Most Companies Plan for New Product Commercial Success Too Late

At the Fierce Pharma Week conference in September, Veeva Systems's Anthony Billinger , Senior Director of Compass Strategy, highlighted a challenge the industry can’t afford to overlook: the widening gap between forecasts and real-world performance.

He mentioned studies show that two-thirds of new therapies underperform in their first year, and up to 70% continue to miss expectations in subsequent years. The takeaway was clear, our industry needs to rethink when and how we prepare for commercialization.

A consistent theme throughout the conference was the importance of investing earlier in commercial infrastructure and data.

At Litmys, LLC, we believe this early investment needs to go even further, all the way back into clinical development decision-making.

About a month ago, we hosted a webinar titled The Battle for Market Share Gets Fought Before Phase 3. Michael Murphy M.D., Ph.D., Chief Medical Officer of Worldwide Clinical Trials, emphasized the need to understand a product’s key differentiation, barriers to adoption, and economic impact on access and uptake, and to build that understanding directly into the development program.

This aligns with insights shared by another panelist, Chris Garabedian, CEO of Xontogeny and Portfolio Manager of the PXV Fund at Perceptive Advisors. With IPO markets tight and investors holding positions longer, companies must be crystal clear on which outcomes will attract strategic partners or new investment. Those outcomes should serve as guideposts for Phase 3 design, ensuring pivotal trials generate the evidence the market truly cares about.

The value of early input into clinical trial design is increasingly important. One client that has developed a highly differentiated new product and launched about a year ago has struggled in generating physician enthusiasm because the clinical data with which they launched was insufficient to convince many that the new product would be as efficacious as the legacy product it was intended to replace.  The situation was further complicated by payers restrictive access policies that made the product more difficult for physicians to obtain without a prior authorization and more expensive for patient in terms of co-pays. The data is now being generated but at the cost of slower uptake than anticipated.

In another client, a Phase 2 drug being developed for a rare disease received significant negative feedback from payers who felt the criteria and data the FDA outlined relative to approval was not relevant to how the product would be prescribed and used. The company has decided on a parallel clinical development path designed to garner approval but also to give payers the data they want in order to make the new product appropriately available without restrictive access policies.

Successful Commercialization is a Marathon, Not a Sprint

No one shows up to a marathon without preparation. Yet many companies still wait far too long before investing in launch readiness. 

In the words of a former, highly successful Chief Commercial Officer, “You can’t outspend a bad label.”

To address this challenge, Litmys developed the RAMPx model. The RAMPx model helps companies identify early, before Phase 3, a new product’s points of differentiation, the strength of its value proposition, and the market dynamics that will drive adoption. The model uses input from the relevant stakeholders who evaluate the new product across 12 factors encompassing not only how the new product’s attributes and clinical data compare to the standard of care, but also how easy it will be for physicians and patients to adopt the new product as well as their willingness to be an early adopter.

With almost 80% of physicians now employed by either a hospital, plan, or private equity, a new product has to have a compelling value proposition to get the attention of time pressured physicians. And, even with DTC, delivering a message that motivates patients to seek out the counsel of their physician to learn more about the new product is a major challenge. The insights from the RAMPx model directly inform Phase 3 trial design, shaping the product’s label, messaging, access, and ultimately, its uptake.

If the industry wants fewer launch disappointments, the solution is clear: start preparing long before the race begins.

Learn more about how Litmys and the RAMPx model can help companies improve the odds of a new product being commercially successful before committing significant dollars to expensive and lengthy clinical trials that may garner approval but not necessarily drive uptake and revenues.