Marc Boutin on PDUFA

An astute marketer will tell you that success of any product is dependent on the wants and needs of the end user. In health care, we need a similar mindset. By collaborating with patients early in drug development, there is an opportunity to improve the success rates in the preclinical stage of the development, which could ultimately accelerate the delivery of new treatments to patients and enhance patient adherence to their treatment plans. The end result will be a win for all stakeholders. To effectively integrate the patient voice throughout the research and regulatory processes, we need to first develop a consistent definition and shared expectations for engagement. We know that some companies have already expanded their programs to more comprehensively intertwine the patient voice; we need to learn which tools and methods have achieved their intended goals. We also need to differentiate when and how the individual with a chronic condition can be an effective partner in the development and regulatory processes and at what point the patient advocacy organization should be engaged. There is little guidance on how to conduct or assess whether an approach to engagement will yield meaningful results. To address this challenge, the NHC and its member patient advocacy organizations are devising a plan to bring together all stakeholders to generate consensus about how to best to advance methods for meaningfully engaging the end user - the patient -  in drug research, development...
Source: PHRMA - Category: Pharmaceuticals Authors: Source Type: news