food for thought - nvfg...food for thought josefien vendrik, quality manager irene jongenelen,...
TRANSCRIPT
Food for Thought
JOSEFIEN VENDRIK, QUALITY MANAGER
IRENE JONGENELEN, COÖRDINATOR CLINICAL SUPPLIES MANAGEMENT/
SENIOR CLINICAL STUDY MANAGER
CLINOPS DAG, 12 APRIL 2018
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
1896 1905 1923 1946 2007
Innovation centre
moves from
Wageningen to
Utrecht Science
Park
2013
Opening of
R&D satellite in
Biopolis Singapore
2011
PART OF DANONE – FOUR DIVISIONS
‘BRINGING HEALTH THROUGH FOOD TO AS MANY PEOPLE AS POSSIBLE’
HEALTH
MAINTENANCE
INTEGRAL
DISEASE
MANAGEMENT
RISK
FACTORS/
EARLY
DIAGNOSIS
EARLY
DEVELOPMENT
Nourishing health
throughout our lifespan
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.
• Fruits, meals, cereals
14% Food
ADVANCED MEDICAL NUTRITION PRODUCT PORTFOLIO
METABOLICS PAEDIATRICS TUBE &
DEVICES SARCOPENIA RECOVERY
TUBE &
DEVICES
ALZHEIMER
/MCI
Healthy growth &
development
Frailty & Disease
SCIENCE IS AT THE VERY HEART OF OUR NUTRITION
AND HEALTH COMMITMENT
UTRECHT
NUTRICIA RESEARCH
INNOVATION CENTRE
SINGAPORE
R&D SATELLITE
Two major R&D hubs
for early life nutrition
• Main R&D centre
• In Utrecht Science Park, one of
Europe's most competitive
regions
• Unique integration of science,
education and business
• Satellite centre in Singapore with focus
on Precision Nutrition D-Lab
• Connecting to the world-class scientific
and medical network in Asia Pacific
R&D Singapore
R&D Utrecht
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
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.
Medical Nutrition
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
MEDICAL NUTRITION: BETWEEN FOOD AND PHARMA
From: Medical Nutrition: the interface between food and pharma Brussels, July 4th 2012. Dr. Ceri Green, Nutricia AMN
Distinct from food Distinct from pharma
Designed to meet medical need Nutrient-based
Used under medical supervision Mixture of nutritional components
Defined nutrient composition Minimal side effects
Clinically tested Broad spectrum of effects
Intended to impact patient outcome Not intended to cure, treat or prevent disease
MEDICAL NUTRITION: BETWEEN FOOD AND PHARMA
Food/ nutrition Medical nutrition
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
• Frequently reimbursed
Drug
• Chemical entities
• In general 1 compound tested in
clinical trials (phase I-IV: safety,
efficacy
• National registration
(EMA / FDA)
• For patients use
(medical supervision)
• Usually reimbursed
• Normal food (known ingredients)
• In general NOT tested in clinical trials
• No registration, food company
responsible for safety
• For (healthy) consumers
- Health claim
• Not reimbursed
BUT
for young infants…
Food for Specific Groups for infant formulae (IF) and follow-on (FO) formulae
INFANT FORMULA /FOLLOW ON (IF/FO) IN EUROPE
IF / FO Medical food
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
• Frequently reimbursed
Drug
• Chemical entities
• In general 1 compound
tested in clinical trials
(phase I-IV: safety,
efficacy
• National registration
(EMA / FDA)
• For patients use
(medical supervision)
• Usually reimbursed
• 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
• Not reimbursed
VRAAG:
WELKE ZUIGELINGENVOEDING(EN) IS EEN FSMP?
PR
EV
EN
TIO
N
STA
ND
AR
D
MA
NA
GE
ME
NT
tolerance development reduced allergenicity
Intact milk protein Partially HP Extensively HP Amino Acids
CURRENT DIETARY MANAGEMENT OF ALLERGY
PR
EV
EN
TIO
N
STA
ND
AR
D
MA
NA
GE
ME
NT
tolerance development reduced allergenicity
Intact milk protein Partially HP Extensively HP Amino Acids
Regulatory
Framework
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)
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
21
OUR INNOVATION
PROCESS
OUR INNOVATION PROCESS
1
2
3 4
5
6
SCIENTIFIC & TECHNOLOGICAL INSIGHTS/
HEALTH CONCERNS/CONSUMER NEEDS
PRECLINICAL STUDIES/
PROOF OF CONCEPT
CLINICAL STUDIES FOR
SAFETY & EFFICACY
PRODUCT
DEVELOPMENT
PACKAGING &
SENSORY SCIENCE
TRANSFER TO
INDUSTRIAL SCALE
From insight to product
EXAMPLE OF NUTRICIA'S CLINICAL STUDY PRODUCT
VOORBEELD VAN NUTRICIA'S CLINICAL STUDY PRODUCT
Our global coverage ELN Clinical Research
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THANK YOU
FOR MORE INFORMATION, VISIT OUR WEBSITE:
HTTPS://WWW.NUTRICIARESEARCH.COM/