Well being can be associated with emotional and physical health in addition to productivity and success. How one interprets their own personal well-being versus the well-being of their society, community, or industry is a more complex conversation. Considering one’s personal well-being wouldn’t be complete without consideration of the effects it can have on the broader common good (a theory previously explored on Radicle Perspectives). As we round out 2023, Radicle Science Cofounder Pelin Thorogood had a chance to catch up with Dr. Susan Mitmesser, Senior Vice President, Chief Science Officer at Pharmavite to explore the important and evolving role data plays in supporting collective wellbeing and the future of the dietary supplement industry growth.
Here are five lessons learned from our conversation:
Lesson #1: Use data and research to ensure safety AND efficacy
“Every industry, every category, whenever you do research has their strengths and weaknesses and pluses and minuses and dietary supplements are no exception,” said Dr. Mitmesser. “One of the consistent complaints for dietary supplements is that products have traditionally not been studied in totality. Its individual components are studied and there are historical reasons for why that is the case.”
Dr. Mitmesser encourages that “as an industry we need to ensure safety, but not far behind that is ensuring efficacy. As an industry, we need to put our best foot forward.”
“When I entered this industry there wasn't a lot of variety in forms, but now there is. Attempting to leverage these different pieces of data from years ago may no longer be relevant. As an industry, we have matured past this and need to commit to studying the new truly novel compounds we are creating.”
Lesson #2: Look past Recommended Daily Allowances and Daily Values to create and study truly novel compounds
“In the past, research was ingredient-focused but what we’ve seen in recent years is an evolution of form factors,” said Dr. Mitmesser. During product development, supplement manufacturers consider many factors when selecting delivery forms. Supplements may be better suited to certain delivery forms based on many factors, such as their stability, uniformity, user experience, release time, and resistance to the gastrointestinal environment.
Lesson #3: Commit to studying the underserved and the under-researched
“When it comes to clinical trial populations and diversity, I have a lot of passion around reversing the wrong. In the 1970s, FDA had guidance to not include females in clinical trials. In the 1990s, this was reversed. This means that almost 20 years of clinical research was done on men as a proxy for a woman. Data was extrapolated from a man to assess the needs of a woman, “ said Dr. Mitmesser, disappointedly.
Dr. Mitmesser was optimistic on changing the trajectory, “One of the areas that we as an industry can reverse and we can be advocates for are studying the underserved and the under-researched populations and learning the nuances. I’m a firm believer in figuring out, understanding, celebrating, and supporting our differences.”
"One of the areas that we as an industry can reverse and we can be advocates for are studying the underserved and the under-researched populations and learning the nuances."
Lesson #4: First start with a commitment to understanding the consumer
During the conversation, Radicle Perspectives explored studying intended populations, dose, and delivery and while the dietary supplements space may not yet be properly suited to make personalized products, dietary supplements can be more targeted. Dr. Mitmesser cautioned that “we need to first make a more concerted effort to understand the consumer. If we understand the consumer first (or the patient for that matter) and the problem, it will naturally lead us to the population we need to test and research.”
Dr. Mitmesser noted that, “…this is where Pharmavite’s innovation and research model starts. By helping a subset of the population, we support the common good because of the larger and collective impact on public health and societal economics.”
Lesson #5: Research validation is the untapped dietary supplement opportunity within the fem-tech revolution
While one half of the world’s population is women and women account for 80 percent of consumer purchasing decisions in the healthcare industry, women’s health has been considered a niche market. But this recent shift in the health care mindset creates opportunities within the dietary supplement industry.
Dr. Mitmesser anticipates that “validation” is the untapped opportunity within the fem-tech revolution. “There is still a ton to learn in FemTech. There are major gaps in research and with the data that does exist, it needs to be validated. We need to move beyond if something is safe, we need to confirm that from an evidence-based perspective that it is truly value-added.”
Dr. Susan Mitmesser concluded with a few big picture trends and variables that she sees as having major impacts on the future of dietary supplement clinical trials.
- The use of AI to screen participants quicker and better
- Leveraging technology to get new products to market sooner without compromising safety and efficacy and working with the FDA to prove out these new models
- Using human cell lines and tissues to aid in research, efficacy, and product confidence
- Examining the evolution of the FDA leadership and priorities and making sure that the dietary supplements industry is getting the support it needs
- Watching the philosophical shift in the off-label use of pharmaceuticals and the impact on the industry
Dr. Susan Mitmesser’s tips didn’t stop at how to use data to promote collective wellbeing, but also included some sage advice for young researchers and scientists in the field that is arguably a good rule of thumb for us all. “There are many times when I have been the only female in the room and this taught me early on to be overly prepared. I always came armed with data and to this day, it is a best practice that I maintain. By focusing on data, it helped me prepare, provided me a voice, and instilled a greater sense of confidence because at the end of the day, it’s hard to argue with the facts.”