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 r…

In this article, we look at how patent filings in three key areas of genome-related research indicate the direction of private and public research in sequencing technology, personalised medicine and synthetic biology. Patent landscaping allows for anal…

The Biotechnology Industry Organization (BIO) held its 2014 Annual Convention at the San Diego Convention Center, CA (June 23-26, 2014). This event was attended by more than 15,660 industry leaders that included 2,500 Chief Executive Officers (CEOs), several U.S. Governors, and ­representatives from 50 states and 70 countries. The BIO Exhibition saw presence of over 1,800 exhibitors with 55 state and international pavilions. Additional features of the Convention comprised 192 company presentations, 800 speakers and 160 sessions in 9 specialty forums and 8 educational tracks and 29,000+ one-on-one partnering meetings between 3,100+ ­companies. Keynote speakers featured Sir Richard Branson and Former Secretary of State Hillary Rodham Clinton. 

There are currently only two biosimilars on the market in the US in contrast to the 21 biosimilars have been approved in Europe since 2006. Part of the reason for the lack of biosimilars is that until recently, there has been no abbreviated pathway for a biosimilar to reach the market meaning that biosimilars had to undergo the long and costly process of obtaining approval just like an innovator biologic product. After years of negotiation, however, the Biologics Price Competition and Innovation Act (the “Biosimilars Act”) was signed into law on March 23, 2010, by President Obama as Title VII of the Patent Protection and Affordable Care Act. The Biosimilars Act established an abbreviated pathway by which the FDA could approve generic versions of previously licensed biological products. The Biosimilars Act sets forth several requirements for biosimilar applications, including the so-called “Patent Dance” which describes the process by which the biosimilar applicant and the reference product sponsor (“RPS”) exchange patent-related information before the biosimilar can enter the market. In this article, we will explore what the Patent Dance is and what it means for biosimilars that are seeking market entry in the US.

The promotion of genetic engineering research and GM crops can help to overcome the future deficit of food production in India. Hunger, poverty, malnutrition etc. are significant problems that still need to be addressed. ‘The National Food Security Act, 2013’ is expected to resolve some of these challenges. Agricultural GDP needs to be augmented by an increase in food crop production. Policy and social considerations related to GM crops continue to be a popular debate in the country. The regulation of transgenic plant research is guided by several legislations in the country. Regulatory agency approvals impact commercialization of transgenic crops. As greater capacity continues to develop in transgenic research on plants in Asia one of the prime considerations is whether Indian legislation and regulation adequately promote transgenic plant research. The present study maps and analyses various legislations that are involved in the research and commercialization of transgenic crops. The framework suggested will serve as a ready reckoner for firms practicing in this area.

Abstract – The robotics industry is achieving a level of commercial maturity as evidenced by innovative products brought to market, and by the increasing pace of emerging robotics companies being acquired by larger players in a diversity of industries. However, there are challenges with accelerating the rate and scale of innovation in this industry. Our hypothesis is that while there are remaining technological challenges, the largest challenge is for the industry to adapt by exploitation of business models that focus more intently on validating product/market fit, building teams to span seamlessly from laboratory to market, and on developing creative structure and vehicles to provide the needed resources to commercialize.  To this end, we suggest that the robotics field could adapt approaches from the emerging “business model playbook” that are now being used in the field of biotechnology.  These industries do compare somewhat in that they are each technologically driven, have long, high- risk development cycles, and have the need for high levels of capital, compared to the software industry.  In this paper we review what has been accomplished in biotechnology, and also suggest how these lessons could be implemented in the field of robotics. 

Genetic engineering (GE) technologies can contribute to improve crop productivity and quality in Ethiopia. Adoption of commercialized insect resistance and herbicide tolerance technologies can help to protect major crops such as cotton, maize, sorghum and small cereals from their main insect pests or prevent heavy weed-inflicted loss. Moreover, key production constraints such as  bacterial wilt of enset, late blight of potato, drought stress on crops like maize and wheat, lodging resistance on tef as well as low nutritive quality of native crops like enset and grasspea can be addressed by strengthening domestic GE research capacity and international collaboration. Cognizant of this potential, the Ethiopian government has made significant investment in modern biotechnology capacity building in the last decade. There has also been specific interest by cotton sector to boost its productivity by adopting insect resistance (Bt) technologies. However, the GE regulatory system based on the existing biosafety law is so stringent that it is not possible for the country to access useful technologies from abroad as well as initiate domestic GE research. Consequently, no GE experiment is approved so far, leaving the country at risk of missing out on the global GE revolution. To catch up and  harness the benefits of GE technologies, the country needs to create conducive regulatory environment, strengthen domestic GE capacity and devise a farsighted strategy.

Transforming medical research findings into viable commercial enterprises is a persistent challenge. Ontario, Canada, has deployed several approaches that could be applied in other regions. The provincial government has created R&D tax incentives, …

In November 2013, the Jordan Food and Drug Administration, in partnership with the Center for Medicine in the Public Interest, held a seminar entitled, “Advancing the Safe Use of Drugs: Enhancing Regulatory Quality Control.” Attendees included members of the JFDA leadership as well as representatives of Jordan’s healthcare community (hospitals, pharmacists, pharmaceutical manufacturers, academics). The seminar began a strategic thinking process aimed at enhancing a regulatory environment that values pharmaceutical manufacturing quality, the importance of stakeholder involvement, the urgent role of pharmacovigilance, and greater harmonization with advanced regulatory practices.  The goal was to develop realistic recommendations that can be implemented within existing authorities and resources; that serve the Jordanian public health; and enhance the stature and reputation of the JFDA as a regional reference and a global leader.

Mergers and acquisitions are regular events for biotechnology companies. I have often been asked if being acquired is a goal