ARTICLES BY LOUIS

• If You're Outsourcing, Your CTO Probably Needs A Hug

  3/7/2022

  You might want to check in on your Chief Technology Officer. “They’re at the center of the storm,” says a biopharma-industry consultant focused on the modern-day CTO. The role has become critical to a company’s success, impacts across the enterprise, and has become highly pressurized.

• Just In Case of War: Back-Integrated Outsourcing

  3/4/2022

  Pandemics, now war. Based on comments from Scott Zook, Primmune Therapeutics, Chief Editor Louis Garguilo analyzes impacts, possible reactions, and particularly de-risking strategies for our development and manufacturing outsourcing industry.

• Big CDMOs Back On Emerging Biopharma Radar

  2/28/2022

  Are established CDMOs making a new play for emerging biopharma customers? COVID-19 induced supply-chain dynamics (and pricing) had Big CDMO concentrating on different customers, providing opportunities for emerging service providers. But once again, we’re sensing the winds of change. 

• Outsourcing Also Starts With the Patient

  2/21/2022

  Whether you develop and manufacture your drug or therapy in-house or at CDMOs, decisions start with patients. This report provides details such as "the ratio of the incidence to prevalence of patients for a given disease" is a calculation for capital expenditures, including to build a manufacturing facility. 

• How Do You Define Manufacturing?

  2/14/2022

  When an executive at a cell-therapy company talks about ‘manufacturing,’ is it the same animal as when an executive of a small-molecule company uses the word? Bone Therapeutics CEO Miguel Forte says, "You can talk about small molecules, biologics, cell therapy ... but manufacturing must always mean the same thing."

• When Outsourcing Fails All Of Us

  2/10/2022

  Sometimes, emerging biopharma – founded by accomplished scientists and professionals – can’t find a CDMO to help them scale up for clinical trials. Even though the compounds are backed by extensive research and test results. This can impact all of us - particularly when the disease target is a threat to human survival.

• 2 Outsourcing Market Reports: It's A 50-50 Split With Internal Capabilities

  2/8/2022

  Two reports suggest we are an industry with equal parts internal capabilities vs. outsourcing for our drug development and manufacturing programs. Smaller biopharma may want to look to established pharma for clues on managing this even hybrid.

• “Nobody Should Work Alone”: An Outsourcing Philosophy

  1/31/2022

  Miguel Forte, CEO, Bone Therapeutics, thinks I’m overly bifurcated in my approach to outsourcing development and manufacturing. “It's interesting that everything is a combination of internal and external,” Forte says. Outsourcing is not an equation of “what we do vs. what they do”; it’s complimentary over contrasting. He’s got quite the example. 

• Cell-Therapy Outsourcing And The Flip Of A Coin

  1/24/2022

  “Heads” and external partners are extraordinary enablers, providing access lanes to expertise, technologies and facilities. “Tails” and find your development programs on-ramping a clogged freeway with few service stops offering the specific assistance you need to complete your development journey.

• “Nick And the Cocoons”: Automation for Autologous Therapies

  1/18/2022

  We’ve dispensed somber analysis on a lack of assistance from established CDMOs for cell and gene therapy developers. The critique particularly emanates from those pursuing autologous-cell or other precision-medicine approaches.  Time to give CDMOs taking the incoming criticism a chance to respond.