The gold industry standard for risk and cost of drug and vaccine development revisited
ABSTRACT 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. . 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?
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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.Technology and Investment 07/2013; 43020(4):168-178. DOI:10.4236/ti.2013.43020
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ABSTRACT: This article provides an overview of FDA's regulatory processes for drug development and approval, and the estimated costs associated with the development of a drug, and also examines the issues and challenges facing the FDA in the near future. A literature search was performed using MEDLINE to summarize the current FDA drug approval processes and future directions. MEDLINE was further utilized to search for all cost analysis studies performed to evaluate the pharmaceutical industry R&D productivity and drug development cost estimates. While the drug approval process remains at high risk and spans over multiple years, the FDA drug review and approval process has improved, with the median approval time for new molecular drugs been reduced from 19 months to 10 months. The overall cost to development of a drug remains quite high and has been estimated to range from $868M to $1,241M USD. Several new laws have been enacted, including the FDA Safety and Innovation Act (FDASIA) of 2013, which is designed to improve the drug approval process and enhance access to new medicines. The FDA's improved processes for drug approval and post-market surveillance have achieved the goal of providing patients with timely access to effective drugs while minimizing the risk of drug-related harm. The FDA drug approval process is not without controversy, as a number of well-known gastroenterology drugs have been withdrawn from the US market over the past few years. With the approval of the new FDASIA law, the FDA will continue to improve their processes and, working together with the ACG through the FDA-Related Matters Committee, continue to develop safe and effective drugs for our patients.The American Journal of Gastroenterology 05/2014; 109(5):620-3. DOI:10.1038/ajg.2013.407 · 9.21 Impact Factor
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ABSTRACT: This exploratory qualitative article analyzes the potentially rate-limiting factors affecting value chain dynamics during adjuvanted-vaccine development. Adjuvants are considered immunostimulating substances that can be added to a vaccine. Although adjuvants have the potential to elicit adverse reactions, they also offer certain benefits. After approximately 90 years of R&D, why have only four adjuvants been approved? Although ample literature is available describing the risks and benefits, it remains unclear as to how these potentially rate-limiting factors compare. Experts – representing knowledge institutes, industry and regulatory/public health authorities – were approached in order to collect a unique weighted-ranking dataset on rate limiting factors. Based on the principal–agent theory, there is a partial conflict of interests between the internal perceptions on the challenges faced. Additionally, content analysis reveals four underlying social constructs influencing this perception, namely: attitudes towards risk management, innovation strategy, valuation and funding. This study was designed to explore the topic of rate-limiting factors, and not intended to solve the issues. Moreover we offer previously unpublished and practical insights on the topic, and offer a validated starting point for further research. Ultimately, we would advocate more transparency on reasons for project discontinuation; sharing lessons learned from failed attempts could prove valuable for advancing the field of virosciences.Technological Forecasting and Social Change 05/2014; 90. DOI:10.1016/j.techfore.2014.04.017 · 1.71 Impact Factor