Official publication of the American Medical Writers Association Pacific Southwest Chapter

AMWAPacificSouthwestChapter

May2016

Postscripts

Volume VI Issue 43May 201 6

POSTSCRIPTS

IN THIS ISSUE:

• Reading Like a Reader

• Jellyfish Diapers

• Digital Health and Internet of Things

• Ownership and Control of Data

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, andbrowse past issues for style and type of articles published. Wewelcome 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, PhDmembership-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

BannerPhotoArtbyChipReuben,www.photoartwindows.com/Redphonebooth.ByPetrKratochvil,publicdomainpictures.n

et

© Chip Reuben 2008

66 POSTSCRIPTS | VOL 6, NO. 43 | MAY 201 6

POSTSCRIPTSMay 201 6 | Volume 6, No.43

COVER:

Bryce Canyon National Park, Utah. By DeeAnn Visk. 201 6.

POSTSCRIPTS | VOL 6, NO. 43 | MAY 201 6 67

• From the President's Desk — Susan Vintilla-Friedman, MWC . . . . . . . . . . . . .• Editor's Desk: Digital Health and Internet of Things — Ajay KMalik, PhD . . . . .

FEATURES

• Jel lyfish Diapers — Rebecca J. Anderson, PhD . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• Praxis: Reading Like a Reader—Hope J Lafferty, AM, ELS. . . . . . . . . . . . . . . . . .

MEDICAL COMMUNICATIONS, PUBLICATION PLANNING

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

FREELANCE

• To Borrow a Page From the Freelancers Book— Lamia Merabet, MS, MBA . . .

CAREER

• Biotech Connection Los Angeles’ Bioscience Career Connections— Lisa Charles, MPH . . . . . . . . . . . . . . . . . . .

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

DEPARTMENTS

• New Members . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .• Chapter Upcoming Events Calendar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .• Backpage: Limerick . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ACKNOWLEDGEMENT

Many thanks to Clare Prendergast, MA (Norton Thoracic Institute, Phoenix, Arizona)for copyediting and proofreading this issue.

© Chip Reuben 2008In this issue. . .

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From the President's Desk

One of the many benefits of living in California is how much thestate has to offer – for example, we have two large and thrivingAMWA chapters. The AMWA Pacific Coast Conference in SanFrancisco last month was a success and a great opportunity toconnect with our Northern California members. Thanks inparticular to Caren Rickhoff and Arushi Shinha for all their hardwork putting it together, and to our own chapter members whoshared their expertise in the early planning stages. As a reminder,our current plan is to present the conference here in San Diego inthe spring of 2017. These conferences are special events becausethey include workshops for credit along with presentations andnetworking opportunities. If you are interested in helping us planthe event please do contact me at president@amwa-pacsw.org.

Our May issue begins with an amusing invention (biomaterial fromjellyfish) and ends with a limerick, and includes lots of usefulinformation in between. Hope Lafferty examines the importance ofcritical reading for writers, and Dikran Toroser discusses datasharing and modern implications for ownership and public access.Two of our writers report on recent meetings of interest -- LisaCharles reviews a career fair hosted by Biotech Connection LosAngeles at the University of Southern California, and LamiaMerabet recaps our April Pacific Southwest Chapter teleconferenceon starting a medical writing business. (This is a topic of suchdirect interest to our members that we are hoping to continue thediscussion soon as a chapter presentation.) Sharyn Batey alsoprovides an update of open positions for medical writers that havebeen posted recently.

We are excited to welcome a new member to our chapterleadership: Garima Chaudhry, who will be helping us withoutreach efforts in the Thousand Oaks and North Los Angeles area.Our chapter is committed to providing member events to serve ourwidely distributed geographic area, which is a challenge, so we areinterested in hearing your ideas for events. We are always open tonew ideas, including digital outreach and the more traditional get-togethers at the local pub!

Happy Memorial Day (coming soon)

Susan

Susan Vintilla-Friedman, MWCPresident, AMWA Pacific Southwest Chapter

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EDITOR'S desk

Digital Health and theInternet of Things

Jel lyfish may lack brains but, as Rebecca Andersonpoints out (page 71 of this issue), they are excellentmaterial for making high-tech diapers. Now imagineincorporating a few sensors in that diapercommunicating with an app on a smartphone. Whatyou end up with is a medical device to preventdiaper rash with the brains of an app managing thissystem. This is how digital medicine is slowlyintegrating into our l ives, one diaper at a time. Suchadvances raise a lot of questions, for example, isthis connected diaper now a medical device thatwarrants regulation by the Food and DrugAdministration (FDA)? How is the FDA handling thisclass of software and web-connected products? Tolearn about this, let’s pay a visit to the FDA andreview the current landscape.

