postscripts v6 n40 _2016feb
DESCRIPTION
Monthly newsmagazine of the American Medical Writers Association (AMWA) Pacific Southwest ChapterTRANSCRIPT
Official publication of the American Medical Writers Association Pacific Southwest Chapter
AMWAPacificSouthwestChapter
February2016
Postscripts
Volume VI Issue 40February 201 6
POSTSCRIPTS
In this issue:
• NewChapter Leadership
• Rules ofGood Scientific Writing
• GPP3 Guidelines
• Pet Clinical Trials
• FDA and Precision Medicine
• KonMari Method
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 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 by Ajay Malik.
EDITORAjay K Malik, [email protected]
EDITOR-AT-LARGESusan Vinti l la-Friedman, [email protected]
AMWA Pacific Southwest ChapterLeadership —
PresidentSusan Vinti l la-Friedman, [email protected]
Immediate Past PresidentDonna Simcoe, MS, MS, MBA, [email protected]
TreasurerElise Sudbeck, [email protected]
SecretaryBrea Midthune, [email protected]
Arizona LiaisonAmy Van Gels, [email protected]
Membership CoordinatorGail Flores, [email protected]
Employment CoordinatorSharyn Batey, [email protected]
Outreach CoordinatorAsoka Banno, [email protected]
Website CoordinatorLaura J Cobb, [email protected]
Newsletter EditorAjay K Malik, [email protected]
AMWA Pacific Southwest Conference ChairsJacqueline A Dyck-Jones, PhD, MScJennifer Grodberg, PhD, RAC
Ban
ner
Photo
Art
byChip
Reu
ben
,www.photoartw
indows.co
m/Red
phonebooth.ByPetr
Krato
chvil,
publicd
omain
pictu
res.net
© Chip Reuben 2008
1 POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6
POSTSCRIPTSFebruary 201 6 | Volume 6, No.40
COVER:
"School Sign". By Emily Roesly (mesantic), Nuclear, Jersey. Emily's webpage: www.emilysimagery.comPicture source: http: //www.morguefi le.com/archive/display/994221 .Used under creative commons licence CC BY 2.0
POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6 2
• From the President's Desk — Susan Vintilla-Friedman, MWC . . . . . . . . . . . .• Editor's Desk: Gavel, Thin Mints and Goals — Ajay KMalik, PhD . . . . . . . . . .• AMWA Pacific Southwest Chapter: Changing of Guards . . . . . . . . . . . . . . . . . . . .• Letter to the Editor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Medical Communications, Publication Planning
• Some Rules of Good Scientifc Writing — Dmitry Budker, PhD . . . . . . . . . . . . . . .
• AMA-zing Style — the AMA Manual of Style Column— Dikran Toroser, PhD, CMPP . . . . . . . . . .
• Best Practices for Developing Figures and I l lustrations for Publications— Lycely Sepulveda, PhD . . . . . . . . . . . . . .
Clinical Research, Regulatory Science
• Pet Clinical Trials — Rebecca J. Anderson, PhD . . . . . . . . . . . . . . . . . . . . . . . . . . . .
• News and Updates from the FDA— Kokil Tandon, MBBS, MBA . . . . . . . . . . . . .
• Precision Medicine Initiative and Communicating Genetic Testing Results— Kokil Tandon, MBBS, MBA . . . . . . . . . . .
Meeting Reports
• AMWA Kicks Off the New Year with Leadership and Mentoring— Eileen Lai-Hoshino, MS, MPH, MBA
• AMWA Event: Successful Mentoring of Medical Writers (Pictures)• Medical Writing as a Career: A Panel Discussion at Sanford Burnham PrebysMedical Discovery Institute —Asoka Banno, PhD . . . . . . . . . . . . . . . . . . . . . . . . . . .
Work-Life Issues, Career
• Ask APRIL: Resolve to Never Tidy Again —April Reynolds, MS, ELS . . . . . . . . .
• Medical Writing Open Positions — Sharyn Batey, PharmD, MSPH . . . . . . . . . . . .
Departments
• Chapter Upcoming Events' Calendar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .• Backpage: Presidents, New Hampshire and Daniel Chester French . . . . . . . . . . .
© Chip Reuben 2008In this issue. . .
3466
7
8
1 0
1 21 3
1 9
2021
22
1 724
2325
From the President's Desk
First of all, let me say that I’m honored to become President of thisthriving chapter whose growth and success is due to its enthusiasticmembers and leadership, and especially to the amazing efforts ofthe current Past President, Donna Simcoe. As everyone knows, wewere very lucky to have Donna as our leader for the past two years,and we’re lucky to have her continuing in the chapter leadership.We’re also very grateful that she will continue to lead the highlyappreciated monthly chapter teleconferences at noon on the firstFriday of the month.
Thanks also to Ajay Malik for his devotion to the award-winningPostscripts, and for asking me to continue the tradition ofwritingan introduction. Our February issue leads with Dimity Budker’srules of good scientific writing, plus Dikran Toroser’s column onauthorship guidelines from the AMA Manual of Style and theGPP3 guidelines. It also includes an “infographic oninfographics,” Lycely Sepulveda’s article on developing figuresand illustrations; an explanation of the new world of petparticipation in clinical trials by Rebecca Anderson; our recurringcolumn on FDA updates from Kokil Tandon; some suggestions onusing the KonMari method of home organization by AprilReynolds; and a review of trends in precision medicine from KokilTandon. In addition, we have reviews of the January chapterevents in Northridge and the Sanford Burnham Prebys Institute byEileen Lai-Hoshino and Asoka Banno.
A note about our chapter communications – we are working onreplacing our current email system, which had the awkward habitof dropping members without notice to us. Our apologies for that,and be sure to let us know if this seems to be happening to you.
Please keep April 1 6 on your calendar for the AMWA Pacific CoastConference in downtown San Francisco. It is being planned by theNorthern California chapter as a one day event at the Park CentralHotel; more details to come soon. As our save the date email hasmentioned, it will include workshops, open sessions, andnetworking events, plus the chance to party in one of the world’smost beautiful cities.
I look forward to meeting as many of our members as possible inthe coming months, and please do drop me a line [email protected] if you have any questions orcomments, or just want to say hi. Have a great month everyone.
Susan
Susan Vintilla-Friedman, MWCPresident, AMWA Pacific Southwest Chapter
BackgroundimagebySandrinjaviamorguefi les.ImageURI:http://m
rg.bz/qe6UMN
3 POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6
EDITOR'S desk
Gavel, Thin Mints and Goals
Welcome to the first issue of Postscripts for 201 6.
Passing the Gavel
The AMWA Pacific Southwest Chapter begins theyear with the changing of the guard. During the lastChapter meeting in Simi Valley on January 1 6th, theoutgoing president, Donna Simcoe, presented theofficial presidential gavel to Susan Vinti l la-Friedmanmarking the beginning of Susan's term as the newChapter President (see page 6). Symbolically, therewas no better place to celebrate this transition thanin the shadow ofanother great president, RonaldReagan, whose library was just 20 minutes away ona hill to the west.
Enriching Members’ Experience
We have been fortunate to have Donna as ourpresident during the last 2 years. She helped growopportunities for peer-to-peer interactions betweenmedical writers in our region by developing newprograms and expanding existing ones. She startedthe monthly chapter teleconferences (where manynon-members have called in to test the waters),increased the frequency of happy hours,represented medical writing community at localuniversities’ career forums and brought in newspeakers for an ever-increasing number of events.Last year, over 500 attendees came to one or moreof these events (Postscripts, Dec 201 5, page 202),and many (who were not AMWAmembers) decidedto join AMWA.
Donna, a ranking member of the InternationalSociety for Medical Publication Professionals(ISMPP) kept us abreast with the latestdevelopments in the scientific research publishingand the publication planning world. With the passingof the gavel to Susan Vinti l la-Friedman, our Chapterremains in very good hands. Susan adds newperspective to the Chapter. She has been on variouseducational committees at Drug InformationAssociation (DIA) and AMWA National. Meanwhile,Donna wil l continue to be engaged with our chapteras the immediate Past President.
