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This is a guest post 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.

As trade featuring Living Modified Organisms (LMOs) began to grow to an international scale during the late 20th century, the Convention on Biological Diversity determined that a framework should exist to ensure information was provided for LMO imports. A convention meeting at Cartagena, Columbia initiated negotiations for an international protocol in biosafety needs. For Africa, a continent increasingly reliant on LMOs to maintain a stable food supply, this protocol would signal the beginning of a convoluted path to establishing its own biosafety standards across dozens of countries.

When negotiations for the Cartagena Protocol stalled in early 1999, both the African Group in the Convention for Biological Diversity and the Organisation for African Unity (OAU, now the African Union) came together to collaborate on a model biosafety law for the African continent. In 2001 a draft was finalised by an OAU working group and presented to representatives of 28 African governments, who welcomed the model law as it addressed several factors the Cartagena protocol then lacked, such as an LMO approval process and liability legislation. By this time negotiations on the Cartagena protocol had resumed with the establishment of an intergovernmental committee (chaired by Ambassador Yang of Cameroon) to facilitate the preparations for the first meeting of the protocol parties.

The Cartagena Protocol finally came into force on September 2003. This, along with increased regional biosafety developments in Africa, prompted a revision of the African biosafety model law. The model law draft from 2001 was sent to major signatories of the Cartagena Protocol for advice on how to review it. This also had the effect of allowing countries that may have a future stake in African agriculture to have more of a say in African biotechnology standards. In August 2007, the Revised Model Law was created and in November presented to the African Ministerial Conference on Science and Technology. By this point, the Model Law had been instrumental in developing the biosafety acts of several African countries such as Ethiopia, Ghana and Mali.

2007 also heralded the arrival of Kenya’s National Biotechnology Development Policy and Biosafety Bill into its parliament for debate. Kenya, the very first country to sign the Cartagena Protocol, had its biosafety bill highly promoted by Dr Noah Wekesa, head of the newly created Ministry of Science and Technology. This bill was encouraged both by Cartagena Protocol directives and by the need to replace Kenya’s outdated Science and Technology Act of 1980. Though initial parliamentary debates were highly supportive of the bill, the 2007 General Election caused a political shake-up that resulted in a new coalition government and a reintroduction of the bill to parliament. This time, however, the bill was met with opposition from parliament members and anti-biotechnology lobbyists. The same report notes that one legislator, Silas Ruteere, claimed that the bill breached the Cartagena Protocol by not educating the public about LMOs. Other protests included negative impacts on trade and a declining quality of food should LMOs be introduced. These objections were largely ignored by parliament, which eventually passed the biosafety law in 2009.

Kenya’s challenge of slow legislative process and misinformation from lobbyists is not unique. The National Biotechnology and Biosafety Act of Uganda also faced a lengthy delay, despite both stakeholders and the Minister for Agriculture calling for a speedy approval to maintain Uganda’s agricultural and commercial viability. Despite the imperative placed by the Cartagena Protocol and the framework provided by the African Model Law, many African countries are still producing legislation that varies between each other. While both Kenya and Uganda were still able to initiate field trials for GM maize in 2010, stricter biosafety laws in Tanzania prevented researchers from doing the same. In a survey of African biotech stakeholders carried out by Obidimma Ezezika et al, such variety and protracted development of these biosafety laws was down to poor communication of the benefits of GM crops, a distrust of the private sector and a conflict with religious ethics.

It is peculiar that a continent so heavily involved in establishing the international biosafety standard should itself falter so close to home. The most recent report on the growth of biotech crops notes that the fastest growing adopters of biotech crops were developing countries; Mexico, Brazil, India and China. The absence of African countries is indicative of the slow development of its own policies.

Fortunately, progress towards harmonisation of biosafety law in Africa is taking place. A 2011 African Union report has recognised the inconsistency in African biosafety law and has emphasised the need to combine regional biosafety practices. Recently the African Model Law has also undergone revisions to reflect the finalised Cartagena Protocol and its amendments. For Africa a speedy adoption may be the only solution, as the lack of a legal biosafety framework is beginning to cost them in terms of foreign investment in research. For a continent infamous for its temperamental climate, the need for a stable LMO based crop for commerce and stability cannot be overstated.

