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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.

The BIO meeting hosted 15 646 participants from across industry, government and the nonprofit sector, focusing on the current state of the biotechnology industry, as well as its challenges in seeking to further improve public welfare. Perhaps partly because this year's meeting was held in Washington, DC – the seat of the federal government and of BIO's headquarters – much attention was paid to the US regulatory environment. In particular, attendees debated the quandary faced every day by the FDA: how to enable access to novel therapies quickly, but only once their safety has been certified.

Full details at the Journal of Commercial Biotechnology

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. In the pharmaceutical sector, some predict that the age of the blockbuster drug has ended as generics present a growing threat to the pharmaceutical giants. Further, with a large number of key patent expirations looming through 2014, analysts expect that large pharmaceutical companies will lose over US$150 billion of revenues of brand name drugs.

In response to declining sales and rising R&D costs, the life sciences industry is pursuing new market opportunities by expanding beyond the developed markets of the United States, Europe and Japan, and into emerging markets such as China and India. Despite market uncertainties, however, venture capital funding in the life sciences sector (including pharmaceuticals and medical devices) is on the rise with $2.1 billion going into 206 deals during the second quarter of 201l, an increase of 37 per cent in dollars and 12 per cent in deal volume. To survive – and thrive – in these tumultuous times, both large and small life sciences companies face pressure to develop new products and technological advancements.

Patents are pivotal to the life sciences industry. In order to succeed, life sciences companies must distinguish themselves from their competitors through their intellectual property portfolios. A successful patent portfolio represents a well-reasoned business strategy, where each patent is a single strategic building block in a larger portfolio that reflects present and future business objectives. A strong patent portfolio is also important in the current life sciences investment climate, where venture capital funding is often dependent on whether a company has secured its intellectual property assets, thereby validating a company's technology and demonstrating its commercial potential. Although building and maintaining a strong patent portfolio is important for all life sciences companies, it is most critical for early-stage companies. Patent portfolios are often the driving force for major events in the life cycle of a life sciences company, including mergers and acquisitions, public offerings, venture capital investment, strategic collaborations, joint ventures and litigation.

As a result of recent measures taken by the US Congress, the US Patent and Trademark Office (USPTO) and the US Supreme Court to reform the current US patent system, life sciences companies must respond with strong patent strategies that address these reforms without sacrificing the company's competitive edge in the marketplace. Such comprehensive technology strategies must maximize patent coverage of a company's current core technology and future improvements, monitor the patent landscape and explore ways to patent white space, and consider cross-licensing opportunities with competitors. With these strategies in place, life sciences companies can withstand patent reform and ensure their success in today's competitive and rapidly evolving global commercialization landscape.

Full details at the Journal of Commercial Biotechnology

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

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. Three key provinces (Quebec, Ontario and British Columbia) that have taken significantly different approaches to attracting VC are large enough to attract as much government investment as whole emerging markets. The aim of this article is to present evidence from a Canadian natural economic experiment in order to evaluate the effectiveness of varying government policies in attracting VC investment, to illustrate how these policies need tailoring to individual sub-sectors of the life sciences sector, and to highlight potential policy mechanisms that may be applicable beyond Canada's borders. We employ VC returns on investment (ROI) and exit data as a proxy for our evaluation. Our results suggest that government biotechnology investment needs to be structured end-to-end from early to late stage in order to be successful, that prevalence of private and international VC flows is critical for generating market efficiency, and that there is an ‘optimal’ efficient amount of capital before ROI result in diminishing returns.

Full details at the Journal of Commercial Biotechnology

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. The forces driving the technological change are a mix of process efficiencies (including cost reduction) and sterility assurance. This article examines the advantages of some single-use systems used for aseptic processing, although in doing so a cautionary approach is adopted, particularly with regard to the validation requirements and practical considerations when such technologies are implemented.

Full details at the Journal of Commercial Biotechnology

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). The article finds that overall, the strength of national pharmaceutical IP environments provide a good estimate of the level of clinical trials taking place in these countries. Accordingly, countries with a more robust level of pharmaceutical IP protection tend to enjoy a greater level of clinical trial activity by multinational research-based companies. In other words, by choosing to improve their level of protection of pharmaceutical IPRs (together with other factors), developing countries may also be exposed to higher levels of biomedical FDI, not least in the field of clinical trials.

Full details at the Journal of Commercial Biotechnology

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. The innovation strategies of design firms are different than traditional models of academic and scientific scholarship and rely on new models of radical collaboration by teams, knowledge sharing, wide-reaching cross-pollination and the habit of gaining early insights through tangible expressions of ideas in order to foster continual and rapid innovation.

Full details at the Journal of Commercial Biotechnology