The use of objective oriented project planning tools for nanosafety and health concerns: a case study in nanomedicine research project
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Mohammad-Reza Nejadmoghaddam
Mohammad-Reza Nejadmoghaddam received his BSc and MSc degrees in Microbiology from Azad University – Tonekabon (1999) and Jahrom Branches (2006), respectively. Since January 2012, he has been a PhD candidate in Nanomedicine at Nanotechnology Research Center, School of Pharmacy, Tehran university of Medical Sciences (TUMS). His PhD thesis is focused on nanomedicine investigating a new generation of antibody-drug conjugates (ADCs). Nejadmoghaddam’s professional life started in 2001 as a microbiologist in the Department of Medical Diagnostics and Biological Products affiliated to ACECR and he was promoted as an academic faculty member to the Nanobiotechnology Research Center at Avicenna Research Institute (ARI),
http://www.ari.ir , in 2006. He also trained in project management theory and the management of research projects in his PhD course and currently is working as a manager of central research laboratories of the ARI.Abdolreza Babamahmoodi received his MD from Shiraz University of Medical Sciences (2000) and studied Psychiatry at University Putra Malaysia (UPM) (2005) and obtained a PhD in Health Services (research and technology in health systems) from Walden University (2012). He joined Baqiyatallah University of Medical Sciences (BMSU) in Iran as an Assistant Professor in 2013. His research interest includes but is not limited to research in medical sciences, health systems, project management and modeling.
Arash Minai-Tehrani is an Assistant Professor at the Avicenna Research Institute, Tehran, IRAN. He received his BS from Azad University in Tehran and his MS and PhD from South Korea. His personal research interests include cancer and gene therapy to find a new method for targeted cancer therapy, risk and reliability, and project management.
Amir-Hassan Zarnani is a Professor in Immunology. He earned his doctoral degree in Medical Laboratory Sciences from Shahid Beheshti University of Medical Sciences of Iran (1993) and his PhD from Tarbiat Modares University (2004). His main focus of interest is using the inspiration of reproductive immunology to discover novel modalities for cancer immunotherapy. He is director of Nanobiotechnology Research Center affiliated to Avicenna Research Institute.
Rassoul Dinarvand, received his PharmD from the University of Tehran in 1988. He then successfully completed his MSc in 1990 and his PhD in 1993 in the field of Controlled Drug Delivery Systems at the University of Manchester, UK. He then joined Faculty of Pharmacy, Tehran University of Medical Sciences in 1994 as a faculty member. He was promoted to full professorship in Pharmaceutics in 2005. He was the Dean of the Faculty of Pharmacy at Tehran University of Medical Sciences in 2009 for 4 years. Prof Dinarvand has been active in pharmaceutical administration in both industry and government. He has also been involved in pharmacoeconomy and national drug policy research. However, his main research interest is in the area of polymeric controlled drug delivery systems and he has published over 200 international papers in this field. In recent years he has focused on the design and application of nano-structures as targeted drug delivery systems mainly in the field of cancer treatment. He is the founder and director of the Nanotechnology Research Centre, Tehran University of Medical Sciences. His list of publication can be found at:
http://scholar.google.com/citations?user=FF109UoAAAAJ https://www.researchgate.net/profile/Rassoul_Dinarvand/ 
Abstract
Potential human health and environmental risks associated with nanoscience research projects and their deliverables, termed nanosafety, is one of the important issues for translating research findings into commercially viable products. This paper examined the applicability of project management tools to address nanosafety in an efficient manner. Using objectives oriented project planning (OOPP) we describe a new integrated content of the problem tree, the result tree, and the logical framework approach (LFA), by modeling our nanomedicine research project entitled “Nanomedicine preparation based on antibody drug conjugate (ADC)” as a case study. As a main result of the case study, we demonstrated an LFA matrix that highlights the need to deal with nanosafety as an activity of the research project. Consequently, the activity can lead to the output, standing operating procedure (SOP), for managing the project waste disposals and its deliverables side effects. In general, such output can be concluded as an important output for all nanoscience research projects to avoid underestimating risks for their nano-objects. Moreover, this article is written in the hope of providing an easy-to-understand template of project management tools for novice nanomedicine researchers who aim to apply OOPP in the design of their research projects.
