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).
This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology
Go to paper
ABSTRACT: The proliferation of biotechnology start-up companies has led to increased scrutiny by the regulators of the securities markets. The author, a former head of a field office of the United States Securities and Exchange Commission, examines the growing cooperation among regulatory agencies in the U...
The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.
Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:
- Management
- Policy
- Finance
- Law
- Regulation
- Bioethics
For more information, see the Journal of Commercial Biotechnology website
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.
Drug Patent Expirations for April 2013
| Tradename | Applicant | Generic Name | Patent Number | Patent Expiration |
|---|
| BROVANA | Sunovion | arformoterol tartrate | 6,589,508 | Apr 3, 2013 |
| RAPLON | Organon Usa Inc | rapacuronium bromide | 5,418,226 | Apr 14, 2013 |
| ACUTECT | Cis Bio Intl Sa | technetium tc-99m apcitide | 5,508,020 | Apr 16, 2013 |
| NICODERM CQ | Sanofi Aventis Us | nicotine | 5,508,038 | Apr 16, 2013 |
| GENOTROPIN PRESERVATIVE FREE | Pharmacia And Upjohn | somatropin recombinant | 5,501,673 | Apr 16, 2013 |
| OXYCONTIN | Purdue Pharma Lp | oxycodone hydrochloride | 5,508,042 | Apr 16, 2013 |
| CAVERJECT IMPULSE | Pharmacia And Upjohn | alprostadil | 5,501,673 | Apr 16, 2013 |
| GENOTROPIN PRESERVATIVE FREE | Pharmacia And Upjohn | somatropin recombinant | 5,435,076 | Apr 16, 2013 |
| AZOPT | Alcon Pharms Ltd | brinzolamide | 5,461,081*PED | Apr 24, 2013 |
| ZELNORM | Novartis | tegaserod maleate | 5,510,353 | Apr 26, 2013 |
| HYTRIN | Abbott | terazosin hydrochloride | 5,412,095 | Apr 29, 2013 |
| HYTRIN | Abbott | terazosin hydrochloride | 5,294,615 | Apr 29, 2013 |
| ALVESCO | Takeda Gmbh | ciclesonide | 6,036,942 | Apr 30, 2013 |
| CEDAX | Pernix Therap | ceftibuten dihydrate | 5,599,557 | Apr 30, 2013 |
| ZETONNA | Takeda Gmbh | ciclesonide | 6,036,942 | Apr 30, 2013 |
| *Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details. |
Subscribers have access to valuable datasets, including:
- Clinical trial information
- International patent families
- International patent priority and PCT information
- Patent maintenance
- Full-text patent downloads
- Sales data (top 200 drugs)
- Paragraph IV challenges
- Tentative approvals
- Dynamic search capabilities with data export
- More…
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 .
This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology
Go to paper
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...
The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.
Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:
- Management
- Policy
- Finance
- Law
- Regulation
- Bioethics
For more information, see the Journal of Commercial Biotechnology website
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
This chart shows the pharmaceutical drugs with the most patents still in force.
The drugs with the most active patents are COMBIVENT RESPIMAT, KALETRA, ADVAIR HFA,FLOVENT HFA, VIVITROL, THALOMID, VYVANSE, OSENI, REVLIMID, and VENTOLIN HFA.
For more infographics, see the DrugPatentWatch Pharmaceutical Innovation Infographics.
Do you have a response to this infographic? Respond in the comments section below.
I will be in Pittsburgh from April 4-5th to give a talk at Carnegie Mellon’s business school, Tepper, and at the Innovation in Healthcare Technology Conference. I will be providing perspectives on changing dynamics in the biotechnology industry based on my work with the Journal of Commercial Biotechnology, and Scientific American Worldview, and my globalization research collected from DrugPatentWatch.com. 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.
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.
There is a saying that if you have a tough problem, you can find the solution if you ask enough people – the answer is in the room. For access early capital for biotech, it may take a whole crowd.
But first, here are a few of the latest data points on access to capital – from the developed and developing world. Just how bad is the funding environment for early stage biotech companies in the UK trying to develop new therapies, cures and novel combination medical devices?
For start ups located outside the Golden Triangle of London, Oxford and Cambridge, the Financial Times’ adjective of choice is “awful.” Earlier this week, the FT reported on research on funding of biotechs in the England’s northwest region, concluding:
“Despite universities in the northwest producing similar levels of research and patents they find it hard to attract investors … attracting only 5 per cent of the early stage funding for life science companies in the UK.”
Apparently, a rose by any other name would not smell so sweet to the City of London.
Given that the City – an early mover in venture finance dating back to Elizabethan times – can’t find Manchester on a map, it should not be surprising that funding for innovative biotech remains weak across the BRICS.
A new meta-analysis of investment patterns in emerging markets published in the March 2013 issue of Nature Biotechnology confirms that governments are no more effective at providing access to early capital than venture funds in emerging markets including China, India, Brazil, Russia and South Africa.
And in an austerity budget environment, more companies also are chasing each public grant dollar in developed countries. So outside of VC comfort zones like London, Boston, and San Francisco, what is a Bio-entrepreneur to do? Are the answers in the crowd?
Crowd-funding promises to do for access to capital what Facebook, G+, YouTube and Twitter have done for freedom of expression. Though associated more with indie-music and movies than commercial R&D, it has already scored a few early successes for biotech.
Websites like Kickstarter may provide important new ways to democratize and expand access to capital, giving early-stage companies an opportunity to reach supporters around the globe, and turning anyone with an internet connection and a laptop, tablet or smartphone into a venture philanthropist.
We know that in the 21st century no nationality has a monopoly on good ideas. If Crowd-funding works, location does not have to be destiny for emerging biotech companies looking for early financial backing.
What do you think – are the answers in the Crowd?
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.
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