AMWA 2016 Conference Registration Brochure

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2016

AMWA

Medical Writing & Communication Conference OCTOBER 5-8|DENVER, CO

Trends and Opportunities for Medical Communicators In 2016, the American Medical Writers Association (AMWA) presents the Medical Writing & Communication Conference.

Keeping with AMWA’s long-standing tradition of educational excellence, the conference offers an innovative and dynamic approach to ensuring you are prepared for the road ahead while sparking your creativity, engaging you in live interactive learning, and connecting you with your colleagues in the industry.

Full Conference Registration provides access to 3 days of unparalleled education and networking, including 2 General Sessions with award winning speakers, numerous educational sessions, the Medical Communications Resource Hall, facilitated roundtable topic discussion with lunch, beverage breaks and an Awards Luncheon.

Participate in AMWA Workshops for the ultimate conference experience!

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Apply yourself. Apply now.

Earn the MWCTM in 2016 Next exam administration: October 6, 2016 Held before AMWA’s Medical Writing & Communication Conference in Denver, CO Application Deadline: July 31, 2016

www.amwa.org/conference |

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SCHEDULE AT A GLANCE WEDNESDAY, OCTOBER 5 9:00 AM–5:00 PM

Full Day Intensive: The Writing Clinic (additional fee) AMWA Workshops (additional fee)

THURSDAY, OCTOBER 6 8:00 AM–5:30 PM 8:30–11:30 AM 9:00–11:00 AM 9:00 AM–12:00 PM 9:00 AM–12:00 PM 10:30 AM–12:00 PM 2:00–3:30 PM 3:30–4:30 PM 4:00–5:30 PM 6:30 PM

Registration and AMWA Information Desk Open Medical Writing Certification Exam (additional fee) Exhibitor move in and poster set up BELS Exam (additional fee) AMWA Workshops (additional fee) New to AMWA and Medical Communication Session Opening General Session with Alvarez Award Address Beverage Break in the Resource Hall Education Sessions and Speed Networking Dine Arounds

FRIDAY, OCTOBER 7 8:30 AM –5:30 PM 7:30–9:00 AM 8:00–9:00 AM 9:00–11:00 AM 10:30–11:30 AM 11:00 AM–12:00 PM 12:15–1:45 PM 2:00–4:00 PM 3:00–5:00 PM 4:30–5:30 PM 6:30 PM

Registration and AMWA Information Desk Open AMWA Chapter Leaders Breakfast Meeting Continental Breakfast in the Resource Hall Education Sessions Beverage Break in the Resource Hall Education and Speed Networking Roundtable Discussions with Lunch Education Sessions High Tea in the Resource Hall Education Sessions AMWA Chapter Dinners

SATURDAY, OCTOBER 8 7:00 AM–3:00 PM 7:30–8:30 AM 8:30–9:30 AM 9:30–11:30 AM 9:45 AM–12:15 PM 12:30–1:45 PM 1:00–4:00 PM 2:00–4:00 PM 2:00–5:00 PM 2:30–4:30 PM 5:00–5:30 PM

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Registration and AMWA Information Desk Open Continental Breakfast in the Resource Hall General Session and McGovern Award Address Beverage Break in the Resource Hall Education Sessions AMWA Sablack Awards Luncheon and Swanberg Address Exhibitor move out Bonus Intensive Session AMWA Workshops (additional fee) AMWA Board of Directors Meeting Annual Business Meeting for AMWA Members

GENERAL SESSION SPEAKERS Roxanne Khamsi, 2016 Alvarez Award Winner Award presentation and address will be on October 6, 2:00-3:30 PM. What to Leave Out, What to Keep In: Inclusion and Exclusion Criteria for Medical Writing Every medical writer has to decide what terminology works best in a piece, and which words are too technical to use for his or her audience. But how can writers keep jargon to a minimum when they want to convey complex ideas in their writing? What is the hard evidence that avoiding jargon is necessary? In this talk, Ms. Khamsi, chief news editor of the international biomedical journal Nature Medicine, will discuss the medical terms that often trip up readers and share new findings that show what happens when you use jargon.

Kevin Pho, MD, 2016 McGovern Award Winner Award presentation and address will be on October 8, 8:30-9:30 AM. Connect and be Heard: Make a Difference in Health Xare with Social Media Kevin Pho, MD is a practicing board-certified internal medicine physician and a health care social media leader since 2004. He is co-author of the book, “Establishing, Managing, and Protecting Your Online Reputation: A Social Media Guide for Physicians and Medical Practices.” Dr. Pho will take you through his decade-long social media journey, and show how social media can make a profound difference in 3 important ways.

First, how social media can facilitate the connection between health professionals and patients. Second, how social media can proactively define and protect an online reputation. And finally, how social media can share the stories of those who intersect with our health care system, but are rarely heard from. Not only will you see how social media made a difference in Dr. Pho’s life, you will also be inspired to use social media and make your own difference in health care.

Flo Witte, PhD, ELS, 2016 Swanberg Award Winner

Award presentation and address will be at the AMWA Sablack Awards Luncheon, October 8, 12:30-1:45 PM. Flo Witte, PhD, ELS, is a freelance medical editor and the owner of Bluegrass Editorial Services Team, LLC, based in Winchester, Kentucky. She earned master’s degrees in English and German from the University of Southern Mississippi; she also earned a master’s degree in international business and a PhD degree in health communication from the University of Kentucky. Flo has served as director of the Publications Office of the Department of Surgery at the University of Kentucky and as director of the Scientific Editing Department at St. Jude Children’s Research Hospital in Memphis.

The Harold Swanberg Distinguished Service Award is named in honor of Harold Swanberg, MD, the founder of the American Medical Writers Association. This award is presented to an active member of AMWA who has made distinguished contributions to medical communication or rendered unusual and distinguished services to the medical profession. www.amwa.org/conference |

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SCHEDULE WEDNESDAY, OCTOBER 5 9:00 AM–5:00 PM

Full Day Intensive: The Writing Clinic (additional fee, see page 19 for listing) AMWA Workshops (additional fee, see page 19 for listings)

THURSDAY, OCTOBER 6 8:00 AM–5:30 PM

Registration and AMWA Information Desk Open

8:30–11:30 AM

Medical Writing Certification Exam (additional fee) (Application and exam registration information is available online.)

9:00–11:00 AM

Exhibitor move in and poster set up

9:00 AM–12:00 PM

BELS Exam (additional fee) (Registration is available through the Board of Editors in the Life Sciences.)

9:00 AM–12:00 PM

AMWA Workshops (additional fee, see page 20 for listings)

10:30 AM–12:00 PM

New to AMWA and Medical Communication Session If you’re new to AMWA or the profession, join us to learn how to get the most out of the conference, with expert advice on must-do sessions and events tailored to your interests and professional goals. Also discover how AMWA programs, products, and services can help enhance your professional skills and how you can further expand your professional reputation by becoming more involved in AMWA.

2:00–3:30 PM

Opening General Session with Alvarez Award Address This session features a welcome from AMWA President Stephen N. Palmer, PhD, ELS, the presentation of the President’s Award, and the Alvarez Award Address, “What to Leave Out, What to Keep In: Inclusion and Exclusion Criteria for Medical Writing,” by Ms Roxanne Khamsi.

3:30–4:30 PM

Beverage Break in the Resource Hall

4:00–5:00 PM

1 Hour Sessions and Speed Networking Asking the Right Questions: Strategies to Avoid the Garbage-in–Garbage-out Conundrum Question writing is integral to many forms of medical communication. For example, openended and probing-type questions often serve as the backbone for developing news reports and needs assessments. Survey questions with open-ended, close-ended, or Likert-scale responses are useful for gathering data on a specific issue or topic or to assess outcomes from educational interventions. Multiple-choice questions may be used to measure clinicians’ knowledge or evaluate their competence or performance. Questions must be written with careful attention to structure, form, and grammar; further, consideration of what the writer hopes to learn by asking is essential, because poorly written questions will elicit misleading and/or meaningless information. This session takes a problem-solving approach to demonstrating question structure and function, differentiating between poorly written and well-written questions, and preparing questions of various types.

Eve Wilson, PhD, ELS, CHCP, Clinical Education Specialist and Medical Writer, MORPHOS Medical Education, LLC, Bowie, MD Scott Kober, MBA, President, MedCaseWriter, Inc., Philadelphia, PA Alexandra Howson PhD, MA, CHCP, Owner, Thistle Editorial, LLC, Snoqualmie, WA ■

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■ Medical Editing in the International Research Arena The program will advise and assist freelancers in editing/writing for non-native English-speaking authors. We will address: • Special needs and expectations of ESL authors – Simple English “polishing” is almost never enough; their work always needs more.

– Papers can be very complex and time consuming.

– If asked, recommend journals with realistic impact factors.

– Respect the authors’ knowledge and expertise.

– Be tactful in making revisions.

• Working with non-US editing companies – A “foot in the door”—very useful for beginning editors.

– But companies often pay too little, expect too much.

– Some reputable companies are these: to be listed – Some disreputable companies are these: to be listed • Financial aspects – Establish with authors the specific details of your service, e.g., verification of references, revision or structuring of tables, covering letter, responses to reviewers’ comments.

– Quote realistic, specific fees.

– Submit a professional-appearing invoice, with expected date of payment.

