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Monthly Archives: October 2011

The November 2011 issue of the Journal of Commercial Biotechnology is now available. The links below will take you to the abstract for each paper:

Journal of Commercial Biotechnology Vol 17, Issue 4 (2011)

Exciting changes
Yali Friedman
Full details at the Journal of Commercial Biotechnology

New technologies for neglected diseases: Can tax credits help biotechnology companies advance global health?
Aarthi Rao
Biotechnology companies can play an important role in advancing technologies for global health. Initiatives such as Genzyme’s Humanitarian Assistance for Neglected Diseases and Alnylam’s Intellectual Property (IP) contributions to the Pool for Open Innovation against Neglected Tropical Diseases show a commitment to helping produce badly needed health technologies, but unmet needs for new drugs, vaccines and diagnostics for diseases affecting developing countries remain…
Full details at the Journal of Commercial Biotechnology

Biotechnology commercialisation in universities of developing countries: A review of the University of Ibadan, Nigeria
Chimdiya Julian Onyeka
The British colonial administration established the University of Ibadan (UI) in 1948 as an extension of the University College London and it became Nigeria’s first full-fledged and premier university in 1962. The university comprises 13 faculties and a distance learning programme. Among the university’s faculties is one for Science, one for Technology and another for Agriculture and Forestry…
Full details at the Journal of Commercial Biotechnology

Innovation in R&D: Using design thinking to develop new models of inventiveness, productivity and collaboration
Tad Simons, Arvind Gupta, Mary Buchanan
By adapting insights and methodologies from design thinking, a modern scientific R&D organization may have the potential to increase the speed, inventiveness and vitality of their output and become an explosive engine of growth. Modern design consultancies face the challenge of producing original, creative work for their clients on project after project, and have thus developed several strategies and behaviors to produce innovative content repeatedly at a fast pace…
Full details at the Journal of Commercial Biotechnology

The strength of pharmaceutical IPRs vis-à-vis foreign direct investment in clinical research: Preliminary findings
Meir Perez Pugatch, Rachel Chu
This article examines the effect of the intellectual property (IP) environment in developing countries on the level of foreign direct investment (FDI) and technology transfer occurring in the biopharmaceutical field in these countries. In particular, it considers the correlation between the strength of IP protection in several developing countries (using the Pharmaceutical IP Index) and the number of clinical trials taking place in these countries (as a proxy of biomedical FDI)…
Full details at the Journal of Commercial Biotechnology

Some considerations for the implementation of disposable technology and single-use systems in biopharmaceuticals
Tim Sandle, Madhu Raju Saghee
This article, written from an industry perspective, examines the current trend towards the implementation of single-use disposable technologies in the biopharmaceutical and biotechnology sectors. Single-use technologies are generally sterile, plastic disposable items implemented to replace traditional pharmaceutical processing items that require recycling, cleaning and in-house sterilisation…
Full details at the Journal of Commercial Biotechnology

Catalyzing capital for Canada’s life sciences industry
Joseph Tucker, Justin Chakma, Paul WM Fedak, Massimo Cimini
Canada’s biotech sector ranks within the top five globally, but its life sciences venture capital (VC) industry is among the worlds weakest. This makes for an interesting case study in understanding the disconnect between low levels of VC and a healthy innovation ecosystem in terms of R&D spending, skilled workforce and enterprise support…
Full details at the Journal of Commercial Biotechnology

Academic entrepreneurship, entrepreneurial universities and biotechnology
Arlen D Meyers, Sarika Pruthi
There are various definitions of an entrepreneurial university, yet there is a lack of agreement about its core components. This article defines the five key characteristics of an entrepreneurial university based on examples of successful bio-clusters in the United States and Europe, and suggests an agenda for stakeholders…
Full details at the Journal of Commercial Biotechnology

Patent strategies for life sciences companies to navigate the changing patent landscape
David J Dykeman, Danielle T Abramson
As a result of the global recession that began in 2008, life sciences companies face a groundswell of new business and regulatory pressures that includes health care and patent reform, increased pricing pressures, and diluted markets. Bringing new products from discovery to market is becoming more expensive and unpredictable…
Full details at the Journal of Commercial Biotechnology

FDA at BIO 2011 – Weighing a hefty mission: Where is the balance?
Suzanne Levy
The mission of the Food and Drug Administration (FDA) is to promote public health by ensuring the safety and quality of food and medical products sold in the United States. At this year’s annual Biotechnology Industry Organization (BIO) convention, significant discussion revolved around the appropriate interpretation and execution of that mission…
Full details at the Journal of Commercial Biotechnology

