Official publication of the American Medical Writers Association Pacific Southwest Chapter

AMWAPacificSouthwestChapter

June2016

Postscripts

Volume VI Issue 44June 201 6

POSTSCRIPTSIN THIS ISSUE:

• ORCIDs for Researchers

• IMRAD has a Design Flaw

• Pollution of Scientific Literature

• Role of Patients in Drug Development

• Toastmasters

POSTSCRIPTS

AIMS AND SCOPEPostscripts is the official publication of American MedicalWriters Association (AMWA) Pacific Southwest chapter. I tpubl ishes news, notices, job postings, and articles of interest inal l areas of medical and scientific writing and communications.The scope covers cl inical and regulatory writing, scientificwriting, publication planning, continuing medical education(CME) and physician/patient education, social media, currentregulations, ethical issues, medical writing training andcertification, and good writing techniques.

MISSION STATEMENTThe 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 significantadvances in issues, regulations and practice of medical writingand communications; ski l ls and language; summaries andreports of meetings and symposia; and book and journalsummaries. Additional ly, to promote career and networkingneeds of the members, Postscripts includes news and eventnotices covering AMWA Pacific Southwest Chapter activities.

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

INSTRUCTION FOR CONTRIBUTORS: We consider articleson any topic of interest to our membership. I t is helpful to lookat the past December issues for year-end table of contents, andto browse past issues for style and type of articles published.We welcome contributions from AMWAmembers. Non-membercontributions are general ly by invitation by the Editor or anymember of the Chapter's Board. Detailed instructions areprovided in the December 201 5 issue, Postscripts201 5;5(39):204.

ADVERTISING : Postscripts is an advertising-free magazine.However, articles describing products and services relevant tomedical writers, editors and communicators may be consideredor solicited. As a service to our members, they may submitadvertisements for their services or products for free. Pleasecontact the Editor.

WEBSITES:Chapter website: http: // www.amwa-pacsw.orgAMWA website: http: //www.amwa.orgPostscripts: http: //issuu.com/postscripts

Copyright 2011 -201 6, American Medical Writers Association PacificSouthwest Chapter, San Diego, CA. All rights reserved. (Authorsretain copyright to their articles. Please contact authors directly forpermission to use or display their work in any form or medium.)Design and typesetting by Ajay Malik.

EDITORAjay K Malik, PhDajay@amwa-pacsw.org

EDITOR-AT-LARGESusan Vinti l la-Friedman, MWCpresident@amwa-pacsw.org

AMWA Pacific Southwest ChapterLeadership —

PresidentSusan Vinti l la-Friedman, MWCpresident@amwa-pacsw.org

Immediate Past PresidentDonna Simcoe, MS, MS, MBA, CMPPpast-president@amwa-pacsw.org

TreasurerElise Sudbeck, PhDtreasurer@amwa-pacsw.org

SecretaryBrea Midthune, PhDsecretary@amwa-pacsw.org

Arizona LiaisonAmy Van Gels, DVMAZliaison@amwa-pacsw.org

Membership CoordinatorGail Flores, PhDmember-coordinator@amwa-pacsw.org

Employment CoordinatorSharyn Batey, PhDemployment-coordinator@amwa-pacsw.org

Outreach CoordinatorAsoka Banno, PhDoutreach-coordinator@amwa-pacsw.org

Website CoordinatorLaura J Cobb, PhDwebsite-coordinator@amwa-pacsw.org

Newsletter EditorAjay K Malik, PhDajay@amwa-pacsw.org

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

Outreach Coordinator for Thousand Oaksand Northern Los AngelesGarima Chaudhry, PhDgchaudhr@usc.edu

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POSTSCRIPTSJune 201 6 | Volume 6, No.44

COVER:

Oceanside Beach, Southern California. By Sangeeta Dhamija. 201 6.

POSTSCRIPTS | VOL 6, NO. 44 | JUNE 201 6 86

• From the President's Desk — Susan Vintilla-Friedman, MWC . . . . . . . . . . . .• Editor's Desk: Role of Patients in Drug Development — Ajay KMalik, PhD . .

MEDICAL COMMUNICATIONS, PUBLICATION PLANNING

• Now We're All Just Numbers — Rebecca J. Anderson, PhD . . . . . . . . . . . . .• Praxis: IMRAD Has a Design Flaw— Hope J Lafferty, AM, ELS . . . . . . . . . .• AMA-zing Style — The AMA Manual of Style Column

— Dikran Toroser, PhD, CMPP . . . . . . .• Latest Research About Medical Writing Support in Publications

—Marissa Romero-Acuña . . . . . . . . . . .PUBLIC SPEAKING

• My Road to Toastmasters — Bernard Delacruz, PhD . . . . . . . . . . . . . . . . . . . . . . .

REGULATORY INTELLIGENCE, CLINICAL TRIALS

• News and Updates from the FDA— Lamia Merabet, MS, MBA . . . . . . . . . . . . . .

• Creating the Future of Clinical Trials Today: How Mobile Technologies andTelemedicine Wil l Radical ly Transform Clinical Trials

— Roberta Alexander, PharmD, PhD . . .

CAREER

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

DEPARTMENTS

• New Members — Gail Flores, PhD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .• Chapter Upcoming Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .• What's Happening at AMWA National . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .• Backpage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ACKNOWLEDGEMENTMany thanks to Clare Prendergast, MA (Norton Thoracic Institute, Phoenix,Arizona) for copyediting and proofreading this issue. Clare's bio and her contactinformation appear in the Apri l 201 6 issue of Postscripts.

© Chip Reuben 2008In this issue. . .

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From the President's Desk

This is our last issue of the spring; we’l l be back in August, but before some ofyou head out for vacation adventures I want to make sure you know that we’veplanned some fun and educational chapter events for when you’re back in town:

• June 11 — Regulatory Operations Update lunch presentation in Carlsbad byAntoinette Azevedo, a noted authority on topics such as esubmissions anddocument management.

• June 22 — Happy hour at the Bella Vista Social Club in La Jolla hosted by ourchapter secretary, Brea Midthune, and our chapter treasurer, El ise Sudbeck.

• July 1 — Monthly chapter teleconference, hosted by our past president, DonnaSimcoe.

• July 1 6 — Chapter lunch, presentation, and tour of Lab Launch, a nonprofitbiotech facil ity in Monrovia that provides office and lab space to entrepreneursand anyone else looking to rent space, including medical writers.

You can check the back pages of the newsletter for more specifics.

We have also begun planning the AMWA Pacific Southwest 201 6 Symposium,hosted again by Amgen, on September 1 0 in Thousand Oaks. Last year’s eventwas very well attended and we are excited about the content being planned.Please do check your emails for more detai ls, coming soon.

By now you should also have received emails from AMWA about the nationalmeeting from October 5-8 in Denver, now called the Medical Writing andCommunication Conference. More detai ls can be found athttp: //www.amwa.org/registration_information, including information about the“Super Saver” rates in effect through June 30. We hope to see you in Denver atthe events that wil l include our annual chapter dinner, which is scheduled forFriday October 7. This should be a beautiful time of the year to see the Mile-HighCity and maybe even a bit of the Rockies if you have time.

Our June issue begins with an article by Rebecca Anderson about namingconventions for authorship, including a description of ORCID, an organizationthat assigns a 1 6-digit number to authors (but presumably doesn’t supply anickname). Hope Lafferty analyzes problems with the classic formatting ofscientific articles, and Dikran Toroser discusses the grave problem of scientificmisconduct and how it affects publications. I f you’re ever been interested inimproving your speaking skil ls by participating in Toastmasters, Bernard Delacruzprovides a first-hand account of his experiences “making the transition fromscientist to science communicator.” Two of our writers report on recent meetingsof interest – Marissa Romero-Acuña summarizes discussions from the May 6chapter teleconference that discussed medical writing support in publications,and Roberta Alexander reviews a joint meeting of SDCRN and SDRAN on May 9that discussed mobile technologies in telemedicine. Our monthly news andupdates from the FDA are provided by Lamia Merabet.

Also please do enjoy the very summery painting at the end of this issue by FridaKahlo (of watermelons, not of herself)!