– Make payment options specific and as simple as possible.

– Beware of scams.

• Positive aspects and rewards of working with non-US authors – Appreciation of their diligence and dedication – Satisfaction in assisting deserving and striving investigators – Awareness of high-quality, innovative medical research originating outside the Western world William Brown, MD, Director, International Medical Editing Service, Denver, CO ■ Speed Networking Facilitator TBD

4:00–5:30 PM

1.5 Hour Sessions ■ All Tech Considered Ever feel like there is a new hot tech every time you turn around? What is social media? Search Engine Optimization? Field code programming and individualized macros? Two medical writers and noted “tech-heads” will give a quick overview and answer all tech questions in a judgment-free, safe atmosphere. Whether you want to update your website or communicate with your tween niece, we have you covered.

Robin Whitsell, President, Whitsell Innovations, Inc., Chapel Hill, NC Natalie Herr, PhD, Medical Writer and Consultant, Whitsell Innovations, Inc., Chapel Hill, NC

Make Your Freelance Business a Perpetual Feast Many freelance medical writers struggle to build their businesses enough to have steady work from great clients (a perpetual feast). In this interactive panel discussion, three seasoned freelances will use case studies to show common problems that often prevent freelance medical writers from making their business a perpetual feast and how you can solve them. Get practical insights and tips on problems such as: not knowing how to get more business—and referrals—from current clients, not knowing how to network effectively and get more referrals from colleagues, and not following up regularly with prospects. We’ll have plenty of time for discussion of the cases and Q&A. Lori De Milto, MJ, Owner, Lori De Milto Writer for Rent LLC and Author, “The Mighty Marketer: Your Guide to Making More Money as a Freelance Medical Writer,” Sicklerville, NJ Cynthia L. Kryder, MS, CCC-Sp, Medical Communication Specialist, Author, “The Accidental Medical Writer,” Phoenixville, PA Brian Bass, MWCTM, President, Bass Global, Inc., Robbinsville, NJ ■

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■ It’s Time for Medical Writers to Get Big and Dirty: Writing Opportunities in Data, Biometrics, and Technology You don’t have to be a data scientist to join the revolution of Big Data and the Internet of Things (IoT) in medicine and health care. These technologies are creating exciting new opportunities for medical writers, ranging from wearables to genetic screening. Do you know how to leverage your existing skills to write for mobile health, biometrics, and other developing data-driven technologies? The market size of these fields is expected to be 15 times larger by 2024, which translates to numerous opportunities for writers capable of tackling complex data and technology topics—writers that can communicate with both clinicians and technology specialists. If you have been writing in medical technology already or if you want to learn to speak the language of datadriven health technology, this session is the right place! Do you want to know what it means to mine, drill, scrape, push/pull, and even chew data? Do you know what it means for machines to learn and use natural language? This session introduces the language of this exciting new field and discusses career opportunities for medical writers in developing medical technologies and applications in biometrics, mobile health, health records, genetics, and online health tools, among others. This session is designed to empower medical writers at all levels to write for dynamic datadriven medical and health fields.

Angela Johnson, MSE, PMP, RAC, Senior Professional Band Clinical Writer, GE Healthcare, Waukesha, WI

Regulatory and Publications–Building Medical Writing Capability This panel discussion with department leads (decision makers) in different pharmaceutical companies and across Regulatory and Publication Medical Writing will include the following discussion topics: How do you build Medical Writing capability? Do you have an in-house or outsourcing model? What drives your decision of either an in-house or outsourcing model?

Advantages/disadvantages of in-house or outsourcing? What documents have you found best to outsource or keep internally? If outsourcing, how have you been able to build effective partnership?

Do you have a formal process to show value to your organization?

Yeshi Mikyas, PhD, ELS, Director, Regulatory and Publications, MedImmune, Rockville, MD Panelists TBD ■

6:30 PM

Dine Arounds These popular dining out events are a great opportunity to spend some quality time with friends and colleagues outside the conference and sample the tastes of Denver. Attendees will be able sign up onsite for a dine-around group and explore the city.

FRIDAY, OCTOBER 7 8:30 AM–5:30 PM

Registration and AMWA Information Desk Open

7:30–9:00 AM

AMWA Chapter Leaders Breakfast Meeting

8:00–9:00 AM

Continental Breakfast in the Resource Hall

9:00–10:30 AM

1.5 Hour Sessions Targeting Lay Audiences Does your writing motivate your lay audiences to act appropriately? In this session, you will learn how to use audience analysis to create health messages targeted to specific lay audiences, which can enhance outcomes. Learn how to develop an argument and use persuasive techniques to get your audience to believe in your message and, most important, to act on it. This session is for medical communicators who have experience writing for lay audiences and want to enhance their ability to reach and motivate audiences.

Lori Alexander, MTPW, ELS, MWCTM, President, Editorial Rx, Inc., North Ft Myers, FL ■

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The Medical Writer’s Role in Helping Patients Make Healthcare Decisions A key element of today’s healthcare environment is making sure that patients can share in making decisions about their health care rather than clinicians making decisions on their behalf. As medical communicators, we have a unique role to play in creating shared decision making tools for healthcare organizations. In this session, you will learn: • Best practices and where to find resources for writing and designing these tools (with before-andafter examples from Intermountain Healthcare) • To consider the role of patients’ personal values and barriers to behavior change when creating shared decision making tools • How to effectively communicate risk to patients with low health literacy • A process for creating shared decision making tools for clinical conditions or procedures. The session will include a hands-on exercise where participants will take a medical fact sheet that “tells” patients about treatment options for a particular condition and translate that information into an actionable, shared decision making tool.

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Kathi Whitman, Senior Medical Writer/Project Manager, Intermountain Healthcare, Sandy, UT Heather Bloyer, Senior Medical Writer/Project Manager, Intermountain Healthcare, Salt Lake City, UT Complex Case Studies for Freelance Writers In this session, each presenter will take 1-2 recent challenging professional experiences as freelance writers and turn them into interactive case studies. Each case will offer learners an opportunity to discuss and reflect upon a variety of key issues faced by experience freelancers such as client recruitment and retention, contracting/subcontracting, business operations, and project management.

Scott Kober, MBA, President, MedCaseWriter, Inc., Philadelphia, PA Debra Gordon, MS, Medical and Healthcare Communications Consultant Michelle Dalton, ELS, Principal, Dalton & Associates, Reading, PA Tracy Bunting-Early, PhD, CHCP, CMPP, Publications Lead, Evidence Generation, US Medical Affairs, AstraZeneca. Wilmington, DE ■

Building an Effective In-house Medical Writing Group (Regulatory and Publications) This is a panel discussion with department heads who make decisions about their Medical Writing groups (both Regulatory and Publications). Discussion will include: When hiring Medical Writers what are you looking for? What kind of qualification/training is important to you? How do you continue to build an efficient group with limited resources? Do you have a formal onboarding/ training process? How do you continue to build your writers/talent? Do you have programs such as mentorship, postdoctoral training, etc?

Yeshi Mikyas, PhD, ELS, Director, Regulatory and Publications, MedImmune, Rockville, MD Panelists TBD ■

■ How to Build a Business Case and Influence Change This workshop is designed to empower people to influence change in their companies. Tech writers learn about new tools and methods yet often are not equipped with the confidence and language necessary to sell an idea back to their companies. As a technical communicator in the medical field, you are up-to-date on all of the new writing methods and innovative tools of the trade. You know how important content reuse is, how critical good templates are, and how best to work on a team.

However, when you identify a better method, a better tool, or recognize opportunities for process improvements, it can be a challenge to convince your company to explore your solution and to get a budget approved.

Lisa Pietrangeli, Managing Partner, 36Software, Rochester, NY

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Optimize Your Online Content: SEO Toolkit for Medical Writers and Editors 72% of internet users say they have looked online for health information within the past year, with 77% of this audience indicating they began their search for information by using a search engine such as Google, Bing, or Yahoo (Pew Research Center). With ever-changing Web standards and search engine ranking algorithms, effective SEO practices are central to leading internet users to your online content. This presentation will overview the most recent search engine algorithm changes that affect content optimization, latest SEO best practices, and tools you can use to ensure your content is optimized and targeted toward your targeted audiences. This hands-on demonstration will include showing the most effective tools to use for SEO research, how to implement findings from research into an SEO strategy, and how to successfully implement that strategy into online content. The presentation will cover topics applicable for those with a beginner to intermediate knowledge of SEO. Sara Wuillermin, Senior Copy Editor, Deardorff Associates, Wilmington, DE Nicole Hess, Director of Strategy, Greenlane Search Marketing, Phoenixville, PA Aryn Gallagher, Advertising Coordinator, Deardorff Associates, Wilmington, DE ■

9:00–11:00 AM

2 Hour Sessions Performing Quality Control Reviews of Regulatory Documents: Jump-start Your Career Path to Regulatory Writing This session will cover techniques and processes to perform thorough Quality Control (QC) reviews of regulatory documents, including some lecture as well as hands-on practice with typical QC tasks and checklists. QC review is much more complex than performing basic proofreading tasks; the skill set for performing QC reviews is similar yet different from the skill sets needed to become a regulatory medical writer, and may offer a path to entry-level regulatory writing.