About the authors
Mohammad-Reza Nejadmoghaddam received his BSc and MSc degrees in Microbiology from Azad University – Tonekabon (1999) and Jahrom Branches (2006), respectively. Since January 2012, he has been a PhD candidate in Nanomedicine at Nanotechnology Research Center, School of Pharmacy, Tehran university of Medical Sciences (TUMS). His PhD thesis is focused on nanomedicine investigating a new generation of antibody-drug conjugates (ADCs). Nejadmoghaddam’s professional life started in 2001 as a microbiologist in the Department of Medical Diagnostics and Biological Products affiliated to ACECR and he was promoted as an academic faculty member to the Nanobiotechnology Research Center at Avicenna Research Institute (ARI), http://www.ari.ir, in 2006. He also trained in project management theory and the management of research projects in his PhD course and currently is working as a manager of central research laboratories of the ARI.
Abdolreza Babamahmoodi received his MD from Shiraz University of Medical Sciences (2000) and studied Psychiatry at University Putra Malaysia (UPM) (2005) and obtained a PhD in Health Services (research and technology in health systems) from Walden University (2012). He joined Baqiyatallah University of Medical Sciences (BMSU) in Iran as an Assistant Professor in 2013. His research interest includes but is not limited to research in medical sciences, health systems, project management and modeling.
Arash Minai-Tehrani is an Assistant Professor at the Avicenna Research Institute, Tehran, IRAN. He received his BS from Azad University in Tehran and his MS and PhD from South Korea. His personal research interests include cancer and gene therapy to find a new method for targeted cancer therapy, risk and reliability, and project management.
Amir-Hassan Zarnani is a Professor in Immunology. He earned his doctoral degree in Medical Laboratory Sciences from Shahid Beheshti University of Medical Sciences of Iran (1993) and his PhD from Tarbiat Modares University (2004). His main focus of interest is using the inspiration of reproductive immunology to discover novel modalities for cancer immunotherapy. He is director of Nanobiotechnology Research Center affiliated to Avicenna Research Institute.
Rassoul Dinarvand, received his PharmD from the University of Tehran in 1988. He then successfully completed his MSc in 1990 and his PhD in 1993 in the field of Controlled Drug Delivery Systems at the University of Manchester, UK. He then joined Faculty of Pharmacy, Tehran University of Medical Sciences in 1994 as a faculty member. He was promoted to full professorship in Pharmaceutics in 2005. He was the Dean of the Faculty of Pharmacy at Tehran University of Medical Sciences in 2009 for 4 years. Prof Dinarvand has been active in pharmaceutical administration in both industry and government. He has also been involved in pharmacoeconomy and national drug policy research. However, his main research interest is in the area of polymeric controlled drug delivery systems and he has published over 200 international papers in this field. In recent years he has focused on the design and application of nano-structures as targeted drug delivery systems mainly in the field of cancer treatment. He is the founder and director of the Nanotechnology Research Centre, Tehran University of Medical Sciences. His list of publication can be found at: http://scholar.google.com/citations?user=FF109UoAAAAJhttps://www.researchgate.net/profile/Rassoul_Dinarvand/
Acknowledgments
The project entitled “Nanomedicine preparation based on ADC” is supported by the Nanotechnology Research Center, Faculty of Pharmacy, Tehran University of Medical Sciences (TUMS) (grant no. 92-03-159-25467) in framework of the PhD program. The authors would like to thank Tehran University of Medical Sciences for financial support and declare no conflict of interest in this research work. We also would like to thank Dr. Roya Ghods from the Monoclonal Antibody Research Center (MARC) for her helpful suggestions regarding the original manuscript.
Conflict of interest statement: Authors state no conflict of interest. All authors have read the journal’s publication ethics and publication malpractice statement available at the journal’s website and hereby confirm that they comply with all its parts applicable to the present scientific work.