Susan

Susan Vinti l la-Friedman, MWCPresident, AMWA Pacific Southwest Chapter

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EDITOR'S desk

Role of Patients in DrugDevelopment

Last month, about 1 00 patients with Duchennemuscular dystrophy (DMD) and 1 ,000 advocatescrammed into a Washington, DC hotel bal lroom,where 50 patients took the mike to make passionatepleas for the approval of Sarepta’s new drug forDMD, Eteplirsen. At these meetings, cal led advisorycommittee meetings—composed of independentexperts—the sponsor company makes a case fordrug approval by presenting the efficacy and safetydata from the pivotal trials; the FDA scientists whoindependently analyze the raw data also presenttheir interpretation of the data. After l istening to bothsides, the committee recommends approval ordenial of the drug by an open vote. The FDA, thoughnot bound by the vote, takes the outcome of thismeeting into account when it publishes the finaldecision a few weeks later.

Patient Power

There were several things that were unusual aboutthe DMD-Eteplirsen meeting. First, the interest fromthe DMD community was so strong that the meeting,which is normally held in a conference room on theNIH campus, had to be moved to a local hotelbal lroom; second, unl ike the impassioned testimonyfrom the patients, the company’s own data werefrom a trial with just 1 2 patients. The trial was poorlyrun, with a fudged placebo arm, questionssurrounding its experimental methodologies, andless-than-convincing efficacy data. One might ask,when and how did the patients start taking centerstage in drug deployment and regulation? Theanswer l ies in the thal idomide disaster and the AIDSepidemic.

The thal idomide disaster of the 1 960s, swung thependulum in favor of tighter regulatory control onnew drugs, and what resulted over the years was atop-down regulatory paradigm and paternalisticmodel of drug development. But the 1 980s AIDScrisis and slow drug development responsecompelled patients and their advocates to maketheir voices heard. Since then, there has been asea-change in attitude at the political/pol icy level,support for expedited and targeted investments inresearch areas and access to drugs. But thereremains a lot more that the patients can teach thedrug development enterprise.

Section 11 37 of FDASIA

In July 201 2, President Obama signed the Food andDrug Administration Safety and Innovation Act(FDASIA) into law. Section 11 37 of FDASIA has a

provision for the FDA to develop and implementstrategies to enhance patient participation in drugdevelopment and regulatory processes. Specifical ly,the law encourages the FDA to actively capturepatients' experiences during the time of drugdevelopment and solicit their perspective at the timeof regulatory discussions.

Currently the FDA is holding public meetings: 4workshops per year over the course of 5 years. Eachmeeting wil l cover a specific disease area and solicitpublic comment on a variety of questions, includingthe unmet medical need (eg, the gap the currenttherapies fai l to bridge between pharmacologicalefficacy and improvement in quality of l ife) orunderstanding the severity and burden of thedisease, so the regulators can objectively weighrisks and benefits of new medicines; creating aroadmap (codifying the process) of involving patientsbeginning with the earl iest stages of drugdevelopment by encouraging the adoption andvalidation of patient reported outcome (PRO)measures in cl inical trials. The spotl ight on PROmeasures is already being felt in healthcare delivery.Payers are increasingly evaluating PRO data as theydetermine the value proposition of new medicinesbefore approving insurance coverage for theirmembers.

FDASIA also passed the 5th reauthorization of thePrescription Drug User Fee Act (PDUFA V). The feescollected under PDUFA V are providing resourcesnecessary for the FDA to undertake a patient-focused drug initiative.

Across the Pond

In Europe, patients are already influencinghealthcare delivery; for example, in Denmark,patients are the major source of adverse drugreporting (ADR). Since 2003, 11 % of al l ADRs in theDanish Adverse Reaction Database were directlyreported by the consumers (ie, patients).

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Last summer, the Copenhagen Center forRegulatory Science (CORS) and Biopeople at theUniversity of Copenhagen, Denmark, organized aworkshop, “Patient Involvement in MedicinesDevelopment and Approvals: A Paradigm ShiftTowards True Patient Impact in MedicinesDevelopment and Regulatory Science.”The Copenhagen meeting noted that scientificadvice, protocol assistance, qualification ofbiomarkers, novel methodologies and healthtechnology assessments as some of the areaswhere patient involvement would benefit drugdevelopment. However, it was also noted thateffective patient involvement requires an “informed”patient. Towards this goal, the European Patients’Academy on Therapeutics (EUPATI), establ ished in201 2, was mandated to fi l l the gap in patienteducation. EUPATI is a consortium of academia,industry, non-profit and advocacy groups that aims toprovide e-Learning, classroom learning and internetl ibrary resources.Similar to the evolution of thinking at the FDA, theCopenhagen group also identified PRO as a criticalcomponent that can inform the selection ofendpoints in cl inical trials. The Europeancounterparts are also moving towards establishing alegal and regulatory framework to securecompliance among all stakeholders and creating amore homogenized inter-operable environment forlogistical purposes.

Leaning Over the Horizon

While the involvement of patients in the regulatoryprocess—for example, advisory committees—iswelcome, their testimony alone cannot trump hardcl inical trial data. The heartfelt pleas of the DMDpatient community for the approval of Sarepta’sEteplirsen in the end could not sway the committeeto vote in favor of granting approval: the committeevoted 7-3 (with 3 absentees) against approval of thedrug. And the FDA has, so far, only al lowedcompassionate use, while continuing to review theapplication. The FDA sti l l has the option of ignoringthe vote of the advisory committee (that it general lydoes not do) or granting conditional approval with arequirement to do additional confirmatory trials.

Grand Experiment

The involvement of patients in drug development ispart of a grand experiment to bring down the wallsbetween science and public. The logic goes that ifthe public has its hand on the pulse of scientific andclinical innovation, it is not only more likely tofinancial ly support the scientific effort through tax

dollars, phi lanthropic giving and policy support, butalso to inform the scientists and industry on theissues that actual ly matter to them. This evolution isalso expediting the need for transparency, publicdata access and accountabil ity. As we discussed inseveral previous issues of Postscripts, medicalwriters and their organizations (ISMPP, AMWA, etc)are at the forefront of this effort. Recently, Danishauthorities mandated open access to all researchpublished using tax dollars by the year 2020.We are currently experiencing an inflection point indrug development that history wil l judge as theRenaissance Period of Drug Development driven by1 960s-style activism! As Pete Townshend of Whosaid:“I 'l l tip my hat to the new constitution / Take a bowfor the new revolution / Smile and grin at thechange all around / Pick up my guitar and play,just l ike yesterday.”

***

Acknowledgement:The author is grateful to Clare Prendergast, MA(Norton Thoracic Institute, Phoenix, Arizona) forproofreading and editing this article. Her corrections,comments and suggestions helped move the qualityof this work up a notch.

Sources:• Borup C, Bach KF, Schmiegelow M, et al. A paradigm

shift towards patient involvement in medicinesdevelopment and regulatory science: Workshopproceedings and commentary. Therapeutic Innovation& Regulatory Science. 201 6 May; 50(3): 304-311 .

• Crow D. US healthcare: Power to patients? FinancialTimes. May 22, 201 6. Available at:http: //www.ft.com/cms/s/0/59587d78-1 dbc-11 e6-a7bc-ee846770ec1 5.html

• Pollack A. Advisors to FDA vote against Duchennemuscular dystrophy drug. New York Times. Apr 25,201 6. Available at: http: //nyti .ms/1 MTPPc7

• Food and Drug Administration Safety and InnovationAct. Public Law 11 2–1 44, 11 2th Congress. July 9,201 2. Available at:https://www.gpo.gov/fdsys/pkg/PLAW-11 2publ1 44/pdf/PLAW-11 2publ1 44.pdf; also see:http: //www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm200271 87.htm

Ajay K Malik, PhDEditor, Postscripts

AMWA Pacific Southwest Chapter

89 POSTSCRIPTS | VOL 6, NO. 44 | JUNE 201 6

Now We're All Just NumbersBy Rebecca J Anderson, PhD, AMWA Pacific Southwest Chapter Member

For people whose careers depend on authorship inpeer-reviewed journals, name ambiguity is a kil ler. I fyou’re a Wil l iams, Johnson, or Smith, you know whatI ’m talking about. I t’s tricky for people to distinguishyou in PubMed or Scopus (or internet) searchesamongst al l the other people sharing the namesWil l iams, Johnson, or Smith. And it’s worse if, inaddition, your first name is John, Jane, Michael, orMary.

I have lived this scenario first hand! Every time I ’verelocated for a new job, there has been at least oneother Rebecca Anderson in the same town.Sometimes, there were two of us in the samecompany. True, it can be fun if your doppelganger isa high-profi le lawyer (yes, that’s happened). But itcan be disconcerting when bil l col lectors mistakeyou for a delinquent student loan debtor (yes, that’shappened, too). On the lighter side, I ’ve lost countof the times that a fictional character with my namehas appeared in television shows and the movies.But usually, she’s the vil lain.

