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98 lines
4.1 KiB
TeX
98 lines
4.1 KiB
TeX
\documentclass[../Main.tex]{subfiles}
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\graphicspath{{\subfix{Assets/img/}}}
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\begin{document}
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This paper sits within an intersection of health and industrial organization economics
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that is frequently studied.
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Encouraging a strong supply of novel and generic pharmaceuticals contributes
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in important ways to both public health and fiscal policy.
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Not only to the pathway to drug approval long, as many as 90\% of compounds
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that begin human trials fail to gain approval
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(\cite{khmelnitskaya_competition_2021}).
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Complicating this is the complex regulatory and competitive environment in
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which pharmaceutical companies operate.
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%%%%%%%%% Why are drugs so expensive?
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% van der Grond, Uyle-de Groot, Pieters 2017
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% - What causes high costs of drugs?
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% - High level synthesis of discussion regarding causes
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% - Academic and non-academic sources
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%%%%%%%%%%%%%%%% What do we know about clinical trials?
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% Hwang, Carpenter, Lauffenburger, et al (2016)
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% - Why do investigational new drugs fail during late stage trials?
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\citeauthor{hwang_failure_2016} (\citeyear{hwang_failure_2016})
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investigated causes for which late stage (Phase III)
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clinical trials fail across the USA, Europe, Japan, Canada, and Australia.
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They found that for late stage trials that did not go on to recieve approval,
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57\% failed on efficacy grounds, 17\% failed on safety grounds, and 22\% failed
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on commercial or other grounds.
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For context, this current work hopes to be able to distinguish some of the
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mechanisms behind those commercial or other failures.
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% Abrantes-Metz, Adams, Metz (2004)
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% - What correlates with successfully passing clinical trials and FDA review?
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% -
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In \citeyear{abrantes-metz_pharmaceutical_2004},
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\citeauthor{abrantes-metz_pharmaceutical_2004}
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described the relationship between
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various drug characteristics and how the drug progressed through clinical trials.
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This non-causal estimate was notable for using a
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mixed state proportional hazard model and estimating the impact of
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observed characteristics in each of the three phases.
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They found that as trials last longer, the rate of failure increases for
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Phase I \& II trials, while Phase 3 trials generally have a higher rate of
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success than failure after 91 months.
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% Ekaterina Khmelnitskaya (2021)
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% - separates scientific from market failure of the clinical drug pipeline
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In her doctoral dissertation, Ekaterina Khmelnitskaya studied the transition of
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drug candidates between clinical trial phases.
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Her key contribution was to find ways to disentangle strategic exits from the
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development pipeline and exits due to clinical failures.
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She found that overall 8.4\% of all pipeline exits are due to strategic
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terminations and that the rate of new drug production would be about 23\%
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higher if those strategic terminatations were elimintated
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(\cite{khmelnitskaya_competition_2021}).
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% Waring, Arrosmith, Leach, et al (2015)
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% - Atrition of drug candidates from four major pharma companies
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% - Looked at how phisicochemical properties affected clinical failure due to safety issues
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%not in this version
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%%%%%%%%% What do we know about drug development incentives?
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% Dranov, Garthwaite, and Hermosilla (2022)
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% - does the demand-pull theory of R&D explain novel compound development?
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% - no, it is biased towards follow-on drug R&D.
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% Acemoglu and Linn
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% - Market size in innovation
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% - Exogenous demographic trends has a large impact on the entry of non-generic drugs and new molecular entitites.
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On the side of market analysis, %TODO:remove when other sections are written up.
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\citeauthor{acemoglu_market_2004}
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(\citeyear{acemoglu_market_2004})
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used exogenous deomographics changes to show that the
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entry of novel compounds is highly driven by the underlying aged population.
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They estimate that a 1\% increase in applicable demographics increase the
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entry of new drugs by 6\%, mostly concentrated among generics.
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Among non-generics, a 1\% increase in potential market size
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(as measured by demographic groups) leads to a 4\% increase in novel therapies.
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% Gupta
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% - Inperfect intellectual property rights in the pharmaceutical industry
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%\cite{GupaPhd2023}
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% Agarwal and Gaule 2022
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% - Retrospective on impact from COVID-19 pandemic
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% Not in this version
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\end{document}
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