For more information, see the Journal of Commercial Biotechnology

Biotechnology companies can play an important role in advancing technologies for global health. Initiatives such as Genzyme's Humanitarian Assistance for Neglected Diseases and Alnylam's Intellectual Property (IP) contributions to the Pool for Open Innovation against Neglected Tropical Diseases show a commitment to helping produce badly needed health technologies, but unmet needs for new drugs, vaccines and diagnostics for diseases affecting developing countries remain. Controlling malaria, visceral leishmaniasis and other infectious diseases that cause significant morbidity and mortality requires new and improved technological tools. Biotechnology companies’ expertise in biologics, point-of-care diagnostics and preclinical drug development is invaluable in this field, which is short of innovators.

Most firms, however, face disincentives in conducting R&D for global health since product markets are small and uncertain, the scientific problems are tough to solve, and few existing financing or policy mechanisms compensate for the risk. Product Development Partnerships and other non-profit initiatives have taken on much of the work in this area through grant financing and have often partnered with industry, but biotechnology firms could play a greater role. New policy and financing mechanisms that can balance the investment equation and encourage biotechnology and pharmaceutical firms to include global health diseases in their R&D portfolios could unleash important advances in global health technologies.

Full details at the Journal of Commercial Biotechnology

Following on the heels of my post on Globalization in the Pharmaceutical Industry, it is also useful to examine the distribution of inventorship across the United States. The stakes aren’t quite as high here — public health and national security don’t come in to play — but there still are important implications for economic development.

Using the same methodology, assigning relative inventorship of the patents from each year’s approved drugs from 2000 through 2010 (source: www.DrugPatentWatch.com), I focused on US inventors and examined the distribution by state.

1: New Jersey and California lead the nation

There aren’t too many surprises at the top of the list; one would expect New Jersey, California, and Massachusetts to top the list. Going further down the list shows strong activity in states that might not get the attention they deserve as leaders of pharmaceutical innovation.

2: Some states show surprising volatility

While the patenting activity in states like New Jersey and California seems relatively stable year-over-year and fairly tracks the graph’s overall trend, there is great volatility in other states. Massachusettts and Ohio, for example, show sharp spikes in absolute and relative terms. This activity merits additional investigation, and is potentially an opportunity for regional economic development authorities to identify and support the activities enabling the spikes.

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

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

I’ve just published the Pocket Biotechnology Industry Primer and Glossary as an ebook. This book, which was previously only available as a printed book, is now available in digital format, which means greater convenience and a significant price reduction. This primer and glossary presents a broad, accessible, and comprehensive overview of the biotechnology industry and the factors shaping it, enabling readers to understand and profit from the expanding influence of biotechnology.

For more information, see Building Biotechnology, the leading textbook in biotechnology management programs, from which this primer was derived.

The global locations of drug invention are important for public health, economic development, and national security reasons. Inventors tend to focus on diseases endemic to where they live. This is one of the problems of neglected diseases — there are few/no researchers working on certain diseases, which can lead to significant public health problems. Drugs are also excellent exports — fetching high prices and being relatively inexpensive to ship — so they can generate foreign currency enabling global trade. The individuals and companies involved in drug development tend to have high wages and revenues, building tax bases. Finally, weak innovative capacity can lead a country to be dependent on others to deliver medicines for domestic needs (see point #1 above) and to resolve health crises.

So, we know that much of drug development, such as medicinal chemistry, compounding, and clinical trials have spread overseas. We also know that much of manufacturing has spread to low wage-cost countries. The remaining question is: Where are drugs invented?

Using a methodology in introduced in my previous publication on the topic, I examined the locations of inventors listed on drug patents from 2000 through 2010 (source: DrugPatentWatch.com). The results are presented below:

1: The US is the global leader in drug inventorship, but is slipping

The top figure shows the relative contribution of each region’s inventors to the set of patents on drugs approved in each year. The data are all normalized, so you can see relative trends in each country’s contribution. The bottom figure below shows the same data, using lines to make it easier to  observe the trends. What is clear is that the US dominance is decreasing and Europe’s representation appears to be rising. The region of East and South Asia appears to be sporadically increasing its representation with it’s activity being mirrored by corresponding decreases in relative European inventorship.

2: Who is gaining?

