Introduction Dr. David Cocker Senior Partner, MDCPartners The ‘Big Pharma’ point of view Dr. Gerd Johnscher 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 Health Care Industry: Are they (in)compatible?
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IntroductionDr. David Cocker Senior Partner, MDCPartners
The ‘Big Pharma’ point of viewDr. Gerd Johnscher Senior Consultant, Pharmakon
Former Senior VP, Adviser to the CEO, UCB
The ‘Regulator’s point of viewProf. Bruno Flamion FUNDP – University of Namur and CHMP
The ‘Economist’s and Innovator’ point of viewProf. Koenraad Debackere Managing Director of K. U. Leuven R&D
Chairman of Gemma Frisius-Fonds
The ‘End-user’s’ point of viewMr. Jo De Cock General Manager, RIZIV/INAMI
Risk Management and Innovation in the Health Care Industry:Are they (in)compatible?
Risk Management and Innovation in the healthcare industry
Good evening, my name is David Cocker and I am in the chair tonight.
are they (in)compatible ?
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 ?• The risk the first speaker will look up • wikipedia.org/historical_background/ “the definition of risk”.
its very simple
Thx Peter Bernstein & Rembrandt
Once risks was in the hands of “others”
Most of us view risk as either ……acceptable
…………..or unacceptable
That’s if we have a choice …………..
Risk
Reputational
• People• Share price
Human Health• Efficacy• Safety
Financial•Investments
•Liabilities
Environmental• Ecotox
• Compliance
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 ?
The industry is good at communicating data.
NGO’s are good at communicating emotion
Risk communication will be as important as the data to substantiate it