The mission of the FDA is to "protect" and "advance”public health. The FDA protects public health byensuring safety, efficacy, and security of medicalinterventions (ie, drugs and devices), food supply,cosmetics, and radiation-emitting devices andproducts; "protecting" public health also involvesoversight of manufacturing and supply chain ofdrugs, devices and tobacco products. FDAadvances public health by approving new drugs anddevices based on the weight of safety and efficacyevidence.

Software as a Device: The 1 976 Medical DevicesAmendment to the Federal Food, Drug andCosmetics Act grants the FDA authority to regulatesoftware. As the amendment's name suggests, thisauthority is exercised by the FDA's Center forDevices and Radiological Health (CDRH). Theapplication process for CDRH review of a newdevice fol lows a risk-based classification system:

• Class I devices: low or no risk (eg, tonguedepressors, etc)

• Class I I devices: moderate risk or well understooddevices (heart-rate monitors, scanning devices,etc)

• Class I I I devices: high risk (eg, pacemakers,catheters, knee replacements, etc)

Historical ly, software has been reviewed under themedical device data systems (MDDS) category andacross all 3 classes, depending on the claims andintended use.

Device Review and Approval Pathways:1 . 51 0(k) pathway: I f a class I I device can claim"substantial equivalence" to a predicate device(ie, preexisting device on the market), it can citethe predicate device's cumulative safety andefficacy experience, based on which the FDA maygrant 51 0(k) premarket notification al lowingmarketing of the device.

2. PMA pathway: A class I I I device or a class I Idevice without a predicate must provide stand-alone safety and efficacy data for FDA review.The FDA grants premarket approval (PMA) forthese devices, al lowing the sponsor to market thedevice.

3. de novo pathway: The sponsor can requestreclassification of any new device that lacks apredicate to class I or class I I based on claimsand perceived risks.

The FDA Confronts the Tsunami of Digital HealthProductsWith several thousands of health apps already inapp stores and an impending tsunami of wearablesand connected devices, the digital health cork hasleft the champagne bottle. But the FDA has done amarvelous job of steering itself ahead of the curve.Most notable is the FDA's Enforcement Discretion(ie, no FDA action)—the FDA chose not to subjectseveral categories of health apps and digitalhealthcare software to the established regulatoryregime, paving the way for further innovation and, asthe FDA's own mission states, promoting publichealth. The FDA in 2011 also released a MobileMedical Apps Guidance document (updated in 201 5)that clarified its position as fol lows:

• Medical apps wil l be regulated as medical devicesbased on claims made and informed risks.

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Sources

1. Brennan Z. FDA Collaborates with FTC on mobile health App regulatory tool. Regulatory Focus. 2016, Apr 5.Available via www. raps. org

2. Brennan Z. EU looks to improve data quality in mHealth Apps. Regulatory Focus. 2016, Jan 25. Available viawww. raps. org

3. Brennan Z. FDA accepts for review first NDA for a ' digital' medicine. Regulatory Focus. 2016, Jan 25. Availablevia www. raps. org

4. Croft J. The internet of things keeps one step ahead of the law. Financial Times. 2015, Jan 27. Available at:https: //next. ft. com/content/59f93954-851d-11e4-ab4e-00144feabdc0

5. Chui M, Loffler M, Roberts R. The internet of things. McKinsey&Company. 2010 Mar. Available at:http: //www. mckinsey. com/industries/high-tech/our-insights/the-internet-of-things

6. Elenko E, Speier A, Zohar D. A regulatory framework emerges for digital medicine. Nature Biotech. 2015Jul; 33(7) : 697-702

7. FDA' s mission statement. http: //www. fda. gov/AboutFDA/WhatWeDo/default. htm8. Murray S. How the internet of things can speed up health delivery. Financial Times. 2015, Apr 6. Available at:

http: //www. ft. com/intl/cms/s/0/8ad4d226¬bdcc¬11e4¬8cf3¬00144feab7de. html

70 POSTSCRIPTS | VOL 6, NO. 43 | MAY 201 6

• Mobile platform (eg, Android, iOS, BB, etc) wil l notbe subject to regulation.

• MDDS has been down-classified from class I I I toclass I . Thus, most health software wil l not besubject to regulation.

• Software making general wellness claims wil l notbe subject to regulation. (The FDA has issuedanother guidance "General wellness: Policy forlow risk devices" on this topic.)

• Key determinant for regulatory review is “Wil l thepatient be harmed if the software fails?”

Across the pond, the UK and European Union havealso published guidance documents. The UK’sguidance states that words, such as, detects,measures, or diagnoses wil l trigger a need forregulatory review and obtaining CE mark beforemarketing.

