Best Practices for Writing and Editing CME Needs Assessments

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Volume 31 Number 3 / Fall 2016

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Contents V31N3 FALL 2016

99

FEATURE Biosimilars: Basic Information for the Medical Writer

Roberta J. Wong and MaryAnn Foote

104

FEATURE Databases Dissected: What Medical Writers Really Use

Arlene Walters, Julie L. Phelan, and Sarah A. Prins

112

RESEARCH A Case Study: Medical Writing as a Feminized Profession

Hilary Graham

118 120

AROUND THE CAREER BLOCK How Did You Get Here? Stories of Bench Research, Bollywood, and Stormy Epiphanies Angela N. Johnson, Carrie K. Lauer, and

Catherine Cadogan

Storytelling: Providing Information Through the Voices of Others Susan L. Towers

122 CALENDAR OF MEETINGS

123

BOOK REVIEW History of Infectious Disease Pandemics in Urban Societies

Reviewed by Larry Lynam

124

SOCIAL MEDIA Social Media: Helping Health Systems Build Empathy and Engagement Jeffrey Edward Stevens and Melanie Fridl Ross

128

CONTINUING EDUCATION UPDATE Best Practices for Writing and Editing CME Needs Assessments: 2014 and 2015 Results From Surveys of Practitioners

Don Harting and Nathalie Turner

Embase

? Emtree (includes MeSH) ? Natural language recognitiona

? ~30 million records ? Includes congress abstracts ? More indexed terms ? Drug/chemical names and

codes updated 3x/yr ? Subscription required

104

? Subject coverage ? Thesauri-based

indexing ? Suggestion of

related articles ? Time of coverage ? Limiting options ? Articles in press ? Search history

PubMed

? MeSH (does not include Emtree)

? ~23 million records ? Less indexed terms ? Drug/chemical names and

codes updated 1x/yr ? Free, including some

full-text articles ? Article loan service

118

133

136

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Contents

V31 N3 / 2016

132 AMWA NEWS

From the President Stephen N. Palmer 2016 Swanberg Award: Flo Witte, PhD, ELS Bart J. Harvey

136 2016 CONFERENCE PREVIEW

Trends and Opportunities in Denver Hope J. Lafferty

138 YOUR STATS REFRESHER!

Linear Regression I Thomas M. Schindler

141 FREELANCE FORUM

Brian Bass, Lori De Milto, Cathryn D. Evans, Debra Gordon, and Ruwaida Vakil

What are some strategies you use to maintain work/life balance and avoid burnout? What tools and techniques do you use to manage your time (including meeting deadlines and avoiding distractions)?

144 AN APPRECIATION

Dear Oh Dear Reader: "YOU match it up!" A Tribute to Guy Whitehead's Heady Guidance

Mary E. Knatterud

e1

Posters for 2016 Medical Writing and Communication Conference

AMWA JOURNAL MISSION STATEMENT The AMWA Journal expresses the interests, concerns, and expertise of members. Its purpose is to inspire, motivate, inform, and educate them. The Journal furthers dialog among all members and communicates the purposes, goals, advantages, and benefits of the American Medical Writers Association as a professional organization.

EDITOR Victoria J. White, MA, ELS

SECTION EDITORS Around the Career Block Kimberly Korwek, PhD

Susan L. Tow ers, MS Commonplaces Lora Arduser, PhD Media Reviews Tara Ann Cartwright, PhD

Ruth Taswell, MA Practical Matters Julie Ravo Regulatory Insights Jennifer Grodberg, PhD, RAC (US)

Science Series MaryAnn Foote, PhD Social Media Cynthia L. Kryder, MS, CCC-Sp

Your Stats Refresher! Thomas M. Schindler, PhD, MA

REGULAR CONTRIBUTORS Freelance Forum

In the Service of Good Writing

Brian Bass, MWC Melissa L. Bogen, ELS Sherri Bowen, MA, ELS Lori De Milto, MJ Cherie Dewar Cathryn D. Evans Debra Gordon, MS Donna L. Miceli Phyllis Minick Elizabeth L. Smith Ruwaida Vakil, MS, Editor Laurie Endicott Thomas, MA, ELS

EDITORS AT LARGE Jennifer Minarcik, MS Peggy Robinson, ELS

EDITOR EMERITUS EDITOR IN MEMORIAM 2015?2016 PRESIDENT 2015?2016 PUBLICATIONS

ADMINISTRATOR EXECUTIVE DIRECTOR

GRAPHIC DESIGNER

Lori Alexander, MTPW, ELS, MWC Ronald J. Sanchez Stephen Palmer, PhD, ELS

Ann Winter-Vann, PhD Susan Krug, MS, CAE Amy Boches, biographics

EDITORIAL OFFICE: JournalEditor@. Abbreviated instructions for authors are available in this issue, with more detailed instructions available at: journal.

