THOUGHT LEADERSHIP

At PROMETRIKA, we provide biostatistical analysis and regulatory medical writing services to our sponsor companies who have reached the stage of New Drug Application (NDA) or Biologic Licensing Application (BLA) preparation. One of the many crucial documents in these applications is the Package Insert (a.k.a., Prescribing Information or Product Information; PI), the summary of safety and efficacy data on proposed new drugs and biopharmaceuticals (‘drug’ will be used to refer to both hereafter). In the following discussion, I will trace the source and distillation of the efficacy data presented in the PI.

On the surface, a medical writer has a simple calling: communicate medical information and research results clearly to the intended audience. How one achieves this goal is what sets apart a great medical writer. Arriving at a high-quality final document requires planning, clear communication, coordination between team members, and building consensus among stakeholders. These are not directly related to writing per se but are central to the success of our projects, so how does a medical writer learn and hone such skills?

Emerging biotech companies must master many challenges in bringing a product to market. Even the acronyms common to early development, like IND (Investigational New Drug Application), SAD (single ascending dose), and MAD (multiple ascending dose) imply that a company must know how their treatment impacts the body, how to analyze study results, and how to express their findings to regulatory authorities. The expertise of medical writers is valuable in helping an emerging biotech reach its drug development goals.

The development of the Package Insert (PI), also known as the Product Information, Prescribing/Prescriber’s Information, or simply “the Label,” is a long, complex process typically managed by a regulatory professional. It is a collaborative document, incorporating contributions from chemistry, toxicology, medical/clinical, biostatistical, writing, and regulatory professionals. Drawing from experience on a recent project, I would like to focus this installment of Protocol to Package Insert on the derivation of the clinical safety data that appear in the PI.