The day started with a 5 o’clock alarm call and me feeling remarkably fresh to begin my journey to Frankfurt for this year’s CPhI Worldwide event. Unfortunately, the idea of a smooth journey was thwarted fairly quickly with the news at Crewe that the 06:33 train to Manchester airport was canceled. Bad start. Read more »

It’s not hard to find employees at large- or small-molecule drug companies who have gripes about FDA. On and off the record, people have complained that the agency’s review process is slow and that its decisions can be erratic. Perhaps hoping to make a positive contribution to this discussion, the Biotechnology Industry Organization (BIO) made several proposals last week for improving FDA’s operations. Read more »

An alliance of researchers at the University of California, Berkeley earlier this month formed the UC Berkeley Synthetic Biology Institute (SBI) to advance efforts to engineer cells and biological systems. Agilent Technologies is providing infrastructure, expertise, and funding for the new institute. The move signals growing research and commercial interest in the nascent field of synthetic biology. Read more »

Big Pharma has offered many explanations for its anemic pipelines. All of the easy drugs have been discovered. Patent law (or another particular form of regulation) stifles innovation. The economy is forcing us to retrench. Although these explanations may be plausible, they all lay the blame elsewhere. Could Big Pharma’s own actions be discouraging research and development (R&D)? Read more »

In a controversial ruling late last month, a federal judge ruled that several patents held by the molecular-diagnostics company Myriad Genetics in a genetic-testing product that covered two genes, BRCA1 and BRCA2, which are associated with risk for developing breast and ovarian cancers, were invalid. The decision raises the larger question of the patentability of genes, a significant issue in determining the rules of the game not only in molecular diagnostics but also in drug discovery and development. Read more »

It’s hard to get precise figures of how many people have been taken off the payroll at pharma and biotech companies recently. According to staffing firm, Challender, Gray and Christmas, the combined industries shed 58,969 jobs in the first nine months of 2009, 15,000 more than the whole of 2008. In total, that makes around 74,000 redundancies in just 21 months, many but not all of which came from sales forces. Figures from FiercePharma, meanwhile, show just ten companies saw 66,850 jobs go in 2009. And this doesn’t include layoffs from the merger of Roche and Genentech, nor the 860 jobs that were announced at Boehringer Ingelheim in August. Read more »

There has been a surge in the number of combination product (i.e. where a drug product is combined with a medical device) launches in recent years and this trend is set to continue as more companies seek to extend the life of existing branded medicines. According to analysts, the combination product market is currently worth 8 billion Euros and will grow by a staggering 40% during the next 3 years. Read more »

Last Thursday, the Biotechnology Industry Organization (BIO) weighed in on a patent issue that will soon be before the Supreme Court. In an amicus brief, BIO argued that the Court should overturn Bilski v. Doll, a decision of the US Court of Appeals for the Federal Circuit. The case involved Bernard L. Bilski’s method for hedging risks in commodities trading. Read more »

Innovation, innovation, innovation .. and a call to focus on science and quality-by-design (QbD) principles. Such was much of the talk yesterday at this year’s AAPS National Biotechnology Conference in Seattle. Speakers discussed the tools the biotechnology industry will need for future innovation and how the industry must center on QbD principles, using lessons learned from small-molecule development and even nonregulated industries. Read more »

While we at PharmTech are very proud of our peer-review process for ensuring quality scientific articles, I was a bit humbled to learn of a massive endeavor by the National Institutes of Health to enlist the help of more than 18,000 scientists to help in their peer-review process. To put things in perspective, the process is in response to NIH receiving nearly 20,000 applications for Challenge Grants, a new program under the American Recovery and Reinvestment Act (ARRA). According to the organization, the number of applications is about equal to the total number of applications it receives in one of its three major review rounds every year. The number of applications and the peer review process is the largest response in NIH history, according to acting NIH director Raynard S. Kington. Read more »