The drug research and development (R&D) cycle and supply chain for pharmaceuticals have been thrust into the spotlight by the ongoing COVID‑19 pandemic. Numerous antiviral and vaccine candidates are progressing through clinical trials and hold promise for a comprehensive solution. Among the factors that impact the timeline to approval of any safe and effective treatment, clinical supplies play a role crucial to successful study execution.  A considered application of innovative methods to clinical supply chain management can unlock value by simultaneously reducing costs and expediting time to market.  This next-generation clinical supply chain model that we need to weather the crisis today should be the one that we embrace as the new standard for tomorrow.

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Clinical Supply Chain Drug Development Lifecycle

Since the end of the blockbuster era at the turn of the century, the drug R&D industry has experienced declining success rates, prolonged timelines and rising costs despite improvements in technology.  This phenomenon has been described within the life sciences industry as Eroom’s law.  The typical R&D lifecycle for a new drug extends 10 to 17 years from discovery to commercial launch with expenses ranging from $157 million to as much as $1.95 billion. Conversely, the likelihood of successfully bringing any given investigational molecule from the laboratory to the market is dauntingly low – as poor as 0.01% to 0.02% by some estimates.  This painful combination of high costs and low success rates pushes the total R&D investment to bring new drugs to market to a range that borders on the astronomical.

Moreover, although eventual patent expiration has always been an element of the pharmaceutical industry, beginning in 2010, a notable wave of high-value blockbuster drugs has lost patent exclusivity.  This “patent cliff” has resulted in sharp revenue declines across the pharmaceutical industry, a trend that is expected to continue. The new reality stemming from this growing financial pressure has pushed drug makers to challenge the traditional drug R&D lifecycle and seek to break Eroom’s law. From a supply chain standpoint, this has led to an increased focus on reducing clinical trial material costs while improving supply lead times.

Crisis Drug Development: A Dilemma in Focus

Prior to the present COVID-19 pandemic, the world outside the life sciences industry had only a limited understanding of the true length and cost of the drug development cycle. However, the current crisis has placed the vaccine development timeline in the crosshairs almost overnight.  There can be little debate that humanity is in immediate need of safe and effective COVID-19 vaccines as the ultimate exit strategy to end the pandemic.

As with other drugs, vaccines are thoroughly tested in clinical studies, generally with a greater number of human trial subjects. Consequently, the timeline for a vaccine candidate to move from discovery to approval historically ranged from 10 to 15 years, with the quickest approval taking four years. In the face of the pandemic, however, even this quickest time frame is generally acknowledged to be outside the acceptable range.  Unfortunately, the development cycle cannot be simply compressed at the expense of patient safety and efficacy. R&D organizations must produce statistically significant clinical data at a large scale to demonstrate adequate safety and efficacy. Without this, we would be risking inoculating patients with unsafe vaccines that could cause consequences far more harmful than the virus itself.

Neither waiting for standard development lead times nor cutting risky corners is acceptable – so how can we realistically resolve this dilemma?

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Contributions by Jason Kerns.