General Biotechnology

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,

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…

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.   

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.

This paper examines the creation of a forensic biotechnology program that engages students, promotes science learning beyond the classroom and makes available novel STEM opportunities to an area which previously had little biotechnology educational off…

The purpose of this investigation was to examine the association between changes in corporate marginal tax rates (MTRs) and measures of both innovative activity and capital structure among publicly-traded biotechnology firms.  Across a 1980-2010 time frame, a five-year distributed Almon lag model was utilized to assess the effect of annual changes in MTRs upon patenting activity, research and development (R&D) expenditures, cash and short-term investments, debt-to-asset ratios, and debt-to-equity ratios.  Across the 99 biotech firms studied, results suggested that increases in MTRs were significantly associated with marked decreases in patents, R&D expenditures, and cash and other short-term investments.  Additionally, large and statistically significant increases in both debt-to-asset and debt-to-equity ratios were observed with annual increases in MTRs.  While this research can not necessarily discern whether capital structure changes occurred either as an ex-ante response to or an ex-post result of MTR increases, the implication of decreased patenting activity warrants continued evaluations of both internal financial decision making and external tax policy.

Good leaders in the biosciences share multiple characteristics, starting with certain personality traits – some that are particularly unique and important to the bioscience sector.   They also understand certain concepts, which are necessary for bioscience companies to be successful.