JOSEFIEN VENDRIK, QUALITY MANAGER IRENE JONGENELEN, COÖRDINATOR CLINICAL SUPPLIES MANAGEMENT/ SENIOR CLINICAL STUDY MANAGER
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1 Food for Thought JOSEFIEN VENDRIK, QUALITY MANAGER IRENE JONGENELEN, COÖRDINATOR CLINICAL SUPPLIES MANAGEMENT/ SENIOR CLINICAL STUDY MANAGER CLINOPS DAG, 12 APRIL 2018
2 HISTORY OF RESEARCH AND DEVELOPMENT Martinus and Jan van der Hagen produced the first infant milk formula, based on research by Prof. Backhaus in Germany First Medical Nutrition for diabetic patients First Nutritional guidelines for infants and patients First Research Centre for Baby and Medical Nutrition in Zoetermeer Became part of Danone 2011 Opening of R&D satellite in Biopolis Singapore 2013 Innovation centre moves from Wageningen to Utrecht Science Park
3 PART OF DANONE FOUR DIVISIONS BRINGING HEALTH THROUGH FOOD TO AS MANY PEOPLE AS POSSIBLE
4 Nourishing health throughout our lifespan RISK INTEGRAL FACTORS/ HEALTH EARLY DISEASE DEVELOPMENT MAINTENANCE EARLY MANAGEMENT DIAGNOSIS
5 EARLY LIFE NUTRITION (ELN) PRODUCT PORTFOLIO 86% Milks Pregnancy and breastfeeding products Infant formula, follow-on formula, young child formula. Tailored nutrition; preterm, allergy, digestion. 14% Food Fruits, meals, cereals
6 ADVANCED MEDICAL NUTRITION PRODUCT PORTFOLIO METABOLICS PAEDIATRICS TUBE & DEVICES SARCOPENIA RECOVERY TUBE & DEVICES ALZHEIMER /MCI Healthy growth & development Frailty & Disease
7
8 SCIENCE IS AT THE VERY HEART OF OUR NUTRITION AND HEALTH COMMITMENT Two major R&D hubs for early life nutrition UTRECHT NUTRICIA RESEARCH INNOVATION CENTRE SINGAPORE R&D SATELLITE R&D Utrecht Main R&D centre In Utrecht Science Park, one of Europe's most competitive regions Unique integration of science, education and business R&D Singapore Satellite centre in Singapore with focus on Precision Nutrition D-Lab Connecting to the world-class scientific and medical network in Asia Pacific
9 QUALITY & FOOD SAFETY IS CRITICAL TO OUR CATEGORY WE HAVE FRAGILE CONSUMERS OUR PRODUCTS OFTEN MAKE UP 100% OF A BABY S NUTRITION HIGH LEVEL STANDARDS ISO certified Quality Management System
10 OUR COMMITMENT TO HUMAN MILK, BEST NOURISHMENT FOR INFANTS 40 years of human milk research. Research for breastfeeding support: influence of diet on the human milk composition, social and psychological factors influencing breastfeeding behavior. Support WHO recommendation for exclusive breastfeeding, respect WHO s Code in clinical studies and in communication.
