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

A brave new Europe with the introduction of the EU Clinical Trials Directive: Impact upon the pharma industry and academic research with special emphasis on pharmacovigilance

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ABSTRACT: 1st May, 2004, saw the national implementation of the EU Clinical Trials Directive (2001/20 EEC). Additionally, Europe changed from 15 to 25 member states, all implementing the Directive nationally at the same time and all being affected by the many and varied aspects covered in the Directive. The paper looks at the new changes to European clinical trials and what this will mean for the pharmaceutical industry and research academia alike, especially in relation to safety reporting and risk/benefit assessments.

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

Intellectual property: The driving force for growth and funding

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ABSTRACT: For most 'bio-entrepreneurs' the science is the easy part -- leveraging that science to create a viable business becomes the real challenge. This paper provides an overview for utilising intellectual property to strengthen a business' attributes, thereby increasing the firm's likelihood of attracting funding and attaining its objectives...

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 Biotechnology Entrepreneurship BootcampMade available by the elective open access option at the Journal of Commercial Biotechnology, this paper is free to view without subscription:

Abstract

The importance of the business development and licensing (BD&L) function in the global biopharmaceutical industry has grown significantly over the past 20 years as pharmaceutical companies have sought to supplement their internal R&D with innovative products and technologies sourced from biotechnology and drug delivery companies. This has required companies to employ BD&L executives to search, evaluate, negotiate and alliance manage deals ranging from small biotechnology companies to the largest of the Big Pharma companies. Nowadays all the large companies have BD&L teams, sometimes in excess of 100 people. To inform new BD&L entrants and to improve the professionalism of the experienced BD&L executives, various training courses are offered by not-for-profit associations and commercial organisations. The leading not-for-profit association in Europe for biopharmaceutical executives is the Pharmaceutical Licensing Group and in the US it is the Licensing Executive Society. Both organisations offer basic training courses but as far as is known, the only university accredited Master’s degree qualification in BD&L is the distance learning MSc offered by the University of Manchester. The dissemination of specialist knowledge and best practice is through the journals and conferences of the professional associations. The need for well-qualified BD&L executives in the biopharmaceutical industry is demonstrated by the fact that 25% or more of Big Pharma sales come from third party products and the cost of licensing deals alone is over $200m on average.

 

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

Fostering the process of adoption of personalised medicine: A matter of communication or a matter of cost?

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ABSTRACT: Pharmacogenetics, along with its derived products, diagnostic tests and customised medicines, has been introduced to the market with high commercial expectations (derived from its obvious science-based benefits). Nevertheless, its commercial success is far below that is expected. Although the favourable arguments for its development are sufficiently documented in the literature, the reality of the market forces the consideration of a scenario with less optimistic elements...

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.
Susan Kling Finston
Perhaps like me you are working and not on vacation this early August.  If so, I hope that you will join me in a mental vacation to the Emerald Isle.  So close your eyes and think of biotech in Ireland.

One data point that may come to mind is the country’s famously low corporate tax rate, particularly following recent reports of M&A activity driven in part by the opportunity to “buy into” Ireland’s 12.5% corporate tax bracket.

The buyer, Perrigo, may be the largest pharma company you never heard of:  a Michigan-based company with strengths in over-the-counter (OTC), generic prescription, and active pharmaceutical ingredients (APIs), nutritional products (formula, supplements), and related consumer products.

In a deal announced July 29th, Perrigo is buying Irish biotech Elan for $8.6 billion and moving to Ireland, reportedly to save $150 million annually in corporate taxes. This latest news involving a major U.S. company pulling up stakes and moving to Ireland to save on taxes likely may relaunch debate by American states over the plusses and minuses of “Ireland’s model for growth using state money and incentives to lure private biotechnology companies.”

So just how likely is it that tax rates are a key driver for M&A decisions and broader biotech growth?  Not very.

It may be unsettling to hear about a major U.S company jumping ship and giving up its nationality for reported tax gains, given our complicated feelings about homeland and nationality.  Corporations, however, are not people – sorry, Mr. Romney – and when they get to be as big as Perrigo, may not retain a clear national identity.

Perrigo’s strengths in generics and OTC products are driven, for example, through international acquisitions over the last decade, including Agis Industries (Israel), Galpharm Healthcare (UK), Laboratorios Diba (Mexico), and Orion Laboratories (Australia, New Zealand), among others.   Given ongoing operations of affiliated business units in Australia/New Zealand, Europe, Latin America, and the Middle East, how American is Perrigo – even before the Elan takeover?

More broadly,  as noted back in Biotechnology in Countries Starting with “I”  (Part 3  –  back in March 2013), Italy, and not Ireland, places third in the EU for biotech after the UK and Germany, as measured by the number of pure biotech companies. Italy’s corporate tax rate is nearly triple that of Ireland.

