Contents V39 N1 SPRING 2024 5 6 8 16 20 21 23 25 27 29 39 40 FROM THE EDITOR › Michael G. Baker CONFERENCE - AWARDS 2023 Harold Swanberg Distinguished Service Award › Joan Affleck 2023 John P. McGovern Award Address › Jessica Steier and Andrea C. Love 2023 Walter C. Alvarez Award Address Building Trust in Public Health: Integrating Communication Every Step of the Way › Katelyn Jetelina CONFERENCE - SESSION REPORTS Next-Level QC Review and Editing in Medical Writing › Angela Trenkle Roads Leading to Approval: The Right Level of Detail for CMC Suvmissions › Sidonie Jones Shackleton’s Ghost Writer: Navigating the Landscape of Appropriately Acknowledging Authors › Lara Burgess Social Media Continuing Medical Education: Next Steps › Laura Tibaquirá Strategies to Prevent Medical Writer Burnout › Sophie Ash SCIENCE SERIES The Gut Microbiome–Human Body Symbiosis: Relevance of the Ubiquitous Microbial Community on Health and Development, Part 2 › Smitha S. Dutt CREATIVE WRITING Harmonies of Justice: Reflections on Virtue and Equality › George Ongoro FREELANCE FOCUS Nourish Your Niche: The Rewards and Risks of Specialized Medical Writing › Alex Howson 44 Human Diseases (Inflammatory bowel disease (IBD), obesity, Parkinson disease, COVID-19, Type 2 diabetes, Cancer, Asthma, Autism) Genetic changes Sporadic or hereditary DNA sequence changes (eg, mutations, deletions, insertions, amplifications) Gut Microbiome Dysbiosis CAUSES: unhealthy diet, age antibiotics, environmental pollution, internal pH changes, type of birth, social determinants EFFECTS: Inflammation, leaky gut epithelium, immune system dysregulation Unhealthy Diet High fat, low fiber diet, alcohol consumption, pesticides in food, processed food Metabolites CAUSES: An unhealthy diet is metabolized by increased pathogenic bacteria EFFECTS: Decrease in beneficial bacteria that produce anti- inflammatory short chain fatty acids (SCFAs), polyphenols & vitamins Increase in inflammatory markers Epigenetic Modulations CAUSES: Environmental changes, age, unhealthy diet, mutations, metabolic disturbance EFFECTS: Increase in acetylation and methylation of DNA cause an imbalance between cell proliferation and apoptosis Disrupted gut - organ axes 29 6 EDITOR-IN-CHIEF Michael G. Baker, PhD MANAGING EDITOR Rachel Mosher, MA SECTION EDITORS Progress in Publications Qing Zhou, PhD, ELS Regulatory Insights Jennifer Bridgers, MS, MWC Science Series Naomi Bishop, MD Statistically Speaking Thomas M. Schindler, PhD Everyday Ethics Julie Ravo, MA Freelance Focus Ruwaida Vakil, MSc CE Craft Corner Haifa Kassis, MD Practical Matters Elizabeth Kukielka, PharmD, MA, MS, MWC Around the Career Block Cecilia Petrus, MSc Technology Talk Kyla Ross, BS, MS REGULAR CONTRIBUTORS Freelance Focus Brian Bass, MWC Melissa L. Bogen, ELS Sherri Bowen, MA, ELS Lori De Milto, MJ Cathryn D. Evans Gail V. Flores, PhD Alex Howson, PhD Phyllis Minick In the Service of Good Writing Laurie Endicott Thomas, MA, ELS Conscious Writing Crystal R. Herron, PhD, ELS EDITORS IN MEMORIAM Lori L. Alexander, MTPW, ELS, MWC Ronald J. Sanchez 2023–2024 PRESIDENT R. Michelle Sauer, PhD, ELS 2023–2024 BOARD LIAISON Qing Zhou, PhD, ELS 2023–2024 STAFF LIAISON Shari Rager, MS, CAE EXECUTIVE DIRECTOR Susan Krug, MS, CAE GRAPHIC DESIGNER Amy Boches, biographics EDITORIAL OFFICE: ManagingEditor@amwa.org. Instructions for authors available at: www.amwajournal.org. ADVERTISING: Contact marketing@amwa.org or (240) 239-0940. All advertising is subject to acceptance by AMWA and should be for products and services relevant to professional medical communicators. AMWA is not responsible for the content of advertising and does not endorse any advertiser or its products or services. SUBSCRIPTION: The AMWA Journal is published quarterly. Subscription is included with AMWA membership. Nonmember subscriptions cost is $75 per year. CONTACT: American Medical Writers Association, 9841 Washingtonian Blvd, Suite 500-26, Gaithersburg, MD 20878. Phone: (240) 238-0940; Fax: (301) 294- 9006; Email: amwa@amwa.org. The AMWA Journal is in the MLA International Bibliography and selectively indexed in the Cumulative Index to Nursing and Allied Health Literature (CINAHL) print index and the CINAHL database. The opinions expressed by authors contributing to the Journal do not necessarily reflect the opinions of AMWA or the institutions with which the authors are affiliated. The association accepts no responsibility for the opinions expressed by contributors to the Journal. ©2024 American Medical Writers Association. All rights reserved. ISSN 2163-5315 AMWA JOURNAL MISSION STATEMENT In support of the mission of the American Medical Writers Association (AMWA) and to advance the broader profession, the AMWA Journal publishes content that reflects the interests, concerns, and expertise of medical communicators. Its purpose is to inform, inspire, and motivate medical communicators. M O RE V39 N1 / 2024 42 TECHNOLOGY TALK Generative AI in Clinical Research: Regulatory Submissions, Clinical Data Management, and Beyond › Ihab Mansoor, Javier García Ortiz, and Matthew Rector TOPICAL FEATURES 44 Using Innovative Tools and Lean Writing Workflow Processes to Accelerate Regulatory Document Writing › Robert Panek, Sara Fernandes, Mauro Meloni, Gregory Morehouse, and Rona Grunspan 51 The Making of the International Standard for Writing in Plain Language ISO 24495-1: Its Usefulness, Content, and How It Came into Existence › Thomas M. Schindler 56 Understanding the Impact of Technology on Medical Writing: AMWA Survey Results from June 2023 › Karen Rutkowski, Kenneth Shapiro, and Laura Sheppard AMWA NEWS 60 From the President › R. Michelle Sauer 61 CALENDAR OF MEETINGS Contents http://www.amwajournal.org