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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 Regulators point of view
Prof. Bruno Flamion
FUNDP  University of Namur and CHMP
The Economists and Innovator point of view
Prof. Koenraad Debackere
Managing Director of K. U. Leuven R&D
Chairman of Gemma Frisius-Fonds
The End-users 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 )
Whats 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
Thats 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 ?
NGOs 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 Regulators point of view Prof. Bruno Flamion FUNDP University of Namur and CHMP The Economists and Innovator point of view Prof. Koenraad Debackere Managing Director of K. U. Leuven R&D Chairman of Gemma Frisius-Fonds The End-users 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. Whats 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 Thats 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. NGOs 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)