Articles by Louis Garguilo

41. Are You – And Your CMOs – Ready For The Second Coming Of DSCSA? 9/16/2019

    Last year at this time we were gearing up for DSCSA’s first November deadline. The second November deadline — specific to salable returns verification — is now upon us. Reaching compliance could depend to a large extent on your CDMO and other supply-chain partners. Are they ready? Are you? Here’s some historic perspective from the Healthcare Distribution Alliance (HDA).

42. Biologics Dose And API Outsourcing: A Decade of Decline? 8/9/2019

    Can it be that today, when we expect increasing demand for CDMO services, biopharmaceutical companies have decided to outsource less of their commercial production needs than in the past? Some new data provided exclusively to Outsourced Pharma by PharmSource, an organization of GlobalData Plc., seems to suggest so. But if so, why that apparent trend reversal? 

43. CDMO-To-Hospital: A Direct Ending For Generic Shortages? 8/1/2019

    Part 2 of our look at the unique business model and ambitious plans of Civica Rx.

44. Ending Generic Drug Shortages At Hospitals: A Capitalist Goes Nonprofit 7/1/2019

    The nonprofit CivicaRX continues to gain momentum, and the company’s president and CEO, Martin Van Trieste, believes it’s a business model that is “pro-competition,” and one that others throughout the biopharma industry can adapt as well.

45. Ranbaxy Revisited: Why We Need To Look Back 6/14/2019

    The fraud, deception and damage Ranbaxy Laboratories Ltd. of India perpetrated around the world a decade ago in the form of shoddy and dangerous drug manufacturing practices, is legendary. It’s time to look back. Katherine Eban, author of “Bottle of Lies: The Inside Story of the Generics Drug Boom” has provided us the means.

46. FDA Leads, C-Suite Lags Continuous Manufacturing Acceptance 6/13/2019

    What happened to the continuous manufacturing (CM) revolution that was barreling down the biopharma turnpike? One measurement of progress is the five FDA-approved drugs utilizing CM. I’ve heard positive dispositions on how the FDA is doing all it can to break down the adoption doors. But there’s a sentiment within the industry CM gets stuck in the C-Suite.  

47. How Important Is Geography To Today's Outsourcing? 6/10/2019

    A recent CDMO press release essentially asserted superiority via proximity: Geography as God of outsourcing. I contacted two biopharma executives familiar with the Boston/Cambridge scene for reactions: Michael Kaufman, Senior Vice President, CMC, Mersana Therapeutics, and 15-year veteran of Merck; and George Avgerinos, Senior Vice President of Biologics Operations, Fortress Biotechnologies, and 22-year veteran of BASF/Abbott/Abbvie.

48. Include CDMOs In “Drugs, Money And Secret Handshakes” 3/8/2019

    “Drugs, Money, and Secret Handshakes” is one hundred power-packed pages from author Robin Feldman, the Arthur J. Goldberg Distinguished Professor of Law at the University of California Hastings. Feldman provided Outsourced Pharma  a pre-publication copy of the book. Here’s part one of my review.

49. A Biotech's Guide To Selecting CDMOs: “35 Or 6 To 2” 3/1/2019

    How one biotech started with a list of 35 possible CDMOs and whittled that list down to two.

50. I Outsource, Therefore I Exist 3/1/2019

    Today, the success of your programs has never been more contingent upon selecting and working effectively with your service partners. This is what our annual CMO Leadership Awards are all about.