Q&A with KGK CEO Najla Guthrie and George Paraskevakos of IPA
October 31st, 2019 is the 4th Annual IPA Probiotics Workshop in DC. As the title sponsor for this one-day workshop bringing valuable direct information from experts in the probiotics industry, KGK Science President & CEO, Najla Guthrie got together with IPA Executive Director, George Paraskevakos for a Q&A to discuss the day’s events.
Q. What can attendees of the 4th Annual IPA Probiotics Workshop expect?
George: This one-day workshop will provide participants with valuable information from experts and stakeholders and provide the opportunity to exchange on a range of key issues, including taxonomy reclassification for the lactobacillus genus, the need for more information and how can we bridge the education gap which exists, perspectives from FDA and IPA on the revision of DSHEA, establishing an adequate intake for dietary microbes, and what IPA’s newest committee the ‘Technology and Standards Committee’ are working on for the sector.
Najla: You won’t find a better lineup of regulatory experts covering probiotics. Substantiation of claims and live microbial ingredient safety are front and center at this year’s workshop. Given FDA’s recent town hall on NDI innovation earlier in the year, the topic of NDI enforcement for probiotics should be on everyone’s radar for the new year.
Q. How has the probiotics market evolved over the last 12 months?
Najla: Even though analysts have projected relatively flat growth for probiotics, interest in clinical trials to uniquely position live microbial ingredients is significant. It has certainly not reflected a pattern of flat growth. It will be interesting to see how a finalized NDI guidance affects investment toward safety. In particular, will enforcement accompany the finalized NDI guidance to protect IP and prevent copycat ingredients?
George: We have seen some interesting market shifts over the past 12 months. A small pullback on market growth in the US probably fueled by a combination of education gaps at the HCP and consumer level and too many generic copycat products in the market. The fact still remains that the US is still one third and the biggest market globally for probiotic dietary supplements. Then in APAC, that market is starting to experience exponential growth. Where in Europe we are starting to see a small comeback in the supplement market. So varying situations that are region-specific, just like the regulatory environments around the globe.
Q. What is on the cutting-edge of probiotics research?
George: As you know the science cycle and research take some time before we start seeing any results. I believe we will begin to see most of the brain/gut research initiated from the last two years. We also began seeing sports application research coming out and I also believe many of these strains will be tied into weight management and metabolic syndrome type applications.
Najla: There is usually a time gap between what people are working on in preclinical models vs. clinical research. At this time, weight management and colon health for probiotics are major areas of interest, but the utility of live microbials for sports related indications is a main departure some companies are willing to investigate in order to differentiate themselves.
Q. What innovations will be most influential for the probiotics market over the next five years?
George: A significant area where companies are working and researching is the other ‘biotic’ segments such as; parabiotic, eubiotic, psychobiotic, etc. The research is starting to report interesting results. As a differentiator, companies are also investing heavily into dose delivery research in a vast array of applications. With a different dose delivery and more targeted condition-specific formulas companies are looking to introduce new and novel products.
Najla: Dose delivery and novel formulations is a significant innovation. I think consumers will have a greater awareness of ingredients. They will want to know if products are backed by clinical research and safety. They have the ability to research those two questions at their fingertips. That will force innovative companies to invest in human clinical trials for substantiation and preclinical for NDI notifications.
Q. What does KGK Science value from sponsoring and attending the workshop?
Najla: KGK continues to be a proud sponsor and partner with the IPA on events like these. We value our business relationships with probiotic companies and pride ourselves on providing results through novel human clinical research designs. The opportunity to connect and share insights across industry stakeholders is really invaluable. KGK Science expects clinical trials for probiotics in the area of weight loss and colon health to be exciting over the next 18 months. We are also launching new regulatory and pre-clinical research services at this workshop. Since the pending NDI guidance set to be finalized very shortly, we look forward to working with new live microbial ingredient suppliers, contract manufacturers and own-label distributors to develop NDI notifications or GRAS conclusions for their novel ingredients and products.
Q. What benefits does IPA provide for its members?
George: To name but a few opportunities but not limited to from being an IPA member: Have a voice and be at the table through our committees and the possibility to be a board member; Help establish regulatory frameworks; Leverage insights and networking opportunities with key stakeholders; Access in-depth information on key developments and market data for the probiotic industry.
The 4th Annual Probiotic Workshop is taking place at the Bethesda Marriott in Bethesda, MD. As part of the day’s agenda, Dr. Corey Hilmas, KGK Science Chief Regulatory Officer, will be giving a talk on NDI Notification for Live Microbial Ingredients.
Visit the full agenda here: https://www.eventbrite.ca/e/ipa-probiotic-workshop-in-dc-tickets-67218924613