Discovery Research From The Editor

  1. DMFs And CDMOs: Surprises At The Regulatory Intersection 6/10/2024

    An integral FDA touchstone with your CDMOs is drug master files (DMFs). Ben Stevens, Director CMC Policy and Advocacy at GSK, advises readers on how to avoid the ramifications taking you by unpleasant surprise.

  2. Drug Development Needs More Focus on Profitability 6/7/2024

    Consultants coordinating with investors offer an ecosystem around the molecule being developed at a biotech, and help to reevaluate development decisions in a more dispassionate way.” Dispassion applied specifically to ultimate commercial profitability.

  3. Do You Know Your QMM? Moderna Might Some Day 6/3/2024

    Don’t panic if you aren’t familiar with the above acronym, which stands for Quality Management Maturity. Chief Editor Louis Garguilo wasn't – until schooled by Jason Kerr, Regulatory Intelligence Senior Manager, Moderna and Adjunct Professor of Quality Systems, Keck Graduate Institute. QMM, it appears, may very well be in your future.

  4. Medicinal Chemist, Meet Your CDMO 5/23/2024

    Ben Stevens of GSK documents his career, and highlights a stage in outsourcing we often overlook –  key interactions between med-chem scientists and research biologists, and contract development and manufacturing providers (CDMOs).

  5. Assassination By Implication? Interview With WuXi AppTec (Part 2) 5/20/2024

    “As you read these accusations, it’s like an attempted death by a thousand implications,” says Rick Connell, former Pfizer supply-chain executive and current WuXi AppTec President, U.S. and Europe. In this part two, he provides a line-by-line analysis of the BIOSECURE Act targeting his company.

  6. Exclusive Interview: WuXi AppTec Responds To BIOSECURE Act 5/13/2024

    Rick Connell, WuXi AppTec’s President, U.S. and Europe, agreed to an exclusive interview with Chief Editor Louis Garguilo to address accusations in the BIOSECURE Act. To understand Connell is to understand the shock at WuXi AppTec – and  among its customers.

  7. A Spy At Moderna 5/1/2024

    Jason Kerr of Moderna is a snoop, a spy, a watcher of all things. More officially, he’s tasked by his employer with monitoring for regulatory changes in the environment. “Some do call it regulatory surveillance,” he says, “Some just regulatory monitoring.” Whichever, you might need to hire a Kerr, too. Here's why.

  8. Nothing To See Here! Just Big Pharma Investments In China 4/22/2024

    WuXi AppTec assists U.S.-based biotechs to develop and supply drugs to U.S. patients. Western-based Pharma assists the development of China's industry, the China Communist Party (CCP) by extension, and patients there. Guess which is under assault? Chief Editor Louis Garguilo tries to figure it all out.

  9. CDMOs Pelted By Slings And Arrows 4/18/2024

    Chief Editor Louis Garguilo thought he was precipitating a frontal assault by canvassing the Outsourced Pharma Editorial Advisory Board with questions such as: When outsourcing development and manufacturing, what are the challenges, and where are your pain points? But before anyone claims “one-sided,” please read on.

  10. You Want To Rein In China? Then Actually Do It 4/12/2024

    Chief Editor Louis Garguilo takes a hard look at proposed legislation H.R. 7085 - the BIOSECURE Act - and draws out some interesting angles and conclusions regarding the biopharma battle between the U.S. and China.