amwa indiana newsletter october 2014
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Indiana Chapter NewsletterOctober 2014
NewsletterExecutive Committee 2013-2014
Let us know if there is anything we can do to helpyou benefit professionally from your AMWAmembership. Volunteering to help our chapter ornational association is a great way to have funwhile meeting some wonderful people, improvingyourself and the profession, and becoming andbeing the leader you were meant to be. Join ourLinkedIn group, come to the chapter events, orclick on the name of a chapter officer orcommittee chair above to join the conversationabout medical communication and our chapter.
Officers
Committee Chairs
Greg AdamsLaura TownEllen Stoltzfus, PhD
Laura Town
Esther Brooks-Asplund, PhD
David Caldwell, PhDLinda Hughes, MA
Editor
Associate Editors
David Caldwell, PhD
Esther Brooks-Asplund, PhD
Svetlana Dominguez, ELS
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American Medical Writers Association Indiana Chapter
October 2014 | AMWA Indiana Chapter Newsletter | 3
Contents
Find AMWA members near you by searching the AMWA member directory by city or zip code.
This map of the locations of our 88 chapter members was created with BatchGeo.
How to Maximize Acceptance of Your Manuscript ina Peer-Reviewed Journal
William S. Pietrzak, PhD
Overview of US Drug Development Requirements forPediatric Populations
Cover
Letter From the President, AMWA Indiana ChapterGreg Adams4
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20 Job Ad
4 | AMWA Indiana Chapter Newsletter | October 2014
Dear Indiana AMWA members,
The upcoming year will be an eventful one for the Indiana chapter!Our chapter is growing, and we have some exciting activities in theworks.
We’ve begun planning next year’s chapter conference, and wewelcome any and all help. If you’d like to volunteer or if you haveideas for the program, let us know. Organizer Laura Town did aterrific job last year and is helping to organize the conference againthis year. If next year’s conference is merely as good as this year’sconference, then it will be a great success. And if you missed out onthis year’s conference, then be sure to attend next year’s. Ourchapter’s programs and people are excellent, and we’d love to getto know you better!
We’re also redesigning our chapter website to launch a chapter blogthat will help us stay connected with each other, learn aboutprofessional and educational opportunities, and find out what ourfellow chapter members are doing. When the blog goes live, we’llbe looking for blog ideas and useful content throughout ourmembership.
Our chapter serves its members, and we promote excellence inmedical communications by supporting excellent medicalcommunicators like you, so please let us know how we can supportyou.
Best,
Greg AdamsPresidentAMWA Indiana [email protected]
From the President, AMWA Indiana Chapter
October 2014 | AMWA Indiana Chapter Newsletter | 5
Editor's Note:Greg is the 2014-2015 president of the AMWA Indiana chapter, managingeditor at Cook Medical in Bloomington, IN, and co-runs Adams Kaul (aninternational communications agency). He specializes in global English andinternationalization, plain language and patient communication, andcontent strategy to create effective content for a global audience.
From the President, AMWA Indiana Chapter
6 | AMWA Indiana Chapter Newsletter | October 2014
Overview of US Drug Development Requirements forPediatric Populations
by Esther Brooks-Asplund, PhD ([email protected])
In 1977, the American Academy of Pediatrics (AAP) Committee onDrugs issued a policy statement entitled “Guidelines for the EthicalConduct of Studies to Evaluate Drugs in Pediatric Populations”addressing the lack of adequate research to support the safe andeffective use of prescription pharmaceuticals in the pediatricpopulation. Two decades later the Food and Drug AdministrationModernization Act (FDAMA) of 1997 was signed into law andcontained provisions that established incentives for conductingpediatric studies on drugs for which exclusivity or patentprotection exists. Shortly thereafter, in 1998, the FDA published aregulation known as the pediatric rule that partially addressed thelack of pediatric use information by requiring manufacturers ofcertain drugs to conduct pediatric studies to support labeling. In2002, Congress passed the Best Pharmaceuticals for Children Act(BPCA) by providing an additional 6 months of marketingexclusivity for sponsors conducting pediatric studies that meet theterms of a Written Request (WR). A WR is a specific documentissued by the FDA requesting a sponsor to conduct certain studiesto evaluate whether a drug or biologic may have meaningfulhealth benefits in the pediatric population [1]. In 2003, thePediatric Research Equity Act (PREA) was codified, replacing andadopting provisions set forth in the pediatric rule. Under PREA, apediatric assessment must be submitted at the time a sponsorsubmits an application for a new active ingredient, indication,dosage form, dosing regimen, or route of administration to theAgency, unless the requirement for the assessment has beendeferred or waived (for all or some pediatric age groups).
