Preventing drug counterfeiting
Counterfeiting is old as money itself. Drug counterfeiting is no exception. In this post, we’ll share an analytical approach that you can use to estimate the risk of drug counterfeiting to your drug products. Why are Medicines a Target for counterfeiting? Pharma is a highly regulated sector. Why do drugs attract counterfeiters? Fakes can be […]
Knowledge Prostitution in clinical data
Friday, a client asked me about privacy, data security and social networking in clinical trials. The client told me that they were considering using a physicians‘ portal to market their digital therapeutic product after they completed their pivotal clinical trial. (See my article on 4 strategies to get FDA approval for your medical device ). […]
Why big data for healthcare is dangerous and wrong
The Mckinsey Global Institute recently published a report entitled – Big data: The next frontier for innovation, competition, and productivity . The Mckinsey Global Institute report on big data is no more than a lengthy essay in fallacies, inflated hyperbole, faulty assumptions, lacking in evidence for its claims and ignoring the two most important stakeholders of […]
Medical device security trends
Hot spots for medical device software security I think that 2011 is going to be an exciting year for medical device security as the FDA gets more involved in the approval and clearance process with software-intensive medical device vendors. Considering how much data is exchanged between medical devices and customer service centers/care givers/primary clinical care teams and […]
What is the value of a trade secret?
My guess is that the value of software patents is on the decline, taking value as the net of the economic upside of the software patent less the cost of patent development, application and enforcement. The dynamic is that the benefit from patent protection in the software industry is less than the cost of the […]
Secure collaboration, agile collaboration
One of the biggest challenges in global multi-center clinical trials (after enrollment of patients) is collaboration between multi-center clinical trial teams: CRAs, investigators, regulatory, marketing, manufacturing, market research, data managers, statisticians and site administrators. In a complex global environment, pharma do not have control of computer platforms that local sites use – yet there is […]
Swine flu and social networking
It just occurred to me – as our partner in Poland was getting ready to drive from Warsaw to Łęczyca for a sales call – that novel H1N1 (swine flu) and seasonal influenza is a great reason to use social media and Web conferencing for customer contacts, sales and support and reduce physical contact and […]
The threat behind the House Tri-Committee Bill on Health Care
Don’t ask me why, but I was invited (and joined) the Pakistan Networkers group on LinkedIn. I see all kinds of cool job opportunities in the Emirates which I can’t really take but the traffic is interesting. I saw this picture in a post today from the Pakistan Networkers group. It graphically describes the complexity […]
Drug counterfeiting, hype or health?
Counterfeiting is a hot issue not only because it hits vendors in the pocket but because of the public health/safety implications. Product counterfeiting ranges from fashion, such as Dolce & Gabbana handbags, high performance bike frames such as Specialized Bikes to faking innovative drugs such as Viagra. The Israeli onlline business daily “The Marker” recently […]
Data security – is psychology more important than technology?
We had a discussion with a prospect for a DLP (data loss prevention) system) that started with discussing the pros and cons of various DLP solutions (Verdasys, Mcafee DLP, Websense, Fidelis Security) and finished with a drill-down into how they can build a business case to acquire and implement data security technology. After a very […]
