Postscripts v5 n35 _2015June

Official publication of the American Medical Writers Association Pacific Southwest chapter

AMWAPacificSouthwestChapter

June2015

Postscripts

Volume V Issue 35June 201 5

POSTSCRIPTSin this issue:

• Introducing: Medical writer's ownfashion experimenter — ASK APRIL• Questioning Drug Approval by theFDA• Reports and Pictures fron theChapter's Annual Conference• Publication Bias and Meta-analysis

POSTSCRIPTS

AIMS AND SCOPE

Postscripts magazine is the official publication of the PacificSouthwest chapter of the American Medical Writers Association(AMWA). I t publishes news, notices and authoritative articles ofinterest in al l areas of medical and scientific writing andcommunications. The scope covers cl inical and regulatory writing,scientific writing, publication planning, social media, currentregulations, ethical issues, and good writing techniques.

MISSION STATEMENT

The mission of Postscripts is to facil itate the professionaldevelopment of medical writers and serve as a tool to advancenetworking and mentoring opportunities among all members.Towards this mission, Postscripts publishes significant advances inissues, regulations and practice of medical writing andcommunications; ski l ls and language; summaries and reports ofmeetings and symposia; and, book and journal summaries.Additional ly, to promote career and networking needs of themembers, Postscripts includes news and event notices coveringChapter activities.

SUBSCRIPTION : Postscripts is published monthly except inJanuary and July. The magazine is available as open accesspublication and is currently distributed online only.

INSTRUCTION FOR CONTRIBUTORS: We consider articles onany topic of interest to medical writers and communicators. I t ishelpful to look at the past December issues for year end table ofcontents, and browse past issues for style and type of articlespublished. We welcome contributions from AMWAmembers andnon-members alike. Please contact editor.

ADVERTISING : Postscripts is an advertising-free magazine.However, articles describing products and services relevant tomedical writers may be considered or solicited. As a service to ourmembers, they may submit advertisements for their services orproducts for free. Please contact editor.

WEBSITES:

Postscripts: http: //issuu.com/postscriptsChapter Website: http: // www.amwa-pacsw.org

Copyright 2011 -201 5, American Medical Writers AssociationPacific Southwest chapter, San Diego, CA. All rights reserved.(Authors retain copyright to their articles. Please contact authorsdirectly for permission to use or display their work in any form ormedium.) Design by Ajay Malik.

EDITORAjay K Malik, [email protected]

EDITOR-AT-LARGEDonna Simcoe, MS, MS, MBA, CMPPPresident, AMWA [email protected]

AMWA Pacific Southwest ChapterLeadership —

PresidentDonna Simcoe, MS, MS, MBA, [email protected]

Immediate Past PresidentJennifer Grodberg, PhD, [email protected]

TreasurerElise Sudbeck, [email protected]

SecretaryAndrew Hellman, [email protected]

Arizona LiaisonKathy Boltz, [email protected]

Membership CoordinatorGail Flores, [email protected]

Employment CoordinatorSharyn Batey, [email protected]

Website CoordinatorLaura J Cobb, [email protected]

Newsletter EditorAjay K Malik, [email protected]

AMWA Pacific Southwest ConferenceChairsJacqueline A Dyck-Jones, PhD, MScJennifer Grodberg, PhD, RAC

BannerPhotoArtbyChipReuben,www.photoartw

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85 POSTSCRIPTS | VOL 5, NO. 35 | JUNE 201 5

POSTSCRIPTSJune 201 5 | Volume 5, No.35

COVER: Cadil lac Ranch, Amaril lo, Texas. By John Lindsay, Ocean Shores, NSW, Austral ia

Used under Creative Commons licence CC BY 2.0. Image URI: http: //mrg.bz/OJ6Cuq

POSTSCRIPTS | VOL 5, NO. 35 | JUNE 201 5 86

• From the President's Desk— Donna Simcoe, MS, MS, MBA, CMPP . . . . . . . . . . . . . . .

• Editor's Desk – Medical Writer Defined and Dissected — Ajay KMalik, PhD . . . . . . . . . .

INAUGURATING COLUMN

• Ask APRIL: Medical writing’s own fashion experimenter and amateur decorator answers

your style questions —April Reynolds, MS, ELS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

FEATURES

• One Drug Approval Too Far— Rebecca J. Anderson, PhD . . . . . . . . . . . . . . . . . . . . . . .

• AMA-zing Style — the AMA Manual of Style Column — Dikran Toroser, PhD, CMPP . .

• San Antonio, Here We Come! — Noelle Demas, MS . . . . . . . . . . . . . . . . . . . . . . . . . . . .

MEETING REPORTS & NETWORKING EVENTS

• You Spoke and we Listened — Jacki Dyck-Jones, PhD, MSc. . . . . . . . . . . . . . . . . . . . . .

• Setting up a Freelance Business — Lycely Sepulveda, PhD . . . . . . . . . . . . . . . . . . . . . .

• Snapshot about Paragraphing and Outl ining Workshops

— Lamia Merabet, MS, MBA, RAC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• Dinner and Laughs at the Chapter Annual Conferene in Old Town San Diego. . . . . . . . . .

• Congress Summary: ISMPP-201 5 — Dikran Toroser, PhD, CMPP. . . . . . . . . . . . . . . . .

DEPARTMENTS

• New Members — Compiled by Gail Flores, PhD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• Chapter Events' Calendar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• Medical Writing Open Positions — Compiled by Sharyn Batey, PharmD, MSPH . . . . .

• Backpage: Cadil lac Ranch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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From the President's Desk

“Summertime is always the best ofwhat might be.”

