ARTICLES BY LOUIS

• Biopharma Supply Chains At Industry 4.0

  9/24/2019

  Have we moved the needle closer to “Biopharma 4.0,” and improved supply chains? Here’s what industry veterans were thinking the beginning of the year. One thing is certain: Pharma and Biotech have different ideas on what happens next. 

• HDA: “Drug Importation” A Concern For DSCSA

  9/6/2019

  I’d bet a bitcoin many readers of Outsourced Pharma know less about the Healthcare Distribution Alliance (HDA) than you should. And something else we all should recognize: Current ideas for “drug importation” into the U.S. could negate DSCSA efforts. An outcome none of us should accept.

• No Freeze In Lyophilization Outsourcing

  8/30/2019

  Ionis Pharmaceuticals considers itself a research and development engine  – and why not, with three commercial drugs and a pipeline of 40-plus clinic-worthy drug candidates. "We don't want to be a large-scale commercial manufacturer,” explains Max Moore, Executive Director, Manufacturing & Operations.  Instead, Ionis relies on CDMOs for that work, which almost always requires lyophilization. And so might your future product development and manufacture.

• CDMOs In An Innovative-Drug Uprising

  8/26/2019

  The goal is to stop force-feeding patients cheaper generics, and keep them on branded-innovator drugs until a more effective one comes along. In this final of our three-part series, we look at the role of drug development and manufacturing outsourcing within this discussion. Because if we’ve learned anything, it's that all drugs are not the same.

• Business Roundtable Reaffirms Capitalism – And The Supply Chain

  8/23/2019

  With the hoped-for media splash accomplished, 181 CEOs, including from Bayer, BMS, J&J and Pfizer, published an updated “Statement on the Purpose of a Corporation.” They’ve committed to benefit “customers, employees, suppliers, communities and shareholders.” What’s it all about really?

• Lyophilizing All The Way To The Biotech Bank

  8/15/2019

  Max Moore, Executive Director, Manufacturing & Operations, Ionis Pharmaceuticals, lays down a challenge to certain drug developers and manufacturers: Try to find a better scientific or economic outcome for bulk API production than lyophilization. He says you won’t. Not if you consider outcomes correctly. (And by the way, expect a lot more of all kinds of “lyo" in your future.)

• CDMO-To-Hospital: A Direct Ending For Generic Shortages?

  8/15/2019

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

• Bury The Hatch-Waxman: Generics Were Not The Answer

  8/5/2019

  The hypothesis is bold: Our emphasis on generics is a detriment to U.S. patients and the entire healthcare system. Instead, these past decades we should have focused intently on increasing the life cycle and distribution of innovator drugs.

• What If Our Generics Strategy Has Been All Wrong?

  7/30/2019

  What if we’ve been going at this all wrong for decades? If generics – and biosimilars – are not a sound solution for patients, hospitals, healthcare systems, governments, pharmaceutical companies, or CDMOs, when it comes to all parties profiting from the miracles of our best drugs? Part one in our investigative series.

• This Biotech Failed At Outsourcing: Here's How You Succeed Instead

  7/24/2019

  It's the immutable law: You can have good, you can have cheap, and you can have fast, but you can only have two together. However, when it comes to drug development outsourcing, veteran biopharma executive Robert Discordia has a “magic” formula of sorts. He presented it at this year’s Outsourced Pharma Boston conference.