Outsourcing Articles

n August, Catalent Pharma Solutions announced that it was launching a new business unit: Development & Clinical Services. I was intrigued by the move, given the dynamics of the development industry, so I spoke with the new unit’s group president, Scott Houlton, about it.

Two years ago, a Pfizer public relations executive was giving a speech before a business group about communications outreach, and he confessed to having a certain amount of confusion over the bad image that has plagued the pharmaceutical industry.

Whether you plan to utilize active or passive packaging systems for transporting your time- and temperature-sensitive healthcare products, there are certain aspects to qualifying the process that are essential. Some are obvious, while others are easily and repeatedly overlooked. It is no longer just about package performance.

It was probably the French drugmaker Sanofi’s buyout of Shantha Biotechnics in June that suddenly turned the global spotlight on India’s biotech scene. Sanofi’s vaccine unit Sanofi-Pasteur paid a huge premium to Merieux Alliance — which owned majority ofshares in Shantha Bio through its subsidiary ShanH — to acquire controlling stake in the Hyderabad based bio firm.

The constant ups and downs of the biotech and pharmaceutical industries can make keeping an innovative and contented staff difficult. In the current recession, each and every manager has to make the tough decisions about who gets cut and who gets to stay. This overall sense of insecurity makes for some very difficult team-building issues.

With respect to factory inspections, section 704 of the Federal Food, Drug, and Cosmetic Act (“FDCA”) generally allows that for the purposes of enforcing the FDCA, appropriate officials of the U.S.

The Rx-360 consortium rolled out in June 2009, with the mission to “create and monitor a global quality system that meets the expectations of industry and regulators that assures patient safety by enhancing product quality and authenticity throughout the supply chain.” Several months earlier, SAFC launched its Vendor Audit Services unit to provide clients with auditor-teams that can cover wider ge

he past 20 years of biopharma outsourcing has seen pendulum swings in strategy as kinks were worked out of the system and this new industry grew and matured. Ten years ago, the drug industry (including biopharma) was in the process of backing away from the ‘fully vertically integrated’ business model that had been in vogue in the early 1990s, and was moving toward an outsourcing model.

There’s an idea that’s been floating around the drug industry for some years now. It goes in and out of focus, but it refuses to completely die: Why not ditch the research labs and just in-license all your compounds? It’s been at least 10 or 12 years since I first heard of this plan (although I’m sure it’s an older idea than that), and it still keeps popping up as a new thought experiment.

There’s an idea that’s been floating around the drug industry for some years now. It goes in and out of focus, but it refuses to completely die: Why not ditch the research labs and just in-license all your compounds? It’s been at least 10 or 12 years since I first heard of this plan (although I’m sure it’s an older idea than that), and it still keeps popping up as a new thought experiment.