Transcript The State of Nanotechnology - International Association of

Roadmap for the new Nano Frontier :
Some suggested frameworks
Lloyd L. Tran
President
International Association of Nanotechnology
Why do we need a roadmap?
• To find the best route
• To identify & avoid obstacles and detours
• To optimize resources
• To collaborate with partners
• To maximize return of investment
• To communicate stakeholders
International Association of Nanotechnology– by Lloyd L. Tran
Important factors in developing a roadmap
• What is the industry we are in?
i.e. semiconductor, chemical, biotechnology, aerospace
• What is the use of it?
i.e. A better computer chip, method to treat diseases, stronger material for
aerospace applications
• What are the obstacles?
i.e. Quantum effects at nanoscale, unknown toxicity, public acceptance
• What is the key strategy?
i.e. focusing on the beneficial applications of nanotechnology
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What are the resources?
i.e. government funding, private investment
• What is the time frame?
i.e. a 5- 10 year plan
International Association of Nanotechnology– by Lloyd L. Tran
Framework of
a Nanotechnology Roadmap
• Scientific Research
• Nano -manufacturing and commercialization
• Venture capital Investment
• Public Relations
• Societal, Ethical, Environmental & Safety Consideration
International Association of Nanotechnology– by Lloyd L. Tran
Scientific Development Factors
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Multi-disciplinary nature of nanoscience and nanotechnology
• More funding are needed to realize the full potential of nanoscience
• Limited resources are available for nano-manufacturing & production
• Need to focus on a certain list of priority of research topics, rather than
scattered resources every where.
• Need to develop internationally accepted nomenclature
• Need to develop internationally accepted standards for research
methodology
and quality control and quality assurance.
• Need to collaborate internationally, while strengthen expertise locally
International Association of Nanotechnology– by Lloyd L. Tran
Economic Factors
• Small technology-based entrepreneurial companies as a source of
innovation and generator of jobs.
• Investors shy away from applications with lengthy time periods
between R & D and market penetration.
• Small companies at risk through the “ valley of death” in funding and
the period nexus between public policy and industry realities.
• Public/Private funding i.e. Incubator facility and seed capital needed to
nurture start-up companies with promising technology
• Building an accessible labor pool of nanotechnologists and workforce
in
nanotechnology to create jobs and foster economic growth.
International Association of Nanotechnology– by Lloyd L. Tran
Public Relations Factors
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Limited public awareness of nature and potential of nanotechnology
• Public funding to date focused on R & D- Ratio of R & D to successful
product development is low
• Limited resources focusing on nano-manufacturing &
Commercialization's
• Government has not yet fully recognized barriers that could be
assisted
through increased public support
• Government support for nanotechnology innovation, i.e. FDA stamp of
approval that a discrete nanomaterial is approved for market.
• Product liability guidelines for nanotechnology to clarify ambiguity
surrounding market opportunities for nanotechnology products
International Association of Nanotechnology– by Lloyd L. Tran
Public Engagement ?
Policy/ Regulation
Scientific Framework
•Nomenclature
•Methodology
•Measurement
•Peer Reviews
•Standards
•Public Trust
•Ethical
•Societal
•Environmental
•Health Safety
Economic Framework
•Costs vs. Benefits
•Utilization
•Intellectual Property
•Value
•Profits
International Association of Nanotechnology– by Lloyd L. Tran
Challenges in developing
international nomenclature/ standards:
 Communication across multi-disciplines
 National and international geo-political differences
 Intellectual Property protection
 Confidential business information
 Lack of funding for this long term endeavor
 Concern about potential government regulations and public policy
International Association of Nanotechnology– by Lloyd L. Tran
Why International Standards are needed ?
 The Standard Project will develop interoperability specifications for
nanomaterials, devices and nanoscale structures and systems.
 To set international standards for testing methods and processes so
data is reported uniformly and results can be compared and verified
 This will help researchers, designers, manufacturers and suppliers as
well as customers to communicate effectively and harmonize best practices
worldwide.
 To optimize the manufacturing processes while ensure the trust and
confidence of customers and public at large
 Without standards the emerging field cannot grow to become an major
industry.
