Should the HHS Decision to Overrule FDA on Plan B Be Reversed

On December 7, 2011, Secretary of Health and Human Services Kathleen Sebelius overruled a decision of the Food and Drug Administration (FDA) on the over-the-counter (OTC) status of emergency contraception.

What will be the repercussions of Secretary Sebelius’s action? Why is the act itself of far greater long-term significance than the transitory regulatory action it impacts?

By reversing an FDA decision, the Secretary has set a dangerous precedent for all-comers to lobby Congress, the Department of Health and Human Services (HHS) and the White House on any and all FDA decisions—directly inserting politics into what must be a scientifically driven process.

Full details at the Journal of Commercial Biotechnology

A Patient Centric Commercial Model for Cancer Care

Cancer is one of the most challenging diseases of all – not only in terms of the clinical barriers to offering its sufferers respite from devastating consequences, but also to manufacturers and marketers of treatments that attempt to control its impact…

Getting Social with Biotechnology Business Development

Social media is becoming increasingly important in business. While the lack of regulations makes marketing online to consumers a challenge in the life sciences, social media offers significant opportunities to the industry by complementing traditional business development and capital raising activities.


With relatively little effort and expense, companies can build networks, gain trust, and obtain introductions with previously inaccessible targets and distant markets. In embracing social media, individuals themselves become more approachable and open themselves up to business growth that might otherwise have been unattainable.

Full details at the Journal of Commercial Biotechnology

The financial ecosystem available to early-stage biotechnology firms and its misalignment with interests of these firms, of the biotechnology industry and with global disease burden

The development and commercialization of new therapeutics have had immense impact on the quality and length of human life.  Nevertheless, the biotechnology and the pharmaceutical industry have evolved to be driven mostly by a profit oriented market system, in which distinct stakeholders interact with different motivations to make the development and commercialization of therapeutics a reality.  This study discusses the funding ecosystem available for early-stage biotechnology companies and its influence on the their strategic business objectives and on the biotechnology industry.  On the basis of this, distinct paradoxes in the funding ecosystem are uncovered, which suggest that the present ecosystem is not well aligned with the interests of these biotechnology firms, the biotechnology industry, and it neglects strategic disease burden needs. It is recommended that even partial resolution of these paradoxes will enable further growth in the industry and lead to more innovative therapies for untreatable diseases with large social and economic burdens.  In light of this, the study proposes improvements of financing approaches and an increase of available capital in the funding ecosystem of early-state biotechnology companies.

Full details at the Journal of Commercial Biotechnology

Challenges and prospects for monoclonal antibodies in China

The technology of monoclonal antibodies has been developed since the 1990s and is attracting more and more attention in China during the 21st century. The first monoclonal antibody product was introduced by the Chinese local producer in 1999, and presently seven products are listed, of which three are humanized products. There are several technical constraints that are affecting the development of monoclonal antibodies in China: limitations to the number of drug targets, restricted biological diffusion, limitations to administration routes, and species-specific issues, as well as China’s own limitations in production and R&D capabilities. This article provides suggestions relevant for the Chinese development of monoclonal antibodies. In the long run China is expected to catch up with its own technology roadmap.

Full details at the Journal of Commercial Biotechnology

Technology Transfer: Bridging academic research and society – a communicative approach

To make basic research transcend the walls of a university for the benefit of the society, technology transfer processes such as patenting, market analysis, and economic assessment are essential. Therefore small dedicated units, called technology transfer offices, have emerged during the last four decades. The emergence is a manifestation of a general political intention to make basic research have direct impact on society – to focus on application and publication, and not just the latter. The process is, however, not straightforward and different universities have different way of doing it.

University of Southern Denmark has recently implemented a highly extrovert and progressive science-based communicative strategy providing an adequate framework for a “grass-roots moving” among researchers. By working on four frontlines we aim to ensure high degree of transparency in the technology transfer activities, to demythologize pseudo-idealistic and inadequate perceptions on the role of e.g. patents, to scout early-stage business opportunities, to map the competence landscape of the university and to ensure a three-faceted political alignment.

We here present what we would call the SDU-model of doing technology transfer anno 2012. Despite the short timeline in which it has been implemented we already harvest the early fruits of the model, which encourage us hereby to present the model, its underlying strategy, its rationale and its perspectives. We believe that the model are unique with respect to the holistic four-frontline focus, addresses some of the major challenges of academic technology transfer and we are confident that universities worldwide could benefit from it or a context-dependent modified versions hereof.

Full details at the Journal of Commercial Biotechnology

Capturing Value

Today’s pressure on pharmaceutical companies reflects greater pressures throughout the entire healthcare ecosystem as payers, patients, and providers wrestle with escalating costs and drive  healthcare systems around the world away from being cost-based to becoming value-based.  For pharmaceutical companies, this means not only a greater emphasis on creating value, but seeking new ways to capture value as well, particularly at a time when drugs will need to demonstrate they provide benefits commensurate with their costs and governments and payers squeeze down prices.    The challenge for drugmakers, broadly speaking, is to both find new ways to create value and capture value.

Full details at the Journal of Commercial Biotechnology

A Business Perspective on IP: Open Innovation vs. Open Source in Commercializing Biotechnology

Abstract – In this article, we address the issues that are involved when developing a strategy for commercializing a discovery that is novel, useful, and non-obvious to someone skilled in the art.  Patent(s) may be used as one means of providing a competitive advantage, and in addition this method is quite common as a means to monetize the intellectual asset.  Alternatively, a more “open-source” method may be employed as is more typical in dealing with software products or services – thereby opening up the field to collaboration and widespread use.  However, other means must then be developed to monetize the asset whether it involves a “hardware” component, software, or both. We argue that to answer these questions, one needs to be very strategic in framing the business model that would be most successful in commercializing the particular discovery keeping in mind that wide dissemination of the innovation is the objective. We focus on issues prevalent for innovation in biopharma, medtech, and medical IT, where high risk, long life cycle, capital-intensive investments are required for commercial introduction.

Full details at the Journal of Commercial Biotechnology

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