ARTICLES BY LOUIS

• Two Cancer Therapies And Ten CDMOs

  10/4/2018

  Vadim Klyushnichenko, PhD, CSCP, VP Pharmaceutical Development and Quality, California Institute for Biomedical Research (Calibr) and The Scripps Research Institute (TSRI), excels at enumeration.

• Outsourcing On The Cheap To China?

  10/2/2018

  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.

   

• Levels Of Risk Severity In Biopharma's Global Outsourcing

  9/28/2018

  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. 

• Biogen Leads Fight Against Supply-Chain Criminals

  9/13/2018

  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.

• Time To Silence Capacity Alarms For Bioprocessing?

  9/4/2018

  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 At Risk: How To Stay Ahead Of The Villains

  8/24/2018

  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.

• “SOPs In Action” For Effective QA Audits Of CDMOs

  8/16/2018

  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 Trump, Communist China, and Pharma Outsourcing

  8/9/2018

  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.

• “China Rx” Looking For The Truth In Biopharma Outsourcing

  8/1/2018

  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.

• Shire's Plasma Facility Built On Training

  7/30/2018

  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.