2026 Pacific Coast Conference
Session Descriptions
*This schedule is subject to change.
Keynote Address
The Healing Power of Music: What Science and Music Reveal
Speaker: Julene K Johnson, PhD
Description: Music has supported human health and well-being for centuries. With the founding of the Sound Health initiative at the NIH, scientific research about the therapeutic effects of music substantially increased, and the general public’s interest in this topic also grew. This session will provide an overview of the state of the science related to the health benefits of music across the life course, with a focus on trends in research about the benefits of music for older adults with and without dementia.
Speaker bio: Julene K Johnson, PhD, is a Professor of Cognitive Neuroscience at the University of California, San Francisco’s Division of Geriatrics (in the School of Medicine). For over 30 years, she has studied the benefits of music to promote health and well-being among older adults. She formerly led the Sound Health Network, which aimed to raise awareness about the health benefits of music across the life course, and she currently leads several NIH- and NSF-supported grants about music and health, including the Music & Dementia Research Network and a study about how music improvisation training affects well-being among older adults. In 2010, she was a Fulbright Scholar in Finland, where she studied how community choirs support well-being among older adults.
Education Sessions
The Verification Bottleneck: Designing QC Processes for AI-Generated Regulatory Documents
Speaker: Josh Kim
Description: Faster drafting has shifted the bottleneck to verification. Medical writers now spend disproportionate time checking AI-generated content against source data, a task that grows more complex with critical-path documents. This session explores what the medical writing process looks like after AI implementation and how to optimize for time, quality, and value in output from there. We will examine how verification and quality control (QC) become the critical path, what this means for team structure and workflows, and what features to build into AI writing tools that support efficient QC. Attendees will leave with frameworks for redesigning handoffs between medical writers and QC teams to maintain accuracy without losing the speed gains AI enables.
Speaker bio: Josh Kim is CEO and co-founder of Artos, a Y Combinator-backed AI platform for regulatory document authoring used by Top 50 pharmaceutical companies. Prior to Artos, Josh worked in regulatory, clinical, and commercial strategy roles at Ignyta (acquired by Roche) and Erasca, with experience authoring regulatory documents for FDA, EMA, and PMDA approvals and working on early-stage IND strategy and trial design. As an NIH-funded researcher at University of Chicago, he developed NLP techniques for clinical workflows and patient recruitment deployed in live drug development scenarios. At Chicago, Josh became the youngest NIH-funded PI in agency history for his work developing AI/ML models for clinical workflows.
Why Most AI Pilots in Medical Writing Stall: And What Changes When They Don’t
Speaker: Anita Modi, MBA
Description: Most pharmaceutical companies have launched AI pilots for medical writing. Many have not progressed beyond them. This session examines the structural reasons AI pilots stall in regulated writing environments, and what distinguishes implementations that achieve sustained adoption. The discussion draws on cross-industry patterns to identify the most common failure modes: misalignment between AI capabilities and writer workflows, underestimating the role of institutional knowledge, over-indexing on speed metrics while neglecting quality and trust, and deploying tools that require writers to change how they think rather than how they execute. Attendees will learn a practical maturity framework for evaluating AI readiness in medical writing organizations, the organizational conditions that predict successful scale-up, and why the transition from pilot to production depends more on change management than on technology selection.
Speaker bio: Anita Modi is CEO and Co-Founder of Peer AI, an agentic AI platform helping life sciences teams produce regulatory and clinical documentation faster and with greater consistency. Her team is comprised of AI engineers and regulatory medical writers and works with emerging biotech through Top 20 pharma. Anita specializes in applying AI to medical writing workflows—translating complex clinical data into clear, submission-ready content across use cases, with user interfaces for medical writers to interject their expertise. Anita has spent her career building technology for regulated workflows in life sciences. Previously, she served as the Chief Quality Officer at Science 37 and supported product strategy through its $1B+ IPO. She studied at Princeton and Harvard Business School and is based in San Francisco.
