How to Avoid Unpleasant Surprises at Product Launch

Product launch missteps are costly. Not only do you lose potential revenue, but you have to invest additional resources in correcting the course. Fortunately, many market surprises are avoidable.

Why it’s critical to listen to patient voices before launch

Puma Biotech recently learned a costly lesson with Nerlynx®(neratinib), their drug for preventing recurrence of HER2 breast cancer in patients previously treated with Herceptin®. The drug performed well below analysts’ expectations in the first quarter of this year. According to a recent article in Fierce Pharma, one contributing factor may have been “higher rates of discontinuation, primarily because of side effects in general, and diarrhea specifically.” Now the company is re-educating prescribers about diarrhea management, including anti-diarrheal medications, as well as dose reductions and dose holds for Nerlynx. 

On top of disappointing financial results and need to re-educate physicians, nurses and patients, add the sting of a Wall Street analyst’s suggestion of “a significant overhaul” of the commercial team. Those things likely could have been prevented had Puma Biotech fully understood the experiences of the patients in their clinical trials.

How to avoid this situation

By listening in-depth to patient experiences during the Nerlynx trials, Puma Biotech could have uncovered this clinical unknown and planned for handling it at launch. This knowledge would have enabled them to set proper expectations with physicians and patients. Had physicians and patients been better prepared to manage the nuisance side effects, perhaps through patient support tactics, patients might not have discontinued the drug at such high rates. 

Companies with truly patient-centered drug development programs have collected patient experience data during various phases of clinical trials and afterward because there is always more to learn prior to launch. The key is working with a research partner with:

  • Sensitivity to the compliance needs of all departments within the sponsor company
  • In-depth knowledge of Institutional Review Board/Ethics Committee (IRB/EC) requirements
  • Experience with recruiting clinical trial patients around the globe—and insight into language issues
  • Track record of successfully designing and conducting compliant research 
  • Proven ability to query into and bridge disease journey insights with treatment journey experience

Prevent missteps on the road ahead

As the old saying goes, “You don’t know what you don’t know.” Gathering patient experience data during clinical trials and prior to launch helps eliminate some of the unknowns that could lead to unwelcome surprises. It may also uncover hidden opportunities for Medical Affairs, Clinical and Commercial to enhance patient-centricity. 

To learn more about minimizing clinical unknowns, visit the Clinical SCORE Knowledge Base and download our white papers:

  • True Patient Centricity: The Key to Clinical and Commercial Success
  • Greenlight Patient-Centricity: How to Collect Patient Insights to Drive Product Success

Then email Blaine Cloud or call (267) 625-7480.