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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 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