AI Tool Requirements for Regulatory Medical Writers
Speaker: Sharon Kim, PharmD; Nancy Katz, PhD
Description: AI adoption in regulatory writing presents a distinct set of challenges that differ from other content development environments. Regulatory medical writers must operate within strict frameworks that prioritize data integrity, patient safety, and compliance with global health authority expectations. Key considerations include meeting robust security and privacy requirements, ensuring alignment with client-specific AI policies and strategic direction, and establishing strong guardrails that support accuracy, consistency, and appropriate message delivery. In addition, writers must understand how AI-generated content is created, validated, and documented to maintain transparency and traceability. This session will explore the essential capabilities regulatory medical writers should look for when evaluating AI tools, along with practical guidance on how to integrate these technologies responsibly and effectively into everyday regulatory writing workflows.
Speaker bios: Sharon Kim, PharmD, is the founder and CEO of MPilot, an AI-driven platform supporting clinical trial documentation. A medical writer with experience at Pfizer, Genentech, and Gilead, she has spent over a decade navigating the regulatory, ethical, and logistical challenges of drug development. Her work now focuses on bridging AI innovation with regulatory rigor, helping writers and clinical teams produce high-quality, compliant documents at scale.
Nancy R. Katz, Ph.D., MWC is President and Principal Medical Writing Consultant at Illyria Consulting Group, which she founded in 2006 after holding senior roles at Genentech, PDL, and other leading biopharma companies. With nearly three decades in the industry, she has led medical writing and development editing teams, contributed to global regulatory submissions, and presented widely at DIA conferences. An active member of AMWA, Nancy has served twice on its national Board of Directors and regularly teaches workshops on regulatory writing. She holds a Ph.D. from UC Berkeley and is a Medical Writer Certified (MWC).
Breakout Sessions
From Writer to Editor: Crucial Knowledge for Effective Editing
Speaker: Christian Small, MA, ELS(D); Leslie Kowitz, MA, ELS
Description: There’s an old axiom that every writer needs an editor. In reality, though, not all medical or regulatory writers have access to an editor, so editorial tasks fall to others, such as reviewers, project managers, or the writers themselves. While many of them have the knowledge, skills, and instincts to be effective editors, they may not be familiar with certain editorial principles and practices that can help them put those skills to use effectively. This session will introduce participants to some of these principles and practices, including the role of editors in producing high-quality documents, how to prioritize editing tasks at certain stages of a project, and best practices for interacting with authors.
Speaker bios: Christian Small, MA, ELS(D), is a senior manager with BeOne Medicines, USA. He earned an MA in English from California State University, Sacramento, and a BA in economics and English from the University of California, Davis. Chris has worked as a technical editor and writer for 26 years with BeOne Medicines, Whitsell Innovations, Genentech, and ICF International. He is certified as a Distinguished Editor in the Life Sciences by BELS. Chris contributed to posters at the 2021 and 2023 AMWA Medical Writing & Communication Conferences, and co-presented a breakout session at the 2024 AMWA NorCal Chapter Pacific Coast Conference.
Leslie Kowitz, MA, ELS, is a senior manager with BeOne Medicines, USA. She earned an MA in instructional technology and a BA in science from San Francisco State University, as well as a Medical Writing and Editing Certificate from UC San Diego Extended Studies. Leslie has worked in numerous roles, such as technical editor and writer, clinical medical editor, and instructional designer, for more than 30 years with BeOne Medicines, Genentech, Medivation, and other companies. She is certified as an Editor in the Life Sciences by BELS. Leslie contributed to a poster at 2023 AMWA Medical Writing & Communication Conference, co-presented a breakout session at the 2024 AMWA NorCal Chapter Pacific Coast Conference, and has published articles in the AMWA Journal.
Overcoming the Challenges of Expedited Submission Times with Planning, Top-Down Messaging and Parallel Writing
Speaker: Brenda Taylor, MS
Description: The time being allowed from receipt of last study data to submission of a marketing or new drug application continues to shrink. The demands of planning realistic timelines, maintaining messaging, and writing documents in parallel continues to increase. Efficiency can be obtained through extensive planning, prototyping, and by agreeing on presentation and messaging in the last CSR before draft 1 of the summaries and overviews. Methods for enabling this simultaneous writing of reports, summaries, and overviews will be discussed, including designating the one source of truth. I will also discuss the pros and cons of lockdown meetings and top-down support for the review and approval process.
