Galadriel Bonnel, PhD, RN, FNP, Medical Writer, Nurse Practitioner, Resonance Medical Writing & Consulting, Berkeley, CA and Saint Raphael, France

Transcription

1 ROUNDTABLES Balancing Identities as a Healthcare Professional and Medical Writer Galadriel Bonnel, PhD, RN, FNP, Medical Writer, Nurse Practitioner, Resonance Medical Writing & Consulting, Berkeley, CA and Saint Raphael, France This roundtable discussion will aim to review potential challenges and advantages of working both as a healthcare professional and medical writer. In the current era involving some skepticism from healthcare providers regarding the role of pharmaceutical industries in medical publications, medical writers can further articulate the need for high quality writing and good publication practices. Healthcare professionals who are medical writers can also sharpen their communication skills to bridge the gap between good medicine and the patient, whether during a consultation or when providing patient education materials. The patient s concerns and growing eagerness for medical information can serve as a reminder to convey the big picture with attention to clarity, avoiding medical jargon when possible. A synergistic relationship between a medical background and medical writing can exist, particularly when mindfulness of the patient s role and the personal need for both continuing medical education and improved medical writing remain central. Discussion between the roundtable participants will include what resources may be best adapted to this type of medical writing identity, and what further training other health care professionals may need to receive in order to fully understand the role medical writers have in robust medical publishing. Beyond the Words: Document Design for Grant Writers Kristina Wasson-Blader, PhD, ELS, Owner, Clearly Communicating Science, Orchard Park, NY Funding success for any grant is an amalgamation of good science, effective writing, and grantsmanship. We will discuss how the principles of document design can be applied to grant proposals to generate awardwinning proposals. Certification of Editors in the Life Sciences Tom Gegeny, MWC, ELS, Team Lead & Senior Medical Writer, Envision Pharma Group, Southport, CT The meaning of professional certification and the history, status, and procedures of the Board of Editors in the Life Sciences. Children are Not Small Adults: Processes and Challenges of Pediatric Drug Development Kent Steinriede, MS, Senior Medical Writer, inventiv Health Clinical, Bala Cynwyd, PA In the last few years, more attention and resources have focused on developing medications appropriate for treating children. The United States and Europe are now requiring clinical studies involving children early in the drug development process and discouraging deferral of pediatric studies. These efforts to improve safety and avoid off-label use on children come with many clinical and ethical challenges and regulatory hurdles. In this presentation, I will discuss the regulatory landscape, current requirements and challenges of pediatric drug development, and the documents regulatory writers will encounter and create. The discussion will cover differences between FDA and EMA requirements; pediatric trial design; creating age-appropriate formation and dosage; and required submission documents (Pediatric Study Plans (FDA), Pediatric Investigation Plans (EMA), protocols, informed consent documents, and clinical study reports).

2 Drug Development for Orphan Diseases: The Regulatory Writer s Role in Paving the Road to Approval Pat Gillis, Synchrogenix Pharmaceutical companies have increasing interest in pursuing development of treatments for rare diseases. Regulatory agencies across the world have offered incentives to encourage drug development for orphan diseases. While most of the same extensive documentation is required as for more common disease treatments, there are additional regulatory processes and document requirements unique to orphan drug development. Regulatory writing is required throughout the process to build the evidence supporting eventual approval of drugs for rare diseases. Currently approved documentation and guidance for orphan drug development will be reviewed and summarized. Agency requirements will be compared between the EU and US. Case studies will be identified and presented to provide examples of specific types of challenges. Issues specific to development of rare diseases are known and can be addressed. Similarities and differences between the EU and US will be highlighted. Conclusions: Developing drugs for the treatment of rare diseases presents a unique set of challenges. The regulatory writer is an integral component of the cross functional development team, providing strategic input and high quality documentation that supports the demonstration of effectiveness and safety required for orphan drug approval. Expectations and Reflections of a New Regulatory Medical Writer Jenny Cochran, PharmD, MBA, Medical Writer, Cardinal Health Regulatory Services, Overland Park, KS This discussion will provide an overview of regulatory medical writing requirements, conveyed by a new writer. We will discuss the expectations of a new writer and how to leverage group collaboration to ensure successful completion of regulatory documents. We will also reflect on examples of writing requests and lessons learned during the first years of medical writing. Finding the Hidden Errors: Conducting a Thorough Quality Control Review Kristy Haslerud, BS, CCRC, Associate Manager, Medical Writing Services, PAREXEL International, Mapleton, ND Quality Control (QC) review of documents written by medical writers is more complex than performing basic proofreading tasks. It is an essential process in ensuring the accuracy, completeness, clarity, and consistency of information. Beyond catching grammar, style, and spelling errors, medical writing QC review includes a deeper look at how information is presented and it can include a focus on content, structure, and clarity. Discussion will cover techniques and processes to perform a thorough medical writing QC review with an emphasis on how to look for non-obvious hidden errors. Additionally, participants will be encouraged to share examples from their own experience. Grow your Own Local Network of Communication Professionals Joanne M. McAndrews, PhD, Freelance, St. Louis, MO Online networking (LinkedIn, Twitter, Facebook, AMWA Engage, etc.) is wonderful, but nothing really beats face-to-face interaction with colleagues. This roundtable will cover the how-tos of starting and maintaining a local network of writers, editors, and other communication professionals in your area. We ll discuss recruiting members, finding a place to meet, meeting formats, meeting topics, maintaining a membership list, and the many benefits of connecting in person on a regular basis with professionals in your field. How can we improve the readability of informed consent forms? Akram Sidhu, Inventiv Health Clinical, Chester, NY Creating an Informed consent form from a protocol involves transforming complex scientific language to a simpler text that could be easily understood by lay audiences (usually 9th grade level). During this session we will discuss some of the good practices that may be used for simplifying the most complex parts of the study protocol such as the study schematic and schedule of events. We will also discuss the importance of these sections from a patient s perspective. 2 amwa.org/conference

