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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...

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

Which drugs have the most patents

This chart shows the pharmaceutical drugs with the most patents still in force.

The drugs with the most active patents are COMBIVENT RESPIMATKALETRAADVAIR HFA,FLOVENT HFAVIVITROLTHALOMIDVYVANSEOSENIREVLIMID, 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.

Susan Kling FinstonThere 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.

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.

Bioethics in the public eye has been recognised as an integral part of modern biology research for a while now. When the Human Genome Project began, James Watson dedicated 5% of the estimated $2.7bn budget to the Ethical, Social, and Legal Issues (ELSI) that concerned the project. As funding trends change and demand for scrutiny of the field increases, the public increasingly needs to be aware of the changes and misinformation presented to them.

Above all else, research is affected by funding. Traditionally biotechnology was funded from government-affiliated agencies, venture capitalists, or deals with Big Pharma. Recently, as the Wall Street Journal noted, funding from the latter two has been dwindling since the 2008 financial crisis. This has lead to researchers applying for grants from some underused sources and in the case of the UK the creation of incentives to bridge the funding gap.

Recognition of the commercial application of biotechnology has lead to the UK’s formation of the Synthetic Biology Leadership council, whose roadmap aims for an “economically vibrant” biology sector “of clear public benefit.” Particular emphasis is put on noting that “public acceptability…cannot be adequately dealt with through communication through the public.” Professor Joyce Tait serves on this leadership council and examines the social impact of scientific developments with the Innogen Center at the University of Edinburgh. “I think what the public needs to be educated about is judging the quality of the evidence that’s presented to them” she says when contacted. “There’s a terrible tendency in this area for any group, no matter what their motivation, to bias the evidence that’s around out there to suit their case … especially when it becomes the potential for conflict.”

 

For Peter Pitts, President and Co-Founder of the Center for Medicine in the Public Interest, communicating any research benefit to the public can be a problem. “Generally speaking the only thing you read about genetically modified foods – from those who actually think they’re a good idea – are extremely technical comments that are of use to almost nobody.” For Peter, scientific jargon and rhetoric are preventing any meaningful public discussion with researchers. “I can sit in a room with scientists, I can talk shorthand and know exactly what’s going on, but everybody else is completely confused like we’re speaking in some sort of ancient Latin or something.”

 

“Every explanation has to be a 94 PowerPoint slide presentation as opposed to the quick, obvious media savvy answer.”

 

Research potential may be further overstated by the press, skewing the image of the research even more. In an interview with the Guardian, Professor Hilary Rose notes the paper’s editorial on new stem cell research (which notes it may someday “make the blind see, the crippled walk, and the deaf hear”) as an example of the misinformation supplied to the public.

Henry I Miller of the Hoover Institution at Stanford University also feels that modern science journalism needs to be redressed. “Specialty journalism is waning, and reporters often create a “moral equivalence” between opposing views of an issue, even after one viewpoint has been discredited. Newspapers are failing, and people increasingly are using websites to become “informed” about issues.” This feeling of declining speciality journalism is echoed by Peter Pitts. “Years ago a journalist covering the FDA, for example, would have been covering the FDA for years; reading the ins and outs of what was going on. Today you’re talking to people who today they’re covering the FDA, yesterday were covering a baseball game.”

Anti-GM companies are also a persistent, unregulated source of biased information for the public. There are, however, indications of public attitudes cooling as seen in a public attitudes survey last year, where extreme pro- and anti-GM attitudes shrank and the indifferent middle ground grew. “I thought that was an excellent outcome” says Prof Tait “it was no longer a politically contentious issue for a lot of people.” She notes however a tendency for anti-biotech lobbies to misreport the findings still exists. “If you actually look at the way… it’s still being represented by anti-GM pressure groups, they’re focusing on the one end of that scale and they’re not pointing out that if you look at if you look at the other end of that scale there’s an equal move in the opposite direction!”

The main risk of a poor public attitude can be seen reflected in the funding decisions made in government. “I think among politicians there’s kind of a fear of the fear of the public, in Europe in particular [there’s] a really strong concern to avoid a kind of public backlash against any particular technology, I think that’s been true for nanotechnology, which was a subject of concern about 4 or 5 years ago” explains Prof Tait. “[Public opinion] seeps through to what governments will decide to fund and that then feeds through to the opportunities there are for the scientists.”

For Peter Pitts, one way to address that is to open up social media. “I think the FDA should facilitate the use of social media by regulated entities, by pharmaceutical companies, etc – to use it more robustly and to send a green light that they want them to do that.”

“I think we can get people more excited and get more people into the fields of science relative to young kids in high school – for example, pursuing a career in science. I think that will probably help politicians support larger budgets for research …and it will also allow people to accept the benefits of the science – GM foods for example – much more readily than they do now.”

