Lessons from the Pandemic: Multiple paths, multiple opportunities
Increasing competition during the design phase will help deliver infrastructure on time and on budget
“In the midst of every crisis, lies great opportunity” Albert Einstein once said and our response to COVID-19 proved just that.
Traditional drug development is excruciatingly slow. From 2010–2020 the average time from the first submission to regulator sign-off was over 9 years, and that’s after potentially decades of R&D to deliver the drug candidate. Yet in response to COVID-19 the pharmaceutical industry, their regulators and governments around the world overcame decades of status quo process to deliver highly effective vaccines within a single year.
In a society crying out for new infrastructure solutions to energy security, climate change and shifting demographics, we must learn from this harrowing experience to accelerate the design and delivery of critical infrastructure projects.
Status quo
The pharmaceutical industry has been under increasing demand for new solutions and ever more stringent scrutiny from its regulators. Between 2000 and 2005 the US Federal Drugs Agency (FDA) approved on average 20 new drugs/year, a decade later the average was 50 drugs/year, whilst the average time for approval rose to over 9 years.
Over time the regulatory process had become increasingly strenuous; requiring more complex studies ever to receive sign-off. This drove pharmaceutical firms to delay clinical trials to manage costs, only starting submission once they were absolutely sure of the technical feasibility of each candidate. Such due diligence took lots of time. Time which no one could afford during the outbreak of the COVID-19 pandemic.
Snakes and ladders
Within the onset of COVID-19, the pharmaceutical industry and its regulators threw out the proverbial book to adopt a far more iterative and collaborative approach. Gone were the long delays between R&D and regulatory submission, gone were concerns of duplication between drug candidates and gone were the delays in collaboration sharing data.
Rather than a single candidate carefully managed through the regulatory gauntlet, multiple options were submitted for consideration in parallel. This enabled rapid iteration of the drug candidates and the operations of the clinical trials. The success or failure of one candidate supported the delivery of the others, and best practices of working in the midst of a pandemic rapidly percolated throughout the entire programme.
In the world of the status quo, this approach would have been argued to be ‘too expensive’, and to be fair during the pandemic budgets were abundant. Regardless, a key learning was that much of the clinical infrastructure for the trials was a fixed cost, and that multiple candidates could be reviewed side-by-side for only a marginally higher expense than reviewing one.
Once the benefits from learning and iteration between the candidates were taken into consideration it is likely this approach was actually cheaper than the traditional ways of working. Staff and infrastructure deployed in this way are needed for far less time overall compared to the traditional approach.
We stand today in 2022 in a new world relatively free of COVID-19 because we were willing to invest up-front in understanding all possibilities and let them battle it out to find the best candidate based on data and outcomes, not guesswork and assumptions.
Pipes and pylons
The infrastructure sector's traditional approach to regulatory sign-offs is similarly tied to the early selection of a single proposal at the concept stage. The costs to deliver a concept to the level of detail required by regulators are substantial, so until now it has made economic sense to only invest such effort in a single option.
Yet given the generational challenge of responding to climate change, energy security and demographic shifts, we no longer have the luxury of time to allow critical projects to be delayed in court for interminable years. If no other options are considered in detail is it a surprise that legal challenges to infrastructure projects have become business-as-usual and that proposals often become ‘all or nothing’ attempts to force a design through the system before the funding runs out.
Unfortunately, this has often spilled into adversarial relationships between the proposer and the regulatory process. Better to hold the line that the proposal represents the only viable option than to be forced into re-working the completed technical analysis.
Without being offered viable alternatives; the regulatory and public decision is purely binary. There is little room for collaboration and compromise because no other options are on the table. Without demonstrating other options have been considered, how can a regulator be sure that the pros and cons of the proposal outweigh those of alternatives?
Rapid Optioneering
What if infrastructure developers and regulators had the processes, technology and culture to understand and critique multiple proposals in parallel?
Technology such as Continuum Industries’ Optioneer exists today to achieve just that. Infrastructure clients and their regulators can investigate multiple options at the level of detail required for regulatory consideration within similar budgets to what they’d have spent on a singular option study in the past.
Developers can showcase to their stakeholders not just a spreadsheet of assumptions but full models of different options, their costs and compromises to communicate and reassure that projects won’t be held up in court or on the tarmac.
From COVID to Climate change
The past three years have taught the pharmaceutical industry that the technology to disrupt the status quo and deliver critical drugs at a pace once thought impossible was already in front of them.
Now it’s the infrastructure sector's turn to challenge their status quo and start looking at the options in front of them to deliver real solutions to climate change, energy security and demographic shift to the timescales and budgets required.
This crisis really is the infrastructure's opportunity to change its ways of working, let's not waste it.
About Continuum Industries
Continuum Industries is a provider of an AI-powered infrastructure development platform, Optioneer, that enables power, utility and renewables companies to instantly visualise, analyse and comprehensively assess routing options for power lines, cables and pipelines.
By incorporating all environmental constraints into the development process from the very beginning and considering them together with social, engineering and cost criteria, Optioneer bridges the gap between existing routing procedures and the pace at which project development needs to happen to meet Net Zero targets.
