ARTICLES BY LOUIS

• Early-Phase Formulation Done Right: An Expert Analysis

  6/12/2025

  Dileep Boinipally has extensive experience in formulation, manufacturing process development, and regulatory strategy. He’s adept at explaining all that, but Chief Editor Louis Garguilo got him to focus for readers on the ins-and-outs of the practice of early formulation development.

• Billions Of Dollars In CDMO Secondary Packaging Of Biologics

  6/10/2025

  Chief Editor Louis Garguilo analyzes a report projecting the biologics CDMO secondary packaging market could rise from $2.59 billion this year to USD $5.50 billion by 2034. Projecting so far into the future is tricky business, but Garguilo explains the ultimate value.

• A Psychedelic Path To CDMO Selection?

  6/5/2025

  "Be prepared. Structured. Work in a systematic fashion towards your CDMO selection." That's a rather non-psychedelic paraphrasing of Anthony Grenier, Reunion Neuroscience, a biotech pursuing the development of novel, synthetic psychedelic molecules. Here's more of his thoughts on CDMO selection.

• Tariffs On Toys … And API? Biopharma As The Next Battleground

  6/3/2025

  Outsourcing drug development and manufacturing is an attempt at purposeful action in a web of interdependent contingencies. The contingency top-of-mind today is President Trump’s tariff strategy, and global "negotiations" that have ushered in a supply-chain disquietude.

• Outsourcing GLP-1 Programs: Is There Capacity For Biotechs?

  5/29/2025

  CDMOs want GLP-1 projects. Doug Bakan of Kailera Therapeutics says, “We see companies growing their existing GLP-1 manufacturing capabilities or communicating plans to introduce them. Our job is to find out which in fact have capacity now, and the actual vision to continue to expand."

• Evolve Or Fade Away? Biotech's Outsourcing Moment In Trump's Tariff Tangle

  5/22/2025

  Ali Pashazadeh is "a deep thinker" that our Chief Editor visits with annually. Recently, he asked Pashazadeh to help us think through the evolving policies of the new U.S. presidential administration and the tariff turbulence, as they relate to a biotech's development and manufacturing outsourcing.

• Squeezing CDMOs Dry? One Big Pharma VP Says Enough Is Enough

  5/20/2025

  A Big Pharma professional is battling in the ring of outsourcing ideas, and she’s in the CDMO’s corner. Lynn Cinelli, VP Global Biologics Supply Chain, Bristol Myers Squibb, is fighting against sponsors who don’t recognize inefficiencies and flawed thinking fall hard on their external partners.

• Lilly's CEO Building On The Trump Agenda

  5/12/2025

  “We hadn’t built a new site in the U.S. in more than 40 years until the first set of Trump tax cuts, so we need to see those either extended or improved to support this,” Eli Lilly CEO David Ricks recently said, announcing — in Washington, DC — plans to invest $27 billion to build four new manufacturing plants in the U.S.

• Investors Create A U.S. Biotech With GLP-1 Assets From China

  5/7/2025

  U.S.-based Kailera Therapeutics formation is a revelatory story highlighting the prowess of today’s investor class. All four of its clinical candidates are GLP-1-based therapies. All were in-licensed from China. Kailera's CTO Doug Bakan fills us in on how it came together, and what's next.

• The Serious Business Of Working With CDMOs At Phase 2

  5/1/2025

  You might call Anthony Grenier, Sr Director CMC at Reunion Neuroscience, a "phase 2 outsourcing specialist." In his discussion with Chief Editor Louis Garguilo, he describes his experiences, and presents some key factors and advice for biotechs at that middle stage of working with CDMOs.