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

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March 31, 2013

31 Mar 2013

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. Products developed and manufactured through biotechnology dominate the commercial landscape for treating a variety of cancer types. The recent spate of new biologic launches for treating cancer delivered through injections, infusions and orally will only increase in the next five years. The task of developing a viable commercial model for the effective delivery of cancer treatments to its customers lies at the center of ensuring that advances in cancer care are harnessed for their full potential. Both by definition and due to the reality of the cancer landscape, such a model is best conceptualized with the patient at its center. This article describes elements of a patient centric commercial model for cancer care, after recognizing the challenges and opportunities inherent in its commercialization and marketing. The impact of such a model resides in its ability to offer tangible benefits to patients by improving access to leading edge treatments, energizing communication at the point of care, and adequately harnessing the emerging promise of new technology - rather than an emphasis on share-of-voice based selling. By viewing the patient at the center of a commercial model, manufacturers and marketers of cancer care treatments can offer products that provide ongoing care for the cancer patient from initiation through palliation, thereby building loyalty and realizing the full potential inherent in such treatments.

Full details at the Journal of Commercial Biotechnology

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March 31, 2013

31 Mar 2013

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

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March 31, 2013

31 Mar 2013

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

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March 31, 2013

31 Mar 2013

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

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