Nanotoxicology and nanomedicine: making development decisions in an evolving governance environment
Source abstract
Abstract
The fields of nanomedicine, risk analysis, and decision science have evolved considerably in the past decade, providing developers of nano-enabled therapies and diagnostic tools with more complete information than ever before and shifting a fundamental requisite of the nanomedical community from the need for more information about nanomaterials to the need for a streamlined method of integrating the abundance of nano-specific information into higher-certainty product design decisions. The crucial question facing nanomedicine developers that must select the optimal nanotechnology in a given situation has shifted from “how do we estimate nanomaterial risk in the absence of good risk data?” to “how can we derive a holistic characterization of the risks and benefits that a given nanomaterial may pose within a specific nanomedical application?” Many decision support frameworks have been proposed to assist with this inquiry; however, those based in multicriteria decision analysis have proven to be most adaptive in the rapidly evolving field of nanomedicine—from the early stages of the field when conditions of significant uncertainty and incomplete information dominated, to today when nanotoxicology and nano-environmental health and safety information is abundant but foundational paradigms such as chemical risk assessment, risk governance, life cycle assessment, safety-by-design, and stakeholder engagement are undergoing substantial reformation in an effort to address the needs of emerging technologies. In this paper, we reflect upon 10 years of developments in nanomedical engineering and demonstrate how the rich knowledgebase of nano-focused toxicological and risk assessment information developed over the last decade enhances the capability of multicriteria decision analysis approaches and underscores the need to continue the transition from traditional risk assessment towards risk-based decision-making and alternatives-based governance for emerging technologies.
Source: openaire · Quality: candidate unverified · Source record ↗
Research context
OpenAlex topics: Nanoparticles: synthesis and applications
SciVX discovery tags are terminology-based. OpenAlex topics are source-provided classifications.
References (61)
Show source-provided references
1. Bates ME, Grieger KD, Trump BD, Keisler JM, Plourde KJ, Linkov I (2015) Emerging technologies for environmental remediation: integrating data and judgment. Environ. Sci. Technol. 50(1):349–35810.1021/acs.est.5b03005 ↗
2. Blaunstein, R., Trump, B., & Linkov, I. (2014). Nanotechnology risk management: an insurance industry perspective. Nanotechnology Environmental Health and Safety. Risks, Regulation, and Management, 247–263
3. Chen G, Roy I, Yang C, Prasad PN (2016) Nanochemistry and nanomedicine for nanoparticle-based diagnostics and therapy. Chem Rev 116(5):2826–288510.1021/acs.chemrev.5b00148 ↗
4. Collier ZA, Kennedy AJ, Poda AR, Cuddy MF, Moser RD, MacCuspie RI, Harmon A, Plourde K, Haines CD, Steevens JA (2015) Tiered guidance for risk-informed environmental health and safety testing of nanotechnologies. J Nanopart Res 17(3):15510.1007/s11051-015-2943-3 ↗
5. Collier ZA, Trump BD, Wood MD, Chobanova R, Linkov I (2016) Leveraging stakeholder knowledge in the innovation decision making process. Int. J. Bus. Continuity Risk Manag. 6(3):163–18110.1504/IJBCRM.2016.078987 ↗
6. Conde J, Dias JT, Grazú V, Moros M, Baptista PV, de la Fuente JM (2014) Revisiting 30 years of biofunctionalization and surface chemistry of inorganic nanoparticles for nanomedicine. Frontiers in chemistry 210.3389/fchem.2014.00048 ↗