Performing QC is an excellent way to a) become familiar with various styles of writing, b) gain experience in working with a wide range of regulatory documents, c) develop the skills needed to transition into a Medical Writer role for regulatory documents.

Peggy Boe, RN, Principal, Nightingale Medical Writing, LLC, Hampstead, NC ■

How to Answer the “So What” Question Whether explicitly or implicitly, all readers expect the writer to answer the crucial “so what” question. Why is this content important to me? Is the topic worth my time or useful in my professional or personal life? Addressing these questions can be especially problematic for the medical writer. We may communicate with diverse groups of potential readers: medical research communities, patients, clinical study participants, grant application decision-makers or general public, to name a few. Sometimes target audiences overlap, requiring multiple versions of the identical content. In this seminar we will identify compositional strategies best suited to addressing different audiences using subject matter drawn from a single source.

We’ll analyze audience expectations characterizing four typical medical writing assignments: 1. research protocol 2. informed consent form 3. website clinical study description 4.peer-reviewed journal article. By exploring how to adapt similar content to varied audiences, participants will learn techniques for answering the “so what” question implicit in each genre. By practicing these skills, writers will improve their ability to successfully complete a wide range of projects. The session includes handouts and activities to reinforce key points.

William Van Nostran, Medical Communications Specialist, Rebecca D. Considine Research Institute, Akron Children’s Hospital, Akron, OH ■

10:30–11:30 AM 11:00 AM–12:00 PM

Beverage Break in the Resource Hall 1 Hour Sessions and Speed Networking The CORE Reference: A Medical Writer’s Guide to Preparing CSRs in an Evolving Context One of the seminal documents prepared by medical writers is the Clinical Study Report (CSR). The current ICH guidance on CSR authoring is ICH E3, and the 2012 Questions and Answers (Q&A) Revision document. Inconsistencies in interpretation require clarification. CORE Reference (see http://www.core-reference.org/) launched in May 2016, provides interpretational guidance on CSR authoring that incorporates real-world insights. These include guidance on writing CSRs that share ■

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clinical trial data responsibly, and in accordance with current public disclosure requirements. Data disclosure and transparency have become an important concept in new guidance from FDA and EMA. A particular point of discussion will be how the CORE Reference can become a valuable tool in the medical writers armamentarium to best comply with current guidance. Attendees will also be given a helpful review of key concepts that can be applied to proactive preparation of CSRs for uses that require redacted personally-identifiable information.

Aaron Bernstein, PhD, Aaron Bernstein Consulting LLC, Millburn, New Jersey Art Gertel, MedSciCom, LLC, Lebanon, NJ Amy Myers, PPD Submit is not a Panic Button… Removing Fear From the Submission Process Does the thought of submitting a manuscript or congress abstract produce a stress response? This session will de-mystify the submission process and provide you with tips and tools to enhance your comfort with the process. We will provide an overview of general requirements for submissions, present some common pitfalls, address potential ethical issues, and provide suggestions to keep your submission on track. During this interactive session, the audience is encouraged to share insights and experiences. A goal of the session is to facilitate networking among participants to help establish peer connections that can be enlisted to assist with navigating possible roadblocks when real-life submission difficulties arise.

Charlotte Kenreigh, PharmD, CMPP, Principal Medical Writer, Envision Pharma Group, Southport, CT Linda Wagner, PharmD, CMPP, Prinicpal Medical Writer, Envision Pharma Group, Southport, CT ■

Social Media and Marketing: Developing Efficient Tools and Techniques Social media is a powerful tool for marketing. There are various key social media platforms that allow medical communicators to establish a brand and their expertise in a particular area. A well-developed content marketing strategy is key in today’s social media landscape. Publication of good content, along with a creative distribution style, can bring your marketing campaign to the next level. This open session will discuss how to use key social media platforms for a traditional approach to social media marketing (inbound marketing and social listening) and for new trends that can set your business apart from others (content curation, real-time social media marketing, and visual marketing). We will also discuss the importance of looking beyond these platforms to novel social media tools currently available for marketing.

Ruwaida Vakil, MS, Principal, ProMed Write LLC, Somerset, NJ Jennifer Minarcik, MS, Principal, Jennifer Minarcik Biomedical Communications LLC, Moorestown, NJ ■

Tempted by Templates? The Dos and Don’ts of Creating Templates in Microsoft Word Document templates vastly simplify the work of medical writers by eliminating duplication in the preparation of similar document types and allowing for standardized documents that comply with regulatory and corporate format and style requirements. In addition, templates ensure consistency across the many documents produced across teams, departments and external agencies. Whilst many companies purchase commercial templates, an understanding of templates, how they work and how to modify them is helpful. This session will briefly cover the benefits of templates and introduce the range of ready-made templates available in Microsoft Word. As these are not necessarily suited to medical writing needs the key thrust of the session will be to provide instruction on how to create custom templates and how to define their style and formatting. It will also cover how to install and run template plug ins and macros to simplify some of the more complex tasks, as well as how to clean old templates of unwanted styles and adapt to current requirements. Learning to use and create templates will increase overall productivity, allowing medical writers to concentrate on the content of their documents rather than the formatting.

Stef Brown, Product Specialist, PleaseTech Ltd ■

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Generating Real-World Evidence: The Emergence of Pragmatic Clinical Trials This session introduces the unique features of pragmatic clinical trials (PCTs), an important study approach increasingly supported by NIH, PCORI, and other national collaborative research efforts.

In contrast to traditional clinical trials typically conducted under highly controlled conditions and in carefully selected groups of participants, PCTs involve a broad population and take place in settings where everyday care happens, such as community clinics, hospitals, and healthcare systems. While traditional trials are designed to inform clinicians about the safety and efficacy of an intervention, PCTs are intended to inform a range of decisionmakers, including patients, providers, health administrators, and policymakers, about the relative benefits, burdens, and risks of a health intervention. This session also will explore challenges and opportunities for scientific communicators engaged in disseminating findings from pragmatic research projects, drawing on initial efforts in developing the NIH Collaboratory’s Living Textbook and other web-based communications. We developed a content platform and communications approach capable of serving multiple stakeholder communities, including both novice and experienced clinical trialists, clinicians, and patient advocates. We will also explore ongoing challenges that include technical constraints, keeping resources relevant for long-term use, engaging subject matter experts in cooperative efforts, and adapting to changing technologies.

Liz Wing, MA, Senior Science Writer/Editor, Duke Clinical Research Institute, Durham, NC Jonathan McCall, MS, Senior Science Writer/Editor, Duke Clinical Research Institute, Durham, NC ■

Patient-Centered Care and Outcomes Research: Overview, Implications, and Opportunities for Medical Communicators As part of the National Quality Agenda, efforts are increasing to improve patient autonomy in healthcare and participation in medical decision making. Patient-centered processes of care are being implemented at many levels as a result of the Patient Protection and Affordable Care Act of 2010. These processes aim to improve clinical outcomes, improve the overall patient experience, and lower costs of medical procedures. To assess the effectiveness of these programs, patientcentered outcomes research (PCOR) is conducted, and the results are used to further improve the delivery of care. Patient-centered processes of care are built on the belief that integration of patients and their families into medical-decision making will result in optimal outcomes. For patients, medical communicators can play a crucial role in improved delivery of information, provision of networking opportunities, and knowledge of risk-reduction practices. For clinicians, medical communicators can clarify the results of PCOR, facilitate improved care delivery, and augment clinical decision-making processes. This session will provide an overview of PCOR with a focus on concepts and terminology. The implications of patient-centered care and PCOR and the wealth of opportunities for medical communicators will be discussed.

Jennifer Barnes, Lead Medical Writer, Carolinas Medical Center, Charlotte, NC ■

Speed Networking Facilitator TBD ■

12:15–1:45 PM 2:00–3:30 PM

Roundtable Discussions with Lunch (See page 23 for listings.)

1.5 Hour Sessions Writing Under Fire: Skills and Opportunities for Writing in a Crisis Life and death can be on the line in medical writing. Have you ever been asked to write for a complex project on a tight deadline, when the information wasn’t complete or was dynamically changing? Whether you write under these conditions occasionally or often, being prepared to manage writing quality and speed—and your own sanity—in high pressure situations can help you succeed when hours or even minutes count. Writing in high pressure situations occurs across medical writing disciplines. These range from documenting serious adverse events in clinical trials to product recalls, audits, PR nightmares, research misconduct, and health care infrastructure failures. In these critical situations, medical communicators are a central liaison between those with critical health information and patients, providers, agencies, and the public that need to know. A panel of writers with diverse backgrounds in medical publications, practice, and research will discuss writing strategies applicable to a variety of high pressure situations. You will have the opportunity to join a conversation about recognizing the good, bad, and ugly of writing under ■

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pressure, which we hope will inspire you to build proactive strategies to perform and deliver in a crisis—and help you achieve satisfaction and new opportunities from challenging situations.

