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86 lines
4.3 KiB
TeX
86 lines
4.3 KiB
TeX
\documentclass[../Main.tex]{subfiles}
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\graphicspath{{\subfix{Assets/img/}}}
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\begin{document}
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Developing new, effective pharmaceutical compounds is a fundamentally difficult task.
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Starting with challenges identifying promising treatment targets and potential compounds, to ensuring the drug can be properly delivered within the body, the scientific work that needs to go well is massive.
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The regulatory and market conditions in which they exist add to this difficulty.
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For example, regulations are designed to reduce the number of drugs released to market
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with significan issues, such as in the case of VIOXX \cite{krumholz_whathavewe_2007}
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or the Perdue Pharma scandal \cite{officepublicaffairsjusticedepartment_2020}.
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These regulations, such as clinical trial standards \todo{add citation to clinical trials here},
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increase the costs of developing new drugs, adding to the business conserns already present, including
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competitors already in the market or close to entering and the overall demand to address a given condition.
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This work is the first that endeavors to separate the causal effect
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of an operational concern (participant enrollment) from that of strategic
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concerns (market size and competitors in the market)
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on individual clinical trials.
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%begin discussing failures
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%I am thinking I'll discuss marketing and operational failures
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%I somehow need to step away from the drug development framing and soften it to ... what? drug investigation?
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Understanding both why and how the development of drugs fail -- for both
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novel and derivative pharmaceuticals -- is key to ensuring that both innovation
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and availability are maximized.
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There are myriad of reasons that a drug candidate may not make it to market,
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regardless of it's novelty or known safety.
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These reasons for failure generally fall into one of the following categories:
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\begin{itemize}
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\item Scientific concerns arise while asking the question
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%Whether or not the drug is sufficiently safe and
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%efficatious for the disease it is trying to treat i.e.
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``Will the drug work for patients?''
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%E.Khm, Gupta, etc.
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\item Strategic concerns ask:
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%Whether or not the drug will be profitiable, or align with
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%the drug developer's future Research \& Development directions i.e.
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``Will producing the drug be beneficial to the
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company in the long term?''
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%E.Khm, Gupta, GLP-1s, etc.
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\item Operational concerns are answers to:
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%Whether or not the developer can successfully conduct
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%operations to meet scientific or strategic goals, i.e.
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``What has prevented the the company from being able to
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finance, develop, produce, and market the drug?''
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\end{itemize}
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It is likely that a drug fails to complete the development cycle due to some
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combination of these factors.
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%MetaBio/CalBio GLP-1 story to illuistrate these different factors.
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\cite{flier_DrugDevelopment_2024} documents the case of MetaBio, a company
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he was involved in founding that was in the first stages of
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developing a GLP-1 based drug for diabetes or obesety before being shut down
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in .
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MetaBio was a wholy owned subsidiary of CalBio, a metabolic drug development
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firm, that recieved a \$30 million -- 5 year investment from Pfizer to
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persue development of GLP-1 based therapies.
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At the time it was shut down, it faced a few challenges:
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\begin{itemize}
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\item The compound had a short half life and they were seeking methods to
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improve it's effectiveness; a scientific failure.
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\item Pfizer imposed a requirement that it be delivered though a route
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other than injection (the known delivery mechanism); a strategic failure.
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\item When Pfizer pulled the plug, CalBio closed MetaBio because they
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could not find other funding sources; an operational failure.
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\end{itemize}
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The author states in his conclusion:
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\begin{displayquote}
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Despite every possibility of success,
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MetaBio went down because there were mistaken ideas about what was
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possible and what was not in the realm of metabolic therapeutics, and
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because proper corporate structure and adequate capital are always
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issues when attempting to survive predictable setbacks.
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\end{displayquote}
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From this we see that there was a cascade of issues leading to the failure to
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develop this novel drug.
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\end{document}
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