ARTICLES BY LOUIS

• Does Diversity At CDMOs Matter?

  7/5/2023

  “That's a really interesting question,” replies Sara McCutchan, during a conversation we had a few months ago. “I've actually seen very diverse representation at our CDMOs, which is great."

• The FDA’s Sway On AI

  6/29/2023

  The FDA’s CDER published a paper titled “Artificial Intelligence in Drug Manufacturing" to facilitate input from outside the agency. Here's some of that input from Chief Editor Louis Garguilo.

• 3 Updated Fundamentals Of Outsourcing

  6/26/2023

  Here are three newly updated key factors for increasing your chances of personal, programmatic, and organizational success, as you pursue the activities known collectively as drug development and manufacturing outsourcing.

• Economical Outsourcing: Should I Stay Or Should I Go?

  6/19/2023

  I doubt The Clash contemplated drug development and manufacturing when they penned their classic song, “Should I Stay of Should I Go.” But they could have. The question of staying internal with your programs or going to service providers - around the world - can be difficult to answer.

• If The Economy Squeezes CDMOs, They Squeeze You?

  6/15/2023

  A tale of outsourcing woe documents challenges biotechs face during economic-challenging cycles. The story serves as a cogent reminder long-duration strategies get crunched by inflation, and biotech is a long-duration strategy.

• CDMOs Shine When Inflation Clouds Innovation

  6/12/2023

  A report says rather than those regularly tagged for any deceleration of innovation (e.g., poor corporate culture; diminishing funding, revenues and/or profits), today CEOs say inflation specifically is the leading culprit. CDMOs to the rescue.

• Rocketing Expectations For CDMOs

  6/5/2023

  “I look forward to a world of gene therapy where the CDMO and biotech models are integrated. I don't know how that happens... How do we integrate further so we can work together earlier and more effectively?” A discussion with an industry leader and CEO.

• Outsourcing From the Empire State Building

  5/30/2023

  “Biotechs must deliver on high expectations with minimal spend. That’s the job description” says Gaurav Shah, M.D., co-founder, CEO, Rocket Pharma, a late-stage gene-therapy company formed in 2015. Fulfilling that description depends in part on where you choose to operate, and with whom.

• A Decline In Cell And Gene Therapy Outsourcing?

  5/22/2023

  Less outsourcing in the cell and gene therapy space? That would grab your attention, whether directly involved in CGT or not. I unfurled this vignette within a report from my colleagues at ISR Reports. They also gave me a hand in understanding the data.

• Small Molecules And The Arc Of Time

  5/15/2023

  “I've been trained, and doing the same stuff since I was 25. The same experiments for 50 some years, a long time. I guess you could call what I am describing as the arc of time for small molecules,” says Kintara Therapeutics cofounder and CSO Dennis Brown.