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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
InformationTechnology
NanoTechnology
Bio-Technology
For better
InformationTechnology
NanoTechnology
Bio-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
Nanowire 'Barcode' System Speeds Up Bio Detection In The Field
… or for worse
InformationTechnology
NanoTechnology
Bio-Technology
Source: Lawrence Livermore National Laboratory & Science Daily, August 8, 2006
“Targeted Nanodelivery” e.g. aerosolization
and/or micro-encapsulation of
pathogens or toxins
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 Smith: Isolation of the first restriction enzyme
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”
Basic “DNA-Research”(predominantly publicly funded)
Applied “DNA-Research”(strong private and public funding)
Pharmaceutical R&D expenditure (Europe, Japan and US: 1990-2005, € million, current exchange rates)
(e): estimate, Source: EFPIA member associations, PhRMA, JPMA, NIH
NIH funding 1990 1995 2000 2004 2005 € billion 5.5 8.8 14 22.4 22.2
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.
Source: Boston Consulting Group
Chronology of Drug Innovation
Biological Risk comes in different shapes
InternalBiological Threats
e.g. Cancer and Cardiac Disease
Unintended Harm
e.g. Lab Accidents and
Toxic Side Effects of
Pharmaceutic
als
Deliberate Misuse
e.g. Pathogens and Toxins
Unintentionally Occurring
External Biological Threats
e.g. Pathogens and Toxins
Unintentionally Occurring
External Biological Threats
e.g. Pathogens and Toxins
Control of Unintentionally Occurring External Biological Threats
Prophylaxis &Treatment
Preve
ntio
n
Early DiagnosisInternal
Biological Threatse.g. Cancer and Cardiac Disease
Different Risk areas require different Risk Management measures
Unintended Harm
e.g. Lab Accidents and
Toxic Side Effects of
Pharmaceutic
als
Deliberate Misuse
e.g. Pathogens and Toxins
Control of Unintended Harm
Lab Safety & Security
Pre-clinical & Clinical Testing
Control of Internal Biological Threats
Prophylaxis &Treatment
Early Diagnosis
Prevention
Control of Deliberate Misuse
Prevention
Prophylaxis &Treatment
Early Detection
Preemptive Action
Control of Unintentionally Occurring External Biological Threats
Prophylaxis &Treatment
Preve
ntio
n
Early Diagnosis
Different Risk areas are interdependent
Control of Internal Biological Threats
Prophylaxis &Treatment
Early Diagnosis
Prevention
Control of Unintended Harm
Lab Safety & Security
Pre-clinical & Clinical Testing
Control of Deliberate Misuse
Prevention
Prophylaxis &Treatment
Early Detection
Preemptive Action
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.
RiskStrategy
RiskIdentifi-cation
Risk Analysis
RiskResponse
RiskControl
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