PHILADELPHIA--(BUSINESS WIRE)--Today, the Biotechnology Industry Organization released a white paper – A Lifecycle Approach to Structured Benefit/Risk Assessment Framework - to encourage companies to incorporate and reflect patient preferences throughout the drug development lifecycle. The white paper release coincides with the BIO International Convention, taking place this week in Philadelphia, Penn.
“The voice of patients can play a critical role in helping to better inform the search for treatments and cures for chronic and deadly diseases throughout drug discovery and development,” said Kay Holcombe, Senior Vice President for Science Policy at BIO. “This needs to be a two-way conversation, with patients serving as advocates for their diseases and providing the research and scientific community with feedback and input. In turn, we must shift our approach to drug development by incorporating this input at key stages throughout drug development in order to meet the unique needs and desires of patients most effectively."
Under the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA 5), FDA is currently implementing a structured benefit-risk assessment framework to help organize its review of a product’s benefits and risks to more effectively communicate the judgments that went into a product approval decision. FDA will begin publishing completed benefit-risk frameworks with approval decisions beginning this year.
The white paper is aimed at companies who choose to proactively utilize FDA’s structured benefit-risk assessment framework earlier and more broadly throughout a product’s lifecycle to solicit patient preferences and align with FDA on key benefit-risk considerations. Systematic and early use of FDA’s structured benefit-risk framework can be a powerful tool to evaluate the views of the patient community on the burden of disease, current treatments options, anticipated benefits, and risk tolerance. When sponsors develop proposed frameworks based on patient input and proactively share it with FDA at key stages in drug development and review, the framework becomes an evolving document that can serve as a decision-support tool to help guide benefit-risk discussions across a product’s lifecycle.
To access the full white paper, please visit www.bio.org/fdasbra.
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.
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