2016
DOI: 10.1186/s12967-016-0838-4
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Changing R&D models in research-based pharmaceutical companies

Abstract: New drugs serving unmet medical needs are one of the key value drivers of research-based pharmaceutical companies. The efficiency of research and development (R&D), defined as the successful approval and launch of new medicines (output) in the rate of the monetary investments required for R&D (input), has declined since decades. We aimed to identify, analyze and describe the factors that impact the R&D efficiency. Based on publicly available information, we reviewed the R&D models of major research-based pharm… Show more

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Cited by 259 publications
(163 citation statements)
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References 49 publications
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“…36 Further, the cost of developing a new drug remains high, ranging from $3 billion to more than $30 billion per approval between 2006 and 2014, 37 reflecting the complex challenges involved in meeting current scientific, regulatory and commercial requirements. An over-reliance on in vitro high-throughput drug screening (HTS)* and the “one-drug-one-target-one-disease” concept is cited by some as a contributing factor in the abundance of late-stage R&D failures in recent years, many of which were the result of poor efficacy and unexpected toxicity of lead compounds developed using HTS technology.…”
Section: Big Data In Therapeutic Discoverymentioning
confidence: 99%
“…36 Further, the cost of developing a new drug remains high, ranging from $3 billion to more than $30 billion per approval between 2006 and 2014, 37 reflecting the complex challenges involved in meeting current scientific, regulatory and commercial requirements. An over-reliance on in vitro high-throughput drug screening (HTS)* and the “one-drug-one-target-one-disease” concept is cited by some as a contributing factor in the abundance of late-stage R&D failures in recent years, many of which were the result of poor efficacy and unexpected toxicity of lead compounds developed using HTS technology.…”
Section: Big Data In Therapeutic Discoverymentioning
confidence: 99%
“…Priority Review Vouchers awarded by the FDA to sponsors of product applications relevant to tropical diseases [67], US President's Emergency Plan for AIDS Relief, which has already awarded US$85 billion [68], and the Qualified Infectious Disease Product program that facilitates fast-track designation [69]. By contrast, the prospect of higher drug prices could trigger novel drug development, particularly in circumstances where pharmaceutical companies (such as GSK, Merck, Pfizer and Takeda) have reduced R&D spending [70] yet numbers of drugs being approved is growing (59 in 2018 compared with 21 in 2010), many being orphan drugs [71]. The Orphan Drug Act has been criticized for enabling firms to charge higher prices for orphan drugs in 'salami sliced' disease indications [72].…”
Section: Potential Alternatives To Compulsory Licensingmentioning
confidence: 99%
“…Proposal for a New Cancer Research Model/Kantarjian et al Cancer 2) shifting the drug cancer discovery process from internal research and development (R&D) to building >75% of their pipelines by buying out smaller biotechnology companies 73,74 ; and 3) a significant buildup of administrative personnel at most large pharmaceutical companies, leading to increasing R&D costs. [75][76][77] At this point, a brief history of CROs is in order.…”
Section: History Of the Cancer Research Structure In The United Statesmentioning
confidence: 99%
“…With the plethora of cancer targets, the explosion of the biotechnology industry ripe for timely buyouts by larger companies, and the unlimited potential for financial profits, the pharmaceutical industry implemented gradual steps to tighten its control of the research process, as well as the communication of research results through publications, advertisements, presence at cancer meetings, and other forums . Additional steps implemented by the drug industry that increased the cost of research included: 1) outsourcing the monitoring of research to contract (or clinical) research organizations (CROs) ; 2) shifting the drug cancer discovery process from internal research and development (R&D) to building >75% of their pipelines by buying out smaller biotechnology companies; and 3) a significant buildup of administrative personnel at most large pharmaceutical companies, leading to increasing R&D costs …”
Section: Introductionmentioning
confidence: 99%