PMC:7784828 / 8489-14239 JSONTXT 3 Projects

Annnotations TAB TSV DIC JSON TextAE

Id Subject Object Predicate Lexical cue
T81 0-2 Sentence denotes 3.
T82 4-58 Sentence denotes Challenges facing the current drug development process
T83 59-159 Sentence denotes The lack of ample effective and affordable medicines is one of the vexing challenges faced globally.
T84 160-303 Sentence denotes It is imperative to generate novel treatment strategies, however, fair pricing and quick access to medicines remain a massive global challenge.
T85 304-435 Sentence denotes Chronic shortages and rising demands for critical drugs affect patient community with many dying from easily curable diseases [24].
T86 436-613 Sentence denotes To a large extent, present day drug development and discovery is controlled oftentimes by private entities which are driven by vested economic interests and boundary conditions.
T87 614-764 Sentence denotes This leads to the burden trickling down to patients, their families and carers either through lack of effective medicines or mounting financial costs.
T88 765-1002 Sentence denotes Addressing these global issues is the need of the hour and a plausible solution could be devising new tools and technologies, novel methodological approaches, and infrastructural changes to streamline the drug discovery review processes.
T89 1003-1140 Sentence denotes On the other hand, the desperate need for new effective drugs raises a concern over the efficacy of many of the currently marketed drugs.
T90 1141-1332 Sentence denotes A study examining efficacy of solid tumors therapies approved by the FDA between 2002 and 2014, found only 30 out of 71 therapies (42%) to have modest clinically meaningful improvements [25].
T91 1333-1434 Sentence denotes Sluggish data sharing and irreproducibility of published research remains as another major challenge.
T92 1435-1587 Sentence denotes A 2016 survey of 1,576 researchers by the journal Nature found that over 70% of researchers have failed to reproduce other scientist’s experiments [26].
T93 1588-1784 Sentence denotes The challenges in drug discovery and development for academics, research communities, and pharma industries needed for successful drug development can be broken down to cost, risk as well as pace.
T94 1786-1790 Sentence denotes 3.1.
T95 1792-1805 Sentence denotes Cost and risk
T96 1806-1961 Sentence denotes The amount spent to develop an individual drug largely depends on the costs to conduct safety and efficacy studies and also to secure regulatory approvals.
T97 1962-2080 Sentence denotes Estimates for the cost for Drug development range from ~ 1 billion to whopping 11.8 billion for a single drug [27,28].
T98 2081-2198 Sentence denotes However, around 90% of drugs in development for human use do not reach the market due to safety or efficacy concerns.
T99 2199-2306 Sentence denotes Such failures can be due to lack of efficacy, safety issues, or a lack of funding to complete a trial [29].
T100 2307-2570 Sentence denotes In other cases, failing to maintain good manufacturing protocols and follow FDA guidance, as well as problems with patient recruitment, enrollment, retention and follow up can all compound to both complicate and increase the cost needed for drug development [29].
T101 2571-2765 Sentence denotes Given this mounting cost with little success due to high attrition rates, it is obvious that the drug development as a business model is very risky purely from an economical and financial sense.
T102 2766-2989 Sentence denotes Aside from the high cost/high attrition rates nature of the drug discovery process, other drugs, like antibiotics or orphan drugs, are often abandoned and don’t reach the market due to little or no commercial interest [30].
T103 2991-2995 Sentence denotes 3.2.
T104 2997-3001 Sentence denotes Pace
T105 3002-3146 Sentence denotes The process of drug research and development is extremely slow taking at least 7 to 10 years for a lead candidate to reach the marketplace [28].
T106 3147-3302 Sentence denotes This is mainly due to the rigorous process needed to ensure safety and efficacy through clinical human trial and as well as obtaining regulatory approvals.
T107 3303-3410 Sentence denotes Duplication and reproducibility are other factors that also contributes to the slow pace of drug discovery.
T108 3411-3636 Sentence denotes While duplication and reproducibility can be seen as a squander of time and resources, they remain essential to provide more data and evidence and ensure the safety and efficiency before they are prescribed to the population.
T109 3637-3883 Sentence denotes The devastating malformations of children born to women prescribed ‘Thalidomide’, to treat morning sickness is a stark reminder of the important of independent rigorous evaluation of a drug’s safety profile before its release for population [31].
T110 3884-4075 Sentence denotes A more recent example, hydroxychloroquine as a treatment for COVID-19, highlights the importance of multiple and independent studies needed to demonstrate a drug’s safety and efficiency [32].
T111 4076-4277 Sentence denotes Other factors include, suboptimal collaboration or lack of meaningful collaborative efforts among academia, industry, and government institutions despite several effort to encourage collaboration [33].
T112 4278-4418 Sentence denotes This have led, on many instances, to academics and pharma sectors working on similar ideas in parallel, in secret, and often in competition.
T113 4419-4585 Sentence denotes Therefore, the establishment of a trusted and fair framework of collaboration and data sharing can both speed up the pace and improve the outcome of successful drugs.
T114 4587-4591 Sentence denotes 3.2.
T115 4593-4625 Sentence denotes Limitations and more of the same
T116 4626-4760 Sentence denotes A large number of drugs approved by the FDA in the past 10 years are new formulations of existing drugs referred to as ‘me too drugs’.
T117 4761-4950 Sentence denotes While in some cases these drugs have offered some improvements over older versions, in many cases improvements remain marginal with slight changes in side effects or activity profiles [34].
T118 4951-5098 Sentence denotes Since these drugs have identical mechanism of action to older versions their innovative value and overall benefit is oftentimes insignificant [35].
T119 5099-5211 Sentence denotes Additionally, the molecular effects of several marketed drugs remain unknown despite their proven effectiveness.
T120 5212-5352 Sentence denotes For example, acetaminophen is used by millions to treat mild to moderate pain while lithium is a first-line treatment for biopolar disorder.
T121 5353-5431 Sentence denotes Yet the exact molecular target and mechanism of action remain unknown [36,37].
T122 5432-5568 Sentence denotes Many diseases particularly those affect the nervous system like Alzheimer, Parkinson’s, and depression lack accurate biomarkers [38,39].
T123 5569-5750 Sentence denotes While progress is being made, the lack of reliable biomarkers remains another impediment for the accurate diagnosis, prognosis and effective drug development against these diseases.