3 How to Conduct Effective Remote-Based Training Sessions Amelia Young, Medical Writer I, PAREXEL International, Fargo, ND Conducting effective on-boarding and refresher training can be a challenge in a remote-based environment. Effective training of staff is essential to ensure they are able to complete the requirements associated with their role and to produce quality documents. This presentation will discuss challenges associated with remote-based training (both for the trainer and trainee) and provide information on how to conduct an effective training session. Attendees will learn how to prepare to conduct a remote training session, how to maintain trainee engagement during the training session, and how to assess retention in a remote-based environment. How to Retain Author Voice When Editing Kerri Hebard-Massey, Medical Writer, Amgen, Thousand Oaks, CA Medical writers must walk a difficult line between improving a document and rewriting a document. Regardless of how many changes we make, the author s voice must be retained. Join this roundtable to discuss best practices for editing to retain author voice. Bring your own suggestions and learn from others. How to Write an Effective Response Letter to a Journal Editor and Reviewers Katherine Molnar-Kimber, PhD, President, KMK Consulting Services of Kimnar Group LLC, Worcester,PA Writing an effective response letter to the journal editor and reviewers can move your client s submitted revised manuscript to the acceptance folder. While many comments are relatively easy to address, others are not. Some reviewer comments may require additional experimentation or analyses; and others may indicate a lack of understanding or disagreement on analysis with the authors. In addition to a template, we ll discuss when and how to disagree with the reviewers and still get published in the journal. This presentation will provide examples of reviewers issues and successful ways to address them. Participants are encouraged to bring (non-confidential) examples of challenging reviewers issues for group discussion. Five issues such as journal prestige and document type can impact the flexibility of the reviewers and editor. After breaking into small groups, they will draft a response to a challenging reviewers issue, and discuss their strategy(s) with the round table participants. Every participant will receive a handout. HTAs & AMCP Dossiers: Find Out What They Are In 5 Easy Steps! Linda Rice, PhD, ELS, CMPP, Medical Writing Senior Manager, Amgen Inc., Thousand Oaks, CA Have you heard the terms HTA and AMCP dossier but weren t quite sure what they meant? Find out by attending a roundtable session entitled HTAs & AMCP Dossiers: Find Out What They Are In 5 Easy Steps! During this roundtable, an overview will be provided on what these terms mean, what agencies use HTAs and AMCP dossiers, what kind of information they contain, and how the development of a payer document (such as an AMCP dossier) compares with writing a scientific publication. Having a basic understanding of HTAs and AMCP dossiers will be useful to AMWA members interested in working on payer-related documents and in learning about how decisions are made regarding drug access/reimbursement in the managed-healthcare setting. Come join us to learn about the brave new world of writing payer-related documents! During the roundtable, handouts will be provided that summarize the information presented. Ideal Situations and Challenges Facing a New Regulatory Medical Writer Kevin Farmer, PhD, Medical Writer, Cardinal Health Regulatory Services, Overland Park, KS This discussion will provide an overview of regulatory medical writing requirements, from a new writer s perspective. We will discuss ideal situations and particular challenges faced by a new writer and illustrate examples of successfully completed regulatory documents within a real-life context. 3 amwa.org/conference

