverability of your work it should never outweigh the importance of good scientific practice and publication.
{"title":"How to get your writing found: Why medical writers and academics need to use search engine optimisation","authors":"Pippa Burns, Belinda Butcher","doi":"10.56012/fvxn4035","DOIUrl":"https://doi.org/10.56012/fvxn4035","url":null,"abstract":"Search engine optimisation (SEO) is the process of optimising your writing so that it can be found easily on the internet. There are five key steps that you can take to increase the discoverability of your work, which will be discussed below. These are: 1. Choose your keywords carefully; 2. Optimise your title; 3. Optimise your abstract; 4. Use your keywords throughout your article; and 5. Build links to your work. It is important to consider SEO when creating all types of medical writing that will be available on the internet. However, while SEO is important for the discoverability of your work it should never outweigh the importance of good scientific practice and publication.","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":"138980564","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":"Trust me on the sunscreen","authors":"Caroline Frith","doi":"10.56012/qfqz4097","DOIUrl":"https://doi.org/10.56012/qfqz4097","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":"139010262","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}
Due to the increasing demand for phytochemicals, plant in vitro cultures are a noteworthy, environmentally sustainable method, enabling the biotechnological production of bioactive compounds. Medical writers can find writing scientific articles in this field quite tricky due to the knowledge required at the intersection of botany, chemistry, pharmacy, and biotechnology. This article aims to provide helpful tips for writing about plant biotechnology to minimise the risk of article rejection by scientific journals due to inaccurate description of methods or inadequate data analysis.
{"title":"In vitro plants: How to open a jar containing bioactive phytochemicals","authors":"Anna Jesionek","doi":"10.56012/wvfc8373","DOIUrl":"https://doi.org/10.56012/wvfc8373","url":null,"abstract":"Due to the increasing demand for phytochemicals, plant in vitro cultures are a noteworthy, environmentally sustainable method, enabling the biotechnological production of bioactive compounds. Medical writers can find writing scientific articles in this field quite tricky due to the knowledge required at the intersection of botany, chemistry, pharmacy, and biotechnology. This article aims to provide helpful tips for writing about plant biotechnology to minimise the risk of article rejection by scientific journals due to inaccurate description of methods or inadequate data analysis.","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":"138979908","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}
Ask 10 people what “biotechnology” means and you will get 10 different answers. In this column, the Editor-in-Chief highlights the variety and breadth of the field and notes the important role of medical writers and communicators in demystifying the complex world of biotechnology and thereby helping with the goal of keeping it honest and safe.
{"title":"Biotechnology – diverse as the colours of the rainbow","authors":"R. Billiones","doi":"10.56012/jewm8154","DOIUrl":"https://doi.org/10.56012/jewm8154","url":null,"abstract":"Ask 10 people what “biotechnology” means and you will get 10 different answers. In this column, the Editor-in-Chief highlights the variety and breadth of the field and notes the important role of medical writers and communicators in demystifying the complex world of biotechnology and thereby helping with the goal of keeping it honest and safe.","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":"138980820","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}
Research on psychotropics is gaining more popularity worldwide and support from drug regulatory agencies, which recognise the unmet medical needs of certain patient communities, such as patients with mental disorders and patients with cancer who experience depression. Cannabinoids and psilocybin have shown promising results in preclinical studies and clinical trials, but the current clinical evidence is scarce, and the regulatory requirements are strict due to high potential for drug abuse. The US FDA has recently released a draft, non-binding guidance on clinical trials with psychedelics. Europe is currently falling behind the US and Canada in terms of regulating psychotropic substances. The article provides a general introduction on conducting clinical trials with psychotropics and the regulatory requirements (as of October 2023) when submitting marketing authorisation application. In the near future, as more data becomes available, research on psychotropics will definitely shape the European regulatory landscape.
