ARTICLES BY LOUIS

• Advising The Biotech C-Suite To Reconsider Quality

  3/16/2026

  “I assist C-suite executives to transfer quality from a painful cost center to a competitive asset." It's the type of bold statement that draws one's attention. Chief Editor Louis Garguilo asked David Grote on what his assertion means materially – and how that’s applied to working with CDMOs. Here's their discussion that focuses on a transformation that moves executives from regarding quality as ‘overhead’ to recognizing quality as “an operational element for business advantage.”

• The Jones Act Hurts U.S. Pharmaceutical Manufacturing

  3/13/2026

  The Jones Act punishes U.S. pharmaceutical manufacturing. It may have taken a modern-day war, one much involved with the free navigation of commercial shipping, but after more than 100 years navigating a policy of protectionism – and fear of competition – are we on the cusp of again waiving the Jones Act? Chief Editor Louis Garguilo says let’s not temporarily waive it. Sink the Jones Act forever.

• A Woman Relegated To The Manufacturing Night Shift

  3/8/2026

  After graduating with a biology degree from Howard University and entering the pharma industry, Stephanie Wimberly found herself the only woman — the only black woman — in a manufacturing facility in Maryland. A supervisor made it clear he didn’t want her on his team; she was reassigned to the night shift at her facility. “I had a family to support, and night shift, or abuse, was not what I signed up for,” she says. “But I didn’t have many options.” Here is how she persevered, and prospered.

• A Biotech Business Model That's Investor-Friendly

  3/2/2026

  For biotechs meeting with current and potential investors, says Edward Ahn, CEO, Medipost Inc., “it should be about demonstrating your business continuity more than anything else.” Investors know, he says, “any supply chain may be fragile.” Indeed, Ahn’s organization has put in place an intriguing business model to address such concerns. It includes owning part of a CDMO.

• The Supreme Court Rules On Trump Tariffs. Why Shout "Hooray!"?

  2/28/2026

  Chief Editor Louis Garguilo says like many readers, he agrees with the "wise and narrow decision" by the U.S. Supreme Court that President Trump cannot use the International Emergency Economic Powers Act to impose sweeping tariffs. At the same time, for those who immediately threw up an instant “Hooray!” he suggests checking yourself on why such enthusiasm. His analysis on what is actually best for our global outsourcing industry.

• From Biology Grad To Manufacturing Guru

  2/24/2026

  Stephanie Wimberly graduated from Howard University in 2012 with a degree in biology. What was next? An online search turned up an intriguing area – pharmaceutical manufacturing. “It was manufacturing,” she thought, “but I could still help patients." It was a fortuitous start. This young female professional with a penchant for helping others started a manufacturing career that has wound through GSK, and leadership roles at Shire/Takeda. Now as a manufacturing consultant, here is her advice for manufacturing outsourcing, and careers.

• Not So Fast Into The Night: Your Outsourcing Needs A Pause

  2/16/2026

  Barreling through the initial months of the year? Here’s a suggestion from Chief Editor Louis Garguilo to pump the breaks for a bit. Take one more glance in the rearview mirror to assess your current progress, reconfirm your pathway is your intended one. An outsourcing pause might pay off handsomely this year, and that’s because a lot happened last year on the supply-chain front. You made plans and formed expectations based on those trends and experiences. Are you currently abiding by those analyses? 

• The Quiet Case For Trusting CDMO Pricing

  2/9/2026

  “Given our industry, with so much forward risk, my overall philosophy is not to necessarily get stuck on pricing," says a commercially successful outsourcing veteran, although he quickly adds, “I don’t broadcast this externally, or even internally – quote me anonymously!" I did, and he proceeded to provide intriguing insight into working with CDMOs.

• With CDMOs Like This, Who Needs Biotechs?

  2/7/2026

  The question struck like a thunderbolt, writes Chief Editor Louis Garguilo. “Where are CDMOs going with all this?” asked Edward Ahn, CEO, Medipost, Inc., referring to the remarkable growth of some CDMOs. “When CDMOs aim to offer every service, capability, and the requisite capacities for an entire drug life cycle – from discovery to clinic to commercialization – what’s actually left for a biotech sponsor to do?” A forward discussion on an evolving outsourcing dynamic.

• At JP Morgan 2026, Few Showed Up For U.S. Manufacturing

  2/2/2026

  What may turn out to be an instructive anomaly emerged at at the JP Morgan Healthcare Conference. Across eight roundtable discussions convened by biopharma investment advisors – covering topics such as Avoidable Drug Development Pitfalls and The Emergence of Highly Competitive Chinese and Korean Biotech – the one where nary a soul showed up was titled U.S. Manufacturing. “I don’t quite understand it,” says Ali Pashazadeh, Treehill Partners founder. Here's a close investigation.