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How Pelin Wood Thorogood Is Pioneering Proof-As-A-Service For Clinical Trials

How Pelin Wood Thorogood Is Pioneering Proof-As-A-Service For Clinical Trials

Pelin Wood Thorogood is a tech executive turned impact entrepreneur who co-founded Radicle Science in 2018, an AI-driven health tech benefit corporation (B-corp). She also serves as Executive Chair for Radicle Science. Ms. Thorogood was previously Chief Marketing Officer of WebSideStory, which was acquired by Adobe/Omniture in 2008, and CEO of Anametrix, acquired by Ensighten in 2015, an award-winning predictive analytics company. Her involvement and work in education and community has had a deep impact. Ms. Thorogood is co-founder and President of the Wholistic Research and Education Foundation, Trustee and Treasurer of the University of California San Diego Foundation, Executive Board member of the UC San Diego Basement start-up incubator, and co-chair of the UC San Diego Innovation and Entrepreneurship Council and the Industry Scholar for the Cornell Institute of Healthy Futures. She previously served as Executive-in-Residence for the Johnson Graduate School of Management. She holds a B.S., M.Eng and MBA, all from Cornell.

What exactly is Radicle Science? What does it do?

Radicle Science is history’s first Proof-as-a-Service company, enabling non-prescription health and wellness products to clinically prove their true effects beyond placebo. We offer non-pharmaceutical products the first easy path to generate first-of-its kind clinical evidence across diverse conditions and populations at unprecedented affordability, speed and scale. Our transformative approach democratizes access to clinical trials and can finally close the “proof gap” between non-prescription wellness products and pharmaceutical drugs. For the first time in history, any natural health product or dietary supplement company can have the clinical proof to develop innovative and effective products, market strong defensible claims and gain the confidence of all stakeholders—from consumers to healthcare providers to retailers.

Why is there such a “proof gap” between pharmaceuticals and non-pharmaceutical products? Can you explain that further?

Great question. We know humans have relied on natural products as medicine for millennia. Many such remedies are still used by billions around the world, including in the US, where more than 80% of Americans use non-prescription natural health products, as these products are not as expensive as pharmaceuticals and can be bought directly by consumers without any gatekeepers. COVID-19 transformed consumer perception of health, wellness and personal accountability with consumers reaching for supplements to improve immunity, mental health, and general wellbeing. However, in spite of their broad use, most supplement companies still don’t have scientifically validated proof of effectiveness for their specific products. That’s because they don’t have easy or affordable access to clinical trials. Most traditional trials have served patented synthetic pharmaceuticals to prove their effects and justify their high price. Unfortunately, this existing model is simply too expensive and slow for natural products and dietary supplements which are generally not patentable. Worse yet, even if natural products could access a clinical trial the results might not be meaningful for most consumers, because traditional trials have mostly studied Caucasian males living in major cities. Essentially, traditional clinical trials were not meant to serve and are not easily accessible for non-pharmaceutical products, and the data from traditional trials often un-personalized and irrelevant to the population at large.

A recent major report released June 2022 by the US Preventive Task Force acknowledges this proof gap, stating “current evidence is insufficient” to determine whether supplements actually help or hurt health, and calling for further research into proving the benefits and risks for each supplement.

What are the societal ramifications of this proof gap for non-pharmaceutical products? How does it affect the individual consumer?

The ramifications of the proof gap are grave for supplement manufacturers, healthcare providers, and consumers alike.

Imagine you’re a supplement company trying to innovate the next blockbuster anti-anxiety product.

You do your best to choose individual ingredients with some theoretical benefit. You want to create a unique product that stands out in the marketplace, but what is the right combination of ingredients, dosage, and product form most effective for your specific customers’ needs? Without easy access to clinical trials, you’re forced to guess and build your product largely based on biased anecdotal feedback from friends or a focus group. Positive feedback from users may all be placebo effects. Even IF you get lucky and your product does work beyond placebo, how do you know it’s the best it can be? How can you take your company to the next level if you have no clinical evidence to make products that truly work, win over skeptical consumers, convince scrutinizing investors, or stand out to picky retailers? You’ve lost the opportunity.

Imagine you’re a doctor who wants to provide the best healthcare to your patients. You learned to distrust anecdotal evidence in medical school, so you struggle to recommend a specific supplement due to lack of clinical trial proof. You’re mainly left with “proven” pharmaceuticals, despite their expense and side effects. And in the absence of diverse trial data, you have no choice but to often recommend the same “unpersonalized” treatment to everyone.

Now imagine you’re one of nearly 70 million Americans suffering from chronic sleep issues, but you want to avoid prescription drugs and all their side effects. You want to try a supplement but there are so many. And, nearly all of them say they use “quality” ingredients and make vague claims about their effects. You don’t have confidence in what to buy, so you turn to online reviews. You don’t realize the placebo effect is driving many of these testimonials. You don’t know that bots could be generating many of these “five-star” reviews.

Essentially, you are flying blind and there’s a good chance the product you pick fails to deliver on its promise. That leaves you still sleepless and not to mention upset about the wasted time and money. Desperate for sleep, you go back to the drug your doctor recommended, even with the potential risk of side effects and addiction, losing faith in supplements.

Each of these scenarios are all too real for countless companies, doctors, and consumers. But it doesn’t have to be this way. This is what the team at Radicle Science is working to solve.

What motivated the formation of Radicle Science in the first place? How did you and your co-founder Dr. Jeff Chen identify such a gap in clinical trials that it justified creating an entire new company and even culture to address it?