In 2012, BPCA and PREA were made permanent by the passage ofthe Food and Drug Administration Safety and Innovation Act(FDASIA). Under FDASIA, manufacturers of drugs and biologicsare required to submit a pediatric study plan (PSP) early in thedrug development process (recommended no later than 60
Drug Development Requirements
October 2014 | AMWA Indiana Chapter Newsletter | 7
calendar days after the end-of-phase 2 meeting, but no later than210 days before submission of a marketing application). Contentrequirements and timing of submission for the PSP are describedin the July 2013 FDA draft guidance for industry entitled “PediatricStudy Plans: Content of and Process for Submitting InitialPediatric Study Plans and Amended Pediatric Study Plans.” ThePSP should outline the pediatric studies that the applicant plans toconduct and include the following 12 sections: an overview ofdisease in pediatric population; overview of drug or biologicalproduct; planned extrapolation of adult data to pediatricpopulations; request for partial or full waiver, if applicable;summary of planned nonclinical and clinical studies; pediatricformulation development; nonclinical studies; clinical data tosupport pediatric studies; planned pediatric clinical studies;timeline of pediatric development plan; plan to request deferral ofstudies, if applicable; and agreements for pediatrics studies withother regulatory agencies. Similar to, but distinct from the PSP,sponsors may still apply for an additional 6 months of marketingexclusivity by submitting a Proposed Pediatric Study Request(PPSR) before expiration of a patent and conducting studies thatmeet the criteria of an FDA-issued WR. Therapeutic uses of thedrug in children beyond the disease or indication being sought inadults may serve as the basis for a WR. A PSP can form the basis ofa PPSR, but they are different documents.
Although challenges remain in conducting pediatric studies, morethan 500 product label changes have been made since the passageof BPCA and PREA [2]. With the permanence of these laws underFDASIA and continued collaboration among regulators, industry,non-profit organizations, and the medical and scientificcommunity, we are slowly approaching those standards set forthby the AAP in their landmark policy statement issued over threedecades ago.
References:1. US Department of Health and Human Services. Food and DrugAdministration. Center for Drug Evaluation and Research (CDER).Center for Biologics Evaluation and Research (CBER). Guidance
Drug Development Requirements
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for Industry. Qualifying for Pediatric Exclusivity Under Section505A of the Federal Food, Drug, and Cosmetic Act. Revised,September 1999.2. FDA New Pediatric Labeling Information Database. Availablefrom:http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=labelingdatabase. Accessed on 7 October 2014.
Editor's NoteEsther is the 2014-2015 AMWA Indiana chapter member resources chair,owns Hoosier Medical Communication Services Inc. in Bloomington, IN,and has been a clinical research scientist and senior regulatory scientist forCato Research.
Drug Development Requirements
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Manuscript Acceptance
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Manuscript Acceptance
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Manuscript Acceptance
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Manuscript Acceptance
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Manuscript Acceptance
l l l l
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Manuscript Acceptance
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Manuscript Acceptance
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Manuscript Acceptance
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Manuscript Acceptance
October 2014 | AMWA Indiana Chapter Newsletter | 19
Manuscript Acceptance
William S. Pietrzak, PhD ([email protected])
Editor's NoteThese slides were presented at open session 26 of the 2014 AMWAnational conference.
20 | AMWA Indiana Chapter Newsletter | October 2014
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