ARTICLES BY LOUIS

• There's An “I” In Biopharma Teams – But It's Not For “Identities”

  7/23/2018

  Today’s "identity splintering" is bad for biopharma teams. And since no organizational activity is more important to the overall success of drug development and manufacturing outsourcing than the formation of competent teams — at the drug owners and CDMOs — we should be particularly concerned. Here’s a discussion on this sociopolitical trend seeping into our industry.

• The “Build Strategy” Behind Shire's Plasma Manufacturing Center

  7/13/2018

  Among other accolades, Shire is a proficient drug development and manufacturing outsourcing organization. So why is the recent excitement from Shire about a large facility “build,” instead of an external services “buy”? Matt Walker, EVP of Technical Operations, explains for Outsourced Pharma readers why Shire built its state-of-the-art plasma manufacturing facility just east of Atlanta, Georgia.

• This CDMO Deal Significant Sign Of The Times

  7/12/2018

  Some deals are more symbolic than others. The recent M&A announcement by PCI Synthesis and Novacap is one of those. The added significance is not lost on Ed Price. He founded PCI at the age of 29, and has been the company’s CEO and president for all 22 years of existence. “Many in the industry were surprised,” says Price. Here’s why, and what it means for the outsourcing market.

• Contract Manufacturing: Descriptions For A Decade Of Growth

  7/5/2018

  Over the next decade, global biopharma contract manufacturing (combined small and large molecule) will grow globally at an annualized rate of 4.8%, according to a new report. The Roots report is chock-full of the quantifying we rarely find in our field of drug development and manufacturing outsourcing, and includes some fundamental but interesting CMO categorization.

• The SEC And The Risk of Biopharma Outsourcing

  6/29/2018

  Two of the most widely covered biopharma-related news stories in the U.S. involve a regulatory agency, as you might expect. But that agency isn’t the FDA. It’s the SEC (United States Securities and Exchange Commission). Both the SEC and FDA are increasingly interested in evolving business models for drug development and manufacturing. For this reason: Your outsourcing is a serious and reportable risk. 

• Biopharma And CDMOs: No Strategic Relationships In The Long Run?

  6/22/2018

  Biopharma companies should recognize some of the vernacular they use for negotiating drug development and manufacturing outsourcing can set CDMOs on edge. In this editorial, we talk to biopharma veterans of outsourcing about some of the "financial frictions" brought out in new models for sponsor-provider relationships.

• 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.