After the establishment of the DOI system for peer-reviewed publications, researchers, funders, andother stakeholders have turned their attention tocreating a unique ID for each researcher, but thetransition has not been easy. Debates over whetherto institute an ID system, and if so, which service touse, have been going on for a decade. Why? Mostresearchers don’t have a name ambiguity problemand saw little need to bother with registering theirtrue identity. But as electronic communications haveprogressively shrunk the world, the problem hasmassively grown.

For example, there are more than 1 00 mil l ion peoplenamed Wang, and more than 1 0 mil l ion people arenamed Nguyen. The problem is even worse whenyou consider transl iteration of those names into theRoman alphabet, generating multiple spell ings of asingle person’s name.

And then there’s the issue of accent marks, umlauts,and the l ike, which appear or disappear in namesfrom one publication to the next. Journal editors(perhaps inadvertently, but who knows?) create adoppelganger of the true researcher. Whenreviewing that researcher’s next grant application,should the funding agency take into account thepublications of the real scientist or his/herdoppelganger?

Last year, academic publishers and scientificsocieties final ly drove a spike in the ambiguityproblem. In an open letter, they said that they willnow require—not just encourage—researchers tosign up with ORCID, a nonprofit organization that

uniquely identifies people. ORCID assigns a 1 6-digitserial number to distinguish you from all the otherJim Johnsons.

Laurel Haak, Executive Director of ORCID, says, notsurprisingly, Asians are among the most receptive toORCID’s ID codes—including a lot of Wangs, Isuppose. Chinese authors comprise her company’ssecond largest demographic.

Your newly assigned ID number wil l onlyautomatical ly tag your papers going forward, but youcan (manually) l ink your past publications throughSCOPUS ID. (ORCID wil l walk you through theprocess.)

One thing that ORCID hasn’t figured out is how todeal with the “dead scientist problem.” Haak says,“ORCID requires a living scientist to sign up for thesystem.” Ok. That’s a pretty safe bet, unless you’rea zombie or something. But after that, there’s noway to determine whether the person using theassigned ID is sti l l al ive. (Maybe in the future,ORCID wil l be able to read all the obits via Facebookand say, “case closed.”)

Starting in January, a number of large publishersand some grant funding organizations (e.g. , PLOS,Science, IEEE, and the Wellcome Trust) beganrequiring authors and grant applicants to includetheir ORCID ID, along with their name.

I f your name is Dostoyevsky, none of this probablymatters very much. But for the rest of us, welcometo the information age. We’ve now been literal lyreduced to a number.

RESOURCES:• Sign up for ORCID ID here: https://orcid.org/signin• SCOPUS Author ID:http: //www.info.sciverse.com/scopus/scopus-in-detai l/tools/authoridentifier (Scopus Author IDintegrates with ORCID)

• ResearcherID: https://www.researchgate.net/

Brain Candy

REBECCA J ANDERSON, PhD, is a freelancemedical 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. Andersonmanaged research and development projects fortwenty-five years in the pharmaceutical/biotech industry. Sheholds a PhD 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 richculture and heritage. She can be reached atrebeccanderson@msn.com.

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IMRAD Has a Design Flaw

At a recent Science of Writing seminar, I started thesession the way I always do. I ask my participantshow they read research articles. Hands down, theanswer is “I read the abstract, then if it’s interesting, Ifl ip to the figures.” My more stalwart participantsread the abstract, then dig into the methods section.However they read, though, it’s never a start-to-finishapproach.

In writing circles, we’re encouraged to study thegenres that we plan to write. Novelists read novels.Poets read poetry. Screenwriters read screenplays.I t’s a proven method. No novelist would skip around.No poet would read only the first and third l ines. Theform follows the function.

In medical and scientific publications, IMRAD is theform. Yet IMRAD (Introduction, Methods, Research,and Discussion—or AIMRAD, if you add theAbstract) does not del iver information the wayreaders consume it. IMRAD has a design flaw.My seminars stress the importance of reader-centered writing. I spend the day teaching bright,motivated people how to embrace the IRMAD formand to view research articles as written works. And Ihave been trying to get them to read the articles, tostudy the form. Perhaps I ’m approaching this fromthe wrong angle.

At the risk of sounding obvious, we’ve changed theway we communicate about everything. We don’twrite letters any more. TV is watched on demand.

Radio is del ivered via satel l ite. Emails shifted to IMs,which shifted further to texts and tweets. Everythingis customized and fast. And yet the way thatinformation is presented in the medical and scientificl iterature hasn’t evolved in more than a century.That said, medical researchers have been in front ofthe curve in how they consume information. Huntingand pecking within the IMRAD form is not a new wayto read the academic l iterature. Reading istransactional. Reading is modular.

How is it that IMRAD persists when even its writerswon’t be its readers? For those of us who promotequality scientific writing, we might be focusing on thewrong skil lset—or the wrong medium. I wonderwhen and how we wil l completely transform the waywe present research narratives. I f we want what l iesahead to be well-written and scientifical ly rigorous,we better act fast. The consumers already knowwhat they want.

PraxisBy Hope J Lafferty, AM, ELS, AMWA Southeast Chapter Member

HOPE J LAFFERTY, AM, ELS, has run her writingand training consultancy, Hope LaffertyCommunications, since 2009. Over her career,she has worked as a writer in radio, high tech,engineering, instructional design, and medicalresearch. Hope completed certificates in medical

writing and editing from AMWA and the University of Chicagoand in training from the Association for Talent Development.She serves as AMWAAnnual Conference Chair-Elect andPresident-Elect of the Board of Editors in the Life Sciences(BELS). When she’s not webcasting, podcasting, or otherwisemodeling good writing practice, she takes road trips with hermusician husband and comedian dog. Connect with Hope athope@hopelafferty.com.

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

In scientific publication, the phrase scientificmisconduct has major connotations. Recent studieshave found that an average of 2% of scientistsadmitted to having fabricated, falsified or modifieddata or results at least once – a serious form ofmisconduct by any standard – and up to 34%admitted other questionable research practices. Insurveys asking about the behavior of col leagues,admission rates were 1 4% for falsification, and up to72% for other questionable research practices.2

Although inadequate record keeping, for example, isnot a form of misconduct in itself, it could permitmisconduct to occur and make investigations ofmisconduct difficult to conduct. None of thedefinitions of scientific misconduct include honesterror or differences in interpretation.

Fabrication, Falsification, and Omission areforms of misrepresentation in scientific publication.Fabrication includes stating or presenting afalsehood and making up data, results, or "facts"that do not exist. Falsification includes manipulationof materials or processes, changing data or results,or altering the graphic display of data or digitalimages in a manner that results inmisrepresentation. Omission is the act ofdel iberately not reporting certain information for adesired outcome.

Misappropriation: Plagiarism and Breaches ofConfidentiality. Misappropriation includesplagiarism and breaches of confidential ity during theprivi leged review of a manuscript. In plagiarism, anauthor documents or reports ideas of another as hisor her own without giving appropriate credit.Plagiarism of published work violates standards ofhonesty and collegial trust and may also violatecopyright law (if the violation is shown to be legallyactionable). The best defense against al legations ofplagiarism is careful note taking, record keeping,and documentation of al l data observed and sourcesused.

Editorial Policy and Procedures for Detectingand Handling Allegations ofScientificMisconduct. Detection of scientific misconduct inpublishing is often the result of the alertness ofcoworkers and/or other authors of the samemanuscript, and much less commonly observed byeditors, peer reviewers, or readers. I f an al legationof scientific misconduct is made in relation to amanuscript under consideration or published, theeditor has a duty to ensure confidential and timelypursuit of that al legation. According to theInternational Committee of Medical Journal Editors(ICMJE),3 “If substantial doubts arise about thehonesty and integrity of work, either submitted orpublished, it is the editor's responsibility to ensurethat the question is appropriately pursued, ” but theeditor is not responsible for conducting theinvestigation. An editor's first step after receiving anallegation of falsified, fabricated, or plagiarized workpublished in her or his journal is to considercontacting the corresponding author, depending onthe circumstances, to request an explanation whilemaintaining confidential ity.

Retractions, Expressions ofConcern. Afterreceiving confirmation from the author or authorsand/or a report from the author's institution or otheragency indicating that fabrication, falsification, orplagiarism has occurred, the journal should promptlypublish a retraction. Preferably this retraction wil l bea signed letter from the corresponding author and allcoauthors. I f none of the authors wil l agree topublish a signed retraction, the editor may requestsuch a retraction from the investigating institution, orthe editor may issue a retraction on behalf of thejournal.

