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.”

Neurodegenerative diseases are one of the leading public health challenges of the next 50 years. Pharmaceutical therapies have traditionally targeted the later stages of neurodegenerative diseases; however, this strategy – as the recent failures of clinical trials for Alzheimer’s drugs have highlighted – has been unsuccessful. Venture capital has underperformed as well during this time, as many new companies have been unable to maintain growth once they reach the public market and have produced less than desirable returns. As a result, venture capitalists have opted for later-stage financing. Nevertheless, new technologies are being developed to answer the question of how to best address neurodegeneration. New tools of detection will allow for much earlier diagnosis and a much greater chance of discovering and applying effective treatments. Realizing that genetic knowledge is insufficient to produce innovative treatments for neurodegenerative diseases, scientists have begun to apply the genetic knowledge attained towards a future of individualized treatments. As these new tools of detection converge with an increased ability to create very precise individual solutions, the risk of successful future investments should come down and provide the potential for outsized returns that have traditionally governed the venture capital financial model.

This paper analyzes the approaches taken by the Russian government to promote innovation in the biotechnology sector within the country.  Russia is economically strong, currently with a trade surplus, and the country is investing broadly in initiatives that have resulted in in-bound technology transfer, as well as an expansion of the private sector.  These initiatives include government venture capital and investment funds, as well as physical technology “incubator” centers.  The result has been an increase in the number of clinical-stage biotechnology companies operating in Russia, as well as an increase in the number of pharmaceutical candidates undergoing trials in the country.  The biotechnology “boom” has also resulted in an increase in the number of early-stage companies.  This paper investigates current deal and investment trends from the funds that are the principal supporters of biotechnology companies in Russia.

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.

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.

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.

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

This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology
Human cell- and tissue- based products: Progress, promise and regulatory issues
Go to paperABSTRACT: The field of cell- and tissue-based products is radical…

The fourth edition of Building Biotechnology, the premier biotechnology industry primer, is now available. Building Biotechnology has been adopted by dozens of

This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology
Embryo and stem cell research: Views from the USA
Go to paperABSTRACT: Presents a study that examined the history, ethical debates and religious views rega…