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Natural Uncertainty: Observations from a CRO Amidst a Global Pandemic

August 24, 2020 – 

It’s been several months since the world was introduced to a crisis, unlike anything we have seen in recent history. The impact that the COVID-19 virus has had on the world has been far-reaching, transforming the way we connect with each other, how businesses interact with one another and their customers, and how we think about and prioritize our health. Below are some of my observations on the impact we’ve seen at KGK Science during this global pandemic.

First and foremost, is the immense pride and gratitude I feel for what our employees have already done to weather this storm and to get KGK Science prepared to deal with this crisis. This isn’t business as usual and even though it’s stressful and uncertain, it’s also a time when the work we do is extremely important. Like most businesses, we’ve had to make some quick and tough decisions on how to operate safely and effectively during a time of great uncertainty. As a CRO with an in-house clinic facility, we have an obligation to our study participants to ensure their safety. In addition to the guidelines provided by the Province of Ontario, we quickly put in place daily leadership briefings and special working groups to assess the impact of safety protocols on our business, study volunteers, and the clients we serve. While there is no clear end in sight at this time, I’d like to think that together we’ve weathered the worst of the uncertainty, and as a result, sharpened our ability to be agile and innovative as a team.

At the time the pandemic hit, and Canada put in place a national state of emergency, KGK had over 30 active projects on the go and was seeing hundreds of clinical trial participants each month. On both the clinical trial and regulatory sides of the business, there were several time-dependent activities in progress. It was an engine that was not easily stopped. With no time to waste, we took immediate action, adjusting our office and clinic operations to retain enrolled study participants, halting only the recruitment of new participants to ensure safety. Study protocols were also reviewed to identify innovative ways for reducing physical contact with participants and we implemented technology that would allow us to connect with participants virtually whenever possible.

Since reopening participant recruitment in June, we continue to receive close to 300 applications to participate in natural health clinical trials each week, on par if not slightly higher than where we were prior to the pandemic. COVID-19 has increased the desire for people to discover new natural health products and advance global health, and the wide-spread impact on employment has made paid clinical trial participation even more appealing as a supplemental source of income. The option for virtual visits has also increased the ease for people to participate in clinical trials, being able to enroll in studies faster and participate from the comfort of their own homes. Continuing to follow the guidance of government and health officials, KGK is now fully operational again, with more than 30 active clinical trial projects being conducted in Canada, the U.S., and Latin America.

The opportunity for natural health solutions to aid in the prevention and treatment for COVID-19 is high. KGK has discussed many clinical trials and regulatory projects related to COVID-19 and is launching our first trial this month with Hofseth Biocare, investigating the efficacy of CARDIO soft gels as a treatment for COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS) as a result of steroid-resistant asthma and/or a history of smoking. This cutting-edge trial will be conducted in Canada and Latin America in patients who are either hospitalized or self-isolating. The primary outcome will be a reduction in the requirement for supplemental oxygen or more advanced ventilator support as a result of the introduction of the natural, salmon oil-based soft gel formulation.

The volume of companies looking to sponsor clinical trials has not been negatively impacted by the pandemic. On the contrary, concern for maintaining personal and family health amidst the pandemic has driven an increase in consumer demand for natural health products, innovative ingredients, and novel formulations. Branded ingredient manufacturers continue to emphasize product development and their commitment to demonstrating the quality of their products to down-stream customers and industry regulators. KGK has seen interest from numerous companies over the past 5 months for clinical trials for a variety of innovative products targeting several different indications, a high number of which were focused on improving immune health. This trend mirrors data published by the New Hope Network NEXT Data and Insights Industry Health Monitor showing an increase in natural health supplements in 2020 and projections for continued growth in the months ahead as consumers are increasingly turning to natural products and placing greater emphasis on proactively managing their health.

This increase in consumer demand for natural health solutions combined with the ease of purchase through online distributors has driven the development of an even more complex regulatory landscape with higher levels of regulatory scrutiny and the need to have federally-compliant, science-based product claims for competitive positioning and market distinction. With increased knowledge at their fingertips and heightened concern for their health, consumers are looking for confidence, driven by tangible proof of quality, ingredient safety, and scientific substantiation of marketing claims. As a result, the regulatory division of KGK Science, led by Dr. Corey Hilmas, has seen exponential growth in services contracted out since January, with many companies focused on launching new health products as efficiently and strategically as possible. Specifically, regulatory gap analyses, path-to-market strategies, and toxicology assessments are on the rise, as are safety dossier filings to the Agency for ensuring the safety of ingredients to consumers. Natural Health Product Masterfiles have also seen a boom, as ingredient suppliers look to ease the regulatory burden for their customers entering the Canadian market while protecting their valuable intellectual property.

Despite the uncertainty and uneasiness presented to us by the COVID-19 pandemic, the team at KGK Science remains positive and encouraged by the work being done in the natural health product industry and the scientific community. We have missed engaging face-to-face with our industry partners and clients, but like the rest of you we’ve transitioned to virtual platforms for communicating and staying connected and we look forward to connecting this Fall at Supply Side West Network 365, the Probiota Americas Digital Summit, and other virtual events. I am proud and inspired by the way KGK has risen to this challenge with innovation, flexibility, and resilience.  Now more than ever, we have an important role to play in providing safe and effective natural health products.

Stay safe. Stay healthy.

Najla Guthrie
President & CEO, KGK Science