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 is a guest post by Ian Scoones, STEPS Centre, University of Sussex, UK

A decade ago, biotechnology was being hyped as the next big thing. Building on the successes of the IT sector, BT (biotech) was, it was argued, going to provide a platform for growth, innovation, job creation and more. So what happened next? A recent seminar jointly convened by the Centre for Public Policy at the Indian Institute of Management in Bangalore, the Association for Biotechnology Led Enterprises and the STEPS Centre, and supported by UKIERI, explored this question.

Certainly the hype around biotechnology has not gone away. The Karnataka State Government’s website proclaims:

“Karnataka has emerged as an undisputed investment destination for investors worldwide, offering vast business opportunities across sectors … Its capital, Bangalore, now a global brand has the largest biotechnology cluster in India, aptly named as Biotech Capital of India. Bangalore has sky-rocketed into the new millennium. A pulsating megapolis, a haven to IT-BT and Fortune -500 companies and today the world’s most preferred investment destination”.

But what are the realities behind the spin? Ian Scoones (STEPS Centre) reflected on some of the changes over the past decade since he carried out research on the emerging biotech sector. Across India the sector has certainly grown. According to the Biospectrum-ABLE survey of 2011, it crossed the $4bn revenue mark. But it did not grow as fast as expected, nor create as many jobs. The ‘big hit’ patents promised a decade ago as part of the pipelines of the start-ups did not materialise, and regulatory challenges have continued to plague the industry.

That said, some important successes have been recorded. Biocon, the flagship biotech company in Bangalore led by Kiran Muzumdar Shaw, has gone from strength to strength. A massively oversubscribed flotation in 2004, has led to year on year growth since. Overall, the biotech sector has grown around 20% each year; an impressive achievement, even through the global downturn of the late 2000s. A comparison of the ‘top 15’ companies (slide 11) by total revenue in the sector in 2003-04 and 2010-11 shows a new dominance of home-grown companies. A noticeable trend has been the growth of the agri-biotech sector. A decade ago, Bt cotton was formally released by Monsanto-Mayhco, and has since expanded on a massive scale, with a whole array of companies taking on the proprietary genetics and incorporating it into their germplasm. The result is that in 2010-11, a third of the ‘top 15’ biotech companies in India are trading Bt cotton.

However, with a few exceptions (perhaps only Biocon, Serum Institute and Panacea Biotec), most biotech companies remain small, dependent on external alliances, and in the case of agri-biotech almost completely reliant on Monsanto’s Bt technology. So what happened to the discovery and innovation model that was touted in 2002, whereby local companies would grow on the basis of new technologies, fostered through R and D investment? This has happened in important areas, including a range of vaccines, some important pipeline drug molecules currently being tested and a locally developed Bt crop application. However, the really big breakthroughs have not emerged. As Vijay Chandru (Strand Life Sciences and ABLE) put it “There has been no second Biocon”.

Why is this? Is the Bangalore biotech innovation system somehow deficient, or is this a normal pattern, reflected elsewhere in the world? The seminar discussion reflected on this. Certainly in the US, the biotech sector is dominated by a few big companies, with many others supporting these in a highly dynamic, fast-turnover setting. Technology clusters are supposed to be the drivers of growth, drawing on geographical synergies, links to academic establishments and strategic state investments. Has this happened in India? In India, clusters have emerged – in Bangalore, Hyderabad, Mumbai, Pune and elsewhere – but how dynamic have they been? Participants at the seminar suggested that it is taking time for such clusters to mature, and that distinct comparative advantages are only now being found. There were mixed views on the benefits of competition between clusters – say between Bangalore and Hyderabad – and a sense that the full advantage of proximity to top-rank scientific institutions was not being realised.

Indeed, one of the big selling points of Bangalore as a biotech destination has always been the presence of the prestigious Indian Institute of Science and the National Centre for Biological Sciences, along with whole host of engineering and technology colleges. Top flight scientific expertise in the biological, information and engineering sciences should, so the theory goes, result in greater innovation capacity. While moves have been made at IISc, NCBS and elsewhere to link basic science with commercial applications, this has only influenced the culture and practice of science in such institutions at the margins over the past decade, and the links between science and business remain weak.

And what about the application of science for development? With the science-business model being influenced by funding flows, patent ownership and market control, the opportunity of biotech businesses to develop technologies responding to the massive local needs of poverty, ill-health, poor environmental conditions, agrarian distress and so on remain structurally limited. The Prime Minister, Manmohan Singh, argued at the Indian Science Congress in January 2012 needs to begin “grappling with the challenges of poverty and development”. He continued:”It is said that science is often preoccupied with problems of the rich, ignoring the enormous and in many ways more challenging problems of the poor and the underprivileged”. Innovation, he argued, should be for social benefit, not just for profit.

