Louis Garguilo's Articles

  1. 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.

  2. 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."

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Lynn Cinelli's Wake-Up Call: Pharma's Forecasting Makes CDMOs Sick 4/28/2025

    Lynn Cinelli, VP Global Biologics Supply Chain at Bristol Myers Squibb, has been strategizing on why Pharma is so poor at forecasting demand. "The entities that feel the pressures most may be our CDMOs,” she says. She has a better way to go about it — and it starts with the patient.

  9. Tariffs Won't Stop Drug-Candidate Licensing From China Biotechs 4/23/2025

    According to Global Data, the total deal value of U.S. licensing of innovator drug candidates from Chinese biopharma companies has surged since 2020. This is an area way upstream of the current tariff focus on manufacturing. But how this R&D trend and those tariffs play out will impact your U.S.-based CDMOs.

  10. Is An Outsourced BD Model Gaining Traction At CDMOs? 4/21/2025

    Why did George Hlass found Pharma Expanse, roughly described as a “BD-for-hire organization”? He says it was born of experiences over a long career in the role of business development (BD) professional. In part two, Hlass describes how, since 2023, the demand for this service has taken him by surprise.