Modern challenges in clinical trials: Strategies to help brands and ingredient suppliers narrow the proof gap
Supplement makers are required to support the health claims of their products with scientific evidence, but a related value lies in crafting top-shelf clinical trials; supplement trials benefit both brands and consumers by revealing insights into a product’s real-world performance.
Since brands use trial results to market their products with science-backed claims—and consumers increasingly trust brands more when their product research includes verified, published clinical trials—it’s important to examine the challenges and common roadblocks found in today’s clinical trial environment. The best strategies run the gamut, ranging pre-clinical analysis, study startup and design, efficient participant recruitment, smooth data capture and analysis, and more.
The session will cover:
• How to best leverage clinical trials during research and development to drive innovation and launch with claims that pass regulatory muster.
• Making sure your brand is properly protected during this era of stringent claims guidelines, especially by focusing on product labeling and quality of evidence returned in trials.
• Inherent challenges with the current clinical trial framework, in which women are not equally represented in terms of trial participation or study design and interpretation.
- AI influence and tech-enabled clinical trials
- 1:05 – 1:25 Leena Pradham-Nabzdyk, Canomiks: Using genomics and AI to innovate and validate efficacy and safety of formulations used in dietary supplements, functional beverages & foods, and cosmeceuticals.
- 1:25 – 1:45 Jeff Chen, Radicle Science: Rapid and reasonable R&D and claims substantiation, through AI and tech
- 1:45 – 2:10 PANEL “Maximizing clinical trials during product development and enabling strong claims.” Led by moderator Duffy Hayes. PANELISTS: Jeff Chen, Radicle Science; Erin McKinney, Gaia Herbs; Alleh Lindquist, Floraworks
- Women In Nutraceuticals focus: Gender disparity and opportunity.
- 2:15 – 2:35 Sudipta Veeramachaneni, SV Scientific: Gender Diversity in Clinical Research
- 2:35 – 2:55 Yalda Shokooh, NOW Foods: NOW Foods: Gender disparity in pain management
- 2:55 – 3:15 Najla Guthrie, KGK Science: Empowering female progress in the psychedelics ecosystem
- 3:20 – 3:50 PANEL “Gender-balance strategies.” Led by Heather Granato, Informa Markets. PANELISTS: Pelin Thorogood, Radicle Science; Karen Hecht, AstaReal; Susan Kleiner, High Performance Nutrition; Doug Kalman, Nova Southeastern University
- 3:50 - 4:00 Q&A
Date & Time
Tuesday October 24th, 2023 1:00pm PDT
End Date & Time
Tuesday October 24th, 2023 4:00pm PDT
Location
Islander Ballroom H
| MODERATOR |
 Duffy HayesManaging Editor, Natural Products Insider, Informa Markets Duffy Hayes joined Informa Markets and Natural Products Insider in January 2020. He has more than two decades of experience as a working journalist, previously as an editor and reporter at a daily newspaper and also as a B2B journalist in the telecommunications and home security industries. |
| SPEAKERS |
 Leena Pradhan-Nabzdyk, Ph.D.CEO & Co-Founder, Canomiks Dr. Leena Pradhan-Nabzdyk is CEO and co-founder of Canomiks. Canomiks uses genomics, bioinformatics, and AI to pioneer new technologies for the botanical ingredient industry. Their company vision is to Make Food as Medicine a Reality®. Dr. Pradhan-Nabzdyk is an assistant professor at Harvard Medical School, where she’s served on faculty since 2013. She earned her PhD in Pharmacology from Tulane University and MBA from MIT Sloan School of Management. |
 Dr. Jeffrey ChenCo-founder & CEO, Radicle Science Jeff Chen MD/MBA is the co-founder/CEO of Radicle Science, history's first proof-as-a-service company, offering an easy path for supplements to clinically prove their true effects. Dr. Jeff has been interviewed by outlets including CNN, Wall Street Journal, and TIME. He’s a graduate of Cornell and UCLA. |
 Sudipta VeeramachaneniPresident, SV Scientific, LLC Dr. Sudipta Veeramachaneni is President of SV Scientific LLC, and consults for the Food and Supplement Industry. With over 20 years of relevant experience, her expertise is in designing clinical trials and translating the science to drive product innovation and commercialization across multiple channels in the USA and various international markets. Her experience with global regulations ensures product compliance with target markets of sale. Prior to SV Scientific, Dr. Veeramachaneni served as Chief Science Officer at GNC (General Nutrition Centers, Inc.). |
 Yalda Shokooh, Ph.D.Director of Science & Nutrition, NOW Foods Yalda Shokooh, PharmD, PhD, is a Director of Science and Nutrition at Now Foods, Bloomingdale, IL. She oversees regulatory affairs, patents, label compliance, new ingredient research, Intl/ domestic documentations, product nutritional information and Protocol for Life science team. Dr. Shokooh has been serving in natural products field for 20 years mostly in academia including 10 years in leadership roles. She has published numerous research articles on botanicals, Phytochemistry and Pharmacognosy and has spoken at various international conferences. |