{"title":"Psychotropics: A scientific, regulatory, and public view on the medicinal uses of cannabinoids and psilocybin","authors":"Ivana Turek","doi":"10.56012/tsen2260","DOIUrl":"https://doi.org/10.56012/tsen2260","url":null,"abstract":"Research on psychotropics is gaining more popularity worldwide and support from drug regulatory agencies, which recognise the unmet medical needs of certain patient communities, such as patients with mental disorders and patients with cancer who experience depression. Cannabinoids and psilocybin have shown promising results in preclinical studies and clinical trials, but the current clinical evidence is scarce, and the regulatory requirements are strict due to high potential for drug abuse. The US FDA has recently released a draft, non-binding guidance on clinical trials with psychedelics. Europe is currently falling behind the US and Canada in terms of regulating psychotropic substances. The article provides a general introduction on conducting clinical trials with psychotropics and the regulatory requirements (as of October 2023) when submitting marketing authorisation application. In the near future, as more data becomes available, research on psychotropics will definitely shape the European regulatory landscape.","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":"138981889","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}
Ruggero Galici is Senior Director of Nonclinical and Clinical Pharmacology Medical Writing at Alexion Pharmaceuticals Inc, AstraZeneca Rare Disease Unit and heads up global early phase regulatory medical writing activities. In this role, he facilitates the transition of early phase programmes from first-in-human research to clinical trial applications and investigational new drug submissions. Ruggero has a background in drug discovery, nonclinical and clinical development, a PhD in pharmacology, and post-doctoral training. He has led pharmacology teams to advance small molecules and biologics to the clinic and has served as subject matter expert to compound development teams. Ruggero has more than 20 years of experience in scientific and regulatory writing. Medical Writing Editor-in-Chief Raquel Billiones asked him five questions about his career and expertise.
{"title":"Five questions for Ruggero Galici on nonclinical medical writing","authors":"","doi":"10.56012/msng4369","DOIUrl":"https://doi.org/10.56012/msng4369","url":null,"abstract":"Ruggero Galici is Senior Director of Nonclinical and Clinical Pharmacology Medical Writing at Alexion Pharmaceuticals Inc, AstraZeneca Rare Disease Unit and heads up global early phase regulatory medical writing activities. In this role, he facilitates the transition of early phase programmes from first-in-human research to clinical trial applications and investigational new drug submissions. Ruggero has a background in drug discovery, nonclinical and clinical development, a PhD in pharmacology, and post-doctoral training. He has led pharmacology teams to advance small molecules and biologics to the clinic and has served as subject matter expert to compound development teams. Ruggero has more than 20 years of experience in scientific and regulatory writing. Medical Writing Editor-in-Chief Raquel Billiones asked him five questions about his career and expertise.","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":"138980512","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 article takes you on an intriguing exploration of the intertwined histories of biotechnology and medical writing. From ancestral plant cultivation to revolutionary advancements in genomics, proteomics, and bioinformatics, we delve into the profound evolution and influence of biotechnology on humanity. We also shine a spotlight on the critical role of medical writers, who meticulously document, interpret, and communicate these scientific breakthroughs to wider audiences. This article offers a key to understanding the convergence of science and communication, highlighting the incredible journey of biotechnology and medical writing.
{"title":"The evolution of biotechnology: From ancient civilisations to modern day","authors":"Lucy Hargreaves","doi":"10.56012/gxcw4769","DOIUrl":"https://doi.org/10.56012/gxcw4769","url":null,"abstract":"This article takes you on an intriguing exploration of the intertwined histories of biotechnology and medical writing. From ancestral plant cultivation to revolutionary advancements in genomics, proteomics, and bioinformatics, we delve into the profound evolution and influence of biotechnology on humanity. We also shine a spotlight on the critical role of medical writers, who meticulously document, interpret, and communicate these scientific breakthroughs to wider audiences. This article offers a key to understanding the convergence of science and communication, highlighting the incredible journey of biotechnology and medical writing.","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":"138980379","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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