In an article called “Beyond magic bullets: true innovation in health care,” published in the February 2013 issue of Nature Reviews Drug Discovery, scientists from Janssen encouraged the healthcare industry to think outside of the drug product-focused box and look at an integrated approach to care, said a Janssen press release. Read more »
PharmTech’s February issue will feature a guest editorial by Aaron Davidson, a partner in the life sciences practice at Baker Botts, on social media and the pharmaceutical industry. In his editorial, Mr. Davidson points to FDA and a lack of regulatory guidance as the reasons that social media has not caught on in the pharma and bio/pharma industries. FDA’s requirement to provide consumers with FDA-approved promotional materials that contain risk information may limit a pharmaceutical company’s ability to use mediums such as Twitter and Facebook effectively.
Once upon a time in the world of healthcare, the only competition for a pharmaceutical company was other pharmaceutical companies.
Times have changed. Pharma companies are now competing with many nontraditional players in the healthcare arena, including electronic and mobile health firms, retailers, financial services companies and IT firms. Healthcare is no longer about just making a new medicine, but about creating greater value for patients, providers and payers, and encouraging a more active and healthy lifestyle.
In PharmTech, we often talk about manufacturing innovations, such as new dosage forms or more efficient manufacturing techniques, but today I’m going to look at some of the innovations that have been made in the healthcare industry as a whole. Read more »
Laboratory best practices for meeting regulatory and compendial requirements are changing. FDA’s emerging expectations on data integrity, operational qualification report generation, along with the ISPE GAMP Good Practice Guide for Validation of Computerized Systems have provided the industry with new ways to approach laboratory compliance. In addition, the status of USP Informational Chapter <1058> on analytical instrument qualification is being discussed across the industry and the pharmacopeial body. A stimulus paper is being written on this chapter, offering some revision proposals.
Paul Smith, EMEA and India Compliance Program Manager at Agilent, spoke about these issues and offered some best practices for moving forward in an educational webcast. You can watch the webcast for free on demand here.
Guest blog by Tim Lozier.
In most industries, businesses run the same way. You can either stick your head in the sand and pretend that everything is going fine, or you can stand up and take the feedback—whether positive or negative—and react to it. This is especially true with Quality Management Systems (QMS).
In today’s dynamic and demand-driven world, businesses are challenged with speeding their product-to-market strategies to remain competitive. In the pharmaceutical industry, regulatory and compliance pressure add another dimension to the QMS. Organizations want to bring their products to market quickly, but need to ensure quality and compliance standards are met—it’s a paradox of “hurry up, but take your time doing so.” Read more »
This morning I received a press invitation from Boehringer Ingelheim for the beta launch of its Facebook game, Syrum. The game is the first of its kind to be developed by a pharmaceutical company. Syrum’s website is already up for people to view but the game won’t be officially launched until September. Read more »
During the past two years, FDA has been looking more closely at enforcing Part 11 of the Title 21 Code of Federal Regulations regarding electronic records and signatures (see back story). As a result, digital signatures are becoming more commonplace throughout laboratories, manufacturing sites, and offices as companies search for ways to track and file processes, SOPs, approvals, supply chain movement, drug applications, and more. Quality management systems, much like our personal lives, are becoming far more digital and far less paper-based.
PharmTech discusses this issue and related compliance issues in a recent webcast, available on-demand here.
Gartner has developed a body of research around the convergence of IT and Operational Technology (OT) and the implications for organizations (1). Much of the research speaks to the opportunities and challenges this convergence presents to organizations. By way of definition operational technology, according to Gartner, refers to “physical-equipment-oriented technology” (e.g., manufacturing equipment) that is shifting from proprietary, hardware-based to open, software-based technology. Thus the lines are becoming blurred as to who “owns” and supports the infrastructure, integration, upgrades, security and analyses of OT software systems. Read more »
Ever wish you were a fly on the wall in another laboratory? Well, a new journal website offers the industry opportunities to do just that—to see through video how other scientists carry out particular experiments and processes. Read more »
We love social media here at PharmTech.com, but many pharma companies have been wary about how to make the most of these new communication platforms—and understandably so given that last year Novartis received an FDA warning letter about a Facebook widgit on its website.
One pharma company that does seem to love social media though is Germany-based Merck KGaA—so much so that the company was prepared to go to court when its Facebook page was recently taken over by US rival Merck & Co. Read more »
From PharmTech.com