Life Sciences and the EUA in Times of Crisis
On January 30, 2020, the World Health Organization declared a Public Health Emergency of International Concern. Forty-nine days later, COVID-19 was officially a pandemic affecting every continent except Antarctica. We’ve been living in this state of emergency for a few months and in that short time, the world has seen wide-spread ramifications across communications, business transactions, global trade, and commerce.
The life sciences industry, in particular, has been impacted by the crisis, with disruptions to routine R&D, clinical development, supply chains, and operations. Now the pressing need is to innovate at breakneck speeds to find a cure, which has caused individuals to rethink every aspect of their businesses.
In response, the US Food & Drug Administration (FDA) issued an Emergency Use Authorization (EUA) “to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.”1
The Impact of Faster Innovation
Under normal circumstances, it would take 12 to 16 years for pharmaceutical and biologic drugs to go from product development to market, with medical devices taking three to seven years. However, with an EUA enacted for the first time in a decade, products that have previously been approved for other uses are now being approved for new or off label uses within days.
Current circumstances necessitate the accelerated approval of medical devices and drug development. However, these regulatory changes have had a ripple effect impacting the FDA, clinical laboratories, biopharma, pharma, medical device organizations, and surprisingly, businesses unrelated to the life sciences industry such as automotive and clothing manufacturers.
The pandemic has put a spotlight on healthcare systems, drug and medical device stock, and availability of personal protective equipment (PPE). The resulting healthcare system is unable to adequately treat patients during a crisis. Knowing there will be future outbreaks of infectious diseases ꟷ though not necessarily at this scale ꟷ the FDA is racing to streamline vaccine approval processes and build greater agility into their systems without compromising the safety, efficacy, and security of drugs, biologics, and devices.
Companies, clinical laboratories, and the FDA are being forced to reevaluate how safety and efficacy studies are conducted and determine if it’s statistically feasible to run these programs in parallel. By simultaneously working on different phases of a study, organizations may be able to speed the product approval cycle. It may sound like a radical shift, but that could be what it takes to get a vaccine approved and in the market in under 18 months.
What does this all mean for businesses? There are now car manufacturers building ventilators, and luxury designers fashioning surgical masks and gowns for healthcare workers. These companies jumping into the life sciences space have had to adapt their manufacturing techniques, equipment, and facilities to produce products they’re not accustomed to making.
Leading Through to the New Normal with the Right Talent
This ‘new normal’ propelled companies in the life sciences sector toward innovating and instituting more rapid treatment deployments while maintaining the same standards of safety, efficacy, and security. However, they are drawing on pre-pandemic business competencies and proficiencies.
Pivoting to a post-pandemic business model requires a new level of expertise and agility to catch up with accelerating trends and the changing composition of the industry. By bringing on experienced professionals with the right knowledge, companies can rapidly scale their business, efficiently implement new technologies, address regulatory affairs and documentation, and adjust their thought processes to navigate around unexpected obstacles. Similar to how automakers had to shift their mindset from “can this car go 250 miles per hour” to “will this produce enough air pressure to help a patient breathe,” partnering with a consulting company that affords a critical wide-angle lens can make all the difference.
Plan for the Unplanned
No one could have anticipated the effect of this pandemic, but predictive modeling can help identify potential contagious agents, classify diseases, and guide the ideal product portfolio. Moving forward, the industry will be asking what innovative drugs or devices are available to handle new contagions, and what’s out there that we don’t see right now.
While we will never know what to expect, businesses can set the groundwork for moving forward by:
- Having a business plan and determining the purpose, scope, and objectives of how this plan can aid in the pandemic.
- Running a risk-reward benefit analysis and confirming it makes sense ꟷ not just for the business, but for everyone.
- Ensuring the availability of appropriate talent resources, utilities, abilities, and equipment to support the newly created business plan.
The EUA has afforded government agencies, clinical labs, organizations, and businesses to move quickly and save lives. But it is also reorienting our perspectives on long-held conventions around processes, innovation, research and development, production, and governance, and have us questioning the blind spots brought into view by the virus. With the right leadership and talent in place, the industry can achieve this new standard of innovation with significant results.
1. US Food & Drug Administration website, “Emergency Use Authorization,” Emergency Preparedness and Response, assessed May 22, 2020, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#othercurrenteuas