Indiana Chapter Newsletter October 2014
American Medical Writers Association Indiana Chapter Executive Committee 2013-2014
Newsletter
Officers President President-Elect Secretary Treasurer
Editor
Greg Adams Laura Town Ellen Stoltzfus, PhD Pam McClelland, PhD
David Caldwell, PhD
Associate Editors Editing
Svetlana Dominguez, ELS
Pharmaceutical
Esther Brooks-Asplund, PhD
Committee Chairs Education
Laura Town
Member Resources Program
Esther Brooks-Asplund, PhD
Publications Marketing
David Caldwell, PhD Linda Hughes, MA
Barbara Lightfoot, BS, CCRP
Links
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Contents
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Letter From the President, AMWA Indiana Chapter Greg Adams Overview of US Drug Development Requirements for Pediatric Populations How to Maximize Acceptance of Your Manuscript in a Peer-Reviewed Journal William S. Pietrzak, PhD Job Ad
Cover 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.
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From the President, AMWA Indiana Chapter
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 the works. We’ve begun planning next year’s chapter conference, and we welcome any and all help. If you’d like to volunteer or if you have ideas for the program, let us know. Organizer Laura Town did a terrific job last year and is helping to organize the conference again this year. If next year’s conference is merely as good as this year’s conference, then it will be a great success. And if you missed out on this year’s conference, then be sure to attend next year’s. Our chapter’s programs and people are excellent, and we’d love to get to know you better! We’re also redesigning our chapter website to launch a chapter blog that will help us stay connected with each other, learn about professional and educational opportunities, and find out what our fellow chapter members are doing. When the blog goes live, we’ll be looking for blog ideas and useful content throughout our membership. Our chapter serves its members, and we promote excellence in medical communications by supporting excellent medical communicators like you, so please let us know how we can support you. Best, Greg Adams President AMWA Indiana chapter greg.adams@cookmedical.com 4 | AMWA Indiana Chapter Newsletter | October 2014
From the President, AMWA Indiana Chapter
Editor's Note:
Greg is the 2014-2015 president of the AMWA Indiana chapter, managing editor at Cook Medical in Bloomington, IN, and co-runs Adams Kaul (an international communications agency). He specializes in global English and internationalization, plain language and patient communication, and content strategy to create effective content for a global audience.
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Drug Development Requirements
Overview of US Drug Development Requirements for Pediatric Populations by Esther Brooks-Asplund, PhD (esther.asplund@att.net) In 1977, the American Academy of Pediatrics (AAP) Committee on Drugs issued a policy statement entitled “Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations� addressing the lack of adequate research to support the safe and effective use of prescription pharmaceuticals in the pediatric population. Two decades later the Food and Drug Administration Modernization Act (FDAMA) of 1997 was signed into law and contained provisions that established incentives for conducting pediatric studies on drugs for which exclusivity or patent protection exists. Shortly thereafter, in 1998, the FDA published a regulation known as the pediatric rule that partially addressed the lack of pediatric use information by requiring manufacturers of certain drugs to conduct pediatric studies to support labeling. In 2002, Congress passed the Best Pharmaceuticals for Children Act (BPCA) by providing an additional 6 months of marketing exclusivity for sponsors conducting pediatric studies that meet the terms of a Written Request (WR). A WR is a specific document issued by the FDA requesting a sponsor to conduct certain studies to evaluate whether a drug or biologic may have meaningful health benefits in the pediatric population [1]. In 2003, the Pediatric Research Equity Act (PREA) was codified, replacing and adopting provisions set forth in the pediatric rule. Under PREA, a pediatric assessment must be submitted at the time a sponsor submits an application for a new active ingredient, indication, dosage form, dosing regimen, or route of administration to the Agency, unless the requirement for the assessment has been deferred or waived (for all or some pediatric age groups). In 2012, BPCA and PREA were made permanent by the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA). Under FDASIA, manufacturers of drugs and biologics are required to submit a pediatric study plan (PSP) early in the drug development process (recommended no later than 60 6 | AMWA Indiana Chapter Newsletter | October 2014
