ARTICLES BY LOUIS

• Rocketing Expectations For CDMOs

  6/5/2023

  “I look forward to a world of gene therapy where the CDMO and biotech models are integrated. I don't know how that happens... How do we integrate further so we can work together earlier and more effectively?” A discussion with an industry leader and CEO.

• Outsourcing From the Empire State Building

  5/30/2023

  “Biotechs must deliver on high expectations with minimal spend. That’s the job description” says Gaurav Shah, M.D., co-founder, CEO, Rocket Pharma, a late-stage gene-therapy company formed in 2015. Fulfilling that description depends in part on where you choose to operate, and with whom.

• A Decline In Cell And Gene Therapy Outsourcing?

  5/22/2023

  Less outsourcing in the cell and gene therapy space? That would grab your attention, whether directly involved in CGT or not. I unfurled this vignette within a report from my colleagues at ISR Reports. They also gave me a hand in understanding the data.

• Small Molecules And The Arc Of Time

  5/15/2023

  “I've been trained, and doing the same stuff since I was 25. The same experiments for 50 some years, a long time. I guess you could call what I am describing as the arc of time for small molecules,” says Kintara Therapeutics cofounder and CSO Dennis Brown.

• Large Balloons Over America, Small Molecules In China

  5/8/2023

  Coinciding with U.S. and China relations continuing to deflate, but with no premeditated intention, my discussion with President and CEO of Kintara Therapeutics, Robert E. Hoffman, and CSO Dennis Brown, focused on the role of China-based CDMOs.

• Is Technology The New Science Of Outsourcing?

  5/4/2023

  That’s the abstruse thought with which I left the 2023 CDMO Leadership Awards ceremony in Manhattan. I’ve subsequently tried to sort this out by referring back to a series of interviews I did with CDMO leaders at the event. I think now I can explain this to readers. 

• 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.