Author name: Yali Friedman

General Biotechnology

Reverse Stock Splits in the Biotechnology Industry: An Effectuation Approach

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. 

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General Biotechnology

Cell Therapy: Early Process Development and Optimization of the Manufacturing Process are Critical to Ensure Viability of the Product, Quality, Consistency and Cost Efficiency

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.   

Cell Therapy: Early Process Development and Optimization of the Manufacturing Process are Critical to Ensure Viability of the Product, Quality, Consistency and Cost Efficiency Read Post »

General Biotechnology

Biogenerics 2007: How far have we come?

Journal of Commercial Biotechnology
This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Biogenerics 2007: How far have we come?

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ABSTRACT: The recent approval of a follow-on version of Pfizer’s Genotropin (recombinant human growth hormone) signalled the beginning of the end of an era in which biopharmaceuticals enjoyed immunity from competition even after expiration of their patent protection. This paper describes many of the key scientific challenges facing the nascent ‘biogenerics’ industry and the evolving regulatory framework that will shape its competition with innovator companies…

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

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General Biotechnology

Kinik: Raising the stakes for importing products derived from US patented processes practised abroad

Journal of Commercial Biotechnology
This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Kinik: Raising the stakes for importing products derived from US patented processes practised abroad

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ABSTRACT: This paper analyses the recent ruling in Kinik Co. v. Int’l Trade Comm’n, 362 F.3d 1359 (Fed. Cir. 2004), and the impact that decision may have on proceedings before the US International Trade Commission under the Tariff Act of 1930 (19 USC §1337(a)) – particularly those concerning the importation of products derived from practising US patented processes abroad.

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

Kinik: Raising the stakes for importing products derived from US patented processes practised abroad Read Post »

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