1 June 2020
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As part of our Thought Leaders series, Mewburn Ellis Partner Sarah Kostiuk-Smith explores whether faster drug development is likely to become the "new normal".

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It is a truth universally acknowledged that getting drugs approved for prescription is a lengthy process. Indeed, it’s often so lengthy that many jurisdictions have legal provisions in place to allow companies to extend patent protection for market-approved drug products to help offset delays involved in getting the drug authorised for use and beginning to make money from it.

Understandably, patient safety is paramount. Before drugs are widely prescribed stringent safety tests are needed. It is also important to determine efficacy – does the drug do what it is supposed to? Often, potential side effects must be weighed against the drug’s ability to end or alleviate symptoms.

These are investigated by one or more clinical trials, which may take months or even years, with approval even to carry out trials often proving a complex endeavour. When the data have been gathered an application is made to the relevant authority – a process that itself typically involves multiple stages. The trip from laboratory to pharmacy is therefore normally the work of years.

Pressure for a panacea

However, the spectre of COVID-19’s infection rate and its consequent economic and social disruption has encouraged governments and regulatory bodies to reconsider the approval process. This is especially true for agents already approved for other indications, for which the toxicity and side-effect profile are already documented.

In short, everyone is looking for the panacea that enables us to return to ‘normal’ and that panacea cannot arrive quickly enough.

As a result, we have seen decisive action on the part of governments, supranational bodies, research institutions and pharmaceutical companies to streamline the research and development (R&D) and clinical trials processes for treatments aimed at COVID-19. For example, the University of Oxford began COVID-19 vaccine Phase I trials in April and is already recruiting for Phase II and Phase III trial participants.

Meanwhile, the World Health Organization (WHO) has launched the so-called ‘Solidarity Trial’ to compare four treatment options against the standard of care and assess their relative efficacy against COVID-19 in countries around the world. As the WHO explains, while randomised clinical trials normally take years to design and conduct, the Solidarity Trial will shorten the timeline by 80%.

This is all promising and has led some to ask whether this rapidity will translate, post-COVID-19, to the wider industry. Should we expect a new paradigm to emerge for fast-track R&D and approval?

"Should we expect a new paradigm to emerge for fast-track R&D and approval? My personal response is ‘no’”

My personal response is ‘no’, or at least not to extent that might be expected. From need and urgency come flexibility. The severity and scale of COVID-19 and its associated disruption mean that both public officials and individual citizens are more willing to ‘give things a go’ – accepting great uncertainty, greater risk, and far more concentrated expense. With public purses opened and the clamour for a solution, the failure of a large-scale trial would be disappointing but doesn’t need to be justified to shareholders and suddenly redundant employees.

No new normal

Outside such unusual times, I expect that officials and the industry will return to the more cautious and more lengthy model. This permits go/no-go decisions about whether or not to proceed to be made at milestones in the data collection process, with detailed consideration of and due regard to market factors and the nuanced balance of safety and efficacy, as well as return on investment. And, indeed, I think that is what the public, shareholders and research scientists will expect for drugs developed in normal circumstances.

What remains to be seen is whether we collectively learn from this experience and maintain the capacity and collaborative networks so that we can respond effectively to new emerging infectious diseases that require a global response. We don’t know when or how the next pandemic will hit. What we do know is that COVID-19 is not the last challenge humanity will face.

Sarah has extensive experience in the drafting and prosecution of patent applications, predominantly in the pharmaceutical sector but with a sizeable materials chemistry practice. Sarah also has both offensive and defensive opposition experience and defended several patents covering approved medicines in the EPO’s Opposition procedure. Sarah has a first class MChem chemistry degree from the University of Oxford and a PhD in organic synthesis from the University of Southampton. Her doctorate research focused on the total synthesis of natural products using radical-based approaches. She spent two years conducting postdoctoral research in Southampton, and has also undertaken a research placement with a pharmaceutical process chemistry team.
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