How does Ireland stack up in the EU looking –  beyond straight numbers of pure biotech companies?  According to the EU’s Innovation Scoreboard (2013), Ireland is the tenth (10th) most innovative market for biotechnology in Europe, falling short of the most successful biotech markets in the EU.

Using its own composite index including human resources, firm investment, strength of research systems, entrepreneurship intellectual assets and related economic impact, the EU’s top-4 picks are Denmark, Finland, Germany and Sweden.  Corporate tax rates play a limited role at best, in the biotechnology ecosystem.

Will we likely see similar transactions this year, where companies outside of Ireland acquire Irish assets and relocate to the Emerald Isle?  Possibly, given that M&A is again on the upswing and at least two Irish healthcare companies are rumored as attractive take-over targets.  There has to be more on the table than a more favorable tax rate to justify a term sheet, as one analyst has noted:

“A deal that is solely driven by tax purposes could be a slippery slope.” 

 

Susan K. Finston is President of Finston Consulting LLC, and, together with biotechnology pioneer Ananda Chakrabarty, is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivoresearch. She is currently preparing to launch her first Crowd Funding campaign for Amrita Therapeutics first-ever therapeutic oncology medical device. For more information see AmritaTherapeutics.com or FinstonConsulting.com.

 

Drug Patent Expirations for July 2013

TradenameApplicantGeneric NamePatent NumberPatent Expiration
AZILECTTevarasagiline mesylate5,532,415Jul 2, 2013
CIPROBayer Hlthcareciprofloxacin6,136,347*PEDJul 6, 2013
EVOXACDaiichi Sankyo Cocevimeline hydrochloride5,340,821Jul 7, 2013
ELOXATINSanofi Aventis Usoxaliplatin5,290,961*PEDJul 12, 2013
METROGEL-VAGINALMedicismetronidazole5,536,743Jul 16, 2013
CADUETPfizeramlodipine besylate; atorvastatin calcium6,126,971*PEDJul 19, 2013
LIPITORPfizeratorvastatin calcium6,126,971*PEDJul 19, 2013
INOMAXInonitric oxide5,485,827*PEDJul 23, 2013
EMENDMerck And Co Incfosaprepitant dimeglumine5,538,982Jul 23, 2013
EMENDMerckaprepitant5,538,982Jul 23, 2013
INOMAXInonitric oxide5,873,359*PEDJul 23, 2013
RELENZAGlaxosmithklinezanamivir5,360,817Jul 26, 2013
DELZICOLWarner Chilcott Llcmesalamine5,541,171Jul 30, 2013
ASACOLWarner Chilcott Llcmesalamine5,541,170Jul 30, 2013
ASACOL HDWarner Chilcott Llcmesalamine5,541,170Jul 30, 2013
IMAGENTImcor Pharms Codimyristoyl lecithin; perflexane6,287,539Jul 30, 2013
DELZICOLWarner Chilcott Llcmesalamine5,541,170Jul 30, 2013
ASACOLWarner Chilcott Llcmesalamine5,541,171Jul 30, 2013
IMAGENTImcor Pharms Codimyristoyl lecithin; perflexane6,280,704Jul 30, 2013
ASACOL HDWarner Chilcott Llcmesalamine5,541,171Jul 30, 2013
IMAGENTImcor Pharms Codimyristoyl lecithin; perflexane6,280,705Jul 30, 2013
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

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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.

One of the more enduring financing trends in recent years has been to turn to public interest to help fund for research. As Susan Finston has noted on this blog before, the successes seen in other areas has more recently been translated into the biotech world, with such sites as Petridish.org and scifundchallenge.org forging ahead in public financing in the sciences.

For emerging technologies a new website promises to add an extra aspect to the crowdfunding framework; innovation in the technology itself. Marblar.com was recently established in order to facilitate crowd-orientated uses for new technologies developed by the patent holder.

Marblar cofounder Gabriel Mecklenburg explains new technologies have limited potential under the old system. “You typically have a physics technology and a professor comes down from tech transfer office, talks to their physics guy and those two people – [who] may be opposed to being thrown into the mix – will then have to come up with the best way of applying this technology. We figured ‘well that’s maybe not the best way of doing it.’ Science has become such a vast field now these days that maybe actually the physicist isn’t the best person to find that killer application for this piece of physics technology.”

“So we figured to really open up the sectoral process to a much much wider crowd and break down the technologies in a way that a non-expert could understand them and open it up to anyone around the world, be they neurologist, chemists, engineers, business people- get all these different perspectives together and create this kind of crowdsourcing platform where [what] we do is put each technology out as a competition and say ‘Okay, come up with the best new market application, the best new way of using this technology.’”