So we can report that the State of the Chapter isstrong and thriving as we continue our tradition ofproviding educational and networking opportunitiesfor medical writers in the Pacific Southwest region ofthe United States.
Thin Mints® and New Year Resolutions
January is also the month of another Americantradition, the Girl Scout Cookies. These yellow,green, pink or purple l ittle boxes are the sign of joyand excitement. The Thin Mints®, Samoas®,Tagalongs®, Trefoils® or Savannah Smiles® are morethan irresistible, del ightful flavors and smiles, theyare reminders of 5 skil ls (l isted on the side of eachbox) that girl scouts strive for:
1 . Goal Setting2. Decision Making3. Money Management4. People Skil ls5. Business Ethics
These are translatable skil ls for the medical writerworld—what fun it is to enjoy these delightful cookieflavors and be motivated to add these skil ls to theNew Year resolutions l ist!
Becoming a Better Writer
My top resolution for the year remains becoming abetter writer and editor with each passing month andeach passing year. Fortunately, there are severaltools available to work towards this goal (DecisionMaking): planning to attend local meetings andevents organized or sponsored by our Chapter, SanDiego Regulatory Affairs Network, and other localorganizations in your area; attending 1 or morenational level meeting (AMWA, ISMPP and DIA);working towards AMWA workshops/certificates; orthinking about certifications (MWC™, CMPP®, RAC®
and ELS®) are some of the ways to achieve thisgoal. Browsing the pages of Postscripts andreaching out to established members for advice,mentorship (see page 20 in this issue) and guidanceare other effective ways towards developing skil ls asa “better” writer.
Common Rules of Good Scientific Writing
Becoming a better writer starts with knowing the"obvious". On page 7 of this issue, we reprintCommon Rules ofGood Scientific Writing1 by DmitryBudker (Professor of Physics at UC Berkeley). Hisadvice on writing is part common-sense partre-educating what medical writers know all along.Here are a few:
• "When in doubt--cross it out."
1Budker D. Some rules of good scientific writing. arXiv:physics/0608246
POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6 4
• "The reader does not know what comes next."(ie, we must build a better story)
• "Avoid colloquial terms." (ie, let the jargon staywithin your shop)
• "Question each and every statement."• "Read the final (draft of) manuscript. " (self-editing is as important as writing)
The best advice, I felt, was “If you can abstain fromwriting – do not write!” Or, do not write a paragraphwhere a sentence would do. This is only possiblewhen a writer reads (and re-reads) draft of adocument, questions each and every statement, andbuilds a compell ing story.
(See complete l ist of Common Rules on page 7.)
People Skills
The fourth skil l , "People Skil ls" is as critical aswriting itself. A medical writer never works in avacuum. (Only writers of suspense novels do, whohide out in the villages ofMaine or disappear in thegreat state ofMontana, only to emerge with a novelfull of characters with complicated lives. ) Medicalwriters occupy the hub of people connectionscollaborating with cl inical investigators, authors,statisticians, and others in the corporate food chain.The issues of authorships, managing reviews, andmanaging timelines require more than steam-rol l inga project to meet publication goals. However,medical writers can use predefined (written)procedures and published guidel ines as tools tomanage “people issues”.
In this issue of Postscripts (page 8), Dikran Toroserprovides an update on recently updated GoodPublication Practice (GPP) guidel ines, known asGPP3, and guidance on authorship from the 1 0th
edition of AMA Manual ofStyle. While relying onpublished guidel ines (as indisputable verses fromBible), the human element wil l continue to remainmore challenging than the process of writing itself.
Outside cl inical research, the awareness of GPP3guidel ines or best practice guidances2 from ISMPPor AMWAmay be poor in the academia. However,academia is not al ien to these issue and theconversation is brewing in the ivory towers too, forexample, Budkar and Kimball (Nature. 21 Jan201 6;529:427-428) provide some notes of caution
and advice when working with collaborators. Since,medical writers often work with investigators andauthors from academia, raising the awareness ofcodified guidel ines (GPP3) and best practicesguidel ines (from professional medical writingorganizations) carry more weight in managing the"people" aspect of developing documents andmanuscripts.
A core part of “People Skil ls” is creating a Feng Suienvironment: how to be nice, how to manageexpectations, and how to get people to do work onyour schedule. A colleague once said, "Take atheater class". Something to consider this year.
AMWA Code of Ethics
The last skil l evokes "Ethics" that is a must in ourprofession and is the right thing to do. Awareness ofethical principles help us to be truthful andtransparent in our writing – this wil l not only help ourindustry be on the right side of the law, but also isthe right thing to do. The membership of AMWArequires us to accept 8 principles that constitute theAMWA Code of Ethics3. As we embark on anotheryear of working towards committing to our craft andhoning our skills, i t is a good time to pause, reviewand absorb the intent of the AMWA Code of Ethics inour work. The journey to becoming a better writercontinues.
—Ajay KMalik, PhD
2Best practice guideleins at AMWA (www.amwa.org) and ISMPP (www.ismpp.org) websites3AMWA Code of Ethics: http://www.amwa.org/amwa_ethics
The Thin Mints®, Samoas®, Tagalongs®, Trefoils® and Savannah Smiles® are the registered trademarksof Girl Scouts of America.MWC™, CMPP®, RAC® and ELS® credentials are awarded by AMWA, ISMPP, Regulatory Affairs ProfessionalsSociety and Board of Editors in Life Sciences, respectively.
5 POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6
AMWA Pacific Southwest Chapter: Changing of Guards
We welcome our new president, Susan Vinti l la-Friedman, MWC (right) andthank the outgoing president, Donna Simcoe, MS, MS, CMPP (left) for her
service to the Chapter. See pages 20 and 21 for the event report and pictures.
4 January 201 6
Editor, PostscriptsVia email
Dear Editor,
As one year ends and a new one starts, it appearsto be a universal habit for al l to review and renew, todetermine what is useful and what is superfluous,and how best to move ahead to make the new yearbetter.
In the spirit of such contemplation, I would l ike tothank you, as Editor, and all the contributing authorsfor providing such a fine journal. Being ratherattuned to the responsibi l ities of an editor, albeit nota managing one who actual ly gets the journal into
the hands of the membership, I want to especial lycommend you for your work. You are an unsunghero of the American Medical Writers Association(AMWA) and my wish for 201 6 is that moremembers recognize and appreciate the work thatyou do and that you are blessed with more high-quality submissions than you can use!
I sincerely hope that you wil l publ ish my letter.
Kind regards,
MaryAnn Foote, PhDAMWA Swanberg WinnerAMWA Golden Apple WinnerFormer AMWA National President
Letter to the Editor
POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6 6
PicturebyEileenLai-Hoshino
Editor's Note—Reprinted from arXiv preprint server with permission from Prof. Dmitry Budker, UC Berkeley.Read the original version at: http: //arxiv.org/abs/physics/0608246v3Cite as: Budker D. Some rules of good scientific writing. arXiv:physics/0608246(Version Dated: March 21 , 201 3)
I . INTRODUCTIONThere are many volumes written about technicalwriting, and I probably do not have too much originalmaterial to add to them. Yet, whenever a studentbrings me a draft of their first research paper, Iinvariably see an almost universal set of problems.Some of these probably stem from the way writing istaught at school. As an example, at school we aretaught to enrich our writing by avoiding repeating thesame term and using synonyms instead.Unfortunately, if one is writing a scientific paper,using different words for the same object could be adisaster.
Hoping that these notes wil l actual ly be read, let us,without further ado, present
I I . THE RULES
• A wise man said: “I f you can abstain from writing –do not write!”
• “When in doubt – cross it out. ” Try it; it real ly worksmiracles!
• The contents of a section should match its title.• An equation appearing in the text should never bepresented without comment, unless it is anintermediate step in a derivation.
• All “letters” (i .e. , variables and constants)appearing in equations should be explicitlydefined, even if seemingly obvious.
• All references, figures, tables, and equationsshould be numbered in order of appearance.
• Sentences cannot start with an abbreviation [e.g. ,Fig. 1 or Eq. (2)], or with “So” or “Also.”
• I t is usually better to use past indefinite tense, forexample “it was found” (as opposed to present orpast perfect – “it has or had been found”), unlessnecessary.