With US relative inventorship dropping, and European inventorship showing volatility around a relatively flat trend, it is important to ask the question: Who is gaining inventorship as the US drops? One might assume that one or both of the emerging economies China and India are responsible for the increase in Asian drug inventorship, but the data do not support this assertion. The figure above shows the top ten countries where drugs were invented from 2000 through 2010 — China and India are not on the list. Rather, it is pharmaceutical veteran Japan, which has the third most inventors, that is responsible for Asia’s increase. What’s more, the top ten countries is largely comprised of the legacy pharmaceutical countries. That data show that there is no significant migration of pharmaceutical invention from the legacy pharma countries.

This metric represents a useful tool with which to monitor globalization of pharmaceutical innovation. There are two interesting observations that merit further examination. 1) Is there a correlation between the mild US decline and the growth of Japan? 2) Is there a correlation between the spikes in Japan’s relative inventorship and Europe’s sharp dips?

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.

“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.

Thanks to a new sponsor, Breathing Additional Life into the Life Sciences is now free.

The Journal of Commercial Biotechnology, published by thinkBiotech along with BiotechBlog, is proud to serve as a media sponsor for this upcoming conference on biotechnology development.

Reaching the Next Milestone

Conference on Breathing Additional Life into the Life Sciences

Date: Friday, November 4, 2011          Time: 7:30 AM to 3:00 PM

Purpose of Conference

The future for life science companies is extremely promising, full of enormous opportunities. However, life science companies face ever increasing challenges, from finding seed money, finding venture or angel investor funding, dealing with universities or the Federal Govern­ment, protecting their intellectual property and resolving IP related disputes, determining specific technologies needed for growth or seeking potential licensees, to mak­ing financial decisions regarding various courses of ac­tion.

This conference is designed for biotechnology/pharmaceutical company decision makers in enabling them to reach the next milestone, no matter what stage their company is in presently. The conference deals with addressing attracting funding, making technology based decisions, and protecting their intellectual property, to best capitalize on their efforts. University technology transfer attorneys, government attorneys and others stand to benefit from attending as well.

Our speakers come from a vast array of perspectives and experiences, spanning in-house counsel, a certified licensing professional, a publisher of biotechnology magazine, a technology transfer and commercialization professional, a Director of Technology Transfer Officer of a division of NIH, a financial consultant and intellectual property professionals.

Speakers and Panelists

Keynote Speaker: Larry R. Miller, Ph.D. – Director, Global & Project Communications for FHI 360 and President/Consultant ISBC Solutions, LLC; former Director Business Operations, Global Drug Discovery, GlaxoSmithKline)
Stephen Auvil, Vice President – Technology Transfer & Commercialization, Maryland Technology Development Corporation
Akihiko Okuno, Partner, SK IP Law Firm, Japan
John Weatherspoon, Ph.D., Of Counsel, Stein McEwen LLP; General Counsel, Gene Facelift LLC
Scott Williams, AVA, CLP, Director, Invotex Group
Yali Friedman, Ph.D., Chief Editor and Publsher, Journal of Commercial Biotechnology
Ginette Serrero, Ph.D., Co-Founder and CEO of A&G Pharmaceutical, Inc.
Claire T. Driscoll, Director, Technology Transfer Office, National Human Genome Research Institute (NHGRI), NIH
Dennis Clarke, Of Counsel, Stein McEwen, LLP
Joseph Zito, Of Counsel, Stein McEwen, LLP

Complete details are available at http://www.smiplaw.com/seminar.cfm

What does selling bacon on the Internet have to do with biotechnology business development? Almost nothing! But, that is what makes this book so valuable.

From Idea to Web Start-up in 21 Days: Creating bacn.com describes a shoestring venture to develop a simple web store. The founders decided to sell bacon due to the strong market draw (everybody knows what bacon is, and many people like it). The challenge is to differentiate a universally-available product, market it, and distribute the perishable good while making a profit.

The relevance of this book to biotechnology business development is that it focuses on all the things that many biotechnology entrepreneurs don’t (but should) think about. There are no patents, there is minimal R&D — the emphasis is on marketing and distribution. Even more, the authors frankly describe their many mis-steps. They struggle to buy inexpensive but effective infrastructure (freezers), they make bad co-promotion deals, and they search for ways to exit the business. These types of challenges are shared by biotechnology companies.

The simple nature of the bacn.com business, and the focus on elements that many early-stage biotechnology founders ignore, make it an excellent resource. I recommend this book for any early-stage entrepreneur.

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: