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 »
Fall is upon us and so is the awards season. And I’m not talking about the Emmy’s (although kudos to Mad Men). Earlier this month the Lasker Foundation gave out its Basic Medical Research Award, its Lasker-deBakey Clinical Medical Research Award, and the Mary Woodard Lasker Award for Public Service (see the Lasker Foundation website for more information). Next week the Nobel Committee will announce its award winners.
But last night belonged to the Pharmaceutical Industry. Read more »
Biosimilars were among the topics on the minds of attendees at the BIO CEO and Investors conference in New York earlier this week. The Biotechnology Industry Organization (BIO) has lobbied Congress for some time to grant innovators of biotech products a fairly long period—12 years, plus or minus—of exclusivity before follow-on products can be marketed. It was interesting, then, to hear the suggestion by Scott Gottlieb, Resident Fellow at the American Enterprise Institute and former Deputy Commissioner for Medical and Scientific Affairs, US Food and drug Administration, that FDA was likely to exert such stringent regulations on follow-on biologics as to make the exclusivity issue practically moot. Read more »
As you know, we at PharmTech have been soliciting the press officers for the two major presidential candidates to share with us their plans for the FDA and other programs that can affect the pharmaceutical industry. Neither campaign has been forthcoming. So we have to keep track of the candidates’ statements as they come. Read more »
People always giggle when I say that, but it’s true. Of all the “basic” sciences, biology is the most slippery. By that I mean that, while the tendency is to study biomolecules and cells in isolation, the total animal, be it a bacterium or a human being, is a federation of molecules, organelles, or organs (depending on how big and multicellular you are), and they all act together to create a phenotype, a behavior, a syndrome, or a disease in the intact organism.
So it should hardly be a surprise to anyone who recognizes this fact that drugs for complex conditions, developed with reductionist biological models, yield disappointing results in the clinic. And yet it is. Read more »
Exhibitors packing up from this year’s Interphex show, 26-28 March, went home happy. Traffic in the aisles was steady, booth personnel were busy and the quality of the visitors was high. It seemed like a higher than usual number of packaging machinery makers were seen engaged in serious discussions with customers. So despite rising oil prices, the mortgage crisis and falling real estate values, there appears to be a fairly high level of active projects for new and upgraded lines. In addition, anticounterfeiting tools/techniques continue to draw a lot of attention along with the use of disposable product contact parts, pedigree solutions, robotics and quality control. Stay tuned for a report about the most interesting new packaging products we found on the show floor.
Posted by Michelle Hoffman for Hallie Forcinio, Packaging Forum Editor, Pharmaceutical Technology
Readers of PharmTech may have noticed that I’ve been concerned about innovation in the pharmaceutical industry and somewhat despairing of the state of early-stage drug discovery work. So you can imagine my thrill–and relief–yesterday when I had a chance to meet the finalists for the “Facility of the Year Awards” (FOYA), sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine, and learned of the truly amazing solutions that engineers are implementing to current industry problems. Among those problems, two stood out in particular: the need to get a plant built and online quickly, and the need for flexible designs in plants engineered to manufacture multiple products and–even more impressive–product classes.
In the first category, speedy, design and manufacture, engineers who designed and built Pfizer’s plant in in Illertissen, Germany, and those who managed the project for Roche’s new facility in Basel, Switzerland, completed their projects four to six months ahead of schedule and remained under budget. Pfizer’s plant is almost totally automated, and requires only two human operators per shift, earning the plant’s engineering team the award for process innovation. The Roche project was completed in record time, earning its project manager the award for project execution. Read more »
Steven Burrill, head of one of biotech’s earliest and largest sources of venture capital, shared his vision of the healthcare landscape in the future in his keynote address, entitled, “Biotech 2008: A 20/20 Vision to 2020.” Pointing out that US consumers spend some $200 billion each year on wellness products, without having a single penny of that reimbursed, Burrill intoned, “Don’t ever argue with me that we’re not willing to spend money on wellness.”
INTERPHEX for our industry is like the Academy Awards to the movie business or the Detroit Car Show to the automotive industry. It’s an event that manufacturers and industry experts plan for all year. We at Pharmaceutical Technology are no different. We produce a special issue that includes a foretaste of the exhibitions and conferences one can expect to see, and we do a wrap-up both in print and online following the conference.
But those reviews cannot possibly capture the sensation of being at the event itself—no more than Read more »
From PharmTech.com