ARTICLES BY LOUIS

• Biopharma Outsourcing Analogs: From Cars To Eggs

  6/13/2024

  An experienced healthcare investor/consultant, and former biotech CEO, puts on his thinking cap to provide readers some intriguing insights into your development and manufacturing outsourcing, and overall business model for new drugs and therapies.

• 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.

• 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.

• 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.

• 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).

• 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.

• 2024 CDMO Leadership Awards Opening Remarks

  5/14/2024

  Chief Editor Louis Garguilo opens the 2024 Leadership Awards with an acknowledgement of the vital role CDMOs play, and also an intriquing insight into this year’s data to determine the award winners.

• 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.

• Don't Blame The Molecule; You May Be The Problem

  5/6/2024

  Ali Pashazadeh has been a healthcare investment banker for 20 years, surgeon for 30, and biotech CEO. Today he leads Treehill Partners. “I can explain our logic in two minutes,” he says of his approach to developing drugs, and targeting diseases.

• 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.