The Internet of Things (IoT) and Clinical DecisionSupport (CDS) SoftwareOur jel lyfish diaper with sensors and apps is one tinypeek into the world of the IoT. Simply put, the IoT isa physical device with sensors that col lects andtransmits medical information. Here again the FDA isalmost in step with the advances in technology. LastJuly, the FDA cleared an ingestible sensor designedto measure drug adherence outside a hospitalsetting. The sensor, made by Proteus Digital Health,Redwood City, California, can be incorporated in apil l and transmits data over WiFi to l inked computersin a doctor's office. So, there is now a precedent forregulatory pathway for IoT-based products.

However, the regulatory pathway for CDS is sti l l aconstruction zone. CDS combines electronic healthrecords and Health IT infrastructure (neither of whichrequires regulatory review) with medical devices and

the IoT that may fal l under the regulatory umbrella.Together this architecture promises to aid inproviding diagnostic and medical decisions with l ittleor no clinician input. This system definitely needsFDA oversight, as the risk of software/system failurehas major consequences for a patient's health. TheFDA plans to issue guidance on CDS in near future.

The IoT and CDS have brought forth new issues:privacy concers and data sharing. While privacyissues are beyond the scope of this discussion, readDikran's article on page 74 on data sharing, thoughin a different context.

Our Generation's Steam EngineThe FDA's support and guidance so far haveprovided a strong tai lwind for innovation in digitalhealth and the IoT. These are the steam engines ofour generation that wil l transform health delivery, justas the introduction of penici l l in transformedhealthcare nearly 1 00 years ago. Digital health wil lnot be cheap, but we wil l find a way to pay for it(! ) orjust innovate our way to cheaper and better options.One thing is clear though; we are privi leged to begiven a front-row seat and experience the drama ofthis technological revolution as it unfolds. As medicalwriters, we can write the first books on thisrevolution.

—Ajay K Malik, PhD

Jellyfish DiapersBy Rebecca J. Anderson, PhD, AMWA Pacific Southwest Chapter Member

Researchers at Tel Aviv University have come upwith a way, in a single stroke, to solve two annoyingproblems: sl imy jel lyfish and smelly diapers. Fewpeople have anything nice to say about jel lyfish. Forthe most part, they are simply stinger-studded sl imethat harass unsuspecting swimmers and destroy fishnets, clog cooling equipment, and disable powerplants, among other things.

Smelly diapers are also annoying (and bad for theenvironment). In the US alone, 27.4 bil l iondisposable diapers are dumped into landfi l ls eachyear, accounting for more than 3.4 mil l ion tons ofwaste. That’s a lot of potty poo. In addition, those“single-use” diapers are made from durablepetrochemicals (ie, plastics) and outl ive their cl ientsby 500 years.

Can you imagine the conclusions that 24th centuryarcheologists wil l draw from these unearthedartifacts? Future museums wil l exhibit rel ics from anancient civi l ization whose ritual istic ceremoniescentered on preserving precious bits of mummifiedexcreta in individual protective wrappers that werepacked in huge pits for some unknown cosmic orholy purpose. Chemical analysis of the droppingswil l reveal that the population subsisted largely on adiet of milk and pureed vegetables.

But back to the jel lyfish. Jel lyfish are no friends ofthe environment either. These creatures with “nobrain” thrive in overfished oceans with risingtemperatures and acidified waters. They competewith bigger fish, whales and smarter creatures withbrains for food—jellyfish not only prey on creatureshigher in the evolutionary tree, but also feed on fishand plankton, further marginal izing ocean mammals.

I t turns out that those sl imy creatures have spentmil l ions of years perfecting a tough but permeablemembrane that can trap liquid (up to 90 percent ofits body mass). Now, in a secret process, Israel iscientists have turned that jel ly-bio-sl ime into a dry,flexible, and strong material cal led Hydromash. I t’ssuperabsorbent and biodegradable—it disintegrateswithin a month! Throw in some nanoparticles forflexibi l ity, color, scents, and antibacterial properties,and voilà! You can make eco-friendly Hydromashproducts l ike medical sponges, paper towels, andtampons.

But the product that Cine’al, Ltd. (an Israeli start-upcompany) is most interested in developing is a bio-degradable diaper. Many applaud their efforts, but Ienvision a few speed bumps on the way to the store

shelf.

First, the preclinical safety studies. Have you evertried to slap a pad on the rump of a beagle ormonkey? Those animals (especial ly monkeys) wil lfind creative uses for Hydromash diapers that thescientists at Cine’al never dreamt of. Needless tosay, moisture absorbency wil l be only a small part ofthe diaper dataset.

Next, the cl inical trials. This is where investigatorswil l confirm whether the company’s secret processreally takes the stingers out of the jel lyfish material ,as they claim. Also, sel l-by date labels wil l be acritical issue for a product that disintegrates in 30days. And what would be the storage conditions?You certainly don’t want a Hydromash diaper to fal lapart when you’re hauling your kid in a car seat on abusy Saturday afternoon.