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 .

I programmed the DNA-o-gram generator over a decade ago as an excuse to learn web programming. In the intervening years it has been suggested as an encryption method, used as a teaching aid, and even cited in a law review.

The basis for the DNA-o-gram generator is quite simple. The genetic code found in all living organisms from bacteria to humans, uses DNA to encode for an alphabet of approximately 20 ‘amino acids’ which are assembled to make proteins, that do work. Despite coding for only 20 amino acids, the genetic code actually has 64 possible combinations — enough for a lower-case and upper-case alphabet, the numbers 0-9, a space and a stop character.

So, I developed the DNA-o-gram generator to illustrate how the genetic code can be used to encode regular words, and to illustrate how different kinds of mutations or reading errors can affect the decoded messages.

Check it out at http://www.thinkbiotech.com/DNA-o-gram/

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.

Susan Kling Finston

While the world watches Rome and awaits the upcoming Papal Conclave, the Italian biotechnology sector has been engaged in some soul-searching of its own.

With nearly 250 pure biotech enterprises, Italy has managed to buck the EU’s negative economic climate with positive growth reported in 2012 (+2,5%).  Even so, it has stayed in third place within Europe, and so failed to catch up with the UK and Germany, much less to break out of the EU biotech ghetto.

Local and national policymakers have prioritized challenges that may sound familiar for developed and developing countries alike – the absence of well-organized VC culture for financing of biotech start-ups; weak linkages between academic researchers and industry resulting in few spin-offs for commercial biotechnology; and the need for greater cultural emphasis and reward for entrepreneurs willing to take on higher risk/high reward ventures like biotechnology.

Experts from industry and academia are coming together to implement solutions and/or adapt work-arounds tailored for the Italian environment to improve availability of funding and encourage partnerships between academic innovators and experienced managers.

These steps, though important, ignore the elephant in the room:  the ongoing opportunity cost of Italy’s failure to develop agricultural biotechnology.

Going back a quarter of a century, Italy led Europe in in agricultural biotechnology with over 250 experimental projects at a national level ranging including olive oil and fruit varieties.  Italy long since fell prey to internal EU politics over GM agriculture, and there is no current research funding on agro-biotechnology.

In 2001, the Italian Ministry of Agriculture banned all agricultural biotechnology research trials.  Despite subsequent EU decrees from Brussels that have been less negative over time, Italy has never reversed course. Continued political opposition at the local and regional level further complicate prospects for GM agriculture in Italy.

While facing an intractable political environment, the European Union’s own independent research concludes that “there is, as of today, no scientific research associating GMOs with higher risks for the environment or for food and feed safety than conventional plants and organisms.”

Lacking advanced agricultural technologies, Italy has not only lost out on potential avenues for industrial biotechnology – it is unable to meet domestic demand for polenta, and has become a net importer of corn for this staple of Italian cuisine.

Italy’s loss has become Spain’s gain –  as in other states where farmers are given the option, Spanish farmers are choosing GM corn and now account for 90% of all EU BT corn production.

How long can Italy afford to turn its back on advanced agricultural technologies as an important part of its biotechnology strategy?

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 March 2013

TradenameApplicantGeneric NamePatent NumberPatent Expiration
THALOMIDCelgenethalidomide8,143,283Mar 1, 2013
THALOMIDCelgenethalidomide7,723,361Mar 1, 2013
THALOMIDCelgenethalidomide6,235,756Mar 1, 2013
ZOMETANovartiszoledronic acid4,939,130*PEDMar 2, 2013
LUNESTASunovion Pharms Inceszopiclone6,864,257*PEDMar 2, 2013
RECLASTNovartiszoledronic acid4,939,130*PEDMar 2, 2013
NATROBAParapro Llcspinosad5,496,931Mar 5, 2013
FLO-PREDTaroprednisolone acetate6,102,254Mar 11, 2013
ABRAXANEAbraxis Biosciencepaclitaxel5,498,421Mar 12, 2013
COMBIVENT RESPIMATBoehringer Ingelheimalbuterol sulfate; ipratropium bromide5,497,944Mar 12, 2013
RYBIX ODTShionogi Inctramadol hydrochloride5,464,632Mar 22, 2013
XOPENEXSunovionlevalbuterol hydrochloride5,362,755Mar 25, 2013
XOPENEX HFASunovionlevalbuterol tartrate5,362,755Mar 25, 2013
SILENORSomaxondoxepin hydrochloride5,502,047Mar 26, 2013
LOVAZASmithkline Beechamomega-3-acid ethyl esters5,502,077Mar 26, 2013
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

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