Transcript Slideshow presentation (Microsoft PowerPoint) (PPT

Rainer Wessel, President & CEO
Responsible stewardship of Life Sciences research: What is the right risk strategy?
RS-IAP-ICSU international workshop on science & technology developments
relevant to the Biological & Toxin Weapons Convention
London, September 2006
Science and technology are swiftly moving
targets for regulatory measures
“Research is what I'm doing when I don't know what I'm doing.”
Wernher von Braun
Three revolutionary converging technologies are
transforming our societies
Three revolutionary converging technologies are
transforming our societies
Information
BioTechnology Technology
Nano
Technology
For better
Nanowire 'Barcode' System
Speeds Up Bio Detection In The Field
Information
BioTechnology Technology
Nano
Technology
Multi-striped
nanowires
developed at
LLNL allow rapid
and sensitive
immunoassays
for biowarfare
agent simulants.
(Image courtesy of
Lawrence Livermore
National Laboratory)
Source: Lawrence Livermore National Laboratory & Science Daily, August 8, 2006
… or for worse
Information
“Targeted BioNanodelivery”
Technology
Technology
e.g. aerosolization
and/or microencapsulation of
pathogens
or toxins
Nano
Technology
Source: Lawrence Livermore National Laboratory & Science Daily, August 8, 2006
The dawn of the age of the Life Sciences
The “DNA” Era
Years
(before present)
1953
Watson and Crick: Propose DNA double helix model
Hayes: Plasmids can be used to transfer introduced genetic
markers from one bacterium to another (F plasmid)
1965
Nirenberg et al: The genetic code was "cracked”
1970
Basic “DNA-Research”
Smith: Isolation
of the first restriction
enzyme
(predominantly
publicly
funded)
1972
Berg: First recombinant DNA molecule
1975
Köhler and Milstein: First monoclonal antibodies
Asilomar Conference on DNA
1976
Foundation of Genentech: 2005 Revenue = USD 6.63 billion
1980
Foundation of Amgen: 2005 Revenue = USD 12.43 billion
2001
Venter: Publication of “The Sequence of the Human Genome”
Applied “DNA-Research”
(strong private and public funding)
Pharmaceutical R&D expenditure
(Europe, Japan and US: 1990-2005, € million, current exchange rates)
NIH funding
€ billion
1990
5.5
1995
8.8
2000
14
2004
22.4
2005
22.2
(e): estimate, Source: EFPIA member associations, PhRMA, JPMA, NIH
Biotech companies are a strong driving force in
Drug Innovation
The US is still the strongest
force in BioTech, but Europe
is on the chase and Asia is
emerging fast.
Chronology of Drug Innovation
Source: Boston Consulting Group
Biological Risk comes in different shapes
Internal
Biological Threats
e.g. Cancer and Cardiac Disease
Different Risk areas require different
Risk Management measures
Control of Unintentionally
Occurring External Biological
Threats
Early Diagnosis
Prophylaxis &
Treatment
Control of Unintended Harm
Control of Internal Biological
Threats
Early Diagnosis
Prevention
Internal
Biological Threats
&
e.g. Cancer andProphylaxis
Cardiac Disease
Treatment
Control of Deliberate Misuse
Early Detection
Lab Safety & Security
Prevention
Preemptive Action
Pre-clinical & Clinical Testing
Prophylaxis &
Treatment
Different Risk areas are interdependent
Control of Unintentionally
Occurring External Biological
Threats
Early Diagnosis
Prophylaxis &
Treatment
Control of Unintended Harm
Control of Internal Biological
Threats
Early Diagnosis
Prevention
Prophylaxis &
Treatment
Control of Deliberate Misuse
Early Detection
Lab Safety & Security
Prevention
Preemptive Action
Pre-clinical & Clinical Testing
Prophylaxis &
Treatment
Responsible Stewardship in Pharma and BioTech
Corporations need to balance risks and rewards.
Different technologies and business models have different risks.
The Pharmaceutical R&D process is inherently difficult to control. In
particular companies that are developing pharmaceutical products have a
very high risk.
Therefore, these companies increasingly monitor their R&D with
extensive Risk Management processes.
Risk
Strategy
Risk
Identification
Risk
Analysis
Risk
Response
Risk
Control
Societies need to balance risk, too
The Life Sciences are, together with IT and Nanotechnology, forming a
new revolutionary force that will fundamentally change our societies.
However, no one is able to really know what exact changes are lying
ahead, because the scientific process itself is non-predictable.
Use of risk management tools in public decision processes can be one
measure to balance the imminent rewards and risks. A particular problem
in this area is public perception of risks.
International legislative processes need to apply these tools in order to
achieve meaningful consensus. Current mechanisms do not seem to
address these issues in an adequate way.
New mechanisms seem to be needed.
International Council for the
Life Sciences (ICLS)
Organization
Non-profit organization, financed by private
foundations, other sources of private nongovernmental
support, and membership subscriptions
Members
Private entities and academic institutions in the Life
Sciences
Associate
Members
Government departments and agencies and
International inter-governmental organizations
Mission
To help ensure global public health, safety, and security
by safeguarding the opportunities offered by advances
in the life sciences and their application through the
promotion of best practices, standards, and codes of
conduct.
Commitments
International and National Laws and Regulations,
Personnel, Information, Safe and Secure Operation of
Facilities, Governance of Research and Development
Activities, Risk Evaluation and Mitigation