When an article is retracted, the original articleshould not be physical ly removed from a journal 'swebsite or other onl ine archival publication. TheNational Library of Medicine does not remove thecitation of a retracted article; the citation is updated

Pollution of Science and Medicine by Scientific Misconduct

A recent article in the Mayo Clinic Proceedings highl ights the problem of questionable practices that may be“polluting” the scientific l iterature. 1 The problems discussed in the article include “predatory journals” and otherfactors that pollute the l iterature. The AMA Manual of Style is a useful resource that both defines andhighl ights some of the potential questionable practices, as well as provides some published controversialquotes from famous authors/editors.

We should ignore whining about the supposedly awful pressures of "publish orperish" when we have little credible evidence on what motivates misconduct, noron what motivates the conduct of honest, equally stressed colleagues. Laziness,desire for fame, greed, and an inability to distinguish right from wrong are just aslikely to be at the root of the problem.

Drummond Rennie

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to indicate that the article has been retracted, andl inks between the original citation and the citation tothe retraction notice are added. Retractions mayalso be used for articles that are seriously andpervasively flawed because of honest error that isnot a result of fabrication, falsification, or plagiarism.

Allegations Involving Manuscripts UnderEditorial Consideration. In the case of amanuscript under consideration that is not yetpublished in which fabrication, falsification, orplagiarism is suspected, the editor should ask thecorresponding author for a written explanation. I f anexplanation is not provided or is unsatisfactory, theeditor should contact the author's institutionalauthority (ie, dean, director, ethical conduct/researchintegrity officer) or governmental agency withjurisdiction to investigate al legations of scientificmisconduct to request an investigation. In al l suchcommunications with authors and institutionalauthorities, the editor should take care to maintainconfidential ity.

See pages 1 55-1 68 in the AMA Manual of Style 1 0th

edition for additional information.

Acknowledgement: Thanks are due to Ajay Malik,PhD, for editorial input.

References1 . Caplan, A.L. (201 5) The problem of Publication-

Pollution Denial ism. Mayo Clin Proc. 90(5):565-566;Available at:http: //www.mayoclinicproceedings.org/article/S0025-61 96(1 5)001 90-1 /ful ltext

2. Fanell i , D. (2009) How Many Scientists Fabricate andFalsify Research? A Systematic Review and Meta-Analysis of Survey Data. PLoS ONE. 4(5):e5738;Available at:http: //www.ncbi.nlm.nih.gov/pubmed/?term=Daniele+Fanell i++falsify+plos

3. Available at: http: //www.icmje.org/

DIKRAN TOROSER, PhD, CMPP, a memberof the AMWA Pacific Southwest chapter, is aregular contributor to the Postscripts

magazine since 201 2. He developed themonthly AMA-zing Style column whichcovers topics from the AMA Manual of Style,and has also written on publication-relatedtopics in these pages. Dikran is currently a Senior MedicalWriting Manager at Amgen Inc. in Thousand Oaks, California.He earned his PhD in Biochemistry from Newcastle University(UK), and did his postdoctoral training in biochemical geneticsat the John Innes Center of the Cambridge Laboratory(Norwich, UK) and in molecular biology with the USDA. Prior toAmgen, Dikran was on the faculty (research) at the School ofPharmacy at the University of Southern California. He can bereached at dtoroser@amgen.com.

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Latest Research About Medical Writing Support in PublicationsMarissa Romero-Acuña, BS, AMWA Pacific Southwest Chapter Member

Last month, Donna Simcoe, the Past-President ofthe AMWA Pacific Southwest Chapter, organized theChapter’s monthly teleconference on May 6th. Thetopic for discussion was the role of the medicalwriter in publication development in biotech andpharma setting. With the ISMPP annual meetingheld in Apri l , this was a good time to review the roleof and challenges faced by medical writers.

The teleconference included discussion on thefol lowing items:

• Challenges faced by medical writers- Many! An online survey evaluating themedical writer’s day-to-day challenges1

showed that only 50% of the medical writer’sdaily work is dedicated to writing. Some of thechallenges reported by medical writersincluded unclear requirements from theircl ients (20%), frequent changes made to thescope of work by clients (1 9%), ad hocrequests (1 7%), working with "difficult people”(24%), multiple iterations (22%), col latingcomments from multiple reviewers (20%), andtask prioritization/management of timelines(1 3%). During the teleconference, cal lersagreed that training medial writers in projectmanagement skil ls wil l help in improvingoveral l project efficiency.

• Online survey regarding the role of medicalwriters2

- Most authors gave medical writers high scoreson “editorial assistance” (84%), “knowledgeabout manuscript submission procedures”(77%), and author/review project management(69%).Also, authors gave medical writers a score of 5on a 6-point scale for the development ofpublications, suggesting that most authorsappreciate the medical writer’s role.

• Acknowledgment of medical writing support inpublications- According to Good Publications Practices(GPP3) guidel ines, medical writers should beacknowledged as authors when they meet theICMJE criteria. However, if that is not thecase, their participation should beacknowledged avoiding the appearance of“ghostwriting” in peer-reviewed publications.GPP3 states that medical writers may assistauthors in the preparation of peer-reviewedpublications with accurate and clear findings,avoiding misleading messages, and assist withevolving transparency guidel ines.

• Acknowledgment of the role of medical writer –a survey- A medical consulting company based in theUK3 surveyed PubMed open access l iteraturefor Phase 3 clinical studies conducted between2004 and 201 5, and assessedacknowledgment statements for reporting perGPP3 recommendations (medical writer’sname, qualification, company, and any third-party medical writing support). They stratifiedtheir findings by the years the GPP guidel ineswere published: first GPP guidel ines (2003),GPP2 (2009), and GPP3 (201 5). The surveyfound that of 41 9 publications (59% of whichwere industry-sponsored), 38% of thepublications from the pre-GPP3 periodacknowledged the role of medical writercompared to 67% of publications in the post-GPP3 period. Although, room for improvementwas identified, the Chapter teleconferenceattendees agreed that with further awarenessof the GPP3 publications guidel ines, theacknowledgment of medical writers’ role isexpected to rise further.

Acknowledgment: Many thanks to Ajay Malik forcomments and editing the early draft.

References1 . Makhija M, Semwal S, Sinha S. A day in the l ifeof a professional medical writer: An online survey-based study. Curr Med Res Opin. 201 6; 32

2. Makhija D, Karanam AK, Vishwakarma S, MittraS, Ford J. Understanding authors’ attitudesregarding the role of professional medical writers:An online survey-based study. Curr Med ResOpin. 201 6; 32

3. El jamel S,Page S. Are we there yet? Doescurrent practice in acknowledging professionalmedical writing support meet the requirements ofGPP3? Curr Med ResOpin. 201 6;32

MARISSA ROMERO-ACUNA has 1 5 years of experienceworking in Regulatory Affairs and Quality Assurance in biotech.Since 201 4, she has been working with medical writerssupporting everything from creation of documention templatesconsistent with ICH guidel ines, creating style guides andSOPs, EndNote and referencing support for publication writers,and providing writing and editorial support. Marissa attendedthe last 2 annual AMWA conferences and is very much involvedwith the local Chapter. She can be reached via LinkedIn:https://www. l inkedin.com/in/marissa-romero-7b54b3b

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My Road to Toastmasters*Bernard Delacruz, PhD, AMWA Pacific Southwest Chapter Member

What is Toastmasters?

First, Toastmasters International (TI) is an 80-year-old organization made up of hundreds of clubsaround the United States and the world. I ts sharedmission is "\ to provide a mutually supportive andpositive learning environment in which everyindividual member has the opportunity to developoral communication and leadership skills, which inturn foster self-confidence and personal growth. "Second, Toastmasters is the organization thathelped me make the transition from scientist toscience communicator.

My road to Toastmasters started in college in thelate 1 980s. While learning to speak in publicsounded like a good idea at the time, I was going tobe a scientist, I would work in the lab, and speakingskil ls would be something I could learn later. In2006, after nearly two decades as anundergraduate, then as a grad student, then as apost-doc in biology, I left the lab bench. Now what?

I lucked out. My first non-bench job was a medicalwriter at a hospital. I thought if I understood science,then I could communicate science. Foolish me. Oneof my tasks was to prepare talks from journal articlesfor different audiences. This was because whatscientists need to know from a paper is differentfrom what patient groups need, which is differentfrom what medical students need—and I am not yetincluding translating jargon!