Speaker bio: Brenda Taylor MS, is a Director of Global Submissions at Certara. Brenda has over 25 years of experience in the biotechnology and pharmaceutical industry, spanning small molecule drugs and biologics. She has been a submission lead for numerous investigational new drug and marketing applications to FDA and other regulatory agencies. A prolific author of Investigator’s Brochures, both nonclinical and clinical summaries and overviews, briefing packages and other regulatory documents. In addition, Brenda continues to author white papers and manuscripts related to submission leadership and improving the submission process. Therapeutic areas of expertise include oncology, cardiovascular and anti-infective agents.
The Medical Writer in 2030: How AI Reshapes Roles Without Replacing Expertise
Speaker: Anita Modi, MBA
Description: The pharmaceutical industry is investing heavily in AI for regulatory documentation, but the conversation about workforce impact often oscillates between two extremes: AI will replace writers, or AI will change nothing. Neither is accurate. This session offers a grounded, evidence-informed perspective on how medical writing roles are evolving as AI becomes embedded in document workflows. Drawing on patterns observed across early AI adopters in pharma, the discussion examines which tasks are being automated, which are being augmented, and which are becoming more important. Attendees will learn how the writer’s core value shifts from content generation toward scientific interpretation, quality assurance, and cross-document consistency and what this means for hiring, training, and career development. The session provides a strategic framework for medical writing leaders preparing their teams for a fundamentally different operating model.
Speaker bio: Anita Modi is CEO and Co-Founder of Peer AI, an agentic AI platform helping life sciences teams produce regulatory and clinical documentation faster and with greater consistency. Her team is comprised of AI engineers and regulatory medical writers and works with emerging biotech through Top 20 pharma. Anita specializes in applying AI to medical writing workflows—translating complex clinical data into clear, submission-ready content across use cases, with user interfaces for medical writers to interject their expertise. Anita has spent her career building technology for regulated workflows in life sciences. Previously, she served as the Chief Quality Officer at Science 37 and supported product strategy through its $1B+ IPO. She studied at Princeton and Harvard Business School and is based in San Francisco.
The Future of Freelance Medical Writing: 2027 And Beyond
Speaker: Sophie Ash, BSc (Hons), DipION
Description: The freelance medical writing profession as we know it will soon be no more. In the coming years, the factors that determine who survives, who thrives, and who quietly exits the field will look very different from today. This session will explore the deeper shifts already underway — economic, technological, relational, and societal — and what they will mean for your work, positioning, and lifestyle. Whether you’re just starting out or well-established, you’ll leave with a clearer understanding of what lies ahead, with more confidence in your ability to navigate the changes required to remain relevant.
Speaker bio: Sophie Ash is a business coach for medical writers, as well as an Adjunct Professor for pharmacists exploring freelance medical writing. As the founder of Prospology with 12+ years of experience in medcomms, she supports accomplished, driven professionals in designing sustainable, freedom-focused medical writing careers on their own terms. Sophie specializes in being able to zoom out and make sense of how industry shifts, human behavior, and belief systems intersect.
When Patient Intake Forms Go Bad
Speaker: Liz Fraley, BA, BS, MA
Description: Everyone dreads filling out my doctor's Annual Wellness Survey Form because, invariably, we're asked to provide data that exists in our record and that the doctor has better access to, especially at the time we are asked to fill it out. I usually skip doing mine. Once I started digging around, I managed to acquire several examples from a variety of doctors. I found myriad examples that fly in the face of modern UX and CX techniques. I'll make you laugh, think, and hopefully design better surveys that your customers will actually fill out, allowing you to collect better data.
Speaker bio: Elizabeth Fraley, CEO of Single-Sourcing Solutions and the author of two books about Arbortext, specializes in helping others grow and develop expertise. She's founded two companies, been on the boards of three non-profits, and is constantly coming up with new ways to share knowledge in the technical communications and content industries. With experience in both high-tech and government sectors, she advocates approaches that directly improve organizational efficiency, productivity, and interoperability. If you ask her, she’ll say she’s happiest when those around her are successful.