Regulatory approval, on the other hand, should be asnap, especial ly in countries wherepharmacoeconomics is a factor. There are too manyjel lyfish in the sea and too many Pampers inlandfi l ls. Harvesting jel lyfish wil l save governmentsmil l ions of dol lars in harbor cleanup costs, and at thesame time, the piles of dirty diapers in landfi l ls wil lbe drastical ly reduced.

However, marketing could sti l l be a problem. I t wil ltake a clever marketer, indeed, to convince mothersto swaddle their babies’ bottoms in a mush fromjel lyfish. Images of sl ime, stingers, and such arehard to overcome, no matter how much of a quicker-picker-upper it is. And, let’s not even get into adiscussion about Hydromash tampons.

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.

POSTSCRIPTS | VOL 6, NO. 43 | MAY 201 6 71

Reading Like a Reader

I t would seem obvious that a person with anadvanced degree would have read a lot during theiracademic career. Love of reading seemssynonymous with academic l ife. In fact, one of thefirst questions that I ask my coaching cl ients is “Whatdo you read?”

This question is typical ly met with a pregnant pause,then some stammering in an effort to answer thequestion and sti l l sound smart. Their responses varybetween novels, the newspaper, and lots of stuffonl ine. And of course academic articles.

From my clients’ responses, I guess they think this isa trick question. I t kind of is. In a publish-or-perishworld, reading seems less than important. Asecondary pursuit. A distraction even. As a youngwriter myself, I scoffed at the suggestion that Ineeded to read more. In my mind, I needed to writemore. Reading, I was good at. Writing, I needed topractice.

I have come to believe, though, that if I wanted toget good at writing, I indeed needed to read more.And not just any reading. I needed to read more inthe genre in which I intended to write. The samegoes for those who work as research scientists andmedical writers.

The good news is that my clients read a lot of theacademic l iterature in their field (on just how myclients read that writing, see next month’s column“IMRAD Has a Design Flaw”). The tragic news is thatthe writing that they are reading is not always wellwritten.

At the risk of declaring that the emperor has noclothes, not every journal has an editorialdepartment. So the quality of scientific writing—andhence its reading—varies widely. Manuscripts arejudged by their science and only receive writingcritique from the peer reviewers if the author is anobvious nonnative English speaker.

The published scientific l iterature has the power toreinforce writing conventions—good or bad,contemporary or outdated. So journals that have

editorial departments (New England Journal ofMedicine, The Lancet, and JAMA, to name a few)offer better writing. Journals that do not have aneditorial department or expect either the peerreviewers, the editorial board (of other scientists), orthe page designers (heavens!) to edit or at leastproofread the piece release poorer quality writinginto the published literature (I wil l not offer examplesof these because I prefer to protect the innocent).

Despite the quality of the writing, published articleswith compell ing science have built-in audiences. Andjust because something got published elevates it asan example of publishable writing, even if it’s not al lthat great. Nonwriters throughout the scientific worlduse these poorly written articles to support their workand the bad writing gets reinforced—andreplicated—without critique.

I do not suggest that we stop reading journals thatpublish less-than-spectacular writing. However, themore we read, the more we are able to judge goodwriting vs bad. And with more deliberateconsumption of writing, we can view our own writingas an audience member and perhaps improve ourwriting with the understanding of a reader.

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.

Data sharing is the practice of making researchdata available to other investigators, and has a longhistory in science. Transparency and openness areconsidered by many to be part of the scientificmethod. In l ight of the recent data sharingproposals1 by the International Committee ofMedical Journal Editors (ICMJE), the AMA Manualof Style (1 0th edition) is a useful resource toexamine relevant history and tradition in this area.

Intellectual Property: Ownership, Access Rights,andManagement. Intellectual property (IP) is alegal term for that which results from the creativeefforts of the mind and that which can be owned,and subject to competing claims. The AMA manualstates that 3 main topics in IP may be relevant:

i . copyright (the law protecting authorship andpublication),

i i . patent (the law protecting invention andtechnology), and

ii i . trademark (the law protecting words andsymbols used to identify goods and services inthe marketplace).

Ownership and Control ofData. The term propertyin scientific knowledge is not new, but recentadvances in medicine and economic factors havefueled disputes. Data in biomedical research areincreasingly complex and now include extremelylarge data-sets. Recent public sentiment hasincreasingly driven scientific data to become a“public good,” regardless of the source of funding1 ;eg, The NIH has a policy on data sharing statingthat "data should be made as widely and freelyavailable as possible while safeguarding the privacyof participants and protecting confidential andproprietary data. "

Ownership ofData. The NIH policy defines finalresearch data as "recorded factual materialcommonly accepted in the scientific community asnecessary to document, support, and validateresearch findings. " The NIH definition does notinclude summary statistics; rather, it pertains to thedata on which summary statistics are based. Inscientific research, 3 primary arenas exist forownership of data: the government, the commercialsector, and academic or private institutions orfoundations.

