ARTICLES BY LOUIS

• Straight Talk From BeiGene On Quality, Compliance, And Outsourcing

  12/3/2018

  It was time within our ruminations on China to speak directly with a quality executive at a drug developer and manufacturer based there. That’s now accomplished via a discussion with Diana Francis, Vice President, Quality & Compliance, BeiGene, Ltd., a biopharma some have dubbed as a potential “Genentech of China.” Francis spoke openly about her role, BeiGene’s global strategy, and outsourcing within and from China. 

• Not Enough Data To Utilize AI And Machine Learning In Drug Development

  11/27/2018

  We’ve heard the calls for help: “We’re drowning in oceans of data.” But I’ve learned that those further “downstream” may end up high and dry when it comes to having sufficient data to allow drug developers and manufacturers to fully actuate artificial intelligence (AI) and machine learning (ML). Here’s what some experts had to say. 

• Biologics In China: Market-Driven Inevitability, New Quality Start

  11/19/2018

  “… the people you’ve been talking with are just not seeing all the components of the global biopharmaceutical industry — and this huge market opportunity. China will become a big player in biologics. This is only natural; there’s good reason for that.” Here’s a more positive outlook on the current situation in China, from Eric Langer, President, BioPlan Associates, Inc.

• Service Provider Establishes U.S. Home For Smaller Drug Sponsors

  11/13/2018

  We ended our last editorial wondering about a regeneration of start-up service provides, after so much M&A in recent years. Will biotechs particularly have smaller service providers to help with their specific drug development and manufacturing needs? Well, there's at least one new option in town. It could be a sign of things to come.

• 2 Reasons Your CDMOs Are Consolidating: Money & Muscle

  11/7/2018

  Private equity is providing the M&A fuel for CDMOs, fill-and-finish specialists, and clinical and commercial packaging partners. Big Pharma readily encourages this industry consolidation. But not everyone is on board. Two experienced financiers agree both investors and Big Pharma have their reasons for pushing consolidation, but the verdict is still out on to what degree, big is better for the industry as a whole. 

• Country Cultures, And Global Vaccine Development And Manufacturing

  11/2/2018

  Often the team [for a biopharma company or NGO/donor] deciding on a grantee or production partner for vaccines does not include both: (a) someone who can predict the credibility of the candidate based on the potential for a sustainable quality system, and (b) diagnose the reliability of the company's promises.” In other words, what's needed is a process to access the culture of  drug development and manufacturing partners, particularly in developing countries …

• 10 CDMOs, 2 Cancer Therapies, And An Eye On Analytical Services

  10/11/2018

  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.

• 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.