2015

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. 

Self-healing concrete has been scrutinized by several researchers and some industrial concrete producers in relation to the remediation of the occurrence of micro-cracks. Such cracks are a quite well known problem that can lead to corrosion of the steel reinforcement and thus to the possible failure of the entire concrete structure. The need to repair these cracks as soon as possible leads to maintenance costs which can be of the order of €130 (direct costs) per m³ of concrete. Recent scientific studies indicate that a Microbial Induced Carbonate Precipitation (MICP), using microbial spores as active agent, can be an alternative for the actual repair methods. However, the production of bacterial spores is yet imposing considerable costs. According to some concrete producers they would be willing to pay about €15 to €20 per m³ of concrete for a bio-based self-healing product. However, the actual cost of spores production and encapsulation represent a total cost which is orders of magnitude higher. This article analyzes the costs for the biological self-healing in concrete and evaluates the industrial challenges it faces. There is an urgent need to develop the production of a bio-additive at much lower costs to make the biological self-healing industrial applicable. Axenic production and a possible non-axenic process to obtain ureolytic spores were analyzed and the costs calculations are presented in this paper.