• Saying “This was demonstrated by J. Doe (1 905)”is correct, while saying “This was demonstrated inJ. Doe (1 905)” is not.
• Things to be compared shall be presented in asimilar manner (for example, on graphs with thesame scale).
• One should avoid self-praise, for example, sayingthat “interesting results were obtained.” I t shouldbe up to the reader to praise the work!
• The reader does not know what comes next in thepaper; consider what the reader should bethinking as they reach this particular point.
• Avoid colloquial terms, for example, “slam” in “Theprojecti le slams the target. ”
• Question each and every statement: is it actual lycorrect? Can you defend it?
• This one is a must: read the finished manuscript!
I I I . CONCLUSION
These rules are quite obvious and “common sense.”Yet, formulating them explicitly and keeping them inmind while writing could, hopeful ly, be useful. I t goeswithout saying, that as with most rules, there may beexceptions. Do we fol low our own advice? Judge foryourself by checking out some of the recentpublished work of our group athttp: //budker.berkeley.edu/.
Acknowledgment
I am grateful to al l of my present and and formerstudents and co-authors, and, particularly, to DerekF. Jackson Kimball (now a Professor at CaliforniaState University, East Bay) for making these rules soapparent.* Electronic address: [email protected]
Some Rules of Good Scientifc WritingBy Dmitry Budker, PhD1,*
1Department of Physics, University of California, Berkeley, CA 94720-7300
A non-native English speaking physics professor formulates obvious yet useful rules for writing research papers.
PACS numbers: 01.20.+x
7 POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6
AMA-zing Style — the AMA Manual of Style ColumnBy Dikran Toroser, PhD, CMPP, Amgen Inc. , Thousand Oaks, Calif.
The AMA manual summarizes and cites the ICMJEguidel ines as a foundation for policies andprocedures on authorship. ICMJE guidel ines arealso reviewed, revised, and updated regularly. Thefol lowing are some comparisons of authorshiprelated information from the AMA manual andGPP3.
• AMA Manual ofStyle—10th edition
Authorship Definition and Criteria. According tothe ICMJE guidel ines, al l authors should haveparticipated sufficiently in the work to be able to takepublic responsibi l ity for the content. Sufficient authorparticipation should include:
i . Substantial contribution to conception anddesign, or acquisition of data, or analysis andinterpretation of the data, and
ii . Drafting the manuscript or revising it critical lyfor important intel lectual content
i i i . Approval of the version of the manuscript tobe submitted/presented and
iv. Agreement to be accountable for al l aspectsof the work thereby ensuring that questionsrelated to the accuracy or integrity of any partof the work are appropriately resolved
To justify authorship, an author must meet each ofthe 4 criteria above. However, the term substantialcontribution has not yet been precisely defined.Many journals require attestation, in writing, on howauthors qualify for authorship and a description oftheir contributions to the work.
Guest and Ghost Authors must not be includedand should be eliminated from the byline.
Medical Writers. To give proper credit to medicalwriters and authors' editors, journal editors shouldrequire authors to identify al l persons who haveparticipated substantial ly in the writing or editing ofthe manuscript. Substantial editing or writingassistance should be disclosed at the time ofmanuscript submission and mentioned in theAcknowledgment.
Number of Authors—a complex history. Thenumber of authors whose names appear in thebyline of scientific papers has increased steadilyduring the second half of the 20th century—oftendue to multidiscipl inary collaborations andmulticenter organizations. Authorship inflation hasthe potential to “dilute” the meaning of authorshipand represents a dilemma—which authors on thebyline containing more than 1 00 names actual lywrote the paper?
In response to this problem, suggestions have oftenbeen made (during the 1 980s and 1 990s) to l imit thenumber of authors l isted in the byline and databasecitations. Interestingly, the present version of theAMA manual of style suggests that setting suchauthor l imitations and arbitrary l imits “may interferewith policies to encourage transparency ofauthorcontributions and thus are not justified. ”
Using the same rationale, MEDLINE/Pubmedremoved limits to the number of individual authors'names listed in an article's citation (see detai ledMEDLINE field descriptions at:https://www.nlm.nih.gov/bsd/mms/medlineelements.html#au).For ful l articles, JAMA does not l imit author number,as long as each author completes an authorshipform indicating specific contributions. For practicalreasons (eg, space), the names of authors may belisted at the end of the article or elsewhere within anarticle instead of in the byline at the beginning.
• GPP3 guidelines
These recently published guidel ines focus on the“principles of good publication practice for company-sponsored medical research” and are now endorsedby many medical journals, and contain significantguidance on authorship issues.2 GPP3 reflectschanges in the rapidly evolving medical publicationsenvironment—including regarding authorship.
GPP3 contains a useful 1 0-item summary (the so-cal led GPP commandments) many of which focuson authorship-related issues (see below.)
Authorship Perspectives from the AMA Manual and GPP3 Guidelines
The AMA manual of style is the industry standard for authors, editors and writersin medical and scientific publishing. Authorship related issues, which can becontroversial and sensitive, are immensely important in publication developmentand are accordingly given significant attention in the AMA manual. This articlesummarizes aspects of authorship-related information, with a historicalperspective, referencing the 1 0th edition of the AMA manual of style and otherimportant publication guidel ines. 1 , 2
POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6 8
Summary ofauthor-related principles ofGPP3for company-sponsoredmedical research
- The rights, roles, requirements, andresponsibilities of all contributors should beconfirmed in writing, ideally at the start of theresearch, before publication preparationbegins.
- All authors should have access to relevantaggregated study data and other informationrequired to understand and report researchfindings.
- The authors should take responsibility for theway in which research findings are presentedand published, be fully involved at all stages ofpublication and presentation development, andbe willing to take public responsibility for allaspects of the work.
- Author lists and contributorship statementsshould accurately reflect all substantialintellectual contributions to the research, dataanalyses, and publication or presentationdevelopment.
- All authors and contributors should disclose anyrelationships or potential competing interestsrelating to the research and its publication orpresentation.
Author-number and Order ofAuthors: Underqualification for authorship, the GPP3 guidel inesstate: “Priority should be given to the keycontributors who have the necessary background toanalyze or interpret the findings. ” Additional ly, theguidel ines state that authorship criteria should beapplied consistently. The guidel ines furthersummarize guidance in tabular format regardingnumber of authors: “8it would be unusual inbiomedical research (with few exceptions) to require>10 authors8Fewer authors are often preferable,and others can be acknowledged8”
As the GPP3 authors have implied, due to the rapidevolution of the publication field, there wil l always be“grey areas” which may become clearer withongoing research into publication practices. Withregards to author number considerations, it may beimportant to refer to both the AMA manual as well asGPP3 for guidance.
See pages 1 27 to 1 40 in the AMA Manual of Style1 0th edition, ICMJE1 and GPP32 for additionalinformation.
REFERENCES
1 . ICMJE authorship criteria.http: //www.icmje.org/recommendations/browse/roles-and-responsibi l ities/defining-the-role-of-authors-and-contributors.html.
2. Battisti et al (201 5) Good Publication Practicefor Communicating Company-Sponsored
Medical Research: GPP3. Ann Intern Med, 1 63,461
DIKRAN TOROSER, PhD, CMPP, amember of the AMWA Pacific Southwestchapter, is a regular contributor to thePostscripts magazine since 201 2. Hedeveloped the monthly AMAzing Stylecolumn which covers topics from theAMA Manual of Style, and has alsowritten on publication-related topics in these pages.Dikran is currently a Senior Medical Writing Manager atAmgen Inc. in Thousand Oaks, California. He earned hisPhD in Biochemistry from Newcastle University (UK),and did his post-doctoral training in biochemical geneticsat the John Innes Center of the Cambridge Laboratory(Norwich, UK) and in molecular biology with the USDA.Prior to Amgen, Dikran was on the faculty (research) atthe School of Pharmacy at the University of SouthernCalifornia. He can be reached at [email protected].
While at TIPPA meeting, join for a happy hour hosted by our chapter on Monday, February29th from 6 pm to 7:30 pm at The Cays Lounge in Loews Coronado Bay Resort.
