Lisette Pregelj's research while affiliated with The University of Queensland and other places
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Publications (7)
We are increasingly challenged to operate within our planetary boundaries, while delivering on United Nations (UN) Sustainable Development Goal (SDG) 2030 targets, and net-zero emissions by 2050. Failure to solve these challenges risks economic, social, political, climate, food, water, and fuel security. Therefore, new, scalable, and adoptable circ...
It is well established that basic research underpins long-term innovation outputs such as transformative drugs and medical devices. However, Australia may be hobbling its long-term innovation capabilities by decreasing investment in basic research. Although there has been recent growth in our local Venture Capital and biopharmaceutical business sec...
Congress created the Breakthrough Therapy designation in 2012 to expedite drug development and review through efficient clinical trial design and intensive interaction with United States (US) Food and Drug Administration (FDA) reviewers. Yet, of the 116 pivotal trials supporting Breakthrough‐designated drugs approved 2013‐2018, 96 (83%) were alread...
Vaccine solutions rarely reach the public until after an outbreak abates; an Ebola vaccine was approved 5-years after peak outbreak and SARS, MERS, and Zika vaccines are still in clinical development. Despite massive leaps forward in rapid science, other regulatory bottlenecks are hamstringing the global effort for pandemic vaccines.
Precision medicines can benefit patients by increasing the probability of a successful treatment response in selected patient populations. The potential for more immediate signals of efficacy during clinical trials suggests such medicines will reach the market more rapidly than traditional drugs will. Using data from the Food and Drug Administratio...
Citations
... For diseases with particularly high medical demands, the effect of prolonged development on patient access is significant, and policies that expedite patient access to drugs as much as possible, while continuing to ensure their efficacy and safety, are warranted. In each country, systems, such as early approval systems [1][2][3][4] and conditional early approval systems [5][6][7], have been established, and drugs are often approved without conducting confirmatory clinical trials (waiver of confirmatory clinical trials), thus decreasing the amount of data available before a drug's approval [8]. Consequently, approval is granted on condition that clinical trials are conducted, and safety measures are adopted after drugs become commercially available. ...
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... Without the foresight of the Coalition for Epidemic Preparedness Innovations (CEPI) in investing in the basic research performed by companies such as Moderna, it is doubtful whether a novel mRNA covid vaccine candidate would have been in clinical trials within 2 months of the outbreak, a timeframe that was substantially faster than for novel vaccine candidates during other epidemics such as the 2009 H1N1 swine flu or 2014 Ebola outbreaks. 14 ...
... In the field of oncology, where the emergence of the precision medicine model has complicated the setup and execution of large and rigorously designed RCTs, regulatory agencies like EMA and FDA have resorted to granting marketing authorizations to novel anticancer agents based on their performance in relatively small trials, which may not employ randomization or feature any comparator arms at all [21]. More concretely, over the past 20 years, the FDA has approved 176 indications for such agents exclusively on the basis of insights acquired from single-arm studies [22]. ...
... For some years, the global higher education sector has been responding to declining government expenditure, rising research costs and unprecedented pressures to evolve in order to remain competitive (Hine et al., 2018). Deloitte's research identified key challenges facing the sector as rising student expectations; technology and digital innovation; globalisation; linking estates strategy and the students; attracting/retaining the best talent; rising cost; shifting funding; and sustaining research (Mercer, 2019). ...
