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SPRING 
2024

 5

6

8

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25

27

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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 
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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-
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The AMWA Journal is in the MLA International Bibliography and selectively 
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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

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