ARTICLES BY LOUIS

• Process Development: Stuck In The Middle With You

  3/8/2024

  There is pressure to accelerate programs out of research, and into development. Then, despite the complexity of new drugs, therapies and technologies, process development chemists are asked to quick-step to clinical grade, and commercial-ready material. For their part, CDMOs need to react to it all.

• Outsourcing Nirvana At Eli Lilly

  3/4/2024

  Mark Butchko has been at Eli Lilly for 24 years, currently serving as Associate Vice President - Global Quality Laboratories. He draws from that longevity to describe what he’s currently experiencing, and what the future of outsourcing might look like from his vantage point.

• Is WuXi AppTec An Enemy Of The State?

  2/20/2024

  I have zero sympathies for the Chinese communist regime. My stance on tariffs and other economic and market-access blocking measures to combat the regime is more ambivalent. But is WuXi AppTec an enemy combatant against the citizens of the U.S., as proposed legislation assumes?

• Why Are Cell-Therapy Outsourcers Unhappy? Investors Know

  2/19/2024

  Some private research indicates cell-therapy sponsors aren't happy with outsourcing options. In this part two with a successful investor, we find out how that sentiment might change for the better.

• CDMO Carve Out Specialists

  2/13/2024

  How do investors influence our outsourcing ecosystem? Chief Editor Louis Garguilo asked one. But not just any investor. He spoke to a CDMO “carve out” specialist, who provides a window into how investors, sponsors, and CDMOs come together, and come apart.

• Novo Holdings Clarifies, But Competitors Circling Catalent

  2/12/2024

  Novo Holdings has responded directly to our request for a more definitive disposition of Catalent once it is acquired by the private investment company Novo Nordisk. The quick reply is fortuitous; competitors are circling.

• A Future Renaissance At Catalent? Employees Think So

  2/8/2024

  Re Monday's news of the purchase of Catalent by Novo Holdings, the seminal question we needed a more definitive answer to is: What specifically is planned for Catalent as a CDMO? Chief Editor Louis Garguilo got some answers. “Customers have been calling me continuously,” said one Catalent executive he spoke with. 

• Novo Acquires Catalent, Shakes Up Outsourcing World

  2/5/2024

  News of Novo Holdings acquiring Catalent, and Novo Nordisk taking in 3 Catalent fill-finish facilities, shakes up the outsourcing industry at a time when so many biopharma sponsors for already starved for capacity. Here's breaking analysis from chief editor Louis Garguilo.

• Creative Outsourcing Strategies, But Fill-Finish Still A Concern

  2/5/2024

  Chief Editor Louis Garguilo wraps up his discussions with Thomas Rademacher, CEO, Emergex Vaccines, focusing on strategies that mix internal capacity, facility purchases, CDMOs, new technologies, and challenges with fill-finish outsourcing.

• Beyond (And Better Than) mRNA: T Cell Vaccines

  2/1/2024

  During an extraordinary discussion with a historic biotech entrepreneur, he matter-of-factly interjects, “We’re leaving mRNA vaccines in the dust and moving onto a different approach to vaccines.” That ‘dust-generating’ approach is a proprietary T cell-based platform. And it has COVID and many other implications.