Here - Stiftung Forschung 3R

Why is a Consortium Needed
While there is considerable interest in the
new toxicology tools being developed,
there is, as yet, also considerable
duplication of effort. In order to bring
the NRC vision (2007) to fruition, both
funding and coordination will be required.
We believe that the vision will eventually be
implemented but, without some initiative
like the proposed Human Toxicology
Project, it could take a lot longer (and a
lot more money) than would be required
if an internationally co-ordinated project
were established—akin to the Human
Genome Project. The analogy highlights
the importance of developing an urgent
focus around a common mission to
overcome what are mostly challenges
entailing technological improvements. It
also stresses the need for international
leadership.
The Human Genome Project launched in
1990 after almost ten years of discussions
and arguments about its appropriateness
and its promise. At the time of its launch,
it cost $10 to sequence one DNA base
pair. Today, authorities are talking about
sequencing an entire human genome
(around 3 billion base pairs) for $1,000
and the current cost is in the $5-10,000
range—a technical improvement of
around 5-million fold. Collins (2003) wrote
about the lessons for running large biology
projects including the importance of:
• Building the best teams
• Ensuring that the process is sciencedriven
• Meeting the managerial challenges
• Seeking international participation
• Establishing explicit milestones and
quality assessments
• Striving for technological advancement
that can accelerate the project
• Releasing data rapidly to demonstrate
the project’s value to the community
• Addressing social consequences as
part of the project.
Many of these lessons speak to the crosscutting
issue of strategic planning, as well
as other themes including communication
and coordination. The Human Toxicology
Project Consortium believes that a Human
Genome Project-type effort should be
marshalled to realise the NRC vision—
and has called this initiative the Human
Toxicology Project (HTP).
In November of 2010, a workshop was
convened in Washington to examine the
prospects for launching a successful HTP.
The themes and recommendations that
emerged from this workshop included
the need to establish an Implementation
Group that would, as a central challenge,
hasten the development and application
of new tools and approaches beyond
screening and priority-setting, to
hazard identification and dose-response
analysis—two key components of risk
assessment. Similarly, the group should
also expedite the use of the new methods
to diverse risk contexts (NRC, 2007), not
all of which demand assays that are highthroughput.
In these ways, decision-makers
can use the next generation tools and
approaches to make more informed and
efficient responses to diverse public health
concerns faced by regulators, industry,
208 AXLR8-2 WORKSHOP REPORT
Progress Report 2011 & AXLR8-2 Workshop Report