The gold industry standard for risk and cost of drug and vaccine development revisited

ArticleinVaccine 29(35):5846-9 · June 2011with10 Reads
DOI: 10.1016/j.vaccine.2011.06.051 · Source: PubMed
Gold dimensions of pharmaceutical drug development indicate that it takes on average 11.9 years, with an investment around US$ 0.8 Billion, to launch one product on the market. Furthermore, approximately 22% of the drug candidates successfully complete clinical testing. These universally acknowledged proportions largely originate from one single, much cited publication; Dimasi et al. [5]. However an additional six articles describing new chemical entities (NCE) development were identified, which contain little, if any, information on vaccines. Published cumulative success rates range from 7% to 78% and investments calculations span US$ 0.8 to 1.7 Billion. Obviously this disserves further clarification?
    • "First, the innovation process comprises the combination of technological development of an inven-tion and the market introduction of that invention to endusers . Application of this combination in the context of the industry as examined in this paper is difficult because invention and market introduction are two activities separated by 10 -14 years of R&D and hundreds of millions of R&D-spent US dollars [28,29] . In addition, conducting these separate activities requires very different knowledge , expertise, resources and capabilities, typically illustrated by the need for nimble biotech companies and incumbent pharmaceutical firms to work in collaborations and alliances303132. "
    [Show abstract] [Hide abstract] ABSTRACT: During the past two decades the biopharmaceutical industry has been facing an innovation deficit, characterized by in- creasing research & development costs and stagnant productivity. From its inception, biotechnology has been expected to counter this deficit by its revolutionary science-based approach to drug discovery. For this study we gathered patent and product data related to the technological development of the first two biotechnologies: recombinant DNA technol- ogy and monoclonal antibody technology. We studied the technological lifecycles of these technologies in terms of sci- entific discoveries and inventions as well as product innovations. Results indicate that over the years inventions related to these technologies have simultaneously become less radical and less valuable. Furthermore, our analysis shows that these biotechnologies have reached a stage of technological limit or saturation, which may be followed by an innovation cliff. Now, more than ever, it is crucial to examine new strategies and opportunities for value creation, capturing, and delivery, within the biopharmaceutical industry.
    Full-text · Article · Jul 2013
    • "This process is also known as the value chain; the consecutive development stages a vaccine or medical compound progresses through to accumulate value and become established as a safe, effective and qualitative product. However, merely 22% of the initiatives were forecasted in 1996 to successfully reach the market after 10 years of development [11,12]. This imbalance is to a large extent caused by rising cost of research and development (R&D), biological and technical challenges associated with targeting more complex diseases, competition with better standards of care, larger scale of clinical studies to prove safety and efficacy and last but not least an increasingly stringent regulatory environment [13,14]. "
    [Show abstract] [Hide abstract] ABSTRACT: To date, vaccination is the most cost-effective strategy to combat infectious diseases. Recently, a productivity gap affects the pharmaceutical industry. The productivity gap describes the situation whereby the invested resources within an industry do not match the expected product turn-over. While risk profiles (combining research and development timelines and transition rates) have been published for new chemical entities (NCE), little is documented on vaccine development. The objective is to calculate risk profiles for vaccines targeting human infectious diseases. A database was actively compiled to include all vaccine projects in development from 1998 to 2009 in the pre-clinical development phase, clinical trials phase I, II and III up to Market Registration. The average vaccine, taken from the preclinical phase, requires a development timeline of 10.71 years and has a market entry probability of 6%. Stratification by disease area reveals pandemic influenza vaccine targets as lucrative. Furthermore, vaccines targeting acute infectious diseases and prophylactic vaccines have shown to have a lower risk profile when compared to vaccines targeting chronic infections and therapeutic applications. In conclusion; these statistics apply to vaccines targeting human infectious diseases. Vaccines targeting cancer, allergy and autoimmune diseases require further analysis. Additionally, this paper does not address orphan vaccines targeting unmet medical needs, whether projects are in-licensed or self-originated and firm size and experience. Therefore, it remains to be investigated how these - and other - variables influence the vaccine risk profile. Although we find huge differences between the risk profiles for vaccine and NCE; vaccines outperform NCE when it comes to development timelines.
    Full-text · Article · Mar 2013
    • "Modern medical studies, especially those intended for high impact journals, can easily cost millions of dollars (USD). For example, cost of drug development, including phase I to III trials, averages about USD 800 million [1,2]. Studies searching for single nucleotide polymorphisms (SNPs) and copy number variants (CNVs) that contribute to disease are also costly. "
    Full-text · Article · Jan 2013
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