4 Instructional Design: What It Is and How to Use It In Medical Writing Deborah Anderson PhD, Medical Writer/Medical Instructional Designer, DGA Medical Communications, Bucks County, PA This round table will provide the elementary skills necessary to begin considering instructional design as a very real and necessary facet to developing medical education. It will build on the foundational knowledge of defining what instructional design is and then progress to the different areas that medical writers need to consider to develop effective medical writing pieces that are useful to the end user. Leaving the Bench: Transitioning from Laboratory Scientist to Medical Writer Rachel Raynes, PhD, Medical Writing Manager, Amgen Inc., Thousand Oaks, CA At this roundtable, participants will discuss common challenges that scientists face when transitioning to a medical writing career. Participants will introduce their background and career stage. Group discussion will begin with steps on how to initiate the transition from academia to industry, including strategies for an industry job search and adapting a resume for medical writing. Discussion will also include the role of the medical writer and publication management in the industry setting. Other potential topics include project management, workflow tactics for success, and approaches for expanding therapeutic knowledge. Medical Information Optimization: Creating Consistency Between Writers and Across Therapies in a Medical and Scientific Affairs Department Kelly K. Haagenson, PhD., Senior Medical Affairs Specialist, Medtronic, Minneapolis, MN A robust medical information service often relies on a team of writers, each covering particular content areas, to provide accurate and balanced summaries of published literature to requestors. In this setting it is critical to establish consistent style and tone between individual writers and across all the therapies or products the team supports. In this session, explore how creating content standards, peer review processes, documentation requirements, and a departmental style guide can elevate the quality of publication summaries prepared by the team regardless of therapy area or expertise. Hear how a medical affairs team of 6 writers who issue 1500 medical information letters a year have optimized their process to ensure they are creating meaningful content that adds value to their business by promoting the safe and optimal use of the products they support. Medical Writing Academy - An Onboarding Tool Julie Wang, DPM, Amgen Inc., Thousand Oaks, CA This Roundtable Discussion will focus on key elements of Amgen s Global Medical Writing (GMW) Academy, an onboarding tool intended for writers new to the department. The GMW Academy presents specific time-bound goals for medical writers to complete, to help them achieve long-term success in their roles. Mentoring and Growing Your Medical Writing Team Angela N. Johnson, MSE, PMP, RAC, Senior Manager Clinical Affairs Operations, GE Healthcare, Waukesha, WI Where are you going in medical writing? Mentoring matters whether you are honing your skills as an individual contributor or leading a medical writing team. Medical writers work in varied environments, with large and small teams playing very different roles across organizations and regions. Despite the differences between teams, we all share a common need to continuously share, improve, and grow. This session will focus on strategies to help mentor medical writing competency and efficiency across teams, with special consideration for how new and growing teams storm and norm as they hit their stride. Do you want to share and learn from others experiences in growing and mentoring medical writers? Well, you ve come to the right place. This roundtable session is led by a seasoned leader in medical writing and is open to both mentees and mentors. This session is suitable for managers and individual medical writers at all levels. Come ready to share your good and bad mentoring experiences, and leave with new insights into your team and your career. 4 amwa.org/conference

