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Nanotoxicology and nanomedicine: making development decisions in an evolving governance environment

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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.

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References

  • 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):349–358

    Article  Google Scholar 

  • 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

  • Chen G, Roy I, Yang C, Prasad PN (2016) Nanochemistry and nanomedicine for nanoparticle-based diagnostics and therapy. Chem Rev 116(5):2826–2885

    Article  Google Scholar 

  • 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):155

    Article  Google Scholar 

  • 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):163–181

    Article  Google Scholar 

  • 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 2

  • 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

  • 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 187:133–144

    Article  Google Scholar 

  • Dhingra R, Naidu S, Upreti G, Sawhney R (2010) Sustainable nanotechnology: through green methods and life-cycle thinking. Sustainability 2(10):3323–3338

    Article  Google Scholar 

  • Elkington J (1997) Cannibals with forks: the triple bottom line of 21st century business. Capstone Publishing, Oxford

    Google Scholar 

  • 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):1–14

    Article  Google Scholar 

  • Genske A, Engel-Glatter S (2016) Rethinking risk assessment for emerging technology first-in-human trials. Med Health Care Philos 19(1):125–139

    Article  Google Scholar 

  • 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):366

    Article  Google Scholar 

  • 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 6

  • Gupta AS (2011) Nanomedicine approaches in vascular disease: a review. Nanomedicine 7(6):763–779

    Article  Google Scholar 

  • 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):2195

    Article  Google Scholar 

  • 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

    Google Scholar 

  • Hutchison JE (2016) The road to sustainable nanotechnology: challenges, progress and opportunities. ACS Sustain Chem Eng 4(11):5907–5914

    Article  Google Scholar 

  • 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

  • Lines MG (2008) Nanomaterials for practical functional uses. J Alloys Compd 449(1):242–245

    Article  Google Scholar 

  • Linkov, I., & Moberg, E. (2011) Multi-criteria decision analysis: environmental applications and case studies. CRC Press

  • Linkov, I. and Satterstrom, F.K., 2008 Nanomaterial risk assessment and risk management. In Real-time and deliberative decision making (pp. 129–157). Springer Netherlands

  • Linkov I, Satterstrom FK, Steevens J, Pleus R (2007) Multi-criteria decision analysis and nanotechnology. J Nanopart Res 9:543–554

    Article  Google Scholar 

  • Linkov I, Satterstrom FK, Corey LM (2008) Nanotoxicology and nanomedicine: making hard decisions. Nanomedicine 4(2):167–171

    Article  Google Scholar 

  • 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):5199–5205

    Article  Google Scholar 

  • 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):57–70

    Article  Google Scholar 

  • 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):155–168

    Article  Google Scholar 

  • Linkov I, Bates ME, Trump BD, Seager TP, Chappell MA, Keisler JM (2013) For nanotechnology decisions, use decision analysis. Nano Today 8(1):5–10

    Article  Google Scholar 

  • 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):740–743

    Article  Google Scholar 

  • Liu, E., Zhang, M. and Huang, Y., 2016 Pharmacokinetics and pharmacodynamics (PK/PD) of bionanomaterials. Biomedical Nanomaterials

  • Malloy, T., Trump, B. D., & Linkov, I. (2016) Risk-based and prevention-based governance for emerging materials

  • Marchant GE, Sylvester DJ, Abbott KW (2008) Risk management principles for nanotechnology. NanoEthics 2(1):43–60

    Article  Google Scholar 

  • 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)

  • Mohan M, Trump BD, Bates ME, Monica JC Jr, Linkov I (2012) Integrating legal liabilities in nanomanufacturing risk management. Environ. Sci. Technol. 46(15):7955–7962

    Article  Google Scholar 

  • Nanotechnology Characterization Laboratory, National Cancer Institute (2017). “About Us.” https://ncl.cancer.gov/about-ncl/about-us. Accessed 2 May 2017

  • 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

    Google Scholar 

  • 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)

  • 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

    Google Scholar 

  • 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. Small

  • 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):2313–2381

    Article  Google Scholar 

  • 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 1–14

  • Renn O, Roco MC (2006) Nanotechnology and the need for risk governance. J Nanopart Res 8(2):153–191

    Article  Google Scholar 

  • 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

  • Sahoo SK, Parveen S, Panda JJ (2007) The present and future of nanotechnology in human health care. Nanomedicine 3(1):20–31

    Article  Google Scholar 

  • 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 235:34–47

    Article  Google Scholar 

  • Subramanian V, Semenzin E, Hristozov D, Marcomini A, Linkov I (2014) Sustainable nanotechnology: defining, measuring and teaching. Nano Today 9(1):6–9

    Article  Google Scholar 

  • 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):23–32

    Article  Google Scholar 

  • Tong R, Kohane DS (2016) New strategies in cancer nanomedicine. Annu Rev Pharmacol Toxicol 56:41–57

    Article  Google Scholar 

  • Trump, B. D. (2017) Synthetic biology regulation and governance: lessons from TAPIC for the United States, European Union, and Singapore. Health Policy

  • 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 & Governance

  • 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_2

  • 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

  • U.S. Food and Drug Administration (2017a). “Nanotechnology programs at FDA.” https://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm. Accessed 17 Jan 2018

  • 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

  • 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

  • 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

  • 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

  • U.S. National Nanotechnology Initiative (2017). “About the NNI—NNI budget.” http://www.nano.gov/about-nni/what/funding. Accessed 2 May 2017

  • 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

  • Walters, C., Pool, E. and Somerset, V., 2016 Nanotoxicology: a review. Toxicology-New Aspects to this Scientific Conundrum 45

  • 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):7195–7206

    Article  Google Scholar 

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Authors and Affiliations

  1. Environmental Laboratory, U.S. Army Engineer Research and Development Center, 696 Virginia Road, Concord, MA, 01742, USA

    Taylor Rycroft, Benjamin Trump, Kelsey Poinsatte-Jones & Igor Linkov

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  1. Taylor Rycroft
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  2. Benjamin Trump
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  3. Kelsey Poinsatte-Jones
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  4. Igor Linkov
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Correspondence to Igor Linkov.

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Rycroft, T., Trump, B., Poinsatte-Jones, K. et al. Nanotoxicology and nanomedicine: making development decisions in an evolving governance environment. J Nanopart Res 20, 52 (2018). https://doi.org/10.1007/s11051-018-4160-3

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