Ihave had the pleasure of participating in national forums on biotechnology development in diverse countries. A common theme I see is that emerging economies wish to develop ‘a biotechnology industry like the United States.’ I generally temper these ambitions by explaining that the United States does not have a biotechnology industry per se, but rather a handful of states have very strong biotechnology concentrations and many other states are still trying to build their domestic biotechnology industries. So the lesson for many emerging economies is to set ambitions at the US-state level rather than the US-national level. Furthermore, I also caution against aiming for drug development. Drug development is extremely expensive and risky—focusing on domestic agricultural or industrial biotechnology opportunities may be a better option.
In recent years, the major research-intensive biopharmaceutical companies (big pharma) have come face to face with a perfect storm of eroding profit margins from blockbuster expiration and generic competition coupled with growing R&D expenses and declining advances in truly novel therapeutics. With long-term research divisions shed in favor of short-term outsourcing options and with public good will at historic lows, industry innovators have sought to reinvent the model of big pharma, its relationship in public-private partnerships, and the role of technology and technology policy in reform. In this paper, we highlight a number of the major alliances reshaping the industry and the role of government, research institutions, and other players in the public-private interface in these endeavors. In particular, this paper looks beyond traditional biotechnology parternships and focuses instead on the developing consortia between biopharmaceutical companies and with clinical research organizations and academic institutions. We examined each alternative model of alliance, identified specific hurdles and potentials for increased productivity.
Canada plays a significant role in the global advancement of scientific discoveries and their translation into commercial opportunities, but is viewed as not fully realizing its commercial potential. A significant problem has been a lack of sufficient venture capital to take early-stage companies to the next level. Several recent developments may signal the arrival of a more positive venture-funding environment for life sciences and health technology enterprises, including the development of the Canadian government’s C$400 million Venture Capital Action Plan; pharmaceutical companies electing to establish or investing in venture funds and providing strategic support to early-stage ventures, including through the creation of research centres; and recent successful liquidity events for venture investors.
The growing share of biopharmaceuticals is paralleled by an increasing interest in biogenerics, as blockbuster biologics are approaching their patent expiries. Companies need to make decisions whether to invest in biosimilars or in biobetters with enhanced properties, the latter enabling favorable differentiation vis-à-vis the original product on the one hand and biosimilars on the other hand. Net present value (NPV) modelling was applied to evaluate the financial attractiveness of two categories of biobetters in comparison to biosimilars, and recommendations are made which options should be preferred depending on a company’s business model.