While working as a medical writer, I started visiting aToastmasters club run by the grad students. Myintention was to write better talks for laypeople. Ireal ized I needed to communicate more effectivelyto everyone. I sti l l didn't join at that time althoughthey let me visit as often as I wanted. Only when thejob ended did I decide it was time to join a clubformally and focus on speaking skil ls.

How does Toastmasters work?

Over the decades, TI has designed a programbased around speech manuals. The first manual isCompetent Communication. In it are ten projectsdesigned to teach you different aspects of givingprepared talks; for example, how to structure aspeech, how to use body language, and how to havea memorable message.

Even more important than giving speeches,however, are the speech evaluations. After eachspeech, a more advanced member gives youconstructive feedback. Evaluations let you knowwhat you did well and what you can improve onand—as stated in the TI mission statement—this isal l done in "a mutually supportive and positivelearning environment. " Also, you learn not just fromthe evaluations you receive, but also from theevaluations others receive. Every speaker—even anexperienced speaker—has something they canimprove on. Eventual ly, it becomes your turn toevaluate other members. Evaluating others meanslearning to give an impromptu speech. You mustl isten careful ly, organize your thoughts quickly, andgive useful advice in a supportive manner.

Furthermore, Toastmasters is not just for speaking.The TI motto is "Toastmasters. Where Leaders AreMade. " Volunteers drive Toastmasters clubs.Through the Competent Leadership manual, youcomplete projects to gain leadership experience; forexample, taking on roles during meetings, organizingclub events, and becoming a club officer. Also, asyou grow in the club, there are opportunities toparticipate at higher levels of Toastmasters. I t wasbeing an officer in my Toastmasters club that helpedme get my next job—at least in part. I volunteered tobe the Vice President of Public Relations and to setup and run the club website. This experienceprepared me, somewhat, for my next job, writingscientific product descriptions for an online catalog.That was a springboard to my current job thatincludes rewriting pages to make the companywebsite more accessible for non-technicalcustomers.

How can you get involved with Toastmasters?

I encourage you to take the first step today: find anearby club and visit it as soon as possible. Visit theToastmasters International website(www.toastmasters.org) and click on the Find a Clubl ink. You can search by zip code, distance, andday/time of the meeting. Most clubs have an email orphone number to contact; many clubs also have awebsite. Guests are welcome at most clubs. You canjust stop by or you may want to contact the clubahead of time to confirm the meeting. I also advisefolks to visit more than one club. There are manykinds of clubs. There are clubs associated withcompanies or with churches. There are clubs at

*Reprinted from: Postscripts. 201 2 Nov; 2(9):7-9

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schools and colleges, at community centers, even atrestaurants. I know of a club for atheists, a club forwine tasters, and a club for improv comedy! Mostclubs meet weekly but some specialty clubs maymeet less frequently. While each club has a differentpersonality and each club runs a little differently, asstated in the Toastmasters mission statement, al lclubs "provide a mutually supportive and positivelearning environment. "

Joining is easy and affordable. Every club wil l haveapplication forms or you can download one from theToastmasters International website. Presently, duesfor Toastmasters International are $36 for sixmonths, and there is a new member fee of $20 toget your first manuals. Additional ly, each club mayhave their own dues to cover club costs. Even better,if it is a company club, your company might coveryour fees. You can also join more than one club andtransfer to a new club if needed.

I f I had a time machine, I would go back and tel l mycollege self, "Join Toastmasters NOW. It wil l be themost bang-for-your-buck you wil l ever get!" I f youfind yourself tongue tied, remember this: everyone inthe club wil l have a story of walking into aToastmasters club for the first time. You can talkabout that.

BERNARD DELACRUZ, PhD, is a medical andtechincal writer with experience working in thebiopharma and medical device companies,including Medtronic, Bachem, and LifeTechnologies. He has passion for words andpublic speaking. He was awarded Toastmasters AdvancedLeader Bronze award and is past President of NarratorsToastmasters. He has been interviewed about scientist-as-communicators. Bernard holds a PhD in Cell & MolecularBiology from University of California San Diego. He currentlyresides in the San Fernando Valley area of Los Angeles,California, and can be reached atBernard.Delacruz@gmail .com or via LinkedIn:https://www. l inkedin.com/in/bjdelacruz

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News and Updates from the FDALamia Merabet, MS, MBA, AMWA Pacific Southwest Chapter Member

During the last two months, the FDA granted approval for novel treatments for rare disease indicationsincluding severe hepatic veno-occlusive disease (VOD), a chronic lymphocytic leukemia (CLL); andbreakthrough therapy designation for first-in-class targeted treatment for bladder cancer.

Defitelio

At the end of March, the FDA approved the first therapy for treatment of severe hepatic VOD, a rare and life-threatening l iver condition in which veins become blocked, causing swell ing and an internal blood flowdecrease, which may lead to l iver damage. In its most severe form, patients might also develop failure of thekidneys and lungs. Hepatic VOD can occur in patients who receive chemotherapy and a hematopoietic stemcell transplantation (HSCT). The efficacy of Defitel io (Jazz Pharmaceuticals) was evaluated in thetransplantation community through prospective cl inical trials where higher survival rates were reported.

Defitel io received an orphan drug designation, and the FDA granted its application priority review status.

Venclexta and Vysis FISH probe kit

In early Apri l , the agency granted approval to the first treatment for chronic lymphocytic leukemia (CLL) inpatients with a specific chromosomal abnormality. Venclexta (AbbVie Inc. and co-marketed with GenentechUSA Inc.) is the only agency-approved therapy for CLL patients who express the so-cal led 1 7p deletion.This targeted therapy inhibits the B-cell lymphoma 2 protein, which supports cancer cell growth and isoverexpressed in many patients with CLL. Venclexta is indicated for daily use after detection of 1 7p deletion isconfirmed through the use of the FDA-approved companion diagnostic Vysis FISH probe kit (AbbottMolecular). The FDA granted the Venclexta application breakthrough therapy designation, priority reviewstatus, and accelerated approval for this indication. An orphan drug designation was received.

Tecentriq and Ventana PD-L1 (SP142)

Tecentriq (Genentech) is approved by the FDA as a new, targeted treatment for the most common type ofbladder cancer, urothel ial carcinoma. In the last two years, FDA has been approving many in the broader classof PD-1 /PD-L1 targeted biologics. Tecentriq, a PD-1 /PD-L1 inhibitor, targets the PD-1 /PD-L1 pathway(proteins found on the body’s immune cells and some cancer cells), and might help the body’s immune systemfight cancer cells by blocking these interactions. While the safety and efficacy of Tecentriq were studied in acl inical trial , the greater effect was observed with treated patients who were classified as “positive” for PD-L1expression and thought to be more likely to respond to treatment with Tecentriq.

The FDA also approved the Ventana PD-L1 (SP1 42) (Ventana Medical Systems) assay complementarydiagnostic for Tecentriq. I t would detect PD-L1 protein expression levels on patients’ tumor-infi ltrating immunecells, and might help physicians determine which patients may benefit from treatment with Tecentriq.The FDA granted the Tecentriq application breakthrough therapy designation, priority review status, andaccelerated approval for this indication.

Voluntary recalls were issued by Well Care Compounding Pharmacy and Medtronic.

A few advisory committee meetings, as well as several other events have been scheduled for May, June,and July, as detai led below.