11 Medical Nutrition
12 WHAT IS MEDICAL NUTRITION? Food for Special Medical Purposes = FSMP Food especially intended for dietary management of patients Which cannot be achieved by modification of normal diet alone To be used under medical supervision Type of use: Total diet replacement or partial feed Intended for patients that do not digest/excrete ordinary food There is a fine line between Medical Foods and Medicines
13 MEDICAL NUTRITION: BETWEEN FOOD AND PHARMA Distinct from food Designed to meet medical need Used under medical supervision Defined nutrient composition Clinically tested Intended to impact patient outcome Distinct from pharma Nutrient-based Mixture of nutritional components Minimal side effects Broad spectrum of effects Not intended to cure, treat or prevent disease From: Medical Nutrition: the interface between food and pharma Brussels, July 4 th Dr. Ceri Green, Nutricia AMN
14 MEDICAL NUTRITION: BETWEEN FOOD AND PHARMA Food/ nutrition Medical nutrition Drug Normal food (known ingredients) In general NOT tested in clinical trials No registration, food company responsible for safety For (healthy) consumers - Health claim Food for Special Medical Purposes (FSMP) FSMP Dossier: data on nutrients tested in clinical studies (tolerance, efficacy) For patients use (medical supervision), e.g. pre-term babies, cow s mild allergy Chemical entities In general 1 compound tested in clinical trials (phase I-IV: safety, efficacy National registration (EMA / FDA) For patients use (medical supervision) Not reimbursed BUT for young infants Frequently reimbursed Usually reimbursed
15 Food for Specific Groups for infant formulae (IF) and follow-on (FO) formulae
16 INFANT FORMULA /FOLLOW ON (IF/FO) IN EUROPE IF / FO Medical food Drug satisfies specific nutritional requirements (composition list) Suitability Dossier (evidence on food safety): submit label + notification when placed on market For infants in good health For infants at risk of developing allergy Food for Special Medical Purposes (FSMP) FSMP Dossier: data on nutrients tested in clinical studies (tolerance, efficacy) For patients use (medical supervision), e.g. pre-term babies, cow s milk allergy Chemical entities In general 1 compound tested in clinical trials (phase I-IV: safety, efficacy National registration (EMA / FDA) For patients use (medical supervision) Not reimbursed Frequently reimbursed Usually reimbursed
17 STANDARD PREVENTION MANAGEMENT VRAAG: WELKE ZUIGELINGENVOEDING(EN) IS EEN FSMP? Intact milk protein Partially HP Extensively HP Amino Acids tolerance development reduced allergenicity
18 STANDARD PREVENTION MANAGEMENT CURRENT DIETARY MANAGEMENT OF ALLERGY Intact milk protein Partially HP Extensively HP Amino Acids tolerance development reduced allergenicity
19 Regulatory Framework
20 FOOD LEGISLATION: SINCE 2002 EUROPEAN FOOD SAFETY AGENCY WHAT EFSA DOES: Provide independent scientific advice to the Decision Makers who regulate food safety in Europe Dossiers EFSA for e.g.: - Food for Special Medical Purposes (FSMP) - Infant Formula/ Follow On (IF/FO) - Health claims: - Positive opinion authorisation (EC + MS decide)
21 EU CTD: FOR MEDICINAL PRODUCTS ONLY No EUDRACT Number No reporting to EMA No harmonized approach EU for conduct of clinical research with (medical) food Submissions and reporting is different per country Ethics Commitees: always needed (local vs central) Competent Authority: not always needed
22 OUR INNOVATION PROCESS
23 OUR INNOVATION PROCESS From insight to product 1 SCIENTIFIC & TECHNOLOGICAL INSIGHTS/ HEALTH CONCERNS/CONSUMER NEEDS PRECLINICAL STUDIES/ PROOF OF CONCEPT 2 PRODUCT DEVELOPMENT 4 CLINICAL STUDIES FOR SAFETY & EFFICACY 3 5 PACKAGING & SENSORY SCIENCE 6 TRANSFER TO INDUSTRIAL SCALE
24 EXAMPLE OF NUTRICIA'S CLINICAL STUDY PRODUCT
25 VOORBEELD VAN NUTRICIA'S CLINICAL STUDY PRODUCT
26 Our global coverage ELN Clinical Research CZECH REP SLOVAKIA GERMANY FINLAND HUNGARY BULGARIA POLAND TURKEY IRELAND CHINA UK TAIWAN PORTUGAL SPAIN FRANCE AUSTRIA SWITZERLAND ISRAEL THAILAND VIETNAM MALAYSIA HONG KONG ITALY SINGAPORE INDONESIA THE NETHERLANDS BELGIUM AUSTRALIA
27 THANK YOU FOR MORE INFORMATION, VISIT OUR WEBSITE:
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