(Pay for your own drinks). Al l are welcome.Address: 4000 Coronado Bay Road, San Diego, California, 9211 8. Phone: 61 9-424-4000
https://www. loewshotels.com/coronado-bay-resort/dining/lounge
9 POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6
continued on next page . . .
Summary prepared by Lycely Sepulveda, PhD
POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6 1 0
LYCELY SEPULVEDA, PhD, has over 20 years of biomedical communication experience in diverse higher educationinstitutions including Stanford University and UC Irvine. After completing her PhD in Microbiology from MichiganState University, Lycely applied her technical communication and management skil ls to lead multi-site andinternational Molecular Biology, Infectious Diseases and Biotechnology projects. Lycely plans to leverage her vastresearch, teaching, regulatory and executive experience to transition into the field of medical writing. Lycely enjoyshiking on the coastal Southern California trai ls with her family and she can be reached at lycely@gmail .com.
11 POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6
Pet Clinical TrialsBy Rebecca J. Anderson, PhD, AMWA Pacific Southwest Chapter Member
As dogs and cats become more like family members,veterinary medicine has also become increasinglyhuman-l ike. In the latest innovation, veterinarianshave joined forces with physicians to conduct drugtrials that wil l benefit both people and pets. We’renot talking about your garden variety toxicologytesting. In this paradigm shift, pet cats and dogs thathave a disease are being recruited just l ike humanexperimental subjects.
Now, when Fido is diagnosed, vets may offer him aslot in a drug trial , with the same sort of studyprotocol as a human trial . Just think about gettingFido’s paw print on the consent form. (And changingthat eighth grade reading level to dog years.)
I t can be a tough sell . Veterinarians must convinceFido’s owners to trust the health of their pet toinvestigators and an experimental drug. (Put“animals” and “experiment” in the same sentence,and you’l l probably trigger an anti-vivisection reflex.)But there are benefits. Besides access to apromising drug when a gut-wrenched family learnstheir beloved pet has an “incurable” disease,expenses are usually covered, just l ike human trials.
Doggy drug trials in oncology have gained the mosttraction. (Just try corral l ing cats!) Veterinarians arequite supportive, because few cancer drugs areavailable for dogs. The trials provide access tosorely needed treatments as well as insight aboutcancer.
As an added benefit, man’s best friend turns out tobe a good model for testing cancer drugs thatresearchers are developing for humans. About 25%of pet dogs wil l suffer some form of cancer in theirl ifetime, and dog tumors often correlate well withhuman cancers. For example, Labrador retrievers,the most popular pet breed in the US, develophuman-l ike lymphomas.
Because dog tumors emerge spontaneously (unl ikelab-induced tumors in experimental mice), they areheterogeneous, l ike human tumors. The size andspeed of growth of those “natural” tumors are alsocomparable between dogs and humans. And unlikemice, dogs and humans share a majority of theirgenetic material , al lowing researchers to use datafrom a dog’s cancer gene to extrapolate to theanalogous gene in humans.
Drug testing in mouse models, however, is unl ikelyto disappear in near-future, in spite of the fact thatjust about 1 0% of the investigational agents thatshow great activity in tumor-bearing mice wil l showsimilar activity in human cancers. As one researcherput it, “I f you have cancer and you’re a mouse, wecan take good care of you.” On the other hand, the
data generated from dog trials provide relevant datafor treating humans, as well as helping the lab Labs.
The National Cancer Institute has launched theComparative Oncology Trials Consortium, a networkof 20 veterinary hospitals with oncology expertise, torecruit pet dogs diagnosed with specific types ofcancer. The protocols and procedures for the four-legged patients mimic human chemotherapy trials.The animals are given well-establ ished treatments,in addition to the investigational drug, just l ikehuman oncology patients.
And the care at those vet hospitals is excellent.According to one distinguished veterinarian, “Thejoke is that oncologists treat their patients l ike dogs,and we treat our patients l ike people.” Datacollection may be a challenge, though. How do youcraft PRO (patient-reported outcomes) forms for adog? Perhaps, Fido wil l get his own App.
Although, as expected, the NCI ’s dog trials areclosely regulated, there is better efficiency: vetinvestigators can run ten trials for the cost of onehuman trial . Not surprisingly, al l of this has piquedthe interest of drug companies. The doggy data wil lspeed drug development, predict human efficacymore accurately, and provide stronger justificationfor the pivotal and costly Phase I I I cl inical trials.Hopeful ly, that translates into a more certain andfaster drug approval. So, someday, a drugcompany’s NDA may be based on trials that savedScooby Doo and his friends, as well as their owners.
REBECCA J ANDERSON, PhD, is a freelance
medical writer and the author of two books,
Nevirapine and the Quest to End Pediatric AIDS
and Career Opportunities in Clinical Drug
Research. Prior to medical writing, Dr. Anderson
managed research and development projects for
twenty-five years in the pharmaceutical/biotech industry. She
holds a Ph.D. in pharmacology from Georgetown University.
She lives in Southern California, and when she is not writing,
she absorbs the sights and sounds of the West Coast’s rich
culture and heritage. She can be reached at
POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6 1 2
News and Updates from the FDAKokil Tandon, MBBS, MBA
Member, AMWA Pacific Southwest Chapter
The agency continued its trend of granting approval to a number of novel treatments in December 201 5. Theindications for these are described below.
KanumaThe FDA approved the first treatment for adult and pediatric patients with a rare enzyme disorder calledlysosomal acid l ipase (LAL) deficiency (or Wolman disease - which is the very severe infant form orcholesteryl ester storage disease [CESD]- which is the milder later onset form). Kanuma (AlexionPharmaceuticals Inc.) is indicated for this inherited disorder, in which patients have little or no LAL enzymeactivity. This causes a build-up of fats within the cells of various tissues, which subsequently can lead to l iverand cardiovascular disease and other complications. Kanuma, provides a recombinant form of humanlysosomal acid l ipase (rhLAL) protein that functions in place of the missing, partial ly active or inactive LALprotein in the patient. Kanuma received a breakthrough therapy designation, as it is the first and onlytreatment for Wolman disease. The FDA granted Kanuma orphan drug designation because it treats a diseaseaffecting fewer than 200,000 patients in the United States. The Kanuma application was also granted a priorityreview, which is granted to drug applications that show a significant improvement in safety or effectiveness inthe treatment of a serious condition The manufacturer of Kanuma was granted a rare pediatric disease priorityreview voucher– a provision that encourages development of new drugs and biologics for the prevention andtreatment of rare pediatric diseases.
Vonvendi, von Willebrand factor (Recombinant)The FDA approved the first recombinant von Wil lebrand factor for use in adults 1 8 years of age and older whohave von Wil lebrand disease (VWD). VWD is the most common inherited bleeding disorder, affectingapproximately 1 percent of the U.S. population. Vonvendi (Baxalta U.S. , Inc.) is indicated for the on-demandtreatment and control of bleeding episodes in VWD patients. Vonvendi was granted orphan productdesignation.
VistogardVistogard (Wellstat Therapeutics Corporation) was approved for the emergency treatment of adults andchildren who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certainsevere or l ife-threatening toxicities within four days of receiving these treatments. While an overdose offluorouracil or capecitabine is rare, the effects are serious and may be fatal. Vistogard, taken oral ly, blocks celldamage and cell death caused by fluorouracil chemotherapy. The safety and efficacy of Vistogard initiatedmore than 96 hours fol lowing the end of chemotherapy have not been established. The FDA granted Vistogardorphan drug designation, priority review and fast track designations.
BridionFDA approved the first drug in a new class of medications that enables medical personnel to reverse theeffects of neuromuscular blocking drugs and restore spontaneous breathing after surgery. Bridion (MerckSharp and Dohme Corp. , a subsidiary of Merck and Company, Inc.) injection is indicated to reverse the effectsof neuromuscular blockade induced by rocuronium bromide and vecuronium bromide. These drugs may beused during tracheal intubation/venti lation during surgery/to prevent patients from moving during surgery whilethey are receiving general anesthesia
Voluntary recalls were issued by a number of companies at the end of last year, as well as at the beginning ofthis year. These include: Glades Drugs, Lipo Escultura Corp. , Lucy's Weight Loss System, Reesna Inc. ,Baxter International Inc. , SmartLipo365 of Dallas, TX, BeeXtreme LLC, PharMEDium Services, LLC, RThomas Marketing LLC in conjunction With Just Enhance LLC, Abbott's Compounding Pharmacy, and MasterHerbs, Inc.
