ARTICLES BY LOUIS

• Small Or Large Molecule: Unifying Essentials For Development

  4/10/2023

  One startup. Two assets – the first a small molecule (SM); the second a biologic. Both assets are being developed via a fully outsourced strategy – the first is in China; the other Europe. It adds up to an informative discussion on outsourcing with Context Therapeutics CEO, Martin Lehr.

• ChatGPT Wrote This Editorial

  4/6/2023

  How could I resist? I just had to direct ChatGPT to do this: “Please write an editorial on drug development and manufacturing outsourcing in the style of Louis Garguilo, Chief Editor of Outsourced Pharma (OutsourcedPharma.com).” Here's what I got back.

• CDMOs And Hospitals Pursue Cures For Rare Disease

  4/3/2023

  A child is diagnosed with an ultra-rare disease. No biotech or pharma is interested in developing a gene therapy for the condition. In this final of our 3-part narrative, we learn how and where the INADcure Foundation found some help.

• A CDMO's Mission For The Pursuit Of Rare Diseases

  3/27/2023

  I understand why the INADcure Foundation, led by co-founder and mother of a daughter with Infantile Neuroaxonal Dystrophy, selected its CDMO … but why would a CDMO select the foundation as a customer? I spoke to the CEO to find out.

• A Mother Picks A CDMO To Advance Treatment For Her Daughter

  3/20/2023

  Until her daughter was diagnosed with Infantile Neuroaxonal Dystrophy (INAD) in 2016, Leena Panwala had been content with her life as a new mom, and selling real estate as a profession. Today, she’s co-founder and president of INADcure Foundation, and outsourcing a novel gene therapy. 

• Women Rising In Biotech

  3/13/2023

  Recent studies show women in the pharma industry represent 61% of the workforce, considerably higher than other industries. However, the percentage of female leaders is significantly lower. I spoke to an up-and-coming professional about this.

• A Third Model For Outsourcing Development And Manufacturing

  3/8/2023

  Biopharma organizations are often counseled to consider the strategy of “mirroring” your outsourcing activities. But what if this were the other way around – your CDMO effectively mirrored your organization? It’s an idea come to life via a partnership development management organization (PDMO) in Aguadilla, Puerto Rico.

• Lentiviral Vectors And The Island Of Partnerships

  3/1/2023

  You need lentiviral vectors. Apparently, so do a lot of others. Demand for lentiviral vectors is estimated to surge at a compound annual growth rate (CAGR) of 11.4 % until 2032. I’ve learned of a location where you can grab some capacity – and related CGT services.

• Moderna And The Building Of Bridge Facilities

  2/27/2023

  In August of 2021, relatively overlooked because of other news swirling around our industry, Moderna became the anchor client in a new cleanroom on demand housed in a bridge facility in Massachusetts. In retrospect, it may have legitimized a new era in outsourcing.

• 6 CDMO Selection Tips From An Experienced Start-Up

  2/20/2023

  Does your process to select a CDMO emerge from within and without? Ryan Crisman, cofounder and Chief Technical Officer, Umoja Biopharma, Inc., says it should. And he's learned that from a wise consultant that became his full-time employee. Here are their 6 tips to successful CDMO partnerships.