― Charles Bowden

Happy start to Summer

I hope you are looking forward to this issue as much as I am! Whether you

attended our AMWA Pacific Southwest Chapter conference or not, we

believe you will enjoy the wonderful pictures and summaries from the

conference in this issue. We thank all of our presenters and Jenny

Grodberg and Jacki Dyck-Jones for all of the behind-the-scenes work they

did to make this a successful meeting with more than 50 attendees! It was

lovely to meet the new members to our chapter and we welcome those

new members listed in this newsletter. A big thank you also to Jacki for

her summary of the conference, Lycely Sepulveda for the colorful visual

on how to set up a freelance business and Lamia Merabet for the snapshot

about the paragraphing and outlining workshop.

New this month, we thank April Reynolds for her fun column about

medical writing and fashion. Also in this issue, Rebecca Andersen keep us

updated about the details of a peculiar response by a pharmaceutical

company to a FDA drug approval. We thank our employment coordinator,

Sharyn Batey, for keeping us informed of jobs in the area. We have two

articles by Dikran Toroser this month: an excellent summary about

publication bias and meta-analyses, and a comprehensive overview of the

ISMPP meeting.

We have been planning fun, interactive and educational events in our

chapter. We look forward to the happy hour that Asoka Banno and Brea

Midthune have scheduled for June 18th in La Jolla. Our next big event will

be the “Medical Writers’ Toolbox Decoded” on September 19th. We’re

also planning an event in Thousand Oaks in July so stay tuned!

For events and other items about our chapter, please see our website,

www.amwa pacsw.org, for more details.

We hope to see you soon!

Donna

Donna Simcoe, MS, MS, MBA, CMPP

President, AMWA Pacific Southwest Chapter

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EDITOR'S desk:

Medical Writer Defined and Dissected

You are introduced to a friend of aneighbor in the driveway.“What do you do?” the “friend”asks.“I am a medical writer, ” yourespond.

That “friend” may look satisfiedwith the answer, but it’s more likelythat “friend” got it al l wrong. Unlessshe works in the pharmaceuticalindustry (or knows someone whodoes), she might assume that youwrite medical stories for amagazine, news medium, website, etc. I t is unl ikely that medicalwriting as it relates to cl inical,regulatory, publications, orphysician/patient education wouldbe on her radar. The answer, “Iam a medical writer, ” is animperfect answer in an imperfectworld.

Who are we?

In the Spring 201 5 issue of AMWAJournal (volume 30, number 1 ),Tom Lang (a senior member ofAMWA and recipient of AMWA’sGolden Apple and Swanbergawards) took up the question ofour identities as medical writers.Tom wrote that medical writing isnot easily defined, known orunderstood; medical writers have alow profi le; and in fact medicalwriting as a career is not widelyknown outside the pharmaindustry. This is not surprisingsince medical writing as a careerhas been around for just about 50years, and there aren’t too many ofus. AMWA has only about 5000members, a mere fleck among thescribes of al l stripes and hues. Sothe short answer, I am a medicalwriter, might leave the otherperson grasping for more clarity.

Medical writing is “writing aboutmedicine”. The discipl ine is clearlydifferent from creative, l iterary, orjournalistic/popular writing; it isalso distinct from general scientific

or technical writing. This nuancemakes it harder to formulate asimple description of a medicalwriter or medical writing. Here isTom’s definition of medical writing:

“Medical writing is the craft ofefficiently and effectivelycommunicating anddocumenting in words, tables,graphs, photographs, andcinematic images theinformation needed to developand use health caretechnologies by preparingindividualized and standardcommunications that providesspecific information, formattedfor a specific medium, to help aspecific audience achieve aspecific purpose;communications that aredesigned to help audiencesunderstand, find, remember,and use this information.”

This definition provides acomprehensive description of ourwork and opens an importantdiscussion. Unfortunately, it is longand is not very uti l i tarian. I t maywork well for written media (web orpaper), but is clunky in a parkinglot or in the front yard talking to acasual neighbor walking his dog.

The AMWA website also has adefinition, which is short butvague: “Medical communicationsis a general term for thedevelopment and production ofmaterials that deal specifical ly withmedicine or health care.”

Thus, “Who are we?” remains anopen question. I f somebody says, Iam a software engineer; most ofus would instantly know he writescomputer code. How about, ifpresident of the United States isever asked what he does, he mightanswer: "I am the leader of thefree world." Can you come up witha definition for medical writer l ikethat? Or, let me ask: how do you

describe yourself in thissituation—please share yourthoughts.

Go to Survey Monkey and fi l l out ashort survey.. I wil l share theresults in the fol lowing issues.Here is the l ink:https://www.surveymonkey.com/s/G3TJKRS

The DNA of a Medical Writer

A useful aspect of Tom’s definitionof medical writing is that it points tothe skil ls that a person needs tobecome an effective medicalwriter. The content outl ine for theMedical Writing Certificationexamination(http: //www.amwa.org/fi les/Certification/MWC_ExamContentOutl ine.pdf) contains a comprehensive l istof the skil ls required of medicalwriters.

Success in medical writingrequires special ized training that isoften acquired on the job, and byavail ing ourselves of theopportunities around us, such as,AMWA's suite of workshops,sessions, webinars, and annualmeetings.

In this issue of Postscripts, wereprint an article by Noelle Demas(201 4-201 5 AMWAAnnualConference Administrator) from theAMWA Journal, describing theprogram planned for the upcomingAMWA’s 75th Annual Conference inSan Antonio this Fall . Thisconference is ful l of workshopsand sessions designed to fi l l theskil ls gap (or further hone ourwriting abil ities). The registration isopen(http: //www.amwa.org/events_annual_conference). We hope to seeyou there!

