ARTICLES BY LOUIS

• End Of The Serialization Line: Aggregation By 2023

  6/15/2018

  The next level of FDA-mandated U.S. Serialization hasn’t received the attention heaped on phase one — item-level labeling. The FDA defines this next phase as “aggregation,” simply defined as “the process of building a relationship between unique identifiers assigned to packaging containers.” In part two of our update on serialization, we’ll look into the status and timeline to aggregation.

• 6 Months To Serialization: A Review And Projection

  6/8/2018

  It’s the six-month countdown to implementation of item-level serialization for drugs sold in the U.S. It seems a good time – “good” depending on your state of readiness – to assess our progress. Moreover, the industry needs to remain cognizant of the fact the November deadline is specific to “item-level” serialization; there’s a second phase the FDA wants completed by 2023: Full “aggregation” of product throughout the supply chain.

• Former Kodak Park Future Super Site For Biopharma?

  5/30/2018

  The last time I stepped foot on the historic Kodak campus in Rochester, NY, it was the early 2000s. Kodak was putting on a brave face, but the situation was dire. Today, what was once the largest operating business park in North America, is looking for a second chance. Those in charge of the park – now the Eastman Business Park (EBP) – think opportunities will come from biopharma and CDMOs. 

• Artificial Intelligence Versus Human Knowledge In The Supply Chain

  5/17/2018

  Will advancing forms of artificial intelligence (AI) help to better integrate supply-chain data to make outsourcing development and manufacturing more efficient, productive and profitable? Only if it’s a human making the decisions.

• Big Pharma Moving The Blockchain Needle

  5/10/2018

  Susanne Somerville is founder and leader of The MediLedger Project, a biopharma-industry working group (including Abbvie, Genentech and Pfizer) for the study of blockchain implementation. She fills us in on the strong industry interest, details of the project, and what the technology could mean specifically for drug development and manufacturing outsourcing. 

• Hire New Biopharma Executives With Old-School Traits

  4/26/2018

  Times change. Industries – surely including biopharma – need to change with them. So, too, the executives leading companies through those transformations? Well, perhaps not so much. John Webber, President, GForce Life Sciences, explains …  

• Janssen Goes From Good To Excellent Supply Chain Partners

  4/20/2018

  Great questions elicit enlightening answers. Especially when the first come from a wise moderator (Brendan Crowley, President, Brendan Crowley Advisors LLC), and the second a seasoned industry veteran (Remo Colarusso, Vice President, Janssen Supply Chain, Johnson & Johnson). Here’s what they had to say about drug development and manufacturing partners.

• Pfizer's Drivers for Manufacturing: New Tech And Regulators

  4/12/2018

  Regarding drug development and manufacturing – including outsourcing – Bob Betzig of Pfizer says technology has led and continues to drive change. And by the way, so do the global regulators of biopharma. 

• 6 Challenges For BioPharma Packaging

  4/2/2018

  Whether it’s innovative product-development; the need to operate globally; dealing with aging and unhealthy populations; stopping counterfeiting and theft; or facing un-harmonized serialization … biopharma packaging has its challenges.    

• A View Of Biopharma From Pfizer's Building 41

  3/20/2018

  This is the story of a man and a building, and their tracing of decades — and hints of the future — at Pfizer, and indeed the entire biopharma industry.