When your drug gets to the market, will you have a compelling answer to the question “how is it better?” That answer could be worth billions of dollars.
Recent research from Syneos Health shows that nearly two-thirds of all drug launches miss the expectations of their sponsors and industry analysts. A key reason according to the study: lack of meaningful data to build compelling label claims.
Until recently, what language goes on the drug label was not only one of the last documents submitted before approval, but also among the last things on new-product planning team minds during early clinical trials. But Pharma has woken up to the idea of label optimization – that is, figuring out, in advance of your pivotal trial, what robust and compelling language you need in your label – and it has become one of the most strategic issues in drug development. We call our proprietary process for this Winning Label.
Best practices start at Phase II – even earlier for orphan diseases and oncology drugs. Following these four steps can help optimize clinical trial design to prepare your product for competition in the marketplace.
Convene a multidisciplinary teamA cross-functional commercial team is essential, and includes stakeholders such as portfolio managers, market analytics experts, brand managers, new product planning teams, and market access strategists who can share with R&D not only what features prescribers desire, but also language they use to describe these needs – language that ideally enters the label.
Define the launch environmentIntelligence-gathering should be future-oriented, in order to identify label claims that will win this drug a compelling value proposition in the years following its launch half a decade from now. Scrutinize word and phrase choices within all current competitive labels, section by section, and review clinical trial designs for pipeline competitors. Look for signs that regulators may have reined in claims for lack of sufficient data. Exceptions – both good and bad – can be clues to what your product is up against and what gaps you may be able to fill. Finally, a deep understanding of audiences and their unmet needs can drive label language that can prevail in current and future markets.
Think about the supportive data requiredImagine your drug being advertised to consumers on TV. What language would move them? What would they be indifferent to? How will you prove it? Do you have sufficient evidentiary support? This is where clinical colleagues can offer valuable counsel early on.
Align on the optimal critical path and executeWith answers in hand, the team can develop or revise a Target Product Profile (TPP) informed by market insights, organization strategy, and clinical feasibility. Alignment within the team and top management buy-in to the TPP are essential to avoid large costs and time delays due to changes down the line – but be flexible and prepared to re-examine and, if necessary, change the TPP when new data emerges or market conditions change.
Does your process include these best practices? Your answer could have a profound impact on your product’s bottom line.