Any information produced by an office or employeeof the US federal government in the course of his orher employment is owned by the government. Data

produced by employees in the commercial sector(eg, a pharmaceutical, device, or biotechnologycompany) are most often governed by the legalrelationship between the employee and thecommercial employer, granting al l rights of dataownership and control to the employer.

Data Sharing, Storage and Risk. The notion thatdata should be shared with others for review,criticism, and replication is a fundamental tenet ofthe scientific enterprise. Sharing research dataencourages scientific inquiry, permits reanalyses,promotes new research, facil itates education andtraining of new researchers, permits creation of newdata sets when data from multiples sources arecombined, and helps maintain the integrity of thescientific record. Yet the practice of data sharing hasvaried widely, and it was not unti l relatively recentlythat guidel ines for data sharing were developed.2

Although data sharing is essential for research,significant costs and risks do exist. These includefinancial obstacles for data storage, loss ofacademic or financial reward; risk of exploitation bycompetitors; and breaches of confidential ity. Thepotential discovery of error is clearly beneficial , andfor research involving human subjects, processes tomaintain confidential ity for individual studyparticipants must be implemented. A number ofresearch sponsors and governmental agencies havedeveloped policies to encourage data sharing. Forexample, in 2003, the NIH began requiringinvestigators to include a “plan for data sharing” inal l grant applications requesting $500,000 or morein direct costs.

Data Sharing, Deposit, Access Requirements ofJournals. In 1 985, the US Committee on NationalStatistics released a report on data sharing thatcontinues to serve as a useful guide for authors andeditors. Among the recommendations, the fol lowinghave specific relevance for scientific publication.Data sharing should be a regular practice. Initialinvestigators should share their data by the time ofthe publication of initial major results of analyses ofthe data except in compell ing circumstances, andthey should share data relevant to public policy asquickly and as widely as possible. However, currentpolicies on data sharing for research institutions andfor scientific journals are highly variable.

Authors of scientific publications should anticipatewhich materials are l ikely to be requested andshould state in the "Materials and Methods" section

Ownership and Control of Data—A Rapid Evolution

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or elsewhere how to obtain them. Many scientificjournals (eg, Science, Nature) already requireauthors to submit large data-sets (eg, protein orDNA sequences, microarray or molecular structuredata) to approved, accessible databases and toprovide accession numbers as a condition ofpublication. I t is appropriate for authors and journalsto include links to public repositories for such data inthe Acknowledgment sections of articles.

Some journals have other conditions of publicationthat require authors to deposit specific informationabout their research in a public repository or archive,although this is not data sharing per se. Forexample, fol lowing the recommendations of ICMJE,3

biomedical journals that publish cl inical trials requireauthors to have registered their trials in approved,publicly accessible trial registries and to provideregistration identifiers as a condition of publication.

Manuscripts Based on the Same Data. An editormay receive 2 or more manuscripts based on thesame data (perhaps even with contradictoryinterpretations and conclusions). The editor shouldconsider each manuscript on its own merit (perhapsasking reviewers to examine the manuscriptssimultaneously). Authors should attempt to resolvedisputes over contradictory interpretations beforesubmission. However, publishing the competingmanuscripts with an explanatory editorial may allowreaders to see and understand both sides.

See pages 1 79 to 1 85 in the AMA Manual of Style1 0th edition for additional information.

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

References

1 . http: //www.icmje.org/news-and-editorials/M1 5-2928-PAP.pdf

2. https://www.researchgate.net/publication/23957381 8_An_International_Framework_to_Promote_Access_to_Data

3. http: //www.ncbi.nlm.nih.gov/pmc/articles/PMC31 42758/

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.

Biotech Connection Los Angeles’ Bioscience Career ConnectionsBy Lisa Charles, MPH

On April 1 9, 201 6, Biotech Connection Los Angeles (BCLA) hosted asuccessful career fair, Bioscience Career Connections, at the University ofSouthern California. This day-long event was a perfect balance ofworkshops, information sessions, and networking opportunities. I t wasattended by over 1 00 graduate students, postdocs, and youngprofessionals.

During the morning session, the two workshops on interviewing skil ls andresume writing/LinkedIn were led by Zach Marks, one of the cofounders ofOystir. Uti l izing his extensive expertise in streamlining the applicationmaterials for job candidates – especial ly the candidates with a PhD whoare seeking non-academic jobs - Zach provided up-to-date tips on how todevelop targeted resumes that are results-oriented. He also discussedhow to prepare for various types of interviews, whether they are on thephone, onl ine or in a group setting. Further, Zach provided valuableinsights on how to build a stel lar LinkedIn profi le that is readily accessibleto recruiters and which helps to foster professional connections. Theengaged audience participated in critiquing an elevator pitch, and theyraised questions about how to approach some of the tricky behavioralquestions that are asked during interviews.