 Najla GuthrieCEO, KGK Science Najla Guthrie is revolutionizing the way we treat and talk about wellness. As the CEO of KGK Science and Wellbeing Digital Science, Najla is a global leader in the nutraceutical and emerging psychedelic industry with a focus on fundamentally changing the way we treat and prevent mental illness. Her original research at Centre for Human Nutrition at the University of Western Ontario led to the development of a cholesterol lowering product that is still on the market today and was the catalyst for the founding of KGK Science. Najla has since published over 50 papers in peer-reviewed journals, holds over 20 US and International patents, and serves on the NPC Board of Directors, and is a shareholder in numerous cannabis and nutrition businesses. She founded and grew KGK Science, a full-service premium contract research organization. Creating a business that focuses on high-quality clinical research and regulatory expertise to bring safe and effective products to global markets. When KGK partnered with Wellbeing Digital Science, an evidence-based healthcare company focused on innovative clinical solutions, her expertise and passion made her a great fit to take on the role of CEO. Today, Najla continues to present and speak at a global level, lobby for the advancement of policy changes in the supplement and cannabis industries, and lead the team at Wellbeing Digital Science and KGK Science. Najla is driven by impact and is proud to be a first generation immigrant and female leader in STEM leading the way for more voices to be shared in the industry. |
| PANEL MODERATOR |
 Heather GranatoVP Partnerships & Sustainability, Informa Markets Heather Granato is a 30-year veteran of the natural products industry, currently serving as vice president, partnerships & sustainability, in the Food EMEA division of Informa Markets. Granato is the founding president of Women In Nutraceuticals (WIN), and is on the board of directors for the Organic & Natural Health Association. |
| PANELISTS |
 Pelin ThorogoodCo-founder & Executive Chairwoman, Radicle Science Pelin Thorogood is a tech executive, data & analytics expert and philanthropist who has made a career out of being at the forefront of emerging business trends and disruptive technologies. Honored as an INC200 Female Founder, Pelin holds a B.S in Information Engineering., M.Eng and MBA, all from Cornell. |
 Susan Kleiner, Ph.D., FACN CNS-E FISSNFounder, High Performance Nutrition, LLC Dr. Susan M. Kleiner is a pioneer in the field of sports nutrition, revered as a practitioner, consultant, educator, author, and international speaker. As founder of High Performance Nutrition, LLC, she has consulted with professional sports teams, Olympians and elite athletes in countless sports. Dr. Kleiner is co-host of the “Your Food Matters Podcast”, and has authored 8 books, including the bestseller The New Power Eating®. She is a co-founder and fellow of the International Society of Sports Nutrition, fellow of the American College of Nutrition, member of the American College of Sports Medicine and The National Strength and Conditioning Association. |
 Erin McKinneyClinical R&D Manager, Gaia Herbs Erin McKinney, MS is a regulatory and quality professional with over 13 years of specialized experience in the herbal supplement and wellness space. She has been with Gaia Herbs for 8 years, moving from quality control to developing Gaia Herbs clinical research program. Erin holds an MS in Biomedical Regulatory Affairs from the University of Washington and a BS in Herbal Sciences from Bastyr University. |
 Karen Hecht, Ph.D.Scientific Affairs Manager, AstaReal, Inc. Dr. Karen Hecht is the Scientific Affairs Manager at AstaReal Inc., producer and purveyor the most studied brand of natural astaxanthin from algae. Dr. Hecht studied algal molecular biology as a postdoctoral associate at the Pacific Northwest National Laboratory. She earned her Ph.D. in Biological Sciences at the University of Pittsburgh, and a B.Sc. in Biochemistry from the University of Toronto. Dr. Hecht has spoken at conferences, on radio shows, and podcasts about natural astaxanthin as an ingredient for human health. |
 Alleh LindquistDirector & CEO, Floraworks Holdings, Inc. Alleh Lindquist is the chief executive officer of FloraWorks Holdings Inc., a leading cannabinoid therapeutics company. In his role as CEO, he is responsible for managing and directing the company toward its primary goals and objectives, strategy and market expansions. Lindquist brings years of expertise in entrepreneurial startups, raising capital, business development, product innovation, strategy, marketing and cannabinoid R&D to his role. |
 Doug Kalman, Ph.D RDClinical Associate Professor, Nova Southeastern University Dr. Kalman is a Clinical Associate Professor in the Dr. Kiran C. Patel College of Osteopathic Medicine at Nova Southeastern University in Fort Lauderdale Florida. Dr. Kalman is also Co-founder and Co-director along with Dr. Susan Hewlings of Substantiation Sciences, a strategic nutrition business consultancy. Additionally, Dr. Kalman was a co-founder of the International Society of Sports Nutrition (ISSN). Most recently, Dr. Kalman served as the Senior Vice President of Scientific and Regulatory Affairs for The Natural Products Association (NPA). Earlier in his career, Dr. Kalman was the VP of Scientific Affairs for Nutrasource, a nutrition-centric Contract Research & Service Organization. He has worked six Olympic games and with a multitude of teams and individuals on the collegiate and professional sport levels. Historically, Dr. Kalman has been involved in over 400 clinical trials and projects within the pharmaceutical, medical and exercise - nutrition fields. He has published over 80 peer-reviewed manuscripts, more than 90 abstracts/poster sessions and has authored or co-authored five academic textbooks. He has been interviewed on various media outlets such as NBC, MSNBC, CBS Evening News, CNN, Discovery Channel plus others along with a host of other media outlets. |
Category
Education Sessions