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Risk Management and Innovation in the Health Care Industry:
Are they (in)compatible?
Introduction
Dr. David Cocker
The ‘Big Pharma’ point of view
Dr. Gerd Johnscher

Senior Partner, MDCPartners

Senior Consultant, Pharmakon
Former Senior VP, Adviser to the CEO, UCB

The ‘Regulator’s point of view
Prof. Bruno Flamion
FUNDP – University of Namur and CHMP
The ‘Economist’s and Innovator’ point of view
Prof. Koenraad Debackere
Managing Director of K. U. Leuven R&D
Chairman of Gemma Frisius-Fonds
The ‘End-user’s’ point of view
Mr. Jo De Cock

General Manager, RIZIV/INAMI
Risk Management and Innovation in the
healthcare industry

are they (in)compatible ?
Good evening,
my name is David Cocker and I am in the chair tonight.
Talking about risk is of course one of
the riskiest things one can do.
There are so many experts about !
( J.D.Remington, HSE, UK )
What’s risk ?

its very simple

• The risk the first speaker will look up
• wikipedia.org/historical_background/ “the definition of risk”.
Once risks was in the
hands of
“others”

Thx Peter Bernstein & Rembrandt
Most of us view risk as either ……acceptable

…………..or unacceptable
That’s if we have a choice …………..
Reputational
• People
• Share price

Environmental
• Ecotox
• Compliance

Risk
Financial
• Investments
• Liabilities

Human Health
• Efficacy
• Safety
Risk Management

Mitigate the risk of injury

Mitigate the risk of accidents
Study suggests heart attack risk
persisted for one year after
patients stopped taking Vioxx.
Oct. 14 issue of The Lancet. The study "also
appears to show the higher risk started soon
after patients began taking Vioxx, though" the
analysis "notes a small sample size precludes
a definitive finding on this issue."
Do you hold a good hand of cards ?
NGO’s are good at communicating
emotion

The industry is good at
communicating data.
Risk communication will be as important as
the data to substantiate it
time

RISK MANAGEMENT
RISK ASSESSMENT

 Hazard identification
 Dose (conc)-response (effect)
 Exposure assessment

RISK CHARACTERIZATION

DECISIONS & ACTIONS

You need a plan

Management option:
Consequences of the options at
public health, economic, social &
political levels
Towards an Evidence-based
Toxicology

Expert-based

vs.

toxicology

evidence-based
Design Strategies
Reducing Environmental
Footprint

•

Reformulate the product

X2

•

Redesign the product

X5

•

New ways to deliver function

X 10

•

Redesign the system

X 20

Source : Miller, Chemistry Innovation (2007)

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INSEAD Risk Management Introduction

  • 1. Risk Management and Innovation in the Health Care Industry: Are they (in)compatible? Introduction Dr. David Cocker The ‘Big Pharma’ point of view Dr. Gerd Johnscher Senior Partner, MDCPartners Senior Consultant, Pharmakon Former Senior VP, Adviser to the CEO, UCB The ‘Regulator’s point of view Prof. Bruno Flamion FUNDP – University of Namur and CHMP The ‘Economist’s and Innovator’ point of view Prof. Koenraad Debackere Managing Director of K. U. Leuven R&D Chairman of Gemma Frisius-Fonds The ‘End-user’s’ point of view Mr. Jo De Cock General Manager, RIZIV/INAMI
  • 2. Risk Management and Innovation in the healthcare industry are they (in)compatible ? Good evening, my name is David Cocker and I am in the chair tonight.
  • 3. Talking about risk is of course one of the riskiest things one can do. There are so many experts about ! ( J.D.Remington, HSE, UK )
  • 4. What’s risk ? its very simple • The risk the first speaker will look up • wikipedia.org/historical_background/ “the definition of risk”.
  • 5. Once risks was in the hands of “others” Thx Peter Bernstein & Rembrandt
  • 6. Most of us view risk as either ……acceptable …………..or unacceptable That’s if we have a choice …………..
  • 7. Reputational • People • Share price Environmental • Ecotox • Compliance Risk Financial • Investments • Liabilities Human Health • Efficacy • Safety
  • 8. Risk Management Mitigate the risk of injury Mitigate the risk of accidents
  • 9. Study suggests heart attack risk persisted for one year after patients stopped taking Vioxx. Oct. 14 issue of The Lancet. The study "also appears to show the higher risk started soon after patients began taking Vioxx, though" the analysis "notes a small sample size precludes a definitive finding on this issue."
  • 10. Do you hold a good hand of cards ?
  • 11. NGO’s are good at communicating emotion The industry is good at communicating data.
  • 12. Risk communication will be as important as the data to substantiate it
  • 13. time RISK MANAGEMENT RISK ASSESSMENT  Hazard identification  Dose (conc)-response (effect)  Exposure assessment RISK CHARACTERIZATION DECISIONS & ACTIONS You need a plan Management option: Consequences of the options at public health, economic, social & political levels
  • 15. Design Strategies Reducing Environmental Footprint • Reformulate the product X2 • Redesign the product X5 • New ways to deliver function X 10 • Redesign the system X 20 Source : Miller, Chemistry Innovation (2007)