These are fine words. They are often repeated in the Indian context where poverty and inequality continue to grow, while the GDP shows 7% (or more) growth rates. In India, there is a vast demand for low-cost, appropriate biotechnologies in India, and many of those at the ‘bottom of the pyramid’ can increasingly afford them. A growing middle class also has new demands – there are, it was noted, 50m diabetics in India. However, the current structure of the biotech industry, with some notable exceptions, cannot respond to these demands. The patents are held by the big companies, the financing is geared to northern markets, and the technological and business capacities are influenced by a US/European model.

So what new ‘inclusive’ innovations exist? As Ravi Kumar (XCyton) explained, medical diagnostics is an important growth area, improving the effectiveness of public health responses, and reducing patient costs. The potentials of portable PCR kits for diagnostics in rural health care are significant, for example. Equally, as Vijay Chandru pointed out, there are growing potentials in the field of ‘biosimilars’ (off-patent generic biological compounds). Low cost production of important pharma products may well open up, Chirantan Chatterjee (IIM-B) explained, as hundreds of important products are released from patent restrictions in the next few years. The current innovator market in biologics is estimated to be around $270bn, with huge potentials for the development of low cost alternatives. According to the ABLE-PWC Vision 2020 Biopharma Strategy, following patent expiry, a potential global market of $40-50bn may emerge over the coming years, although numerous legal hurdles will be encountered. Maybe it is in this area where Indian biotech will really thrive. As Vijay Chandru observed, while ‘Brand India’ (and perhaps particularly Bangalore) is dominated by the IT sector, perhaps the greatest global contribution in the technology field over the past few decades has been the development and supply of low-cost generic drugs to the world.

What then are the challenges ahead for the Indian biotech sector? There has been much talk of state support and investment, the ‘midwifery’ that Peter Evans talks of. But has state support been well directed over the last decade? Most believe it hasn’t. The Bangalore Helix Biotech Park has been plagued by controversy, and has only just got off the ground. State support for early financing has improved, but what about the next-stage financing?, participants asked. In a complex industry like biotech, returns are often slow and uncertain, and the parallels with IT and the software development successes of Infosys, Wipro and the rest are inappropriate.

And then there are the controversial challenges around regulation. Vijay Chandru argued that the “genie is out of the bottle”. Biotechnology is massively powerful, but also potentially hugely dangerous, he said. “We really need to have a good regulatory process in place”, he noted. “And we need to do it soon, or there will be all kinds of chaos”. Everyone agrees that biotech regulation in India needs an overhaul. There are too many, overlapping responsibilities, unclear mandates and lots of red tape. Regulatory delays result in losses of revenues for businesses, and the lack of transparency and unclear procedures are frustrating for applicants and opponents alike. The debacle over Bt brinjal (aubergine/egg plant) that dominated the headlines in 2010, illustrated the limits of the current system. An independent authority with a clear mandate and streamlined procedures – the Biotechnology Regulatory Authority of India – has been proposed. But at the seminar, its design came under much critique. Leo Saldhana (Environment Support Group) presented the results of a comprehensive critique of the Bill. It is damning on a number of fronts. The proposed Authority is seen to centralise decision-making; mix sector promotion with regulation, creating a conflict of interest; be democratically unaccountable, failing to recognise the multiple tiers of government; be excessively reliant on narrow technocratic expertise; override other important legislation (including the Right to Information Act); and ignore public concerns, making objection and protest impossible. Participants at the seminar concurred that “a major rethink is required”.

Biotech in Bangalore retains the hype and much of the hope of a decade ago. Today, however, commentators are more sanguine about the potentials. The sector is clearly thriving, but in a different way to what was envisaged. As Chirantan Chatterjee explained, more hybrid science-business models are emerging which switch between innovation/discovery and generics imitation/contract research. This may be a more realistic expectation, and one that can capture the potentials of biosimilars production, genomics-based diagnostics and more. However, direction of innovation remains a concern, as well as the diversity of applications and the distribution of benefits. The seminar concluded that much more could be done by states and the union government to build the industry, incentivise entrepreneurs, foster links with the diaspora, forge links between science, engineering and management training, protect and support emerging companies, and direct innovation towards the principles of inclusivity, poverty reduction and sustainability that the Indian Prime Minister talks of.

