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

RISK ASSESSMENT

RISK CHARACTERIZATION

DECISIONS & ACTIONS

RISK MANAGEMENT

Hazard identification Dose (conc)-response (effect) Exposure assessment

Regulatory

oversight

Management option: Consequences of the options at public health, economic, social & political levels

time

Chain of evidenceProof

You need a plan

Towards an Evidence-based Toxicology

Expert-based vs. evidence-based

toxicology

• Reformulate the product X 2

• Redesign the product X 5

• New ways to deliver function X 10

• Redesign the system X 20

Reducing EnvironmentalFootprint

Source : Miller, Chemistry Innovation (2007)

Design Strategies