Leadership Skills in the Biotech Start-Up
This is a guest post from Isabela Oliva. Do you have a response to Isabela’s post? Respond in the comments section […]
General Biotechnology, Guest content
General Biotechnology
Solid organ xenotransplantation: Progress, promise and regulatory issues
This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology
Solid organ xenotransplantation: Progress, promise and regulatory issues
Go to paperABSTRACT: Xenotransplantation, the process of transplanting live cel…
Solid organ xenotransplantation: Progress, promise and regulatory issues Read Post »
General Biotechnology
Genomics: A promising investment opportunity
This is a guest post from Zhen-Xia Chen. Do you have a response to Zhen-Xia’s post? Respond in the comments
General Biotechnology
Ethical, Legal, and Regulatory Issues Regarding the Study and Use of Medications in Pregnant Women
Despite the prevalence of off-label drug prescriptions for pregnant women, little attention is paid to the ethical, legal, and regulatory issues regarding this practice. This paper discusses some of these key issues relevant to the practice of off-labe…
General Biotechnology
USPTO Guidance On Patentable Subject Matter: Impediment to Biotech Innovation?
In June 2013, the U.S. Supreme Court issued a unanimous decision upending more than three decades worth of established patent practice when it ruled that isolated gene sequences are no longer patentable subject matter under 35 U.S.C. Section 101.While many practitioners in the field believed that the USPTO would interpret the decision narrowly, the USPTO actually expanded the scope of the decision when it issued its guidelines for determining whether an invention satisfies Section 101. The guidelines were met with intense backlash with many arguing that they unnecessarily expanded the scope of the Supreme Court cases in a way that could unduly restrict the scope of patentable subject matter, weaken the U.S. patent system, and create a disincentive to innovation. By undermining patentable subject matter in this way, the guidelines may end up harming not only the companies that patent medical innovations, but also the patients who need medical care. This article examines the guidelines and their impact on various technologies.
USPTO Guidance On Patentable Subject Matter: Impediment to Biotech Innovation? Read Post »
General Biotechnology
Who Lost Opioids?
Google “opioid abuse deterrence” and you’ll find a lot of hits from lawyers and elected officials. What you won’t find is a lot of expert thinking from the FDA.
That needs to change. FDA Commissioner Hamburg’s March 13, 2014 testimony in front of the Senate HELP Committee) hopefully represent a more aggressive stance by the agency. That’s good. But there needs to be more. The FDA must be the leading voice on the issue of abuse deterrence and the safe use of opioids.
At present, politicians and pundits (not to mention trial lawyers) own the conversation. They’re the ones talking about it. They’re the ones the media goes to when they write about it. Have a look at a sampling of the press coverage surrounding Zohydro and see who’s quoted and what they’re saying.
The struggle over control of the opioid abuse deterrence story is, shall say, not going the right way for the FDA.
General Biotechnology
Staking an Advantage in an AIA World: Practical Patent Tips for Biotechnology Companies
With passage of the Leahy-Smith America Invents Act (AIA), new rules and procedures related to the application of prior art now apply to patenting under a “first-inventor-to-file” system. This article summarizes certain key prior art provisions that biotechnology companies should be aware of and details practical steps that can be implemented to help stake a competitive advantage under the new law including the use of patent liaisons, early provisional and patent application filings, and in certain circumstances, defensive publication of patentable subject matter.
Staking an Advantage in an AIA World: Practical Patent Tips for Biotechnology Companies Read Post »
General Biotechnology
What makes a happy team? Data from 5 years’ entrepreneurship teaching suggests that working style is a major determinant of team contentment.
I report on five years’ testing of what makes a happy team, using students in a Bioscience Entrepreneurship Masters programme at Cambridge University as a test-bed. I looked at measures of personality (using the IPIP test for the Big Five personality characteristics) and a measure of work style derived from the time of submission of work that I term Deadline Brinkmanship. I find that teams selected to have a similar working style are generally happier working together than those selected by other criteria. Entrepreneurial activity is uncorrelated with psychological characteristics in this study, but is slightly correlated with working style and the willingness to accept a “good enough” result now rather than an ideal result in the future. I conclude that it is important for a nascent entrepreneurial team to work together on an important, deadline-driven task before committing to a new venture.