Angela N. Johnson, MSE, PMP, RAC, Senior Professional Band Clinical Writer, GE Healthcare, Waukesha, WI Catherine Cadogan, BS, Senior Professional Band Clinical Writer, GE Healthcare, Waukesha, WI Carrie Lauer, MS, Contract Clinical Writer, GE Healthcare, Waukesha, WI ■ Weeding Out the Myths: How Colorado Public Health Officials and Providers are Managing Recreational Marijuana How is Colorado faring since it legalized recreational marijuana in 2012? If you need to write an article or prepare a presentation on recreational marijuana, where do you go for reliable information? Panelists from the Colorado Department of Public Health and Environment, the University of Colorado School of Pharmacy, and University of Colorado School of Medicine will discuss what they are observing, the information they are collecting and reviewing, and how this information is being communicated to the public and health care professionals. The focus of this panel is not only to report real-world data but also to discuss the process by which evidence-based information is gathered, evaluated, and communicated.

Elise Eller, PhD, Freelance Medical Writer, Eller Medical Writing, LLC, Lafayette, CO Mike Van Dyke, PhD, CIH, Chief of the Environmental Edidemiology, Occupational Health, and Toxicology Branch, Colorado Department of Public Health and Environment, Denver, CO Laura Borgelt, PharmD, FCCP, BCPS, Associate Dean and Professor, Department of Clinical Pharmacy and Family Medicine, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO Andrew Monte, MD, Associate Professor of Emergency Medicine and Medical Toxicology, University of Colorado School of Medicine, Aurora, CO

Principles of Regulatory Writing for Academic and Scientific Writers There are situations when scientific writers (eg, bench scientists, manuscript writers) not ordinarily involved with writing regulatory documents, such as protocols or clinical study reports have opportunities to author and/or review these documents. While these writers are familiar with scientific writing, there may be a gap in their understanding of the audience and approach for writing regulatory documents. The proposed session is a modular training workshop to provide information regarding the purpose, audience, and basic principles of regulatory writing for scientific writers who have not written regulatory documents. Also, we have found that experienced medical writers that have attended these trainings really appreciated having a refresher. Using examples and exercises, we show the differences between regulatory and scientific deliverables (ex, manuscripts, nonclinical protocols), with attention to the fundamental principles of clear, concise authoring style, including: Writing with clarity, impact, precision, and conciseness: using sentence and paragraph structure to promote quick, accurate interpretation of intended meaning, avoiding ambiguity; How to effectively compare and contrast information across regulatory documents; How to author with the end in mind (eg, authoring text for repurposing within and across documents in a program).

Joanna Harris, Principal Medical Writer, Global Medical Writing, PPD, Morrisville, NC Kimberly Jochman, PhD, Senior Manager, Global Medical Writing, Document Review, PPD, Morrisville, NC Rachel Eckert, DVM, PhD, Principal Medical Writer, Global Medical Writing, PPD, Morrisville, NC ■

Best Practices in Writing Test Items The demand for test items in continuing medical education is increasing, creating new opportunities for medical communicators. Learn how to write and edit cases, questions, and answer options according to best practices in this how-to session. The content emphasizes key points in the National Board of Medical Examiners (NBME) guidelines on writing test questions for the basic and clinical sciences. The session is targeted to writers and editors who have little to no experience with writing test items, but will also be of benefit to more experienced writers and editors.

Lori Alexander, MTPW, ELS, MWCTM, President, Editorial Rx, Inc., North Ft Myers, FL ■

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■ Value-Based Purchasing: What Medical Writers Need to Know About the New Healthcare Environment The US healthcare system is undergoing a tsunami of change, all of which affects medical writers.

The greatest shift occurring is in reimbursement as we move from a fee-based to a value-based system. In this presentation, you will learn about the various forms of value-based purchasing (capitation, shared savings, risk, etc), how it is playing out today (penalties for readmissions and hospital-acquired conditions, accountable care organizations, mergers and acquisitions), and how it will fundamentally shift priorities (and is shifting priorities) for drug and device companies, insurers, employers, and businesses (not to mention patients).

Debra Gordon, MS, President, GordonSquared, Highland Park, IL

Public Access to Clinical Documents – the new Transparency Policies in Europe This session will introduce the new ways of access to data currently available in Europe. The presentation will focus on the new EMA (European Medicines Agency) policies on reactive (EMA policy 0043) and proactive (EMA policy 0070) release of clinical documents to the public. With the implementation of these policies, many clinical documents that are submitted as a part of marketing authorization applications (MAA) will become publically available. EMA only permits the redaction of personal information and of ‘commercially confidential information’. Examples of the two categories will be presented and discussed. The new policies will impact on the way clinical documents need to be written in the future. Sponsors will need to define their redaction and anonymization policies. Authors of clinical documents will have to find a balance between retaining the medical usefulness of the published clinical documents and minimizing the risk of re-identification of study participants. In addition, the new EU regulation (536/2014) mandates that every study report is accompanied by a summary that is understandable for lay persons. Key elements of these lay person summaries will be presented. Available guidance documents on format and content of the study result summaries for lay persons will be presented and discussed.

Thomas Schindler, PhD, Head Medical Writing Europe, Boehringer Ingelheim Pharma GmbH & Co.KG, Biberach ad Riss, Germany ■

2:00–4:00 PM

2 Hour Sessions Principles of Pharmacology for Medical Writers The presentation will describe and discuss essential pharmacology terminology (i.e. half-life, Cmax, Tmax, clearance, plasma and blood exposure, bioavailability). It will also provide guidelines on data interpretation and statistical analysis and will describe how to write results and appropriate conclusions for scientific and regulatory submissions.

Ruggero Galici, PhD, Medical Writer, Celgene Corporation, Summit, NJ ■

Publications for Launch Products: Managing Accelerated Timelines and High Volume The Bard wrote, “Some are born great, some achieve greatness, and some have greatness thrust upon them.” Whether your high-volume/launch-product publication plan was crafted with intent or created by changing priorities, we will provide guidance for successfully driving and managing the implementation. We will present the particular challenges of launch-product publications, including constrained timelines, simultaneous conference-journal article publications, and interactions with high-profile opinion leader authors. We will explain the challenges associated with executing high-volume publication plans, regardless of the product’s place in its lifecycle, including resource management, work distribution, freelance/agency contracting, and industry/ academic role-setting. We will explain key strategies for successfully executing global publication plans, such as managing stakeholder relationships, standardizing communications, clarifying roles for industry and academic authors, and working with journal/publisher staff. Finally, we will share our experiences in working as a closely linked medical writing team—what has worked, has not worked, and may work for your situation.

Annalise Nawrocki, PhD, Medical Writing Manager, Amgen Inc, Thousand Oaks, CA Tim Peoples, MA, ELS, CMPP, Medical Writing Manager, Thousand Oaks, CA Janice Carlson, PhD, Medical Writing Manager, Amgen Inc, Thousand Oaks, CA ■

3:00–5:00 PM

High Tea in the Resource Hall

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4:30–5:30 PM

1 Hour Sessions Tools Editors Use All editors use tools, both electronic and analog. Join us as we discuss some of the many tools (style guides, online tools, Word macros, paper “cheat sheets,” and more) that speed our editing process, save us time, and help us avoid embarrassing errors. Be prepared to share your favorite editing tools as well. This course is meant for anyone who edits any copy that goes out to the public (website content, letters, e-mails, procedures, reports, forms) or internal documents. Determine the best style guide(s) for editing your particular content. Watch demonstrations of online tools that help to automate editing, including Microsoft Word tools (spellcheck, TRK changes, macros, etc). View sample analog cheat sheets that might help you prepare your own cheat sheets. Learn about professional editing organizations (AMWA, EFA, EEI, STC TE-SIG) that might help you professionalize your editing practice. Explore resources (books, websites, blogs) about editing and the business of editing.

Bette Frick, PhD, ELS, President, The Text Doctor LLC, Boulder, CO ■

Build Your Freelance Business with a Strong Online Presence A strong online presence—LinkedIn, AMWA Freelance Directory, and website—is now essential for freelance medical writers. Yet, developing these marketing tools can seem overwhelming. In this session, two seasoned freelance online marketers will share their insights and tips on where and how to focus your online energy to ensure the biggest impact. We’ll cover LinkedIn and the AMWA Freelance Directory first, and show you how you can use that information in your website content too. Then we’ll cover how to plan and write your web content and develop and maintain an effective business website. We’ll share examples of effective LinkedIn profiles, AMWA Freelance Directory listings, and websites for freelance medical writers.

Ciranna Bird, MS, Medical Writer, Independent, Raleigh, NC Lori De Milto, MJ, Owner, Lori De Milto Writer for Rent LLC and Author, “The Mighty Marketer: Your Guide to Making More Money as a Freelance Medical Writer,” Sicklerville, NJ ■

Medical Writing in Real Time: The Evolution of an Outbreak Outbreaks like Ebola and Zika virus require real-time reporting of limited evidence-based data. It is imperative that medical writers adapt to shifting needs for clinical information while maintaining rigorous evaluation of data available at any given time. In this session, medical writers from the Infectious Disease publishing group at DynaMed Plus will discuss their approach to the Zika virus outbreak, providing a time-lapsed perspective on the creation and evolution of their Zika virus infection content from January 2015 to present. We will 1) review strategies for data mining from public health resources and systemic review of literature, 2) discuss processes for identifying content critical for decision-making at the point-of-care, and 3) introduce methods for monitoring and surveillance of ongoing outbreaks.

