Manfred Ruthsatz
Regulatory Affairs Professionals Society ,Switzerland
Title: Nutrition Innovation: Opportunities, Challenges & strategies
Biography:
Dr. Ruthsatz’ expertise & passion is to build and strengthen relations between regulators, policymakers, healthcare professionals, patient organizations world-wide to change people’s lives through nutrition. He held lead regulatory positions in healthcare industries (Nestlé Health Science, L’Oréal-innéov, Abbott, Roche), providing him with a wide blend of hands-on experiences in nutrition, drugs, devices, biotech, botanicals and cosmetics, rounded out by quality, safety, vigilance, health economics & reimbursement. He was a NIH R&D Visiting Fellow (cancer virology; microbiology) & served as a reviewing pharmacologist at the US-FDA (CDER, HIV/AIDS division).
Dr. Ruthsatz maintains a long-standing recognition on governing, scientific & editorial boards (VP ISDI; ERNA; MIRRI; European Botanical Forum’s past president; RAPS faculty, editorial, awards, EU, CH) & lead working groups with global and regional medical nutrition and dietary/food supplements associations. He has published extensively & been a frequent speaker worldwide to governments and associations in Europe, the Americas & Asia (China, India, ASEAN), covering a wide array of healthcare & safety related topics on the food-drug borderline (i.e. disease-related malnutrition, targeted nutrition, the microbiome, global convergence, multi-stakeholder engagement & policymaking.
He upholds Board Certifications in Pharmacy, Toxicology (DABT), Regulatory Affairs (RAC) & received the rare distinction as a Fellow by the Regulatory Affairs Professionals Society (RAPS).
Abstract:
New scientific insights and technological opportunities coming at an unprecedented pace promise new perspectives and potential solutions to currently unmet needs considering demographic changes, increase in non-communicable diseases (NCDs) and exploding healthcare costs. Novel nutrition therapeutic findings, dietary/food/health supplements, the microbiome, and ‘omics’ diagnostics will transform health and disease management, how we approach disease prevention, personalize nutrition, counter the negative impact of disease related malnutrition, and even define a patient.
Our regulatory frameworks have historically aimed for and demonstrated consumer and patient protection. Disruptive findings in diagnostics and innovative nutritional approaches make the once separate silos of food (health) and drug (disease) systems move closer together, and hence provide ample opportunity for product developers, multi-stakeholder, public-private partnership engagement to address divergent expertise, interests, with improved quality of healthcare and patient-centered outcomes, and cover the magnitude and complexity of issues. Examples are the EU Commission endorsed Optimal Nutrition Care for All (ONCA) multi-stakeholder campaign across multiple member states, or the OECD Microbiome, Diet and Health initiative, as a promising way for an open dialogue to promote a science and technology based, yet flexible and appropriate regulatory and policy guidance framework in the food-medicine continuum.
By sharing the voice of regulators, policymakers, payers, developers, medical associations, healthcare professionals, as well as consumers and patients, multi-stakeholder platforms have the great potential to align on big objectives to better serve the needs of society. Current thinking and frameworks need to adapt rapidly, in particular addressing legal limitations on the use of disease prevention claims for nutrition, dietary disease management, personalized nutrition, as well as to create favorable development conditions for the human microbiome to provide innovative solutions in consumer and healthcare.