This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology
Growth of Indian biotech companies, in the context of the international biotechnology industry
Go to paperABSTRACT: The paper discusses the evolution and…

This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology
Technology transfer in the biomedical sciences: The Medical Research Council approach
Go to paperABSTRACT: This paper describes why the UK Medical Resear…

This is a guest post from Robert E. Wanerman, a member of Epstein Becker Green’s Health Care and Life Sciences

This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s

Patents require regular ‘maintenance’ payments to keep them in force. Because the cost of maintaining large patent portfolios can be substantial,

Healthcare innovation saves lives, saves money, promotes economic growth, and provides hope for hundreds of millions of people (both patients and care-givers) in the United States and around the world. But innovation isn’t easy.

There are many roadblocks beyond those of discovery and development. The complicated and conflicting dynamics of politics, perspectives on healthcare economics, of friction between payers, providers, manufacturers, and regulators, the battle for better patient education, and the need for a more forceful and factual debate over the value of innovation all create the need for a more balanced and robust debate.

Should we blame our skewed priorities? American healthcare often works miracles when people become very ill, but it needs to do a better job with preventive care. Equally to blame is the fact that we spend a disproportionate amount of our healthcare budget for end-of-life care.

Rather than tangle up the already volatile healthcare debate in ethical arguments over whose life is worth more, it would be smarter to shift the focus to keeping people healthier longer. Earlier diagnosis and care are crucial to the future health of both Americans and American healthcare—and pharma has a starring role here.

We cannot afford, in terms of dollars or lives, to continue the blame game. In order to deliver on the promise of affordable and quality healthcare for all citizens, all the players in the healthcare debate must work together. At the end of the day, we should unite against our common enemy—disease.

And our most potent weapon in innovation.

In recent years cell therapies have evolved and matured, moving from academia to industry. Scale up of a process is the natural path of any product evolutionary development and maturation, this process not only allows higher manufacturing capacity to meet demands but rather to increases the yields and reduces cost of goods. Cells are living things that react to the environment and conditions in which they grow, therefore process changes should be done as early as possible. The traditional 2D culturing systems can be truly up scaled, therefore there is a need to advance to bioreactors that will influence the product. Additionally, in order to make cell therapy a viable one, the cost of manufacturing is critical. Cost drivers such as media, serum, footprint, human resource and infrastructure must be optimized without changing the cells critical quality attributes. The paper analyze the main cost drivers on the cost of goods and is based on the experience of cell manufacturing in both traditional 2D and three dimensional (3D) bioreactor systems produced in Pluristem therapeutics GMP site. Furthermore, the paper discussed possible process development steps to insure cost efficiency emphasizing the need and benefit of early process development investment.   

The paper presents the limited quantitative and qualitative analysis of the biotechnology and ICT industries in Lithuania and Estonia, as well as public policy instruments aimed at supporting the development of these industries. In depth analysis of th…

Using an effectuation theory lens, we study reverse stock splits in the biotech industry where significant uncertainty makes specific scenarios of success difficult to predict. We conjecture and find that, in contrast to other environments where there is less uncertainty, reverse stock splits in the biotech industry are followed by positive abnormal returns over the subsequent 1- to 12-months. Also consistent with our effectuation-based predictions, we find that these returns are positively related to the reverse split ratio, size, cash holding, and long-term debt, and negatively related to the market-to-book ratio and firm age. We also find that liquidity increases after a reverse stock split. These results suggest that the concept of effectuation theory is better suited to analyzing reverse stock splits in the biotech industry.