Heather Marshall, Medical Writer, DynaMed Plus, Ipswich, MA Pei Chun Yeh, Senior Medical Writer, DynaMed Plus, Ipswich, MA ■

■ The Future of Print Medical Journals: Strategies for Medical Writers to Lead and Stay Relevant in a Changing Publication Arena Medical communication soothsayers suggest that the traditional peer-review print publication model is dying. Dissemination of clinical data occurs at a faster pace, through more channels, and through multiple mediums. Customary measures of publication prestige are shifting, including impact factor, access, editorial board membership, and publication timelines. And, there is a lack of trust due to the increase in predatory journals. What should our community of medical writers know about this changing paradigm so that they can adapt to the new environment, be savvy consumers of published data, and work with their stakeholders to adapt communication strategies to this new environment? What approaches should they incorporate to lead clients to successful medical communications. This session will present a lively discussion of trends in the medical journal publishing field, consolidate the recent spate of editorials on the subject from various publishers, and discuss success strategies for medical writers to acclimatize and lead in the new journal medical publishing world.

Patti Peeples, RPh, PhD, CEO and Principal Researcher, HealthEconomics.Com, Ponte Vedra Beach, FL Michelle Dalton, ELS, Founder, Dalton & Associates, Reading, PA Jeanne McAdara, PhD, Principal, Biolexica, Longmont, CO

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QC Review of Safety Narratives: More Than Just Checking the Data QC Review of Safety Narratives: More Than Just Checking the Data Safety narratives are an integral part of submissions for new drugs and new indications as well as ongoing pharmacovigilance.

These concise, data heavy documents require that QC reviewers to use special attention to detail, understand clinical settings, and exercise a keen sense of logic during the QC process. In this open session, attendees will learn how to review safety narratives for completeness, accuracy, clarity, and consistency. Discussion will include how to identify and reconcile discrepancies in CIOMS forms versus listings; how to create systems to increase productivity during QC review; and using tools for verifying dates and tracking a large QC project.

Kent Steinriede, MS, Senior Medical Writer, inVentiv Health Clinical, Bala Cynwyd, PA ■

■ CMC 101: Introduction to the Chemistry, Manufacturing, and Controls Sections of a Regulatory Dossier This course is designed to give technical writers that typically write the clinical or nonclinical sections of a regulatory submission a basic understanding of chemistry, manufacturing, and controls (CMC) information required for the dossier. A general knowledge of this content and the associated timing for generating data can help teams understand and/or anticipate potential hurdles faced by CMC when working to meet filing deadlines and requirements. This session will begin by defining important nomenclature used in CMC. After the nomenclature is described, there will be a brief discussion about the CTD pyramid and how Quality or Module 3 fits into that pyramid.

Details about the actual information found in the sections and the section organization will be explored using a D Ration bar from World War II as an example product to be registered. CMC information discussed includes manufacturing process, container closure, materials and excipients, analytical testing, specifications, batch analyses, and stability details for both drug substance and drug product. Example timelines will also be shown to illustrate the steps and timing needed to acquire CMC information and to generate data needed to support the submission. Finally, there will be a discussion about some factors that can affect submission timing.

RS Robin Robinett, PhD, Director, Merck, West Point, PA ■ Jam Session for Seasoned Freelances When accomplished musicians jam, their combined talent, energy, and experience make a special kind of synergy. A similar kind of magic happens when seasoned freelances get together to discuss their thoughts, ideas, concerns, and challenges with peers of equal or greater experience. These rare gems of collegial conversation and commiseration happen spontaneously and usually unpredictably. (Often they involve a glass of wine.) So in the mile-high city of Denver we’re looking to make some jam session freelance magic! This no-holds-barred open session will provide a supportive space for freelances who have a minimum of 10 years of continuous and current freelance experience to wrestle their demons and share their experiences. Whether you emerged bloodied and bruised, valiant, or victorious, we all have stories to tell, and we can all learn from and teach each other. The session will be unstructured to permit a free flow of discussion among participants, and for the immediate interests of the group to guide topics and segues. Sorry, there won’t be any wine during the session. But we’re scheduled for the end of the day, so those who are interested can continue their conversations over happy hour and/or dinner and wherever the journey takes you.

Brian Bass, MWCTM, President, Bass Global, Inc., Robbinsville, NJ

6:30 PM

AMWA Chapter Dinners Meet up with your chapter colleagues before heading out for dinner.

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SATURDAY, OCTOBER 8 7:00 AM–3:00 PM

Registration and AMWA Information Desk Open

7:30–8:30 AM

Continental Breakfast in the Resource Hall

8:30–9:30 AM

General Session and McGovern Award Address This session features the presentation of the McGovern Medal Address, “Connect and be heard: Make a difference in health care with social media,” by Kevin Pho, MD.

9:45–10:45 AM

1 Hour Sessions You Don’t Have to Build Software to Do DITA Medtronic ENT deployed a brand-new DITA solution, employing all the traditional strategies and best practices for DITA such as specializing only where absolutely necessary and adopting minimalist approach to topic-based authoring. As a global organization, they had a lot of resources to draw upon when architecting their design. They had two specific goals. First, they wanted to take control of content that had a complex organizational responsibility and ownership matrix.

Several content components which have multiple uses in both customer documentation and federal filing; and, the authoring and ownership of this content belongs to different organizations in the enterprise at different times during the product lifecycle. Second, they wanted to avoid customization wherever possible. Other divisions hadn’t managed to avoid building software tools or doing heavy customizations. Rather than developing extensive customizations to their content management system or to the tools that join different organizations and parts of the process, they applied methodologies from the disciplines of library science, change management, and process management. This approach not only had significant cost savings at implementation time, but it secured their system against lengthy and complicated upgrade cycles going forward as well.

Elizabeth Fraley, CEO, Single-Sourcing Solutions, Sunnyvale, CA ■

How to (and Not to) Create Presentations in PowerPoint PowerPoint has become a “necessary evil,” a skill all medical writers should possess. I maintain that PowerPoint is not evil, and can be—or at least has the potential to be—one of the most effective communication mediums there is. Effective communication of content is what we do as medical writers, but lethal PowerPoint presentations (I’m sure you’ve seen them) seriously detract from effective delivery of information. The presentation focuses on some of the specific components of PowerPoint presentations that make them engaging, effective communication tools.

Kelleen Flaherty, MS, MWCTM, Adjunct Assistant Professor, University of the Sciences in Philadelphia, Biomedical Writing Programs, Jamison, PA ■

6 Steps to Writing Health Content That Moves People Turn “same old, same old” messages into engaging, informative health content that helps nudge consumers into changing behaviors—from eating healthy to quitting smoking. This interactive session will reveal secrets to writing health education that inspires and motivates—and keeps consumers engaged from beginning to end. Learn best practices and principles borrowed from scriptwriting, advertising, and health psychology, and explore ways you can use them to enhance how you write health information for print, web, or video.

Debbie Dakins, Content Manager, Healthwise, Boise, ID Colleen Cronin, Medical Writer, Healthwise, Boise, ID ■

It’s Good to Talk: In-Depth Interview Techniques and Best Practices Do you interview subject matter experts, key opinion leaders, clinicians, or patients? Although talk and conservational exchange is at the heart of day to day communication, it’s not always easy to get the right information from interviewees. This practical session (yes, you’ll have to interview someone!) will focus on improving your interview know-how. Learn new techniques or brush up on rusty skills.

Alexandra Howson PhD, MA, CHCP, Owner, Thistle Editorial, LLC, Snoqualmie, WA ■

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Touchdown! or Fumble? The Medical Writing-to-Publishing Handoff Before the magical submit button in any eCTD submission can be clicked, a series of handoffs must occur across multiple functions of drug development. Proper planning and communication between medical writing and publishing can facilitate a clean handoff and minimize threats to the submission timeline. Medical writing deliverables are on the critical path and compete with publishing directives for the medical writers’ attention. This session will detail common risks, risk mitigation strategies, and how to establish integrated workflows across functions. Shared experiences and perspectives of project managers, medical writers, and publishers will be provided to cover the end-to-end process of submission documents. A discussion of overall strategies and case studies will wrap up the conversation. Topics for discussion to support the learning objectives will include: medical writing-publishing cross-training; source document formatting, style, granularity; medical writer and publisher-friendly formatting style guides and templates; document management systems; rolling handoffs; pre-handoff checklists.

Natalie Herr, PhD, Medical Writer and Consultant, Whitsell Innovations, Inc., Chapel Hill, NC ■

9:45–11:15 AM

1.5 Hour Sessions ■ What’s Behind That Curtain, Anyway? Create eCTD Compliant Regulatory Documents and Protect Your Professional Reputation Regulatory publishers compile electronic Common Technical Document (eCTD) submissions to global Health Authorities like the FDA. Regulatory publishers (including internal Regulatory Operations teams) typically want content one month before a submission deadline. As a writer, does this time requirement seem excessive to you? It’s not! Did you know that publishers spend approximately 70% of their time remediating content provided by vendors, including regulatory writers? For companies that outsource their publishing, Reg Ops contracts assume the receipt of eCTD-compliant content. After all, the technical specifications for this content are published in Health Authority guidances. Therefore, content remediation efforts are out-of-scope and are billed at-cost to Sponsors. This is a very unpleasant surprise to Sponsors that impacts the professional reputation of the regulatory writer–very often unknown to them! Templates for regulatory documents are a good start, but they are commonly used incorrectly and inconsistently. With pending eCTD mandates, discover what is behind the eCTD publishing curtain and how to align with eCTD compliance; learn how to consistently achieve it and to demonstrate it. As a regulatory writer, your reputation can depend on it.

