ARTICLES BY LOUIS

• May I Present, The Consultant

  5/1/2023

  We’ve been investigating the importance of consultants for outsourcing assistance. It’s time to get personal. How much value-addition and experience can one individual bring to your outsourcing operations, and your odds of success?Allow me to present exhibit one: Antkisha Joshi.

• Your Consultants, Your Destiny

  4/24/2023

  Chief Editor Louis Garguilo has been doggedly pursuing this hypothesis with biopharma professionals: Consultants have become more important than ever. His resulting correspondences shed light on the role of consultants, and also on where we are as a development and manufacturing outsourcing community.

• Create A Quality-System Plan Before Outsourcing

  4/20/2023

  A first piece of advice for those companies outsourcing to CDMOs: Create and have firmly in place your own quality-system plan. And it doesn't matter if you're a virtual company, says Antiksha Joshi, a quality management systems professional. Do this before approaching those potential partners. 

• Check The Rolodex: China For Steroids, Europe For Biologics

  4/17/2023

  Part 2 of our discussion with Philadelphia-based Context Therapeutics CEO Martin Lehr, in which he shares his Rolodex and some intriguing outsourcing advice for both biologics and small molecules, both a part of his pipeline.

• 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.