ARTICLES BY LOUIS

• A Biopharma CEO's Revelation: “We Outsource, Therefore We Exist”

  1/28/2019

  The new chief executive slowly made her way to the makeshift stage in the largest of the three meeting rooms at the young biopharma where she was taking leadership. She had a degree in chemistry, and a PhD in philosophy. Perhaps not your typical candidate for chief executive at a start-up biopharma. She’d thought deeply about the company and its future. What was at its core? 

• The Biotech And The Behemoths

  1/22/2019

  Can a smaller biopharma have any leverage with bigger, multinational CDMOs? Biotech Genisphere is giving it a try. So far, so good. Here’s why.

• A Biotech's Guide To Selecting CDMOs: “35 Or 6 To 2”

  1/14/2019

  As I spoke to Tom Bliss, veteran pharma and bio executive (e.g., Amgen, Baxter, Kyocera), and most recently CEO of platform-biotech Genisphere LLC,  I kept recalling Chicago’s iconic 70s rock song, “25 or 6 to 4.” That’s because Bliss was detailing how Genisphere went from a list of 35 or 6 candidate CDMOs to 2 selected as its development and manufacturing partners. 

• New Data And Analysis On Biopharma Capacity

  1/10/2019

  Readers may recall some spirited back-and-forth last year between me and Industry Standard Research (ISR) Vice President Kate Hammeke over conclusions on biopharma capacity at CDMOs. To measure more adequately, and get us on the same page, Hammeke inserted some specific questions on this subject into a recent ISR survey. That data is now in, and exclusive to Outsourced Pharma readers.

• The “Unexpecteds” Leading Us Into 2019

  12/26/2018

  What industry trends, developments or outcomes did not shape up as you had expected at the start of 2018? Here are replies to this question from the Outsourced Pharma Editorial Advisory Board, starting with an insightful list from Darren Dasburg, VP, Head Learning and Development, Global Operations, AstraZeneca. Considering what didn’t work out should help us focus in 2019.

• 2018 A Year Of Big Biopharma Capturing Capacity

  12/17/2018

  Will bigger biopharma successfully streamline supply chains by capturing the capacity and technologies under the umbrellas of bigger service providers? Will start-ups and smaller biotechs find new options for the unique solutions they need? Here’s a look at what transpired in 2018 to help answer both these questions. Oh, and Happy Holidays.

• China Biopharma: Recognizing The Past, Recasting The Future

  12/11/2018

  In part two of our discussion with BeiGene’s Diana Francis, VP Quality & Compliance, we turn her attention back to two concerns with China: IP theft and quality breaches. Then I’ll wrap up our overall discourse to date, with two observations on what we’ve learned this past year about China’s growing connection to the global biologics industry.

• Straight Talk From BeiGene On Quality, Compliance, And Outsourcing

  12/3/2018

  It was time within our ruminations on China to speak directly with a quality executive at a drug developer and manufacturer based there. That’s now accomplished via a discussion with Diana Francis, Vice President, Quality & Compliance, BeiGene, Ltd., a biopharma some have dubbed as a potential “Genentech of China.” Francis spoke openly about her role, BeiGene’s global strategy, and outsourcing within and from China. 

• Not Enough Data To Utilize AI And Machine Learning In Drug Development

  11/27/2018

  We’ve heard the calls for help: “We’re drowning in oceans of data.” But I’ve learned that those further “downstream” may end up high and dry when it comes to having sufficient data to allow drug developers and manufacturers to fully actuate artificial intelligence (AI) and machine learning (ML). Here’s what some experts had to say. 

• Biologics In China: Market-Driven Inevitability, New Quality Start

  11/19/2018

  “… the people you’ve been talking with are just not seeing all the components of the global biopharmaceutical industry — and this huge market opportunity. China will become a big player in biologics. This is only natural; there’s good reason for that.” Here’s a more positive outlook on the current situation in China, from Eric Langer, President, BioPlan Associates, Inc.