A few advisory committee meetings, as well as workshops have been scheduled for February.
Selected FDA Announcements
AnnouncementDate
FDA announced the voluntary nationwide recall issued by Glades Drugs of compoundedmultivitamins. The recall was issued due to the presence of high amounts of Vitamin D3(Cholecalciferol) in the capsules. Consumption of the multivitamins could result in vitamin Dtoxicity, which may be severe and cause life-threatening outcomes if left untreated. 1
1 1 -25-1 5
Regulatory Intelligence
1 3 POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6
Lipo Escultura Corp. of Brooklyn, NY dba JAT Productos Naturales Corp. , and JAT NaturalProducts Corp. issued a voluntary nationwide recall of al l Lipo Escultura within expiry. The weightloss dietary supplement was found to contain two potential ly undeclared harmful ingredients--sibutramine and diclofenac. Sibutramine was removed from the market for safety reasons and isknown to substantial ly increase blood pressure and/or pulse rate and may present a significant riskfor patients with a history of coronary artery disease, congestive heart fai lure, arrhythmias orstroke. Diclofenac may cause increased risk of cardiovascular events and serious gastrointestinaldamage.2
1 2-03-1 5
Lucy's Weight Loss System, issued a voluntary nationwide recall of al l lots of Pink Bikini Whitepowder Capsules, 30 white (750MG per capsule). Pink Bikini dietary supplement has been foundpositive for diclofenac after FDA sampling and testing. This undeclared ingredient makes thisproduct an unapproved new drug for which safety and efficacy have not been established.Diclofenac can increase the risk of fatal heart attack or stroke, especial ly on long term use/withhigh doses/ with pre-existing heart disease. I t can also harm the unborn baby if taken by apregnant consumer in the last trimester.3
1 2-09-1 5
Reesna Inc. issued a voluntary nationwide recall of al l lots of the Fuel Up Plus and Fuel Up HighOctane distributed in August 201 5 . Fuel Up is marketed as dietary supplement sexual enhancerfor men. The recall was issued as the supplements contain undeclared hydroxythiohomosildenafi l ,an analogue of si ldenafi l . Si ldenafi l is an FDA-approved drug for the treatment of male Erecti leDysfunction (ED), making Fuel Up an unapproved drug. Hydroxythiohomosildenafi l has a similarstructure to si ldenafi l and is expected to possess a similar pharmacological and adverse eventprofi le.4
1 2-11 -1 5
Baxter International Inc. issued a voluntary recall of two lots of intravenous solutions due to thepotential presence of particulate matter (i .e. an insect). The recalled solutions included lot no.C980227 of 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container; and lot no.C9851 50 of 70% Dextrose Injection (2000 mL) USP. The lots being recalled were distributed tocustomers and distributors in the United States between June 6, 201 5 and December 1 6, 201 5.5
1 2-1 8-1 5
SmartLipo365 of Dallas, TX issued a voluntary nationwide recall of al l lots of the dietarysupplement Smart Lipo (800, 900, 950 mg) capsules. FDA's analysis found the Smart Lipoproducts to contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein. Theseundeclared ingredients make these products unapproved new drugs for which safety and efficacyhave not been established. These products may also interact with other medications taken by aconsumer in l ife-threatening ways.6
1 2-1 8-1 5
BeeXtreme LLC issued a recall of al l lots of its dietary supplements La' Trim Plus, Jenesis andOasis. The FDA found undeclared sibutramine and phenolphthalein in these supplements.Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 201 0.Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because ofconcerns of carcinogenicity, it is not currently approved for marketing in the United States. Boththese ingredients pose significant health hazards.7
1 2-23-1 5
PharMEDium Services, LLC issued a voluntary nationwide recall of 29 lots of 4mg NorepinephrineBitartrate (1 6mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 3 lots of 8mgNorepinephrine Bitartrate (32mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag,distributed to hospital customers. This recall was issued due to complaints of productdiscoloration, which is indicative of degradation and could result in decreased potency due tooxidation of Norepinephrine Bitartrate.8
1 2-31 -1 5
U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplementRelaKzpro, worth more than $400,000. RelaKzpro is manufactured for and held by DordonizNatural Products LLC, in South Beloit, I l l inois. I t is labeled as containing kratom, which has beenidentified as a botanical substance, indicated to have narcotic and stimulant-l ike effects. I tsconsumption can lead to several health impacts, such as respiratory depression, vomiting,nervousness, weight loss and constipation. In February 201 4, the FDA issued an import alertal lowing U.S. officials to detain imported dietary supplements and bulk dietary ingredients that are,or contain kratom without physical examination. A complaint was fi led by the U.S. Department ofJustice, on behalf of the FDA, in the U.S. District Court for the Northern District of I l l inois, al legingthat kratom is a new dietary ingredient for which there is inadequate information to substantiatethat it does not present a significant or unreasonable risk of i l lness or injury; thus, dietarysupplements containing kratom are adulterated under the Federal Food, Drug and Cosmetic Act(FD&C Act). The FDA is warning consumers not to use any products labeled as containing kratom.Further, they should report any related adverse events to the MedWatch program.9
01 -06-1 6
POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6 1 4
Selected FDA Approvals
IndicationDrug
Metastatic renal cal l carcinoma, previously treated withanti-angiogenic therapy1 4
Opdivo®
Company
Bristol-Myers Squibb
Metastatic squamous non-small cel l lung cancer(NSCLC), in combination with gemcitabine and cisplatin(in patients who have not previously receivedmedication specifical ly for treating their advanced lungcancer)1 5
PortrazzaTM Eli Li l ly and Company
Multiple myeloma, in combination with Revlimid anddexamethasone, in previously treated with one to threeprior medications1 6
EmplicitiTM
(orphan drug)
Bristol-Myers Squibb
Metastatic anaplastic lymphoma kinase(ALK)-positiveNSCLC patients who worsened after/ were intolerant toXalkori1 7
Alecensa®
(orphan drug)
Genentech
Type 1 diabetes mell itus and Type 2 diabetes mell itus1 8Basaglar® Eli Li l ly and Company
Hyperuricemia, associated with gout, in combinationwith a xanthine oxidase inhibitor20
Zurampic® AstraZeneca Pharmaceuticals LP
Master Herbs, Inc. issued a voluntary nationwide recall of al l lots of the cough syrup called LicoriceCoughing Liquid in 1 00 ml bottles. I t was recalled due to the presence of Morphine, which is anopioid, and is not declared on the label. Thus, consumers using this product may not be awarethey are ingesting morphine, which can lead to l ife-threatening respiratory depression and death,as well as severe allergic reactions in hypersensitive patients. In addition young children with arespiratory i l lness are vulnerable to respiratory depression from opioids and should not beexposed to morphine in any event. 1 3
01 -20-1 6
A U.S. District Judge entered a consent decree of permanent injunction between the United Statesand Downing Labs LLC, of Dallas, Texas, the company’s co-owners, and pharmacist-in-charge.The action was brought by the U.S. Department of Justice, on behalf of the FDA. According to thecomplaint fi led with the decree, Downing Labs (formerly known as NuVision Pharmacy)manufactured and distributed purportedly steri le drug products that were adulterated because thedrugs were made under insanitary conditions and in violation of current good manufacturingpractice requirements under the FD&C Act. The decree prohibits Downing Labs and its ownersfrom manufacturing, holding or distributing drugs unti l they comply with the FD&C Act and itsregulations, in addition to other requirements. Most recently, Downing Labs conducted a voluntarynationwide recall of its purportedly steri le drug products due to a lack of steri l i ty assurance andceased steri le operations, due to serious deficiencies identified by the FDA during an inspectionending in October 201 5. The deficiencies included microbial contamination of injectable drugproducts, inadequate cleaning and sanitization of steri le processing areas, and inadequate steri lepractices. FDA investigators also determined that Downing Labs distributed drug products thatfai led steri l i ty testing. 11
01 -11 -1 6
R Thomas Marketing LLC in conjunction With Just Enhance LLC, issued a voluntary nationwiderecall of the fol lowing products marketed as dietary supplements for male sexual enhancement:Black Ant, Herb Viagra, Real Skil l , Weekend Prince, African Black Ant and Stree Overlord alongwith multiple other products. These were tested by the FDA and found to contain Sildenafi l , whichis not l isted on the product labels. Since Sildenafi l is the active ingredient in an FDA-approveddrug for ED, these dietary supplements are unapproved. Sildenafi l may interact with nitrates foundin some prescription drugs such as nitroglycerin and may lower blood pressure to dangerouslevels. Also it may cause side effects, such as headaches and flushing. 1 0
01 -09-1 6
Abbott's Compounding Pharmacy issued a voluntary recall of al l lots of unexpired steri le humanand animal compounded products due to lack of steri l i ty assurance. These include injectablemedications, steri le solutions, eye drops, and eye ointments. This recall impacts al l steri le productsdistributed between 01 /01 /201 5 and 01 /1 4/201 6, to patients, physician offices and clinics, andveterinarians within California. 1 2
01 -1 6-1 6
Pulmonary arterial hypertension1 9Uptravi®
(orphan drug)Actel ion Pharmaceuticals US, Inc.
