CorporateNovember 29, 2021

Safety and Efficacy at Speed

Traditionally, drug exploration put speed and risk at opposite poles. You could always go faster but the risk of accidents, poor quality, or impacts on drug safety were possible consequences.

Yet, in the case of the pandemic, the urgent need for a response saw specialists from across the world join forces and achieve an unprecedented medical feat – the creation and rollout of the Covid-19 vaccine in under a year. The average vaccine takes at least ten years to develop.

The AstraZeneca vaccine went from the first construct, in the second week of January 2020, into a human inside 100 days. The pandemic response has set a new standard for what can be achieved, both in terms of vaccine development and how pharma can respond to other diseases and treatments.

New technology and lab and trial techniques enable a much faster pace of discovery and development. But how is the industry’s risk management rebalancing in order to keep pace with the speed of response?

For Sir John Bell, an instrumental figure in the development of the AstraZeneca vaccine, the pandemic response shows that the industry must not forget how fast it can act when the pressure is on.

"Delays in the development of transformative therapies cost lives in the same way that you could save lives with a new vaccine for COVID or a new antiviral for the disease. It's just worth remembering that we can do stuff faster, and we should probably try and set the standard at a much higher level for what we would expect to be normal."

The introduction of new processes, such as working in tandem with regulators on rolling reviews, are the kinds of learnings that Sir Bell sees driving long-term efficiencies in the drug approval cycle. It is also an important example of how collaboration between pharma and regulators can be made more efficient, without compromising on safety.

The pandemic has taught us that safety does not have to be compromised for speed. The industry must take the learnings from the pandemic and find ways to embed quicker processes and greater collaboration into the drug development cycle for pharma to get treatments to patients as early as possible.

Listen to the Pharma Unlimited Podcast series – a new series where host Bertrand Bodson goes under the microscope to examine some of the biggest issues facing the pharma sector.

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