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Monthly Archives: April 2013

This guest post is from the BiotechBlog Intern,  Fintan Burke. Fintan is a student at the School of Biotechnology at Dublin City University. Do you have a response to Fintan’s post? Respond in the comments section below.

This month sees the introduction of the UK’s Open Access policy as recommended by the government-commissioned Finch Report into Open Access (OA) and initiated by Research Councils UK (RCUK). Under this new policy, any published scientific paper in the UK must be made OA immediately if it qualifies for Gold OA (an upfront payment to the publisher to allow access by anyone), or be made Green OA (have the article stored in some repository after being published in the journal) after 6-24 months embargo period. In order to pay for those Article Processing Costs (APCs) charged by journals, the RCUK is giving research institutions the cost of APCs as a subsidy as part of research grants to ensure that OA is achieved.

The original policy announced by Research Councils UK (RCUK) was drafted in March 2012, fuelled by the Minister for Science’s positive reaction to the Finch report into Open Access recommendations. Since this initial policy was announced, however, significant changes have been made to the policy which has attracted a variety of responses:

  • After liaising with research organisations, learned societies and scientific publishers, July saw the final draft released. Although fundamentally unchanged, the ability for publishers to impose non commercial clauses on Green OA was met with some criticism from researchers who viewed this as impeding the ability of a paper to reach Open Access.
  • By January 2013, RCUK announced that the embargo periods were not to be enforced, following up on an announcement in November that only 45% of APCs would be funded as Gold OA in the first year.
  • In February the government’s own Lords Science and Technology Committee’s released a highly critical report of the RCUK’s actions. Among the critiques were a lack of clarity in the policy about which papers qualify, how long embargos could last until OA is allowed and why the RCUK did not carry out a full cost-benefit analysis for Gold OA funding.
  • In response the RCUK adopted a “decision tree” developed by the UK’s Publisher’s Association in March in order to clarify which papers qualify for what type of access.

Instead of clarifying the matter, however, the revised policy guidelines drew renewed criticism from the research community. Paul Jump’s report at the Times Higher Education notes that spokespeople from the RCUK and the Publishers Association were encouraging different routes for Green or Gold options. Another article at The Scholarly Kitchen questions what procedures are in place to enforce the various avenues a researcher can go down for APC funding or publishing. Questions were also raised over the lack of enforcement for the proper management of the APC grants, given the chequered history of reporting NIH-sponsored trials.

When contacted, the RCUK was able to address the reasoning behind the block grant funding mechanics. “We see the early years of implementation as a journey so there will be a transition” said Alexandra Saxon, Head of Communications at RCUK. “As we recognise the differing nature of each research organisation, how they manage the funds is best left to them – however, we will be working with them to share best practice across the sector.  How research organisations are managing the funds will also be an area of focus for the review in 2014 and subsequent reviews.” In terms of establishing any regulatory body for the block grants, Ms Saxon did not indicate any future plans for doing so, saying “we want to ensure that the monitoring of the policy does not become a burden to research organisations.” However, she also acknowledged that the open access arena is a “very fast moving landscape” and stressed the importance of monitoring various aspects of the policy within its 2014 review.

The UK’s approach to mandating Open Access is similar to the germinating sentiment internationally. An international coalition of academic and research libraries broadly welcomed the recommendations made in the Finch report, while Australia and Ireland have already mandated Green Open Access for some time. The US has also recently initiated plans to launch its own Open Access policy for federally-funded papers. (Ms Saxon notes that any international research collaboration that acknowledges RCUK funding “should be publish[ed] under the RCUK policy.”)

None of this is to say that publishers are not readying themselves for an open access transition. Dr Neil Henderson of Palgrave Macmillan notes that currently a hybrid publishing option exists for 41 of their titles, with other open publishing options being announced. “We launched OA for 20 titles in June 2011 and added a further 20 in January 2013. Those titles that we do not yet offer OA for are largely society journals where the discussions with the society is still ongoing.” While some may hold the notion that OA may someday reduce the need for costly scientific journals, Dr Henderson notes that current standards come at a price. “As soon as you add levels of service to the package (eg online submission and peer review systems) and do something with the content (eg copy edit and typeset it, adding DOIs, ensuring the content is fed to abstracters and indexers etc) there is a cost involved. Unless someone is going to do all of this work for free someone needs to pay for it.”

While the APC subsidy indicates change from the current library subscription model, the staggered development of the UK’s own OA policy – considered a front runner in Europe for Golden Access mandates – suggests a long path to a change in the current publishing model internationally. While the UK developments bring a cautious optimism among OA enthusiasts, Dr Henderson suggests “it will take quite some time though before any significant switch occurs.”

About the author:

Fintan Burke is a student at the School of Biotechnology at Dublin City University. His main fields of interest include biomedical therapies and recombinant organisms.  Fintan may be contacted at fintan.burke2@mail.dcu.ie .

Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Taking stock in biotechnology futures

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ABSTRACT: Investors now have a new tool to help them manage the risk associated with biotechnology investment. Individual and professional investors can more confidently invest in companies whose products take years to develop and potentially several more to gain regulatory approvals and commercialise. This paper focuses on the development of the first stock index futures for the biotechnology market...

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Drug Patent Expirations for March 12 2013

TradenameApplicantGeneric Name Patent Expiration
ABRAXANEAbraxis BiosciencepaclitaxelMar 12, 2013
COMBIVENT RESPIMATBoehringer Ingelheimalbuterol sulfate; ipratropium bromideMar 12, 2013

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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…
Full details at the Journal of Commercial Biotechnology

Defining valuable information in a shifting industry
Andrew F Bourgoin
Full details at the Journal of Commercial Biotechnology

Commercial Biotechnology in Mexico
Minerva Valdes, Fernando Quezada
Full details at the Journal of Commercial Biotechnology

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…
Full details at the Journal of Commercial Biotechnology

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…
Full details at the Journal of Commercial Biotechnology

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…
Full details at the Journal of Commercial Biotechnology

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…
Full details at the Journal of Commercial Biotechnology

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…
Full details at the Journal of Commercial Biotechnology

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…
Full details at the Journal of Commercial Biotechnology

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…
Full details at the Journal of Commercial Biotechnology

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…
Full details at the Journal of Commercial Biotechnology

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…
Full details at the Journal of Commercial Biotechnology

 

For more information, see the Journal of Commercial Biotechnology