ARTICLES BY LOUIS

• Emerging Biotechs Judge CDMOs More Harshly

  7/15/2024

  At the 2024 CDMO Leadership Awards, we learned that smaller sponsors do not feel CDMOs are performing to expectations, or provide their programs with requisite attention. Frankly, we'd never seen such a strong divergence in results before. Here's a closer look, and other takeaways from the Awards.

• What's In Your DMF?

  7/8/2024

  Are relevant Drug Master Files (DMFs) at your CDMO in good order or fully under consideration as part of your upcoming new-drug submissions to the FDA or other agencies? “I've lived with this on both sides, as an FDA official and at biopharma organizations,” says Ben Stevens, Director CMC Policy and Advocacy, GSK, and former  Branch Chief / Chemistry Reviewer at FDA. Here's what he advises.

• Select Your CDMO Based On How You Operate

  7/1/2024

  “We tell them up front we will be hands on. That's a good way to pick the right partners. In other words, we select and view our CDMOs based on the way we operate," explains BlueSphere Bio CEO Keir Loiacono. With a background as an attorney, it's an interesting outsourcing operations indeed.

• Breaking: BIOSECURE Act Out. Long Live Wuxi Apptec?

  6/25/2024

  The U.S. House Rules Committee did not include the BIOSECURE Act in the final list of amendments for the National Defense Authorization Act (NDAA). Chief Editor Louis Garguilo has been outspoken in defending WuXi Apptec’s right to due process. Readers have responded in spades. Here's the latest.

• Power Of Attorney For Cell Therapy Outsourcing

  6/24/2024

  “I always say I’ve brought a little New Jersey litigator to Pittsburgh biotech,” says BlueSphere Bio CEO Keir Loiacono. And to the CDMOs he works with. Today, his attorney-informed focus is applied to T cell receptor (TCR) technology. Here's part one of his unique insights to outsourcing.

• So You Want To Be An Outsourcing-Industry Entrepreneur?

  6/18/2024

  Secretly, somewhere inside you, is the thought: I’d like to leave this job at my established biopharma company. You wonder: How would I start my own, wait for it: contract service organization? Jeffrey Kiplinger, formerly of Pfizer, did just that. And wrote a book about it.  

• 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.