B4: Are current efforts sufficiently well-funded and
coordinated internationally?
Current Programs:
United States
• Government intramural (e.g., EPA ToxCast, NCGC, Molec Librairies NTP, FDA)
• Government extramural (e.g., NIH, STAR grants)
Europe
• Framework programmes (FP7 and forthcoming FP8)
• Member state intramural/centres (e.g., ZEBET, NC3Rs, Netherlands Genomics Initiative)
• Member state extramural
Industry and public/private partnerships
• Individual companies
• Direct corporate funding (e.g., grants to Hamner, ACC/CEFIC LRI)
• Public/private partnerships (e.g., EC/COLIPA Joint Research Initiative, Innovative
Medicines Initiative)
Others?
B4: Are current efforts sufficiently well-funded and
coordinated internationally?
1. Are we missing any significant programs?
United States
• Government intramural (e.g., EPA ToxCast, NCGC, Molec Librairies, NTP, FDA, DoD)
• Government extramural (e.g., NIH, STAR grants)
Europe
• Framework programmes (FP7 and forthcoming FP8)
• Member state intramural/centres (e.g., ZEBET, NC3Rs, Netherlands Genomics Initiative)
• Member state extramural
Industry and public/private partnerships
• Individual companies
• Direct corporate funding (e.g., grants to Hamner, ACC/CEFIC LRI)
• Public/private partnerships (e.g., EC/COLIPA Joint Research Initiative, Innovative
Medicines Initiative)
Other
• Academic centers (e.g., CAAT), charitable/private foundations, transatlantic think tank
B4: Are current efforts sufficiently well-funded and
coordinated internationally?
2. What are current funding levels, future targets (generally low, about right, high)?
Baseline figures supplied by Andrew Rowan
Lots of activity; if funds are well spent, additional funding will help to accelerate progress
• BUT funding needs to be targeted and coordinated (intramurally/extramurally &
nationally/internationally)
US perspective
• Sufficient funding for the time being to maintain existing activity levels
• Doubling of Tox21 size would saturate ability to deal with the data
–
Increased capacity must ensure adequate human resources to understand data being produced
(pharmacologists, physiologists, etc.)
EU perspective
• No targeted EU FP funding foreseen in 2011; possibly final FP7 call in 2012
• Targeted carve-out under FP8 (2013-2018)?
B4: Are current efforts sufficiently well-funded and
coordinated internationally?
3. Are there strategic opportunities for growth: what, where, when, how?
• Within sectors
• Across sectors
•
Public policy initiatives/legislative mandates (e.g., TSCA reauthorization, revision of EU
biocides regulation)
–
–
–
•
•
Send clear message to regulators that change is needed
Lay the groundwork for flexible data requirements
Authorizing language
EU research ‘flagship innovations’ introduced by new Research Commissioner
Frame in broader context (e.g., systems medicine)
B4: Are current efforts sufficiently well-funded and
coordinated internationally?
4. What are the barriers to growth ... solutions to overcome them?
• Fiscal constraints
• Others?
•
•
“Not invented here” syndrome – how to internationalize?
Lack of research roadmap = critical knowledge gap for third countries; now to tap in?
–
•
•
•
•
•
•
•
Global strategy  research gaps analysis  S&T strategy  portals to plug in
How we articulate the final objective (“tox testing” vs. “3Rs” vs. “safer products/medicines”)
Present new concept in a way that makes people want to participate vs. intimidation
Industry needs to see impact/end-game – unclear whether regulatory policy makers are
sufficiently on board (e.g., EOGRTS experience, same risk assessment paradigm or 2.0?)
Unclear whether regulators have bought in to the new paradigm; regulations need to be
flexible and able to adapt; in-house expertise / need for training
Health / environment split (implications for funding schemes)
Bottom-up vs. top-down approaches
Global economic downturn
B4: Are current efforts sufficiently well-funded and
coordinated internationally?
Research coordination
• OECD Molecular Screening & Toxicogenomics Advisory Group
• Tox21 Community
• AXLR8
• HTP Consortium
• Others?
B4: Are current efforts sufficiently well-funded and
coordinated internationally?
5. Is research effectively coordinated ... how can it be done better?
• Gaps, redundancies
• International opportunities
•
•
•
•
OECD lacks management (“scientific potluck”) but can work (e.g., nano working groups)
Environment Directorate = limit (e.g., doesn’t capture pharma regulators)
OECD membership limitations (academics)
Transatlantic/pacific collaborations possible (no “us vs. them” mentality)
B4: Are current efforts sufficiently well-funded and
coordinated internationally?
6. Is there one key step that will get us there faster than expected?
•
•
•
•
Successful pilot program = something tangible to point to; rally behind
Commitment by regulatory policy makers to “risk assessment 2.0”
Engagement of pharma industry and its knowledge of human biology and data
Public policy drivers (e.g., new/revised legislation, mandates)