This week the California Institute for Regenerative Medicine (CIRM), which is the California state body responsible for stem-cell research funding, and two international partners in Canada and the United Kingdom, announced awards totaling $230 million to 14 research teams in California, Canada, and the UK to develop stem-cell-based therapies for 11 diseases. The funding, in the form of four-year grants, marks the first CIRM funding that is explicitly expected to result in filings with the US Food and Drug Administration for initial human clinical testing of therapies based on stem-cell research, according to a CIRM press release. Read more »

Is comparative effectiveness antithetical to personalized medicine? A report posted on Reuters suggests that Francis Collins, the new head of the National Institutes of Health and champion of the Human Genome Project, thinks so. Reuters quoted Collins predicting “a potential collision [between personalized medicine and comparative effectiveness],” at a forum sponsored by the American Association for the Advancement of Science. Read more »

Last week, Alexis Pellek of Pharmaceutical Technology wrote about a pilot project launched by the European Federation of Pharmaceutical Industries and Associations to test a new system designed to battle counterfeit drugs (See the blog post.) The system involved using DataMatrix 2D barcodes, which enable pharmacists to test the legitimacy of each packet.

We spoke with Mark Beauchamp, European Marketing Manager of Citizens Systems Europe, a firm that specializes in barcode technology, to better understand how barcoding can help the pharmaceutical industry to clamp down on counterfeit drugs. Read more »

This week, the European Federation of Pharmaceutical Industries and
Associations (EFPIA) launched a two-month pilot project in Sweden designed to test a serialization and verification system in pharmacies that would fight counterfeit drugs. Read more »

What is the outlook for contract manufacturing of active pharmaceutical ingredients and intermediates? In gaining feedback from exhibitors and attendees at CPhI Worldwide, the large exhibition and conference of pharmaceutical ingredients, which was held in Madrid last week, the prevailing sentiment was one of cautious optimism. Most said business conditions have improved since the financial crisis began in September 2008, but that the level of outsourcing has not returned to levels reached before the start of the economic downturn. Read more »

In just a few weeks, FDA will hold its public meeting to discuss the use of social media tools in marketing pharmaceutical drug products. (See back story.) The last time the agency held a meeting to discuss these types of items was in 1996 when the Internet’s popularity was growing by leaps and bounds.   Read more »

I’ve been paying attention to Merck’s (Whitehouse Station, NJ) Gardasil vaccine ever since I first heard of it because it’s a subject that combines biopharmaceuticals, gender issues, and the politics of public health. At first, critics contended that giving young girls Merck’s human papillomavirus (HPV) vaccine would not just prevent cervical cancer, but also promote promiscuity. This concern may have subsided, but two new wrinkles in the Gardasil story came to light on Friday. Read more »

ISP Pharmaceuticals is embarking on a drug-solubility Initiative to support pharma companies working with poorly soluble drug actives. At a press conference held at CPhI Worldwide in Madrid, Spain, on Wednesday, the company explained that a huge amount of drugs in the pharmaceutical developmental pipeline present solubility issues. Read more »

Reading PharmTech’s October article on Critical Challenges to Implementing QbD gave me the impression that we might have the road map to Moksha or Nirvana. Unfortunately that was not meant to be. Somehow there is a belief that PAT in pharmaceutical industry is the roadmap to QBD, pharmaceutical industry salvation. In this article, blame of not achieving “pharmaceutical industry salvation” has been attributed to unfamiliarity with the used equipment and corporate culture. I do not believe either of these is completely true. Read more »

Complex Documents in the Pharmaceutical Industry Made Easy
Thursday, October 22, 2009 at 10:00 AM GMT (United Kingdom) Read more »