ARTICLES BY LOUIS

• How Do You Define Manufacturing?

  2/14/2022

  When an executive at a cell-therapy company talks about ‘manufacturing,’ is it the same animal as when an executive of a small-molecule company uses the word? Bone Therapeutics CEO Miguel Forte says, "You can talk about small molecules, biologics, cell therapy ... but manufacturing must always mean the same thing."

• When Outsourcing Fails All Of Us

  2/10/2022

  Sometimes, emerging biopharma – founded by accomplished scientists and professionals – can’t find a CDMO to help them scale up for clinical trials. Even though the compounds are backed by extensive research and test results. This can impact all of us - particularly when the disease target is a threat to human survival.

• 2 Outsourcing Market Reports: It's A 50-50 Split With Internal Capabilities

  2/8/2022

  Two reports suggest we are an industry with equal parts internal capabilities vs. outsourcing for our drug development and manufacturing programs. Smaller biopharma may want to look to established pharma for clues on managing this even hybrid.

• “Nobody Should Work Alone”: An Outsourcing Philosophy

  1/31/2022

  Miguel Forte, CEO, Bone Therapeutics, thinks I’m overly bifurcated in my approach to outsourcing development and manufacturing. “It's interesting that everything is a combination of internal and external,” Forte says. Outsourcing is not an equation of “what we do vs. what they do”; it’s complimentary over contrasting. He’s got quite the example. 

• Cell-Therapy Outsourcing And The Flip Of A Coin

  1/24/2022

  “Heads” and external partners are extraordinary enablers, providing access lanes to expertise, technologies and facilities. “Tails” and find your development programs on-ramping a clogged freeway with few service stops offering the specific assistance you need to complete your development journey.

• “Nick And the Cocoons”: Automation for Autologous Therapies

  1/18/2022

  We’ve dispensed somber analysis on a lack of assistance from established CDMOs for cell and gene therapy developers. The critique particularly emanates from those pursuing autologous-cell or other precision-medicine approaches.  Time to give CDMOs taking the incoming criticism a chance to respond.

• Defending Your Supply Chains From “Foreign Suppliers”

  1/13/2022

  In “defense” of the integrity of your (offshore and onshore) drug development and manufacturing outsourcing, and during this year 3 CE (Covid Era): Considering suppliers as separate and somewhat removed entities – putting them at a distance – might be what it takes to subsequently bring you even closer to reliable partnerships. 

• CDMOs Can Serve CGT Companies, Make Money, And Support A Nation

  1/10/2022

  C3i Center Inc. is a CDMO on a mission to grow a national biopharma ecosphere in Canada by accelerating the commercialization of cell therapies and cancer immunotherapies. “There’s a lot of Canada in our story,” says CEO Louisa Petropoulos. She’s correct, but I found a lot of story in C3i. It’s well worth reading no matter where you reside. 

• No Joke: A Cell-Therapy Start-Up Meets A Super-Sized CDMO

  1/3/2022

  Did you hear the one about a cell-therapy start-up asking a behemoth CDMO to install its newest technology at an emerging CDMO? And the behemoth CDMO sent them some Cocoons? Part 1 of an intriguing narrative of a new outsourcing paradigm.

• Outsourcing For Duchenne: Techniques For All Biopharma

  12/28/2021

  Louise Perry, an outsourcing veteran (Amgen, Novartis and Shire) is securing the development and supply chain for a gene-transfer clinical candidate targeting Duchenne muscular dystrophy. The technique she's using at Solid Biosciences for working with CDMOs, though, is transferable to all drug developers.