When preparing regulatory submissions, especially in fields like oncology, it’s crucial to focus on the end goal—the drug’s label or Summary of Product Characteristics (SmPC). These documents aren’t just regulatory requirements; they serve as the foundation for how the drug will be positioned in the market. Writing with the label in mind means threading key messages through every layer of your submission, from summary documents to the clinical overview, culminating in the Summary of Basis for Approval (SBA) and, ultimately, the label itself.
Why Focus on the Label Early?
The label is a strategic document that communicates the drug’s benefits, risks, and appropriate use to healthcare providers, payers, and patients. Every claim made in the label must be backed by data presented throughout the regulatory submission. By developing your key messages with the label in mind, you’re ensuring that the clinical data will align with the drug’s intended commercialization strategy. This approach minimizes the risk of disjointed messaging and maximizes the drug’s potential for market success.
Threading Key Messages from Summary Documents to the Label
- Define Key Messages Early in the Process
Start by identifying the key messages that you want to see reflected in the label. These messages should be supported by clinical data and align with the drug’s therapeutic claims, safety profile, and differentiation from competitors. Engaging cross-functional teams ensures that these messages reflect both regulatory and market needs; note, however, that this should be done in a manner that makes it clear that commercial needs and promotional claims did not unduly influence any aspect of the regulatory process but, rather, that the regulatory process was constructed in a way that fully supports the business goals and medical needs of the patients.
- Integrate Key Messages into Summary Documents
The Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) play a pivotal role in shaping the label’s content. Structuring these summaries around the key messages ensures that the efficacy endpoints, patient populations, and safety data that are critical to the label are clearly highlighted. Consistent messaging throughout these documents helps reviewers connect the dots between your submission and the proposed label content.
- Carry the Key Messages into the Clinical Overview
The Clinical Overview allows you to narrate the story behind your data and make the case for the drug’s approval. This is where the key messages solidify and tell the important story of your drug and your patient population. Highlight how your clinical data support the proposed label claims, emphasizing the drug’s benefits, target population, and unique attributes. Ensuring that these messages are well structured and evident within the Clinical Overview creates a clear link between your data and the proposed label.
- Leverage Oncology-Specific Pathways like RTOR and the Assessment Aid
In oncology, submissions can benefit greatly from pathways like the Real-Time Oncology Review (RTOR). Products using the Assessment Aid under RTOR offer an advantage by structuring the information in a way that facilitates easy input into the SBA, the document that summarizes the FDA’s position on the drug’s approvability. This streamlined process helps regulatory reviewers assess the drug more efficiently and strengthens the overall submission, as it is designed to clearly map data to the label’s content in a way that aligns with regulatory expectations.
Utilizing the Target Product Profile (TPP) for Early Label Development
The Target Product Profile (TPP) is a valuable tool in facilitating the early development of label concepts. It serves as a strategic blueprint that outlines the desired characteristics of the drug, including its intended use, target population, and key differentiators. By developing a TPP early in the drug development process, teams can align their clinical trials, regulatory submissions, and commercialization strategies around the intended label. Moreover, the TPP encourages early and frequent cross-functional collaboration, ensuring that the entire team is focused on delivering a product that meets both regulatory requirements and market needs. Using the TPP to inform label development helps streamline the submission process, ensuring that key messages are well supported and the label reflects the product’s clinical and commercial potential.
Start with the Label, Finish with Success
Regulatory submissions aren’t just about gaining approval; they’re about setting the stage for commercial success and usability by the intended patient population. By writing with the label in mind, you’re ensuring that the drug will be well positioned in the marketplace. Highlight unique aspects of your drug, such as superior efficacy or safety. Every claim in the label must be backed by robust clinical data, which should be presented strategically throughout your submission to support the commercial positioning of the drug.
Whether utilizing oncology-specific pathways like RTOR or following traditional submission routes, threading key messages throughout the documentation ensures that the final label accurately reflects the clinical data and positions the drug for market success. Starting with the end in mind—the label—can lead to a more coherent submission, a smoother approval process, and a stronger commercial launch.
Need help developing your TPP or program regulatory strategy? Reach out to us at info@synterex.com or 888-760-9906.
