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Nanotechnology-Based Biopharmaceutical Systems
Published in Bhupinder Singh, Om Prakash Katare, Eliana B. Souto, NanoAgroceuticals & NanoPhytoChemicals, 2018
Rajashree Gude, Sarwar Beg, Harmanjot Kaur, Teenu Sharma, Bhupinder Singh, Umesh Banakar
The scientific literature, since the advent of the principles of nanotechnology and their potential bioefficacious use in delivering drug substance, is replete with such reports over the past two decades. During the period of 2000 through 2018, it is estimated that there have been over 90 conferences, over 3000 scientific findings reported, over 1200 reports and publications, over 250 patents, and billions of dollars spent in the pursuit of developing nanotechnology-based drug-delivery systems. These reports range from feasibility studies and patent applications, as well as published patents, abstracts presented at numerous conferences and other scientific publishing formats, several theses and dissertations, and the likes. Considering such proliferation of activity in the scientific community, it has resulted in gaining improved understanding of various physical, chemical, mechanical, and mechanistic functioning of nanotechnology-enabled drug-delivery systems, that is, pharmaceutical formulations. In this process, while there is substantial creation of new knowledge, the number as well as the frequency of approved nanotechnology-based pharmaceutical systems is quite limited. It is seen that the drug substance used to formulate nanoparticulate-based pharmaceutical systems is often well-known and the processes employed for the preparation/manufacture of such formulations are also fairly common. Additionally, on a strict time-scale comparison basis, the overall time required in developing a new chemical entity (NCE) subsequent to a confirmed lead compound status to its approval to market through the various stages of safety and efficacy evaluation is over 10 years. While such a comparison may not be completely fair, time has come to assess the potential reasons for such disparity—that is, unseemingly lengthy development time spent on bringing forth successful and so-called “approvable” nanotechnology-based drug-delivery systems.
A responsibility to commercialize? Tracing academic researchers’ evolving engagement with the commercialization of biomedical research
Published in Journal of Responsible Innovation, 2019
Kelly Holloway, Matthew Herder
Participants tended to rehearse a certain compromise around commercialization, indicating that they were not completely opposed to such practices but felt they could conflict with the ‘traditional’ norms of academia, which they claimed to value. A full professor who commercializes said: It's a bit of a necessary evil but it also does have rewards at the end as well. If you are trying to get a drug into patients there's an expense associated with that depending on the size of the patient population and whether it's a new chemical entity or not […] basically you’re trying to turn your product into something that can get into the clinic and the marketplace and people aren't going to pay to get it tested and see if it's worthwhile unless there's a market for it. So it's just the way the world works right now, whether it's right or not but it's the only way to do it at this point in time.This description of a ‘necessary evil’ indicates that commercialization is not fully endorsed – it is an evil. Yet, it is also necessary – ‘the only way’ to develop a product in this professor's view. This participant appeared unknowledgeable of alternative approaches to commercialization such as ‘open science’ (Edwards et al. 2009); commercializaiton – through heavy reliance on intellectual property rights – was in his eyes the only way forward.
DNA-interaction studies of a copper(II) complex containing ceftobiprole drug using molecular modeling and multispectroscopic methods
Published in Journal of Coordination Chemistry, 2018
Nahid Shahabadi, Soraya Moradi Fili
The introduction of a new drug from initial concept to public release is a slow expensive process. Developing a new chemical entity drug and delivering it to market is estimated to take 10–17 years and cost ∼$1.8 billion [1]. Alternative strategies are therefore needed and the process of drug repositioning or repurposing, where new applications for existing drugs or drug candidates are discovered and refined, has become increasingly common. Drug repurposing can speed up access to new therapeutic options for cancer patients. With more than 2,000 drugs approved worldwide and 6 relevant targets per drug on average, the potential is quantitatively important. Hence, we propose that a more plausible and faster approach is the utilization of drugs originally developed for other purposes besides antimicrobial activity. Among these, there are some antibiotics which their most common mode of action is the inhibition of cell wall synthesis.