“What is the biggest challenge in moving a foreign biotechnology company to the United States?”

I asked this question at the Delaware-New Jersey-Pennsylvania annual biotechnology conference and received a surprising response. The consensus was neatly stated by one of the panelists: “Moving to the US is like stealing in church.”
For all the problems one might perceive that foreign companies may have, the panelists agreed that the reduced bureaucracy, relative to European and Asian nations, made the United States a relatively easy place to grow. They stated that they had few problems with visas or recruitment, and the greatest problem one panelist experienced was finding the time to apply for a drivers license.
This sentiment is in stark contrast with the software industry, where visas and recruitment are cited as significant impediments.

I’m back from the Filling the Pipeline conference in Boston, where I presented a talk on pharmaceutical globalization.

Maintaining control of pharmaceutical drug innovation is key for national security, public health, and economic development. We know that much of late-stage development has gone overseas, but the question remains: Where are drugs invented? Using the DrugPatentWatch database, I demonstrate a model to track pharmaceutical globalization using patents and reveal the locations of pharmaceutical innovation. For more, see the slide deck below:

The third issue of Scientic American’s Worldview is now available at www.saworldview.com.

In this latest issue I continue my comparative assessment of the biotechnology innovation environment in different countries. I also include additional highlights:

  • Which country is home to the most drug inventors?
  • Which country has the greatest biotechnology patenting intensity?
  • Which country has the greatest relative biotechnology R&D spend?
  • Which country has the most global collaboration on innovation?
  • Which region has the fastest growing drug market?
  • Which country has the largest drug market?
  • Which country has the longest drug approval lag
  • Which country has the most publications in the field of biotechnology?
  • Which country is the largest drug exporter?
  • Which country has the strongest public biotechnology markets?

I have also increased the number of countries measured from 38 last year to 48 this year.

The answers to these questions may suprise you. For answers to these questions and more, see the Scientific American Worldview project at www.saworldview.com

I will be presenting in an upcoming webinar:

Going Global

Partnering and Investing in International Life Sciences

 

Today, successful life sciences companies are feverishly evaluating international partnerships in search of places that are rapidly expanding. Some make the costly mistake of only using market size as the deciding factor, which is often misleading. Success in the global marketplace is driven by many factors. Overlooking these additional factors may be detrimental to your international goals.

During this webinar, you will:

  • Hear why a deep understanding of your potential partner’s innovation record is essential
  • Learn how to measure the true size and growth rate of a specific market
  • Understand why focus must center on individual countries rather than region
  • Discover how to identify and mitigate commercial risk abroad
  • Learn how to create a checklist for partnering and investing internationally
  • See how one company has used technology to securely and efficiently accomplish their international licensing goals

Go here to learn more about this complimentary webinar sponsored by MERRILL DATASITE®.

Date & Time

June 7, 2011
1:00PM EDT / 10:00AM PDT
90 Minutes

Add to Outlook Calendar Add to Outlook Calendar

Register

 

Speakers

Yali Friedman, PhD

Yali Friedman, PhD Founder

thinkBiotech

Yali Friedman, Ph.D., is Founder of thinkBiotech. His book, Building Biotechnology, is used as a course text in dozens of biotechnology programs. His other books include Best Practices in Biotechnology Education and Best Practices in Biotechnology Business Development. Dr. Friedman also has strong exposure to leading issues in international biotechnology. Dr. Friedman teaches biotechnology management at the NIH and regularly guest-lectures for other biotechnology education programs, and writes and speaks on diverse topics such as biotechnology entrepreneurship, strategies to cope with a lack of management talent and capital when developing companies outside of established hubs, and new paradigms in technology-based economic development.

Jim Weissman

Jim Weissman Vice President of Business Development

MannKind

As Vice President of Business Development for MannKind, Jim Weissman leads MannKind’s strategic alliance and licensing partnership efforts. He brings over 20 years of experience in general management, business development, and marketing in biotech and pharmaceuticals having worked in senior management positions at Pharmacia and Pfizer. Weissman served as the General Manager for Pharmacia Biotech UK & Ireland where he headed country operations including sales, marketing, customer support, and operations. He also served as the Director of Business Development for Pfizer Japan where he headed the New Product Planning, Licensing, and Corporate Strategic Planning Departments. Weissman received his B.S. in Chemistry from Bates College and has extensive international experience having lived and worked in Europe for 5 years and Japan for 11 years prior to returning to the USA in 2006.