References
1. Sanhai WR, Sakamoto JH, Canady R, Ferrari M. Seven challenges for nanomedicine. Nat Nanotechnol 2008;3:242–4.10.1038/nnano.2008.114Search in Google Scholar PubMed
2. Bremer-Hoffmann S, Amenta V, Rossi F. Nanomedicines in the European translational process. Eur J Nanomed 2015;7:191–202.10.1515/ejnm-2015-0027Search in Google Scholar
3. PourGashtasbi G. Nanotoxicology and challenges of translation. Nanomedicine 2015;10:3121–9.10.2217/nnm.15.131Search in Google Scholar PubMed
4. Sweeney AE. Nanomedicine concepts in the general medical curriculum: initiating a discussion. Int J Nanomed 2015;10:7319.10.2147/IJN.S96480Search in Google Scholar PubMed PubMed Central
5. Fontaine O, Boskovic B, Ge Y. Nanomedicine as a business venture. In: Yi Ge, Songjun Li, Shenqi Wang, Richard Moore, editors. Nanomedicine. Berlin: Springer, 2014:305–19.10.1007/978-1-4614-2140-5_14Search in Google Scholar
6. Morigi V, Tocchio A, Bellavite Pellegrini C, Sakamoto JH, Arnone M, Tasciotti E. Nanotechnology in medicine: from inception to market domination. J Drug Deliv 2012;2012:389485.10.1155/2012/389485Search in Google Scholar PubMed PubMed Central
7. Date AA, Patil RR, Panicucci R, Souto EB, Lee R. Translating nanotechnology from bench to pharmaceutical market: barriers, success, and promises. J Drug Deliv 2012;2012:678910.10.1155/2012/678910Search in Google Scholar PubMed PubMed Central
8. Reid SE, De Brentani U. Market vision and market visioning competence: impact on early performance for radically new, high-tech products. J Prod Innovat Manag 2010;27:500–18.10.1111/j.1540-5885.2010.00732.xSearch in Google Scholar
9. Venditto VJ, Szoka Jr FC. Cancer nanomedicines: so many papers and so few drugs! Adv Drug Deliv Rev 2013;65:80–8.10.1016/j.addr.2012.09.038Search in Google Scholar PubMed PubMed Central
10. Bystrzejewska-Piotrowska G, Jerzy Golimowskib PL. Nanoparticles: their potential toxicity, waste and environmental management. Waste Manag 2009;29:2587–95.10.1016/j.wasman.2009.04.001Search in Google Scholar PubMed
11. Eaton MA, Levy L, Fontaine OM. Delivering nanomedicines to patients: a practical guide. Nanomedicine 2016;11:983–92.10.1016/j.nano.2015.02.004Search in Google Scholar
12. Gajewicz A, Rasulev B, Dinadayalane TC, Urbaszek P, Puzyn T, Leszczynska D, et al. Advancing risk assessment of engineered nanomaterials: application of computational approaches. Adv Drug Deliv Rev 2012;64:1663–93.10.1016/j.addr.2012.05.014Search in Google Scholar
13. Goudarzi S, Babamahmoodi SA, Farhadi M, Kamrava SK, Mobarrez F. Nano technology risks: a 10-step risk management model in nanotechnology projects. Hypothesis 2013;1:4.Search in Google Scholar
14. Maynard AD. Nanotechnology: assessing the risks. Nano Today 2006;1:22–33.10.1016/S1748-0132(06)70045-7Search in Google Scholar
15. Posner JD. Engineered nanomaterials: where they go, nobody knows. Nano Today 2009;4:114–5.10.1016/j.nantod.2009.01.001Search in Google Scholar
16. Singh S, Nalwa HS. Nanotechnology and health safety-toxicity and risk assessments of nanostructured materials on human health. J Nanosci Nanotechnol 2007;7:3048–70.10.1166/jnn.2007.922Search in Google Scholar PubMed
17. Vorup-Jensen T, Peer D. Nanotoxicity and the importance of being earnest. Adv Drug Deliv Rev 2012;64:1661–2.10.1016/j.addr.2012.09.002Search in Google Scholar PubMed
18. Yildirimer L, Thanh NT, Loizidou M, Seifalian AM. Toxicology and clinical potential of nanoparticles. Nano Today 2011;6:585–607.10.1016/j.nantod.2011.10.001Search in Google Scholar PubMed PubMed Central
19. Paez-Aviles C. Innovation ecosystems and market challenges in Nanobiotechnology and Nanomedicine: A multi-KET analysis within Horizon 2020. 15th edition of Trends in Nanotechnology International Conference TNT2014 2014.Search in Google Scholar
20. Couillard J, Garon S, Riznic J. The logical framework approach-millennium. Proj Manag J 2009;40:31–44.10.1002/pmj.20117Search in Google Scholar
21. Sartorius RH. The logical framework approach to project design and management. Eval Pract 1991;12:139–47.10.1177/109821409101200204Search in Google Scholar