Selected FDA Announcements

AnnouncementDate

Well Care Compounding Pharmacy performed a voluntary statewide recall in Nevada on allunexpired steri le compound products due to the FDA’s concern over lack of steri l i ty assurance.The recall impacts al l steri le compounded products distributed between 01 /01 /201 6-04/29/201 6.Administration of a steri le drug product intended to be steri le that is compromised may result inserious and potential ly l ife-threatening infections or death. 1

05-1 7-1 6

Regulatory Intelligence

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Selected FDA Approvals

IndicationDrug Company

Inflectra (infl iximab-dyyb) is approved as a biosimilar notan interchangeable to Janssen Biotech, Inc. ’ Remicade(infl iximab), original ly l icensed in 1 998. Prescribed formultiple indications: active Crohn’s disease (adult andpediatrics), active ulcerative colitis, active rheumatoidarthritis, active ankylosing spondylitis, active psoriaticarthritis, chronic severe plaque psoriasis6

Inflectra® Celltrion, Inc. for Hospira

The FDA final ized a rule extending its authority to al l tobacco products, including e-cigarettes,cigars, hookah tobacco and pipe tobacco. Since the first Surgeon General’s report on Smokingand Health in 1 964, which warned Americans about the risks associated with smoking, significantprogress has been made to reduce smoking rates. In 2009, Congress took a historic step bypassing the bipartisan Family Smoking Prevention and Tobacco Control Act (TCA) giving the FDAauthority to regulate the manufacturing, distribution and marketing of tobacco products to protectthe public health. The TCA is implemented with the final ized rule, whereas new provisions aimedat restricting youth access, wil l go into effect in 90 days. All manufacturers, importers and/orretai lers of newly regulated tobacco products -not on the market as of Feb. 1 5, 2007- aresubjected to these requirements: registering to the FDA of manufacturing establishments andlisting products; reporting ingredients, and potential ly harmful constituents; requiring FDApremarket review and authorization of new tobacco products; placing health warnings on productpackages and advertisements; and not sel l ing modified risk tobacco products (including thosedescribed as “l ight”, “low” or “mild”) unless authorized by the FDA.2

05-05-1 6

A federal judge entered an order of permanent injunction between the United States and Paul W.Franck, a Florida drug manufacturer and distributor doing business as Franck’s Compounding Laband Trinity Care Solutions. The action was brought by the U.S. Department of Justice, on behalf ofthe FDA. According to the complaint fi led with the consent decree, Franck unlawful ly manufacturedand distributed adulterated and misbranded drug products. In 201 4, Trinity Care Solutions recalledal l steri le drugs and ceased compounding operations after an FDA’s inspection revealed violationsthat could compromise drug steri l ity. In 201 2, contaminated ophthalmic drugs compounded byFranck’s Compounding Lab were linked to eye infections, including temporary or permanent visionloss; subsequently, the company recalled al l steri le products, ceased operations, and received awarning letter from the agency.The order of permanent injunction prohibits Franck from manufacturing, holding and distributingsteri le drug products unti l he complies with the Federal Food, Drug and Cosmetic Act (FD&C Act)and its regulations, in addition to other requirements.3

04-29-1 6

The FDA announced a proposal to ban electrical stimulation devices (ESDs) used for self-injuriousor aggressive behavior because they present an unreasonable and substantial risk of i l lness orinjury to public health that cannot be corrected or el iminated through changes to the labeling. Theagency stands ready to work with health care providers to help facil itate safe transition to alternatecare for al l of those in need since the proposed rule, if final ized, would ultimately remove thesedevices from the marketplace completely. In making this determination, the FDA considered allavailable evidence, including cl inical and scientific data, input from experts in the field and stateagencies, comments from the Judge Rotenberg Educational Center (JRC) – the only one facil itythat is using these devices in the US, individuals and parents of individuals on whom ESDs havebeen used, and disabil ity rights group, as well as insights from an April 201 4 FDA advisory panel.The proposed rule is available onl ine for public comment for 30 days.4

04-22-1 6

Medtronic is notifying customers worldwide of a voluntary recall for the battery pack used in itsCovidien Oridion labeled CapnostreamTM20 and CapnostreamTM20p Patient Monitors.Capnostream monitors are external (non-implantable) medical devices used to assess patients’respiratory status and identify changes in breathing, which prescription is operated by trainedhealthcare professionals in a cl inical setting and in the home. This voluntary recall is beingconducted due to a battery manufacturing defect that may increase the risk of thermal damage inthe battery pack. The scope of this recall includes battery pack model numbers 01 6400 and01 0520 that were manufactured by a contract manufacturer between Apri l 201 4 and February201 6.5

04-20-1 6

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May & June 201 6 Advisory Committee Meetings

CommitteeDate

Meeting of the Antimicrobial Drugs Advisory Committee Meeting Announcement – Discussion ofthe Biologics License Application (BLA), submitted by Merck Sharpe & Dohme Corp.11

06/09/1 6

Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anestheticand Analgesic Drug Products Advisory Committee Meeting Announcement– Discussion ofresults from assessments of the extended-release and long-acting (ER/LA) Opioid AnalgesicsREMS (Risk Evaluation and Mitigation Strategies). 1 4

05/03-04/1 6

First FDA-approved leadless pacemaker to teat heartrhythm disorders. Micra is intended for patients withatrial fibri l lation or other dangerous arrhythmias, such asbradycardia-tachycardia syndrome.1 0

Micra®

TranscatheterPacing System

Medtronic

WEBLINKS

• For additional information on approvals, including labeling revisions, tentative approvals, efficacy supplements withsupporting cl inical data, manufacturing changes or additions, or chemistry; new strength, seehttp: //www.fda.gov/NewsEvents/Newsroom/default.htm

• For additional information on recalls, market withdrawals, and safety alerts, seehttp: //www.fda.gov/Safety/Recalls/default.htm

June & July 201 6 Conferences, Workshops and Public Meetings

Third Annual Drug Discovery and Development Symposium for Pulmonary Hypertension. 1 507/11 -1 2/1 6

TitleDate

Circulatory System Devices Panel of the Medical Devices Advisory Committee MeetingAnnouncement – Discussion, recommendations and vote on information related to thepremarket approval application submitted by St. Jude Medical. 1 2

05/24/1 6

Fifth annual FDA-ISPE Quality Conference.1 906/05-08/1 6

First FDA-approved drug to treat hal lucinations anddelusions associated with Parkinson’s disease.7

Nuplazid® Acadia Pharmaceuticals Inc.

Vaccines and Related Biological Products Advisory Committee Meeting Announcement –Discussion of updates of the research program in the Laboratory of Bacterial Polysaccharides,Division of Bacterial , Parasitic, and Allergenic Products, Center for Biologics Evaluation andResearch, FDA.1 3

05/11 /1 6

First FDA-approved generic version of Crestor(rosuvastatin calcium) tablets with diet observance fortreatment of hypertriglyceridemia and primarydysbetal ipoproteinemia, and either alone or incombination with other cholesterol treatment for adultpatients with homozygous famil ialhypercholesterolemia.8

Crestor® Watson Pharmaceuticals

DEVICES

Cobas® ZikaTest

Teva PharmaceuticalsThe FDA’s Center for Biologics Evaluation andResearch announced the availabi l ity of aninvestigational test to screen blood donations for Zikavirus. Used under an Investigational New Drugapplication (IND), it might help protecting the nation’ssupply of blood and blood components during theoutbreaks.9

The FDA and co-sponsor American Association for Cancer Research (AACR) are announcing apublic workshop entitled “Liquid Biopsies in Oncology Drug and Device Development”. 1 6

06/1 9/1 6

The FDA, in co-sponsorship with the American Association for Cancer Research (AACR), isannouncing a public workshop entitled “Oncology Dose Finding Workshop”. 1 7

06/1 3/1 6

Public Meeting: Over-the-Counter Monograph User Fees.1 806/1 0/1 6

POSTSCRIPTS | VOL 6, NO. 44 | JUNE 201 6 1 00

• For information on current drug shortages, see http: //www.accessdata.fda.gov/scripts/drugshortages/default.cfm• For information on drugs to be discontinued, see http: //www.accessdata.fda.gov/scripts/drugshortages/default.cfm• For Orange Book drug product l ist additions or deletions, see

http: //www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm

1http: //www.fda.gov/Safety/Recalls/ucm501 543.htm2http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm499234.htm3http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm498447.htm4http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm4971 94.htm5http: //www.fda.gov/Safety/Recalls/ucm497035.htm6http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm7http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm498442.htm8http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm498373.htm9http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm493081 .htm1 0http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm49441 7.htm11http: //www.fda.gov/AdvisoryCommittees/Calendar/ucm496386.htm1 2http: //www.fda.gov/AdvisoryCommittees/Calendar/ucm495808.htm1 3http: //www.fda.gov/AdvisoryCommittees/Calendar/ucm491 263.htm1 4http: //www.fda.gov/AdvisoryCommittees/Calendar/ucm490628.htm1 5http: //www.fda.gov/Drugs/NewsEvents/ucm489693.htm1 6http: //www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm49461 0.htm1 7http: //www.fda.gov/Drugs/NewsEvents/ucm492762.htm1 8http: //www.fda.gov/Drugs/NewsEvents/ucm499390.htm1 9http: //www.fda.gov/Drugs/NewsEvents/ucm482626.htm

LAMIA MERABET, BS, MS, MBA, is a member of the AMWA PacificSouthwest chapter and a Postscripts columnist on regulatory trends. Shenarrated several networking events and discussions including “To Borrowa Page from the Freelancers Book.” Lamia is a Quality and Regulatoryprofessional at Arianne Corp. handling international projects ondiagnostics and pharmaceutical compounds. Her career spans the fieldsof cl inical research, medical writing, safety reporting, post-marketsurveil lance, and regulatory compliance in pharma and medical devices. She earned herMS in Clinical Pharmacology from Henri Poincaré University (Nancy, France), and herMBA in Healthcare Administration from National University (San Diego, California). Atthe San Diego Regulatory Affairs Network (SDRAN) Program Committee, shebroadcasts keynote speakers. She can be reached atLamiaMerabetProBono@gmail .com and via LinkedInhttps://www. l inkedin.com/in/lamiamerabetcl inicaltrialfda

1 01 POSTSCRIPTS | VOL 6, NO. 44 | JUNE 201 6

Creating the Future of Clinical Trials Today: How Mobile Technologiesand Telemedicine will Radically Transform Clinical TrialsRoberta Alexander, PharmD, PhD, Exagen Diagnostics, Inc, Vista, Calif.

