ARTICLES BY LOUIS

• 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.   

• Biopharma Require Close Relationships And Recruiting At CDMOs

  12/23/2021

  Solid Biosciences took 3 steps to ensure supply wouldn't be “a barrier to delivering for Duchenne muscular dystrophy patients": Recruited manufacturing/process development experts; built a development and characterization lab; partnered with CDMOs. SVP Louise Perry and I focused on the third. 

• How A Virtual Biotech Lands A Large CDMO

  12/21/2021

  I hope you’ll agree we’ve been an honest broker when it comes to recording the frustrations emerging (and mid-sized) biopharmas have when trying to land capacity at established CDMOs. But there’s some good news of late: The tide could be turning.

• A Biotech Outsourcing For Sickle Cell Anemia

  12/16/2021

  CEOs are excellent communicators - so good, they easily slide into a bit of over-promotion. With Rahul Ballal, CEO, Imara, Inc., you get the clear communication without the ballyhoo. That’s why his tale of an incubator-bred biotech, its small-molecule program for sickle cell anemia, and outsourcing strategy, is so relatable. 

• Inflation Bites Biopharma In The Outsourcing Budget

  12/13/2021

  “I don't see how prices come down when they won't need to. Demand for outsourcing services is not going away.” “Suddenly a year from now you're going to get people to take a lower salary to do the same job?” Here's the real inflation bite at biopharma.

• Inflation Fears: Supply-Chain Lessons From Past Periods In US, And USSR

  12/1/2021

  I’m old enough to be concerned with inflation in the US because of direct experience in the '70s. Experience was also Vadim Klyushnichenko's starting point for a discussion on today’s inflation. His experience was in Russia in the '90s. Perhaps both he and I are overreacting? You be the judge.

• How Inflation Deflates Domestic Outsourcing

  11/23/2021

  Rising inflation in the U.S. is a major worry for biopharma CEOs who – as most all of them do – rely on outsourcing drug development and manufacturing. But what politicians and others are trying to enact here is not going to accomplish what they want – lower drug prices. And it's not helping U.S.-based CDMOs.

• Why Do We Outsource To China?

  11/18/2021

  We do so because many CDMOs there provide excellent drug/therapy development and manufacturing services, pricing is lower, available skilled workforce, etc. But we are also propelled there by circumstances created by political policy and societal fiat.

• Inflation Sticks, Supply Chains Stall, Outsourcing A Struggle

  11/17/2021

  Year two of COVID closes precariously as we face multiplying supply-chain challenges, and mounting inflation. What of drug development and manufacturing outsourcing specifically? I asked executives how much these two factors are affecting projects, particularly related to working with CDMOs.