1 5 POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6
February 201 6 Advisory Committee Meetings
CommitteeDate
Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement –Discussion of cognitive dysfunction in major depressive disorder and discussion of the NDA204447/supplemental NDA 006 submitted by Takeda Development Center Americas, Inc.20
02-3-1 6
Arthritis Advisory Committee Meeting Announcement – Discussion of the BLA submitted byCelltrion, Inc.22
1 2-9-1 6
WEBLINKS
• For additional information on approvals, including labeling revisions, tentative approvals, efficacysupplements with supporting cl inical data, manufacturing changes or additions, or chemistry; new strength,see http: //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
• For information on current drug shortages, seehttp: //www.accessdata.fda.gov/scripts/drugshortages/default.cfm
• For information on drugs to be discontinued, seehttp: //www.accessdata.fda.gov/scripts/drugshortages/default.cfm
• For Orange Book drug product l ist additions or deletions, seehttp: //www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm
February 201 6 Conferences, Workshops and Public Meetings
8th Annual Sentinel Initiative Public Workshop – convened by Duke-Margolis Center for HealthPolicy, under cooperative agreement with FDA.23
02/3/1 6
TitleDate
1 http: //www.fda.gov/Safety/Recalls/ucm474636.htm2http: //www.fda.gov/Safety/Recalls/ucm475550.htm3http: //www.fda.gov/Safety/Recalls/ucm476494.htm4http: //www.fda.gov/Safety/Recalls/ucm476978.htm5http: //www.fda.gov/Safety/Recalls/ucm479877.htm6http: //www.fda.gov/Safety/Recalls/ucm4781 46.htm7http: //www.fda.gov/Safety/Recalls/ucm478883.htm8http: //www.fda.gov/Safety/Recalls/ucm479677.htm9http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm480344.htm1 0http: //www.fda.gov/Safety/Recalls/ucm481 054.htm11http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm481 228.htm1 2http: //www.fda.gov/Safety/Recalls/ucm4821 01 .htm1 3http: //www.fda.gov/Safety/Recalls/ucm482524.htm1 4http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm473971 .htm1 5http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm4741 31 .htm1 6http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474684.htm1 7http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476926.htm1 8http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm477734.htm1 9http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm478599.htm20http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm478791 .htm21http: //www.fda.gov/AdvisoryCommittees/Calendar/ucm47531 2.htm22http: //www.fda.gov/AdvisoryCommittees/Calendar/ucm481 969.htm23http: //www.fda.gov/Safety/FDAsSentinelInitiative/ucm1 49341 .htm24http: //www.fda.gov/Drugs/NewsEvents/ucm479200.htm
KOKIL TANDON, MBBS, MBA, is a physician MBA, initiating her
journey into the arena of Medical Writing. Previously she worked as a
healthcare consultant where she focussed on projects involving
healthcare delivery systems and processes. She is an active
volunteer in her local community. She can be reached at
kokiltandon@gmail .com.
Arthritis Foundation & Food and Drug Administration Accelerating OA Clinical TrialsWorkshop.24
02/23-25/1 6
POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6 1 6
Ask APRIL: Resolve to Never Tidy AgainBy April Reynolds, MS, ELS, AMWA Pacific Southwest Chapter Member
According to Google Trends, interest in Marie Kondoand her NewYork Times bestsel l ing book onorganizing entitled The Life-Changing Magic ofTidying Up reached an all-time high this January, 1
l ikely due to an increased interest in de-cluttering forthe New Year. The book has permeated popularculture, and Kondo, a former Shinto shrine attendantmaiden turned cleaning consultant, boasts a heftycl ientele and a months-long waitl ist for herorganizing services. Her book promises that you'l lnever have to tidy your home again after fol lowingher eponymous KonMari Method.
The method starts with discarding, fol lowed byorganizing your l iving space thoroughly andcompletely in one session. Kondo says it should takeabout 6 months to properly go through an entirehouse. After sorting and discarding, everything thatremains should be given its own place. Once youare done using something, you simply put it backwhere it belongs and you'l l never have to tidy again.
The method and me
The book was recommended to me by my Feng shuiconsultant, in part, because I have too many clothesbut also because it’s very closely al igned with Fengshui. The idea is to create a living space, andultimately a l ife, that reflects your best self. Don'thold on to something out of obligation or theassumption that you'l l use it in the future. Livehappily and joyful ly in the present.
I revisited the book recently after renovating mybedroom to include a much larger closet. But evenwith the new space, there is sti l l not enough room tohouse all of my clothes. I struggled with decidingwhat to keep and what to donate because collectingclothes has been a pastime of mine for many years.
Some say to get rid of clothes you haven’t worn in[insert amount of time, ie, 6 months or 1 year]. Thatdoesn’t work for me because I often bring things outof hiding 5, 6, or even 7 years later. And because Itend to buy timeless pieces, this arbitrary time limitdoesn't seem applicable.
Another idea is to construct a custom closet interior,with storage so ample I ’ l l probably forget what al l Ihave. Kondo says storage is for hoarders, and Ihave to agree. I can envision myself buying thesame thing more than once simply because I can’tsee it.
Ask yourself: does this bring me joy?
The selection criterion for keeping or discarding anitem, according to the KonMari Method, is to askyourself if an item brings you joy. This means youmust handle every object under consideration. Thegoal is to feel if an item continues to spark a senseof joy or if it has served its purpose in your l ife andneeds to move on. But focus on the positive: thinkabout what you want to keep instead of what youshould discard.
I l ike this idea of respect. I put a lot of time andmoney into building a wardrobe, so to just discardsomething on the basis of an arbitrary time limitseems a bit cal lous. And once I ’m done fi l l ing mynew space with only those items that make myhappy, I ’ l l have a closet ful l of my favorite things!
Tidy by category not by type
The book has some practical advice on how toapproach organization, l ike tidying by categoryinstead of location, meaning going through all yourshirts instead of going through your house room byroom. This is because people often store the sametypes of items in different locations.
The book warns against starting with mementos, asthey elicit too emotional of a response. Instead,beginners should build confidence in their decision-making skil ls by adapting a sequence that includesclothes first, then books and papers, fol lowed lastlyby mementos. Kondo gives more explicit instructionson tidying that include practical advice on folding,arranging clothes in a way that energizes the closet,and drawer organization techniques.
Psychology plays a role
At first, you may think Kondo is over the top. Shecomes across as obsessed with organization from avery young age. And she credits her services withdiscarding over a mil l ion items, including one client'scol lection of 20,000 unused cotton swabs. But themessage becomes softer and more palatable as youget deeper into her thought process on discarding,joy, and respect.
An article on Marie Kondo in The Atlantic exploresunderlying themes that cause us to buy things wedon't need, keep things we don't use, and continueto perpetuate this cycle.2 As resistant as we may be
With the New Year always comes talk of resolutions. Maybe one of them could begetting your home in order so your l ife wil l fol low. Marie Kondo's book on
organizing tel ls us how.
