ARTICLES BY LOUIS

• Impacts Of The Inflation Reduction Act (IRA)

  3/18/2024

  Jesse Mendelsohn, a "pharmaceutical regulatory compliance and government pricing” guru, who manages a life sciences group of over 100 consultants, says currently the biggest disruptor to our industry in 2004 is the Inflation Reduction Act (IRA), the 2023 legislation passed by Congress and signed into law by President Biden. 

• BIO Expels WuXi, Agrees With U.S. Government

  3/14/2024

  “BIO is taking steps now to separate from WuXi-AppTec regarding membership in the organization," says Biotechnology Innovation Organization President & CEO John F. Crowley. But to Chief Editor Louis Garguilo, this seems like a strange company to target.

• What Investors Teach Us About CDMO Selection

  3/12/2024

  “My advice to a biotech when outsourcing to a CDMO is really understand what you want. I don’t mean this as a criticism, but selecting a CDMO is most often not within your circle of competence." Advice on overcoming that deficit from a successful biotech and CDMO investor. 

• 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.