Have a Great Summer.

— Ajay KMalik, PhD

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Ask APRILMedical writing’s own fashion experimenter and amateur decorator answers

your style questions.

Email me at [email protected]

Visit my Pinterest page (pinterest.com/writecorrect) for more ideas.

Together, we can make medical writing a l ittle more beautiful .

I ’m a ful l-time medical writer andeditor and part-time beautyproduct and fashion guinea pig.When I ’m not chasing a deadline,I ’m chasing my spirited young son.I ’m busy, but I sti l l want to lookpresentable. I ’m always looking forfast techniques and fuss-free oufitsthat can take me from in-homenerd behind a computer to real-world businesswoman with a touchof personal style. And I want tospend my workday in a space thatis both appealing and inspiring.

Dressing Yourself for the Office

In 2011 , I led a klatch at the AMWAannual meeting called “EditingYour Work Wardrobe,” which wasabout making smart fashionchoices for the office or cl ientmeeting. (I revisited the topic in a201 2 session entitled “I f LooksCould Kil lVYour Career.”) Theidea came about after I got anediting job in an office—WITHOTHER HUMANS!—after manyyears of working at home. Iwondered what to wear, and Icame up with a l ist of 5 essentials Ineeded to buy (nice bag, loafers,button-up shirts, tai lored pants,and a statement accessory l ike ascarf).

I gathered feedback fromcoworkers and other writers aboutprofessional attire. I found thatwomen (and some men) wanteddirection on how to dress to meetcl ients, information on crafting theirpersonal style, and instructions onstyl ing their hair. People sharedstories about coworkers showingtoo much cleavage or wearingnoisy, distracting jewelry or toomuch cologne. Others confessedto being woeful ly underdressed for

an interview, eg, wearing yogapants instead of a suit and beingmistaken for a food-deliveryperson instead of a professionalwriter.

My goal was to teach people theskil l of dressing well by studyingbody type, learning what colorsand styles work, and editing thescope to exclude items that do nothighl ight a person’s bestprofessional profi le.

Decorating the Office to Workfor You

Another aspect of working in anoffice is appropriately decoratingthe space. When I took an officejob, I wanted to carve out a spacethat was both comfortable andprofessional so I could be mostproductive. I incorporated somebasic Feng Shui techniques, l ikehaving my back to a wall to giveme a sense of stabil ity and powerand using table lamps instead offluorescent overhead lighting tocreate a calming effect. (Don’t getme started on the evils offluorescent l ighting.)

At first, my predominantlyPhiladelphian coworkers thought Iwas being a hocus pocus-yCalifornian, but they soon came toadmit that my office was wherethey liked to go to de-stress. Myboss at the time suggested Ipresent the topic at AMWA, andthe “Creating Your Own Zen Zone”session was born.

Now, I ’m back to working fromhome (in California) and recentlyhired a Feng Shui consultant.Overal l , her report came backpositive; however, my office could

use some alignment. I ’ l l save thatstory for another day, but suffice itto say that there’s more than justmedical writing work to be done inthere.

APRIL REYNOLDS, MS, ELS, is amedical writer & editor and the presidentof Write/Correct, Inc. She has publishedworks on topics that range from jeans(for fashion magazines) to genes (formedical publications). She lives in SanDiego with her husband and son.


InPicture:AprilReynolds

One Drug Approval Too FarBy Rebecca J. Anderson, PhD, AMWA Pacific Southwest Chapter Member

Well, it’s final ly happened. A drug company hassued the FDA for approving i ts drug. For decades,industry executives complained that the agencymoved too slowly, imposed too many barriers, andrequired too much data. In response, the FDAintroduced a variety of expedited regulatorypathways, including fast track, priority review,breakthrough therapy designation, and acceleratedapproval.

Now, instead of lagging behind foreign regulatoryagencies, the FDA approves drugs faster than itscounterparts—often, it’s the first agency in the worldto approve a new drug. (I f your drug goes through a“traditional” review cycle, you’re now the exception,and you can expect your CEO to ask why yourNDA/BLA didn’t qual ify for special FDAconsideration.)

But just as departing FDA Commissioner MargaretHamburg was taking a victory lap, someoneslammed on the brakes: a drug companycomplained that the FDA went too far. Thecompany is Otsuka Pharmaceuticals, and the drug isits bestsel l ing antipsychotic, Abil ify. Here is thelowdown.

Last December, FDA approved Otsuka’s Supplementto the Abil ify NDA (original ly approved in 2002 forschizophrenia) to add an indication for pediatricTourette syndrome, a neurological disorder thatcauses tics. Because childhood Tourette’s isconsidered an orphan indication, Otsuka expected toget a seven-year extension of the Abil ify patent(which was on the verge of expiring). That wouldpush generic competitors to December 2021 . (Popthe champagne corks!)

However, in February, FDA notified Otsuka that itwas amending its decision and granting approval totreat adults as well as children with Tourettesyndrome. According to the FDA, the changecorrected an error in the earl ier approval, but theerror was not explained. This correction broadenedthe approved patient population. You’d thinkeveryone would be happy, especial ly the patientswith Tourette’s. But no! FDA’s action eliminatedAbil ify’s orphan indication status and permittedgeneric competition. (Stuff that champagne back inthe bottle!)

