The other night I happened to see the first movie in the “Paranormal Activity” series. If you aren’t familiar with the plot, it’s a horror flick based around a family haunted by demons. The uniqueness is in the filming, though; the series is filmed as if it was actual footage, recorded via security and handheld cameras.
Even more interesting than a house full of spiteful demons are the financials behind the “Paranormal Activity” movie. The director, Oren Peli, filmed the movie in seven days, in his own house, for $15,000. The movie ended up making $193 million.
A feat like this could never have been possible 25 years ago. Before the days of online streaming movie services, obscure, low-budget films went unnoticed and never had the chance to generate millions in profits. With immediate access to films of all sizes and budgets, the smaller independent movies that have a more personal feel to them now have a chance to thrive and the film industry landscape is forever changed.
A similar shift is upon us in the pharmaceutical industry. The trend toward producing smaller batches of more personalized medicines, as opposed to relying entirely on flashy, Blockbuster drugs is transforming the industry. But these specialized drug products necessitate flexible manufacturing systems capable of rapid changeover.And it’s in this area that drug manufacturers have traditionally stalled.
But as you’ll read in this month’s cover story, change is on the horizon. FDA is working with drug makers in a more intimate way to help the industry adopt novel manufacturing technologies. The FDA has established the Emerging Technology Team (ETT), which works directly with industry to help identify and resolve issues surrounding new technologies. What’s unique about this approach is that this dialogue can occur during early technology development prior to the submission of a drug application to the FDA.
As ROI becomes clear and strong business cases emerge, the industry is slowly but surely adopting technologies to reduce risk and increase efficiency. In parenteral dosage manufacture, for example, the industry is seeing better designs that lead to better assurance of sterility and productivity, as technology such as isolators, barrier systems and rapid microbiological detection methods become more common.
The right conversations are being had between the right parties, and the future of pharma manufacturing looks to be a big hit.