22. Project Management I. A guide to the project management body of knowledge: (PMBOK® Guide). 4th ed. Project Management Institute: 2008.Search in Google Scholar
23. Ehteram H, Sharif-Alhoseini M. Designing trauma registry system using a logical frame-work approach. Chin J Traumatol 2013;16:316–8.Search in Google Scholar
24. Lakhoua MN. Refining the objectives oriented project planning (OOPP) into method of informational analysis by objectives. Int J Phys Sci 2011;6:7550–6.Search in Google Scholar
25. Lakhoua MN, Khanchel F. Overview of the methods of modeling and analyzing for the medical framework. Sci Res Essays 2011;6:3942–8.10.5897/SRE10.555Search in Google Scholar
26. Attarzadeh I, Ow SH. Modern project management: essential skills and techniques. Communicat IBIMA 2008;2:1–9.Search in Google Scholar
27. Pons D. Project management for new product development. Proj Manag J 2008;39:82–97.10.1007/978-3-319-05915-0_15Search in Google Scholar
28. Kaur S. Bioanalysis special focus issue on antibody-drug conjugates. Bioanalysis 2013;5:981–3.10.4155/bio.13.68Search in Google Scholar PubMed
29. Panowksi S, Bhakta S, Raab H, Polakis P, Junutula JR. Site-specific antibody drug conjugates for cancer therapy. MAbs 2014;6:34.10.4161/mabs.27022Search in Google Scholar PubMed PubMed Central
30. Sievers EL, Senter PD. Antibody-drug conjugates in cancer therapy. Annu Rev Med 2013;64:15–29.10.1146/annurev-med-050311-201823Search in Google Scholar PubMed
31. Widdison WC, Chari RV. Factors involved in the design of cytotoxic payloads for antibody-drug conjugates. In: Gail Lewis Phillips, editor. Antibody-Drug Conjugates and Immunotoxins. Berlin: Springer, 2013:93–115.10.1007/978-1-4614-5456-4_6Search in Google Scholar
32. Chari RV. Targeted cancer therapy: conferring specificity to cytotoxic drugs. Acc Chem Res 2008;41:98–107.10.1021/ar700108gSearch in Google Scholar PubMed
33. Lammers T, Hennink WE, Storm G. Tumour-targeted nanomedicines: principles and practice. Br J Cancer 2008;99:392–7.10.1038/sj.bjc.6604483Search in Google Scholar PubMed PubMed Central
34. Sengupta S, Kulkarni A. Design principles for clinical efficacy of cancer nanomedicine: a look into the basics. ACS Nano 2013;7:2878–82.10.1021/nn4015399Search in Google Scholar PubMed PubMed Central
35. Ortengren K. The Logical framework approach: a summary of the theory behind the LFA method. Sida 2003. 2004.Search in Google Scholar
36. Parsons J, Gokey C, Thornton M. Indicators of inputs, activities, outputs, outcomes and impacts in security and justice programming. Vera Institute of Justice, 2013.Search in Google Scholar
Supplemental Material:
The online version of this article (DOI: 10.1515/ejnm-2015-0050) offers supplementary material, available to authorized users.
©2016 Walter de Gruyter GmbH, Berlin/Boston
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Articles in the same Issue
- Frontmatter
- In this issue
- Guest Editorial
- Nanomaterials for medicine: benefits and risks
- Original Articles
- Synthesis and surface characterization of nanosized Y2O3:Eu and YAG:Eu luminescent phosphors which are useful in photodynamic therapy of cancer
- Benzyldimethyl[3-(miristoylamino)-propyl]ammonium chloride stabilized silver nanoparticles (Argumistin™) in medicine: results of clinical trials for treatment of infectious diseases of dogs and perspectives for humans
- Preparation of electroconductive aluminum-silicon oxide ceramic sensors modified with silver and bismuth nanoparticles
- Exposure of nano- and ultrafine Ni particles to synthetic biological solutions: predicting fate-related dissolution and accumulation
- Regular contributions
- Original Article
- Exposure to bleomycin nanoaerosol does not induce fibrosis in mice
- Short Communications
- The use of objective oriented project planning tools for nanosafety and health concerns: a case study in nanomedicine research project
- Crede’s method in eye water finds a nanomedicine base: a potential candidate to control ophthalmia neonatorum