Drug Development Requirements calendar days after the end-of-phase 2 meeting, but no later than 210 days before submission of a marketing application). Content requirements and timing of submission for the PSP are described in the July 2013 FDA draft guidance for industry entitled “Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.� The PSP should outline the pediatric studies that the applicant plans to conduct and include the following 12 sections: an overview of disease in pediatric population; overview of drug or biological product; planned extrapolation of adult data to pediatric populations; request for partial or full waiver, if applicable; summary of planned nonclinical and clinical studies; pediatric formulation development; nonclinical studies; clinical data to support pediatric studies; planned pediatric clinical studies; timeline of pediatric development plan; plan to request deferral of studies, if applicable; and agreements for pediatrics studies with other regulatory agencies. Similar to, but distinct from the PSP, sponsors may still apply for an additional 6 months of marketing exclusivity by submitting a Proposed Pediatric Study Request (PPSR) before expiration of a patent and conducting studies that meet the criteria of an FDA-issued WR. Therapeutic uses of the drug in children beyond the disease or indication being sought in adults may serve as the basis for a WR. A PSP can form the basis of a PPSR, but they are different documents. Although challenges remain in conducting pediatric studies, more than 500 product label changes have been made since the passage of BPCA and PREA [2]. With the permanence of these laws under FDASIA and continued collaboration among regulators, industry, non-profit organizations, and the medical and scientific community, we are slowly approaching those standards set forth by the AAP in their landmark policy statement issued over three decades ago. References: 1. US Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER). Guidance October 2014 | AMWA Indiana Chapter Newsletter | 7
Drug Development Requirements for Industry. Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act. Revised, September 1999. 2. FDA New Pediatric Labeling Information Database. Available from: http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=la belingdatabase. Accessed on 7 October 2014.
Editor's Note
Esther 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 for Cato Research.
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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
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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
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Manuscript Acceptance
William S. Pietrzak, PhD (billsp@uic.edu)
Editor's Note
These slides were presented at open session 26 of the 2014 AMWA national conference. October 2014 | AMWA Indiana Chapter Newsletter | 19
Job Ad
Job Ad SUMMARY OF POSITION The Medical Writing Director/Assoc Director plays a key role in our regulatory processes. The Medical Writing group supports the Regulatory Affairs as well as the Clinical Operations functions by developing clinical study protocols, clinical study reports, and regulatory documents across a variety of therapeutic areas. Members of the Medical Writing group work closely with internal teams comprised of Medical experts, Regulatory experts, and Biostatisticians to create high-quality documents tailored to the specific needs of each Sponsor. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Working onsite at our global headquarters in Cincinnati, Ohio the Medical Writing Manager is an integral part of the drug development team. DESCRIPTION OF JOB DUTIES -
Integral member of the team responsible for departmental hiring, training, management, and evaluation of Medical Writers and
other support personnel; -
Supports the Medical Writing group in the development of clinical study protocols, clinical study reports, briefing documents,
and IND, NDA, and MAA components across a variety of therapeutic areas; -
Acts a primary writer and/or project manager for key documents or projects;
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Works with global Medical and Regulatory experts to understand, interpret, and apply the clinical considerations and regulatory
strategies pertinent to document development; -
Works with Sponsors and internal departments to develop timelines for writing projects; and
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Involved in determining and presenting the scope of work for bid proposals.;
QUALIFICATIONS/REQUIREMENTS -
Master’s degree or PhD with at least 3 years of medical writing experience or Bachelor’s degree with at least 5 years medical
writing experience; -
Previous supervisory experience required;
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Strong computer skills, project management skills, and a high attention to detail;
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Strong communication skills (both written and oral);
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Strong analytical and problem-solving skills;
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Experience writing US and/or EU regulatory documents preferred;
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Scientific background preferred.
We are seeking a Medical Writer manager (director or associate director level) for our client, a CRO based in Cincinnati. This position is based in house in Cincinnati, OH. I can share other details with interested candidates. If you are interested in hearing about other Medical Writer contract or perm opportunities, please feel free to forward your CV to me in confidence so that I can reach you. Jennifer Hull
Director of Resourcing
jhull@jemres.com
JEM Resources View my profile on LinkedIn
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