1 7 POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6
to her message of discarding, Kondo insists that wemust change our thinking in order to change ourhabits and, ultimately, our l ives.
Care for your things so they can do the same foryou
Do you thank your bag for carrying your things allday? Or your house for giving you shelter andwarmth? Do you smile when you open your closet?According to Kondo, you should.
In this New Year, I 'd l ike to be more mindful of how Ispend my time and money. I invite you to join me inconsidering the fol lowing from Marie Kondo: "thequestion of what you want to own is actual ly thequestion of how you want to l ive your l ife."
For more, fol low Marie Kondo's blog at:http: //tidyingup.com/
References:1 . https://goo.gl/rQJxcg2. http: //goo.gl/41 DzJf
APRIL REYNOLDS, MS, ELS,is a medical writer & editor andthe president of Write/Correct,Inc. She has published workson topics that range fromjeans (for fashion magazines)to genes (for medicalpublications). She lives in SanDiego with her husband andson.
Medical writing’s own fashion experimenter and amateur decorator answersyour style questions.
Email your questions to: [email protected].
POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6 1 8
Precision Medicine Initiative and Communicating Genetic Testing ResultsKokil Tandon, MBBS, MBA
Member, AMWA Pacific Southwest Chapter
The Precision Medicine Initiative (PMI) waslaunched by President Obama in January 201 5. I tenables providers to develop customized treatmentand prevention strategies for patients, based onindividual differences in their genes, environments,and l ifestyles. This initiative was launched with a$21 5 mil l ion investment in the President’s 201 6budget and may involve the analysis of geneticinformation gathered through Next GenerationSequencing (NGS) technologies. 1 Thus, as part ofPMI , the FDA was charged with developing a newapproach to evaluate NGS technologies, so thataccurate and innovative tests can be developed togenerate knowledge about genetic changes relevantto patient care.
What is NGS?
NGS is a cutting-edge process that determines theDNA sequence of an individual by assessingmultiple genes in a single assay. I t can be applied toa subset of key genes or the entire genetic code.This method offers several advantages overtraditional genetic tests in terms of providing highlysensitive and accurate results with a rapidturnaround. Also, NGS is more economical andeliminates the need to order multiple tests, as it is amulti gene approach.
A noteworthy example of the diverse uti l ization ofdata garnered from NGS-based tests can be seen inthe practice of oncology. For instance, oncologistsare increasingly using these tests to gatherinformation about the factors which underl ie cancerprogression. Additional ly, they are beginning to useresults of NGS-based diagnostics to tai lor the choiceof drugs or drug combinations for a specific patient.2
A number of biotechnology companies have beenworking on developing and refining NGS based non-invasive tests for cancer screening and real-timedetection.
I t is envisioned that these tests wil l lead to earl ierdiagnosis, improved survival rates, and better qualityof l ife for cancer patients.3
FDA Workshop on Communicating GeneticTesting Results
On January 1 4, 201 6, the FDA announced that it wil lconduct a public workshop entitled “Patient andMedical Professional Perspectives on the Return of
Genetic Test Results”, on March 2, 201 6.4
The meeting notice in the Federal Registerspecifical ly cites the PMI.
What is the purpose of this workshop?
Overall , NGS based tests have allowed theavailabi l ity of a multitude of patient and diseaserelated data. However, given the copious amounts ofdata generated, physicians are sometimespresented with information that may be difficult toanalyze on the basis on current scientific andmedical knowledge. Further, not al l of the datagenerated may be helpful to patients in terms ofenhancing their understanding of a particulardisease state or translate into viable preventive ortreatment options. Thus, the FDA is planning tosolicit input from patients and healthcareprofessionals, via the aforementioned workshop,about how the results of genetic tests can beconveyed to them in a manner that is meaningfuland can aid medical decision-making. Various topicswil l be discussed by speakers including the differentuses of genetic testing; how to present the result ofgenetic tests effectively; patients’ preferences toreceive results supported by limited/confl ictingevidence/ if no medical action can be taken;providers’ preferences to receive results supportedby limited/confl icting evidence; which informationcan be included/excluded from test reports and howto present information so it can be easily integratedinto cl inical care by providers.
Electronic or written comments wil l be accepted unti lMarch 31 , 201 6.4
Sources:1 https://www.whitehouse.gov/the-press-office/201 5/01 /30/fact-sheet-president-obama-s-precision-medicine-initiative
2https://www.i l lumina.com/content/dam/i l lumina-marketing/documents/products/other/primer-ngs-oncology.pdf
3http: //www.technologyreview.com/news/545326/i l luminas-bid-to-beat-cancer-with-dna-tests/
4https://www.federalregister.gov/articles/201 6/01 /1 4/201 6-00540/patient-and-medical-professional-perspectives-on-the-return-of-genetic-test-results-and
1 9 POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6
AMWA Kicks Off the New Year with Leadership and MentoringEileen Lai-Hoshino, MS, MPH, MBA
Member, AMWA Pacific Southwest Chapter
Meeting Report
On January 1 6, 201 6, AMWA’s Pacific
Southwest Chapter convened with a
presentation and luncheon held at Cal State
Northridge to usher in the New Year and new
leadership. The luncheon began with Donna
Simcoe handing over the AMWA President’s
gavel to newly elected President, Susan Vinti l la-
Friedman, for the next two-year term of chapter
leadership. Ms. Simcoe, who helmed the
Southwest Chapter from 201 4-201 5, was
instrumental in bringing new types of events
such as the popular, monthly teleconference call
for AMWAmembers to connect with one
another, share ideas and discuss relevant
industry issues. The audience members
applauded Ms. Simcoe for her dedication and
the many contributions under her leadership.
Fol lowing the inauguration of the newly elected
president, Michele Vivirito presented an
informative lecture on how to successful ly
mentor junior medical writers. Drawing on her
30 plus years at Amgen as a professional
medical writer and mentor, Ms. Vivirto discussed
what the essential qual ities of a good mentor
should be, such as compassion, candor, and
confidential ity. She also emphasized the
differences between being a mentor (versus
being a trainer) and that developing a
productive mentor/mentee relationship should
be based on mutual respect and trust.
Ms. Vivirto also introduced several useful tools
and models such as the SMART goals (Specific,
Measurable, Achievable, Relevant, Time-bound)
and CMO model (Competency, Motivation,
Opportunity) to help potential mentors guide
their mentees through career development
issues. According to Ms. Vivirto, good
communication is not only imperative to
successful medical writing, but also to
successful mentoring. She recommended the
use of personality assessment tools such as the
Myers-Briggs temperament sorter into
effectively develop communication styles based
on personality types. The presentation elicited
an informative discussion between the audience
members, which included both experienced
industry writers and newly aspiring medical
writers. All in al l , the presentation on mentoring
was a wonderful introduction to the New Year
and new leaderships.
EILEEN LAI-HOSHINO, MS, MPH, MBA is an
experienced healthcare professional with
experience in both the medical and business
fields. She has experience working in the clinical
environment as a licensed medical professional
(PA-C) and management consultant in strategic planning,
marketing, performance management and training design. She
holds a Masters of Medical Science, an MBA in health care
marketing strategy and MPH in healthcare policy and
economics.
She can be reached at [email protected]
POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6 20
Event: Successful Mentoring of Medical WritersSpeaker: Michele Vivirito is a medical writing consultant with more than 30 years of experience in thepharmaceutical industry. She has mentored many medical writers, including newly hired writers andexperienced writers taking on new responsibi l ities. She has also developed programs to train mentors.
