DIA Annual Meeting 2023

In our pursuit to bring medicines to patients faster, we must continuously evolve alongside an endlessly-changing regulatory landscape. For Medical Writers, this translates into increased complexity, additional writing requirements, and less time to complete the work. This session will explore the past 40 years and next 40 years of regulatory submissions, from the perspective of the Medical Writer. Together, we will discuss how both writing methodologies and technologies are evolving.

Collapsing timelines for marketing submissions is an increasing phenomenon in recent years, due to a demand to move from pivotal study table/figure delivery to submission in weeks instead of months. Solutions to this problem will be discussed.

Recognize challenges in preparing clinical summary documents for New Drug Applications (NDAs); Analyze the differences and gaps relative to NDAs based on adequately powered controlled studies; Initiate plan of action including contingency planning; Identify stakeholders (internal and external) to engage.

FDA’s Project Optimus emphasizes the importance of dose optimization oncology. Often, oncology drugs are studied in combination with other therapies. This session will focus on dose optimization for combinations and challenges still to be addressed.

In this forum, three experienced medical writers will describe the ways in which artificial intelligence (AI) tools and technology are changing the life of a medical writer when preparing clinical study reports (CSRs). They will present small case studies that show how the tool used at their company is changing the medical writing space and how medical writers work differently because of it. The speakers will then open the floor to field questions and have a general discussion/debate with the audience about where technology will take CSR production.

Join the DIA Medical Writing, Patient Engagement, Regulatory Affairs, Study Endpoints Communities for a follow up roundtable discussion tied to session: Writing Summary Documents for Rare Disease Submissions: Unique Challenges (Wednesday, June 28, 8:30AM-9:30AM). Space is limited.