The afternoon session was even more interactive. Attendees met withrecruiters from One Lambda, Kite Pharma, Episona, Gilead Sciences, andthe Keck Graduate Institute. This was a great opportunity to gain in-depthinformation about the companies and the types of candidates they werelooking for. Attendees also received valuable one-on-one resume editingsessions with the USC Career Center. The day ended with a networkingmixer in a relaxed atmosphere.

CAREER

LISA CHARLES, MPH is a science/health writing consultant. She uti l izes

her public health background and biomedical research experience to

develop educational, fundraising, and publicity-related content on a wide

variety of topics. These include disease states, global health, emergency

preparedness, water science research, and sustainabil ity. Her writing and

editing portfol io includes patient guidebooks, abstracts, sl ide and poster

presentations, articles, reports and press releases. Connect with Lisa at

l isaccharles@gmail .com

https://biotechconnection-losangeles.org/

Meeting Report

76 POSTSCRIPTS | VOL 6, NO. 43 | MAY 201 6

To Borrow a Page From the Freelancers BookLamia Merabet, MS, MBA, AMWA Pacific Southwest Chapter Member

On April 1 st, 201 6, an AMWA Pacific SouthwestChapter Lunch Teleconference was held. The themerevolved around starting one’s own medicalcommunication writing business. The Chapter’smonthly lunch teleconferences are organized by ourpast-president, Donna Simcoe, and are open to allmembers and non-members interested in medicalwriting.

The audience asked the fol lowing questions duringthe teleconference about how to start a medicalcommunication writing business:

• What is the nature of the services? What arethe areas of special ization?

• Which business structure is chosen mostoften, and why?

• What triggers the choice for a particularbusiness structure?

• How could the business evolve over time?• What are the associated costs?• What protection, insurance to contract?• How to build cl ientele?

Donna Simcoe strongly recommends collectingrelevant information from the Internet as well asattending entrepreneur-directed seminars (seereferences).

The array of business consulting structures,spanning from Sole Proprietorship, Partnerships (LPand GP), Limited Liabil ity Company (LLC) toCorporate, was further described through sharedexperiences. These business options are definedbelow, along with administrative steps to register thebusiness.

Sole Proprietorship. I t is set up to al low anindividual to own and operate a business. A soleproprietor has total control, receives all profits fromand is responsible for taxes and liabi l ities of thebusiness. When applicable, a Fictitious BusinessName Statement must be fi led with the countywhere the principal place of business is located. 1

The business is registered with the local Chamber ofCommerce, and assigned a D&B (D-U-N-S®Number, which stands for data universal numbersystem, which is a unique nine-digit identifier forbusinesses). I t is used to establish a business creditfi le.2

Limited Partnership (LP). Shares are defined andresponsibi l ities are attributed in an LP. A CaliforniaLP may provide l imited l iabi l ity for some partners.There must be at least one general partner who actsas the control l ing partner and one limited partner

whose liabi l ity is normally l imited to the amount ofcontrol or participation of the l imited partner.6

General Partnership (GP). A California GP musthave two or more persons engaged in a business forprofit where all partners are l iable jointly andseveral ly for al l obl igations of the partnership. Profitsare taxed as personal income for the partners.6

Limited Liability Company (LLC) allows owners toconcomitantly work at the company for non-competing activities. A California LLC general lyoffers l iabi l ity protection similar to that of acorporation but is taxed differently. Domestic LLCsmay be managed by one or more managers or oneor more members. In addition to fi l ing the applicabledocuments with the Secretary of State, an operatingagreement among the members as to the affairs ofthe LLC and the conduct of its business is required.6

Self-Corporation . A more structured organizationwould be to “incorporate” yourself. A Californiacorporation general ly is a legal entity which existsseparately from its owners. While normally l imitingthe owners from personal l iabi l ity, taxes are leviedon the corporation as well as on the shareholders.6

I t appears that the fiscal advantage is worth thecommitment in terms of time and effort to set it up.The business owner can eventual ly acceptshareholders and divide up the share, might payoneself as an employee, and has the obligation tocontribute to the Employment Disabil ity Department(EDD). All l isted employees of the business wouldreceive an Employee Identification Number fi ledthrough the Internal Revenue Service.

I t is noteworthy to consider switching a businessstructure from consulting or sole proprietorship to acorporation, bringing a new dynamic with potentialtax benefits.

Flexibi l ity is the key in addressing the clients’contracting request. While some prefer contractingwith an Independent or through a proprietorship orLLC, other cl ients may only do business with acontract organization.

