Shaping drug development success: how does artwork play a role?

 The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world. While the entire lifecycle of the development process must be carefully navigated, and as the life sciences sector develops, there will be more significant investment in the preclinical stage, specifically around labelling and artwork.

While it may not seem like a priority at first glance, the success of a drug can hinge on early decisions around artwork. The role of artwork and labelling, including decisions around target product profiles (TPP), aspirational label claims and competitor label assessments, within this complex regulatory landscape cannot be underestimated.

The preclinical role of often-overlooked artwork

During preclinical stages, labelling decisions can significantly impact clinical trials and eventual drug commercialisation. Packaging is typically the patient’s first interaction with a product, and it is critical for communicating safety and benefit-risk information. High quality artwork ensures that the product packaging conveys reliability and professionalism to foster trust within the product. Precise labelling and artwork help prevent confusion and enhance overall patient safety.

However, making informed labelling decisions during preclinical stages is complex and requires expertise in a variety of areas, including clinical pharmacology, toxicology, regulatory affairs and medical writing. Failure to consider these areas can lead to errors that pose significant risks and delays to the drug development process. For example, inadequate consideration of the target patient population or potential drug interactions can lead to labelling errors that negatively impact clinical trials and eventual commercialisation.

Additionally, insufficient attention to the wording and presentation of the label information can lead to delays in regulatory approval or even rejection of the drug, prolonging the delivery of treatments to patients that need them most. Specific considerations include the consistency of text within artwork when translating into various languages. Drug developers must have access to the necessary expertise and tools during preclinical stages to minimise risks and ensure success in the competitive landscape of personalised medicines. Through innovative technology and access to expertise in clinical pharmacology, toxicology, regulatory affairs, medical writing and competitive intelligence, organisations can leverage transformative tools to significantly improve business outcomes.

Where priorities must remain  

A proactive approach to labelling during preclinical stages is crucial. This process involves competitor label analysis, aspirational label claims, TPP guidance and early regulatory engagement. Developing a company core data sheet (CCDS) and reference safety information (RSI) document within preclinical stages can also help guide later, critical labelling decisions. The CCDS of a drug product provides data from clinical information and core safety details, while the RSI is a list of the expected adverse reactions of a drug.

Informed labelling decisions during preclinical stages are vital for the success of drug development. By analysing competitor labels, using aspirational label claims and TPP to guide decisions and engaging with regulatory authorities early in the process, drug developers can better position their drugs in the competitive personalised medicine landscape. To access necessary expertise, developers can hire experienced staff, partner with external consultants or contract research organisation and engage with regulatory bodies.

A proactive approach to labelling and artwork creation in preclinical stages helps avoid common mistakes and, in turn, maximises drug potential and brings treatments to market faster. This increases the chances of success in clinical trials and commercialisation, leading to better patient outcomes and a more competitive pharmaceutical industry.