Six Months in a Leaky Boat

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Six Months in a Leaky Boat featured in 2019 at the ARCS (Association of Regulatory and Clinical Scientists) conference, it explored the reasons for uncertainty contributing to rejections of reimbursement submissions at Australia’s Pharmaceutical Benefit Advisory Committee (the PBAC). 

Companies spend a considerable amount of time and money developing submissions for the PBAC, the evaluation of these submissions is extensive and focuses on identifying areas of uncertainty in the claims. 

Uncertainty can ‘sink’ your PBAC submission, Biointelect analysed multiple submissions to identify the common areas of uncertainty and other contributors to rejections and found that many of these ‘leaks’ can be ‘plugged’ with comprehensive and robust new product planning. The six months corresponds to the period it takes for the PBAC to evaluate submissions.

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