Outsourced Pharma Chief Editor Louis Garguilo continues his coverage of the current state of China pharma manufacturing by interviewing Diana Francis, VP of quality and compliance for BeiGene.
To get to a full digital dialogue that includes everything from AI to blockchain to machine learning, drug sponsors and CDMOs alike will need to muster their resources to usher in what the rest of the world already calls Industry 4.0.
“Basically, industry perceives, reports, and expects no major capacity crunches” related to global bioprocessing needs. So concludes an editor of BioPlan Associates, Inc.’s Fifteenth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (April 2018), in a response to my recent editorial saying as much. Now we have the data to back the assertions up.
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.
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.
Why has the biopharma industry insisted upon dual (or triple) sourcing for materials? Why does Big Pharma perform outsized due diligence on offshore CDMOs and CMOs? Why do we focus on costs of all materials and supply? One reason is so we can calmly weather uncertainties such as the current tariff troubles between the U.S. and China.
Vinita Kumar, VP of quality at Versartis, talks about how her philosophy on CMO collaboration has been field-tested. “Never does that importance of real collaboration reveal itself more than in hard times for your program when you need it most,” she says.
Outsourced Pharma Chief Editor Louis Garguilo talks about what makes this seventh edition of the Life Science Leader CMO Leadership Awards different from the previous years.
A panel of supply chain experts share best practices and perspectives on what parameters to use in evaluating CMOs/CDMOs, how to address low performance partners, and how to meet growing FDA expectations.