7. Cornelissen, R., Jongeneelen, F., Van Broekhuizen, P. and Van Broekhuizen, F., 2011 Guidance working safely with nanomaterials and products, the guide for employers and employees. FNV, VNO-NCV and CNV
8. Dawidczyk CM, Kim C, Park JH, Russell LM, Lee KH, Pomper MG, Searson PC (2014) State-of-the-art in design rules for drug delivery platforms: lessons learned from FDA-approved nanomedicines. J Control Release 187:133–14410.1016/j.jconrel.2014.05.036 ↗
9. Dhingra R, Naidu S, Upreti G, Sawhney R (2010) Sustainable nanotechnology: through green methods and life-cycle thinking. Sustainability 2(10):3323–333810.3390/su2103323 ↗
10. Elkington J (1997) Cannibals with forks: the triple bottom line of 21st century business. Capstone Publishing, Oxford
11. Etheridge ML, Campbell SA, Erdman AG, Haynes CL, Wolf SM, McCullough J (2013) The big picture on nanomedicine: the state of investigational and approved nanomedicine products. Nanomedicine 9(1):1–1410.1016/j.nano.2012.05.013 ↗
12. Genske A, Engel-Glatter S (2016) Rethinking risk assessment for emerging technology first-in-human trials. Med Health Care Philos 19(1):125–13910.1007/s11019-015-9660-7 ↗
13. Geraci C, Heidel D, Sayes C, Hodson L, Schulte P, Eastlake A, Brenner S (2015) Perspectives on the design of safer nanomaterials and manufacturing processes. J Nanopart Res 17(9):36610.1007/s11051-015-3152-9 ↗
14. Gopinath, P. M., Ranjani, A., Dhanasekaran, D., Thajuddin, N., Archunan, G., Akbarsha, M. A., and Padmanabhan, P. (2016) Multi-functional nano silver: a novel disruptive and theranostic agent for pathogenic organisms in real-time. Scientific reports 610.1038/srep34058 ↗
15. Gupta AS (2011) Nanomedicine approaches in vascular disease: a review. Nanomedicine 7(6):763–77910.1016/j.nano.2011.04.001 ↗
16. Hansen SF, Jensen KA, Baun A (2014) NanoRiskCat: a conceptual tool for categorization and communication of exposure potentials and hazards of nanomaterials in consumer products. J Nanopart Res 16(1):219510.1007/s11051-013-2195-z ↗
17. Höck J, Epprecht T, Furrer E, Hofmann H, Höhner K, Krug H, Lorenz C, Limbach L, Gehr P, Nowack B, Riediker M, Schirmer K, Schmid B, Som C, Stark W, Studer C, Ulrich A, von Götz N, Weber A, Wengert S, Wick P (2011) Guidelines on the precautionary matrix for synthetic nanomaterials. Federal Office of Public Health and Federal Office for the Environment, Berne Version 2.1
18. Hutchison JE (2016) The road to sustainable nanotechnology: challenges, progress and opportunities. ACS Sustain Chem Eng 4(11):5907–591410.1021/acssuschemeng.6b02121 ↗
19. Knowles III, E.E., 2005. Emerging health, safety and environmental issues associated with nanotechnology. In ASSE Professional Development Conference and Exposition. American Society of Safety Engineers
20. Lines MG (2008) Nanomaterials for practical functional uses. J Alloys Compd 449(1):242–24510.1016/j.jallcom.2006.02.082 ↗
21. Linkov, I., & Moberg, E. (2011) Multi-criteria decision analysis: environmental applications and case studies. CRC Press10.1201/b11471 ↗
22. Linkov, I. and Satterstrom, F.K., 2008 Nanomaterial risk assessment and risk management. In Real-time and deliberative decision making (pp. 129–157). Springer Netherlands10.1007/978-1-4020-9026-4_8 ↗
23. Linkov I, Satterstrom FK, Steevens J, Pleus R (2007) Multi-criteria decision analysis and nanotechnology. J Nanopart Res 9:543–55410.1007/s11051-007-9211-0 ↗
24. Linkov I, Satterstrom FK, Corey LM (2008) Nanotoxicology and nanomedicine: making hard decisions. Nanomedicine 4(2):167–17110.1016/j.nano.2008.01.001 ↗