Otsuka sued, claiming that it was “i l legal” for the FDAto broaden Abil ify’s therapeutic indications beyondwhat the company requested. (Otsuka’s sNDA andthe corresponding FDA-approved package insertaddressed only pediatric use.) With the patent clock

counting down and generic competitors salivating onthe sidel ines, events quickly escalated. Otsuka andFDA traded searing legal briefs in this high-stakesbattle. (Abil ify brought in a whopping $7.8 bil l ion lastyear—by far, Otsuka’s top revenue generator.)

Both sides had powerful players. FDA was backedby legislators and third-party payers who championearly adoption of generic alternatives. Otsuka’s leadlawyer was Ralph Tyler, who previously was chiefcounsel at the FDA.

The plot twists rivaled the Game ofThrones (orThorns! ) Facing a lawsuit, the FDA rolled back itsapproval and again restricted Abil ify for use only inchildren with Tourette syndrome—but i t alsocontinued reviewing applications from genericcompanies who wanted to sell the drug. Otsukamaintained that one orphan indication protected itsentire Abil ify franchise from generic competition.FDA, obviously, disagreed.

At the last minute, Otsuka threw a Hail Mary,requesting a temporary restraining order. Thecompany wanted to stop the clock and negotiate theorphan drug status with FDA officials before thebuzzer. However, when the Abil ify patent expired onApri l 28, FDA immediately approved four—countthem, four—generic compounds, al lowing therespective generic companies to market their Abil ifyknock-offs for the drug’s original indications(schizophrenia and bipolar disorder). Game over.

Presumably, Otsuka retains exclusive marketing ofAbil ify for pediatric Tourette’s, but the drug fel l off thepatent cl iff, and the champagne’s flat. Pharmabloggers say other companies with drugs nearingthe same cliff watched this saga closely and arelearning lessons from it. “Winter is coming.” So staytuned.

REBECCA J ANDERSON, PhD, is a freelance

medical writer and the author of two books,

Nevirapine and the Quest to End Pediatric AIDS

and Career Opportunities in Clinical Drug

Research. Prior to medical writing, Dr. Anderson

managed research and development projects for

twenty-five years in the pharmaceutical/biotech industry. She

holds a Ph.D. in pharmacology from Georgetown University.

She lives in Southern California, and when she is not writing,

she absorbs the sights and sounds of the West Coast’s rich

culture and heritage. She can be reached at

[email protected].


AMA-zing Style — the AMA Manual of Style ColumnBy Dikran Toroser, PhD, CMPP, Amgen Inc. , Thousand Oaks, Calif.

A meta-analysis quantitatively summarizes theevidence regarding a treatment. I t is a morestatistical ly powerful test of the nul l hypothesis thanis provided by the separate studies because thesample size is substantial ly larger than those in theindividual studies.

Of particular importance to the medical writer, tohelp standardize the presentation of meta-analysis,JAMA recommends use of the QUOROM flowdiagram and checklist (http: //www.consort-statement.org/) for reporting meta-analyses ofRCTs, and the MOOSE checklist(http: //www.equator-network.org/reporting-guidel ines/) for reporting meta-analyses ofobservational studies.

To ensure that the meta-analysis accurately reflectsthe available evidence, the methods of identifyingpossible studies for inclusion should be explicitlystated (eg, l iterature search, reference search,and/or unpublished work). Authors should state thedates that their search covered and the searchterms used. A search strategy that includes severalapproaches to identify articles is preferable to asingle database search.

Publication BiasThe tendency to publish articles with positiveresults, and hence the resulting publication bias, is apotential l imitation of any systematic review. I f theymeet predefined inclusion criteria, unpublishedstudies may be included in a meta-analysis. Oneapproach to addressing whether publication biasmight affect the result is to define the number ofnegative studies that would be needed to changethe results of a meta-analysis from positive tonegative. To address the problem of publicationbias, the ICMJE requires, as a condition ofpublication, that a cl inical trial be registered in apublic trials registry. The policy defines a clinical trialas "any research project that prospectively assigns

human subjects to intervention or comparisongroups to study the cause-and-effect relationshipbetween a medical intervention and a healthoutcome."

Other significant issues include which study designsare acceptable for inclusion, whether and howstudies should be rated for quality,2 and how tocombine results from studies with disparate studycharacteristics. While few would disagree that meta-analysis of RCTs is most appropriate when possible,many topics include too few randomized trials topermit meta-analysis or cannot be studied in a trial .

Study heterogeneityWhether studies can be appropriately combined canbe determined statistical ly by analyzing the degreeof heterogeneity (ie, the variabil ity in outcomesacross studies). Assessment of heterogeneityincludes the effect size, the sample size in eachgroup, and whether the effect sizes from differentstudies are homogeneous. I f statistical ly significantheterogeneity is found, then combining the studiesinto a single analysis may not be valid. Anotherconcern is the influence a small number of largetrials may have on the results; large trials in a smallpool of studies can dominate the analysis, and themeta-analysis may reflect l ittle more than theindividual large trial . In such cases, it may beappropriate to perform sensitivity analysescomparing results with and without inclusion of thelarge trial(s).

A meta-analysis is useful only as long as it reflectscurrent l iterature. Thus, a concern of meta-analystsand clinicians is that the meta-analyses should beupdated as new studies are published. Oneinternational effort, the Cochrane Collaboration,4

publishes and frequently updates a large number ofsystematic reviews and meta-analyses on a varietyof topics.

Publication bias and meta-analyses—a primer from the AMA manual

Meta-analysis is a systematic pooling of results from 2 or more studies to address a question or hypothesis.The motivation behind meta-analyses is to compile sufficient data to achieve a higher statistical power, asopposed to a less precise measure derived from a single study.

