ARTICLES BY LOUIS

• An Infantile Supply Chain

  5/27/2022

  Imagine a country with a $4 billion, government-regulated market for a life-vital product supplying a large and vulnerable part of its population. And a woefully inefficient supply chain and management of it all. 

• Optimism Is Not A Strategy For Outsourcing

  5/26/2022

  When you embark upon your drug development program, and connect that to patients, you have to be optimistic. Optimism is a biopharma’s opening gambit. Danger lurks, though, when optimism gets codified in unrealistic, aspirational planning and timelines.

• We Need More University-Based CDMOs

  5/24/2022

  What the outsourcing world needs now is university-based or -affiliated, CDMOs. So says Joanne Beck, COO, Boston Pharmaceuticals, and whose career has spanned Amgen, Abbott/AbbVie, Shire, and Celgene.

• Breaking Down The CDMO Size Barrier

  5/16/2022

  We recently discussed a “mutual growth” strategy for working with smaller to mid-sized CDMOs. Now we’re on to a “bigger-than-you” strategy for biotechs working with “Big CDMO.”

• Here's How To Grow With Your CDMO

  5/9/2022

  There's an opportunity - and strategy - for a biotech to grow as your CDMO partners are growing, says a former Genzyme executive and now industry consultant. And if the CDMO is already big, there's a plan for that as well.

• Process Development: The Rodney Dangerfield Of Outsourcing?

  5/2/2022

  Rodney Dangerfield's schtick revolved around his saying, “I don’t get no respect.” In the biopharma industry, process development (PD) may be our Dangerfield. However, giving short shrift to the art, science – and need – of PD can end up leading you down a primrose path.

• Catching Lightning In A Biopharma: Now What?

  4/28/2022

  Lightning strikes: Your once early-phase program suddenly arrives at the precipice of commercial approval. Large scale production looms. An experienced CEO warns executives starting out with one outsourcing model must now recognize a future including the bigger “tier” of CDMOs.

• Are You Cut Out To Be An Outsourcing Phenom?

  4/25/2022

  Outsourcing is a risk-laden operational strategy, but to a lesser degree if you’re an organization with an outsourcing professional like Kent Pryor. CEO or otherwise: Do you or your colleagues fit that bill? The answer could be vital to your chances of success.

• Call It What You Like, This Biotech Model Makes Money

  4/18/2022

  “We are a biotech that makes money,” replies Helen Torley, CEO, Halozyme, when I ask her what her company is exactly. A significant amount of money, along with notably high margins, and plenty of new drug opportunities. Here's the model for success.

• Halozyme's Outsourcing Tip: The External Manufacturing Site Lead

  4/11/2022

  Halozyme's API production has occurred at two U.S.-based CDMOs since its first commercial approval in 2013. The biotech works closely with both on new API generations and biologic processes, leading to additional regulatory filings. Here's a key ingredient to that success.