25. Linkov I, Loney D, Cormier S, Satterstrom FK, Bridges T (2009) Weight-of-evidence evaluation in environmental assessment: review of qualitative and quantitative approaches. Sci Total Environ 407(19):5199–520510.1016/j.scitotenv.2009.05.004 ↗
26. Linkov I, Trump BD, Pabon N, Collier ZA, Keisler JM, Scriven J (2012a) A decision analytic approach for Department of Defense acquisition risk management. Mil Oper Res 17(2):57–7010.5711/1082598317257 ↗
27. Linkov I, Rosoff H, Valverde LJ, Bates ME, Trump B, Friedman D, Keisler J (2012b) Civilian response corps force review: the application of multi-criteria decision analysis to prioritize skills required for future diplomatic missions. J Multi-Criteria Decis Anal 19(3–4):155–16810.1002/mcda.1468 ↗
28. Linkov I, Bates ME, Trump BD, Seager TP, Chappell MA, Keisler JM (2013) For nanotechnology decisions, use decision analysis. Nano Today 8(1):5–1010.1016/j.nantod.2012.10.002 ↗
29. Linkov I, Trump BD, Wender BA, Seager TP, Kennedy AJ, Keisler JM (2017) Integrate life-cycle assessment and risk analysis results, not methods. Nat Nanotechnol 12(8):740–74310.1038/nnano.2017.152 ↗
30. Liu, E., Zhang, M. and Huang, Y., 2016 Pharmacokinetics and pharmacodynamics (PK/PD) of bionanomaterials. Biomedical Nanomaterials10.1002/9783527694396.ch1 ↗
31. Malloy, T., Trump, B. D., & Linkov, I. (2016) Risk-based and prevention-based governance for emerging materials10.1021/acs.est.6b02550 ↗
32. Marchant GE, Sylvester DJ, Abbott KW (2008) Risk management principles for nanotechnology. NanoEthics 2(1):43–6010.1007/s11569-008-0028-9 ↗
33. Marchant, G.E., Sylvester, D.J., Abbott, K.W. and Danforth, T.L., 2009 International harmonization of regulation of nanomedicine. Studies in Ethics, Law, and Technology 3(3)10.2202/1941-6008.1120 ↗
34. Mohan M, Trump BD, Bates ME, Monica JC Jr, Linkov I (2012) Integrating legal liabilities in nanomanufacturing risk management. Environ. Sci. Technol. 46(15):7955–796210.1021/es3003266 ↗
35. Nanotechnology Characterization Laboratory, National Cancer Institute (2017). “About Us.” https://ncl.cancer.gov/about-ncl/about-us . Accessed 2 May 2017
36. National Research Council Committee on the Institutional Means for Assessment of Risks to Public Health (1983) Risk assessment in the federal government: managing the process. National Academies Press, Washington
37. Ostiguy, C., Riediker, M., Triolet, J., Troisfontaines, P. and Vernez, D., 2010 Development of a specific control banding tool for nanomaterials. French Agency for food, environmental and occupational health and safety (ANSES)
38. Paik SY, Zalk DM, Swuste P (2008) Application of a pilot control banding tool for risk level assessment and control of nanoparticle exposures. Ann Occup Hyg 52(6):419–428
39. Paluri, S.L., Ryan, J.D., Lam, N.H., Nepal, D. and Sizemore, I.E., 2017 Analytical-based methodologies for examining the in vitro absorption, distribution, metabolism, and elimination (ADME) of silver nanoparticles. Small10.1002/smll.201603093 ↗
40. Pelaz B, Alexiou C, Alvarez-Puebla RA, Alves F, Andrews AM, Ashraf S, Balogh LP, Ballerini L, Bestetti A, Brendel C, Bosi S (2017) Diverse applications of nanomedicine. ACS Nano 11(3):2313–238110.1021/acsnano.6b06040 ↗
41. Ragelle, H., Danhier, F., Préat, V., Langer, R. and Anderson, D.G., 2016 Nanoparticle-based drug delivery systems: a commercial and regulatory outlook as the field matures. Expert Opinion on Drug Delivery 1–1410.1080/17425247.2016.1244187 ↗
42. Renn O, Roco MC (2006) Nanotechnology and the need for risk governance. J Nanopart Res 8(2):153–19110.1007/s11051-006-9092-7 ↗
43. Rycroft, T., Larkin, S., Ganin, A., Thomas, T., Matheson, J., Van Grack, T., Chen, X., Plourde, K., and Linkov, I, (in preparation) A framework and pilot tool for the risk-based prioritization of nano-enabled consumer products