[Meta-analyses] provide a systematic and explicit method for synthesizing evidence,

a quantitative overall estimate (and confidence intervals) derived from the individual

studies, and early evidence as to the effectiveness of treatments. They also can

address questions in specific subgroups that individual studies may not have

examined. 1


See pages 847-8 in the AMA Manual of Style 1 0th

edition for additional information.

Acknowledgement: Thanks are due to Ajay Malik,PhD, for useful discussions

REFERENCES1 . Moher D, Olkin I . Meta-analysis of randomizedcontrol led cl inical trials: a concern for standards.JAMA. 1 995;274(24): 1 962-1 964.

2. Dickersin K, Scherer R, Lefebvre C. Identifyingrelevant studies for systematic reviews. EMJ.1 994;309(6964): 1 286-1 291 .

3. http: //www.wjgnet.com/2222-0682/ful l/v2/i4/27.htm4. http: //www.cochrane.org/

DIKRAN TOROSER, PhD, CMPP, amember of the AMWA Pacific Southwestchapter, is a regular contributor to thePostscripts magazine since 201 2. Hedeveloped the monthly AMAzing Stylecolumn which covers topics from theAMA Manual of Style, and has alsowritten on publication-related topics in these pages.Dikran is currently a Senior Medical Writing Manager atAmgen Inc. in Thousand Oaks, California. He earned hisPhD in Biochemistry from Newcastle University (UK),and did his post-doctoral training in biochemical geneticsat the John Innes Center of the Cambridge Laboratory(Norwich, UK) and in molecular biology with the USDA.Prior to Amgen, Dikran was on the faculty (research) atthe School of Pharmacy at the University of SouthernCalifornia. He can be reached at [email protected].

About SSP*

The Society for Scholarly Publishing (SSP), founded in 1 978, is a nonprofit organizationformed to promote and advance communication among all sectors of the scholarlypublication community through networking, information dissemination, and facil itation ofnew developments in the field.

SSP members represent al l aspects of scholarly publishing — including publishers,printers, e-products developers, technical service providers, l ibrarians, and editors. SSPmembers come from a wide range of large and small commercial and nonprofitorganizations. They meet at SSP’s annual meetings, IN Conferences, educationalseminars, and Librarian Focus Groups to hear the latest trends from respected colleaguesand to discuss common and mutual (and sometimes divergent) goals and viewpoints.

*From SSP website: http: //www.sspnet.org/

Plan for the next SSP Annual Meeting in June 1 - 3, 201 6 at Vancouver, BC

Read SSP's blog Scholarly Kitchen here: http: //scholarlykitchen.sspnet.org/


Reprinted with permission from the AMWA Journal, Spring 201 5 issue,

©201 5 Noelle H. Demas and the American Medical Writers Association.

Please visit http: //www.amwa.org/events_annual_conference for updated information.

—Editor




201 5 AMWA Pac-SW ConferenceMay 1 – May 2, 201 5

Courtyard Marriott San Diego, Old Town

2435 Jefferson St, San Diego 9211 0

Join us for small-group workshops, networking opportunities andprovocative conversations with writers, editors, scientists, and othermedical communicators in fun-fi l led and historic Old Town, home tonumerous food, shopping, entertainment and cultural venues.

Here’s a taste of the open sessions:

• Preparing a Clinical Study Report• Setting up a Freelance Business• Using Storytel l ing Skil ls to TailorCommunications for DifferentAudiences• Medical communications careers(panel discussion)

Plus 2 Workshops!

• Outl ining for Writers and Editors (ES/EW/FL) [2007], Sue Hudson• Effective Paragraphing (ES/G) [2003], Helen Hodgson

REGISTER HERE:

www.amwa.org//calendar_day.asp?event=1 545&date=5/1 /201 5

AMWAPacific

Southwest C

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You Spoke and We Listened!A Resoundingly Successful 2015 Pacific Southwest Chapter Conference, May 1-2

By Jacki Dyck-Jones, PhD, MSc, Past-President, AMWA Pacific Southwest Chapter

Meeting Report

I t al l started with a Survey Monkey analysis early in201 4. As co-directors, Jenny Grodberg and Ireal ized that in order to plan a successful event wereally needed to know what the membership wantedin our first annual chapter conference. With thesupport of President Donna Simcoe and the otherchapter officers, a survey was designed to identifywhat would work for the most people: we needed toknow everyone’s preferences regarding location,duration and content for the event.

The responding members indicated that their timewas limited and the previous 3 day conferencemodel that required 2 days of travel was wonderfulbut just not doable. And in the current financialcl imate, with self-funding more prevalent, keepingthe cost down was also critical. A location that wasconvenient by airplane, train, and automobile wasalso requested. Members sti l l wanted coreworkshops and quality open sessions.

As you can imagine, hours and hours of deepthinking went into solving how to meet al l of theserequirements. I t was encouraging to learn thatseveral of our sister chapters had successful ly runtheir own single day conferences. After weighing themerits of al l of our options we settled on a Saturdayevent at the Old Town San Diego location. At first,the registration seemed to lag, however, now we canboast of a turnout of 54, with every single registrantshowing up! This has enabled our balance sheet tobe “in the black” (although our sponsors Amgen andSynchrogenix contributed mighti ly to this happyfact!).

Participants came with guests in tow, from allcorners of the chapter, as well as the NorthernCalifornia Chapter, Utah, and Albuquerque! We evenhad a participant from Canada. We included aFriday night Happy Hour on the hotel patio whichwas attended by over 30 people (Thank youSynchrogenix for supporting this event!). This was agreat opportunity for the travelers to unwind thenight before the conference sessions began.

