ARTICLES BY LOUIS

• Building In Boulder – A Biotech Finds A Manufacturing Base

  2/13/2023

  If any of you have thoughts of building internal development and manufacturing facilities (to supplement or augment your outsourcing,) this is a discussion for you. It describes how on cell-therapy company made key decisions.

• A Bridge To Capacity For The Cell & Gene Industry

  2/8/2023

  Bridge facilities have been built for cell and gene therapy (CGT) sponsors – and CDMOs – to access here-and-now available, fully outfitted GxP capacity. But bring your own skilled workers. Here's how it works.

• Solving The Equation For A Cell Therapy Development Strategy

  2/3/2023

  Nowadays, “biotechs” emerge with unique business models, are hybrids of one kind or another, and operate as developers, platform/technology creators and service providers rolled up into one glorious organization. I found another one at Umoja Biopharma, Inc., a Seattle, Washington-based cell-therapy company. 

• Multiplying Forces Of Clinical Supply Outsourcing

  1/30/2023

  There are a number of varying and converging forces baring down on sponsors looking for CROs/CDMOs who can provide a full slate of services around their clinical-trial material. Both CDMOs and sponsors need to add or subtract from their strategies to adjust.

• CPHI Report Presents Shifting Outsourcing Realities

  1/24/2023

  While positive in tone, the 6th annual CPHI report demonstrates our outsourcing sands are indeed shifting. Which way for sponsors, CDMOs, and individual countries? Here's an analysis from our Chief Editor.

• CDMO Performance, The Workforce, And Reshoring

  1/19/2023

  There’s a broadening concern among U.S.-based drug and therapy developers regarding some of the challenges facing CDMOs in this country. Along with factors contributing to momentum for reshoring and investment in the U.S., we face some strong headwinds, including price and wage inflation.

• The Best CDMOs Are Redundant

  1/16/2023

  The top CDMO-selection criteria for Perry Calias, Chief Operations Officer, Revolo Biotherapeutics, and a veteran outsourcer, is redundancy. Redundancy laced with relationships, that is. Here's how it can work for you.

• A Historic Outlook For 2023

  1/9/2023

  You might say John Koleng has been living in the drug development and outsourcing future throughout his decades-long career. That career began in 1996 when as a grad student he helped cofound a CDMO. Today, as a VP at TFF Pharmaceuticals, he's as visionary as ever.

• Will 2023 Bring A New (Stable) Normal To Outsourcing?

  1/3/2023

  “Stability and balance are critical in developing a new equilibrium with vendors across the drug development spectrum, and that means getting to a future where there’s a new normal to feel stable within," says Sara McCutchan of Aristea.

• An Industrialization Strategy For Cell Therapies

  12/29/2022

  If cell therapy is the art of engineering, the industrialization of these therapies – many of which are stymied by an inability to scale up or produce at various locations  –is fully contingent upon the application of engineering concepts and practices. Part two of our look into "cell therapy industrialization."