There’s a lot riding on a drug sponsor’s selecting the right CDMO. Kim K. Burson, Head of Quality Assurance (QA) and Quality Control (QC) at Achaogen, has some advice for those initial audits. A critical component is the “witnessing" of standard operating procedures (SOPs) in action. Burson explains this, and also helps us separate the QC and QA functions.
President Clinton once said to reject permanent normal trade relations with China would be a mistake of hugely historic proportions. But years later will history judge “free" trade with China "a blunder of truly historic proportions from which America will never recover”? Enter Donald Trump. Our drug industry, dependent on China, should join the public discourse.
Outsourced Pharma is quoted in a new book, “China Rx: Exposing the Risks of America's Dependence on China for Medicine.” Award-winning author and senior advisor at The Hastings Center, Rosemary Gibson, says drug companies rely on China to the detriment of U.S. patient safety, and we’ve ceded control of drug supply chains to Chinese CMOs, and potentially an adversarial government across the Pacific.
Parcel to the success of Shire’s state-of-the-art plasma manufacturing facility outside of Atlanta – and a behind-the-scene contributor to the news regarding the first FDA-approval there – is a second state-of-the-art facility, located across the street. That facility is a training center. Shire’s Matt Walker, EVP of Technical Operations, explains the importance of these types of training facilities to biopharma manufacturing in the U.S.
Today’s "identity splintering" is bad for biopharma teams. And since no organizational activity is more important to the overall success of drug development and manufacturing outsourcing than the formation of competent teams — at the drug owners and CDMOs — we should be particularly concerned. Here’s a discussion on this sociopolitical trend seeping into our industry.
Among other accolades, Shire is a proficient drug development and manufacturing outsourcing organization. So why is the recent excitement from Shire about a large facility “build,” instead of an external services “buy”? Matt Walker, EVP of Technical Operations, explains for Outsourced Pharma readers why Shire built its state-of-the-art plasma manufacturing facility just east of Atlanta, Georgia.
Some deals are more symbolic than others. The recent M&A announcement by PCI Synthesis and Novacap is one of those. The added significance is not lost on Ed Price. He founded PCI at the age of 29, and has been the company’s CEO and president for all 22 years of existence. “Many in the industry were surprised,” says Price. Here’s why, and what it means for the outsourcing market.
Over the next decade, global biopharma contract manufacturing (combined small and large molecule) will grow globally at an annualized rate of 4.8%, according to a new report. The Roots report is chock-full of the quantifying we rarely find in our field of drug development and manufacturing outsourcing, and includes some fundamental but interesting CMO categorization.
Two of the most widely covered biopharma-related news stories in the U.S. involve a regulatory agency, as you might expect. But that agency isn’t the FDA. It’s the SEC (United States Securities and Exchange Commission). Both the SEC and FDA are increasingly interested in evolving business models for drug development and manufacturing. For this reason: Your outsourcing is a serious and reportable risk.
Biopharma companies should recognize some of the vernacular they use for negotiating drug development and manufacturing outsourcing can set CDMOs on edge. In this editorial, we talk to biopharma veterans of outsourcing about some of the "financial frictions" brought out in new models for sponsor-provider relationships.