Mitchell Seymour, PhD, RAC, CEO/Principal, R&D Advisors, LLC, Ann Arbor, MI

$200 (or More) an Hour? Yes, You Can do it.

This session features three experienced freelancers discussing how they managed to earn hourly rates far higher than those most clients would pay — without the client blinking. You’ll learn the how and why of project pricing and tips and tricks to work more efficiently, ie, faster — a key component to increasing your hourly rate.

Debra Gordon, MS, President, GordonSquared, Highland Park, IL Michelle Dalton, ELS, Principal, Dalton & Associates, Reading, PA Scott Kober, MBA, President, MedCaseWriter, Inc., Philadelphia, PA ■

9:30–11:30 AM 11:15 AM–12:15 PM

Beverage Break in the Resource Hall 1 Hour Sessions Writing Effective Academy of Managed Care Pharmacy (AMCP) Dossiers The Academy of Managed Care Pharmacy (AMCP) dossier is the U.S. document standard by which managed care organizations request evidence-based information to evaluate pharmaceuticals, biologics, and vaccines for formulary placement, coverage, and reimbursement decisions. In this presentation, you will learn about: the role of AMCP dossiers in value story communication, how the AMCP dossier is used to help make market access decisions, recent updates to the dossier format (version 4.0, due April 2016), as well as other practical issues related to drafting these documents. We will also discuss the e-dossier submission system, how payers view AMCP dossiers, and how drug pricing can affect the quality of economic models in AMCP dossiers.

Caitlin Rothermel, MA, MPH, Principal, MedLitera: The Medical and Health Economics Writing Group, Vashon, WA ■

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Steps to Create a Medical Writing Handbook Do you need to provide your team with accurate and consistent information about your organization, important processes, best practices and handy tips that can be changing from time to time? This presentation describes the process of creating a medical writing handbook, a concise index document that provides one-click access to a wide range of the most current information for your intended audience. This handbook has been used as an onboarding tool that complements the training and development of new staff, as well as a single source of day-to-day information for all members in a global medical writing team. The types of topics to be included in the handbook and the way to maintain the handbook will also be discussed. The concept of the handbook can also be extended to provide your clients or contractors with pertinent and up to date information.

Rebecca Wong, PhD, Manager, Medical Writing Services, North America, PAREXEL International, Port Coquitlam, BC ■

Closing the Deal: Getting That Freelance Project Do you have lots of prospects but not enough work? You’re not alone. Many of us went independent because of our strong communication skills, and realized in hindsight that we weren’t as strong in business skills. In this session, Alisa will discuss different ways to identify solid prospects, ask for what you need, and close the deal with prospective clients without feeling like a used car salesman.

Alisa Bonsignore, Writer & Strategist, Clarifying Complex Ideas, Pleasanton, CA; Director, Society for Technical Communication ■

■ Content be Nimble: Creating More Versatile Consumer Health Information Through Structured Content Today’s information consumers are busy people. They want to find the exact piece of content they need – on their desktops, laptops, pads, cell phones – rapidly, without wading through unrelated information. And medical information providers want to get targeted health information into the hands of the right patient or member. To provide the vital information that medical consumers need, your content has to be focused, adaptable, and deliverable over multiple platforms and formats. Healthwise is accomplishing these goals by reformatting their large documents into small, reusable focused chunks of content. In this session, you’ll gain insights about how to apply this strategy at your own organization to: support the creation of tailored pieces of information; liberate content creation from presentation requirements; output content in multiple formats from a single source; and promote content reuse to save operational costs on functions such as translation.

You will also hear how Healthwise is evolving the use of DITA–Darwin Information Typing Architecture, a standard from the technical writer’s toolbox that provides structures for authoring and organizing topic-based information. You will learn how DITA and software tools are extending into mainstream medical writing and are helping one consumer health information provider to better fulfill its mission.

Maria Essig, MS, ELS, Content Technical Manager, Healthwise, Inc., Boise, ID

Toxicology 101 for Medical Writers This session will present an overview of the basic principles of toxicology , some mechanisms of toxicity and the toxicological testing of drug substances, products and environmental samples, using a slide presentation, and interactive discussion. Basic toxicology topics include: a. Brief history of toxicology b. Dose-response concepts c. Route of administration: oral, dermal, inhalation, and injection d. Types of toxicity: acute, sub-chronic, and chronic e. Toxicity testing i. six pack: acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, acute eye irritation, acute dermal irritation, skin sensitization ii. Preclinical toxicity testing for an NDA ■

Thomas Burns, Jr, Managing Member, Tekrighter, LLC, Wendell, NC

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How to Conduct an Effective Comment Resolution Meeting When writing documents where client team members provide input, medical writers may be called upon to participate in or conduct comment resolution meetings. Effective communication with the client team is essential to reach consensus during comment resolution. This presentation will focus on best practices in setting up, maintaining control of, and conducting an effective comment resolution meeting. Attendees will learn how to prepare for, lead, and follow-up on comment resolution.

Kristy Haslerud, BS, CCRC, Senior Medical Writer, PAREXEL International, Mapleton, ND ■

■ Leveraging Your Knowledge of Medical Publishing to Demonstrate Value and Build Customer Loyalty Nothing demonstrates value and engenders loyalty like helping someone avoid (or stay out of) a difficult situation. The increasing complexity of medical publishing can pose many hazards and pitfalls for busy clinicians and scientists. How can editorial services, in-house authors’ editors, and freelance editors and writers help authors avoid these dangers? The presenters will answer this question in a discussion of approaches and strategies used by Scientific Publications (the editorial service) at Mayo Clinic in its role as an expert publishing resource for authors, in addition to its editorial function. In turn, providing specialized knowledge can demonstrate value and relevancy and build customer loyalty. The presentation will touch on the import of maintaining a knowledge base on current publishing trends and issues (eg, copyright and plagiarism, predatory journals, open access, retaining author rights, HIPAA and NIH compliance, compliance with institutional policies, reporting guidelines such as CONSORT, Open Researcher and Contributors ID [ORCID] identifiers). Applicability of this “expert” approach to participants with various editorial and writing roles will be discussed, and participants will be encouraged to share strategies that they or their customers have found valuable.

LeAnn Stee, Head, Scientific Publications, Mayo Clinic, Rochester, MN Kenna Atherton, Manager, Scientific Publications, Mayo Clinic, Rochester, MN

12:30–1:45 PM

AMWA Sablack Awards Luncheon and Swanberg Address Named after AMWA’s first executive director, Lillian Sablack, this event recognizes the outstanding service and contributions of medical communicators.

Presentation of 2016 Fellowships: 2016 Fellowship Committee chair, Brian Bass, MWCTM, will present Fellowship Awards to Hilary Graham, MA, Cynthia L. Kryder, MS, CCC-Sp and Barbara Zimmerman, PhD, for significant contributions to the goals and activities of the association.

Presentation of the Golden Apple Award: Kristina Wasson-Blader, PhD, ELS, administrator of the 2016 Education Committee, will present this award for excellence in workshop leadership to Jill Shuman, MS, ELS. Presentation of the Harold Swanberg Distinguished Service Award and Swanberg Address: Bart Harvey, PhD, 2016 Swanberg Committee Chair, will present the Swanberg Distinguished Service Award, given for distinguished contributions to medical communication and the medical profession, to Flo Witte, PhD, ELS, who will then present her award address.

1:00–4:00 PM

Exhibitor move out

2:00–4:00 PM

Bonus Intensive Session ■ Medical Writing for Mobile Learning Applications and Programs This how-to session will focus on best practices for medical writers working in mobile learning development, including content generation and organization, instructional design and learning architecture, and the basics of UI/UX (user interface/user experience).

Michelle Nolin, CPLP, President and CLG, LearnEthos, Marshallberg, NC

2:00–5:00 PM

AMWA Workshops (additional fee, see page 21 for listings)

2:30–4:30 PM

AMWA Board of Directors Meeting

5:00–5:30 PM

Annual Business Meeting for AMWA Members All AMWA members are encouraged to attend, to get an update on AMWA from 2015-2016 President, Stephen N. Palmer, PhD, ELS, and Treasurer, Christine Wogan, MS, ELS, to witness the passing of the gavel to Lori Alexander, MTPW, ELS, MWCTM, the 2016-2017 President, and to meet the 2016-2017 officers and Executive Committee.

