Modern Strategy for Preclinical Pharmaceutical R&D: Towards the Virtual Research Company
Contents:
Outsourcing Today, outsourcing and collaborations with service providers are a standard in the pharmaceutical sector.
Open source The open source philosophy is based on transparency, freedom-to-operate, access to results and products for everybody, collaborative improvements, no financial reward for contributors, but recognition in providing a better solution to a challenge. Crowdsourcing Eli Lilly is a pioneer and leader in the crowdsourcing field in the pharmaceutical industry. To become a knowledge leverager, pharmaceutical companies need to make the following modifications: Competing interests There are no financial and non-financial competing interests to declare in relation to this manuscript.
Contributor Information Alexander Schuhmacher, Email: Accessed 15 Feb European Commission—Joint Research Centre. Nat Rev Drug Discov. Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Schuhmacher A, et al. Value creation in the pharmaceutical industry: Paul SM, et al.
Risks in new drug development: Prinz F, et al. Believe it or not: Bergren R, et al. Novelty in the target landscape of the pharmaceutical industry.
Swinney DC, Anthony J. How were new medicines discovered? Scannell JW, et al. Pammolli F, et al. Arrowsmith J, Miller P. Cook D, et al. DiMasi JA, et al. Trends in risks associated with new drug development: Abrantes-Metz R et al. US Federal Trade Commission: Hay M, et al.
Mergers and acquisitions in the pharmaceutical and biotech industries. Towards the Virtual Research Company. Support Center Support Center. By working together in an open manner, we have focused on ensuring the alliance is meeting the goal of moving through to an optimal formulation strategy in weeks. Zielinski,Rupert Bartsch,Thomas Progress issue receptors have lengthy been recognized to force malignant transformation and melanoma development. Swinney DC, Anthony J.
Clinical development success rates for investigational drugs. Pharmaceutical innovation in the 21st century: Dickson M, Gagnon JP. Key factors in the rising cost of new drug discovery and development. The price of innovation: Cost of innovation in the pharmaceutical industry. The truly staggering cost of inventing new drugs. Mergers and acquisitions in the pharmaceutical and biotech industries. Mergers and innovation in big pharma.
Int J Ind Organ. Mergers and innovation in the pharmaceutical industry.
The impact of collaborative and risk-sharing innovation approaches on clinical and regulatory cycle times. Ther Innov Regul Sci.
Kruse S, et al. Douglas FL, et al. Tralau-Stewart CJ, et al. Ekins S, et al. Four disruptive strategies for removing drug discovery bottlenecks. Frye S, et al. US academic drug discovery. Biotechs follow big pharma lead back into academia. Models for open innovation in the pharmaceutical industry. Accessed 28 Oct Outsourcing in the pharmaceutical industry: Accessed 15 Mar Mehta S, Peters LS. These partnerships may vary depending upon the needs, skill sets and capacities of the partners. Large CROs already offer almost every component of preclinical research, from early drug discovery to process chemistry formulations, preclinical ADMET testing and animal model development.
Some CROs have also begun to offer clinical trials in addition to other services. These consultants develop a business providing services in the preclinical outsourcing industry, based on the provision of high quality and excellent customer service. The global preclinical outsourcing market is expected to strengthen in the coming months and years due to drying pipelines, the increasing cost of launching new drugs, the patent expiries of leading brands and cost advantages associated with outsourcing.
However, significant change has been witnessed in the way preclinical outsourcing is conducted, with new and more collaborative models continuously evolving in the preclinical outsourcing landscape. In the future, outsourcing contracts are expected to be more long-term and collaborative in nature, and will focus on capitalizing on the strengths of both partners and optimizing the cost structure of preclinical research. He can be reached at jmehta gbiresearch. GBI Research is a business information company providing global business information reports and services.
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Subscribe Free Magazine eNewsletter. GBI Research found five major reasons behind the outsourcing of preclinical studies and development activities: Outsourcing Testing Development Clinical Trials. Solving the Pharma Talent Crunch. Astellas Adds Communications Role.
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In the contract services sector, there has been a clear trend towards mergers and acquisitions, often aimed at expanding services and capabilities, as well as increasing geographic presence. Arguably, this could be seen as an effort to resurrect the one-stop-shop organizational model that existed within big pharma companies prior to the advent of modern drug development outsourcing as it is today.
Many believe that this model was dismantled to improve efficiencies and remove the need for heavy footprints, capital expenditure and fixed costs. Interestingly, while larger CDMOs expand their in-house capabilities, the industry is also witnessing the emergence of more and more strategic alliances between smaller contract service providers that have specialist expertise to bring to the table.
While growing in popularity, this coming together approach dates back to the late s, when a groundbreaking collaboration led to the discovery, development and manufacture of penicillin. In , Sir Alexander Fleming realized that a substance released by mold inhibited the growth of bacteria but was unable to develop a stable form. After distributing the original mold to chemists around the world, a group from the University of Oxford was able to produce stable penicillin in , which then went on to be scaled up and manufactured by groups in the U.
In total, it took more than 15 years of collaborative research and development to transform the original discovery into a mass produced drug. While timelines for collaboration aim to be shorter today, there is a lot that can be learned from this early example of successful alliances. Drivers for change There are a number of factors that are leading to the need for strategic alliances among contract service providers.
For many years, drug developers have been under increasing pressure to speed up time taken to bring new drugs to market, while also reducing costs during drug development and manufacture. In many cases, small-scale providers can offer the operational flexibility needed to move products from the clinical development stages through to commercial scale in a nimble and agile manner. However, if they are to deliver the range of services needed to handle complex and challenging projects, they may need to form strategic alliances with complementary service providers.
The so-called biotech boom is also contributing to the trend towards alliances. As the fastest growing segment of the industry, with annual growth rates of 8 percent, funding is being pumped into the sector from investors.
In addition, the molecules in development are increasingly providing technical challenges that require specialist skills and a science-led approach to drug development. Benefits of collaborative working By their nature, specialist contract service providers are nimble and able to make quicker decisions, which speeds up the research and drug development process. By working together collectively and combining their expertise into one offering, CDMOs can become more competitive in an increasingly buoyant outsourcing market. When faced with the choice between a one-stop-shop provider or working with multiple partners, pharmaceutical companies may opt for the former to simplify communication and relationship management.