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New Journal of Commercial Biotechnology issue

Journal of Commercial Biotechnology Vol 19, Issue 2 (2013)

Capturing Value
G. Steven Burrill
Today’s pressure on pharmaceutical companies reflects greater pressures throughout the entire healthcare ecosystem as payers, patients, and providers wrestle with escalating costs and drive  healthcare systems around the world away from being cost-based to becoming value-based.  For pharmaceutical companies, this means not only a greater emphasis on creating value, but seeking new ways to capture value as well, particularly at a time when drugs will need to demonstrate they provide benefits commensurate with their costs and governments and payers squeeze down prices…
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Defining valuable information in a shifting industry
Andrew F Bourgoin
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Commercial Biotechnology in Mexico
Minerva Valdes, Fernando Quezada
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Technology Transfer: Bridging academic research and society – a communicative approach
Martin Vad Bennetzen, Lars Stig Møller
To make basic research transcend the walls of a university for the benefit of the society, technology transfer processes such as patenting, market analysis, and economic assessment are essential. Therefore small dedicated units, called technology transfer offices, have emerged during the last four decades…
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The funding ecosystem of early-stage biotechnology firms and its misalignment with interests of firms, of the biotechnology industry and with global disease burden
Gergely Toth
The development and commercialization of new therapeutics have had immense impact on the quality and length of human life.  Nevertheless, the biotechnology and the pharmaceutical industry have evolved to be driven mostly by a profit oriented market system, in which distinct stakeholders interact with different motivations to make the development and commercialization of therapeutics a reality…
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A Patient Centric Commercial Model for Cancer Care
Sanjay Rao
Cancer is one of the most challenging diseases of all – not only in terms of the clinical barriers to offering its sufferers respite from devastating consequences, but also to manufacturers and marketers of treatments that attempt to control its impact. Products developed and manufactured through biotechnology dominate the commercial landscape for treating a variety of cancer types…
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Developing Cell Therapies: Enabling cost prediction by value systems modeling to manage developmental risk.
Mark Joseph McCall, David John Williams
This work quantifies the highest risk activities and interdependencies in cell therapy new product development (NPD).  A simulation model based upon an activates based and information driven  approach of the Design Structure Matrix (DSM), using Latin Hypercube sampling methods with discrete event simulation evaluated the interdependencies between critical development tasks…
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Challenges and prospects for monoclonal antibodies in China
Honghao Shi, Meiwan Chen, Yunzhen Shi, Hao Hu, Yitao Wang
The technology of monoclonal antibodies has been developed since the 1990s and is attracting more and more attention in China during the 21st century. The first monoclonal antibody product was introduced by the Chinese local producer in 1999, and presently seven products are listed, of which three are humanized products…
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A Business Perspective on IP: Open Innovation vs. Open Source in Commercializing Biotechnology
Arthur A. Boni
Abstract – In this article, we address the issues that are involved when developing a strategy for commercializing a discovery that is novel, useful, and non-obvious to someone skilled in the art.  Patent(s) may be used as one means of providing a competitive advantage, and in addition this method is quite common as a means to monetize the intellectual asset…
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Getting Social with Biotechnology Business Development
Tim McCready
Social media is becoming increasingly important in business. While the lack of regulations makes marketing online to consumers a challenge in the life sciences, social media offers significant opportunities to the industry by complementing traditional business development and capital raising activities…
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Bowman v. Monsanto: Revisiting the Exhaustion Doctrine and its Application to Biotechnology and Digital Technologies
Susan Kling Finston
On February 19, 2013, the U.S. Supreme Court heard oral argument in Bowman v. Monsanto – the first case to directly present the question of how the Exhaustion Doctrine should apply to patents relating to biotechnology and digital technology inventions.  The Petitioner, Vernon Hugh Bowman, asserts that the Exhaustion Doctrine should be extended to advanced agricultural technologies where the technology itself is contained in genetically modified seeds that may be reproduced through successive generations of seeds without limitation, and that companies like Monsanto can instead rely on remedies found in contract law to protect its commercial interests…
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Should the HHS Decision to Overrule FDA on Plan B Be Reversed
Peter J. Pitts
On December 7, 2011, Secretary of Health and Human Services Kathleen Sebelius overruled a decision of the Food and Drug Administration (FDA) on the over-the-counter (OTC) status of emergency contraception. What will be the repercussions of Secretary Sebelius’s action? Why is the act itself of far greater long-term significance than the transitory regulatory action it impacts? By reversing an FDA decision, the Secretary has set a dangerous precedent for all-comers to lobby Congress, the Department of Health and Human Services (HHS) and the White House on any and all FDA decisions—directly inserting politics into what must be a scientifically driven process…
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