AMWA 2023 Medical Writing & Communication Conference

In CMC regulatory writing, there is a difference in the level of detail required for NDA and BLA products. The expectations tend to diminish as time elapses and the regulatory authority becomes more familiar with a specific type of medicinal product. Small molecule oral solid products have been submitted to, approved more frequently, and represent a different set of expectations than biologics, vaccines, and gene therapy (GT) products. Biologics, vaccines, and GT products tend to be comparable to each other, yet they contain significant differences in requirements for certain modules. This seminar will provide a high-level overview of the expectations required for Module 3 submissions for a small molecule oral solid product NDA, a biologic BLA, a vaccine BLA, and a GT BLA.

Investigational New Drug (IND) applications are diverse and encompass a broad range of programs: first time application for a new drug to a new indication for a previously studied or approved product. Data summarized in INDs range from nonclinical only (eg, to allow a first in human study), both nonclinical and clinical (eg, for an early/mid-stage program with ex-US clinical data), or a mature program (new indication of an approved or abandoned product). Regulatory submission leads work closely with all stakeholders to weave in the various pieces in conformance with existing regulatory guidelines and provide guidance to a multifunctional team. This session aims to use various case studies as examples to share lessons learned and potential ways to navigate the challenges for a successful application.

The main goal of scientific medical writing is to inform the target audience objectively of a new scientific development. The target audience typically consists of researchers and healthcare professionals, but laypersons are increasingly a focus too. However, scientific writing is often focused on what authors want to convey instead of considering the target audience. Several suggestions will be provided for scientific medical writing geared towards the target audience, with a focus on considerations for plain language summaries and shorter scientific communications (eg, brief reports). Attendees will learn, amongst others, how scientific plain language writing can make use of lessons learned from writing plain language medical documents (eg, patient information), while facing some unique challenges too.

There is a lot of buzz currently on how Artificial Intelligence (AI) and applications like ChatGPT will transform the writing industry. Like most transformative technologies, such as the phone, computers, and robots, our natural tendency is to fear what we do not understand. However, we embraced these technologies once we established the utility of these tools and learned how they improve our lives through efficiency and quality improvements. When applied to medical writing, I foresee a similar outcome for using AI tools, such as machine learning, natural language processing, and data fabric. These automation tools will simplify the authoring process, allowing medical writers to focus on higher-order activities. As a result, the medical writer’s role will evolve and become even more impactful in the future.