Saturday fol lowed with four open sessions and twoworkshops (Thank you Amgen for this support!).TheEssential Skil ls workshops are always crowdpleasers for AMWAmembers working on theircertificates, and the workshops offered at thisconference were no exceptions! Susan Hudsontaught her outl ining course in the morning. Shepresented her methods for organizing content and

strategy to prepare for writing a complex document.Helen Hodgson taught Effective Paragraphing,which is targeted to writers of al l levels ofexperience to assist them in developing their writingskil ls in the analysis and correction of text.

We were fortunate to have 4 open sessions led byour talented fel low AMWAmembers. First, MichaelBaker presented “Preparing a Clinical StudyReport. ” The talk was both an overview and anintroduction and thus held everyone’s attention.There were tales from the trenches mixed in withexplanations of ICH guidance and tips on meetingtimelines. Amy Lindsay led a stimulating interactivesession on using storytel l ing skil ls to tai lorcommunications to different target audiences. Theattendees paired up to participate in the exercises tohone their communication skil ls and find theessence and compell ing story in their messages.Heather Oliff gave us invaluable tips on how to setup a successful freelance business includingdemystification of contract legalese. Please seepage 98 of this issue for a graphic summary ofHeather’s presentation outl ined by Cely Sepulveda.

The last open session of the day was a lively paneldiscussion on careers in medical writing with NoelleDemas, Gail Flores, Michel Merrigan, and YeshiMikyas, moderated by Sue Hudson. The topicscovered included publication writing, regulatorywriting, freelancing working for a CRO, and workingfor a pharmaceutical company. Throughout thesession the audience was ful ly engaged withparticipation by both newcomers and seasonedwriters.

I bel ieve the success of the conference wasmanifested by every session running over withenthusiastic audience participation, with non-stopchatter at our meals and breaks, and the manysmiles on everyone’s faces. We overheard manyglowing compliments about the high quality of thespeakers and the workshops and about the overal ljoie de vivre which permeated the day. The positiveresults of the fol low-up Monkey Survey confirmed ahigh level of satisfaction with the event. To top it off,many of us were able to enjoy an Old Town Cinco deMayo impromptu dinner at the historic CosmopolitanHotel.

What a perfect conference!


LYCELY SEPULVEDA, PhD, has over 20 years of biomedical communication experience in diverse higher educationinstitutions including Stanford University and UC Irvine. After completing her PhD in Microbiology from MichiganState University, Lycely applied her technical communication and management skil ls to lead multi-site andinternational Molecular Biology, Infectious Diseases and Biotechnology projects. Lycely plans to leverage her vastresearch, teaching, regulatory and executive experience to transition into the field of medical writing. Lycely enjoyshiking on the coastal Southern California trai ls with her family and she can be reached at lycely@gmail .com.


Snapshot about Paragraphing and Outlining WorkshopsBy Lamia Merabet, BS, MS, MBA, AMWA Pacific Southwest Chapter Member

At the AMWA Pacific Southwest conference, I wasdelighted by the opportunity to participate in severalprofessional, educational, and networking activities.The conference was strategical ly organized at theOld Town Marriott Resort, in a friendly venue, thelocation being close to the San Diego airport andtrain station (wonderful as I was riding the Amtrakfrom Irvine). The conference opened on Fridayevening with a laid back note, mingl ing withattendees and sharing savory appetizers andbeverages. To my surprise, everyone was extremelyapproachable, enjoying this gathering as a pleasantritual, and showing a great welcoming attitude tonew comers alike.

I chose to attend both workshops offered at theconference, for which assignments were mailed outahead of time (about a month prior to theconference). This pre-workshop assignments forboth workshops were an educational eye-opener,and the candidate had to apply whatever waslearned. I l iked this "Learn & Assess" approach. Theinstructors fol lowed up with email to explain theassignments if needed, taking the time to email thecandidates before the workshop.

At the workshop, being prepared and "warmed up"by the homework, we had the great chance to gobeyond and in depth into the topics. The instructorswere extremely knowledgeable, professional, and

they encouraged an active participation. To crack ajoke, I would say that Writers are also Talkers! Theparticipants at both workshops were very proactive,sharing insights, and collaborative. As all werehappily tuned in, we had the opportunity to practicel ive exercises in sub-groups, as a hands-onassessment of the acquisition on the topic, and ateamwork for writers. I t was very instructive, a lot offun, and shifting the perception of writers from solewalkers to 4-wheel movers through the hurdles of aproject.

LAMIA MERABET, BS, MS, MBA is a Quality

Assurance/Regulatory Affairs Special ist at Nihon

Kohden America, Irvine. She earned her MS in

Clinical Pharmacology from Henri Poincare

University in Nancy, France, and has an MBA in

Healthcare Administration. She speaks several languages

including French, Spanish, Russian, Arabic, and English.

When not handling regulatory affairs documents, she

volunteers her time as pro bono translator for Casa Cornelia (a

human rights organization) and serves at the San Diego

Regulatory Affairs Network (SDRAN) with the Education

Committee as Monitor of EU RAC Class, and recently in

Communication management. She also actively assists in

reaching out to well-known speakers through the SDRAN

Program Committee. She can be reached at

iamlamiamerabet@gmail .com.

