Over the past decade patent expiries have forced many Big Pharma to close production plants that supported decades of growth. With the current and next generations of small molecules and biologics raising the bar for manufacturing complexity, Eli Lilly, Merck and their peers face a choice: build plants or outsource?
The FDA has been inspecting the largest compounding pharmacies and in December said it had concerns about the sterility of calcium gluconate 10% injections made by Rx Formulations of Mesa, AZ. The FDA now says testing has confirmed those concerns.
With the spiraling amount of time and money needed to bring a drug to market weighing heavy on their Big Pharma clients, CROs have invested in efficiency boosting technology to gain a competitive edge. And the trend is tipped to continue, with an analyst predicting CROs will be at the forefront of developments in IT and genomics in 2014.
The rise of cybersecurity threats gives biopharma and other industries a new and unfamiliar problem that they are ill-equipped to handle alone. In response, an increasing number of biopharma companies are outsourcing cybersecurity activities, a strategy that has been vindicated by a new report.
Speaking at an investor day late last week, Novartis chief financial officer Harry Kirsch outlined how the company plans to generate "substantial savings" by working with external data management vendors.
While it's not a needed blockbuster approval, Merck's clinical crew has claimed a modest victory on the off-shoring front with a reduction in data-management expenses.
As software providers know well, AstraZeneca has been one of the most prolific users of information technology in the pharma world. So the drugmaker's IT preferences and activities garner attention, including the messy court showdown between the company and IBM.
An influential group of industry critics has reshuffled its listing of Big Pharma companies, lauding some big players like Johnson & Johnson for improving access to therapies and promoting R&D on neglected diseases while handing out worsening grades to many others. And the entire industry earned a black eye for outsourcing more of their drug development efforts without safeguards to make sure the work being done for them is safe and ethical.
Drawn by a growing drug market and a massive patient population, the pharmas have been creating their own research organizations in the country. And in the process a multibillion-dollar market in partnerships with R&D outsourcers, local drug developers and academic groups has flowered--with the promise of billions more to come.
Under its private equity masters at Bain Capital and TPG Capital, Quintiles has been rapidly beefing up its clinical-to-commercial outsourcing operations around the globe. Now Bloomberg reports that the makeover may lead to one very big cash-out as Quintiles execs ponder filing an IPO.