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