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AMWA workshop SCHEDULE WEDNESDAY, OCTOBER 5 9:00 AM–5:00 PM 9:00 AM–12:00 PM

Full Day Intensive: The Writing Clinic Facilitated by Hope J Lafferty, AM, ELS, Hope Lafferty Communications, Nashville, TN Summarizing Clinical Safety Data for an NDA (RR) Peggy Boe, RN, Principal, Nightingale Medical Writing, LLC, Hampstead, NC Marijke Adams, PharmD, PhD, President, MH Adams & Associates, Inc., Davie, FL Jennifer Bridgers, MS, MWCTM, Medical Writer Manager, Quintiles, Raleigh, NC ■

Clinical Study Report Writing: From Tables, Listings, and Graphs to Text (RR) Kathy Spiegel, PhD, Regulatory Writing Senior Manager, Amgen Inc., Grass Lake, MI ■

Serving Two Masters—Comparing and Contrasting US and EU Regulatory Processes (RR) Art Gertel, MedSciCom, LLC, Lebanon, NJ ■

■ Macroediting (ADV) Elliott Churchill, MS, MA, Presidents, A World of Words, Tucker, GA

Essential Ethics for Medical Communicators (ES) Jill Shuman, MS, ELS, Principal, Writers Group, Woburn, MA ■

Essentials of Copyediting (CP) Loretta Bohn, BA, Senior Editor/Writer, RTI International, Research Triangle Park, NC ■

Usage: Choosing the Right Word for the Job (CP) Stephen N. Palmer, PhD, ELS, Manager and Senior Scientific Medical Writer, Texas Heart Institute, Houston, TX ■

Pharmacokinetics in Clinical Practice and Drug Development (SM) Gayle Nicholas Scott, PharmD, ELS, Scientific Solutions, Envision Pharma Group, Southport, CT Shirley Teng, PhD, Scientific Solutions, Envision Pharma Group, Southport, CT ■

One-on-One Mentoring: Taxonomic Analysis and Revision of Medical Writing Facilitated by Michael Schneir, PhD, Professor, Herman Ostrow School of Dentistry of the University of Southern California, Los Angeles, CA ■

2:00–5:00 PM

Composing Narratives for Safety and Adverse Event Reporting (RR) Sara Ewing, BSN, RN, President, Accurate Biomedical Communication, LLC, Yardley, PA ■

Summarizing Clinical Efficacy Data for an NDA (RR) Peggy Boe, RN, Principal, Nightingale Medical Writing, LLC, Hampstead, NC Marijke Adams, PharmD, PhD, President, MH Adams & Associates, Inc., Davie, FL ■

Writing a Protocol in Compliance with ICH Guidelines (RR) Jennifer Bridgers, MS, MWCTM, Medical Writer Manager, Quintiles, Raleigh, NC ■

Regulatory Aspects of the Drug Development Process (RR) Aaron Bernstein, PhD, Aaron Bernstein Consulting LLC, Millburn, New Jersey ■

Advanced Writing (ADV) Marianne Mallia, ELS, MWCTM, Editor, Scientific Publications, Mayo Clinic, Scottsdale, AZ ■

Microediting (ADV) Elliott Churchill, MS, MA, Presidents, A World of Words, Tucker, GA ■

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Preparing CME Materials: Concepts, Strategies, and Ethical Issues (CP) Eve Wilson, PhD, ELS, CHCP, Medical Writer/Editor & CME Consultant, MORPHOS Medical Education, LLC, Bowie, MD Marcello Morgan, MD, MPH, CHCP, Associate Medical Director, Haymarket Medical Education, Paramus, NJ ■

Introduction to Cancer Pharmacology (SM) Sunil Patel, MS, Oakland, CA ■

Launching a Freelance Writing Career (B) Eleanor Mayfield, ELS, ELM Communications, Pittsburgh, PA ■

One-on-One Mentoring: Taxonomic Analysis and Revision of Medical Writing Facilitated by Michael Schneir, PhD, Professor, Herman Ostrow School of Dentistry of the University of Southern California, Los Angeles, CA ■

THURSDAY, OCTOBER 6 9:00 AM–12:00 PM

Investigational New Drug Applications (RR) Jenny Grodberg, PhD, RAC, Regulatory Affairs Consultant, Carlsbad, CA ■

Electronic Common Technical Document (RR) Nancy Katz, PhD, MWCTM, President, Illyria Consulting Group, Inc., Soda Springs, CA ■

■ Understanding the Principles of Kaplan-Meier Analysis (RR) Thomas Schindler, PhD, Head Medical Writing Europe, Boehringer Ingelheim Pharma GmbH & Co.KG, Biberach ad Riss, Germany Sybille Eibert, PhD, Senior Manager Medical Writing, Teva Pharmaceuticals International GmbH, Basel, Switzerland

Fundamentals of Ethics and Practical Applications (RR) Art Gertel, MedSciCom, LLC, Lebanon, NJ ■

■ Risks and Ratios (ADV) Tom Lang, MA, Principal, Tom Lang Communications and Training International, Kirkland, WA

Statistics for Medical Writers and Editors (ES) Bart Harvey, MD, PhD, Associate Professor, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada ■

Tables and Graphs (ES) Cindy Hamilton, PharmD, ELS, Principal, Hamilton House, Virginia Beach, VA ■

Bibliographic Resources for Medical Communicators (ES) Joan Nilson, Policy Development/Research Analyst, UPMC Health Plan, Pittsburgh, PA ■

Basic Grammar I (ES) Jude Richard, MA, ELS, Senior Medical Writer, INC Research, Austin, TX Erica Goodoff, BA, ELS, Scientific Editor, The University of Texas MD Anderson Cancer Center, Houston, TX ■

Ethical Standards in Medical Publication (CP) Andrea Gwosdow, PhD, President, Gwosdow Associates Science Consultants, LLC, Arlington, MA Ann L. Davis, MPH, CMPP, Scientific Director, StemScientific, Lyndhurst, NJ ■

Ethics in Communicating Science and Medicine (SM) Tami Ball, MD, Principal Medical Writer, inVentiv Health Clinical, Asheville, NC Michelle Sauer, PhD, ELS, CRA, Principal Editor, RnA Editing, LLC, Cypress, TX ■

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SATURDAY, OCTOBER 8 2:00–5:00 PM

■ How to Write an Exceptional Safety Narrative (RR) Sara Ewing, BSN, RN, President, Accurate Biomedical Communication, LLC, Yardley, PA

Reporting Correlation and Regression Analyses (RR) Tom Lang, MA, Principal, Tom Lang Communications and Training International, Kirkland, WA ■

Assessing and Communicating the Benefits and Risks of Medicines (RR) Lawrence Liberti, MS, RPh, RAC, Executive Director, CIRS-Centre for Innovation in Regulatory Science, Holland, PA ■

Writing Clinical Evaluation Reports for Medical Devices (RR) Felicia R. Cochran, BS, PhD, CMPP, Associate Director, Regulatory and Scientific Affairs, CTI Clinical Trial and Consulting Services, Cincinnati, OH ■

Understanding Sample Size and Study Power (ADV) Bart Harvey, MD, PhD, Associate Professor, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada ■

■ Effectively Searching Online Databases (ES) Thomas Gegeny, MS, ELS, MWCTM, Scientific Director, Envision Pharma Group, Southport, CT

Punctuation for Clarity and Style (ES) Helen Hodgson, PhD, Professor of Communication, Westminster College, Salt Lake City, UT ■

Sentence Structure and Patterns (ES) Michael Schneir, PhD, Professor, Herman Ostrow School of Dentistry of the University of Southern California, Los Angeles, CA ■

Plain Language (CP) Sharon Nancekivell, MA, MWCTM, Freelance Medical Editor, Writer, Educator, and Plain Language Consultant, Guelph, ON, Canada Genevieve Long, PhD, Freelance Medical Writer - Patient Education, Health Literacy, and Marketing Specialist, Portland, OR ■

Evidence-Based Medicine for Medical Communicators (SM) Tami Ball, MD, Principal Medical Writer, inVentiv Health Clinical, Asheville, NC Tim Peoples, MA, ELS, CMPP, Medical Writing Manager, Amgen Inc., Thousand Oaks, CA ■

➲ More information about workshops is available online.

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Posters on Display Back to the Future: Reinventing Medical Writing at Merck & Co. Joan Affleck, MA, MBA, ELS Executive Director, Head of Medical Writing, Merck & Co., Inc., Rahway, NJ Mary McKenna, MS, Director, Medical Writing Business Operations & Service Development, Merck & Co., Inc., Rahway, NJ Programmed Narratives: Working Smarter not Harder Gia Barss, Associate Medical Writer, Veristat LLC., Southborough, MA Spotting the Wolf in Sheep’s Clothing: Predatory Open Access Publications Chandler Wilson Carroll, Medical Editor, Baylor Scott and White Health, Temple, TX Readability of Informed Consent Forms: Requirements and Tools for Success Jeffrey Cohn, PhD, Senior Medical Writer, inVentivHealth Clinical, Princeton, NJ Kent D. Steinriede, MS, Senior Medical Writer, inVentivHealth Clinical, Princeton, NJ David Meats, Principal Medical Writer, inVentivHealth Clinical, Princeton, NJ Best Practices for Posting Clinical Trial Results to ClinicalTrials.gov: How Medical Writers Can Prepare

by Utilizing the Clinical Study Report (CSR).

