To modernize the FDA and improve the drug development process, Congress recently passed the 21st Century Cures Act. One important strategy within the act is patient-focused drug development (PFDD). Read on to find out why PFDD is a game changer for pharma.
Patient-focused, patient-centered, and patient centricity are buzzwords right now, and for good reason. Life sciences companies that act with patients at front of mind are often met with positive reactions from patients, resulting in business growth. WEGO Health acutely understands the power of patients. Patient centricity is good for patients – and it’s good for business.
Many of today’s patients are very knowledgeable and engaged. These patients are often willing to share their experiences and even their health data, especially when it can advance research and product development. WEGO Health’s Chief Strategy Officer David Goldsmith, recently spoke with PM360 about using real-world evidence and patient data to advance drug development. David highlighted the relative ease of finding patients for this purpose today and the value this data can provide to healthcare companies.
The Cures Act makes it easier to leverage this data. Patient-reported data can be utilized in the pre-clinical stage through to clinical trials and the commercial stage. As PM360 shares, preventative migraine treatment Aimovig is a good example of how the patient voice can be integral to the product development process. The labeling for Aimovig even includes patient-reported outcomes.
PFDD Moving Forward
PFDD will become even more vital as the Center for Medicare and Medicaid Services pushes this year for 50% of payments to be value-based. As manufacturers must further prove the efficacy of their drugs, patient insight will be invaluable.
Although the Cures Act makes using patient data easier, there are still challenges to consider. Meeting data privacy laws will be important, both for avoiding sanction and maintaining patient trust. We find many patient leaders are eager to share their experiences but expect transparency in return.
At WEGO Health, we believe companies developing patient-relevant products will always see benefit by partnering with patients. Visit PM360 to read more about the patient-focused drug development strategy within the 21st Century Cures Act and how PFDD is a game changer.