Author Archive

Biopharmaceuticals: Pharma’s Shining Star

Michelle Hoffman PharmTech editorBy all accounts, biopharmaceuticals are the supernovae in the pharma firmament. In an article in Pharmaceutical Technology’s August 2010 Outsourcing Resources supplement, for example, Datamonitor’s Bornadata Bain and John Shortmoor suggested that by 2014, sales of small molecules would shrink by $17 billion, while sales of monoclonal antibodies alone would increase by $23 billion. Given that, the editors of Pharmaceutical Technology want to hear from all those in the development and manufacture of biopharmaceuticals about what you produce and how you produce them. Click here to fill out the survey. Responses will be kept confidential, and the results will be published in Pharmaceutical Technology’s May 2011 supplement on Sterile Manufacturing and Bioprocessing. Those of you who complete the survey will have a chance to win a $100 gift certificate.

Continued Focus on Continuous Processing

Michelle Hoffman PharmTech editorAs we construct the editorial calendar each year for the coming year, the editors of Pharmaceutical Technology consult just about everyone with an opinion on what topics we should be covering. We ask you, our readers in our annual Reader Assessment Survey, we ask our editorial board members, and other industry experts what topics and technologies will emerge as important in the coming year. Usually, we get suggestions as broad as our coverage, from novel catalysis for API synthesis, to innovative excipients, to novel process analytics, emerging regulations, new drug-delivery paradigms, and novel aseptic approaches to process and fill/finish operations. So it caught us somewhat by surprise when last year these usually disparate opinions converged on a single topic: Continuous processing. Read more »

Passionate about Packaging

Michelle Hoffman PharmTech editorItalians are known for their passions. They are passionate about their food, their wine, their art, their design, and in Bologna, they are passionate about their packaging industry. And well they should be. In a time of economic crisis, Italy’s packing industry seems extremely healthy, based on the statistics offered last week by Dr. Guido Corbella, at the Pharmintech exhibition.
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Healthcare Reform: Other Rooms, Other Voices*

Michelle Hoffman PharmTech editorI get a lot of email on a normal day, but yesterday the day after the House passed “The Patient Protection and Affordable Care Act of 2009,” my email box was full of opinions and reactions. Barack Obama himself wrote me to say “thank you.” Because of me, it appears “every American will finally be guaranteed high quality, affordable health care coverage.” Read more »

Comparative Effectiveness Versus Personalized Medicine

Michelle Hoffman PharmTech editorIs 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 »

Pharma Celebrates its Own

Michelle Hoffman PharmTech editorFall 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 »

A View of Biosimilars to Come

Michelle Hoffman PharmTech editorBiosimilars 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 »

The McCain Campaign Makes a Statement on Spending for Science, Sort of

Michelle Hoffman PharmTech editorAs 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 »

Biology is Perverse, Part I

hoffman.jpgPeople 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 »

Packing in Packaging

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

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