ARTICLE BY LOUIS

• Should Your CDMO Become A 503B?

  4/1/2021

  A reader pulled me down an Alice-In-Wonderland rabbit hole. I’m glad she did, though. If you read the headline above and thought, “What exactly is a 503B?” you’ll be glad, too.  

• Position Your CDMO For Competitive Advantage

  3/1/2021

  “Outsourcing is really about positioning your CDMO to your competitive advantage,” says Lisa Wyman, SVP technical operations and quality at Acceleron Pharma.

• The Challenges Provided Us A Deeper Meaning

  3/1/2021

  The past year of travel and other restrictions have skewed the biopharma outsourcer’s mantra of “trust but verify” to a heavier weight on the first of those two components. For some, this was easier to deal with than others.

• Can Your CDMO Relationships Survive Another “Virtual” Year?

  12/1/2020

  Lori Hoffman, head of alliance management, Slayback Pharma; and Greg Birrer, quality head, Elusys Therapeutics, talk about how the pandemic has affected CDMOs.

• What’s A “Biopharma CDMO”?

  11/16/2020

  In part two of my exclusive interview with Phlow Corporation's CEO Dr. Eric Edwards, we turn our attention to biopharma business models and CDMO partnerships.

• You Don’t Know Phlow: The Backstory Of A Misread Biopharma Start-Up

  11/10/2020

  No biopharma start-up has been as misconstrued, hastily judged in strategy and capability, or even labeled “political.” Now Phlow Corporation’s CEO Eric Edwards sets the record straight in an exclusive interview.

• Is PhRMA’s White House Rebuttal Acceptable?

  8/24/2020

  While the biopharmaceutical industry can only be commended for the work underway to bring the world vaccines and therapies to halt the spread and severity of COVID-19, it would be ironic if PhRMA uses the pandemic as leverage to maintain the drug supply-chain status quo.

• A Word From Germany On U.S. Manufacturing Productivity

  8/12/2020

  Of 367 production plants BASF operates worldwide, six are Verbund sites. Those six produce more than 50% of all BASF volumes. A CEO of a U.S.-based CDMO thinks Verbund is the kind of thinking needed at drug development and manufacturing facilities in this country.

• Why You Need People Like Jana Spes At Your Company

  4/1/2020

  Industry veteran Jana Spes provides some uniquely qualified analysis and guidance on the outsourcing industry and working with CDMOs. Don’t be surprised if you come away thinking for your next outsourcing operations hire, specialization is out, and the Spes model is in.

• Award-Winning Questions: “Who Are We?” And “Who Are They?”

  4/1/2020

  Outsourcing Pharma Chief Editor Louis Garguilo explains what you can expect from this year’s CMO Awards publication and how it can help you when choosing an outsourcing partner.