Why do drugs fail? Research shows that efficacy and safety are significant reasons – as you might expect. But one surprising statistic is that one quarter of failures at phase II and III are because of commercial or strategic reasons (1). In addition, a number of drugs, although meeting safety and efficacy endpoints, struggled post-approval for other reasons. Will Dunlop, Head of Market Access at Mundipharma International, set out to find an explanation and embarked on a recent study with Nektarios Oraiopoulos, Judge Business School, to identify the key barriers to a customer-focused drug development process, and then set out a comprehensive framework to overcome them (2). Here, Dunlop tells us more.
What are the most important factors in preventing commercial or strategic drug failures?
Collaboration between R&D, commercial and market access teams is crucial to the success of a drug. It’s well reported that payers are playing an increasingly important role in the success of a medicine – and regulatory approval can no longer be considered a guarantee for market success and profitability. Given the increasing budgetary pressures payers are under, pharma companies quite rightly have to demonstrate the benefit of new medicines when compared with existing standards of care. Global healthcare systems cannot afford innovation for innovation’s sake anymore. Companies must have a vision in mind of the difference their therapies will make, and only look for innovations that address both payer and patient needs.Do you have any specific examples of strategic failures?
Exubera is an example of a good drug that met regulatory requirements, but was widely reported as being taken off the market due to low sales. The inhalable insulin product cost $5 compared to $2-3 for injectable insulin. In the US, many insurance companies refused to cover the cost of the more expensive treatment; and in the UK, NICE argued that Exubera should only be approved for diabetics with a proven fear of needles.Can you sum up the main barriers to successful internal collaboration, and your proposed solutions?
The report that we developed in partnership with Cambridge Judge Business School revealed that good science is simply not always enough to get a product to the patient who needs it. We concluded that the main barriers to collaboration can be divided into economic, organizational and behavioral ones – each bringing unique challenges. Economic barriers to collaboration are linked to the substantial timeline required to develop a new therapy. R&D teams are often, understandably, focused on driving their product to the next stage without ensuring it’s the right decision overall. Too many times, we’ve seen these drugs go on to fail at a later stage, when hundreds of millions have been invested. There are also behavioral barriers to collaboration where scientists have invested a lot of time into a compound and become such strong believers in it that they fail to acknowledge the evidence against it. Understanding that this behavioral bias exists and seeking advice from experts is key to overcoming it. Organizationally, there is often an insular culture in which people work closely with and learn only from their own group. Having goals that require a collective effort from all departments forces teams to work togethermore effectively.
What is the most important thing to consider when developing a commercial strategy?
The most important thing is that you really understand the market in-depth at a local level; you need to look through the lens of each of your stakeholders – what does the payer need to see? What will the patient want? What does the health system require? Shaping your strategy around these insights and improving the communication flow between R&D, commercial and market access teams, coupled with strong science, is a good recipe for success.Newsletters
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References
- RK Harrison, “Phase II and phase III failures: 2013-2015”, Nat Rev Drug Discov, 15 (12), 817-8 (2016). PMID: 27811931. N Oraiopoulos and WCN Dunlop, “When science is not enough: a framework towards more customer-focused drug development”, Adv. Ther., 34 (7), 1572-1583 (2017). PMID: 28625003.