Date: Saturday, January 1 6, 201 6Location : Cal ifornia State University Northridge, Orange Grove Bistro, 1 8111 Nordhoff Street,Northridge, CA 91 330-8271
AMWA Event: Successful Mentoring of Medical Writers (Pictures)
PicturesbyEliseSudbeckandEileenLai-Hoshino
Clockwise from top left: (1 ) Donna and Susan, (2) Michele V, (3) Michele, Susan,Lamia, (4) meeting participants, (5) Susan E, Ajay, Aaron, (6) Jenny, Jacki, J im
H. Read the meeting report by Eileen Lai-Hoshino on page 20.
21 POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6
Medical Writing as a Career;A Panel Discussion at Sanford Burnham Prebys Medical Discovery InstituteBy Asoka Banno, PhD
Outreach Coordinator for AMWA Pacific Southwest Chapter Member
On January 27, 201 6, in col laboration with Sanford Burnham
Prebys Medical Discovery Institute, AMWA Pacific Southwest
Chapter hosted a panel discussion on career in medical writing for
the audience of approximately 1 5 postdocs at the institute. Three of
our chapter members, Amy Lindsay, Noelle Demas, and Robin
Weaver kindly volunteered to participate as panelists.
Fol lowing brief introductions about their career paths, the panelists
introduced medical writing as a profession and described its nature
and diversity. We then opened up the floor for questions from the
audience, during which many interesting topics were discussed.
The panelists agreed that the maintenance of data/science integrity
is one of the key responsibi l ities of a medical writer, whether it is
peer-to-peer communication or regulatory writing. Traits that the
panelists thought are necessary to be a successful medical writer
included adaptabil ity and flexibi l ity, project management and
leadership skil ls, attention to detai l , abi l ity to work as a team and
independently, and wil l ingness to learn, in addition to data analysis
and logic building skil ls and mastery of writing and oral
communication. The panelists also noted that some of the ways that
individuals can show their commitment to the field and to distinguish
themselves from others with similar background are to obtain formal
training in medical writing, such as through AMWA, UCSD
Extension, and other local or onl ine-based programs, and to get
involved with local professional societies.
Another session about career in medical writing, with Amy Lindsay,
Noelle Demas, and Laura Alper, has been planned for February 22
at University of California, San Diego.
CAREER
ASOKA BANNO, PhD, is currently a freelance medical writer based in San
Diego. Her current projects include clinical overviews on a variety of human
diseases and research manuscripts based on clinical study reports. Before
embarking on medical writer career, she was an oncology researcher at UC
San Diego and Mount Sinai School of Medicine. Her research projects
included mechanism of epithel ial-mesenchymal transition, a key phenomenon that takes
place during cancer metastasis, the role of R-Ras in tumor metastasis of gl ioblastoma
and the role of BCR-ABL in myeloid leukemic stem cells. She earned her PhD from UC
San Diego. She is fluent in English and Japanese. She can be reached at
asoka828@gmail .com or via LinkedIn is at https://www. l inkedin.com/in/asokabanno
POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6 22
Chapter 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#)
Discussion topic for Feb 5, 201 6 - Dealing with a difficult work environment
February 9, 201 6 ,Tuesday. Orange County Happy Hour at 5:30 PM.
Where: El Torito in Tustin, 1 7420 East 1 7th Street, Tustin, CA 92780
Everyone is invited to join for an evening of networking with AMWA colleagues.
February 22, 201 6 – UCSD campus. Medical writing workshop. Details to be
announced soon via chapter email blast.
While at TIPPA meeting, join for a happy hour hosted by our chapter on Monday,
February 29th from 6 pm to 7:30 pm at The Cays Lounge in Loews Coronado
Bay Resort. (Pay for your own drinks). Al l are welcome. Address: 4000 Coronado
Bay Road, San Diego, California, 9211 8. Phone: 61 9-424-4000
https://www. loewshotels.com/coronado-bay-resort/dining/lounge
March 1 2, 201 6 – AMWA presentation at CareFusion. Mari lyn All ison wil l speak
on Career Transitions.
April 1 6,201 6 – AMWA Pacific Coast Conference
Where: Park Central San Francisco, A Starwood Hotel, 50 Third Street, San
Francisco, CA 941 03. Visit http: //amwancal.org/ for more information.
April 29, 201 6 (tentative) – Webinar presentation by Thomas Purcell on Project
Management for Medical Writers.
23 POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6
Medical Writer, Senior ManagerAvanir Pharmaceuticals, Inc, Aliso Viejo, CAhttp://job-openings.monster.com/monster/c7b9c55e-73ec-4ec5-b75d-1 cce1 9f67ac7?mescoid=2700440001 001 &jobPosition=3#
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=1 0
Medical Writer – Continuing Medical Education (CME)Neuroscience Education Institute, Carlsbad, CAhttp://jobview.monster.com/Medical-Writer-%E2%80%93-Continuing-Medical-Education-CME-Job-Carlsbad-CA-US-1 62924785.aspx?mescoid=2700440001 001 &jobPosition=11
Medical WriterMedtronic Inc. , Goleta, CAhttp://job-openings.monster.com/monster/5938cbbe-2032-4b6f-9e2e-0d6fd1 4ce02e?mescoid=2700440001 001 &jobPosition=7#
Medical WriterRecruiting for Undisclosed CompanyALKU, Los Angeles, CAhttp://job-openings.monster.com/monster/41 bdacc2-d985-4dde-bf7c-23947a91 7e1 0?mescoid=2700440001 001 &jobPosition=9#
Senior Medical Content EditorCline Davis & Mann, Inc. , Los Angeles, CAhttp://job-openings.monster.com/monster/ac456d70-341 6-435b-9b9c-4462860be4c6?mescoid=2700439001 001 &jobPosition=4#
Technical Writer/Editor (Pharmaceutical/Device)Recruiting for Undisclosed CompanyConsignMed, Santa Ana, CAhttp://jobview.monster.com/Technical-Writer-Editor-Job-Santa-Ana-CA-US-1 61 846084.aspx?mescoid=2700440001 001 &jobPosition=1 6
Senior Medical Writer (Medical Communications)Recruiting for Undisclosed Company in San Diego AreaLiberty Jobs, San Diego, CAhttp://job-openings.monster.com/monster/1 2bcfad0-d23b-4b0e-b3d9-5a0bb79b2c20?mescoid=2700440001 001 &jobPosition=2
Medical Communications ManagerRecruiting for position at Amgen (2 year contract)Hart Employment Services, Thousand Oak, CAhttp://hartjobs.com/careers/?cjobid=HS938238527&rpid=1 6202
Principal Scientific Communications ManagerBoston Scientific, Valencia, CAhttp://job-openings.monster.com/monster/75ac8e64-97e2-4e29-b54c-384626233089?mescoid=11 00009001 001 &jobPosition=1 6#
***I f you want to share job leads with the members of the Pacific Southwest Chapter, please contact
Sharyn at [email protected].
Medical Writing Open PositionsCompiled By: Sharyn Batey, PharmD, MSPH
Employment Coordinator, AMWA Pacific Southwest Chapter
Career Corner
POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6 24
Backpage
25 POSTSCRIPTS | VOL 6, NO. 40 | FEBRUARY 201 6
February is the month of All Things Presidents: Lincolnand Washington's birthdays, and New Hampshire givingus the first primary contest which will lead us to thePresident’s election in November. New Hampshire also isthe birthplace of a famous sculptor and artist, DanielChester French (1 850-1 931 ) who designed the Lincolnstatue for the Lincoln Memorial in Washington, DC.
Daniel Chester French, born in Exeter,New Hampshire, studied anatomy anddrawing, and spent a year studying artin Italy. His first commissioned workand source of acclaim was the MinuteMan statue for the town of Concord,Massachusetts, which wasunveiled on April 1 9, 1 875, onthe centenary of the battle ofLexington and Concord.
Over his career, he designed numerous publicmonuments and statues. With H AugustusLukeman, he also designed the Pulitzer Prizemedal in 1 91 7 – French designed the picture ofBenjamin Franklin on one side, and for the otherside of the medal, Lukeman came up with thedesign of a printing press and wordings, “For thedisinterested and meritorious public servicerendered by an American newspaper during the year.”
French was the founding member of US Commission of Fine Arts and also ofNational Sculpture Society, fellow of American Academy of Arts and Sciences,and a member of several other major organizations. In 1 940, he was one of fiveartists to be honored on a US First-Class stamp. He died in Stockbridge,Massachusetts, and was buried in Sleepy Hollow Cemetery in Concord, the townwhere he started his career with the Minute Man statue.
— EditorSources: Wikipedia and Wikimedia
Presidents, New Hampshire and Daniel Chester French