As the biopharmaceutical industry undergoes restructuring, its focus shifts to the efficiency of drug development and overall costs of delivering affordable medicines. A question often raised concerns the manufacture of drug substances overseas to tap into a cheaper manufacturing base (1). There are many issues to consider when looking at overseas locations, such as intellectual property (IP), the availability of skilled labor, and the emergence of new markets. The situation is more complex with biopharmaceuticals because the products…
BioRegions
Planning Export Compliance for Cross-Border Growth
Business or research groups planning to expand research, manufacturing, sales, or distribution activities beyond the United States should plan for compliance with US and international export and import rules and understand how these rules apply to various technologies. Export and import requirements can be complex and highly technical. Failure to allow for the long lead times needed to frame and implement internal export policies and procedures as well as engage third-party export services can lead to additional expenses, delayed export…
Ireland for Science, Technology, and Innovation
Ireland is an exciting place when it comes to research, development, innovation, and commercialization in biologics and life sciences. The government of Ireland’s strategy for Science Technology and Innovation (ST&I 2006–2013) includes key deliverables stressing the importance of a dynamic infrastructure to enable further growth in these important fields. A strong foreign direct investment policy has secured >US$5 billion from global players including Genzyme, Centocor, Merck, Wyeth, and Pfizer in recent years. Ireland also has built a strong indigenous biotech…
A World of Possibilities
Biotechnology truly is global, with some form of the industry in progress on every continent but Antarctica. Countries such as Brazil are even outpacing Europe and North America in the advancement of biofuels technology. But as in the developed world where this industry began, we see other countries looking first and foremost to the medical applications of biotech — because historically that’s where the money has been. Some countries are building their own fully integrated bioindustrial sectors.…
Growing the Future
No segment of the biotechnology industry has received more public scrutiny than agricultural biotech — except maybe its application to food. And none has been subject to more “hype†and high hopes for instant results than biofuels. By contrast, industrial biotechnology seems almost invisible to the public at large. In general, the more immediate the effects on consumers, the more likely they are to pay attention and either laud or loathe the associated technology. The general public…
The Future of US Science and Technology Policy
The United States’ global leadership in science and technology (S&T) is accompanied by a disturbing anomaly: a lack of interest in S&T issues in the country’s policy community. Although controversy has focused on specific issues (notably, embryonic stem cell research and climate change), its context has been less S&T and more about wider policy issues. The Center for Policy on Emerging Technologies (C-PET) is a nonpartisan think tank established with bipartisan support and participation from the corporate, policy, and civil…
Puerto Rico Aims to Be the Biotech Island
Our vision is to be the preferred partner for industry and academia for biotech training, research, and development in the American hemisphere by 2012.” That’s the vision statement of the Bioprocess Development and Training Complex (BDTC) in Mayaguez, Puerto Rico, which opened 11 September 2008. The BDTC is the latest in a series of developments designed to make Puerto Rico “Bio Island,” the goal of Governor Anibal Acevedo-Vila. As he described in a conversation with BPI at the 2008 BIO…
Partnering with a CMO in China
Many biopharmaceutical companies are evaluating the option of working with contract manufacturing organizations (CMOs) in China. There are probably as many reasons for following that strategy as there are companies doing the evaluating. However, regardless of the strategic plan behind pursuit of a CMO in China, there are key issues each company must consider as part of its due diligence before selecting one. Through a fast growing economy and government supported transition from low-margin to high-margin products, China is quickly…
Accelerating Commercialization
In summer 2007 the MaRS (Medical and Related Sciences) center in downtown Toronto broke ground for a massive expansion. The fact that this innovative science and technology commercialization facility is more than doubling in size — to 1.6 million ft2 — less than two years after its official opening, indicates the healthy state of life sciences in Ontario. MaRS is a state-of-the-art convergence center where leading venture capitalists, pharmaceutical companies, research funding agencies, and cutting-edge businesses come together under one…
The Biotech Boom Down Under
Australia is a key global player in biotechnology investment for the Asia-Pacific region. The environment is characterized by outstanding research facilities, accelerating employment in the industry, uniquely Australian discoveries, and burgeoning alliances between Australian and international companies. Australia’s biotech companies are rapidly maturing. The country has 427 core biotech companies that are active in human therapeutics (48% of companies), agricultural biotech (16%), and diagnostics (14%) (1). Partnerships between multinationals and Australian companies and research organizations indicate growing international appreciation of…