5 Proposal Writing for Freelancers Stephanie M. Vargas, MD, Medical Communications Consultant, Med Ink, Chicago, IL Being a strong proposal writer can convince potential clients that you are the best medical communicator for the job and can help make your growing business a success. A good proposal should highlight the value you add to a client s project team and help you beat out competitors for the best paying work in the medical communications field. However, proposal writing can be daunting to freelancers, even seasoned professionals. In this roundtable discussion, we will focus on the elements that make a strong proposal. This includes reviewing the essential components of a proposal; understanding a client s needs and communicating meaningful solutions; selecting and including high-quality, relevant samples of your work; and using templates to streamline proposal writing and create a visually appealing, well-organized, and professional document. Scientific Congress Coverage for a Pharmaceutical/Biotechnology Company Albert Rhee, PhD, Medical Writer/Manager, Amgen Inc., Thousand Oaks, CA Attending a scientific congress and writing daily summaries along with the comprehensive executive summary for a pharmaceutical/biotech company takes significant preparation. This roundtable will be a practical guide on how to effectively cover a conference for a pharmaceutical/biotechnology company. We will take a generalized overview on how to cover the congress and producing the key written deliverables. Sitting is the New Smoking: Increasing the Longevity of You and Your Medical Writing Career Meg Robison, Chief Executive Officer, Signa Medical Writing, Lincoln, NE Strict timelines, urgent needs, multiple projects and deadlines, and often unrealistic expectations result in medical writers spending many hours sitting in front of a computer screen every day. The effects are not only poor posture and eye strain, but potentially brain, spine, and heart strain that can shorten a writer s career. Research shows that we sit an average of 9.3 hours per day, and medical writers are at particular risk for this habit because of the nature of our profession and the particular personality traits that led us to this exciting profession in the first place. Longevity in medical writing isn t just about ergonomics, it is about recognizing changes that are needed in both working environment and attitude to focus on physical, emotional, and spiritual health. Our career and even our lives depend on it. So, You re Going to Take the BELS exam Leslie Neistadt, ELS, Managing Editor, St Louis University, St Louis, MO We ll discuss the BELS exam: what to expect and how to prepare for it. Strategic Partnerships: Any Way You Want It, That s the Way You Need It Ann Benesh, MPH, RAC, Associate Director, Synchrogenix, Nashville, TN Pharmaceutical companies outsource more medical/regulatory writing activities every year. At the same time, the expectations for medical writing service providers are growing. New trends that are emerging include: outsourcing the entire writing department, including document planning and interfacing with internal management; and mixing of internal, freelance, and provider regulatory writers to meet sponsor s writing needs. These and other models each have strengths and weaknesses, so the sponsor and the provider must align on which one best addresses that sponsor s particular writing needs. We will examine case studies of several of these outsourcing models, with emphasis on strengths and weaknesses. Included in these cases, and key to sponsor-provider model selection, will be helpful approaches for clear communication, positive attitudes, and optimal work environments. 5 amwa.org/conference

6 Teaching Research Writing in Academia Damiana Chiavolini, Instructor, UT Southwestern, Dallas, TX In-house editors in academic departments have been playing an increasingly critical role to teach essential writing skills to faculty and trainees. Academics should have excellent writing skills to publish manuscripts effectively, secure extramural funding, and become better writing mentors in their future career. In the last two years, the editing team at the Department of Radiation Oncology at UT Southwestern has established a three-fold approach to continuously improve the writing abilities of faculty and trainees: 1) Didactic editing through an accurate explanation of the changes with examples and links to resources; 2) One-to-one coaching sessions to strategically develop specific scientific documents; 3) Teaching of courses, seminars, and workshops in a classroom environment to facilitate the hands-on writing experience, provide examples, and promote interdisciplinary collaboration. Each strategy will be discussed with a focus on applying different techniques to different academic levels and language backgrounds. The Differences (and Similarities) Between Nonclinical and Clinical Writing Christina Pligavko, Senior Medical Writer, Veristat, LLC, Southborough, MA This proposed roundtable would be geared toward new medical writers who are interested in learning about nonclinical/technical writing or come from a background in nonclinical research. Nonclinical and clinical documents have their own specific purpose in drug development which goes beyond animal versus human. This roundtable will discuss how the writing process and content differs between nonclinical and clinical writing as well as the points of overlap. Topics for discussion would include (but are not limited to) the differences and similarities in: the guidances and regulations which oversee and define the content of each, the sources used in the generation of nonclinical versus clinical documents, and the challenges faced when given early development data in animals versus late stage human data. The Expanding Role of the Medical Writer and Adding Value in a Small to Mid-Sized Company Nissa Mollema, PhD, Clinical Science Manager, Monteris Medical, Plymouth, MN If you currently describe yourself as a writer or editor, you may be underappreciating the scope of what you can bring to a small or mid-sized company. Medical writers are currently being called on to fill a variety of roles within small to mid-sized companies and can cross-functionally add value in groups such as quality-control, clinical research, regulatory, and marketing. Identifying new areas for growth and expertise are becoming more essential as small companies often look for broadly-talented people to fill a role with many varied responsibilities. In this session, we will identify and discuss the cross-functional talents of the medical writer and how those skills can be applicable and useful to a variety of departments or clients. We will explore potential pitfalls of being a Jack of all trades, master of none and if there are challenges with trying to do too much. We will also discuss how a solid command of the English language and technology can increase your efficiency and allow for more opportunities to take on new projects. The Fears and Frustrations of Newbies Rebecca Mueller, PAC, MSc, Freelance writer, owner PA Helpers, Shelburne, ON This is a simple and straight forward round table proposal that discusses a common topic among new freelance medical writers; how to get started. Questions from newcomers are added to the AMWA engage site weekly and discussed enthusiastically with a somewhat concerned undertone. This group aims to alleviate concerns and offer possible solutions to the common problems of entering the practice today. Translating Traditional Medical Word Usage Into Bias-Free and Patient-Centered Language Heather Friedman, MPH, Founder and CEO, Friedman Medical Communications, LLC, Pittsburgh, PA Health care professionals, and physicians in particular, have a long-established habit of speaking in a sort of 6 amwa.org/conference

7 medical shorthand when discussing cases with one another, and sometimes even when speaking to patients directly. This style of speaking spills over into written materials such as medical charts, research reports, and continuing education materials, and it is so inculcated in the practice of medicine that medical students still learn it by example today. Although there is undoubtedly no ill intention, some of this traditional language can be perceived through a modern lens as patronizing, dehumanizing, and culturally or emotionally insensitive to patients. As medical communicators, we have a responsibility to set higher standards by replacing potentially offensive terms with language that eliminates bias, reduces negative connotations, and establishes respect for patients as individuals. This obligation applies not only to the choice of words used in patient education materials targeted to laypersons, but also and perhaps even more importantly to journal manuscripts and other publications written explicitly for clinician audiences. In this roundtable, we will review the most commonly encountered insensitive medical terms and usage, and we will explore respectful and bias-free alternative language choices. The Role of the Medical Writer in Study Protocol Development Jeanette Towles, President, Synterex, Inc., Dedham, MA The study protocol is a dynamic document that may or may not fall within the medical writing purview at a biotech or pharmaceutical company. This roundtable session will explore what factors or context may contribute to the success of using medical writing for protocol development at one company and the failure of such an approach at a different company. The roundtable moderator will contribute her own observations on what gaps medical writing can fill during protocol development, as well as inviting the opinions and observations of the participants. Trends on Women at Work & Maximizing Your Compensation Hilary Graham MA, Senior Manager, Scientific Marketing, Luminex Corporation, Austin, TX While women are better educated than men, a gendered pay gap persists. Learn the factors that contribute to diminished labor force participation and wage disparities as well as how you can best negotiate for maximum total compensation. When Communication Lacks Clarity: Scientific Communication in The Immortal Life of Henrietta Lacks Angela Nichols Leonard, MA, Technical Writer II, inventiv Health Clinical, Wilmington, NC The Immortal Life of Henrietta Lacks (TILHL), a best-selling work of literary non-fiction by Rebecca Skloot which is being adapted into an HBO movie, has particular pertinence to medical writers. Skloot writes about the origin of the HeLa cell line, and in doing so, reveals the interwoven strands of race, gender, class, and science which make up this complicated story. In TILHL, Skloot writes intelligibly about complicated scientific ideas; conversely, Skloot provides many examples in the text of unsuccessful scientific communication. Our roundtable discussion will examine the lessons medical writers can learn from Skloot s engaging and clear writing about medical research. We will analyze what constitutes good medical writing, and think about how to implement these concepts into our writing. We will also consider the skepticism towards science and scientists evinced by some characters in the book, and how medical writers can help to overcome public distrust of science. Writing a Business Plan for Your Freelance Business Mark Weiss, President, Apothaceutics International, Inc., Congers, NY Business lore is that the business plan that Fred Smith wrote for what was to become FedEx got a grade of C from his Yale University professor. Now, the company is has 300,000 employees and approximately $42 billion in revenue (2012). One-person freelance businesses can develop and write a business plan like Fred Smith did. Such business plans are excellent tools to help define the freelance business, describe its services, document the market analysis, and describe how the business will work, its organization, and financial projections. 7 amwa.org/conference

8 No Discussion Just lunch Open Discussion: Academia Open Discussion: Big Data Open Discussion: Breaking Into the Field Open Discussion: CME Open Discussion: Emerging Infectious Disease Viruses Open Discussion: Evidence-Based Medicine Open Discussion: Freelance Business Open Discussion: Government Funded Grants Open Discussion: HEOR Open Discussion: Medical Devices Open Discussion: Networking Open Discussion: New Technologies Open Discussion: Patient-Centered Publications Open Discussion: Plain Language Open Discussion: Predatory Publishers Open Discussion: Repeal/Replacement of ACA Open Discussion: Social Media 8 amwa.org/conference