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Volume 34 No 1

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Preface to the Postconference Issue

Jim Cozzarin, ELS, MWC®




Learning From Our Aging Population: Studying Immune Checkpoint Inhibitors Sheds New Light on the Changing Immune System

Liz Kuney



The aging of the Baby Boomer generation and the general rise in life expectancy continue to expand the proportion of older adults (≥65 years of age) across global and US populations. As the adult years progress, so does the potential for a diagnosis of cancer. The need to determine whether evolving trends in cancer treatment benefit an aging population is vital. Immune checkpoint inhibitors (ICIs) represent a radically new approach in modern cancer treatment. They target the immune system instead of the disease and unleash the body’s natural defenses against tumor growth. ICIs are valued for their reduction in toxicity and superior treatment effect compared with many conventional therapies. Although clinical trial results show generally comparable efficacy and safety in younger and older populations, the proportion of older cancer trial participants does not accurately reflect the general population. This article describes the body’s cycle of immunity in combatting mutations and how ICIs can aid the most vulnerable aspect of that cycle. The article discusses the challenges and possible opportunities in an aging immune system, the immune-related side effects of ICIs, and the role of genomic biomarkers in predicting response to treatment. Regulators and activists are advocating for better representation of older patients in clinical trials; however, comprehensive investigation into the risks and benefits of immune-modulating therapies for this growing population is still needed.


*Click here to listen to audio abstract.







Jam Session for Early-Career Freelances

Report by Claire L. Jarvis


Added to this report on one of our most highly attended sessions, our expert panel of Freelance Forum contributors share their unique and practical insights from years of experience as business owners and freelance medical writers.


18    Awards


Harold Swanberg Distinguished Service Award Address

Bart Harvey, MD, PhD, FRCPC, FACPM


Award Sidebar


24    Open Session Reports

  • A Practical Introduction to the Clinical Evaluation Report (CER) and How to Make It Compliant With MEDDEV
  • Using a Focused Authoring Strategy to Create a Message-Driven Deliverable
  • Building a Successful Freelance Writing and Editing Business






Strategies to Advance Your Medical Writing Career, Part I: Working Effectively With Recruiters

Yanni Wang, PhD


Have you ever thought about working with a recruiter? In an exclusive Q & A, Principal Medical Writer Dr. Yanni Wang sits down with expert recruiter Lindsey Summers, MBA, to discuss the do’s and don’ts and how this relationship can advance the careers of medical writers. 




For Safety's Sake, Part 2: Reporting of Adverse Event Data

Thomas M. Schindler and Helen Bridge


In the second part of this series, discussions continue into the benefits of collecting specific data to better understand the individual patient experience and to discuss the possibility of including patients in data collection for drug development.




In a Relationship?

Laurie Endicott Thomas


An in-depth look at examples of implied relationships in communication. Does the reality of whether or not these relationships exist matter to medical writers?




AMWA Annual Business Meeting


From the President

Cynthia L. Kryder, MS


Preparing for the Future of Medical Writing in Biopharma: AMWA’s Inaugural Medical Writing Executives Forum

Joan Affleck, MBA, ELS; Cynthia L. Kryder, MS; Kathy Spiegel, PhD, MWC; and Ann Winter-Vann, PhD



Executives of medical writing departments share unique yet common concerns, needs, and perspectives and can benefit from engaging one another in an exchange of ideas and experiences. At its annual Medical Writing & Communication Conference in November, 2018, the American Medical Writers Association (AMWA) convened executives of medical writing departments at 22 of the world’s top biotech and pharmaceutical companies to discuss workforce trends and advancements in medical writing, elaborate on best practices, develop solutions to challenges, and exchange ideas and strategies with peers in a rare collaborative environment. Also attending the forum were executives from several companies that provide regulatory medical writing and consulting services and the head of a university degree program in biomedical communications. This article summarizes that discussion.


Chapter Advisory Council: Making Strategic Strides

Katrina Burton


Why Your Participation in the AMWA 2019 Compensation Survey Matters





Conference Compendium


Explore over 50 additional pages of conference coverage featuring the John P. McGovern award address by Stacy Robison, 33 educational session reports, 8 exhibitor precis, and 12 posters.



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