Marblar works by having the patent holder post their technology up on the website and having the community suggest potential applications. Those viewed as particularly innovative get voted on and discussed before entering a final shortlist. The community then continues to vote for what is deemed the best use of the new technology, which is finally selected by the technology holder and is rewarded with a cash prize and points towards their Marblar profile. “Ultimately it’s not a life changing amount of money. More importantly than that there is this community that we’ve built all working towards the same goal that I mentioned earlier; realising the promise of science and actually being in this community of really really bright, motivated people and working with them and collaborating in coming up with these ideas is actually hugely rewarding for a lot of these people, much more so than the money. It’s what drives actually self creativity, pretty senior people in some cases, very very qualified people spend a lot of time on the site and developing these ideas.”

In order to open up the doors for innovation as wide as possible, Gabriel and his team have put considerable effort to elucidate the technology. “We actually spend quite a lot of time digesting down the key features of the technology and presenting them in a way that makes them easily understandable to someone who’s coming cold to the technology. And one key feature of the platform itself is its open nature; that the inventors can interact in real time with the crowd. So the inventor can actually mould each idea with their feedback pack and that way – even if the original application wasn’t quite technically feasible – through this real time tech feedback between the crowd and the inventor the ideas are actually shaped into much more feasible incarnations. You do want the outsider’s perspective.”

As crowdfunding in science grows, the benefit of the outsider’s perspective is increasingly being recognised. As Jeanne Garbarino notes in her post at Nature.com, the growth in science-based crowdfunding has helped lead the way in a new era in connecting science to the general public. By opening their project funding (or even part thereof) to the public, there is an extra imperative to scientists to explain and engage with the public about their research, their methods and eventually their end goal. This potential for outreach-through-crowdfunding is being recognised by websites such as scifundchallenge.org which aim to not only raise funds for research, but also help researchers with outreach activities and help the public connect with the work being carried out. In one of the first papers to fully explore the psychology of crowdfunding from the individual’s perspective, Crowdfunding: Why People Are Motivated to Post and Fund Projects on Crowdfunding Platforms, Elizabeth Gerber et al found that as crowdfunding grows and becomes more common, people will tend to be more discerning about who they choose to fund, increasing the imperative for researchers who choose to crowdfund their research to illustrate its benefits. In the same paper, however, they noted that people who chose to undergo the crowdfunding route found added validation to their work, establish long-lasting professional connections and expand the awareness of their work to both the public and other like-minded professional bodies, thereby helping to increase their chances of getting funding through crowdsourcing in the future.

For Gabriel and the rest of the team at Marblar, having a simplified, accessible explanation for emerging technologies has already shown itself to be beneficial in reaching a wider-than-predicted range of people looking to be a part of the next big thing. “Where our last count it’s people from a hundred and thirteen countries and that’s really running the gamut all the way from a gang of high school students that are sneaking past the age limit all the way to emeritus professors kind of spicing up their retirement by having a go at some of the new science coming through some cutting edge discoveries.”

In a 2001 paper Belinda Clarke suggested that the best way to tackle the worsening lack of interaction between researchers and the public would be to create a forum where the two could interact in non-technical dialogue, away from issues of the media and interest groups acting as middle men and obscuring the message. With the financial appeal that crowdfunding offers and the relative ease in collaborating and explaining to the public about emerging technologies, researchers may yet realise the benefits to putting their mouth where the money is.

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 .

In the last weeks, India has seen serious setbacks to its life sciences industry. The NIH recently announced that they were cancelling 40 clinical trials in India due to an ‘unstable regulatory environment’. Earlier, the UK Medicines and Healthcare products Regulatory Agency (MHRA) recalled 16 Indian drugs, citing deficiencies in manufacturing procedures.

These recent occurrences compound prior concerns over the patentability of medicines (here and here), and low drug innovation rates. Furthermore, in the recent issue of Scientific American Worldview I showed how the sum of India’s API production revenues were exceeded by the the top-selling patented drug. So, even having a focus on generic drugs is not generating substantial revenues for India.

These developments lead one to question — does India present a postive environment for biotechnology?

worldview-5-yearsFive years ago I built a biotechnology innovation index and I have been using it since tracking global biotechnology innovation in Scientific American’s Worldview. It has been a very rewarding project, and I have enjoyed the opportunity to present my research data at international conferences, business schools, and even National Defense University.

Now, Worldview’s editor Mike May has compared my innovation scores with the Venture Capital and Private Equity Country Attractiveness (VCPECA) index. I was quite pleased to see a relatively strong correlation between my innovation index and the VCPECA index.

I am always looking for feedback on the index and opportunities to expand it. I invite you to visit the scorecard at http://www.saworldview.com/wv/scorecard/ and send me your suggestions and feedback.