While technology solutions to enhance patient care and clinical trials have been evolving behind the scenes for quite some time, there’s been a major hindrance: the life science industry’s resistance to change. However, with Covid-19’s unexpected disruption of the entire healthcare system, companies are adopting the latest-and-greatest digital and data strategies in order to keep their trials and businesses afloat.
But these approaches shouldn’t be temporary, band-aid solutions – otherwise, they’re destined to fail. Pandemic or not, how can organizations integrate crucial technologies in a way that’s both successful and long-term?
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Roadblocks on the path to implementation
I understand that ‘technology’ is a broad, umbrella-like term, but the type of technologies I’m referring to fall within two different buckets. The first includes those that can perform procedures, tests and assessments remotely. These advancements allow for clinical trials to take place outside of the hospital, as they enable patient monitoring for safety and outcomes to be accomplished at any location – doctor’s office or at home. The second bucket includes technologies that can gather and analyze this data to monitor for patterns and forecast future trends, such as different bioinformatics, machine learning and artificial intelligence capabilities. These technologies enable companies to make informed decisions about the patient journey and their adherence to protocol. Taken together, these solutions have the potential to transform patient care and clinical research as we know it.
But if both the patient and the product development benefits are this evident, why has the industry been so resistant to adopting new advancements?
Historically, life science companies are as risk-averse as they come. And given both the regulatory and business pressures in our industry – developing novel treatments to help patients in need – this mindset makes a lot of sense. But when it comes to implementing new clinical data strategies, this has been magnified by an additional “I don’t know where to start” mindset. There are a bewildering number of clinical technologies on the market. It’s a daunting task for companies to decide on a technology strategy that is best-suited for them, and then to implement that strategy – it can be both time- and cost-intensive, especially given the pressures to move as quickly as possible and the reticence to make any mistakes that could impact data quality and ultimately delay key milestones or marketing submissions.
Beyond the typical cautionary mindset our industry is known for, there’s been another major hurdle: recruiting the talent to identify, validate the solutions and implement the strategy. Because the employees that can successfully select and deploy these new technologies should have a background both in digital solutions and in life science, it can be really challenging to bring in the proper talent. This is compounded by the fact that larger tech companies with the household names (think G and A) are the ones to nurture the data scientists and digital strategists currently in the field – making it that much more difficult for the life sciences to compete for talent.
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Time and time again, I’ve witnessed someone who isn’t comfortable in the digital solutions/data science field – such as a chief medical officer, clinical project manager or clinical operations head – attempt to implement these technologies. And they hesitate, backslide or fail. Why? These individuals often don’t possess the experience to properly integrate these tools into the execution of the program, and it quickly becomes an unproductive use of resources. So, it is easier to just not do it.
A change of pace
But as with most things in the “new normal” we now live in, the Covid-19 pandemic is shifting how our industry is open to these types of innovative clinical solutions. More are beginning to understand that a digital strategy is necessary in order to stay afloat during this unpredictable, socially distant time. Suddenly, companies are being forced to revise and update their protocols to be as remote as possible. New monitoring tools and data acquisition strategies are necessary in order to continue conducting clinical trials and keep the patients safe and compliant with their course of study treatment.
And it turns out that the biopharmaceutical industry is also behind this shift. Both PhRMA and BIO – the largest national advocacy groups representing the industry – have been meeting with the FDA to discuss implementing digital strategies for clinical trials moving forward, including artificial intelligence and digital health solutions.
While more lenient regulations surrounding these technologies will certainly help facilitate their adoption, that’s only one piece of the puzzle. On an individual, case-by-case basis, how can life science companies begin implementing these technologies – successfully?
In working with many different organizations to adopt resilient clinical trial strategies, one thing has become clear to me: the directive must come from the C-suite. If the CEO isn’t driving this data strategy implementation, chances are, it won’t stick (or won’t be effective enough to become the new way of doing clinical development). If these ideas start at the operation level (which they often do), they don’t translate into bringing value to the organization in time or money, because they may not translate the value in language that resonates with the c-suite.
As an executive interested in adopting these digital strategies, you must ask yourself: Do we have the right people to adopt them? If not, can we train them or recruit the right talent? Do we have the right processes? Can we integrate the solutions to make our development program more cost effective and efficient in execution? If you don’t know the answers, start looking outside to get them.
Saying that Covid-19 has completely altered how our industry conducts its business would be an understatement. And while some companies may hope we return to “business as usual” once the pandemic is behind us, these innovative clinical technologies are here to stay and will be adopted by the forward-thinking organizations to insulate against the next crisis. Whether that means investing in educational opportunities to properly fill the talent pipeline, being open to revising protocols, or just taking the time to invest in a sound digital strategy, the life science industry is more than capable of handling these changes. It just needs to decide that it’s time.
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Laurie Halloran founded Halloran Consulting Group in 1998, originally operating out of an unfinished bathroom. Her time as a pediatric ICU nurse had inspired her to start a company that helps move new therapies through FDA processes to get them into the hands of patients desperately in need. By providing a strategic development team, innovative start-up companies could have access to world-class expertise at a fraction of the cost. Since its humble beginnings, Halloran has grown into a successful consultancy of like-minded experts who are dedicated to improving human health by making life science companies better at what they do.
Laurie has been named 2018 Women’s Business Enterprise Star by the Women's Business Enterprise National Council (WBENC) and has won a 2017 Enterprising Women of the Year Award from Enterprising Women Magazine. Halloran Consulting Group was also named an Inc. 5000 Fastest Growing Company for the past three years in a row. In 2015, Laurie was honored by the Boston Business Journal as a Woman of Influence, in 2010 was selected as one of the 100 Most Inspiring People in Life Science by PharmaVoice, and in 2009, she was awarded Clinical Researcher of the Year by the New England Chapter of the Associate of Clinical Research Professionals.