David Yeary

David Yeary Moderator

Merrill Corporation

David Yeary is the Vice President of Sales-Life Sciences for Merrill’s DataSite. Most recently, Mr. Yeary worked at Morgan Lewis as Director, Business and Practice Development where he assisted and lead business development opportunities in Life Sciences, Technology, Clean Tech and Digital Media and Entertainment. He also worked with private equity, venture capital and investment banks to bridge between client and investor. Mr. Yeary gained his experience at Synarc, Celera, IMS, Agouron/Pfizer and Roche/Syntex in various business development, sales and marketing roles. He has and continues to work with numerous startups as an advisor for business development, commercialization and marketing and communication functions. Periodically he can be heard on the radio or speaking at Stanford discussing the challenges and opportunities for the new entrepreneur. He holds a BS and MBA in business from California State University, Fresno.

I will be giving a talk on “Using patent information to track globalization” at the ACS conference in Anaheim next week. The talk is part of the ACS Division of Chemistry and Law session on What Can Patent Information Do For Scientists, and is based on analysis of data from DrugPatentWatch. I look forward to meeting BiotechBlog readers who may be in attendance. For those who cannot make the event, my talk will be based on my work on globalization of pharmaceutical innovation.

The public portion of the International Symposium Development of an R&D Cluster in Okinawa has been posted. The symposium brought experts from around the world, with a particular emphasis on regions such as San Diego, Singapore, and Israel. Complete coverage, including video links in English and Japanese are on the Okinawa Institute for Science and Technology website.

I will be writing up my comments in a future issue of the Journal of Commercial Biotechnology, and linking to them from this blog.

I’ve just had a paper published in Nature Reviews Drug Discovery, using data from DrugPatentWatch to profile the locations of drugPharmaceutical Globalization: Where are drugs invented? invention for the past decade.

The location of drug development is important for two reasons. Firstly, it is important to track the global spread of innovation. Much late stage drug development (e.g. clinical trials) and manufacturing have moved to lower wage-cost countries, but trends in the location of invention has not been clearly described. Knowing where drug invention is occurring can help streamline drug development by identifying ideal locations for research facilities. Secondly it is important to know where invention is occurring, because that may affect which drugs are developed. Early-stage research funding and, by extension, the research itself, is likely to be focused on conditions affecting the countries in which these activities are occurring. For example, research in the United States might focus on conditions such as heart disease and stroke, whereas research in Japan might emphasize stomach cancer.

By examining the patents covering drugs developed over the last decade, I was able to ascertain the locations of the inventors. Focusing on inventors is important because it gives a clear indication of where the control of the invention was located. Patents are required to list the names and locations of the individual(s) who maintained intellectual domination of the invention. Failure to list all inventors, or listing too many inventors, can yield an invalid patent. Whereas one might consider assessing globalization of invention by focusing on the location of the company funding the research, or the company listed on the patent, these strategies are flawed. The company funding the research may not be the same company which conducted the research (e.g. Japanese companies funded many of the early US biotechnology companies, but the inventions occurred in the US by US researchers, so focusing on the funder might produce the incorrect conclusion that the innovation was Japan-based), and many companies have facilities in multiple countries, making it impossible to determine in which of the countries an invention might have occurred. Looking at the company listed on a patent is also flawed. The company listed on a patent might not have been the company that housed the researchers or, even worse, it may be a tax shelter based in a country where no invention occurred. So, by focusing on the locations of the listed inventors it is possible to determine where the invention occurred. An additional benefit of this strategy is that it enables inclusion of patenters from numerous countries. For example for a patent listing one US-based and two Canadian inventors, the US would be given 1/3 credit for an invention, and Canada 2/3 credit.

So, what did I find? In short, the US and the legacy pharmaceutical countries in Europe (United Kingdom, Germany, Sweden, France and Switzerland) have been responsible for the bulk of new drugs invented over the past decade, and there is no indication that this dominance is waning. Emerging economies such as India and China were largely absent. For more details, please see the paper at Nature Reviews Drug Discovery: Location of pharmaceutical innovation: 2000–2009.

You can also get more detailed information on the complete set of drug inventors and where they live in my Global Drug Patent Inventor Report and Individual Country Drug Patent Inventor Reports.

What do you think of the findings? Are you surprised? Do you disagree? Sound off in the comments.