ARTICLES BY LOUIS

• Merck, Medimmune, And Keytruda: An Ultimate Outsourcing Story

  10/12/2022

  This editorial illuminates the highest possibilities of the strategic and tactical application of manufacturing outsourcing. “I put a pretty famous deal together with Merck, as an example,” Darren Dasburg says suddenly during a discussion on developing business requirements ... it also involves Medimmune, and drug called Keytruda.

• Outsourcing: It's A Practice, Has Requirements, And Needs Governance

  10/6/2022

  Among all there is to learn about drug development and manufacturing outsourcing, there are three fundamental areas to focus on: it should be treated as a practice; given specific business requirements; and effectively governed.

• Lessons For Outsourcing: Can You Pass The Test?

  10/3/2022

  Back to class. Here's part 2 of our "Outsourcing Master Class," created by Darren Dasburg. We'll cover the final five of the 10 modules: provider selection; financial analysis; contracts; transitions; and governance. If you want to outsource better, sit up straight, and focus.

• The “Outsourcing Master Class”: 10 Modules For Success

  9/26/2022

  Darren Dasburg didn’t write the book on outsourcing. He did, though, design and teach the defining class on the subject. He then went on to executive roles at GSK, MedImmune(AZ), and CRISPR Biotech, where he put his teachings to work. Now he's back to teaching that class - right here for Outsourced Pharma readers.

• FDA, CDMOs, And COVID: How To Talk About 483s

  9/23/2022

  Let’s discuss our manufacturing partnerships, the innovation and investments required, and the spectacular quality it takes to produce a vaccine. When the FDA does its job and feels it must issue 483s, let’s put that into context, and educate the public on the rigors of drug development and manufacturing.

• Stand Shoulder-To-Shoulder With Your CDMO

  9/20/2022

  “I love the Shire outsourcing model, although of course Shire's gone now,” says Ken Ford, who worked at the drugmaker for six years. Now as a consultant, he teaches clients of differing size, resources, and attributes how to optimize their outsourcing with the model he cut his teeth on.

• 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.