Meeting Report (AMWA Pacific Southwest chapter conference)


Dinner and Laughs at the Chapter Annual Conferene in Old TownSan Diego, May 2, 2015

Clockwise from top left: Mary Kay Stein and Helen Hodgeson; Jim and Sue Hudson; Donna, Michele and ??;Elise, Donna and Mimi; Jenny, Jacki, El ise and Maggie; Sue, ??; Noelle, ??; Heather, Michele, Cely, J im and

Sarah; Helen, Jenny and Jacki; (in middle) ?? and Mary Ann. Pictures by Valerie Breda.

POSTSCRIPTS | VOL 5, NO. 35 | JUNE 201 5 1 00

Congress Summary: ISMPP-201 5By Dikran Toroser, PhD, CMPP, Amgen Inc. , Thousand Oaks, Calif.

The 11 th Annual Meeting of ISMPP took place onApri l 27-29 in Arl ington, VA. There were 526attendees this year—the highest number ever. Therewas significant participation from our AMWA chapter.Donna Simcoe, our chapter president, was electedto the ISMPP Nominating Committee to work withthe ISMPP Board of Directors over the next year.

Due to popular request, ISMPP reorganized themeeting format this year, focusing on sessions withhigh interaction and case-based learning. Thegeneral theme of the congress was “OptimizingScientific Value: Smart and Systematic Approachesto Medical Publications. ”

Key SessionsThe patient perspective in research and publishingwas in the spotl ight, reflecting patients’ increasinginvolvement in research and effect on scientificexchange. The 1 st of 3 keynote lectures wasdelivered by Ide Mil ls, who was diagnosed withcancer four years ago. Key messages from Ide’skeynote address were: increasing health l iteracy iscrucial and publication professionals play a majorrole in promoting patient centricity. The patientperspective theme was further augmented by afascinating panel on “The Patient Voice.” DanielShanahan, an editor from BioMed Central, gave anupdate on the role of patient peer-review andintroduced two journals that focus on this trend.Patient and public involvement (PPI) in thepublications space is l ikely to be important in thefuture.(seehttps://www.youtube.com/watch?v=9Vgchwjio2E)

Clinical data sharing was also a major theme at thecongress. I t was reiterated that funding bodies areadopting policies mandating data sharing, which is afunction supported by public opinion. Sessionsdiscussed how data sharing wil l help the researchcommunity realize ful l benefits from the resourcesdevoted to cl inical research. As an example, the YaleUniversity Open Data Access (YODA) Project washighl ighted for making data available to researchersin a sustainable way. Iain Hrynaszkiewicz, Head ofData Publishing from the Nature Publishing Groupgave a fascinating keynote on the subject.

The Sunshine Act, which requires manufacturers ofdrugs, medical devices and other healthcare-relateditems to report any direct payments and transfers ofvalue to US licensed physicians and teachinghospitals was the focus of numerous sessions.

The 3rd and final keynote address was delivered byDr John Kampp (Executive Director of Coalition ofHealthcare Communication). Dr Kampp describedthe achievements of the medical communicationscommunity and the various upcoming publications-related legislation initiatives. He invited the audienceto “stay tuned”—undoubtedly, there are numerousimpactful legislative changes that are on the horizonin the publications space!

Other notable updates included the practicalimplications of Good Publication Practice-3 (GPP3).The GPP guidel ines, updated approximately every 6years, aims to promote integrity and transparency inindustry-sponsored publication planning anddevelopment. The GPP3 guidel ines are l ikely to bepublished in the Annals of Internal Medicine later thisyear. Members of the Steering Committee arepresently addressing referees’ comments. Poster and Roundtable SessionsThere were over 40 poster presentations, on varioussubjects, including developments in the use of socialmedia to disseminate special ist cl inical research andthe adherence rates to various pivotal guidel ines. Afew posters explained the benefits of medical writingsupport for publications in optimizing timelines andimproving the quality of reporting cl inical trial data.There were also 2 roundtable sessions held duringthis year’s program, both of which were extremelypopular.

ISMPP-201 5 was an excellently organized andvaluable congress. Particularly, ISMPP’s chosenvenue was also a remarkable place to hold thiscongress—just a stone throw’s away from varioushistoric national monuments and accessible to awide range of ISMPP members.

1 01 POSTSCRIPTS | VOL 5, NO. 35 | JUNE 201 5

Brandon Samson - Studio City

Brea Midthune - San Diego

Jessica Meyer - San Diego

List courtesy of Gail Flores, PhD, AMWA Pacific Southwest chapter membership coordinator.

AMWA Pacific Southwest chapter warmly

welcomes our new members


Chapter Events' Calendar

May 29th, 1 2 to 1 pm Central time - Webinar The AMWA North CentralChapter has invited us to attend their webinar True RegulatoryIntel l igence for Medical Devices Please register early if you areinterested in attending.

Presented by North Central President-elect, Karen Bannick,this webinar wil l provide a practical perspective on what regulatoryintel l igence is and how it can be incorporated into your regulatorystrategies and tai lored to enhance your own career through masteringits use.

To register, email [email protected] is also available on the AMWA North Central Chapterwebsite

June 5th, 1 2-1 pm Pacific time - Monthly Teleconference I wil l sendmore detai ls before our monthly cal l . I f you would l ike to receive theappointments to add to your calendars, please send me an email .

June 1 8th, 5:30 pm Pacific time - Happy Hour We thank Asoka andBrea, who you may have met at our conference earl ier this month, forhosting a medical writers happy hour. More detai ls in the flyer below.

