Quality and Standardization Elevate the Industry: 5 Key Learnings on What Happens After Beating Placebo

by Leo Robinton

MDbio – The Doctor’s Brand? recently underwent a clinical trial involving 620 participants. The results for their product MDsleep,?, published in a peer-reviewed journal, showcased statistically significant enhancements in sleep quality, anxiety, stress, and well-being against placebo. Now, several months after the completion of the study, Radicle Science Cofounder Pelin Thorogood had an opportunity to catch up with Dr. Babak Larian, Clinical Chief, Division of Otolaryngology, Head and Neck Surgery at Cedars-Sinai Medical Center and Founder of MDBio, and Brenden Dougherty, CEO/COO at MDBio, to discuss what they learned going through the clinical trial process and how the clinical trial transformed the organization.

Learning #1: Do your homework upfront.

When it comes to winning formulations with hero ingredients and what comes first, “the chicken or the egg,” Dougherty responded? “It always makes sense when you are striving to make an effective product to start with at least some ingredients that have know-how, white papers, and clinical trials. Start with that hero ingredient or a couple hero ingredients. It’s not just a matter of starting with raw ingredients that have been proven. This doesn’t mean that your formulation will be effective as there are synergistic and antagonistic effects and many risks are involved (raw material, manufacturing, delivery, etc.) You constantly have to mitigate those risks along the way. It requires the rigor of testing, which we do in house with our patients. From there, we determine which seemed the most effective. Then we used the knowledge and discipline of Radicle Science to prove that the formulation is more effective than placebo.”?

For MDBio, gathering initial patient feedback was key in helping to identify what formulations appeared to have the greatest impact. They then used Radicle Science for more comprehensive validation.

Learning #2: Expect very different responses from consumers, retailers, and medical practitioners.

“Consumers assume that all supplements on the retail shelf have been tested and trialed. Initially, they don’t understand ‘clinically proven.’ They hear that the product is clinically proven and assume all brands are doing the same thing. So, it initially didn’t really affect consumers. We needed more proactive education with consumers to convey the value,” said Dr. Babak Larian. “On the other hand, it has absolutely significantly impacted our conversations with doctor’s offices. Now we have a scientific way to say that we have truly tested this product and that they can comfortably and reliably give it to their patients. The conversation with retailers and investors is easier as the value proposition speaks for itself.”?

When it comes to consumers, it’s a matter of improving consumer literacy and providing consumer education in order to fully differentiate from other products.

Learning #3: Expect consumer skepticism.

“A few months ago we were at a conference and our clinical trial results were prominently featured within our booth. Consumers that walked passed were skeptical and questioned how our product was different because they had tried everything in the market and nothing had worked,” stated Dougherty. “When a clinician would walk past, they would immediately gravitate to our booth wanting to talk about the results, the paper, and the clinical evaluation process. There is a dichotomy between the clinician-response and the consumer-response because effective (bad) marketing pulled consumers in to try these product types in the first place. Because of the lack of efficacy, consumers are now skeptical and in some cases have abandoned the category. The clinicians see what we are doing and understand how what we’ve done is so unique.”?

The realities of consumer cynicism is unfortunate for the industry because as an industry we now need to collectively overcome the public perceptions that exist around a lack of efficacy.?

Learning #4: Trials contribute to an increase in long-term value.

“We did see an increase in long term value because we were able to convey that our products work not because we said it or because we had the pretty packaging and branding for it, but because we had clinical efficacy data behind it. This gave us more leeway,” said Dougherty. “This is a supplement, it’s not a pharmaceutical, so it takes a little bit of time because it’s a more gentle process. Customers now let the supplement work to its full extent and work through the dosing protocols and allow for the time that it takes for that to occur. Before, we would see where consumers would take the wrong dosing protocol and then throw it away because it didn’t work. While the acquisition cost did not change when it comes to consumers, it is much easier to get meetings with doctors offices and retailers.”?

MDBio is now able to sustain new customers for the long term because of its ‘clinically proven’ claim. Consumers have greater patience to allow for the product to work than was the case in the past. The resulting efficacy that the consumers experience contributes to a longer term relationship and thereby an increase in long-term value.

Learning #5: Consider the impact of a drug holiday.

“Looking back, I would definitely do this again”, says Dr. Babak Larian. “But I would consider incorporating a drug holiday into the process. As I’m getting more educated, I would consider the effect of having a consumer take a supplement for a while and then take a holiday to optimize the efficacy. That might be our next iteration. The next product we have, we might incorporate a drug holiday into our clinical trial and see how it affects the person and the long-term efficacy. Every two weeks, incorporate a four-day break to allow your receptors to upregulate again so you are maximizing efficacy as opposed to getting the body habituated to the product.”?

Bonus: What might the future hold? When Dr. Babak Larian looks to the future, he sees polypharmacy and polypharmacology as a central theme. “When you put different compounds together, you hope it works and doesn’t have deleterious effects and hopefully has synergistic effects. We are evolutionarily designed for exposure to countless plant chemicals. Each plant has 300-500 phytochemicals. We are designed to get small doses of multiple things that have similar impacts on the body. The notion of polypharmacy is how we’ve evolved.” Other trends he sees are the use of big data, AI analytics, and how best to leverage wearables to optimize health outcomes.? “Health care has to become holistic. In this new generation, we need to take advantage of all the technologies available to us.”?

To summarize and give tips for others thinking about going through a clinical trial, Dougherty offered this advice, “In order to pass a clinical trial, your scientific rigor and manufacturing process has to be buttoned up. The marketplace allows for certain variability in the product, but that variability is totally different from the variability that can work in a clinical trial. Internally, you must get buttoned up or you will have downstream issues. But, if you make this commitment and this investment, downstream, it will improve your manufacturing, and make you a better company. Quality and standardization in the clinical trial process really elevates the game across the board.”?

Want to learn more about MDbio's commitment to quality standardization? Contact us for their case study and gain more valuable insights, about gold standard clinical trials.