ARTICLES BY LOUIS

• Takeda's Award-Winning Facility Teaches You About Outsourcing

  4/3/2025

  A Takeda production site in Linz, Austria, received an ISPE’s 2024 Facility of The Year Award. What’s so special about that location? The explanation from Roland Fabris, Site Head, will actually help you benchmark your CDMO, and demonstrate much about facility selection applicable to your own outsourcing needs. 

• Pain And Pleasure In Project Management Of CDMOs

  3/17/2025

  Tony Sampognaro of Stoke Therapeutics, says, “We're having to rearrange and bolster the constellation of CDMOs we're working with." The nice thing is, Stoke has a comprehensive extended enterprise model. Nonetheless, an all-outsourced model “can add hidden complexity." Here's how to manage that.

• 'Fractional Hiring' At Your CDMO. Okay With You?

  3/14/2025

  We need a flexible hiring marketplace – a new ecosystem – to generate increased awareness by professionals and students of positions in the biopharma industry. “It’s no longer about simply posting full-time jobs,” says Chris Frew, Founder/CEO of BioBuzz Networks. But is "fractional hiring" the answer?

• Talent Logistics Turns Biotech Winter To Hiring Spring

  3/3/2025

  After our "Biotech Winter" – a period starting circa 2021 with tens of thousands of layoffs and stagnating investment — is it springtime for biotech? Chris Frew, Founder/CEO of BioBuzz Networks, says yes. “We have demonstrably entered a turning point in biotech hiring.”

• How Do We Categorize CDMOs?

  2/24/2025

  Are we on the same page? Do we need to be? That is, how do we differ on what might seem like the mundane defining of CDMOs as small, medium, or large? Some readers have been asking. How might this determination be relative and important to individual sponsors? Our Advisory Board members weigh in.

• CDMOs Bet Big On Asia Expansion. Can Trump Reverse The Tide?

  2/20/2025

  Facility investments by CDMOs continue to be magnetized to Asia. Recent examples abound. Chief Editor Louis Garguilo details some of those, and discusses whether, for example, a President Trump-intensified focus on increasing manufacturing in the U.S. can change this. Will your outsourcing in 2025 change direction? The answer may surprise you.

• Stop Hiring Now! Stay Virtual

  2/17/2025

  Robert Discordia, Co-Founder, President and CEO, EQUULUS Therapeutics, knows that to advance early-stage development assets most economically, biotechs should (a) stay within their virtual model, and (b) base that outsourcing strategy on initial business objectives. Here are his dos and don'ts.

• They Said What? Unexpected Insights Into CDMO Selection

  2/10/2025

  An assortment of conversations with experienced biopharma executives have generated some surprising commentary about CDMO selection. Chief Editor Louis Garguilo puts those insights together in this editorial. They include selection preparation/responsibilities, and some interesting CDMO behaviors of late.

• Regulatory-CMC: A Core Practice For Successful CDMO Partnerships

  2/6/2025

  Regulatory-CMC is the denominator through the career of Sai Prathyusha Bhamidipati, currently at Moderna. Regulatory-CMC focuses on ensuring compliance with regulations regarding the production and quality control of your pharmaceutical products. Bhamidipati explains the importance for the practice of which when dealing with CDMOs.

• Training Specifically For Tech Transfer Skills Does Exist

  2/3/2025

  Professionals in our development and manufacturing outsourcing ecosystem are worried about inadequate training – in-house at their biotechs, and at their CDMOs. A main concern is a lack of sufficiently trained personnel to perform the various technology transfers to keep our industry running efficiently.