I f anyone is interested in hosting an event in your neighborhood, pleasecontact Donna ([email protected])

September 1 9, 201 5 - Chapter organized symposium: "Medical Writers’Toolbox Decoded". Location: Thousand Oaks, CA (Amgen) -- SAVETHE DATE



Technical Writer/Editor

Undisclosed Company in Phoenix, AZRecruiter: Sterl ing-Hoffman Executive Searchhttp: //www.mybiotechcareer.com/JD/Medical-Writing-Arizona-Biotechnology-Jobs-Careers-8659

Medical Device/Technical Writer

Bard Peripheral Vascular, Tempe, AZhttps://jobs-crbard. icims.com/jobs/81 80/technical-writer/job?mode=job&iis=Indeed&iisn=Indeed.com

Medical Writer - Pharmaceutical

Brandkarma, Irvine, CAhttp://job-openings.monster.com/monster/8af005f9-c97d-4303-b0e9-a0ce8b5b4e77?mescoid=2700440001 001 &jobPosition=5

Manager, Scientific Communications - Heart Valve Therapy

Edwards Lifesciences, Irvine, CAhttps://edwards.taleo.net/careersection/edwards_external_cs/jobdetai l . ftl?job=0061 65&src=JB-1 0046

Medical Writer

Sonendo, Inc. , Laguna Hil ls, CAhttps://www.smartrecruiters.com/SonendoInc/82527360-medical-writer

Technical Writer, Biotech

Sequoia, Oceanside, CAhttps://www.smartrecruiters.com/Sequoia/83226607-technical-writer-biotech

Regulatory Technical Editor

Ardea Biosciences, San Diego, CAhttp://www.biospace.com/jobs/job-l isting/regulatory-technical-editor-344336

Manager, Copywriting

I l lumina, San Diego, CAhttp://job-openings.monster.com/monster/fe3bbc6d-6378-4da5-8803-7c0cf76d47b1 ?mescoid=&jobPosition=1 5

Medical Writer (Orthopedic Spine Devices and Related Areas)

Nuvasive, San Diego, CAhttp://job-openings.monster.com/monster/e6d03020-00ac-4556-92a2-cfac1 fb99a72?mescoid=2700440001 001 &jobPosition=2

Medical Writing Open PositionsCompiled By: Sharyn Batey, PharmD, MSPH

Employment Coordinator, AMWA Pacific Southwest Chapter

Career Corner

*Note: Occasionally weblinks in the PDF document may not work if the web address is long and

splits into 2 l ines. You may copy and paste the complete l ink into a new browser tab or window

to reach the correct website.


Medical Writer

Undisclosed Company in South Region of CaliforniaRecruiter: Sterl ing-Hoffman Executive Searchhttp: //www.mybiotechcareer.com/JD/Clinical-Research-Affairs-R-AND-D-Science-Medical-Affairs-California-South-Region-Biotechnology-Jobs-Careers-9911

Medical Writing Manager

Amgen, Thousand Oaks, CAhttp://www.biospace.com/jobs/job-l isting/medical-writing-mgr-344972

Medical Communications Manager

Kaztronix LLC, Thousand Oaks, CAhttp://jobview.monster.com/Medical-Communications-Mgr-Job-Thousand-Oaks-CA-US-1 51 053877.aspx?mescoid=11 00009001 001 &jobPosition=6

Scientific Writer (Process)

Peregrine Pharmaceuticals, Inc. , Tustin, CAhttp://www.biospace.com/jobs/job-l isting/scientific-writer-process-344486

If you want to share job leads with the members of the Pacific Southwest Chapter, pleasecontact Sharyn at [email protected].


Cadillac RanchBackpage

Cadil lac Ranch is a public art and sculpture along Old Route 66 west of Amaril lo, Texas.I t was created in 1 974 by Art Farm, an art group in San Francisco. Chip Lord, HudsonMarquez and Doug Michels (Art Farm members) came up with the idea of creating anart project celebrating the evolution of Cadil lac’s (Caddie’s) signature tai lfins from 1 949to 1 963 models. With financial backing of Stanley Marsh 3, a bil l ionaire from Amaril lo(think Texas oil boom), ten caddies were buried nose-down at an angle (same as inpyramids) in a l ine facing west. Today, visitors make pilgrimage from as far as Austral iaand Russia, with spray cans in hand to add their designs, painting over the ones madehours before by others, and take pictures. Visiting this part of Old Route 66 is toexperience the magic of old Americana of open skies, big cars, and freedom. Thisis another thing to add to your bucket list!

Sources:Wikipedia: http: //en.wikipedia.org/wiki/Cadil lac_Ranch;

Roadside America:

http: //www.roadsideamerica.com/story/2220

—Editor

Picturesandmapfro

mWikipedia,WikimediaandPixabay.UsedunderCC-BYlicence.Websitesfororiginalcontent:

http://e

n.wikipedia.org/wiki/Cadillac_Ranch,http://e

n.wikipedia.org/wiki/File:Cadillac_Ranch.jpg,http://e

n.wikipedia.org/wiki/File:Underside_of_Cadillac.jpg,

http://c

ommons.wikimedia.org/wiki/File:Amarillo

,_TX_Cadillac_Ranch_4889030995.jpg,http://p

ixabay.com/en/cadillac-auto-cuba-oldtim

er-660800/,

http://p

ixabay.com/en/art-c

olorful-cadillac-ranch-343868/,http://p

ixabay.com/en/cadillac-art-v

intage-car-oldtim

er-343869/,

http://c

ommons.wikimedia.org/wiki/File:Route_66_Attra

ctions_Map.jpg,http://c

ommons.wikimedia.org/wiki/File:Route_66_artw

ork_roadmap.jpg


Documents

Postscripts v5 n35 _2015June