During our years of working in the industry and working together at CSC, we’ve developed a good understanding of the challenges that our clients face, as well as the opportunities in helping them meet those challenges and achieve the best outcomes for their companies and their patients.
By Sunshine Bruce, Global Head, Regulatory Strategy & Content Services, CSC and Michelle Gyzen, Regulatory Submission Services, CSC
As we observe the wider industry, our experience with those on the R&D side of the business is that it is about the science and about bringing life-changing, and very often life-saving, drugs to market. However, we’ve noticed that, on occasion, the day-to-day pressures of the business can obscure the real purpose, which is to focus on the end goal of serving patients.
There is undoubtedly a need to meet corporate objectives, and sometimes these pressures can be driven by the need to deliver shareholder value and meet certain end goals. But equally the problem can be attributed to a disconnect between corporate and R&D. For example, stakeholders can lose sight of the time pressures involved in conducting a test. They may be told that a test will take 20 days to carry out. The expectation can then be that at the end of those 20 days, documentation should be delivered. But it may not be properly communicated to all stakeholders that it will likely take another 5 days to do the analysis and even more to write the report or documentation to support the testing. So in actual fact, when R&D says 20 days to carry out a test, they really need a 5 to 10 day buffer, but that needs to be clearly communicated. Whatever the time pressure to deliver, the science requires that the full amount of time needed is factored in.
Collaboration Is Key
Our experience is that those challenges often have to do with not having measures in place to ensure true collaboration between corporate and regulatory, alongside the inevitable pressure to deliver results in order to meet revenue goals.
Certainly, some of these pressures are driven by the high and ever growing costs of bringing products to market. Beyond the time and effort that goes into conducting all the testing that is required to prove efficacy, there are the fees that are paid to the regulatory authorities. Each time the Prescription Drug User Fee Act (PDUFA) gets revised – which it has been five times since PDUFA began in 1992 – the fees increase. In Europe, fees can be extraordinarily high. For example, the cost of a label change can range between 3000 and 7000 euros or more depending on the type of change involved.
As we all know, this places enormous pressure on companies, who are trying to bring medicinal products to market.
Safety Is the Priority
Equally, the regulators need to remain focused on their task, which is to ensure that only products that are both efficacious AND safe are brought to market.
We live in a world of cheaper, faster. We see it with all consumer products, and pharma is subject to same rules. However, what pharma produces is about far more than the latest gadget, and so as an industry it must be more rigorous with the science. This is something we need to think about and remain true to. Regardless of who you are, we are all consumers of these products and we would all want safety to be paramount – whether scientist, regulator or business leader.
We would like to hear your opinion on this issue. What are the challenges you are facing and how do you believe the goals of both corporate and R&D can be better aligned – to the benefit of patients and the business?
In the next blog, we will explore content management and improving the filing process.