ARTICLES BY LOUIS

• Stop Fixating On CDMO Pricing!

  4/8/2024

  You may have an ill-advised idée fixe on the prices your CDMO is charging you. Who says? Among others, members of our Outsourced Pharma Editorial Advisory Board – a practical and practiced assembly of successful outsourcing professionals. And they start with an offensive C-suite.

• From Ally To Adversary: BIO's Swift Rebuke Of WuXi

  4/5/2024

  The CEO of the Biotechnology Innovation Organization (BIO) spearheading expulsion of WuXi Apptec relied on WuXi Biologics as CEO of the biotech he founded. More on this and some breaking news on the U.S. government's accusations regarding WuXi, from Chief Editor Louis Garguilo.

• Gene Circuits And Biofabs: Building The Evolution

  4/1/2024

  Can’t find a bio fabrication plant for your gene circuits? Chief Editor Louis Garguilo has located a candidate. It arrives in a for-contract, state-of-the-art capability being carved out by an emerging biopharma. Circuits and biofab described within.

• Outsourcing Through An Industry-Government Battle

  3/25/2024

  A PhRMA survey concludes 63% of member companies expect to shift at least some of their r&d investment away from small molecules as a result of the new legislation called the Inflation Reduction Act (IRA). But a lot of this movement has been ongoing for almost 20 years. So what's the real scene, as the industry and government are at loggerheads.

• 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’s so much pressure to accelerate programs out of research and into development. Despite the complexity of new drugs, therapies and technologies, process development chemists are then asked to quick-step to clinical grade and commercial-ready material. CDMOs overall need to move quickly at all stages.

• 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?