SAN DIEGO, May 9th, 201 6

The San Diego Clinical Research Network (SDCRN)(http: //thecl inicalresearchconnection.com/) and theSan Diego Regulatory Affairs Network (SDRAN)(http: //www.sdran.org/) came together to discussways to uti l ize telemedicine and mobile technologiesin cl inical research. Speakers were Dr. Kevin Bruhnfrom Science 37 (https://www.science37.com/) andKim Tyrrel l-Knott, a partner at the law firm ofEpstein, Becker & Green (http: //www.ebglaw.com/).The event was moderated by Dr. Brad Pruitt fromParallel 6 (http: //www.paral lel6.com/) and took placeat BD (formerly Carefusion) in San Diego. Manymembers of SDCRN and SDRAN attended, inaddition to others interested in cl inical research anddigital medicine.

PATIENT RECRUITMENT AND ENGAGEMENT INCLINICAL RESEARCHDr. Kevin Bruhn of Science 37

It is definitely an exciting time to use mobiletechnology in cl inical research to reach morepatients and keep them engaged. In fact, although90% of patients say that they would l ike toparticipate in a cl inical trial , only 3% actual ly do.Many patients l ive too far away from a site, don’tknow that a study is even going on, or maybe theylack trust and education about cl inical research.Patient recruitment suffers, and time and costs goup. I t takes 6 to 9 years to do the necessary trials toget a new drug approved, and clinical trials accountfor approximately 40% of the total budget of drug

development. In addition, lengthy cl inical studiesleave less and less time for patent protection.Science 37 aims to streamline cl inical trials bydecentral izing them and facil itating virtualinteractions between the patient and the investigator.Science 37 uses a unique platform called NORA(Network-Oriented Research Assistant) thatfunctions as electronic medical record storage anddatabase for data collection and management.Patients can interact with NORA via an app and stayengaged throughout the trial , without theinconvenience of traditional site visits. They caninteract with the investigator and study coordinatorvia the app, have blood draws and other lab testsdone at any local lab, and non-special izedassessments can be done by a local physician.Science 37 acts as a metasite to coordinate protocolapproval through a central IRB, patient recruitment,and study implementation via a network of localphysicians and nurses and via the use of mobiledevices that keep the patient at the center of thestudy. This setup allows them to reach a greaternumber of patients in al l geographical areas and ofal l racial backgrounds, increasing the enrol lment ofminorities in the study. Science 37 was founded byNoah Craft in 201 4, and has already collaboratedwith sponsors and CROs on several trials in varioustherapeutic areas. So far, their focus has been ononcology, dermatology, and rare diseases, wheretraditional patient recruitment is particularly slow.Science 37 has helped to accelerate studies and cutcosts, and has established collaborations withvarious organizations, including Genentech, HarvardClinical Research Institute, and Los AngelesBiomedical Research Institute, among others.

Dr. Teresa Gallagher of SDCRN

Dr. Kevin Bruhn

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ROBERTA VEZZAALEXANDER, PharmD, PhD,is the Associate Director of Clinical Researchand Medical Affairs at Exagen Diagnostics, Inc.where she designs and oversees theCompany’s cl inical studies. Dr. Alexandertransitioned recently in the diagnostics space, as she spentmost of her career in drug discovery working in thepharmaceutical industry. She holds a PharmD and a PhD fromthe University of Perugia, I taly, and came to the USA for apostdoctoral fel lowship at the University of Pennsylvania. Shehas been living in San Diego with her husband since leavingPhiladelphia, and loves to walk on the beautiful beaches ofSouthern California. She can be reached via LinkedIn:www. l inkedin.com/in/robertavalexander/

THE REGULATORY FRAMEWORK IN THE ERAOF TELEMEDICINEKim Tyrrel l-Knott of Epstein, Becker & Green

Clinical research, either done in a traditional way, ordone using modern technologies l ike thoseimplemented by Science 37, is highly regulated.Good clinical practices, patient rights, privacy laws,rules by the department of Health & Human Services(HHS) and other federal or state laws, al l regulatecl inical research. From a digital health perspective,many changes are happening, and the FDA is takinga more liberal and risk-based approach. Overal l ,certain aspects of digital health are sti l l highlyregulated, while others are not regulated at al l . Agood example of an unregulated technology is theFitBit: lots of people have one, and each collects lotsof data, but how to use these data for a highlyregulated process l ike a clinical study, if the device

itself is not regulated at al l? Cybersecurity is also anissue with telemedicine for the FDA and otherentities. The Food and Drug Administration Safetyand Innovation Act (FDASIA) has drafted a guidancefor industry for the use of mobile medicalapplications. For example, cl inical decision-support(CDS) software are more or less regulated based onthe significance of the healthcare decision (eg,diagnose vs. treat disease) and on the severity ofthe condition. Overal l , data acquired viatelemedicine and mobile devices need to beregulated in ways similar to data acquired in moretraditional ways, avoiding the risk of subjecting newtechnologies to higher standards!

SDCRN and SDRAN are each planning otherexciting events throughout the summer, and we lookforward to the networking opportunities and thelearning experience!

Kim Tyrrel l-Knott

http: //www.diaglobal.org/DIA201 6

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Malini Vashishtha - IrvineLeslie Bruce - La Jolla

Garima Chaudhry - Foothill RanchKathleen Wood - San DiegoVanita Gupta - Los Angeles

Miranda Rindlisbacher - Mesa, AZ

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

Email : member-coordinator@amwa-pacsw.org

AMWA Pacific Southwest Chapter WarmlyWelcomes Our New Members

http: //www.amwa.org/conference

POSTSCRIPTS | VOL 6, NO. 44 | JUNE 201 6 1 04

Upcoming Chapter Events

AMWA Pacific Southwest Chapter Lunch (Monthly) TeleconferenceOccurs First Friday of the month, 1 2-1 PM Pacific time

Hosted by Donna Simcoe, Past President of the ChapterDial in number: 706-91 3-11 55Participant code: 02041 57# (or from your iPhone: 706-91 3-11 55,02041 57#)

Saturday, June 11 - Lunch Presentation:Regulatory Operations Update for Medical Writers

Are you interested in learning more about current regulatory operations and best practices for medicalwriters? Regulatory operations work is an important part of the process for submission ofdocuments and drug data to regulatory agencies worldwide, and includes work with electronicdocument management systems (EDMSs) and document templates. On Saturday, June 11 pleasejoin us for an educational lunch presentation given by Antoinette Azevedo, an independentconsultant who has extensive experience advising l ife sciences companies on solutions forregulatory publishing and document management.

In this presentation, Antoinette wil l describe the latest eCTD mandates from the FDA, thestandardizing of content through template use, and best practices for MS Word and conversions toPDF.

Location: Carlsbad by the Sea, 2855 Carlsbad Blvd, Carlsbad, CA 92008

Agenda:11 :30am-1 2:00pm: Registration1 2:00pm-1 2:30pm: Lunch (a catered lunch wil l be provided)1 2:30pm-1 2:45pm: AMWA chapter announcements1 2:45pm-2:30pm: Presentation

Cost: $25 AMWAmembers, $30 non-AMWA guestsDeadline for registration or cancellation is June 6, 201 6.

Wednesday, June 22, 201 6 at 5:30 pm - 7:30 pm, Happy Hour in San Diego!Please join the AMWA Pacific Southwest chapter for good food, drinks, and conversation! With anexpansive outdoor area and beautiful views, Bella Vista Social Club & Caffé is the perfect place tochat with colleagues and enjoy the fresh summer air.

