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

CZECH REP SLOVAKIA FINLAND

POLAND

IRELAND

UK

SPAIN

HUNGARY

BULGARIA

GERMANY

SWITZERLAND

ITALY

THE NETHERLANDS

BELGIUM

AUSTRALIA

AUSTRIA

FRANCE

CHINA

VIETNAM

THAILAND

MALAYSIA

SINGAPORE

TURKEY

ISRAEL

INDONESIA

PORTUGAL

TAIWAN

HONG KONG

THANK YOU

FOR MORE INFORMATION, VISIT OUR WEBSITE:

HTTPS://WWW.NUTRICIARESEARCH.COM/