Expert tips for REMS success: Page 4

Do user and product homework; form a cross-development team

Horner: Accumulate knowledge, create mitigation strategies early, and revise often.

Building on the lifecycle approach I mentioned in the first point, planners need to begin building the product safety profile before it is used in humans.

To build the profile, start by examining the safety profiles of similar products. Analyze available preclinical safety data, and design clinical protocols that collect data on suspected safety issues.

Proactively continue to collect such information in a way that is easily accessible and transferable within your organization, and as responsibility for the product moves through the stages of development and into marketing.

Design and periodically update mitigation strategies according to this growing body of internal knowledge about the drug.

Fetterman: Use a science-based process to characterize the risks associated with the care delivery process for the medication. 

It is essential to understand how the existing care delivery process may fail to protect the patient from product risks. This insight guides the development of targeted interventions that are likely to be effective.

Gallo: Form a committed cross-development team.

Given the nature of REMS programs, multiple departments that traditionally worked together only in a peripheral way or during transitions are now jointly supporting products throughout the life of a product.  Each department responsible for executing specific components of the program should be involved from the beginning of the process. 

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Expert tips for REMS success: Page 4