Where: Bella Vista Social Club & Caffé, 2880 Torrey Pines Scenic Drive, La Jolla(858) 534-9624

Hosted by: The AMWA Pacific Southwest ChapterRSVP: Brea Midthune, secretary@amwa-pacsw.org or Elise Sudbeck, treasurer@amwa-pacsw.org

Notes: AMWA-PacSW wil l provide some appetizers.Pay for your own drinks.Happy hour specials, 4-7 PM.Non-AMWAmembers welcome!

Save the Date! September 201 6AMWA Pacific Southwest's 201 6 Annual Medical Writers' Toolbox Symposium

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What's Happening at AMWA National

AMWA 201 6 Medical Writing & Communication ConferenceREGISTRATION NOW OPEN!

Be a Super Saver. Save $1 00 on if you register by June 30. (And an extra $25 off Saturday workshops)www.amwa.org/conference

New this year – Workshops wil l be held before and after the general conference activities. Note: BODmeeting wil l be on Saturday, so there may be a confl ict there, but otherwise workshops do not confl ictwith general sessions or networking events.

CORE ReferenceAMWA partnered with EMWA to create the CORE Reference, a user manual to help medical writersnavigate relevant guidel ines as they create cl inical study report (CSR) content.http: //www.amwa.org/core

AMWA Online LearningOur catalog of onl ine learning activities continues to grow with more coming this month! Interactive, self-guided online learning includes:

• The Role of the Regulatory Writer• Drug Development Essentials: Regulatory Documents for Developing Clinical Studies and ReportingClinical Data

• Drug Development Essentials: Regulatory Documents for Getting a Drug to Market and MonitoringSafety

• Ten Characteristics of Effective Tables and Graphs• Harness the Power of EndNote: Manage Your Library's Data

Find these activities, archived recordings of AMWA Live Webinars, Pocket Trainings, and more in AMWAOnline Learning at www.amwa.org/onl ine_learning.

Live Webinars – upcoming webinars in June:

June 1 5, 201 6Unlock the Secrets to Freelance Success: Bad Behaviors That Can Sabotage Your Businesshttp: //www.amwa.org/calendar_day.asp?date=6/1 5/201 6&event=1 602

September 8, 201 6Unlock the Secrets to Freelance Success: Getting the Clients You Deservehttp: //www.amwa.org/calendar_day.asp?date=9/8/201 6&event=1 599

Visit the AMWA Event Calendar (http: //www.amwa.org/calendar_list.asp) for a ful l l ist of upcoming events.

MWC –Next exam administration, October 6, 201 6 in Denver, CO, in conjunction with the Medical Writing &Communication Conference. Application information at: http: //www.amwa.org/mwc_apply

Essential Skills packagePurchase all 7 Self-Study Workbooks and earn the AMWA Essential Skil ls certificate at your own pace.Certificate enrol lment is included. http: //www.amwa.org/es_express

Package sale price: $950 member/$1 ,250 nonmemberES Express Package offers over 25% in savings!

POSTSCRIPTS | VOL 6, NO. 44 | JUNE 201 6 1 06

Medical WriterGreenkey Resources recruiting for undisclosed company in Arizonahttp: //www.greenkeyllc.com/jobs/1 34677/pharmaceutical/medical-writer/arizona-az/?utm_source=Indeed&utm_medium=organic&utm_campaign=Indeed

Medical WriterAmbry Genetics, Aliso Viejo, CAhttp://job-openings.monster.com/monster/83c1 3884-1 eac-4a76-b667-722f79fe578f?mescoid=2700440001 001 &jobPosition=8

Medical Writer, Senior ManagerAvanir Pharmaceuticals, Inc, Aliso Viejo, CAhttp://chm.tbe.taleo.net/chm04/ats/careers/requisition. jsp?org=AVANIR3&cws=1 &rid=81 4&source=indeed.com

Medical Writer - Promotional ActivitiesArbor Scientia, Carlsbad, CAhttp://jobview.monster.com/Medical-Writer-Promotional-Activities-Job-Carlsbad-CA-US-1 6224841 3.aspx?mescoid=2700440001 001 &jobPosition=9

Grant WriterTargazyme, Inc, Carlsbad, CAhttp://jobview.monster.com/Grant-Writer-Job-Carlsbad-CA-US-1 681 32527.aspx?mescoid=2700440001 001 &jobPosition=8

Scientific WriterCity of Hope, Duarte, CAhttp://job-openings.monster.com/monster/594c0047-5695-45a5-98d8-f233d6f9c533?mescoid=2700440001 001 &jobPosition=1 7

Director, Medical WritingAtara Biotherapeutics, Los Angeles, CAhttp://app. jobvite.com/CompanyJobs/Careers.aspx?k=Job&c=qk0aVfw9&j=o7CS1 fwm&s=Indeed

Medical Content & Scientific WriterInsyght Interactive, Inc, Los Angeles, CAhttp://job-openings.monster.com/monster/798b9be6-665b-478c-adb5-7e1 566fd7700?mescoid=2700440001 001 &jobPosition=1 2#

Scientific Writer IPublic Health Institute, Monrovia, CAhttps://www.phi. jobs/postings/361 9

Medical Writer/Senior Medical WriterAdvanced Clinical, San Diego, CARecruiting for undisclosed company in San Diego, CAhttp://jobview.monster.com/med-writer-sr-med-writer-job-san-diego-ca-us-1 6751 7834.aspx?mescoid=2700440001 001 &jobPosition=7

Principal Medical WriterHalozyme, San Diego, CAhttp://job-openings.monster.com/monster/a68811 91 -7a82-43a2-8969-d020637591 54?mescoid=2700440001 001 &jobPosition=1 2

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

Employment Coordinator, AMWA Pacific Southwest Chapter

Career Corner

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Lead Medical WriterNuVasive, San Diego, CAhttps://nuvasive.avature.net/careers/JobDetail/Lead-Medical-Writer/321 ?source=Indeed

Manager, Marketing CommunicationsTandem Diabetes Care, San Diego, CAhttps://tandemdiabetescare-openhire.si lkroad.com/epostings/index.cfm?fuseaction=app.dspjob&jobid=1 321 &company_id=1 6293&version=1 &jobBoardId=111 2

Medical WriterTocagen Inc, San Diego, CAhttp://www.biospace.com/jobs/job-l isting/medical-writer-352509

Medical Writer (part-time)Recruiting for undisclosed company in San Diego, CAMorgan McCormick of Aerotek: mmccormi@aerotek.com

Senior Medical WriterPrecision for Medicine, Inc, Santa Ana, CAhttp://chp.tbe.taleo.net/chp01 /ats/careers/requisition. jsp?org=PRECISIONFORMEDICINE&cws=39&rid=567&source=Indeed.com

Medical Writing ManagerAmgen, Thousand Oak, CAhttp://careers.amgen.com/job-en/6537661 /medical-writing-mgr-thousand-oaks-ca/?aasi=2&codes=JB_Indeed

Regulatory Writing Senior ManagerAmgen, Thousand Oak, CAhttp://www.biospace.com/jobs/job-l isting/regulatory-writing-sr-mgr-357405

Scientific Communications, Senior ManagerAmgen, Thousand Oak, CAhttp://careers.amgen.com/job-en/642881 0/scientific-communications-sr-mgr-thousand-oaks-ca/

Medical Communication Manager (2-year contract)Hart Employment Services recruiting for Amgen, Thousand Oak, CAhttp://hartjobs.com/careers/?cjobid=HS938238527&rpid=1 6202

Senior Medical Writer - RemoteMMS Holdings Inc, Thousand Oaks, CAhttp://mmsholdingsinc.applytojob.com/apply/job_201 603241 95943_2AWKLUK7SF9W1 7VR/Senior-Medical-Writer-Remote?source=INDE

***If you want to share job leads with the members of the Pacific Southwest Chapter, please

contact Sharyn at employment-coordinator@amwa-pacsw.org.

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Backpage

Viva la Vida by Frida Kahlo

Frida Kahlo - Viva la Vida, Watermelons. 1 954. Oil and masonite on canvas

Frida Kahlo de Rivera was a Mexican painter famous for self portraits, depictionof Mexican culture and heritage, and feminism. Her personal l ife was ful l ofstruggles, starting from polio at the age of 6, that left her left leg thinner than theother; a near-death experience in a bus accident at age 1 8 that left her bed-ridden for months, robbing her of her abil ity to bear children; and an anxietydisorder. She was married to Diego Rivera, also a famous Mexican artist.Besides her strong identity as a Mexican, she also embraced her father'sGerman Lutheran heritage by becoming fluent in German. In 2001 , shebecaame the first hispanic woman to be honored on the US postage stamp. Herl ife has been a subject of books, musicals, and music albums.

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