44. Sahoo SK, Parveen S, Panda JJ (2007) The present and future of nanotechnology in human health care. Nanomedicine 3(1):20–3110.1016/j.nano.2006.11.008 ↗
45. Saraiva C, Praça C, Ferreira R, Santos T, Ferreira L, Bernardino L (2016) Nanoparticle-mediated brain drug delivery: overcoming blood–brain barrier to treat neurodegenerative diseases. J Control Release 235:34–4710.1016/j.jconrel.2016.05.044 ↗
46. Subramanian V, Semenzin E, Hristozov D, Marcomini A, Linkov I (2014) Sustainable nanotechnology: defining, measuring and teaching. Nano Today 9(1):6–910.1016/j.nantod.2014.01.001 ↗
47. Thomas K, Aguar P, Kawasaki H, Morris J, Nakanishi J, Savage N (2006) Research strategies for safety evaluation of nanomaterials, part VIII: international efforts to develop risk-based safety evaluations for nanomaterials. Toxicol Sci 92(1):23–3210.1093/toxsci/kfj211 ↗
48. Tong R, Kohane DS (2016) New strategies in cancer nanomedicine. Annu Rev Pharmacol Toxicol 56:41–5710.1146/annurev-pharmtox-010715-103456 ↗
49. Trump, B. D. (2017) Synthetic biology regulation and governance: lessons from TAPIC for the United States, European Union, and Singapore. Health Policy10.1016/j.healthpol.2017.07.010 ↗
50. Trump, B., Cummings, C., Kuzma, J., & Linkov, I. (2017a) A decision analytic model to guide early-stage government regulatory action: applications for synthetic biology. Regulation & Governance10.1111/rego.12142 ↗
51. Trump, B. D., Pabon, N., Barber, M., Hartz, R., Linkov, F., & Linkov, I. (2017b) Risk assessment and decision analysis within surgical applications. In Gastrointestinal operations and technical variations (pp. 7–17). Springer, Berlin, Heidelberg. doi: https://doi.org/10.1007/978-3-662-49878-1_210.1007/978-3-662-49878-1_2 ↗
52. U.S. Food and Drug Administration (2016). “Considering whether an FDA-regulated product involves the application of nanotechnology.” https://www.fda.gov/aboutfda/transparency/basics/ucm269834.htm . Accessed 2 May 2017
53. U.S. Food and Drug Administration (2017a). “Nanotechnology programs at FDA.” https://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm . Accessed 17 Jan 2018
54. U.S. Food and Drug Administration (2017b). “How FDA evaluates regulated products: drugs.” https://www.fda.gov/aboutfda/transparency/basics/ucm269834.htm . Accessed 2 May 2017
55. U.S. National Institute for Occupational Safety and Health (2016). “Prevention through design: program mission.” https://www.cdc.gov/niosh/topics/ptd/ . Accessed 31 Aug 2016
56. U.S. National Institute for Occupational Safety and Health (2017a). “ Current Intelligence Bulletin 63: Occupational Exposure to Titanium Dioxide .” https://www.cdc.gov/niosh/docs/2011-160/pdfs/2011-160.pdf . Accessed 2 May 2017
57. U.S. National Institute for Occupational Safety and Health (2017b). “ Current Intelligence Bulletin 65 : Occupational Exposure to Carbon Nanotubes and Nanofibers.” https://www.cdc.gov/niosh/docs/2013-145/pdfs/2013-145.pdf . Accessed 2 May 2017
58. U.S. National Nanotechnology Initiative (2017). “About the NNI—NNI budget.” http://www.nano.gov/about-nni/what/funding . Accessed 2 May 2017
59. U.S. Occupational Safety and Health Administration (2017). “Working safely with nanomaterials—current occupational exposure limits for nanomaterials.” https://www.osha.gov/Publications/OSHA_FS-3634.html . Accessed 2 May 2017
60. Walters, C., Pool, E. and Somerset, V., 2016 Nanotoxicology: a review. Toxicology-New Aspects to this Scientific Conundrum 4510.5772/64754 ↗
61. Wang J, Mao W, Lock LL, Tang J, Sui M, Sun W, Cui H, Xu D, Shen Y (2015) The role of micelle size in tumor accumulation, penetration, and treatment. ACS Nano 9(7):7195–720610.1021/acsnano.5b02017 ↗