ARTICLES BY LOUIS

• CDMOs Need To Digitize Now

  9/13/2022

  What can the CDMOs do to hold up their end of the drug development and manufacturing outsourcing relationship? Kenneth Ford, Founder and Principal Consultant, CMC Tech, LLC, has an answer at the ready: digitize. Here’s what he means, and why the slow burn to digitization still sets fire drills downstream.

• Trade-offs And Priorities: The Authentic CDMO Model

  9/7/2022

  Not recognizing the perspective and drivers of CDMOs is the root cause of communication issues and frustration between biopharma customers and these service providers. Conversely, understanding CDMO motives can lead to strategies for taking advantage of mutual "tradeoffs" that benefit both sides of the relationship.

• Take Control: Your Drugs Digitally Directed To Your Patients

  9/2/2022

  If you are a drug sponsor or manufacturer (or soon to be) you may benefit from an online, direct-to-patient (DTP) strategy. “Selling DTP allows for larger margins and bigger markets. You don't have to pay all the middle people to get your product out there. It’s a great proposition. You gain more control.”

• Go Digital: Sell Your Drugs Directly To Patients

  8/31/2022

  What if you could sell your drugs from your internal facilities or your CDMO more directly to patients, eliminating the middle bloat in our healthcare system? And CDMOs with their own drug-products could do the same? I looked into a new direct-to-patient (DTP) option.

• What's A South Korean CDMO Doing On A New Jersey Campus?

  8/24/2022

  What’s a South Korean company doing with a CDMO on the campus of the New Jersey Institute of Technology (NJIT)? The answer has both specific and global implications for our drug development and manufacturing outsourcing industry. Here's the full story and the potential implications.

• “We're Not A Company Without Continuous Manufacturing”

  8/19/2022

  Lyndra Therapeutics is designing in-house a specialized, continuous and automated manufacturing line to manufacture its new long-acting oral-drug products. Someday, it hopes to export that line to partners around the world. The strategy starts with a basic scientific knowledge that propels an organization to continuous.”

• A Star Is Born To Deliver Drugs: Can It Be Outsourced?

  8/15/2022

  A miniature manmade “star” – with round middle and triangular arms – collapses to fit into a capsule and provides patients an oral drug. The creators of this device-like drug are devoted to production through continuous manufacturing. Can the company also outsource some of what they've developed internally?

• Should You Hire Talent Away From Your CDMOs?

  8/10/2022

  There's a hiring crunch out there, and today drug sponsors are recruiting from inside some of their CDMOs. Is that a good strategy? We'll take a look at both sides of the equation.

• No Matter Modality, A Methodology For Managing CDMOs

  8/3/2022

  Steve Goodman, Vertex Pharmaceuticals has been outsourcing development and manufacturing for years. “I’ve been successful because my approach to managing a CDMO is mostly agnostic to modality,” he says. Here are a few more of his best practices.

• Executive Director, AAV: Title As Leading Indicator

  7/27/2022

  Steve Goodman’s new title at Vertex Pharmaceuticals catches the eye: Executive Director, AAV Process Development and Manufacturing. It points us to where our industry is rapidly heading. In fact, we might say Goodman himself has been a leading indicator.