The initial setup of the business is not onerous,considering working from home. The basicinvestment includes a good laptop, a phone, afunctional desk, and an ergonomic chair. Mostbusiness expenses are tax-deductibles, includingtravels and cost of uti l i ties. There are additionalcosts with regard to the business registration,accountant and legal counseling fees,teleconference memberships, and insurance.

POSTSCRIPTS | VOL 6, NO. 43 | MAY 201 6 77

LAMIA MERABET, BS, MS, MBA, is a Qualityand Regulatory professional at Arianne Corp. , aCRO in San Diego, California, where shehandles international projects in severallanguages. Her career spans clinical research inpharmaceuticals, post-market surveil lance, andregulatory compliance in medical devices. Sheearned her Master of Science in Clinical Pharmacology fromHenri Poincaré University (Nancy, France), and her MBA inHealthcare Administration from National University (SanDiego, California). She is currently preparing for an AMWACertificate in Regulatory Writing. She also volunteers for theSan Diego Regulatory Affairs Network (SDRAN) ProgramCommittee where she broadcasts keynote speakers onregulatory trends. She can be reached atlamiamerabetvolunteer@gmail .com.

Administrative tasks such as resource management,payrol l , accountancy, and tax-fi l ing are time-consuming and should be streamlined by using aservice provider. For instance, Bank of America wasrecommended at the teleconference for their Intuit®

system to manage the payrol l , to take care ofquarterly taxes, EDD, and Unemployment fi l ing for amonthly fee of $1 2. The business owner remains incharge of the 1 099 Form to reconcile, which can bedone using Quick Books.

The nature of the business is crucial in determiningthe need for a professional insurance that protectsany properties, assets, and the business itself for thebusiness owner and all potential legal partners.

The scope of the project, precedence of contracts,and collaborative history are factors that impact thedecision to contract an insurance. Clients mightrequest sub-contractors to be insured.

Building up the business appeals to soft ski l ls, socialpresence, and networking.

Tremendous experiences were shared oninvolvement in several organizations, committeesand chapters as were promoting and developinglong-term partnerships.

The visibi l ity of the business and its value is ensuredby advertising on social media/LinkedIn, posting onthe AMWA website, and by creating a professionalwebsite.

The demand for freelance and contract medicalwriters in Southern California is steady as a myriadof small companies would rather contract than hire apermanent staff in medical writing. A professionalwho is proactive, di l igent and involved, is increasingthe odds of success.

Resources and References:

1 . Alex Padil la California Secretary of State(http: //www.sos.ca.gov) to get a l isting on how tostart a business,

2. http: //www.dnb.com/duns-number.html

• Small Business Development Center(http: //sandiegosmallbiz.com)

• San Diego Regional Chamber of Commerce(http: //www.sdchamber.org) National Associationof Women Business Owners - San Diego Chapter(http: //www.nawbo-sd.org)

• SCORE: Service Corps Of Retired Executives asan opportunity for an advisory consultation(https://sandiego.score.org/chapters/score-san-diego)

• http: //www.oldtownsandiego.org/business-assistance-organizations .

• NOLO (http: //www.nolo.com), versed on legalaspects of a business

• GO-Biz: Governor’s Office of Business andEconomic Development (http: //business.ca.gov)

• Legal Shield (https://www. legalshield.com), legalservice for a monthly fee

Due to the high interest expressed on this topic, theAMWA Pacific Southwest chapter is considering aworkshop on how to start freelancing, in the fal l201 6.

78 POSTSCRIPTS | VOL 6, NO. 43 | MAY 201 6

Abhivyakti Sawarkar – Newbury ParkAdia Shy – Cerritos

Androulia Hadjikyriacou – Los AngelesCaroline Johnson – Los Angeles

David O’Keefe – La JollaDominik Wolf – San Diego

Fabiola Castro Alvear – Phoenix, AZJasmina Radoicic – La JollaJennifer Choi – Los AngelesLaurent Huyett – Goleta

Lynn Griggin – CarpinteriaMaria Dunton – Laverne

Megan Garlapow – Tempe, AZNaiYuan Wu – Taipei , TaiwanRachel Johnson – CarlsbadSamantha Jones – La JollaSherman Ho – Yorba LindaSmita Malhotra – Pasadena

Sophia Hourigan – Long BeachSrujal Parikh – Chandler, AZ

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

AMWA Pacific Southwest Chapter WarmlyWelcomes Our New Members

POSTSCRIPTS | VOL 6, NO. 43 | MAY 201 6 79

Medical WriterAmbry Genetics, Aliso Viejo, CAhttp://job-openings.monster.com/monster/83c1 3884-1 eac-4a76-b667722f79fe578f?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

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

Scientific Technical WriterAdecco, Irvine, CAhttp://job-openings.monster.com/monster/1 49752d5-ef8a-4ffd-a1 ea-b8d6b351 e066?mescoid=2700440001 001 &jobPosition=1 7

