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We often use the expression ‘black box’ to describe a common object or process where we understand the inputs and the outputs, but struggle to comprehend or explain the underlying process. A literal and figurative example might be the laptop computer. We certainly understand that typing letters and figures on the keyboard produces characters on the screen, or causes words and images to be printed, but we would be challenged to explain how the computer actually does this. It’s a black box we use every day and don’t even think about. In some ways, drug delivery product development is a black box. We conceptually understand the process of how products enter the development process and emerge as approved, manufactured and marketed products. But if we look closely, we come to realise that we really don’t understand what controls the output. If we did, the outcomes would be as predictable as typing letters on a keyboard and fully expecting the words to appear on the screen of our computer. With drug delivery enabled/enhanced pharmaceutical product (DDEP) development, we too are often surprised when the outcomes are not what we had expected.
THE DDEP BLACK BOX
A key parameter of understanding any process is being able to anticipate the outcomes based on the inputs. In the case of DDEP, there has always been a sense that these products are quicker to develop than traditional new chemical entity products and carry less development risk, because they generally incorporate previously approved pharmaceutical actives.
One company developing drug delivery enabled/enhanced products wrote in their annual report, “Shorter development timelines. Faster market penetration. Lower development costs” (1). Perhaps – but how much shorter and how much lower? Similar comments are often tossed out at industry conferences, boardrooms and product development meetings without any points of reference.
We do have reference points for the average development times and success rates of pharmaceutical products. In a series of studies over more than a decade, Dr Joseph DiMasi and colleagues have given us a good idea of the critical numbers that define the pharmaceutical product development black box (see Table 1). Many people in the drug delivery business reference these figures, pointing out that their DDEP business model has shorter product development cycle times and higher success rates.
It’s worth remembering that these figures represent the overall averages for pharmaceutical products, almost all of them new chemical entities. While the success rate is applicable to the sector as a whole, individual products can have clinical development and approval times shorter or longer than the eight year average. |
