Vadim Klyushnichenko of The Scripps Research Institute works with some 10 CDMOs at any given time. He's developed methodologies for handling due diligence, project and product quality for both drug substance and drug product, and timelines and budgets. But perhaps most instructive is his management — and best practices — for handling all the analytical services his programs require through development and manufacturing at his service providers.
I’ve reached out to biopharma companies for answers to this question: “Why does your organization outsource so much drug development and manufacturing to China?” Prompted by President Trump’s remarks on the subject on October 1st, seems like a good time to present some of those initial industry responses, and further analysis of what we are facing.
Drug development and manufacturing outsourcing professionals from AstraZeneca, Boehringer Ingelheim, and GE Life Sciences tell us: Global playing fields are uneven, the players unequal, and the supply-chain risks imbalanced. Here are their global assessments, and strategies for coping.
Things have progressed nicely for Ruby Casareno, Vice President, Chemistry, Manufacturing and Controls (CMC), Allakos Inc. For executives wishing the same for your CMC leadership and organization, there are lessons on why that’s the case. Those lessons also recall for Casareno an earlier experience where progression traversed a rockier road. It all adds up to 6 best practices particular to outsourcing drug development and manufacturing.
Lee Spach, Director, Global Product & Supply Chain Security, Biogen, says there are about 35,000 online pharmacies in the world. Ninety-eight percent are fake. They transact billions of dollars annually and seriously endanger patients. The criminals can expect a large return on their investment, with relatively little risk. Spach and Biogen are trying to change that. You can help.
Alarms have rung persistently in biopharma quarters. Have the dire warnings staved off the actual emergency? Some executives from Big Pharma whisper that the anticipated “capacity crunch” for contracting bioprocessing services has not nor appears to be materializing. A study from Industry Standard Research (ISR) seems to confirm that. Or does it?
Your supply chain – raw materials and intermediates, APIs and particularly commercial products – is at serious risk from bad actors. We are talking about falsified or stolen materials, counterfeiting, gray-market diversion, and other nefarious behaviors. How can you fight back? Supply chain experts, including from Sanofi and Biogen, offer some sound advice.
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.