General Biotechnology

In the wake of the repositioning of Maryland’s Shady Grove Incubator from biotechnology to cyber security, Virginia has stepped up […]

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

The Journal of Commercial Biotechnology is published by BiotechBlog’s producer, thinkBiotech. Journal of Commercial Biotechnology Volume 20, Number 1 Russia-Focused

This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology
Mergers and acquisitions: A consideration of the drivers and hurdles
Go to paperABSTRACT: Mergers and acquisitions (M&A) are increasingly being include…

The role of marketing communications is to advance the bottom line and the public good – and not necessarily in that order. Giving back is an integral part of the New Normal. And there has never been a better tool to accomplish this mission than social media.

But healthcare marketing –and particularly of the regulated variety –is between a rock and a hard place. On the one hand, marketers understand the importance and opportunity in social media. It’s where the people are. It’s where the action is. But then there are all those pesky regulatory concerns.

As Walter O’Malley –the man who moved the Brooklyn Dodgers to Los Angeles once commented, “The future is just one damn thing after another.”

Since World War II, the majority of American wartime engagements have been characterized by a series of low-intensity, asymmetric conflicts. These conflicts have increased the importance of understanding the dynamics of individual actors within complex battlespaces which in turn has led U.S. military commanders, intelligence professionals, and wartime decision makers to seek a variety of means for identifying, tracking, and differentiating persons of interest. From the jungles of Vietnam to the mountains of Afghanistan, the process of understanding the movements and activities of hostile actors has become paramount to successful military targeting and combat operations. Over the last 50 years, the military and intelligence communities have developed a plethora of technologies capable of accomplishing this task to include overhead satellites, infrared imaging, unmanned aerial vehicles (UAV), advanced biometrics, and host of other personnel identifying and tracking technologies. While these technologies have closed the gap in enabling U.S. military and intelligence professionals to understand the human aspect of the battlespace, there are still significant challenges in uniquely identifying the movements and activities of specific persons or groups of persons.

            Given the above outlined challenge of understanding the battlespace, this article will explore an alternative means of identifying and uniquely tracking individuals. Specifically, this article will explore the combined use of remote sensing technologies and genetically engineered biomarkers in order to uniquely identify, track, and differentiate persons of interest. Such a combination of two disparate technical fields would be technologically challenging both within the biological and remote imaging scientific fields, thus emphasizing the paramount importance of combining biological markers with distinct signatures that are detectable by specific and technologically matching visualization means. In addition to discussing the technical challenges associated with such a combination of technologies, this article will also discuss both the potential military benefits and negative implications this process could have in ethical, legal, and diplomatic terms. At the conclusion of this article, the reader should have a fundamental understanding of how remote sensing technologies and biomarkers can be combined to better understand the battlespace as well as the possible implications of this technological paring. 

This paper offers some insights on the European regulatory situation with respect to raw materials used in production of gene, cell and tissue therapy products, including advanced therapy medicinal products. By focusing on the existing EU and French rules, the purpose of this paper is to review the content and scope of the measures restricting their placing on the market and/or use, the legal implications and hence key challenges ahead. Also known under the specific term ‘ancillary products’ in France, raw materials are subject to a fragmented regulatory environment that could indirectly hinder innovation in this rapidly evolving area. Taking account of contamination risk that could originate from such materials, the question as to whether it is necessary to assure their quality and safety by means of one or various regulatory instrument(s) does not arise. Nevertheless, it is vital that, in a sector as innovative as this one, an appropriate and more predictable regulatory regime applies in Europe, which requires undertaking a constructive work aimed at harmonising the rules in relation to production of and trade in raw materials intended to be used for advanced therapies while ensuring the EU objective of public health protection: a work already in progress.

According to the World Intellectual Property Organization, nearly 100,000 pharmaceutical and biotechnology patent applications are filed each year around the world, and the trend is increasing. These companies have very little room for error in the work they conduct each day. As a result, the translations of these patent applications need to be completely accurate, which requires a translation service provider who follows best practices. These best practices include centralized processes, highly specialized teams, quality control, terminology management and advanced technologies.

By following them, they will ultimately reduce office actions and litigation risks, as well as decrease time to grant. 

This case study will highlight how a large biotechnology company worked with their translation service provider to develop a series of best practices for the translations of their intellectual property, focused primarily on their patent applications. Readers will come away with an understanding of how their multinational enterprises can leverage these best practices to get improved quality, reduced time to grant and more filings for the budget.

Investment in start-up biotech. companies outside the USA has essentially disappeared. VC investment in biotechnology and healthcare as a whole has nearly returned to pre-2008 levels, but almost all is in later stage opportunities. But companies continue to be founded, and continue to flourish. We examine the VC investment patterns for the past 7 years, and show that a start-up today can expect little VC support. We show from companies’ financial records that companies are adopting financial models based on angel investment, grants and revenue, and moving away from business models that need substantial investment. There is a time lag, but government and research council policy is beginning to recognize and align with the new investment realities. We believe this trend will accelerate as internet-mediated angel investing, such as crowd-funding schemes seen in other sectors, become a developing force in the next decade.