It’s quite a serendipitous story. Jeff and I were on separate yet parallel missions to prove what non-pharmaceuticals could do and transform their role in society for all future generations. As a tech CEO turned philanthropist, I’d started a non-profit research foundation to fund ground-breaking natural medicine trials at renowned research institutions across the U.S. That’s how I personally witnessed the glacial speed and tremendous cost issues of the traditional clinical trial approach. What’s more, given my big data background, I also came to the realization that the small scale and homogeneous populations of those studies were never going to achieve my mission to create personalized medicines that were affordable and accessible by all.

I met Jeff during those years and immediately recognized him as a like-spirited colleague. Jeff is a physician researcher who wanted to find better and cheaper health treatments. He was leading first-of-its-kind natural product clinical trials at UCLA, where he’d received his MD and MBA. Like me, Jeff had also grown frustrated with how slow and expensive the trials were and knew there was a better way.

Once the pandemic hit, and most clinical trials that were not directly focused on COVID came to a halt, Jeff and I started to discuss ways we could fix what we saw as an inefficient, broken system – and decided to join forces to start a health tech venture with a fundamentally new approach to research that could eliminate the proof gap. And that is how Radicle Science was born.

So how do you do it? What’s unique about the Radicle Science approach?

The Radicle Proof Engine™ combines gold-standard double-blind, randomized, placebo-controlled design, with a unique AI-driven, crowdsourced, virtual, direct-to-consumer approach, to create standardized and automated clinical trials that deliver rigorous health outcome data at unprecedented affordability and speed. In parallel, we make the study participation experience easy and valuable for diverse groups of volunteers across the nation: We mail them quality tested, free health products, give them intuitive tools to track their usage and outcomes from the comfort of their home. And, at the end of each Radicle study we do something that traditional trials rarely do: we unblind our volunteers and provide them with personalized health reports so they can understand their product usage and the outcomes on their unique body. The large scale of the studies and diversity of the populations make our findings personalized and relevant for the population at large.

In essence, with standardization, automation and productization, we’ve transformed clinical trials the same way that Ford Motors transformed auto manufacturing a century ago. We support the entire lifecycle of these non-pharmaceutical products with proof to develop the most effective products, make strong clinically proven claims, build loyalty with consumers, and build trust among doctors, retailers, and investors. That’s what we call transformation through proof.

Is the Radicle approach complementary or competitive to traditional clinical trials as they are done in academic medical centers? Explain.

Since Radicle Science democratizes access to clinical trials for non-prescription products that cannot be patented, our approach is highly complementary and additive to traditional trials on patented pharmaceuticals that are conducted in academic medical centers. Given dietary supplements are already commercially available without requiring a prescription, Radicle’s trials are not subject to the cumbersome FDA “Investigational New Drug” (IND) framework for pharmaceuticals. We do not study impacts on disease but rather effects on the structure or function of the human body and brain, to enable strong defensible claims for natural health products. Due to our low-cost crowdsourced virtual approach, we are able to study much larger and diverse clinical and cultural populations. As a B-Corp, safety and health equity are high priorities, therefore all study products go through independent quality and safety testing by Radicle, and all Radicle studies are monitored and approved by an Institutional Review Board (IRB).

What’s your biggest success to date?

I am proud to say we have a bona fide claim for “largest” and/or “history’s first” for nearly all of our studies to date. True to Radicle form, we launched our company last year with history’s largest randomized controlled trial on cannabidiol (CBD), the Radicle ACES (Advancing CBD Education and Science) Study, involving nearly 3,000 participants randomized to one of 14 treatment arms. We’ve completed Radicle ACES in record time and the manuscript has already been accepted by a peer reviewed journal and will be published any day now. We ended 2021, our very first year in business, with the ground-breaking completion of 25 randomized controlled trials involving nearly 10,000 participants. In 2022, we launched history’s first large-scale, blinded, placebo-controlled clinical trials on a variety of natural ingredients to study their effects on energy, focus, appetite, sleep, pain, stress, and anxiety. We’ve been growing our portfolio of IRB-approved standardized clinical trials on an array of health areas including cognition and digestive health, with immunity and women’s health in the pipeline. With all that said, I still believe our biggest success has been growing our team with the foremost experts and trailblazers in AI, clinical trials, and technology to make all this possible.

Has Radicle pursued trials related to brain health? Can you give some examples?

Several of our standardized trials are for conditions related to brain health. We have standardized trials on cognition (assessing focus, memory, and executive function), as well as other areas related to brain health, such as sleep, stress, mood, and energy. Contractually, we need to keep the identity and study data of our clients confidential, but some clients who have been public about embarking on these ground-breaking studies with us include Gaia Herbs, Neurohacker, and BiOptimizers.

Given the novelty and ambitious nature of the Radicle Science business model and clinical trial approach, how are investors reacting to what you’re doing and your growth potential?

Investors love Radicle’s opportunity to disrupt a massive market, the positive social impact we are creating, and our execution to date. We are the right people at the right time, at the perfect intersection of science, technology, and culture to establish a new paradigm and offer a unique solution to a critical societal problem. 2021 was our first year in business and we generated 7 figures in revenue, with many repeat clients ranging from startups to billion dollar publicly traded companies. We’ve experienced incredible growth this year with significant client wins as well as major recognition, including being named by KPMG as one of America’s Top 10 “Tech Innovators” and being a finalist for the prestigious UCSF Rising Star award in Consumer Wellness. All this momentum has contributed to our success with investors, resulting in our oversubscribed seed raise in Q1 2022, with a total of $9M raised to date. We’re honored to claim leading technology venture capital and the families behind some of the largest American life science, technology, and consumer goods companies as Radicle investors.

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