Jennifer Houser, MS, RAC, CCRP, Senior Medical Writer II, Seattle Genetics, Inc., Bothell, WA Collaborative Writing Toolkit: Results of a Survey of American Medical and Technical Writers in Health Care Angela Johnson MSE, PMP, RAC, Senior Professional Band Clinical Writer, GE Healthcare, Waukesha, WI Ensuring the Accuracy of Cited Claims in the Medical Literature: An Important Role for Medical Writers Scott A. Mogull, PhD, Assistant Professor, Texas State University, San Marcos, TX Evaluation of a Workshop-Based Approach to Writing a Theme Issue of an Academic Journal Gina Uhlenbrauck, ELS, Senior Science Writer/Editor Duke Clinical Research Institute, Durham, NC Jonathan McCall, MS, Senior Science Writer/Editor, Duke Clinical Research Institute, Durham, NC Karen Staman, MS, Senior Science Writer/Editor, CHB Wordsmith, Inc., Raleigh, NC Liz Wing, MA, Senior Science Writer/Editor, Duke Clinical Research Institute, Durham, NC Darcy M. Louzao, PhD, Project Leader, Duke Clinical Research Institute, Durham, NC MariJo Mencini, Administrative Coordinator, Duke Clinical Research Institute, Durham, NC Tammy Reece, MS, PMP, CCRA, Project Leader, Duke Clinical Research Institute, Durham, NC Life-Changing Decisions: What Patients Need to Know Kathi Whitman, Senior Medical Writer/Project Manager, Intermountain Healthcare, Sandy, UT

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AMWA roundtableS FRIDAY, OCTOBER 7 12:15–1:45 PM

Top Ten Tips for Breaking into the Medical Communications Field Tamara Ball, MD, Principal Medical Writer, inVentiv Health, Asheville, NC Stephanie Brillhart, Manager, Medical Writing, inVentiv Health, Aurora, CO ■

■ The ABC’s of Regulatory Medical Writing Cynthia Barber, PhD, Sr. Medical Writer, Vertex Pharmaceuticals, Boston, MA

Decentralized Medical Writers–You Are Not Alone Sharyn Batey, PharmD, Director, Medical Writing Services, PAREXEL International, San Diego, CA ■

Teachable Moments: Sharing Writing Lessons with Specialists (in everything but writing) Loretta Bohn, Senior Editor/Writer, RTI International, Research Triangle Park, NC ■

Demonstrating the Publication Medical Writer’s Value Janice Carlson, Medical Writing Manager, Amgen, Inc, Thousand Oaks, CA ■

Email Tones in Science and Medical Communication Damiana Chiavolini, MS, PhD, Writer and Editor, UT Southwestern Medical Center, Dallas, TX ■

■ Integrative Medicine: An Emerging Opportunity for Medical Writers Sarah Cook, ND, Freelance Medical Writer, Westminster, CO

Tips on Developing a Writing Course at Your Institution Susan Daniels, PhD, Managing Editor, Methodist DeBakey Cardiovascular Journal, Houston Methodist DeBakey Heart & Vascular Center, Houston, TX ■

Fostering Successful Partnerships Between Editors and Authors at Academic Medical Centers Jill Delsigne-Russell, PhD, Associate Scientific Editor, The University of Texas MD Anderson Cancer Center, Houston, TX ■

First-Time Quality: Writing a High-Quality Document Fabiana Ebihara, Senior Manager, Medical Writing Services, PAREXEL International, Orlando, FL ■

How Much Error is Acceptable in Medical Writing?

Thomas Purcell, MS, Principal Medical Writer, PAREXEL, Saline, MI ■

■ How to Find a Job Kelleen Flaherty, MS, MWCTM, Adjunct Assistant Professor, University of the Sciences in Philadelphia, Biomedical Writing Programs, Jamison, PA

Increasing Efficiency to Maximize Freelance Income Gail Flores, PhD, Principal Writer, Encore BioMedical Communications, Encinitas, CA ■

Outsourcing Medical Writing: The View from Both Sides Vicki Foster, MSPH, Principal Medical Writer, PAREXEL International, Raleigh, NC ■

How Do I Pick the Right Tool for Me? Elizabeth Fraley, CEO, Single-Sourcing Solutions, Sunnyvale, CA ■

■ Learning Medicine One Day at a Time: Tools and Techniques for Medical Research and Communications Newbies Tim Peoples, MA, ELS, CMPP, Medical Writing Manager, Amgen Inc., Thousand Oaks, CA

How to Mistake-Proof Your Documents Jodi Pollock, Principal Medical Writer, InVentiv Health, Apex, NC ■

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Cybersecurity: How do we protect ourselves and our clients?

Amanda Prescott, Editor, Business Development and Document Manager, Summit Medical Writing Group, Inc., Hillsborough, NC ■

Scientific Congress Coverage for a Pharmaceutical/Biotechnology Company Albert Rhee, PhD, Medical Writer Manager, Amgen Inc, Thousand Oaks, CA ■

HTAs & AMCP Dossiers: Find Out What They Are In 5 Easy Steps!

Linda Rice, PhD, CMPP, Medical Writing Senior Manager, Amgen Inc., Eagle, ID ■

■ Mining Medical Information in 0 to 60 Lori Rochelle, PhD, Senior Medical Writer, InventivHealth, Durham, NC

Introduction to Pediatrics for the Medical Communicator Margaret Burke, PharmD, BCPPS, Precision Medical Writing, LLC, Manchester, CT ■

Working in North America for European Medical Writers: How to Face New Challenges?

Zineb Roumane, Senior Medical Writer, PAREXEL International, Billerica, MA ■

Lean Authoring in Clinical Study Reports (CSRs): Balancing Brevity with Clarity Suzanne Sobel, PhD, Senior Medical Writer, PAREXEL, Inc, Billerica, MA ■

■ Birthing and Rearing an Investigator’s Brochure: Have I Created a Model Citizen or a Monster?

Mark Sobnosky, President and Principal Medical Writer Summit Medical Writing Group, Inc., Hillsborough, NC

The World at Your Fingertips: Working Remotely in a Multicultural Setting Kent Steinriede, MS, Senior Medical Writer, inVentiv Health Clinical, Bala Cynwyd, PA ■

■ From Lab to Laptop: Discussing the Transition from Laboratory Scientist to Clinical/ Regulatory Medical Writer Jessica Tesell, PhD, Veristat LLC, Southborough, MA ■ From Bench Top to Desktop: How to Effectively Transition From a Scientist to a Medical Writer Ruwaida Vakil, MS, Principal, ProMed Write LLC, Somerset, NJ

Building Your Online Presence DeeAnn Visk, PhD, Principal Writer, DeeAnn Visk Consulting, Poway, CA ■

■ Beyond Tables & Graphs: Communication and Process Mark Weiss, President, Apothaceutics International, Inc., Congers, NY

Prize-Winning Medical Journalism: A Resource for Enjoyment, Learning, and Teaching Barbara Gastel, MD, MPH, Professor, Texas A&M University, College Station, TX ■

Using Document Design to Get Your Message Across Lyn Gattis, Assoc Professor, Dept of English, Missouri State University, Springfield, MO ■

Finding Corporate Clients Debra Gordon, MS, President, GordonSquared, Highland Park, IL ■

Certification of Editors in the Life Sciences Norman Grossblatt, ELS(D), Senior Editor, The National Academies, Chevy Chase, MD ■

■ Blogging for Profit Andrea Gwosdow, PhD, President, Gwosdow Associates Science Consultants, LLC, Arlington, MA

FDA’s Breakthrough Therapy Designation Natalie Herr, PhD, Medical Writer and Consultant, Whitsell Innovations, Inc., Chapel Hill, NC ■

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Interpersonal Communication in a Landscape of Introverts–Soft Skills Really Do Matter Tara Hun-Dorris, MMC, ELS, Principal, THD Editorial Inc., Raleigh, NC ■

Writing for Consumers and Patients Nancy Hunton, MS, Freelance Writer/Editor NKH Communications, Acton, MA ■

Health Literacy: Why It Matters and How You Can Help Kelly Kilibarda, PhD, Medical Writer & Consultant, Whitsell Innovations, Inc., Denver, CO ■

■ A Case for Standard Nomenclature: When a 3+3 Design is Inadequate Candace L. Larson, MS, CCRP, Medical Writer, Seattle Genetics, Inc., Bothell, WA

The AMCP Format for Formulary Submission: Implementing Version 4.0 Beth Lesher, PharmD, BCPS, Lead Scientist, Medical Communications, Pharmerit International, Bethesda, MD ■

Screening for Cancer-A Moving Target Janet Macheledt, MD, MS, MPH, Oncology/Hematology, Bellaire, TX ■

Grow your Own Local Network of Communication Professionals Joanne McAndrews, PhD, Freelance Medical Writer, St Louis, MO ■

■ Structural Racism and the Unfulfilled Promises of Personalized Medicine: Clinical trials in the Age of Colorblindness Guinevere Murphy, PhD, Owner and Principal, Murphy Medical Writing, LLC, Westminster, CO

“So, You’re Going to Take the BELS Exam...”

Leslie Neistadt, ELS, Managing Editor, Saint Louis University, St Louis, MO ■

Patient Narratives From Initiation to Finalization Katy Zabell, Medical Writer II, PAREXEL, Avon, IN ■

Comparisons of Medical Writing in the United States and China Lili Zhou, PhD, Medical Writer II, PAREXEL International, Billerica, MA ■

Working with Statisticians: How to Achieve a Stronger Partnership?

Qing Zhou, PhD, ELS, Scientific Communications Scientist, Cook Research Incorporated, West Lafayette, IN ■

■ Transitioning from Freelance Medical Writing to Retirement Barbara T. Zimmerman, PhD, Owner/Manager, Biomedical Communication & Consulting, Denver, CO

Enjoy the Silence Jennifer Bridgers, MS, MWCTM, Medical Writer Manager, Quintiles, Raleigh, NC ■

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