See you at BIO in Chicago

I will be at BIO 2013, representing BiotechBlog, the Journal of Commercial Biotechnology, and Scientific American Worldview. I look forward to meeting new and existing readers.

If you have an interest in guest-posting on BiotechBlog, an interest in submitting a paper to the Journal of Commercial Biotechnology, or have perspectives on global biotechnlogy that may be of interest to Worldview, I’d be happy to meet up — drop me a line on the contact form.

If you would rather have an informal meeting, please stop by my book signing at on Tuesday April 23 from 2-3:30pm (I will be signing my books and demoing DrugPatentWatch.com and BiologicPatentWatch.com).

ISO a Scientific Revolution in Cancer Research

This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.

Even if you have never heard of Thomas Kuhn, your thinking about science has most likely been effected by his theory of what causes paradigm shifts.

Over 50 years ago, Thomas Kuhn published The Structure of Scientific Revolutions (1961), one of the most cited academic books of all time.  Kuhn’s theories about the fashion of research challenged the conventional wisdom of science as a logical, step-wise progression.

Kuhn demonstrated that rather than a step-by-step process, scientific research proceeds in fits and starts, with new, potentially important discoveries bumping up against established theories and prevailing fashions. He documented the empirical difficulties of establishing new science paradigms, where scientists may have a vested interest in preservation of the status quo.

Simply put, scientists with funding are loathe to discard research programs, regardless of whether they are breaking new ground – that is the human condition.  And grant-making organizations and corporate funders similarly prefer the familiar over the unknown.  This has the effect of pushing away new, possibly better ideas, even in the face of inconsistent data.

So until an overwhelming amount of these data points accumulate that cannot be reconciled with the existing paradigm, the science establishment resists change.  Then once the tipping point is reached, we come to Kuhn’s paradigm shift where continuing the status quo becomes unacceptable and change is unavoidable.

Now we can add Cancer R&D models to the long list of Kuhn’s illustrations where a science revolution is long overdue and blocked by over-commitment to the status quo.

Given the vast financial resources needed to bring new cancer drugs to market, the substantial time required to move from in vitro to in vivo research and through the regulatory process, and the professional stake of countless scientists and institutions to the status quo, the area of cancer research may be the least open to science revolution.

This is a research environment that rewards predictable R&D over truly ground-breaking research models, and where over $100 billion dollars is spent on research yielding few new effective therapies or cures:

“Jim Watson, the Nobel-winning discoverer of DNA’s double-helix structure, caused a minor sensation recently by arguing that curing most metastatic cancers — cancers that spread in the body — remains more daunting than ever, while researchers pursue scientific dead ends.  Lamenting a “conservative” research establishment that he suggested is reluctant to take scientific risks, he urged scientists to follow new, unexplored, yet more promising directions.”

Given recent high profile failures of late-stage cancer programs, even cancer research fast may be reaching the point where it is no longer possible to ignore the need for truly novel approaches.

Are you ready for the coming revolution in cancer R&D?

About the author:
President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues. Susan has extensive background and special expertise relating to intellectual property and knowledge-economy issues in advanced developing countries including India and South Asia, Latin America and the Middle East North Africa (MENA) region. She also works with governments, s and NGOs on capacity building and related educational programs through BayhDole25. Together with biotechnology pioneer Ananda Chakrabarty, she also is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivo research. Previous experience includes 11 years in the U.S Foreign Service with overseas tours in London, Tel Aviv, and Manila and at the Department of State in Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.

Will the UK be the Goose that Lays The Golden Access?

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 .