ADVERTISING: Contact Laura Gaenzle at laura.gaenzle@; (717) 430-2351. 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, 30 West Gude Drive, #525, Rockville, MD 20850-4347. Phone: (240) 238-0940; Fax: (301) 294-9006; Email: amwa@.

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, the CINAHL database, and the Cumulative Index of Journals in Education (CIJE).

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.

?2016 American Medical Writers Association. All rights reserved, worldwide. ISSN 1075-6361

FEATURE

Biosimilars: Basic Information for the Medical Writer

By Roberta J. Wong, PharmD,1 and MaryAnn Foote, PhD2 1Affiliate Assistant Professor, Department of Bioengineering, University of Washington, Seattle, WA 2Adjunct Faculty, International Center for Regulatory Science, University of Southern California, Los Angeles, CA

ABSTRACT

Biosimilars are a relatively new type of drug category. The rules and regulations surrounding them are evolving. In this primer for medical writers and editors, we define biosimilars and biologics; discuss how they differ from small molecule drug products; differentiate biosimilars from the more-familiar idea of generic medicines; and provide an outline of United States (US) regulatory requirements.

Biosimilars, also known as biosimilarities, are biological products that are not identical to but are highly similar to products that are available to patients, ie, marketed reference products, with minor differences in their inactive components. Biosimilars do not have clinically meaningful differences in terms of safety and efficacy between themselves and the marketed reference product. Biosimilars are not generic drugs. Interest has increased in the development and approval of biosimilars because many biopharma products have lost or soon will lose patent protection, leading to billions of dollars (US$) in potential sales for the biosimilar sponsor and potential cost savings for health care payers and patients without insurance. Biosimilars are relatively new to the marketplace, and the rules and regulations for necessary documentation to obtain marketing approval are evolving. Also in their infancy are many aspects of the entire approval process, postmarketing surveillance, and pharmacovigilance reporting processes. Unlike traditional biopharma products that are submitted to a regulatory agency with a Biologic License Application (BLA) [351(a)], a biosimilar product submission uses a 351(k) format. Because this is a new and developing area of regulatory writing, medical writers are in a key position to help set standards for documentation.

WHAT ARE BIOSIMILARS?

To understand what biosimilars are, it is essential to first understand the term biologic. A biologic is a product from a natural source, often animal, human, or bacterial in origin.

Through a series of complex steps that are proprietary, such as cell culture, expansion, recombinant DNA technology, and glycosylation, products are manufactured that are not easily characterized.1 Biosimilars, also known as biosimilarities, are biological products that are highly similar to a reference biologic product, that is, a marketed product, with minor differences in clinically inactive components. Although biosimilars do differ from the biologic reference product, they do not have any clinically meaningful differences between themselves and the reference product in terms of safety, efficacy, purity, potency, or mechanism of action.2-4 A biologic is any pharmaceutical product that is manufactured in, extracted from, or semisynthesized from biological sources, eg, E coli cells.5 It should be noted that biologics differ from small molecule products and that biosimilars are not generic drugs (Table 1).

In terms of data required for marketing authorization, biologics and biosimilars have different requirements. In the United States, biologics require the submission of a BLA [351(a)] with nonclinical (animal) and clinical (patient population of intended use) data that demonstrate safety and efficacy and dosing.4 A biosimilar requires the submission of an abbreviated document, a BLA 351(k), and the pharmacokinetics requirement may be satisfied with a single-dose study and a clinical trial that demonstrates similarity in dose and response to the reference standard.

Because the manufacturing processes of the biologic remain proprietary, biosimilars are manufactured using independent newly developed exclusive methods. The new biosimilar drug is a complex molecule of biological origin, produced with different steps from the reference biologic, and not chemically identical to the originator. Biosimilars are assessed more rigorously than generics by health authorities, and the regulatory requirements of the European Medicines Agency (EMA) for the approval of biosimilars are more demanding than those for generics.6

AMWA Journal / V31 N3 / 2016 / 99

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