Associate Director, Clinical WritingPfizer, La Jolla, CAhttp://job-openings.monster.com/monster/f749c845-6f5d-40d4-8333-1 8f66d74b0b3?mescoid=11 00047001 001 &jobPosition=1 3

Scientific Writer IPublic Health Institute, Monrovia, CAhttps://www.phi. jobs/postings/3504

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

Senior Specialist, Scientific CommunicationsAbbott Laboratories Inc, Santa Ana, CAhttp://job-openings.monster.com/monster/70c7bbec-e6c5-4560-87c7-92e92fea2e5f?mescoid=2700440001 001 &jobPosition=1 0

Medical Writing ManagerAmgen, Thousand Oak, CAhttp://careers.amgen.com/job-en/6236808/medical-writing-mgr-thousand-oaks-ca/

Regulatory Writing, Senior ManagerAmgen, Thousand Oak, CAhttp://careers.amgen.com/job-en/61 89343/regulatory-writing-sr-mgr-thousand-oaks-ca/

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

Employment Coordinator, AMWA Pacific Southwest Chapter

Career Corner

80 POSTSCRIPTS | VOL 6, NO. 43 | MAY 201 6

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

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

Senior Medical WriterBoston Scientific, Valencia, CAhttp://job-openings.monster.com/monster/ee005a0b-b40b-4966-9b5d-88d800494d74?mescoid=2700440001 001 &jobPosition=1 4

Report CoordinatorCharles River Laboratories, Reno Nevadahttp: //job-openings.monster.com/monster/4c93bbaa-3eaa-4cd2-931 0-b1 0c4061 7c33?mescoid=1 5001 44001 001 &jobPosition=4

Medical WriterRecruiting for Undisclosed Company in San Diego AreaContact Laura Ciminera: Laura@elitesearchgroup.net

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

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

POSTSCRIPTS | VOL 6, NO. 43 | MAY 201 6 81

Upcoming Events Calendar

AMWA Pacific Southwest Chapter lunch (monthly) teleconference

Occurs First Friday of the month, 1 2-1 pm Pacific time

Dial in number: 706-91 3-11 55

Participant code: 02041 57# (or from your iPhone: 706-91 3-11 55,02041 57#)

Sunday, May 1 5: Brunch with the AMWA Pacific Southwest Chapter in OC!

Please join us for the AMWA Pacific Southwest Chapter’s inaugural Spring Brunch on May 1 5,

201 6 in Orange, CA to leisurely feast, connect and network with your fel low AMWA colleagues in

Orange County. Every Sunday, Chef’s Catering and Events hosts a special, themed buffet

brunch that showcases a different cuisine in their beautiful banquet room. Culinary themes have

ranged from Ital ian, French, Brazil ian, and Middle Eastern inspired brunch and lunch items so be

sure to bring your appetites and business cards! Vegetarian options are available as well .

Time: 1 0am-1 pm Location: Chef's Catering and Events

1 840 North Tustin Street, Orange, CA 9286 (Located across from Home Depot in a small

shopping center.) (71 4) 998-4890

Cost: $1 9.99/meal + tax and gratuity. Refreshments are available a la carte. Purchase meal

individual ly at event.

RSVP: Please contact event sponsor, Eileen Hoshino, at ELai06@gsb.columbia.edu by

Wednesday, May 11 .

Save the Date! Sunday, June 11 , 201 6

Are you interested in learning more about current regulatory operations and best practices

for medical writers? If so, please join us on Saturday, June 11 for an educational lunch

presentation given by Antoinette Azevedo.

In this presentation, Antoinette wil l describe the latest eCTD mandates from the FDA, the

standardizing of content through template use, and best practices for MS Word and conversions

to PDF.

Antoinette Azevedo is an independent consultant who has extensive experience advising l ife

sciences companies on solutions for regulatory publishing and document management.

More information and registration detai ls wil l be available soon.

Date: June 11 , 201 6

Time: 11 :30 am - 2:30 pm

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

Save the Date! September 201 6

AMWA Pacific Southwest's 201 6 Annual Medical Writers' Toolbox Symposium

82 POSTSCRIPTS | VOL 6, NO. 43 | MAY 201 6

POSTSCRIPTS | VOL 6, NO. 43 | MAY 201 6 83

Backpage

LimerickDo you know that May 12th is National Limerick Day?

I t was King Edward Lear who popularized l imericks in his Book of Nonsense. The National Limerick Day iscelebrated to honor King Lear, whose birthday fal ls on May 1 2, and is a good excuse to try your poetic tendencies.A limerick fol lows the rhyming scheme AABBA.

Readings

Wikipedia: Limerickhttp: //www. lear200.com/

84 POSTSCRIPTS | VOL 6, NO. 43 | MAY 201 6