International Association of Nanotechnology– by Lloyd L. Tran
International nomenclature and standards in
Nanotechnology are urgently needed for
• Research laboratory
• Publication
• Patent Protection
• Communication
• Clinical study
• Manufacturing
• Commercialization
International Association of Nanotechnology– by Lloyd L. Tran
Example of some nanotechnology terms:
 “Bottom-up”
 “Top-down”
 “Wet/wet”, “wet/dry”, “dry/dry”
 Nano-scale hybrid materials
 Taxonomy of carbon nanostructured:
carbon black, diesel exhaust, filtration carbon,
C60, fullerene, single-wall carbon nanotubes,
multiwall carbon nanotubes
http://www.mb.tn.tudelft.nl/images/AnimatedTube.gif
International Association of Nanotechnology– by Lloyd L. Tran
Current Nomenclature & Standards Development Effort
 IEEE has had standard for electrical characteristics of carbon nanotubes
 IUPAC and CAS have had some nomenclature frameworks for fullerene
 American National Standard Institute (ANSI) initiated a Nanotech panel
 ASTM and ASME has recently begun metrology effort
 ISO has begun development of international standards in nanotechnology
International Association of Nanotechnology– by Lloyd L. Tran
Nanotechnology Standard Development:
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Metrology and test Methods:
Properties and characteristics of nanomaterials
Risk assessment and management
Toxicology study
Environmental impact
International Association of Nanotechnology– by Lloyd L. Tran
Nanotechnology Standards
1. Metrology and test methods:
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Aggregation
Agglomeration
Airborn concentration
Aspect ratio
Dispersivity
Hydroxylation
Zeta potential
Light scattering absorbance
Mass concentration
Surface area/ concentration
Standards for calibration
Statistical significance
and others…
International Association of Nanotechnology– by Lloyd L. Tran
Nanotechnology Standard Development:
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Metrology/measurement test methods
Properties and characteristics of nanomaterials
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naturally occurring vs. engineered particles
size, shape, morphology
surface area
porosity
solubility
magnetic
electrical
bioactive
composite, etc…
International Association of Nanotechnology– by Lloyd L. Tran
Single Wall Carbon Nanotube contains Redox-Active Iron
Source: Valerie E. Kagan, Dept. Environmental & Occupational Health, University of Pittsburgh
Nanotechnology Standard Development:
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Metrology/measurement test methods:
Properties and characteristics
Risk Assessment and management
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exposure assessment
hazard identification
dose-response assessment
risk characterization
containment procedures
threshold levels
adverse effect report
etc….
International Association of Nanotechnology– by Lloyd L. Tran
Nanotechnology Standard Development:
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Metrology/measurement test methods:
Properties and characteristics
Risk Assessment and management
Toxicology study
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bioaccumulation
bio-interaction
pathogenicity
toxic levels: ppm, ppb
acute vs chronic
in vitro vs. in vivo
by-products, metabolites, degradation products
exposure route: external, ingestion and inhalation,
animal toxicity vs. human toxicity
susceptibility: children vs. adult exposure
short-term and long term toxicity
Etc…
International Association of Nanotechnology– by Lloyd L. Tran
Nanotechnology Standard Development:
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Metrology/measurement test methods:
Properties and characteristics
Risk Assessment and management
Toxicology study
Environmental impact
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water and air quality
land and soil quality
energy conservation
pollution and life cycle
waste disposal
route of exposure
measures of exposure
distribution of hazardous waste
balanced risk/benefit evaluation
pollution prevention
Etc…
International Association of Nanotechnology– by Lloyd L. Tran
Nanoparticle Characterization :
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What are the forms in which particles are presented to host, cells and
organelles?
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What are residual solvents, processing variables, impurities and
excipients?
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What are validated assays to detect and quantify nanoparticles in in
vitro and in vivo?
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How do we determine long and short-term stability of nanomaterials?
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How do you analyze the degradation of nanoparticles
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How to maintain quality assurance in scaling-up to mass production.
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What are the reference materials and manufacturing standardization
International Association of Nanotechnology– by Lloyd L. Tran
Nanoparticle Safety
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What are the nanoparticle’ pathways inside the human body?
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How long do the nanoparticles remain in the tissues and how
are they cleared?
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What effects do nanoparticles have on cellular and tissue
functions?
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Can nanoparticles gain access to the systemic circulation from
dermal exposure? If nanoparticles enter skin cells, is there an
effect on cellular functions?
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What are unanticipated reactions in vivo?
International Association of Nanotechnology– by Lloyd L. Tran
Nanomaterial Environmental Issues:
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How to protect workers from exposure to nanoparticles?
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Following human and animal use, can nanoparticles be
released or excreted into the environment
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How to determine the extent of quantity of nanoparticle
release in the environment?
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What might the nanoparticles effect on the environment?
International Association of Nanotechnology– by Lloyd L. Tran
FDA Standard Test Methods for Biological Responses
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Guidelines for evaluating biological safety for pharmaceutical products
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Guidelines for nanoparticles are in development
International Association of Nanotechnology– by Lloyd L. Tran
Toxic Substances Control Act
15 U.S.C. s/s 2601 et seq. (1976)
 The Toxic Substances Control Act (TSCA) of 1976 was enacted by
Congress to give EPA the ability to track the 75,000 industrial chemicals
currently produced or imported into the United States.
 EPA repeatedly screens these chemicals and can require reporting or
testing of those that may pose an environmental or human-health hazard.
 EPA can ban the manufacture and import of those chemicals that pose
an unreasonable risk.
International Association of Nanotechnology– by Lloyd L. Tran
Public Engagement ?
Policy/ Regulation
Scientific Framework
•Nomenclature
•Methodology
•Measurement
•Peer Reviews
•Standards
•Public Trust
•Ethical
•Societal
•Environmental
•Health Safety
Economic Framework
•Costs vs. Benefits
•Utilization
•Intellectual Property
•Value
•Profits
International Association of Nanotechnology– by Lloyd L. Tran
Conclusion
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A priority list of scientific research topics should be developed and focused
 Nano-manufacturing and quality control/assurance to be developed to expedite
commercialization
 International nomenclature and standards are urgently needed
 Venture investment is needed for start-up nanotech companies
 Societal, safety consideration are important for public acceptance
 Public engagement should be part of the decision making process
International Association of Nanotechnology– by Lloyd L. Tran
THANK YOU !
Lloyd L. Tran
President
International Association of Nanotechnology
http://www.ianano.org
Email: [email protected]