Síofradh McMahon is the Senior Manager, Clinical Translation and Regulatory Affairs at CCRM. Siofradh works with academic and industry partners to advance promising products and technologies to commercialization. Having worked worldwide, Síofradh brings more than a decade of experience in pharmaceutical and biotech regulatory affairs and policy. She is an active member of the Alliance for Regenerative Medicine’s Regulatory and Value & Access working groups, and lends her expertise to groups in Canada too.
Photo credit Alexey Hulsov, Pixaby
COVID-19 has turned the world upside down in a mere matter of months, and we’re all seeing and feeling the effects in everything we do. As of April 7, 2020, more than 80,000 people have died worldwide, and the virus is spreading rapidly in almost all parts of the world. Four out of five jobs worldwide are estimated to be affected in some way, and as we start to get to grips with the direct public health threat, it’s becoming increasingly clear that there are significant and potentially long-lasting indirect threats related to the economic shutdown this has triggered. This in itself is a public health threat, and likely one of the longer-term impacts if not managed well.
Because of COVID-19, governments around the world are looking for ways to encourage and accelerate the development of vaccines, therapeutics, diagnostics and techniques for supportive care that will at least help us “flatten the curve,” and hopefully even turn that curve into a cliff, stopping the virus in its tracks.
One of the many tools governments are employing is regulatory incentives. All major regulators have developed policies or interim guidance on their approach to accelerating the review and assessment of COVID-19-related clinical trials and new drug authorizations.
Regulators review new trials and products on a benefit:risk basis; in other words, is the potential benefit outweighed by the potential risk? Under normal circumstances, we would expect a certain standard of data to be generated by therapy developers to demonstrate the potential benefit and the potential risk of a treatment, and it’s important to note that this is still expected of developers of COVID-19 technologies.
However, in a pandemic situation such as this, the level of risk that we, as a society, may be willing to take with new therapies and technologies is higher than it would be with, say, a follow-on statin where there are already proven, safe and effective options on the market. Additionally, many therapies are intended to treat the sickest patients whose situations may also warrant the acceptance of more risk. Finally, we also need to consider the risk of doing nothing, and it’s abundantly clear to us all that this is not an option.
So looking at some of these COVID-19 technologies through that lens, it’s obvious that the standard of data that might need to be generated for a first-in-human trial may be a little different to what we are used to, or could be something collected at a later date. It’s also apparent that implementing some form of fast-tracking, or additional regulatory guidance and support, is going to be helpful, and it’s encouraging to see how quickly regulators have been able to prioritize, support and help propel promising therapies into early clinical trials. Every day we see more press releases from around the world heralding another new potential treatment or technology entering clinical trials or gaining approval to do so, so this approach is having the desired effect.
However, there are also serious consequences to this accelerated process and, according to Leigh Turner, Associate Professor at the Center for Bioethics, University of Minnesota, we should exercise caution when considering the potential merits of it. “Lowering such standards risks allowing unproven and potentially dangerous products into the marketplace and increases the likelihood of harms to patients. Ratcheting down regulatory standards also makes it more likely that large sums of money will be spent on products that in the end do not prove to treat or prevent COVID-19.”
In particular, many industry observers have questioned whether we can apply this accelerated, streamlined approach to the review and approval of all promising technologies, including those unrelated to the current pandemic.
To those hoping to access a highly lucrative market quickly with their products, this may seem like an excellent long-term outcome from this difficult time. However, this could not only increase the risk to patients and the health-care system, but also to the long-term commercial success of those same products.
Understanding to the fullest extent possible both the potential benefits and potential risks to patients prior to commercialization is the cornerstone of regulation, and this ultimately ensures that appropriate treatments and technologies are available to health-care systems and that inappropriate ones are not.
We would potentially be risking peoples’ lives to secure faster, short-term commercial success. I say short-term because even those products that enter the market with very little data do eventually gather enough information to tell us whether they are safe and efficacious or not. Those that do not meet those standards are withdrawn, recalled, or discontinued at great cost to developers and shareholders. And as Dr. Turner highlighted above, we risk pouring money and resources into something and being left with nothing to show for it at the end.
So is this fast-tracking approach a good idea and should we do more of it? The short answer is no, not really, but it’s an excellent idea in this pandemic scenario and is likely our best shot at coming out of this with intact and functioning health-care systems.
However, the fact that we can and should do it for this situation does not mean it is possible, appropriate, or even a good idea for all other products. Ideally we can learn something from the current scenario and maybe we will learn that there are ways in which we can streamline regulatory processes and the data generation to support them.
For now though, we need to understand that the COVID-19 accelerated regulatory pathways are an exceptional measure to manage an exceptional circumstance, and our industry and regulators need our support during these challenging times.
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