COVID-19 and the Impact on Dietary Supplement Clinical Research 

Event Start Date
May 21, 2020
Event Start Time
2 pm Eastern

Free for CRN Members | $149 non-members

Free on demand for CRN members (log-in required).

Available on demand for non-members for $149

The COVID-19 pandemic is affecting dietary supplement industry operations at every level—clinical research is no exception. As research organizations have adjusted their practices to ensure the safety of study participants and their own teams while delivering on their commitments to their clients, they’ve learned lessons and fine-tuned best practices for facing new challenges. CRN has convened a panel of experts who will share insights to help companies manage their clinical trial plans, addressing disruptions and minimizing them where possible. We'll hear about the COSMOS study, a 22,000 participant, 5-year trial examining cocoa flavanol and multivitamin use on health outcomes, and learn how researchers quickly pivoted to collect data on how the interventions may impact COVID-19. In addition, we'll discuss considerations for planning future trials in the post-COVID-19 landscape.

Hear from experts about:

  • Regulatory issues during COVID-19 that affect clinical trials in the U.S., Canada, and abroad
  • Best clinical practices and changes in procedures during COVID-19
  • New considerations for subject recruitment, safety, and compliance
  • Planning study close-outs and publication timing
  • What risk assessments can or should be done in advance of new trials?
  • What might the future hold for clinical research in upcoming months and years—considering potential second or third waves of the virus, and beyond?

Moderated by:

Annahita Ghassemi
Director, Global Product Safety & Clinical Affairs, Church and Dwight Co. Inc.

 


With:

Andrew Gregg
Director Clinical Research, dicentra


John Marshall
General Manager, Biofortis Clinical and Sensory Research


Joshua Baisley
Vice President, Clinical Design & Delivery, Nutrasource Pharmaceutical & Nutraceutical Services 


Catherine Kwik-Uribe
Global Scientific & Regulatory Affairs Director, Mars Edge


CRN Staff:

Luke Huber
Vice President, Scientific & Regulatory Affairs

 

 

 

 

More on our speakers:

Andrew Gregg
Director Clinical Research, dicentra

Andrew brings clinical research experience in Phase I-IV studies focusing on the investigation of safety and efficacy for nutraceuticals, functional foods, dietary supplements and pharmaceuticals for a wide range of health conditions. Andrew joins our team after his extensive work as a research Nutritionist with a special focus on the development of standardized diets for bioavailability and metabolism research.  See on LinkedIn.


John Marshall
General Manager, Biofortis Clinical and Sensory Research

John Marshall, RN, MBA, is General Manager at Biofortis, a leading Contract Research Organization that conducts research for dietary supplement, ingredient, food, and pharmaceutical companies.  He transitioned from a nursing career in the mid-90s to work for Kendle International, an international CRO, as a study monitor for pharmaceutical trials in North America, Latin America and Europe.  John became an independent consultant to the pharmaceutical industry for ten years, managing major programs consisting of multiple clinical trials.  Today, John oversees all CRO, clinic operations, and Sensory testing and has been at Biofortis for twelve years. He has a BS in Nursing from Northern Illinois University and an MBA from Lake Forest School of Management. See on LinkedIn. 


Joshua Baisley
Vice President, Clinical Design & Delivery, Nutrasource Pharmaceutical & Nutraceutical Services 

Joshua Baisley is the Vice-President Clinical Design & Delivery of Nutrasource Pharmaceutical & Nutraceutical Services, a leading contract research organization that helps companies bring products to market with strong science and regulatory confidence—from concept to claim. Before devoting his work full-time to Nutrasource, Mr. Baisley participated on Health Canada’s Vigilance Expert Working Group representing the dietary supplement industry to work on harmonization of safety reporting for supplements, drugs and biologics. With over 20 years health products industry experience in quality assurance, clinical, preclinical & regulatory affairs, Joshua has been an active member of the probiotic community serving on the International Probiotics Association (IPA) Board of Directors, co-chairing the IPA Technology & Standards Committee, publishing articles as well as presenting at various industry workshops and events. See on LinkedIn. 


Catherine Kwik-Uribe
Global Scientific & Regulatory Affairs Director, Mars Edge

Catherine Kwik-Uribe, Ph.D., is the Global Scientific & Regulatory Affairs Director, Mars Edge, a segment of Mars, Incorporated. Since joining Mars, Inc., Dr. Kwik-Uribe has focused on evidence-based ingredient and product development.  Catherine is responsible for the translation, and integration of science and regulatory into new ingredients and products in support of human health and nutrition.  In addition to her scientific and regulatory expertise, in her time at Mars, Catherine has been responsible for a global research program focused on studying the human health benefits of a class of natural plant compounds collectively known as cocoa flavanols.  This   research program has taken a multi-disciplinary approach to understanding the role that these compounds can have in supporting human health, with her research spanning from the development and validation of analytical methods to human dietary invention trials focused on aspects of cardiovascular and cognitive health.  As an expert in the field, Dr. Kwik-Uribe has co-authored numerous papers and book chapters. Dr. Kwik-Uribe received her doctorate degree in Human Nutrition from the University of California, Davis and went on as a post‐doctoral fellow at the University of California, Santa Cruz in the Department of Toxicology. See on LinkedIn.


CRN Staff:

Luke Huber
Vice President, Scientific & Regulatory Affairs

Dr. Huber focuses on CRN’s scientific affairs and nutrition policy activities that support the appropriate role for dietary supplements and functional food in health promotion and disease prevention. He has 20 years of experience in the dietary supplement industry leading product development, scientific and technical affairs, clinical research, and regulatory affairs. In his prior roles, he has been a leader in product innovation and scientific initiatives. Most recently, Dr. Huber held the position of global R&D director, VMS with RB (Reckitt Benckiser). Prior to RB, he held senior scientific & technical leadership roles at prominent companies within the dietary supplement industry. Dr. Huber received his doctorate of naturopathic medicine from Bastyr University in Bothell, WA, completed his residency at Cancer Treatment Centers of America in Zion, IL, and earned his MBA from University of Massachusetts at Amherst. See on LinkedIn.


Moderator:

Annahita Ghassemi
Director, Global Product Safety & Clinical Affairs, Church and Dwight Co. Inc.

Dr. Ghassemi has 30 years of experience in consumer product safety, clinical efficacy and claims substantiation and scientific affairs. She has had global safety and clinical leadership responsibility for a diverse product portfolio at the Church & Dwight Company for the past 20 years including dietary supplements; medical devices; fabric and home care products; and personal and beauty care products. Dr. Ghassemi has been actively involved in over 1,500 safety and efficacy studies and managed academic research partnerships and scientific advisory councils.  She collaborates with clinical researchers in nutrition, dentistry, dermatology, allergy and women’s health to develop programs to confirm product safety and efficacy.  She chairs the Senior Scientific Advisory Committee of the Council for Responsible Nutrition and serves on the Safety and Regulatory Toxicology Committee of the Personal Care Product Council. See on LinkedIn.

 

Coming soon on demand.