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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.
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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
Three revolutionary converging technologies are transforming our societies
Three revolutionary converging technologies are transforming our societies Information Technology Bio- Technology Nano Technology
For better Nanowire 'Barcode' System Speeds Up Bio Detection In The Field Information Technology Bio- Technology Multi-striped nanowires developed at LLNL allow rapid and sensitive immunoassays for biowarfare agent simulants. (Image courtesy of Lawrence Livermore National Laboratory) Nano Technology Source: Lawrence Livermore National Laboratory & Science Daily, August 8, 2006
… or for worse Information Technology Bio- Technology “Targeted Nanodelivery” e.g. aerosolization and/or micro-encapsulation 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 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
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 Unintentionally Occurring External Biological Threats e.g. Pathogens and Toxins Internal Biological Threats e.g. Cancer and Cardiac Disease Unintended Harm e.g. Lab Accidents and Toxic Side Effects of Pharmaceuticals Deliberate Misuse e.g. Pathogens and Toxins
Control of Internal Biological Threats Control of Unintentionally Occurring External Biological Threats Early Diagnosis Prevention Early Diagnosis Prevention Prophylaxis & Treatment Prophylaxis & Treatment Control of Unintended Harm Control of Deliberate Misuse Early Detection Lab Safety & Security Prevention Preemptive Action Pre-clinical & Clinical Testing Prophylaxis & Treatment Different Risk areas require different Risk Management measures Unintentionally Occurring External Biological Threats e.g. Pathogens and Toxins Internal Biological Threats e.g. Cancer and Cardiac Disease Unintended Harm e.g. Lab Accidents and Toxic Side Effects of Pharmaceuticals Deliberate Misuse e.g. Pathogens and Toxins
Control of Unintentionally Occurring External Biological Threats Prevention Early Diagnosis Prophylaxis & Treatment Control of Unintended Harm 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 Internal Biological Threats Early Diagnosis Prevention Prophylaxis & Treatment
Risk Strategy Risk Identifi- cation Risk Analysis Risk Response Risk Control Responsible Stewardship in Pharma and BioTech