Starting with the End in Mind: How Pharma Can Build a Smarter Path to Commercialization
To chart a clear path to commercialization, a manufacturer must begin with the end in mind. Early market research helps pharma companies understand which clinical endpoints and differentiators an asset will need to succeed at launch.
Today, one-third of pharma companies start market access planning in Phase I, and 80% start by Phase III. Manufacturers were once reluctant to invest in market research during development, when an asset’s future is uncertain. But the questions raised by early access planning are pivotal for your business, as their answers will drive decisions about your asset’s viability.
In Phases II and III, manufacturers should follow these steps to lay the groundwork for commercialization:
1. Develop Your Value Story: First, think about how your trials will feed market access. Is progression-free survival a key indicator for payers? Should you collect other patient outcomes data in Phase IIB? What are common treatment complaints? Is cost avoidance a potential benefit to payers?
Answering such questions requires research on what matters most to payers and HCPs. In turn, addressing their concerns in your trial design enables the collection of essential outcomes data to fuel your value story. One of our most strategic clients began developing its PIE deck at the start of Phase II, which helped it identify the precise endpoints required for creating a compelling value story.
2. Map the Patient Journey: In early clinical trials, manufacturers should focus on epidemiology. How large is your potential patient population? Where are these patients located, and what are their unmet needs? By Phase II, your team should revisit how a patient is diagnosed and treated. How can you address diagnostic roadblocks and treatment delays?
For uncommon disease states, delays are often caused by a lack of physician knowledge about symptoms. If your product requires testing that is not routinely ordered, you’ll need to educate physicians about when testing is indicated—and ensure these tests are covered. By understanding what access looks like today, your team can better understand your product’s differentiation.
Read the full article in Drug Channels to learn the six planning steps manufacturers should take in early development.
To predict market reaction to your future launch scenario, consider analog analysis with our Strategic Launch Report.
